class iii canadian license application and documentation
DESCRIPTION
Canadian License Application for class III patient monitoring deviceTRANSCRIPT
ATREBLA Monitor
Canadian License Application
TABLE OF CONTENTS
1. Application form………………………………………………………………………………………………………………1
2. Quality Management System Certificate………………………………………………………………………….9
3. Design Philosophy……………………………………………………………………………………………………………10
4. Marketing History……………………………………………………………………………………………………..…….13
5. Biocompatibility statement……………………………………………………………………………………………..15
6. ATREBLA Monitor Supplies and Accessories Canadian License Summary………………………. 17
7. Canadian Standards Summary……………………………………………………………………………………….. 18
8. Declaration of Conformity to Health Canada recognized standards………………………………. 20
9. Safety and Effectiveness Summary Table………………………………………………………………………. 23
10. ATREBLA Monitor Components and Interfaced devices Summary ………………………………… 32
11. Supportive documentation……………………………………………………………………………………………. 34
12. References………………………………………………………………………………………………………………………35
NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM (disponible en français)
New Class III (April 2014) For Therapeutic Products Directorate use
Device Licence Application No._______________ -1-
Before completing this form, you must consult the document guidance for Industry – How to Complete the Application for a New Medical
Device Licence (available on the website).
1. NAME OF THE DEVICE (as it appears on the label) ATREBLA Monitor
2. MANUFACTURER INFORMATION (as it appears on the label) Contact Name and Title: Mary Doe, Manufacturing Production Manager
Company ID (if known):
Company Name: Tiger Technology, Inc. Telephone: 555-111-5555
Fax: 555-111-5557
E-mail: [email protected]
Street: Canada Drive
Suite: #99
P.O. Box:
City: Big City
Province/State: Michigan
Country: USA
Postal/Zip Code: 99999
3. REGULATORY CORRESPONDENT INFORMATION Same as Manufacturer Other (specify below) Contact Name and Title: Manasa Survi, Regulatory Correspondent
Company ID (if known):
Company Name: Tiger Technology Telephone: 888-888-8888
Fax: 888-888-8889
E-mail: [email protected]
Street: Wall street
Suite: #99
P.O. Box:
City: Boston
Province/State: Massachusetts
Country: USA
Postal/Zip Code: 02020
4. INVOICIN INFORMATION Same as Manufacturer Same as Regulatory Correspondent Other (specify below) Contact Name and Title: Brian Doe, Billing Contact
Company ID (if known):
Company Name: Tiger Technology, Inc. Telephone: 555-111-5555
Fax: 555-111-5557
E-mail: [email protected]
Street: Canada Drive
Suite: #99
P.O. Box:
City: Big City
Province/State: Michigan
Country: USA
Postal/Zip Code: 99999
5. QUALITY MANAGEMENT SYSTEM CERTIFICATE (ensure that certificate is attached)
Quality Management System Certificate Number: SM 14343 Name of Registrar: Reg Blake
6. ATTESTATIONS I, as a senior official of the manufacturer named in Item 2 of this application, hereby attest that I have direct knowledge of the items checked above
and declare that these identified statements are true and that the information provided in this application and in any attached documentation is
accurate and complete.
I, as a senior official of the manufacturer named in Item 2 of this application, hereby attest that I am also providing the information and documents
set out in Part 1, section 32(3) of the Medical Devices Regulations.
Where a person is named in Item 3 of this application, I hereby authorize that person to submit this application to the Minister on my behalf. I
further authorize the Medical Devices Bureau to direct all correspondence relating to this application to the person named in Item 3 of this
application.
Name: ______ Mary Doe ____________________________ Title: __ Manufacturing Production Manager _________
Signature: _______ Mary Doe ____________________________ Date: _______06/22/2014_________________________
NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM (disponible en français)
New Class III (April 2014) For Therapeutic Products Directorate use
Device Licence Application No._______________ -2-
7. PURPOSE/INTENDED USE OF DEVICE: A description of the medical conditions, purposes and uses for which the device is manufactured, sold
or represented [Note: Failure to supply an appropriate level of detail may result in the application not being accepted for review.]
The device ATREBLA Monitor is indicated for physiological patient monitoring. The monitor is used to monitor a variety of parameters including ECG,
Oxygen and the electroencephalogram (EEG) signal from the brain in adult patients.
The device is for use in a hospital and clinics under the supervision of physician.
The ATREBLA Monitor uses standard EEG electrodes (Class II Canadian license 88888), EEG lead sets (Class II Canadian license 88889), ECG electrodes
(Class II Canadian license 93334), ECG lead sets (Class II Canadian license 93333) and also oxygen sensors (Class II Canadian license 93344), all of
which have been previously licensed by Health Canada.
The ATREBLA Monitor meets the definition of an active device as per Rule 8 (1) under Part 1 MEDICAL DEVICES OTHER THAN IN VITRO
DIAGNOSTIC DEVICE of Schedule 1 CLASSIFICATION RULES FOR MEDICAL DEVICES. An active device is a “device intended to emit ionizing
radiation, including any device or software intended to control or monitor such a device or directly influence its performance, is classified as Class III. So,
the device ATREBLA Monitor is a Class III device.
8. LICENCE APPLICATION TYPE (check one only) Single device
Test kit
Medical device Group
System
Medical device family
Medical device Group family
9. PLACE OF USE Is this device sold for home
use?
Is this device an IVDD?
Yes No
Yes No
Is this device used at a point of care, such as a pharmacy, bedside, or healthcare
professional=s office? (In Vitro Diagnostic Devices [IVDD] ONLY)
Yes No
10. MEDICAL DEVICES CONTAININ DRUGS
10.1 Non-IVD Devices Containing Drugs
If the device contains a drug and is not an IVDD, indicate the Drug Identification Number (DIN) or the Natural Product Number (NPN) and complete the
information listed below. If the drug does not have a DIN or NPN, please provide the Drug Establishment Licence (DEL) number of the company from where
the drug is sourced.
Brand / Trade Name of Drug: DIN/NPN:
Active Ingredient(s):
Drug Manufacturer:
DEL Number:
10.2 IVDD Test Kits containing Controlled Substances
If this device is an IVDD test kit containing a substance listed in Schedule I, II, III, or IV of the Controlled Drugs and Substances Act, complete the section
below.
Is this an IVDD Test Kit containing a controlled substance? Yes No
Test Kit Number (T.K. Number):
Please note: The manufacturer will need to contact the Office of Controlled Substances to obtain a T.K. Number if one has not yet been issued.
11. DEVICE HISTORY Has this device been previously authorized for sale in Canada under the Investigational
Testing or Special Access provisions of the Medical Devices Regulations?
Yes No
If yes, provide the authorization number or the device identification number:
NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM (disponible en français)
New Class III (April 2014) For Therapeutic Products Directorate use
Device Licence Application No._______________ -3-
12. IDENTIFIER OF DEVICE (include a device identifier for each device or medical device group listed and indicate (by a check mark) if it contains
≥ 0.1% w/w of Di (2-Ethyl hexyl) Pthalate [DEHP] or is manufactured from raw materials containing or derived from bisphenol A [BPA]) Name of device, components, parts and/or accessories as per product label
Identifier for
device (bar code,
catalogue, model
or part number)
DEHP BPA Preferred Name
Code
(FOR HEALTH
CANAD USE
ONLY) ATREBLA Display
Cat. No: AD1000
ATREBLA Keyboard
Cat. No: AD2000
ATREBLA Frame
Cat. No: AD3000
ATREBLA EEG Measurement Module
Cat. No: AD4000
ATREBLA Oxygen Measurement Module
Cat. No: AD4100
ATREBLA ECG Measurement Module
Cat. No: AD4200
ATREBLA software version 2.0
Cat. No: SW2000
NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM (disponible en français)
New Class III (April 2014) For Therapeutic Products Directorate use
Device Licence Application No._______________ -4-
13. COMPATIBILITY OF INTERDEPENDENT DEVICES: For a Class III medical device intended to be used with another Class II, III, or IV device,
provide a list of all medical devices that this device is intended to be used or function with, including their medical device licence number. See
Notice to Industry – Licensing Requirements of Interdependent Medical Devices (April 30, 2002) available on the website. (For a complete list of
licenced medical devices, refer to: www.mdall.ca) Name of compatible device
Licence Number
Tiger Tail Network
99999
Tiger Tail Monitor
99991
14. LIST OF RECONIZED STANDARDS COMPLIED WITH IN THE MANUFACTURE OF THE DEVICE:
Please answer AYes@ to one, and only one, of the following. The medical devices subject to this application conform with Recognized Standards as set out in the guidance
Document on Recognition and Use of Standards under the Medical Devices Regulations, which is available on
the website.
Yes No
If yes, I am including with this application Declarations of Conformity that the medical device(s) comply with the following Recognized Standards:
IEC 60601-1:2005-Ed.3.0
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006
IEC 60601-1-2:2007-Ed.3.0
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic
compatibility – Requirements and testing
IEC 60601-2-26:2012-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of electroencephalographs- Edition
3.0
IEC 60601-2-27:2011-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring
Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012
The medical devices subject to this application DO NOT conform with Recognized Standards but meet an
equivalent or better standard.
Yes No
If yes, I am including detailed information proving that the device(s) meet the following equivalent or better standards:
The medical devices subject to this application DO NOT conform with Recognized Standards, NOR do they
meet an equivalent or better standard, but I am including detailed information as evidence of the safety and
effectiveness of these devices.
Yes No
NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM (disponible en français)
New Class III (April 2014) For Therapeutic Products Directorate use
Device Licence Application No._______________ -5-
15. REVIEW DOCUMENTS – Indicate () which documents listed below are included as attachments to this application. For details regarding content
and format, you are requested to consult the guidance Document – Preparation of a Premarket Review Document for Class III and Class IV Device
Licence Applications (available on the website).
Executive Summary
Table of contents
Background, which includes Device Description, Design Philosophy, and Marketing History
Summary of Safety and Effectiveness Studies, which includes List of Standards, Method of Sterilization, Summary of Studies, and
Bibliography
Near Patient Diagnostic Device Testing Results (if applicable)
Labelling material
16. REVIEW FEES FOR LICENCE APPLICATIONS
The fees for the review of licence applications or requests for the reinstatement of a licence are shown below. For further information on the applicable fees,
refer to the guidance Document - Fees for the Review of Medical Device License Applications
Category Fee
Class III - Licence application
$5,361
Class III - Licence application for a near patient
in vitro diagnostic device
$9,127
17. FEE FOR LICENCE APPLICATION Enter the appropriate fee in box 17.1
Do not send payment with the licence application. Health Canada will send out an invoice for the amount due.
17.1
$5,361CAD
18. DEFERRED PAYMENT: If a manufacturer has not completed its first fiscal year on the day that the medical device licence application is
submitted, the manufacturer will be granted a one-year deferral of payment from the day the application is submitted. The deferral will also
be applicable to fees associated with a licence amendment for the medical device that become payable within that one-year period. In order
to qualify for the deferral period, a statement signed by the individual responsible for the manufacturer’s financial affairs specifying
the commencement date of the fiscal year must be submitted with the application. At the end of the one-year period, the manufacturer
must pay all of the applicable fees. Please indicate if the applicant is applying for a deferred payment: □ A deferred payment is requested
CURRENCY: The dollar ($) amounts on this form refer to Canadian dollars. All payments must be made in Canadian Dollars.
NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM (disponible en français)
New Class III (April 2014) For Therapeutic Products Directorate use
Device Licence Application No._______________ -6-
19. FEE REMISSION
19.1 Eligibility for Remission and Necessary Documentation When applying for a fee remission, the necessary documentation must accompany the licence application. Failing to do so will result in the rejection of
the fee remission application.
In order to be eligible for a remission, the anticipated gross revenue must be less than $100,000, and the full fee, as indicated in box 17.1 above, must be
greater than 2.5% of the anticipated gross revenue from sales of the medical device in Canada during the fee verification period. For the purposes of fee
remissions, the fee verification period is the period beginning on the date that the medical device is first offered for sale in Canada and ending two years after
that date.
Necessary Documentation:
(1) The applicant must provide a statement signed by the individual responsible for the applicant’s financial affairs indicating that the anticipated gross
revenue during the fee verification period is $100,000 or less, and certifying that the fee indicated in box 17.1 above is more than an amount equal to 2.5% of
the anticipated gross revenue.
(2) The applicant must present information to establish that the applicable fee is greater than 2.5% of the anticipated gross revenue from sales of the medical
device in Canada during the fee verification period. The information should provide an accurate measure of the current market situation for the proposed
product. Information to support the anticipated revenue should include as a minimum:
marketing plan/product plan for the medical device;
sales history prior to product upgrades or sales history of similar products;
estimated market share (that is [i.e.], product’s market potential compared to the total market for similar products in Canada);
average sale price and demand; and
comparison to similar products on the Canadian market or other similar markets (for example [e..], United States, European Union, etc.)
The calculation for the applicable fee following remission is as follows:
Anticipated gross revenue for this medical device during the fee verification period _____$CAN (A) (if amount is less than $100,000)
2.5% of amount (A) = $ _____ = Applicable fee
Refer to the Guidance Document - Fees for the Review of Medical Device Licence Applications for further information on fee remissions.
19.2 Application for Fee Remission
Enter the anticipated gross revenue for this medical device during the fee verification period in box 19.1 19.1
Enter 2.5% of amount in box 19.1 in box 19.2 19.2
Enter $55 processing fee in box 19.3 19.3
Total fee to be paid: Enter the sum of boxes 19.2 and 19.3 in box 19.4 19.4
20. METHOD OF PAYMENT (check method)
MasterCard / Visa / American Express (AMEX) Cheque Money order International bank draft
Payment using existing credit Wire
21. PAYMENT BY CREDIT CARD Company=s Full (Leal) Name:
Application Name (e.., product name, file
name): Credit Card: Visa MasterCard AMEX
Credit Card Number (full number):
Credit Card Valid Date:
Credit Card Expiry Date:
Cardholder’s Name and Address: Street: City:
Province/State:
Country:
Postal/Zip Code:
Cardholder’s Telephone Number (including country and area codes):
NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM (disponible en français)
New Class III (April 2014) For Therapeutic Products Directorate use
Device Licence Application No._______________ -7-
22. PAYMENT BY CHEQUE / MONEY ORDER / INTERNATIONAL BANK DRAFT
Cheques, money orders or international bank drafts must be made payable to the “Receiver general for Canada”. All cheques are to be in Canadian funds
drawn from a Canadian Bank. Cheques drawn from non-Canadian banks MUST be issued in coordination with a referenced Canadian bank (that is [i.e.],
referenced on the cheque), otherwise they are NOT ACCEPTED.
23. PAYMENT BY WIRE Company’s Full (Legal) Name:
Application Name (e.., product name, file name):
Name of Originator Bank:
Date Funds Wired:
Amount of Funds Wired (Canadian $):
Transaction Receipt Included (must attach)
Wire payments of fees will be accepted only when wired to:
$ The Bank of Nova Scotia, Toronto Business Service Centre, 40 Kin St., West, Toronto, Ontario, Canada, M5H 1H1
$ SWIFT code: NOSCCATT
$ Institution number: 002
$ Transit number: 47696
$ Beneficiary Name: HEALTH CANADA – CFOB (Department Name)
$ Account number: 476961242210*(please ensure 12 digit #)
$ Description Field: Authorization Number: 022-22879 (please ensure 8 digit # is provided)
Please remit payments in CANADIAN FUNDS only. All other currencies will be rejected.
Note that the wire standards used in Canada offer 4 lines of description fields, each with a maximum of 35 characters. For customer identification and ease of reconciliation, it is
recommended that you also request that your customers input other pertinent information in these fields, e.g. invoice number, payment period, contact information. Please be
aware that wires are often passed through intermediary financial institutions, especially in the case of wires originated outside of Canada, and it is possible that details within the
description fields might be truncated.
Note that your bank may deduct a fee for this service which may then result in an unexpected balance owing. You must ensure that all service charges are covered by
your payment. For further information on wire payment, contact Accounts Receivable at tel. 1-800-815-0506 or (613) 957-1052 or via e-mail at [email protected].
24. PAYMENT USIN EXISTIN CREDIT (attach to the application a copy of the most recent statement) Account # Containing Credit:
Account Owner=s Name:
Existing Credit Amount:
Total Device Licence Application Fee: $
Portion of Device Licence Application Fee to be Paid for by Credit:
$
Remainder of Fee to be Paid by Another Method (check one of the methods above, see Items 21 to
24):
$
CREDITS: Overpayment of fees will be automatically credited to account. Refunds of credit balances must be requested in writing by the account owner and
must be on company letterhead. Address: Health Canada, Accounts Receivable, P/L 3203B, Room B350 Ottawa, Ontario, K1A 0K9, Canada.
LICENCE APPLICATION DISCLOSURE REQUEST
NEW CLASS III MEDICAL DEVICE LICENCE APPLICATION FORM (disponible en français)
New Class III (April 2014) For Therapeutic Products Directorate use
Device Licence Application No._______________ -8-
As you are aware, Health Canada is striving to add transparency to the medical device review process. One area we
would like to address is the requests from interested parties regarding whether or not a licence application has been
received by the Medical Devices Bureau (MDB).
The purpose of this form is to request your signed authorization - in advance - if we receive such a request, to disclose
the date on which a licence application has been received by the MDB. No other information would be supplied.
Please indicate your consent by completing this form and sending it with your application for a new medical device
licence, or any time after a licence has been granted.
Disclosure Statement: In the case where the Medical Devices Bureau (MDB) has received requests concerning the status of the new licence
application, amendment application, or fax-back application for (enter device name)
______________________________________________________________________________________________
from interested parties,
□ this certifies that (enter the manufacturer's name)_________Tiger Technology Inc. _______________
has no objection to the disclosure to the requester, by the MDB, of the date when an application for the
device entered above, has been received by the MDB
□ this certifies that (enter the manufacturer's name)_________ Tiger Technology Inc. ________________
objects to the disclosure to the requester, by the MDB, of the date when an application for the device
entered above, has been received by the MDB
In accordance with the Access to Information Act, confidential, third party information will not be disclosed without
your expressed consent.
Mary Doe Manufacturer's authorized signing official
Application forms should be sent to:
Device Licensing Services Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
2934 Baseline Road
Address Locator: 3403A
OTTAWA, Ontario K1A 0K9
Phone: (613) 957-7285
Facsimile: (613) 957-6345
E-mail: [email protected]
CERTIFICATE
OF REGISTRATION QUALITY MANAGEMENT SYSTEM – ISO13485: 2003 CMDCAS CERTIFICATE
This is to certify that:
Tiger Technology, Inc.
99 Canada Drive
Big City
Michigan
99999
USA
Holds Certificate No: SM 14343
and operates a Quality Management System which complies with the requirements of ISO13485: 2003
for the following scope:
The design and manufacture of devices for use in patient monitoring, use of medical electrical
equipments, oxygen measuring devices, electrocardiographic monitoring equipments,
electroencephalographs and software components.
For and on behalf of BSI:
Reg Blake
Vice President BSI Management Systems America, Inc.
Originally Registered: 02/12/2012 Expiry Date: 02/12/2015
This certificate remains the property of BSI and shall be returned immediately upon request.
CMDCAS Recognized
Registrar
TIGER TECHNOLOGY INC
ATREBLA Monitor
Canadian Design Philosophy
Document Change History
Date Owner Change History
June 15, 2014 Manasa Survi Original Release
Product Comparison:
ATREBLA Monitor is a new patient monitoring device interfaced to the Tiger Tail Network (Canadian
license 99999) and Tiger Tail Monitor (Canadian license 99991) devices manufactured by Tiger
Technology Inc. The main predicate device used for ATREBLA Monitor is the Widget 2008 (Canadian
license 98464).
ATREBLA Monitor is indicated for physiological patient monitoring. The monitor is used to monitor a
variety of parameters including ECG, Oxygen and the electroencephalogram (EEG) signal from the brain
in adult patients.
The device is for use in a hospital and clinics under the supervision of physician.
The monitor uses standard EEG scalp surface electrodes and lead sets (Note: These electrodes are
placed on the head and the wires that connect them to the EEG Measurement module) that have been
previously licensed separately (EEG leads Class II Canadian license: 88889, EEG electrodes Class II
Canadian license: 88888).
In addition, the ATREBLA monitor uses ECG electrodes and lead sets (Note: These are the electrodes
placed on the chest and the wires that connect them to the ECG measurement module) that have been
previously licensed separately (ECG leads Class II Canadian license: 93333, ECG electrodes Class II
Canadian license 93344).
The ATREBLA monitor uses an O2 sensor (Note: This is the sensor placed in the patients breathing tube
and connects to the OXYGEN measurement module) previously licensed separately (O2 Sensor Class II
Canadian license: 93344).
Table 1: Differences and similarities between the ATREBLA Monitor and the predicate-Widget 2008
(Canadian license no. 98464).
Specifications ATREBLA Monitor Predicate- Widget 2008 Differences between ATREBLA Monitor and
Widget 2008
EEG Frequency range 5-15 Hz 5-19 Hz The frequency range for ATREBLA Monitor is slightly less than the
predicate Widget 2008
Operational Temperature range
-15 to 115 degrees F -20 to 110 degrees F The new ATREBLA Monitor is more
effective operating at slightly higher
temperature range than the predicate Widget
2008
O2 measurement range 0-21% 10-21% The ATREBLA Monitor has higher oxygen
measuring range than the predicate device
Power 110V at the rate of 50-60 Hz
110V at the rate of 50-60 Hz
Power is the same for both ATREBLA Monitor
and Widget 2008
Display 19 inches color display 19 inches color display Display is similar for both ATREBLA Monitor
and Widget 2008
Humidity range 15-90% 15-90% ATREBLA Monitor and the predicate Widget 2008 both work in the same humidity range
EEG leads displayed at once
Up to 10 Up to 10 EEG leads displayed is the same for the new ATREBLA Monitor and the predicate device
Widget 2008
Keyboard Hospital grade Hospital grade Keyboard is similar for both the ATREBLA Monitor and the
predicate Widget 2008
TIGER TECHNOLOGY INC
ATREBLA Monitor
Marketing History
Document Change History
Date Owner Change History
June 15, 2014 Manasa Survi Original Release
Table of Contents
Document Change History
1. Special Access requests
2. Regulatory Approvals
3. Number of units sold
4. Summary of reported problems and recalls
1. Special Access requests
No special access requests have been made for the device ATREBLA Monitor.
2. Regulatory Approvals
The ATREBLA Monitor system has been sold for more than 3 years in the following countries.
Table1: Current regulatory approvals for the ATREBLA Monitor are:
Country License Application Information
USA ATREBLA Monitor 510(k) number is K088706
South Africa License number for ATREBLA Monitor is 12ADR456
Australia ATREBLA Monitor was included in the ARTG and the inclusion
number is 23456
Sweden, France &
United Kingdom
Declaration of Conformity was signed on August 18, 2010
Canada Application for new Class III medical device submitted for ATREBLA
Monitor is pending
3. Number of units sold
Until today, 800 units were sold worldwide and are listed.
Table2: Number of units sold in the countries worldwide:
Country Units sold
USA 320
South Africa 40
Australia 80
Sweden 120
France 120
United Kingdom 120
Total 800
4. Summary of reported problems and recalls
There has been one recall of the ATREBLA monitor ATREBLA software version 1.0 Cat. No:
SW1000 since sales have started. It has been replaced by ATREBLA software version 2.0 Cat.
No: SW2000. There were 4 safety complaints concerning a software malfunction causing false
high O2 readings when using ATREBLA software version 1.0 Cat. No: SW1000. There have been
no safety complaints using ATREBLA software version 2.0 Cat. No: SW2000.
TIGER TECHNOLOGY INC
ATREBLA Monitor
Biocompatibility Statement
Document Change History
Date Owner Change History
June 15, 2014 Manasa Survi Original Release
Table of Contents
Document Change History
Biocompatibility ATREBLA Monitor
Biocompatibility ATREBLA Monitor
The ATREBLA Monitor is not in contact with the patient.
There are no new patient supplies and accessories for ATREBLA Monitor. All the supplies and accessories
used along with ATREBLA Monitor are previously licensed by Health Canada and shown in the document
below enclosed with this submission.
DOC123456789: ATREBLA Monitor Supplies and Accessories Canadian License Summary.
TIGER TECHNOLOGY INC
ATREBLA Monitor
DOC123456789: ATREBLA Monitor Supplies and Accessories Canadian License Summary
Table1: Description of the accessories and supplies, Canadian license number and their classification,
these accessories are used along with ATREBLA Monitor.
The Oxygen sensor, EEG and ECG lead sets and electrodes used are previously licensed by Health Canada
separately.
Accessories and Supplies Class Canadian License Number
EEG leads II 88889
EEG electrodes II 88888
ECG leads II 93333
ECG electrodes II 93334
Oxygen Sensor II 93344
TIGER TECHNOLOGY INC
ATREBLA Monitor
Canadian Standards Summary
Document Change History
Date Owner Change History
June 15, 2014 Manasa Survi Original Release
Table of Contents
Document Change History
Canadian Standards Summary
Canadian Standards Summary
The device ATREBLA Monitor meets the following Canadian Standards:
a) IEC 60601-1:2005-Ed.3.0
Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006
b) IEC 60601-1-2:2007-Ed.3.0
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential
performance- Collateral standard: Electromagnetic compatibility – Requirements and testing
c) IEC 60601-2-26:2012-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential
performance of electroencephalographs- Edition 3.0
d) IEC 60601-2-27:2011-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential
performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-
Ed.3.0/Cor.1:2012
In addition to that, ATREBLA Monitor also meets International Standards for medical devices.
a) ISO13485:2003 Medical devices-Quality management systems- Requirements for regulatory
purposes
b) ISO 14971:2007 Medical devices – Application of risk management to medical devices
Revised Date: 2006/09/11
1
Declaration of Conformity
Name of the medical device as it appears on the label: ______ATREBLA Monitor_____
Name of the Manufacturer of the medical device: ____Tiger Technology, Inc. _______
1. List of recognized standard(s) applicable in part or in whole to this Medical
Device:
In the case where only specific parts or Sections of a recognized standard apply to the
device, Sections 2 through 7 must be completed.
In the case where all parts and Sections of a recognized standard apply to the device,
Section 5 through 7 must be completed.
2. In the case where only specific parts or Sections of a recognized standard apply to
the device, note the requirements that are not applicable to the medical device:
Recognized Standard(s) Inapplicable Requirements of the Recognized
Standard
Full name of Standard(s) as stated on the TPD Recognized Standards List
IEC 60601-1:2005-Ed.3.0
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-
1:2005-Ed.3.0/Cor.1:2006
IEC 60601-1-2:2007-Ed.3.0
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance- Collateral
standard: Electromagnetic compatibility – Requirements and testing
IEC 60601-2-26:2012-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of
electroencephalographs- Edition 3.0
IEC 60601-2-27:2011-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of
Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012
DEMONSTRATION OF CONFORMITY WITH RECOGNIZED STANDARDS
TO SATISFY THE SAFETY AND EFFECTIVENESS REQUIREMENTS OF
THE CANADIAN MEDICAL DEVICES REGULATIONS
Revised Date: 2006/09/11
2
3. In the case where only specific parts or Sections of a recognized standard apply to
the device, note the deviations from the recognized standard(s). For example: To
meet requirements of other Federal or Provincial legislation in Canada.
Name of Recognized Standard Deviation
4. In the case where a standard has been adapted, note the requirements of the
standard(s) have been adapted for application to this medical device. For example:
In the case of a standard that offers alternative methods, specify which method
has been followed.
Standard Adapted Section(s)
5. The medical device which was tested against the recognized standard(s) is
identical to the medical device intended to be marketed in Canada:
Yes □ No □
If the answer above is No, the difference(s) between the tested medical device and
the medical device intended to be marketed in Canada are as follows:
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
________________________
Given the difference(s) between the tested medical device and the medical device
intended to be marketed in Canada, the application of the recognized standard(s)
is justified for the following reason(s):
__________________________________________________________________
__________________________________________________________________
Revised Date: 2006/09/11
3
6. An independent testing laboratory or certification body was used to determine the
conformance of the medical device with the recognized standard(s):
Yes □ No □
If the answer to the above is Yes, the name and address of the testing laboratory
or certification body and their accreditations are as follows:
Name and Address of Testing Laboratory or
Certification Body
International, National or Provincial
Accreditations of the Testing Laboratory or
Certification Body
7. As a senior official of the manufacturer, having responsibility for the regulatory
compliance of the medical device with the requirements of the Canadian Medical
Devices Regulations and this Declaration of Conformity, I hereby declare that the
information I have provided in support of the safety and effectiveness of the
medical device to be true and accurate.
I also acknowledge that any false statement made with respect to the conformity
of the medical device with an applicable recognized standard(s), or a
determination by Health Canada that the medical device does not conform to the
requirements of the recognized standard(s), could result in the suspension of any
medical device license which has been issued for the medical device subject of
this Declaration of Conformity.
Name of Senior Official ___________Mary Doe________________
Title of Senior Official ________ Manufacturing Production Manager_
Signature of Senior Official __________ Mary Doe __________________
Date: ____________06/22/2014______________
TIGER TECHNOLOGY INC
ATREBLA Monitor
Safety and Effectiveness Summary
Document Change History
Date Owner Change History
June 15, 2014 Manasa Survi Original Release
Table of Contents
Document Change History
Safety and Effectiveness Summary Table
Table1: Safety and Effectiveness Summary Table:
Section number
Requirements Applicable (Yes/No)
Standard or Procedure
Proof of Conformity
10 A medical device shall be designed and manufactured to be safe, and to this end the manufacturer shall, in particular, take reasonable measures to (a) identify the risks inherent in the device; (b) if the risks can be eliminated, eliminate them; (c) if the risks cannot be eliminated, (i) reduce the risks to the extent possible, (ii) provide for protection appropriate to those risks, including the provision of alarms, and (iii) provide, with the device, information relative to the risks that remain; and (d) minimize the hazard from potential failures during the projected useful life of the device.
Yes ISO 13485 ISO 14971 ISO60601-1 ISO60601-1-2 ISO60601-2-26 ISO60601-2-27
ISO13485:2003 Medical devices-Quality management systems- Requirements for regulatory purposes
Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
IEC 60601-1:2005-Ed.3.0
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006
IEC 60601-1-2:2007-Ed.3.0
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility – Requirements and testing
IEC 60601-2-26:2012-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of electroencephalographs- Edition 3.0
IEC 60601-2-27:2011-Ed.3.0
Medical electrical equipment –
Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012
ATREBLA Risk analysis report
11 A medical device shall not, when used for the medical conditions, purposes or uses for which it is manufactured, sold or represented, adversely affect the health or safety of a patient, user or other person, except to the extent that a possible adverse effect of the device constitutes an acceptable risk when weighed against the benefits to the patient and the risk is compatible with a high level of protection of health and safety.
Yes ISO14971 ISO60601-1 ISO60601-1-2 ISO60601-2-26 ISO60601-2-27
Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
IEC 60601-1:2005-Ed.3.0
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006
IEC 60601-1-2:2007-Ed.3.0
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility – Requirements and testing
IEC 60601-2-26:2012-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of electroencephalographs- Edition 3.0
IEC 60601-2-27:2011-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC
60601-2-27:2011-Ed.3.0/Cor.1:2012 ATREBLA Risk analysis report
12 A medical device shall perform as intended by the manufacturer and shall be effective for the medical conditions, purposes and uses for which it is manufactured, sold or represented.
Yes ISO14971 ISO60601-1 ISO60601-1-2 ISO60601-2-26 ISO60601-2-27
Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
IEC 60601-1:2005-Ed.3.0
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006
IEC 60601-1-2:2007-Ed.3.0
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility – Requirements and testing
IEC 60601-2-26:2012-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of electroencephalographs- Edition 3.0
IEC 60601-2-27:2011-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012 ATREBLA Clinical trial report
13 During the projected useful life of a medical
Yes ISO14971
Medical devices – Application of risk management to medical
device, its characteristics and performance shall not deteriorate under normal use to such a degree that the health or safety of a patient, user or other person is adversely affected.
ISO60601-1 ISO60601-1-2 ISO60601-2-26 ISO60601-2-27
devices (ISO 14971:2007, Corrected version 2007-10-01)
IEC 60601-1:2005-Ed.3.0
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006
IEC 60601-1-2:2007-Ed.3.0
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility – Requirements and testing
IEC 60601-2-26:2012-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of electroencephalographs- Edition 3.0
IEC 60601-2-27:2011-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012 ATREBLA Mechanical and Environmental test report
14 The characteristics and performance of a medical device shall not be adversely affected by transport or conditions of storage, taking into account the
Yes ISO14971 ISO60601-1
Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
IEC 60601-1:2005-Ed.3.0
manufacturer’s instructions and information for transport and storage.
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006
ATREBLA Mechanical and Environmental test report
15 Reasonable measures shall be taken to ensure that every material used in the manufacture of a medical de- vice shall be compatible with every other material with which it interacts and with material that may come into contact with it in normal use, and shall not pose any un- due risk to a patient, user or other person.
Yes ISO14971 ISO60601-1
Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
IEC 60601-1:2005-Ed.3.0
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006
ATREBLA Risk analysis report
16 The design, manufacture and packaging of a medical device shall minimize any risk to a patient, user or other person from reasonably foreseeable hazards, including (a) flammability or explosion; (b) presence of a contaminant or chemical or microbial residue; (c) radiation; (d) electrical, mechanical or thermal hazards; and (e) fluid leaking from or entering into the device
Yes ISO14971 ISO60601-1
Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
IEC 60601-1:2005-Ed.3.0
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006
ATREBLA Mechanical and Environmental test report
ATREBLA Electrical Safety report
ATREBLA Device plate label
17 A medical device that is to be sold in a sterile condition shall be manufactured and sterilized under appropriately controlled conditions, and the sterilization method used
No -- Not a sterile device
shall be validated.
18 A medical device that is part of a system shall be compatible with every other component or part of the system with which it interacts and shall not adversely affect the performance of that system.
Yes ISO14971 ISO60601-1 ISO60601-1-2 ISO60601-2-26 ISO60601-2-27
Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
IEC 60601-1:2005-Ed.3.0
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006
IEC 60601-1-2:2007-Ed.3.0
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility – Requirements and testing
IEC 60601-2-26:2012-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of electroencephalographs- Edition 3.0
IEC 60601-2-27:2011-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012
ATREBLA Electromagnetic Compatibility test report
ATREBLA Clinical trial report
19 A medical device that Yes ISO14971 Medical devices – Application of
performs a measuring function shall be designed to perform that function within tolerance limits that are appropriate for the medical conditions, purposes and uses for which the device is manufactured, sold or represented.
ISO60601-1 ISO60601-1-2 ISO60601-2-26 ISO60601-2-27
risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
IEC 60601-1:2005-Ed.3.0
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006
IEC 60601-1-2:2007-Ed.3.0
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility – Requirements and testing
IEC 60601-2-26:2012-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of electroencephalographs- Edition 3.0
IEC 60601-2-27:2011-Ed.3.0
Medical electrical equipment – Part 2-26: Particular requirements for basic safety and essential performance of Electrocardiographic Monitoring Equipment – Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012
ATREBLA EEG Performance Report
20 If a medical device consists of or contains software, the software shall be designed to perform as intended by
Yes ISO14971
Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
IEC 60601-1:2005-Ed.3.0
the manufacturer, and the performance of the software shall be validated.
ISO60601-1
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006
ATREBLA Software Description, ATREBLA Software Specification and ATREBLA Software Test Summary Reports
ATREBLA Monitor Components and Interfaced devices Summary
ATREBLA Monitor consists of the following components:
ATREBLA Display, ATREBLA Keyboard, ATREBLA Frame, ATREBLA EEG Measurement Module,
ATREBLA Oxygen Measurement Module, ATREBLA ECG Measurement Module and ATREBLA
software version 2.0.
Table1: Components of ATREBLA Monitor:
Type of Component
Model Description Part/Catalogue Number
License application type according to Canadian Medical Device Regulation
ATREBLA
Display ATREBLA Display
displays continuous
physiological data on the
LCD screen as data
channels along the time
axis.
Catalogue No:
AD1000 System
ATREBLA
Keyboard ATREBLA Keyboard can
be connected to the
monitor using a USB
connection.
Catalogue No:
AD2000 System
ATREBLA Frame ATREBLA Frame is a
pivotal component
designed to work
efficiently in clinical
environment.
Catalogue No:
AD3000 System
ATREBLA EEG
Measurement
Module
ATREBLA EEG
Measurement Module is
placed on the head to
measure electrical signals
along the scalp.
Catalogue No:
AD4000 System
ATREBLA
Oxygen
Measurement
Module
ATREBLA Oxygen
Measurement Module is
connected to the Oxygen
sensor to measure oxygen
concentration.
Catalogue No:
AD4100 System
ATREBLA ECG
Measurement
Module
ATREBLA ECG
Measurement Module is
used to record electrical
activity of the heart.
Catalogue No:
AD4200 System
ATREBLA
software version
2.0
ATREBLA software
version 2.0 collects patient
data.
Catalogue No:
SW2000 System
The ATREBLA Monitor is designed to use standard EEG electrodes (Class II Canadian license 88888),
EEG lead sets (Class II Canadian license 88889), ECG electrodes (Class II Canadian license 93334), ECG
lead sets (Class II Canadian license 93333) and also oxygen sensors (Class II Canadian license 93344), all
of which have been previously licensed by Health Canada. The ATREBLA can be interfaced to the two
other devices manufactured by Tiger Technology Inc. They are Tiger Tail Network (Canadian license
99999) and Tiger Tail Monitor (Canadian license 99991).
Supportive documentation available for the device ATREBLA Monitor:
ATREBLA Sales Brochure
ATREBLA USER MANUAL
ATREBLA Device plate label
ATREBLA Mechanical and Environmental test report
ATREBLA EMC test report
ATREBLA Risk analysis report
ATREBLA Electrical Safety Test report
ATREBLA Software Description
ATREBLA Software Specification
ATREBLA Software Test Summary Report
ATREBLA EEG Performance report
ATREBLA Device Description and Technical Specification
ATREBLA Clinical trial report
References and Guidance documents
1. Medical Devices Regulations (SOR/98-282). (n.d.). Justice Laws. Retrieved June 22, 2014, from
http://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-23.html
2. Guidance for the Interpretation of Sections 28 to 31: Licence Application Type [Health Canada,
1999]. (2013, September 24). Health Canada. Retrieved June 22, 2014, from http://www.hc-
sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/apptype_typedem-eng.php#a21
3. Guidance Document: Preparation of Summary Technical Documentation (STED)-based Class III
and Class IV Premarket Medical Device Licence Applications, not including In Vitro Diagnostic
Devices (IVDDs). (2011, November 1). Health Canada. Retrieved June 22, 2014, from
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_gd_im_ld_sted-eng.php
4. Declaration of Conformity. (2009, June 18). Health Canada. Retrieved June 22, 2014, from
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_doc_im_ddc_form-eng.php
5. ISO14971:2007 Medical devices - Application of risk management to medical devices
6. ISO13485:2003 Medical devices – Quality management systems – Requirements for regulatory
purposes
7. IEC 60601-1:2005-Ed.3.0 Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance IEC 60601-1:2005-Ed.3.0/Cor.1:2006
8. IEC 60601-1-2:2007-Ed.3.0 Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance- Collateral standard: Electromagnetic compatibility –
Requirements and testing
9. IEC 60601-2-26:2012-Ed.3.0 Medical electrical equipment – Part 2-26: Particular requirements
for basic safety and essential performance of electroencephalographs- Edition 3.0
10. IEC 60601-2-27:2011-Ed.3.0 Medical electrical equipment – Part 2-26: Particular requirements
for basic safety and essential performance of Electrocardiographic Monitoring Equipment –
Edition 3.0 IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012