Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents, not for providing therapy itself.

Diagnostic

Yes

The device is intended for the "infusion of diagnostic or therapeutic agents." While it doesn't perform diagnosis itself, its use in delivering diagnostic agents classifies it as having a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical catheter with various material and structural components, not a software-only device.

IVD (In Vitro Diagnostic)

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 and infusion of agents into the body (neuro, peripheral, and coronary vasculatures). This is an in vivo application, meaning it's used within a living organism.
Device Description: The description details a catheter designed for navigation within blood vessels, which is consistent with an in vivo use.
IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests on samples.

Therefore, the Phenom® Catheter is an interventional medical device used in vivo, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Phenom® Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

Product codes (comma separated list FDA assigned to the subject device)

DQY, KRA

Device Description

The Phenom® 27 Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to aid in navigation in the vessel. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

neuro, peripheral, and coronary vasculatures

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)

Study Type: Bench Testing

Catheter Flow Rate:

Test Method Summary: The purpose of the testing is to provide the user with a flow rate reference when using various contrast media and pressure conditions. Similar to the predicate device, 2 pressure conditions and 3 commonly used contrast media are used for the testing. High pressure vessel and tank, timer and scale are used to determine flow rate.
Results: Flow rate data was collected for the modified (160cm) device and the predicate device (150cm). As expected, the new geometry result in slightly different fluid dynamics (i.e., lower flow rates). The results are within the expected range and therefore are equivalent.

Flow rate for each lumen, according to ISO 10555-1:

Test Method Summary: Test method is to verify compliance to catheter standard BS EN ISO 10555-1: 2013. Conditions, method and equipment as prescribed in the standard.
Results: Flow rate data was collected for the modified (160 cm) device and the predicate device (150 cm). As expected, the new geometry result in slightly different fluid dynamics (i.e., lower flow rates). The passing results are within the expected range and therefore are equivalent.

Dead Space Volume:

Test Method Summary: The purpose of the testing is to provide the user with the dead space volume (fill volume) of the catheters.
Results: Data was collected for the modified (160 cm) device and the predicate device (150 cm). As expected, the new geometry result in slightly larger dead space volume. The passing results within the expected range and therefore are equivalent.

Accessibility/Tractability Test:

Test Method Summary: The purpose is to verify that the modified Catheter can reach M1 region of tortuous neurovascular model. Test were conducted at body temperature, using the appropriate guidewires, guide catheters, RHV and continuous flushing conditions to mimic actual use.
Results: Data was collected for the modified (160 cm) device and the predicate device (150 cm). Similar to the predicate device, all tested articles were able to reach M1 region of model neurovasculature. All samples passed. This confirms functional equivalence between the predicate and the modified device. The added length to the proximal shaft does not affect the working (distal) shaft of the catheter.

Dimensional Verification:

Test Method Summary: Purpose is to verify that all dimensional requirements will meet the specified attributes. Performed visual and dimensional inspection on pre- and post-sterile.
Results: Test samples were inspected and passed the specified attributes as specified. All test articles met the visual and dimensional specifications pre-sterilization and post-sterilization. Modified and predicate device meet the same equivalent requirements.

Material verification:

Test Method Summary: The purpose is to verify that all materials are as specified in raw material, final assembly, subassembly specifications and vendor certifications.
Results: The results verified that all materials are as specified and confirms that all material of the modified device and the predicate are identical therefore equivalent.

Catheter/Guide Catheter Compatibility:

Test Method Summary: The purpose is to verify that the catheter can track through a guiding catheter with an I.D. ≥ 0.0445".
Results: The added length to the proximal shaft does not affect the working (distal) shaft of the catheter that goes through the guide catheter. The passing test results of the predicate device apply to the modified device and therefore equivalent. Results are also confirmed with Accessibility/Tractability Test (above).

Catheter/Guide Wire Compatibility:

Test Method Summary: Catheter is able to track over the guide wire that is ≤ 0.025" in diameter.
Results: The added length to the proximal shaft does not affect the working (distal) shaft of the catheter that goes through the guide catheter. The passing test results of the predicate device apply to the modified device and therefore equivalent. Results are also confirmed with Accessibility/Tractability Test (above).

Catheter/RHV Compatibility and Leakage Verification:

Test Method Summary: Catheter is compatible with rotating hemostasis value (RHV) in dimension and RHV will not leak during use.
Results: The added length to the catheter shaft does not affect the RHV connection. It is the identical RHV. The passing test results of the predicate device apply to the modified device and therefore equivalent.

Shaft Stiffness:

Test Method Summary: Catheter shaft to meet specification on stiffness.
Results: The added length to the proximal shaft does not affect the shaft stiffness of the working (distal) shaft of the catheter that goes into the body. The passing test results of the predicate device apply to the modified device and therefore equivalent. Results are also confirmed with Accessibility/Tractability Test (above).

Chemical Compatibility:

Test Method Summary: Catheter should show no damage when exposed to saline and contrast medium.
Results: Materials are all identical. The passing test results of the predicate device apply to the modified device and therefore equivalent.

Shaping Mandrel compatibility & shapeability:

Test Method Summary: The purpose is to verify that the steam shaping mandrel fits the distal lumen of the catheter; the tip meets retention specification and dimensional shrinkage OD and ID requirements.
Results: The added length to the proximal shaft does not affect the working (distal) shaft of the catheter is subjected to tip shaping. The passing test results of the predicate device apply to the modified device and therefore equivalent.

Kink Resistance:

Test Method Summary: The purpose of the test is to verify that the catheter distal shaft will not kink when tested in accordance with BS EN 13868:2002 Annex A; and lumen integrity when catheter is looped to predetermine diameter. Method, equipment and conditions as prescribed in standard.
Results: The added length to the proximal shaft does not affect the working (distal) shaft of the catheter is subjected to kinking. The passing test results of the predicate device apply to the modified device and therefore equivalent.

Conical Fitting for Hub:

Test Method Summary: The purpose of the test is to verify that the catheter hub will meet the testing requirements as specified in BS EN 1707:1997. Method, equipment and conditions as prescribed in standard.
Results: The added length to the catheter proximal shaft does not affect the hub connection. It is the identical hub. The passing test results of the predicate device apply to the modified device and therefore equivalent.

Corrosion Resistance:

Test Method Summary: Catheter shall show no sign of corrosion per ISO10555-1:2013 Annex A. (material characterization only)
Results: Materials are all identical. The passing test results of the predicate device apply to the modified device and therefore equivalent.

Tensile Strength of catheter body, hub attachment, distal attachment:

Test Method Summary: The tip, distal, mid, proximal and hub junctions should meet the tensile strength requirement per EN ISO-10555-1: Annex B. Method, equipment and conditions as prescribed in standard.
Results: The added length to the proximal shaft does not affect the various catheter segments, hub or distal attachments of the catheter. The passing test results of the predicate device apply to the modified device and therefore equivalent.

Liquid Leakage at Hub:

Test Method Summary: No liquid leakage detected per BS EN ISO 10555-1:2013 Annex C. Method, equipment and conditions as prescribed in standard.
Results: The added length modification does not affect the hub attachments to the catheter. The passing test results of the predicate device apply to the modified device and therefore equivalent.

Air Leakage During Aspiration:

Test Method Summary: No leak detected when tested BS EN ISO 10555-1:2013 Annex D. Method, equipment and conditions as prescribed in standard.
Results: The added length does not affect the various catheter segments and joints of the catheter. The passing test results of the predicate device apply to the modified device and therefore equivalent.

Rupture Pressure:

Test Method Summary: Verify that the catheter can withstand predetermined static and dynamic rupture pressure testing.
Results: The added length does not affect the various catheter segments, joints or methods of fabrication of the catheter. The passing test results of the predicate device apply to the modified device and therefore equivalent.

Particulate:

Test Method Summary: Verify particulate levels catheter.
Results: The added length does not affect the material, method and environment of fabrication of the catheter that affects particulates. The passing test results of the predicate device apply to the modified device and therefore equivalent.

Outer Surface Coating Lubricity and Durability:

Test Method Summary: Test is to verify predetermine friction force of the coating.
Results: The added length to the proximal shaft does not affect the working (distal) shaft of the catheter which is coated. The passing test results of the predicate device apply to the modified device and therefore equivalent.

Flexural Fatigue:

Test Method Summary: The test method is to verify that the catheter structure will remain intact after predetermined number of cycles when used to accessing in a simulated torturous path model.
Results: The added length does not affect the design of the shaft segments or joints of the catheter which affect flexural fatigue. The passing test results of the predicate device apply to the modified device and therefore equivalent.

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.

Phenom® 27 Catheter (510K # K151638)

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.

Not Found

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

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 11, 2018

Cathera, Inc. Victor Ham Chief Regulatory & Quality Officer 627 National Avenue Mountain View, California 94043

Re: K180959

Trade/Device Name: Phenom 27 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: May 30, 2018 Received: May 31, 2018

Dear Victor Ham:

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. Iisting 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 (OS) regulation (21 CFR Part 820);

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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 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,

Xiaolin Zheng -S

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

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Indications for Use

510(k) Number (if known) K180959

Device Name Phenom 27 Catheter

Indications for Use (Describe)

Phenom® Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary - K180959

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Submitted by:

Cathera, Inc. 627 National Ave. Mountain View, CA 94043 Tel.: (650) 388-5088 Fax: (650) 390-0107

Contact Person: Victor Ham

Date summary prepared: April 22, 2018

Trade Name: Phenom® 27 Catheter

Common Name: Catheter

Classification Name & Product Codes:

Percutaneous Catheter (21 CFR 870.1250, Product Code DOY) Continuous Flush Catheter (21 CFR 870.1210, Product Code KRA)

Predicate Devices: Phenom® 27 Catheter (510K # K151638)

Device Description:

The Phenom® 27 Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to aid in navigation in the vessel. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy.

Indications for Use:

Phenom® Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

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Device Comparison of Technological Characteristics

Table A provides a comparison of the technological characteristics of the Phenom® 27 Catheter and the modified Phenom® 27 Catheter with additional effective length.

| Technological
Characteristic | Phenom® 27, predicate
(510k # K151638) | Phenom® 27, modified
(510k # K180959) | Rationale for
Difference (if present) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Phenom® Catheters are intended
for the introduction of
interventional devices and infusion
of diagnostic or therapeutic agents
into the neuro, peripheral, and
coronary vasculatures. | Identical | N/A-No difference |
| Composite Shaft | PTFE composite polymeric
catheter | Identical | N/A-No difference |
| Composite Shaft
support | Stainless Steel Reinforcement | Identical | N/A-No difference |
| Hub | Polyamide | Identical | N/A-No difference |
| Stain Relief | Thermoplastic elastomer | Identical | N/A-No difference |
| Marker(s) | Platinum/Iridium Alloy | Identical | N/A-No difference |
| Coating | Polymeric hydrophilic coating | Identical | N/A-No difference |
| Proximal OD | 3.1F (1.02mm) | Identical | N/A-No difference |
| Distal OD | 2.8F (0.91mm) | Identical | N/A-No difference |
| Proximal ID | 0.027 inches (0.69 mm) | Identical | N/A-No difference |
| Distal ID | 0.027 inches (0.69 mm) | Identical | N/A-No difference |
| Effective Length Range
(cm) | 75 to 150 | 75 to 160 | Increasing the length of the
proximal shaft provide the
physicians extra length for set-
up. Working (distal) shaft of
catheter is the same therefore
equivalent. |
| Tip Configurations | Steam shapeable straight tip | Identical | N/A-No difference |
| Accessories | | | |
| Steam shaping mandrel | Stainless Steel | Identical | N/A-No difference |
| Packaging & Sterilization | | | |
| Packaging materials
and configuration | Catheter package inside
dispensing coil; inside Tyvek®
pouch; inside cardboard box | Identical | N/A-No difference |
| Sterilization | Ethylene Oxide | Identical | N/A-No difference |

Table A-Summary of Technological Characteristics, Components and Materials

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Conclusion- Based on the comparison shown in Table A (above), the technological characteristic of the modified Phenom® 27 and the predicate Phenom® 27 are equivalent. The only design modification was to increase the effective length from 150 cm to 160 cm. This provides the user with additional length during the set-up procedure which does not alter the intended use or the fundamental scientific technology of the device as originally cleared for the predicate device and therefore substantially equivalent.

Performance Testing - Bench

As identified in the risk analysis, the increased length would require testing of the flow rate and dead space volume. Testing was conducted according to the same method used for the original predicate device. Accessibility and tractability testing was performed to verify that modified catheter can reach M1 region of tortuous neurovascular model. The modification to add extra length to the catheter did not affect the design or function of the distal shaft of the catheter that enters the body. All other tests performed on the predicate device apply to the modified version. A summary of the pre-clinical bench testing performed for the Phenom® 27 Catheter and the modified Phenom® 27 Catheter is presented in the Table B below:

Test Description	Test Method Summary	Results
Catheter Flow Rate	The purpose of the testing is to
provide the user with a flow rate
reference when using various
contrast media and pressure
conditions. Similar to the
predicate device, 2 pressure
conditions and 3 commonly
used contrast media are used for
the testing. High pressure vessel
and tank, timer and scale are
used to determine flow rate.	Flow rate data was collected for the
modified (160cm) device and the
predicate device (150cm). As expected,
the new geometry result in slightly
different fluid dynamics (i.e., lower flow
rates). The results are within the expected
range and therefore are equivalent.
Flow rate for each
lumen, according to
ISO 10555-1	Test method is to verify
compliance to catheter standard
BS EN ISO 10555-1: 2013.
Conditions, method and
equipment as prescribed in the
standard.	Flow rate data was collected for the
modified (160 cm) device and the
predicate device (150 cm). As expected,
the new geometry result in slightly
different fluid dynamics (i.e., lower flow
rates). The passing results are within the
expected range and therefore are
equivalent.
Dead Space Volume	The purpose of the testing is to
provide the user with the dead
space volume (fill volume) of
the catheters.	Data was collected for the modified (160
cm) device and the predicate device (150
cm). As expected, the new geometry
result in slightly larger dead space
volume. The passing results within the
expected range and therefore are
equivalent.
Test Description	Test Method Summary	Results
Accessibility/
Tractability Test	The purpose is to verify that the
modified Catheter can reach M1
region of tortuous neurovascular
model. Test were conducted at
body temperature, using the
appropriate guidewires, guide
catheters, RHV and continuous
flushing conditions to mimic
actual use.	Data was collected for the modified (160
cm) device and the predicate device (150
cm). Similar to the predicate device, all
tested articles were able to reach M1
region of model neurovasculature. All
samples passed. This confirms functional
equivalence between the predicate and the
modified device. The added length to the
proximal shaft does not affect the working
(distal) shaft of the catheter.
Dimensional
Verification	Purpose is to verify that all
dimensional requirements will
meet the specified attributes.
Performed visual and
dimensional inspection on pre-
and post-sterile.	Test samples were inspected and passed
the specified attributes as specified. All
test articles met the visual and
dimensional specifications pre-
sterilization and post-sterilization.
Modified and predicate device meet the
same equivalent requirements.
Material verification	The purpose is to verify that all
materials are as specified in raw
material, final assembly,
subassembly specifications and
vendor certifications.	The results verified that all materials are
as specified and confirms that all material
of the modified device and the predicate
are identical therefore equivalent.
Catheter/ Guide
Catheter
Compatibility	The purpose is to verify that the
catheter can track through a
guiding catheter with an I.D.
≥ 0.0445".	The added length to the proximal shaft
does not affect the working (distal) shaft
of the catheter that goes through the
guide catheter. The passing test results of
the predicate device apply to the
modified device and therefore equivalent.
Results are also confirmed with
Accessibility/Tractability Test (above).
Catheter/Guide Wire
Compatibility	Catheter is able to track over the
guide wire that is ≤ 0.025" in
diameter.	The added length to the proximal shaft
does not affect the working (distal) shaft
of the catheter that goes through the
guide catheter. The passing test results of
the predicate device apply to the
modified device and therefore equivalent.
Results are also confirmed with
Accessibility/Tractability Test (above).
Catheter/ RHV
Compatibility and
Leakage
Verification	Catheter is compatible with
rotating hemostasis value (RHV)
in dimension and RHV will not
leak during use.	The added length to the catheter shaft
does not affect the RHV connection. It is
the identical RHV. The passing test
results of the predicate device apply to
the modified device and therefore
equivalent.
Test Description	Test Method Summary	Results
Shaft Stiffness	Catheter shaft to meet
specification on stiffness.	The added length to the proximal shaft
does not affect the shaft stiffness of the
working (distal) shaft of the catheter that
goes into the body. The passing test
results of the predicate device apply to the
modified device and therefore equivalent.
Results are also confirmed with
Accessibility/ Tractability Test (above).
Chemical
Compatibility	Catheter should show no damage
when exposed to saline and
contrast medium.	Materials are all identical. The passing
test results of the predicate device apply
to the modified device and therefore
equivalent.
Shaping Mandrel
compatibility &
shapeability	The purpose is to verify that the
steam shaping mandrel fits the
distal lumen of the catheter; the
tip meets retention specification
and dimensional shrinkage OD
and ID requirements.	The added length to the proximal shaft
does not affect the working (distal) shaft
of the catheter is subjected to tip shaping.
The passing test results of the predicate
device apply to the modified device and
therefore equivalent.
Kink Resistance	The purpose of the test is to
verify that the catheter distal
shaft will not kink when tested
in accordance with BS EN
13868:2002 Annex A; and
lumen integrity when catheter is
looped to predetermine diameter.
Method, equipment and
conditions as prescribed in
standard.	The added length to the proximal shaft
does not affect the working (distal) shaft
of the catheter is subjected to kinking.
The passing test results of the predicate
device apply to the modified device and
therefore equivalent.
Conical Fitting for
Hub	The purpose of the test is to
verify that the catheter hub will
meet the testing requirements as
specified in BS EN 1707:1997.
Method, equipment and
conditions as prescribed in
standard.	The added length to the catheter proximal
shaft does not affect the hub connection.
It is the identical hub. The passing test
results of the predicate device apply to
the modified device and therefore
equivalent.
Corrosion
Resistance	Catheter shall show no sign of
corrosion per ISO10555-1:2013
Annex A.
(material characterization only)	Materials are all identical. The passing
test results of the predicate device apply
to the modified device and therefore
equivalent.
Test Description	Test Method Summary	Results
Tensile Strength of
catheter body, hub
attachment, distal
attachment	The tip, distal, mid, proximal and
hub junctions should meet the
tensile strength requirement per
EN ISO-10555-1: Annex B.
Method, equipment and
conditions as prescribed in
standard.	The added length to the proximal shaft
does not affect the various catheter
segments, hub or distal attachments of the
catheter. The passing test results of the
predicate device apply to the modified
device and therefore equivalent.
Liquid Leakage at
Hub	No liquid leakage detected per
BS EN ISO 10555-1:2013
Annex C. Method, equipment
and conditions as prescribed
in standard.	The added length modification does not
affect the hub attachments to the catheter.
The passing test results of the predicate
device apply to the modified device and
therefore equivalent.
Air Leakage During
Aspiration	No leak detected when tested BS
EN ISO 10555-1:2013 Annex D.
Method, equipment and
conditions as prescribed in
standard.	The added length does not affect the
various catheter segments and joints of
the catheter. The passing test results of
the predicate device apply to the
modified device and therefore equivalent.
Rupture Pressure	Verify that the catheter can
withstand predetermined static
and dynamic rupture pressure
testing.	The added length does not affect the
various catheter segments, joints or
methods of fabrication of the catheter.
The passing test results of the predicate
device apply to the modified device and
therefore equivalent.
Particulate	Verify particulate levels
catheter.	The added length does not affect the
material, method and environment of
fabrication of the catheter that affects
particulates. The passing test results of
the predicate device apply to the
modified device and therefore equivalent.
Outer Surface
Coating Lubricity
and Durability	Test is to verify predetermine
friction force of the coating.	The added length to the proximal shaft
does not affect the working (distal) shaft
of the catheter which is coated. The
passing test results of the predicate
device apply to the modified device and
therefore equivalent.
Flexural Fatigue	The test method is to verify that
the catheter structure will remain
intact after predetermined
number of cycles when used to
accessing in a simulated
torturous path model.	The added length does not affect the
design of the shaft segments or joints of
the catheter which affect flexural fatigue.
The passing test results of the predicate
device apply to the modified device and
therefore equivalent.

Table B- Summary of Pre-Clinical Bench Testing

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Conclusion of the Pre-Clinical Bench Testing

Based on the non-clinical testing provided above in Table B, the proposed modified device is as safe, as effective, and performs as well or better than the legally marketed device. The additional length will assist the user in the set-up procedures without affecting the performance or safety of the device. The accessibility, trackability, high pressure flow rate testing show that the modified device is substantially equivalent to the predicate device.

Substantial Equivalence Determination

The information presented in the 510k shows that the modified Phenom® 27 Catheters are substantially equivalent to predicate Phenom® 27 catheters regarding the following aspects:

Design:	The subject and predicate devices are substantially equivalent with respect to design characteristics. The modified devices provide the user with additional effective length on the proximal shaft of the catheter which remain outside the patient. The working (distal) shaft of the catheter that enters the body is identical.
Function:	The subject and predicate devices are substantially equivalent with respect to functional characteristics. The modified devices provide the user with additional length on the proximal shaft of the catheter to assist in the procedural set-up. The working (distal) portion of the catheter that enters the body is identical. Trackability and accessibility testing was performed to verify that the modified catheter can reach the MI region of the neurovascular model.
Manufacturing:	The subject and predicate devices are the same with respect to technological manufacturing processes.
Materials:	The subject and predicate devices are composed of identical materials, all of which have an extensive clinical history of safe use in medical devices.
Indications:	The subject and predicate devices have identical indications.
Packaging:	The subject and predicate devices utilize same packaging configurations.
Sterilization:	The subject and predicate devices are both sterilized utilizing an Ethylene Oxide sterilization cycle validated in accordance with ISO 11135 - Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization.
Labeling:	Both the subject and predicate devices have similar labeling.

Conclusion for Substantial Equivalence Determination

Based on the comparison of the technological characteristics and the non-clinical testing provided in Table A & Table B (respectively, above), the proposed modified device is as safe, as effective, and performs as well or better than the legally marketed Phenom ® 27. The additional length of the proximal shaft will assist the user in the set-up procedures without affecting the safety performance of the device.

Testing was conducted to show that no new risks were identified, and that the performance and risk profile is the same as the predicate devices cleared for the market. Additional testing as identified in the risk analysis was performed to show that the modified Phenom® 27device is substantially equivalent to the predicate Phenom® 27 device.