department of health & human services public health … · 2017. 7. 3. · department of health...
TRANSCRIPT
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
PAR Medizintechnik GmbH & Co. KG Thomas Fischer Sachsendamm 6 10829 Berlin Germany Re: K170966
Trade/Device Name: TONOPORT VI Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 12, 2017 Received: May 15, 2017
Dear Thomas Fischer: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-
June 14, 2017
Page 2 - Thomas Fischer K170966
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
for
PAR Medizintechnik GmbH & Co. KG Special 510(k) TONOPORT VI
Special 510(k) TONOPORT VI - Doc.-Rev. C from May 12th, 2017 4-1
4 Statement of Indications for Use
PAR Medizintechnik GmbH & Co. KG Special 510(k) TONOPORT VI
Special 510(k) TONOPORT VI - Doc.-Rev. E from June 14th, 2017
5-1
5 510(k) Summary Table 2: Submitter information Submitter: PAR Medizintechnik GmbH & Co. KG
Sachsendamm 6 10829 Berlin Germany
Contact person: Mr. Thomas Fischer Research and development department PAR Medizintechnik GmbH & Co. KG E-mail: [email protected] Phone: +49 30 235070 10 Fax: +49 30 2138542
Date: March 29th, 2017
Table 3: Device information Device: Trade name: TONOPORT VI
Common name: Non-Invasive Blood-Pressure Monitor Classification name: Non-invasive blood pressure measurement system (21 CFR 870.1130, Product Code DXN, Class II)
Legally marked device:
Device name: TONOPORT V 510(k) number: K012647
5.1 Device Description
Table 4: Device description Device functions: The TONOPORT VI measures the blood pressure non-invasively and
provides the systolic, diastolic, mean arterial blood pressure and the heart rate of human beings. The cuff is borne on the upper arm of the patient and an electrical pump in the device generates the pressure in the cuff. The TONOPRT VI is powered by two AA size batteries (alkaline or rechargeable NiMH batteries). The device records up to 400 blood pressure measurements at predefined intervals. In order to assess the measurements, the stored data can be transmitted via a RS-232, USB 1.1 or USB 2.0 interface to a PC for further evaluation or archiving purposes by analysis software. It is intended to get used by physicians (primary care physician, specialists and hospitals).
K170966 Page 1 of 9
PAR Medizintechnik GmbH & Co. KG Special 510(k) TONOPORT VI
Special 510(k) TONOPORT VI - Doc.-Rev. E from June 14th, 2017
5-2
Basic scientific concept:
The blood pressure is measured by the oscillometric method. The criteria for this method are the pressure pulsations superimposed with every systole on the air pressure in the cuff. In order to measure the blood pressure, a blood pressure cuff wrapped around the upper arm needs to be inflated and subsequently deflated.
Device design: The TONOPORT VI is a small-sized, light weighted and portable NIBP monitor with an easy to read display.
Used materials: Polycarbonate (PC) and acrylonitrile butadiene styrene (ABS) for the case and plastic foil for the labels of the device. Tested biocompatible materials (Nylon and PVC) are used for the cuffs.
Physical properties:
Size: width: 73.0 mm / height: 27.0 mm / depth: 108.0 mm Weight: under 190 g, incl. batteries Connectors: cuff, USB and RS-232 connector
5.2 Indications for Use
The TONOPORT VI is a small-size, lightweight, portable, non-invasive blood pressure
(NIBP) monitor for ambulatory measurement of the blood pressure by the oscillometric
method. The cuff is borne on the upper arm and an electrical pump in the device
generates the pressure in the cuff. The TONOPRT VI is powered by two AA size
batteries (alkaline or rechargeable NiMH batteries). The device records up to 400 blood
pressure measurements at predefined intervals. In order to assess the measurements, the
stored data can be transmitted via a RS-232, USB 1.1 or USB 2.0 interface to a PC for
further evaluation or archiving purposes by analysis software.
TONOPORT VI is intended to be used for measuring the systolic, diastolic, mean arterial
blood pressure and the heart rate of human beings.
The intended patient populations are adults and children (but not neonates) with a
circumference of the upper arm in the range of 17 to 42 cm.
TONOPORT VI is a prescription device in health care medicine and is intended for use
following consultation and instruction by a physician (family doctor, specialist or
hospital). It can be used, if the physical condition of the patient allows an automatic, non-
invasive blood pressure measurement. Preparation and application of the TONOPORT VI
is done by medically trained staff. The patient does not operate with the TONOPORT VI
K170966 Page 2 of 9
PAR Medizintechnik GmbH & Co. KG Special 510(k) TONOPORT VI
Special 510(k) TONOPORT VI - Doc.-Rev. E from June 14th, 2017
5-3
by himself. TONOPORT VI is not intended to be used in intensive care medicine or for
alarming of life-threatening conditions.
A measurement with TONOPORT VI can be combined with other measurements and
medical examinations at the patient that a diagnosis about the patient’s health condition
depends not alone from the measurement of the TONOPORT VI.
K170966 Page 3 of 9
PAR
Med
izin
tech
nik
Gm
bH &
Co.
KG
Sp
ecia
l 510
(k) T
ON
OPO
RT V
I
Spec
ial 5
10(k
) TO
NO
POR
T V
I - D
oc.-R
ev. E
from
June
14t
h, 2
017
5-4
5.3
Com
pari
son
of th
e T
ON
OPO
RT
VI a
nd th
e pr
edic
ate
devi
ce
The
TON
OPO
RT
VI i
s sub
stan
tially
equ
ival
ent a
nd e
mpl
oys t
he sa
me
func
tiona
l tec
hnol
ogy
as th
e pr
edic
ate
devi
ce T
ON
OPO
RT
V.
Tab
le 5
: Dev
ice
com
pari
son
Cha
ract
eris
tic
Subj
ect d
evic
e TO
NO
POR
T V
I Pr
imar
y pr
edic
ate
devi
ce
TON
OPO
RT
V (5
10(k
) -N
o.: K
0126
47)
Exp
lana
tion
of th
e di
ffer
ence
s Pr
oduc
t cod
e D
XN
D
XN
Id
entic
al
Cla
ssifi
catio
n nu
mbe
r 21
CFR
870
.113
0 21
CFR
870
.113
0 Id
entic
al
Com
mon
nam
e N
on-I
nvas
ive
Blo
od-P
ress
ure
Mon
itor
Non
-Inv
asiv
e B
lood
-Pre
ssur
e M
onito
r Id
entic
al
Cla
ss
Cla
ss II
C
lass
II
Iden
tical
In
tend
ed u
se
The
TON
OPO
RT
VI m
easu
res
and
stor
es
the
bloo
d pr
essu
re d
ata
(sys
tolic
pre
ssur
e,
dias
tolic
pre
ssur
e an
d he
art r
ate)
at h
uman
be
ings
. Th
e bl
ood
pres
sure
ca
n be
m
easu
red
seve
ral t
imes
at t
he p
hysi
cian
or
up
to
400
times
du
ring
a lo
ng-te
rm
mon
itorin
g w
ith o
ne s
et o
f fu
lly c
harg
ed
batte
ries .
Med
ical
ly t
rain
ed s
taff
has
to
appl
y th
e de
vice
and
the
phys
icia
n ha
s to
an
alyz
e th
e re
sults
. Th
e pa
tient
doe
s no
t op
erat
e w
ith
the
TON
OPO
RT
VI
by
him
self.
Th
e st
ored
da
ta
can
be
trans
mitt
ed to
a P
C b
ased
app
licat
ion
via
seria
l in
terf
ace
for
anal
ysis
an
d ev
alua
tion.
The
TON
OPO
RT
V m
easu
res
and
stor
es
the
bloo
d pr
essu
re d
ata
(sys
tolic
pre
ssur
e,
dias
tolic
pre
ssur
e an
d he
art r
ate)
at h
uman
be
ings
. Th
e bl
ood
pres
sure
ca
n be
m
easu
red
seve
ral t
imes
at t
he p
hysi
cian
or
up
to
200
times
du
ring
a lo
ng-te
rm
mon
itorin
g w
ith o
ne s
et o
f fu
lly c
harg
ed
batte
ries.
Med
ical
ly t
rain
ed s
taff
has
to
appl
y th
e de
vice
and
the
phys
icia
n ha
s to
an
alyz
e th
e re
sults
. Th
e pa
tient
doe
s no
t op
erat
e w
ith t
he d
evic
e by
him
self.
The
st
ored
dat
a ca
n be
prin
ted
dire
ctly
on
a pr
inte
r an
d/or
tra
nsm
itted
to
a PC
-bas
ed
appl
icat
ion
via
seria
l int
erfa
ce fo
r ana
lysi
s an
d ev
alua
tion.
Equi
vale
nt
The
stor
age
capa
city
is
in
crea
sed
and
the
trans
mis
sion
inte
rfac
es a
re
stat
e of
th
e ar
t fo
r th
e cl
eara
nce
times
. Th
ese
chan
ges
are
docu
men
ted
and
do n
ot i
nflu
ence
the
in
dica
tions
for u
se.
K170966 Page 4 of 9
PAR
Med
izin
tech
nik
Gm
bH &
Co.
KG
Sp
ecia
l 510
(k) T
ON
OPO
RT V
I
Spec
ial 5
10(k
) TO
NO
POR
T V
I - D
oc.-R
ev. E
from
June
14t
h, 2
017
5-5
Cha
ract
eris
tic
Subj
ect d
evic
e TO
NO
POR
T V
I Pr
imar
y pr
edic
ate
devi
ce
TON
OPO
RT
V (5
10(k
) -N
o.: K
0126
47)
Exp
lana
tion
of th
e di
ffer
ence
s In
dica
tions
for u
se
Targ
et p
opul
atio
n:
Adu
lts a
nd c
hild
ren,
but
not
neo
nate
s A
nato
mic
al si
te:
Upp
er a
rm (s
ee se
ctio
n 0)
W
here
use
d:
In
hosp
ital
and
at
hom
e (f
ollo
win
g co
nsul
tatio
n an
d in
stru
ctio
n by
a
phys
icia
n)
Targ
et p
opul
atio
n:
Adu
lts a
nd c
hild
ren,
but
not
neo
nate
s A
nato
mic
al si
te:
Upp
er a
rm
Whe
re u
sed:
In
ho
spita
l an
d at
ho
me
(fol
low
ing
cons
ulta
tion
and
inst
ruct
ion
by
a ph
ysic
ian)
Iden
tical
Des
ign
N
ew a
nd g
ood
look
ing
ergo
nom
ic d
esig
n of
the
case
and
the
user
inte
rfac
e
Fu
nctio
nal d
esig
n of
the
case
and
the
user
in
terf
ace
Equi
vale
nt
The
chan
ges
of t
he c
ase
ergo
nom
ics
and
the
user
in
terf
ace
that
enh
ance
the
op
erat
or’s
an
d pa
tient
’s
conv
enie
nce
are
docu
men
ted
and
are
not
rele
vant
fo
r th
e in
dica
tions
for u
se.
K170966 Page 5 of 9
PAR
Med
izin
tech
nik
Gm
bH &
Co.
KG
Sp
ecia
l 510
(k) T
ON
OPO
RT V
I
Spec
ial 5
10(k
) TO
NO
POR
T V
I - D
oc.-R
ev. E
from
June
14t
h, 2
017
5-6
Cha
ract
eris
tic
Subj
ect d
evic
e TO
NO
POR
T V
I Pr
imar
y pr
edic
ate
devi
ce
TON
OPO
RT
V (5
10(k
) -N
o.: K
0126
47)
Exp
lana
tion
of th
e di
ffer
ence
s D
ispl
ay
27
.0 m
m x
58.
0 m
m
(w
idth
to h
eigh
t)
30
.0 m
m x
10.
5 m
m
(w
idth
to h
eigh
t) Eq
uiva
lent
Th
e ch
ange
of
th
e er
gono
mic
s of
th
e us
er
inte
rfac
e in
to a
cle
ar a
nd
easy
to
read
dis
play
tha
t in
crea
ses
the
safe
ty o
f th
e de
vice
an
d en
hanc
e th
e co
nven
ienc
e ar
e do
cum
ente
d.
Dim
ensi
ons a
nd
wei
ght
Smal
ler
with
low
er w
eigh
t co
mpa
red
to
TON
OPO
RT
V
Smal
l siz
e an
d lo
w w
eigh
t Eq
uiva
lent
Th
e ch
ange
s in
di
men
sion
al s
peci
ficat
ions
ar
e do
cum
ente
d,
do
not
affe
ct t
he i
ndic
atio
ns f
or
use
and
enha
nce
the
oper
ator
’s
and
patie
nt’s
co
nven
ienc
e.
W
idth
73
.0 m
m
80.0
mm
Hei
ght
27.0
mm
27
.0 m
m
D
epth
10
8.0
mm
10
0.0
mm
Wei
ght
App
roxi
mat
ely
190
g w
ith b
atte
ries
App
roxi
mat
ely
199
g w
ith b
atte
ries
Com
mun
icat
ion
Mea
sure
men
t se
tting
s of
the
dev
ice
and
the
read
out
of t
he st
ored
dat
a ca
n be
don
e vi
a se
rial i
nter
face
Mea
sure
men
t se
tting
s of
the
dev
ice
and
the
read
out
of t
he st
ored
dat
a ca
n be
don
e vi
a se
rial i
nter
face
Iden
tical
Even
t mar
king
B
y pr
essi
ng th
e ST
AR
T ST
OP
But
ton
By
pres
sing
the
STA
RT
STO
P B
utto
n Id
entic
al
Ener
gy so
urce
Po
wer
ed
by
two
AA
si
ze
batte
ries
(alk
alin
e or
NiM
H b
atte
ries)
.
Pow
ered
by
tw
o A
A
size
ba
tterie
s (a
lkal
ine
or N
iMH
bat
terie
s).
Iden
tical
K170966 Page 6 of 9
PAR
Med
izin
tech
nik
Gm
bH &
Co.
KG
Sp
ecia
l 510
(k) T
ON
OPO
RT V
I
Spec
ial 5
10(k
) TO
NO
POR
T V
I - D
oc.-R
ev. E
from
June
14t
h, 2
017
5-7
Cha
ract
eris
tic
Subj
ect d
evic
e TO
NO
POR
T V
I Pr
imar
y pr
edic
ate
devi
ce
TON
OPO
RT
V (5
10(k
) -N
o.: K
0126
47)
Exp
lana
tion
of th
e di
ffer
ence
s St
orag
e ca
paci
ty
Up
to 4
00 m
easu
rem
ents
U
p to
200
mea
sure
men
ts
Equi
vale
nt
The
eval
uatio
n of
us
er
need
s sh
owed
tha
t m
ore
stor
age
capa
city
is
need
. Th
e ch
ange
is d
ocum
ente
d an
d do
not
inf
luen
ce t
he
indi
catio
ns fo
r use
. M
easu
ring
met
hod
Osc
illom
etric
mea
surin
g m
etho
d du
ring
defla
tion
of th
e cu
ff
Osc
illom
etric
mea
surin
g m
etho
d du
ring
defla
tion
of th
e cu
ff
Iden
tical
Mea
surin
g ra
nge
syst
olic
pre
ssur
e
60 t
o 26
0 m
mH
g di
asto
lic p
ress
ure
40
to 2
20 m
mH
g pu
lse
rate
(HR
)
35
to 2
40 m
in-1
syst
olic
pre
ssur
e
60 t
o 26
0 m
mH
g di
asto
lic p
ress
ure
40
to 2
20 m
mH
g pu
lse
rate
(HR
)
35
to 2
40 m
in-1
Iden
tical
Max
cuf
f pre
ssur
e 30
0 m
mH
g 30
0 m
mH
g Id
entic
al
Mat
eria
ls
PC a
nd A
BS
for
the
case
and
pla
stic
foi
l fo
r the
labe
ls o
f the
dev
ice.
Bio
com
patib
le
mat
eria
ls a
re u
sed
for
the
appl
ied
parts
(c
uff )
.
PC f
or t
he c
ase
and
plas
tic f
oil
for
the
labe
ls
of
the
devi
ce.
Bio
com
patib
le
mat
eria
ls a
re u
sed
for
the
appl
ied
parts
(c
uff)
.
Equi
vale
nt
The
chan
ge o
f the
mat
eria
l fo
rmul
atio
n to
in
crea
se
the
dura
bilit
y of
th
e de
vice
is d
ocum
ente
d. T
he
chan
ged
mat
eria
ls a
re n
ot
in c
onta
ct w
ith t
he b
ody
of th
e pa
tient
.
K170966 Page 7 of 9
PAR
Med
izin
tech
nik
Gm
bH &
Co.
KG
Sp
ecia
l 510
(k) T
ON
OPO
RT V
I
Spec
ial 5
10(k
) TO
NO
POR
T V
I - D
oc.-R
ev. E
from
June
14t
h, 2
017
5-8
Cha
ract
eris
tic
Subj
ect d
evic
e TO
NO
POR
T V
I Pr
imar
y pr
edic
ate
devi
ce
TON
OPO
RT
V (5
10(k
) -N
o.: K
0126
47)
Exp
lana
tion
of th
e di
ffer
ence
s En
viro
nmen
tal
cond
ition
s fo
r op
erat
ion
Tem
pera
ture
+5
to +
40 °C
Te
mpe
ratu
re
+10
to +
40 °C
Eq
uiva
lent
Th
e en
viro
nmen
tal
cond
ition
s ar
e ch
ange
d ac
cord
ing
to
the
requ
irem
ents
of
th
e st
anda
rds
IEC
806
01-2
-30
and
6060
1-1-
11.
Thes
e ch
ange
s do
not
aff
ect
the
indi
catio
ns fo
r use
.
Hum
idity
15
to 9
3 %
H
umid
ity
30 to
75
%
Atm
osph
eric
pre
ssur
e 70
0 to
106
0 hP
a A
tmos
pher
ic p
ress
ure
700
to 1
060
hPa
Envi
ronm
enta
l co
nditi
ons
for
trans
port
and
stor
age
Tem
pera
ture
-2
5 to
+70
°C
Tem
pera
ture
-2
0 to
+70
°C
Hum
idity
10
to 9
3 %
H
umid
ity
10 to
90
%
Atm
osph
eric
pre
ssur
e 50
0 to
106
0 hP
a A
tmos
pher
ic p
ress
ure
500
to 1
060
hPa
Safe
ty
Incr
ease
d sa
fety
A
n ad
ditio
nal
pres
sure
se
nsor
an
d a
pres
sure
rele
ase
valv
e ar
e ad
ded.
Tw
o co
ntro
llers
(m
ain
and
supe
rvis
or
cont
rolle
r) th
at m
onito
r eac
h ot
her a
nd th
e sa
fety
rela
ted
com
pone
nts a
re u
sed.
Stan
dard
safe
ty
One
pre
ssur
e se
nsor
and
one
val
ve fo
r the
de
flatio
n of
the
cuff
are
use
d.
One
con
trolle
r (m
ain
cont
rolle
r) is
use
d.
Equi
vale
nt
The
impr
ovem
ent
of t
he
safe
ty
prop
ertie
s of
th
e de
vice
is d
ocum
ente
d.
Ster
iliza
tion
Not
app
licab
le
Not
app
licab
le
Iden
tical
Ex
pira
tion
date
N
ot a
pplic
able
N
ot a
pplic
able
Id
entic
al
K170966 Page 8 of 9
PAR Medizintechnik GmbH & Co. KG Special 510(k) TONOPORT VI
Special 510(k) TONOPORT VI - Doc.-Rev. E from June 14th, 2017
5-9
5.4 Summary of performance testing
Table 6: Performance testing to demonstrate equivalence Characteristic Standard/Test/FDA Guidance Result
Safety (electrical, mechanical, chemical, thermal and radiation) and essential performance
IEC 60601-1 IEC 60601-1-11 IEC 80601-2-30
Pass Pass Pass
Usability IEC 60601-1-6 Pass Software IEC 62304 Pass
Risk Management Risk analysis ISO 14971 Pass
The TONOPORT VI complies with the voluntary and mandatory standards. The
following quality assurance measures were applied to the development of the
TONOPORT VI to ensure that design inputs, safety requirements, new features, pre-
existing requirements were met and re-tested:
Requirements specification review
Software and hardware testing
Safety testing
Environmental testing
Final verification and validation
Compliance with performance standards
An assessment of clinical data to show safety and performance of the device was not
made, because the TONOPORT VI uses identical algorithms for the blood pressure
measurement like the predicate device TONOPORT V. Consequently the form FDA-
3674 ‘Certification of compliance with requirements of ClinicalTrails.gov data bank’ is
not completed and submitted.
5.5 Conclusion
The TONOPORT VI is substantially equivalent to the TONOPORT V with respect to the
indications for use and the basic scientific concept.
K170966 Page 9 of 9