slide 1 of 22 rob packard, president [email protected] 510(k) project management

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Rob Packard, Presidentwww.MedicalDeviceAcademy.com

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510(k)ProjectManagement

http://www.medicaldeviceacademy.com/


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Agenda

• Overview• Device Classification• Predicate Selection • Table of Contents • Team Member Selection• Performance Testing Plan • FDA Pre-Sub Meetings



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510(k) Overview



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Product Classification

1. Identify a device similar to yours

2. Use the registration and listing databasehttp://bit.ly/CDRH-Registration-Listing-Database

3. Identify the 3-letter product code

4. Click on the code to go to the product classification page

5. Click on the TPLC link http://bit.ly/FDATPLC

http://medicaldeviceacademy.com/fda-device-classification/



http://bit.ly/CDRH-Registration-Listing-Database



http://bit.ly/FDATPLC

http://bit.ly/FDATPLC



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Find Classification Other Wayshttp://bit.ly/ProductClassification



http://bit.ly/ProductClassification

http://bit.ly/ProductClassification

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Predicate Selection

1. Is the predicate device legally marketed?

2. Do the devices have the same intended use?

3. Do the devices have the same technological characteristics?

4. Do the different technological characteristics raise different questions of safety and effectiveness?

5. Are the methods of evaluating new/different characteristics acceptable?

6. Does the data demonstrate substantial equivalence?



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How FDA Evaluates SE?http://bit.ly/Substantial-Equiv-Guidance



http://bit.ly/Substantial-Equiv-Guidance

http://bit.ly/Substantial-Equiv-Guidance

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Section 2 - Table of Contents

• 20 Sections

• Create a Template (http://bit.ly/510k-ToC)• eCopy Guidance (http://bit.ly/FDA-eCopy)• RTA Checklist (http://bit.ly/Acceptance-Checklist)

http://bit.ly/510k-Format



http://bit.ly/510k-ToC

http://bit.ly/510k-ToC

http://bit.ly/FDA-eCopy



http://bit.ly/Acceptance-Checklist





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Use ToC as Planning Tool

• red = the information does not appear to be available

• yellow = document requires revision and/or reformatting of content

• blue = ready for the client’s review and approval• green = ready for submission• Add a column to assign team responsibilities• Prioritize task completion



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Example of ToC ToolSection # Description of 510(k) Section Comments Assigned To Target Completion Date1 Medical Device User Fee Cover Sheet (Form FDA 3601) Missing Client2 Table of Contents Missing Rob Packard

3510(k) Cover Letter & CDRH Premarket Review Submission Cover Sheet

May want to add a confidentiality statement and need to include coverletter Client

4 Indications for Use Statement Does not match the predicate - is this more narrow or just different Rob Packard

5 510(k) Summary or 510(k) StatementYou have both and only need one; there is a new guidance for 510k summary Client

6 Truthful and Accuracy Statement ok - must be signed Client7 Class III Summary and Certification need to explain why it's not applicable Rob Packard8 Financial Certification or Disclosure Statement need to explain why it's not applicable Rob Packard

9 Declarations of Conformity and Summary Reports

Need all the form 3654s completed for each applicable standard and a summary document--ideally in tabular format Rob Packard

10 Executive Summary Need to review in detail, but looks good Client

11 Device Description You might want these to be documents referenced rather than embedded figures TBD

12 Substantial Equivalence Discussion Needs lots of work to comply with current guidance - July 24, 2014 Rob Packard

13 Proposed Labeling

Needs to include PDF of labels and IFU; IFU needs to include indications for use and it must match Section 4 exactly Client

14 Sterilization and Shelf Life Missing TBD15 Biocompatibility Missing TBD16 Software need to explain why it's not applicable Rob Packard17 Electromagnetic Compatibility and Electrical Safety need to explain why it's not applicable Rob Packard

18 Performance Testing – BenchMissing - should include simulated use--maybe with an anotomical "dummy" TBD

19 Performance Testing – Animal need to explain why it's not applicable Rob Packard20 Performance Testing – Clinical need to explain why it's not applicable Rob Packard21 Other N/A N/A



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Team Member Selection

• Boilerplate – 1, 3, 6 & non-applicable• 9 - Declarations of Conformity (FDA Form 3654)• Biocompatibility & Sterility – 14 & 15• Software & EMC – 16 & 17• Labeling - 13• Performance Testing

– Bench Testing - 18– Animal Testing - 19– Clinical Studies – 20 + Sections 7 & 8



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Most Critical Sections

• 4 – Indications for Use (1st)• 5 - 510(k) Summary (4th)• 10 – Executive Summary (my last)• 11 - Device Description (2nd)• 12 – Substantial Equivalence (3rd)

• RTA Checklist is a great quality



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Planning Performance Testing

• Look for a special controls guidance document 1st.

• Look for any device-specific standards (e.g., ASTM F483)

• Review each of the possible 510(k) Summaries carefully

• Order 510(k) submissions through FOI



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Bench Testing

• ASTM testing methods• Simulated use experiments• Validation tools (known input data for

software/hardware devices)• Finite Element Analysis (FEA)• Cadaveric studies



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Animal Studies

• The agency allows rationales for reduction of sample number in order to spare the lives of animals.

• Try to find another submission or 510(k) summary that specifies the number of animals

• Test more than once per animal or your device and the predicate in each animal (i.e., animal is it’s own control)

• Small animal vs. large animal and duration…



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Human Studies

• 10-15% of 510(k) submissions require clinical study data• Steps:

– Study Synopsis– Investigator Package– Protocol Approval– Conduct Study– Summary Report

• Non-significant risk studies do not require IDE• IRB approval is always required• Paper data collection vs. electronic data collection



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FDA Pre-Sub Meetings

• Guidance released February 18, 2014• Consultants and RA Experts have used

these for years, but weren’t called “pre-sub” meetings

• Do your homework 1st

• In-person vs. Tcon• Timing = Prior to Performance Testing• Identify Proposed Predicate Device(s)

http://bit.ly/FDA-Pre-Sub





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Pre-Sub Questions

• Is justification of no carcinogenicity testing acceptable?

• Does FDA agree with “worst-case” rationale?• Is software “moderate level of concern”?• Is planned approach for human factors

acceptable?• Are there concerns of predicate selected?• Have an expert present that can “kick you”.



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What not to do for Pre-Sub…

• Do not ask if data is acceptable?• Do not bother if you already did your testing?• Do not argue, because you don’t have to agree

with the agency.



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http://medicaldeviceevents.com/conference-registration/





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Q & A

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mailto:[email protected]

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Need a quotation for a510(k) Submission?

Rob Packard

[email protected]

+1.802.258.1881

rob13485



mailto:[email protected]

slide 1 of 22 rob packard, president [email protected] 510(k) project management

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