(53 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a support catheter, with no mention of AI or ML technologies.
No.
The device description indicates its purpose is to facilitate the introduction of other devices into the vasculature, acting as a "reinforcing conduit for other intravascular devices" rather than directly treating a condition itself.
No
The device is a support catheter used to introduce other interventional devices, not to diagnose a condition.
No
The device description clearly outlines physical components such as a catheter, hemostasis valve, and split sheath introducer, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction of interventional devices into the peripheral and neuro vasculature." This describes a device used within the body for a therapeutic or procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into blood vessels to facilitate the delivery of other devices. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Zenith Support Catheter is an interventional medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DOY, DTL, DYB
Device Description
The InNeuroCo Zenith Support product consists of a catheter, a hemostasis valve, and a split sheath introducer. The Zenith Support catheter is a single lumen, variable stiffness catheter that has an outer polymer shaft and is reinforced with a Stainless Steel cross coil. The Zenith Support catheter has a radiopaque Platinum/Iridium marker band on the distal end. The Zenith Support is available with an internal diameter of 0.074 inches and a nominal outer diameter of 0.086 inches. There are three working lengths available: 95 cm, 105 cm, and 115 cm in either diameter. The Zenith Support catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith Support catheter is inserted through a guide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a split sheath introducer. The Zenith product line is supplied sterile, non-pyrogenic, and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Each non-clinical test was analyzed to determine whether or not re-testing should be conducted for the Zenith Support Catheter. The results of the analysis and re-testing showed that the Zenith Support Catheter is substantially equivalent to the predicate device.
Simulated Use - Bench: Zenith underwent simulated use testing by a physician in a benchtop model. Zenith Support Catheter test samples met the acceptance criteria for Simulated Use- Bench to demonstrate that it is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 26, 2018
InNeuroCo, Inc. Marianne Grunwaldt Director, Quality Assurance and Regulatory Affairs 4635 NW 103rd Avenue Sunrise, Florida 33351
Re: K173709
Trade/Device Name: Zenith Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY, DTL, DYB Dated: January 4, 2018 Received: January 5, 2018
Dear Marianne Grunwaldt:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
William J. Heetderks -A 2018.01.26 16:50:00 -05'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173709
Device Name Zenith Support Catheter
Indications for Use (Describe)
The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
ADMINISTRATIVE INFORMATION
| Date of Summary Preparation: | December 1st, 2017 |
|---|---|
| CONTACT INFORMATION | |
| Submitter/Manufacturer | InNeuroCo Inc |
| 4635 NW 103rd Avenue | |
| Sunrise, Florida 33351 | |
| Tel: 1-954-742-5988 | |
| Fax: 1-954-742-5989 | |
| Primary Submission Contact | Marianne Grunwaldt |
| Cell:1-305-495-3883 | |
| Fax: 1-954-742-5988 | |
| Email: Marianne@InNeuroCo.com | |
| Secondary Submission Contact | Ming Cheng Chew |
| Regulatory Consultant, Libra Medical, | |
| 8401 73rd Ave North, Suite 63 | |
| Brooklyn Park, MN 55428 | |
| Cell: 763-232-3701 | |
| Fax: 763-477-6357 | |
| Email: mcchew@libramed.com |
DEVICE INFORMATION
Device Trade or Proprietary Name Zenith Support Catheter
Device Common or Classification Name: Catheter, Percutaneous, 21 CFR 870.1250, Class II Hemostasis Valve, 21 CFR 870.4290, Class II Catheter Introducer, 21 CFR 870.1340, Class II
Product Code: DQY (Catheter) DTL (Hemostasis Valve) DYB (Catheter Introducer) Inc.
4
IDENTIFICATION OF THE LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS BEING CLAIMED
| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|---|---|---|
| Zenith 074 | InNeuroCo | K171672 |
DEVICE DESCRIPTION
The InNeuroCo Zenith Support product consists of a catheter, a hemostasis valve, and a split sheath introducer. The Zenith Support catheter is a single lumen, variable stiffness catheter that has an outer polymer shaft and is reinforced with a Stainless Steel cross coil. The Zenith Support catheter has a radiopaque Platinum/Iridium marker band on the distal end. The Zenith Support is available with an internal diameter of 0.074 inches and a nominal outer diameter of 0.086 inches. There are three working lengths available: 95 cm, 105 cm, and 115 cm in either diameter. The Zenith Support catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith Support catheter is inserted through a guide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a split sheath introducer. The Zenith product line is supplied sterile, non-pyrogenic, and intended for single use only.
INDICATIONS FOR USE / INTENDED USE
The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
| | Predicate Device
InNeuroCo, Inc.
Zenith 074 | Reference
Device
InNeuroCo SDA | InNeuroCo, Inc.
Zenith Support |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K171672 | K161262 | K173709 |
| Classification | 21CFR870.1250,
Class II | 21CFR870.1250,
Class II | 21CFR870.1250,
Class II |
| Product Code | DQY | DQY | DQY |
| Review Panel | Cardiovascular | Cardiovascular | Cardiovascular |
| | Predicate Device
InNeuroCo, Inc.
Zenith 074 | Reference
Device
InNeuroCo SDA | InNeuroCo, Inc.
Zenith Support |
| Indications For
Use | The Zenith is
indicated for the
introduction of
interventional devices
into the peripheral and
neuro vasculature. | The Super Distal
Access (SDA) is
indicated for the
introduction of
interventional
devices into the
peripheral and
neuro vasculature. | The Zenith
Support Catheter
is indicated for
the introduction
of interventional
devices into the
peripheral and
neuro vasculature. |
| Components
Supplied | Zenith Catheter, Peel
Away Introducers,
Hemostasis Valve,
Scout Introducer | Catheter, Peel
Away Introducer,
Hemostasis
Valve | Zenith Support
Catheter, Peel
Away Introducer,
Hemostasis Valve |
| Catheter Shaft
Material | Polymeric Catheter | Polymeric
Catheter | Polymeric
Catheter |
| Inner Liner | PTFE | PTFE | PTFE |
| Catheter Shaft
Reinforcement | Stainless Steel | Stainless
Steel/Nitinol | Stainless Steel |
| Reinforcement
pattern | Cross Coil | Braid | Cross Coil |
| Lubricious
Coating | Hydrophilic Coating | Hydrophilic
Coating | Hydrophilic
Coating |
| Radiopaque
Marker Band | Platinum/ Iridium | Platinum/ Iridium | Platinum/ Iridium |
| Packaging | Tyvek/Nylon Pouch,
polyethylene support
tube, packaging card,
SBS carton | Tyvek/Nylon
Pouch,
polyethylene
support tube,
packaging card,
SBS carton | Tyvek/Nylon
Pouch,
polyethylene
support tube,
packaging card,
SBS carton |
| Working
Lengths | 115, 125, 132 cm | 105, 115, 125 cm | 95, 105, 115 cm |
| | Predicate Device
InNeuroCo, Inc.
Zenith 074 | Reference
Device
InNeuroCo SDA | InNeuroCo, Inc.
Zenith Support |
| Proximal
Internal
Diameter (ID) | 0.074 inches | 0.062 inches | 0.074 inches |
| Distal ID | 0.074 inches | 0.060 inches
distal | 0.074 inches |
| Proximal Outer
Diameter | 0.086 inches | 0.079 inches | 0.086 inches |
| Distal Outer
Diameter | 0.086 inches | 0.072 | 0.086 inches |
| Peel Away
Introducer | Aid in catheter tip
introduction into
hemostasis valve | Aid in catheter tip
introduction into
hemostasis valve | Aid in catheter tip
introduction into
hemostasis valve |
| Hemostasis
Valve | Minimizes blood loss | Minimizes blood
loss | Minimizes blood
loss |
| Luer Tapered
Hub | Yes | Yes | Yes |
| Compatible
Guidewire | 0.038 inches | 0.038 inches | 0.038 inches |
| Scout
Introducer | Yes | No | No |
| Sterilization | EO SAL 10-6 | EO SAL 10-6 | EO SAL 10-6 |
| Pyrogenicity | Nonpyrogenic | Nonpyrogenic | Nonpyrogenic |
| Biocompatibility | Meets ISO 10993-
1:2009 | Meets ISO
10993-1:2009 | Meets ISO
10993-1:2009 |
COMPARISON TO THE PREDICATE DEVICE
5
6
7
SUMMARY OF NON-CLINICAL DATA
Each non-clinical test was analyzed to determine whether or not re-testing should be conducted for the Zenith Support Catheter. The results of the analysis and re-testing showed that the Zenith Support Catheter is substantially equivalent to the predicate device.
8
| Test | Test Method
Summary | Acceptance
Criteria | Re-Tested? | Analysis |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibilit
y-Material
Mediated
Pyrogen | Testing
completed per
ISO 10993-11 | The test article
extracts must not
cause a febrile
reaction greater
than 0.5°C in any
individual
subject. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device.
Manufacturing
process is identical
to the predicate.
Only the segment
lengths were
changed and pitch
adjustments were
within the predicate
device's tolerance |
| Biocompatibilit
y- Cytotoxicity
MEM Elution | Testing
completed per
ISO 10993-5 | The cultures
treated with the
test article must
not have a
reactivity grade
greater than 2. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device.
Manufacturing
process is identical
to the predicate.
Only the segment
lengths were
changed and pitch
adjustments were
within the predicate
device's tolerance |
| Biocompatibilit
y-Hemolysis
ASTM Method,
extract human
blood | Testing
completed per
ISO 10993-4 | The hemolytic
index above the
negative control
article must be
less than 5%. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device.
Manufacturing
process is identical
to the predicate.
Only the segment
lengths were
changed and pitch
adjustments were
within the predicate
device's tolerance |
| Biocompatibilit
y-Hemolysis,
ASTM method, | Testing
completed per
ISO 10993-4 | The hemolytic
index above the
negative control | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device. |
| Test | Test Method
Summary | Acceptance
Criteria | Re-Tested? | Analysis |
| direct contact
(human blood) | | article must be
less than 5%. | | Manufacturing
process is identical
to the predicate.
Only the segment
lengths were
changed and pitch
adjustments were
within the predicate
device's tolerance |
| Biocompatibilit
y-Unactivated
Partial
Thromboplastin
Time | Testing
completed per
ISO 10993-4 | There must be no
statistical
decrease between
the UPTT of
plasma exposed
to the test article
and to the
negative or
untreated control. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device.
Manufacturing
process is identical
to the predicate.
Only the segment
lengths were
changed and pitch
adjustments were
within the predicate
device's tolerance |
| Biocompatibilit
y-Complement
Activation | Testing
completed per
ISO 10993-4 | There must be no
statistical increase
between either the
C3a or SC5b-9
concentrations in
plasma exposed
to the test article
as compared to
the negative and
untreated
controls. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device.
Manufacturing
process is identical
to the predicate.
Only the segment
lengths were
changed and pitch
adjustments were
within the predicate
device's tolerance |
| Biocompatibilit
y-Dog
Thromboresista
nce | Testing
completed per
ISO 10993-4 | The test articles
must receive a
thrombus
formation score
less than or equal
to that of the
control. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device.
Manufacturing
process is identical
to the predicate.
Only the segment
lengths were
changed and pitch
adjustments were
within the predicate
device's tolerance |
| Test | Test Method
Summary | Acceptance
Criteria | Re-Tested? | Analysis |
| Biocompatibilit
y-Maximization
Sensitization | Testing
completed per
ISO 10993-10 | The test article
must elicit a
positive response
in less than 10%
of the test
animals. | Testing was not
repeated for the
Zenith Support
Catheter | changed and pitch
adjustments were
within the predicate
device's tolerance
There are no
material changes
from the predicate
device.
Manufacturing
process is identical
to the predicate.
Only the segment
lengths were
changed and pitch
adjustments were
within the predicate
device's tolerance |
| Biocompatibilit
y-
Intracutaneous
Toxicity/Reacti
vity | Testing
completed per
ISO 10993-10 | The test article
extracts must not
induce a
significantly
greater biological
reaction than the
control. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device.
Manufacturing
process is identical
to the predicate.
Only the segment
lengths were
changed and pitch
adjustments were
within the predicate
device's tolerance |
| Biocompatibilit
y-Acute
Systemic
Toxicity Test | Testing
completed per
ISO 10993-11 | The test article
extracts must not
induce a
significantly
greater biological
reaction than the
control. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device.
Manufacturing
process is identical
to the predicate.
Only the segment
lengths were
changed and pitch
adjustments were
within the predicate
device's tolerance |
| Test | Test Method
Summary | Acceptance
Criteria | Re-Tested? | Analysis |
| Animal
Testing-
Angiographic
Evaluation | Product
evaluated
within a
porcine model
for clinically
significant
injury. | No units tested
can cause vessel
injury. | Testing was not
repeated for the
Zenith Support
Catheter | The tips, materials,
and transitions are
identical to the
predicate, and the
initial evaluation for
the predicate
included the use of
the device without
the Scout Introducer |
| Chemical
Compatibility | Catheter
exposed to
chemicals
readily
available in a
clinical setting. | Chemicals have
no negative effect
on the catheter or
accessories. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device, and pitch
adjustments are
within the tolerance
of the predicate
device |
| Radiographic
Detectability | Testing
completed per
ISO 10555-1 | Product shall be
visible under
fluoro imaging. | Testing was not
repeated for the
Zenith Support
Catheter | The marker bands
are identical to the
predicate |
| Visual
Inspection | Testing
completed per
ISO 10555-1 | Catheter shall
appear free from
damage,
including a
rounded tip and
smooth transition
points. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device, and pitch
adjustments are
within the tolerance
of the predicate
device |
| Working
Length | Testing
completed per
ISO 10555-1 | Test samples
should be within
existing working
length
specification. | Testing was not
repeated for the
Zenith Support
Catheter | The segment lengths
do not impact the cut
to length step in
addition the working
length test compares
the output to the
target length |
| Hub
compatibility | Testing
completed per
ISO 594-1 and
ISO 594-2 | Hub shall meet
existing Luer
specifications. | Testing was not
repeated for the
Zenith Support
Catheter | The hub is identical
to the predicate
device |
| Outside
diameter | Testing
completed per
ISO 10555-1 | Test samples
should be within
existing outside | Testing was not
repeated for the
Zenith Support
Catheter | OD is unaffected by
the working length
change |
| Test | Test Method
Summary | Acceptance
Criteria | Re-Tested? | Analysis |
| Leak – Air | Testing
completed per
ISO 10555-1 | Test samples
should be within
existing Air -
Leak
specifications. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device, and pitch
adjustments are
within the tolerance
of the predicate
device |
| Leak – Liquid | Testing
completed per
ISO 10555-1 | Test samples
should be within
existing Leak -
Liquid
specifications. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device, and pitch
adjustments are
within the tolerance
of the predicate
device |
| Particulates | Testing
completed per
USP 788 | Test samples
should be within
existing
Particulate
specifications. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device, and pitch
adjustments are
within the tolerance
of the predicate
device |
| Simulated Use -
Bench | Zenith
underwent
simulated use
testing by a
physician in a
benchtop
model | Test samples
must meet
predetermined
user needs | Yes | Zenith Support
Catheter test samples
met the acceptance
criteria for
Simulated Use-
Bench to
demonstrate that it is
substantially
equivalent to the
predicate device |
| Catheter Burst | Testing
completed per
ISO 10555-1 | Test sample burst
pressures must
meet or exceed
existing minimum
burst pressure
specification. | Testing was not
repeated for the
Zenith Support
Catheter. | There are no
material changes
from the predicate
device, and pitch
adjustments are
within the tolerance
of the predicate
device |
| Test | Test Method
Summary | Acceptance
Criteria | Re-Tested? | Analysis |
| Tensile | Testing
completed per
ISO 10555-1 | Test sample
ultimate tensile
strength must
meet or exceed
existing tensile
strength
specifications. | Testing was not
repeated for the
Zenith Support
Catheter | The bonds and joints
are the same as the
predicate Zenith 074
device. Any pitch
adjustments are
within the tolerance
of the predicate
device. |
| Corrosion | Testing
completed per
ISO 10555-1 | Test samples shall
exhibit no
evidence of
corrosion. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device, and pitch
adjustments are
within the tolerance
of the predicate
device |
| Packaging -
Dye Leak | Testing
completed per
ASTM F1929-
12 | Test sample shall
not exhibit any
visual leaks or
channels | Testing was not
repeated for the
Zenith Support
Catheter | The packaging is
identical to the
cleared reference
SDA device |
| Packaging -
Peel | Testing
completed per
ASTM F88-09 | Test sample
tensile strength
must meet or
exceed existing
tensile strength
specifications. | Testing was not
repeated for the
Zenith Support
Catheter | The packaging is
identical to the
cleared reference
SDA device |
| Kink Resistance | Samples are
subjected to
different
diameters until
kink is
observed. | Test sample kink
resistance must
meet or exceed
existing Kink
Resistance
specifications. | Testing was not
repeated for the
Zenith Support
Catheter | All transitions are
the same, only the
location of the
transition changes,
in addition, the pitch
adjustments are
within the Zenith
074 tolerance |
| Torque | Conditioned
samples are
torqued to
failure | Test sample
torque results
must meet or
exceed existing
torque
specifications. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device, and pitch
adjustments are
within the tolerance
of the predicate
device |
| PTFE Liner
inspection | Zenith was
challenged to | Test sample liner
adhesion must | Testing was not
repeated for the | There are no
material changes |
| Test | Test Method
Summary | Acceptance
Criteria | Re-Tested? | Analysis |
| | demonstrate
liner
adherence. | meet or exceed
existing PTFE
Liner inspection
specifications. | Zenith Support
Catheter | from the predicate
device, and pitch
adjustments are
within the tolerance
of the predicate
device |
| Hydrophilic
Coating
Integrity | Conditioned
samples were
repeatedly
exposed to
friction to
demonstrate
that the
hydrophilic
coating is not
affected. | Test sample
results must meet
or exceed existing
Hydrophilic
Coating Integrity
specifications. | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device, and pitch
adjustments are
within the tolerance
of the predicate
device |
| Labeling
Legibility | Label is legible
after printing. | Test samples shall
demonstrate text
legibility. | Testing was not
repeated for the
Zenith Support
Catheter
substantially
equivalent to the
predicate device. | The label is almost
identical to the
predicate device,
except that the Scout
Introducer is
removed from the
labeling |
| Barcode | Barcode is
readable with a
standard
barcode reader. | Test samples shall
demonstrate
readily readable
barcodes | Testing was not
repeated for the
Zenith Support
Catheter | Barcodes are similar
to the predicate |
| Sterilization | ISO 11135 and
AAMI TIR 28 | Sterilization load
shall pose an
equal or lesser
challenge to
sterilize than
existing sterile
product loads. | Testing was not
repeated for the
Zenith Support
Catheter | The Zenith Support
Catheter was
adopted into the
Zenith Family
Sterilization Cycle |
| Shelf Life | ASTM F1980 | Aged test samples
must meet or
exceed existing
specifications | Testing was not
repeated for the
Zenith Support
Catheter | There are no
material changes
from the predicate
device, therefore
shelf life testing
conducted for the
Zenith 074 still
applies |
Table 1: Non-Clinical Testing Analysis
9
10
11
12
13
14