The Wildcat 5F Guidewire Support Catheter (Kittycat 2) is intended to be used to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and, other interventional devices. It may also be used to deliver sàline or contrast.

Device Description

The Wildcat 5F Guidewire Support Catheter (Kittycat 2) is a 5F sheath and 0.014" guidewire compatible over-the-wire device. It consists of a catheter shaft with handle assembly at the proximal end and an atraumatic distal tip. The catheter is available in a working length of 150 cm. A locking luer connector at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only.

AI/ML Overview

The provided text describes the regulatory submission for the Wildcat 5F Guidewire Support Catheter (Kittycat 2) and its substantial equivalence to a predicate device. However, it does not contain a detailed study with specific acceptance criteria, sample sizes, expert qualifications, or ground truth establishment for AI/algorithm performance. The document focuses on non-clinical performance testing to demonstrate the device's functionality and safety based on pre-determined product specifications and external standard requirements.

Therefore, many of the requested items cannot be extracted directly from the provided text.

Here is the information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance

The document states that "All data fell well within pre-determined product specifications and external standard requirements." However, the specific quantitative acceptance criteria and the exact reported performance values are not detailed in the provided text. The non-clinical tests conducted include:

Acceptance Criteria (Inferred from tests)	Reported Device Performance (General Statement)
Visual and Dimensional Verification	Data fell well within pre-determined product specifications and external standard requirements.
Tensile Testing	Data fell well within pre-determined product specifications and external standard requirements.
Torque Testing	Data fell well within pre-determined product specifications and external standard requirements.
Guidewire advancement capability	Data fell well within pre-determined product specifications and external standard requirements.
Device Advancement capability	Data fell well within pre-determined product specifications and external standard requirements.
Tip Deflection Testing	Data fell well within pre-determined product specifications and external standard requirements.
Device leak testing	Data fell well within pre-determined product specifications and external standard requirements.
Luer Leak Testing	Data fell well within pre-determined product specifications and external standard requirements.
Flexibility/Trackability	Data fell well within pre-determined product specifications and external standard requirements.
Spiral Blade Functional Testing	Data fell well within pre-determined product specifications and external standard requirements.
Coating Friction Testing	Data fell well within pre-determined product specifications and external standard requirements.
Biocompatibility	Data fell well within pre-determined product specifications and external standard requirements.
In Vitro Simulated Use Testing	Data fell well within pre-determined product specifications and external standard requirements.
Packaging Testing	Data fell well within pre-determined product specifications and external standard requirements.
Shipping Testing	Data fell well within pre-determined product specifications and external standard requirements.
Shelf Life Testing	Data fell well within pre-determined product specifications and external standard requirements.
Sterility Testing	Data fell well within pre-determined product specifications and external standard requirements.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for each test. The data provenance is not mentioned, but it refers to "non-clinical testing," which typically implies laboratory-based or in-vitro tests rather than human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the study described is for a medical device (guidewire support catheter) and involves non-clinical performance testing, not diagnostic or image interpretation tasks requiring clinical expert review for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the type of non-clinical device performance testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was conducted or mentioned in the provided text, as the device is a physical medical instrument, not an AI or diagnostic application.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable, as the device is a physical medical instrument and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance testing, the "ground truth" would be established by the pre-determined product specifications and external standard requirements for each test (e.g., a specific tensile strength value, a certain flexibility parameter, evidence of no leaks, etc.). This is not clinical ground truth.

8. The sample size for the training set

This information is not applicable, as no AI model or algorithm requiring a training set is involved.

9. How the ground truth for the training set was established

This information is not applicable, as no AI model or algorithm requiring a training set is involved.

Summary

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K112579 page 1 of 3

OCT - 6 2011

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

A. Name and Address of Applicant Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063 B. Contact Person Sevrina Ciucci Regulatory Affairs Consultant (408) 316-4837

C. Date Prepared

September 2, 2011

D. Device Name

Trade Name:	Wildcat 5F Guidewire Support Catheter (Kittycat 2)
Common Name:	Guidewire Support Catheter
Classification Name:	Percutaneous Catheter

E. Device Classification

Classification:	21 CFR §870.1250
Product Code:	DQY
Device Class:	Class II

F. Predicate Device

The Avinger Wildcat 5F Guidewire Support Catheter (Kittycat 2) is substantially equivalent to the Avinger Wildcat 5F Guidewire Support Catheter (K101647).

Device Description G.

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H. Intended Use

The Wildcat 5F Guidewire Support Catheter (Kittycat 2) is intended to be used to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It.may also be used to deliver saline or contrast.

l. Substantial Equivalence

The Avinger Wildcat 5F Guidewire Support Catheter (Kittycat 2) is substantially equivalent to the Avinger Wildcat 5F Guidewire Support Catheter (K101647). The subject and predicate devices have the same mechanism of action (manual advancement) and perform the same function (access discrete regions of the peripheral vasculature). The primary differences between the subject and predicate device consist of an increased device working length and modifications to the Distal Tip deflection mechanism. The Slider based Distal Tip deflection mechanism was eliminated in favor of a pre-shaped Distal Tip. This modification required changes to the Distal Tip Scaffold, Distal Tip / Torque Shaft attachment, and Driveshaft construction. In addition, a change to the Fluid Seal Tube dimensions located in the Handle was made for ease of manufacturing purposes. The changes to the Wildcat 5F Guidewire Support Catheter cleared under K101647 results in no significant changes to technological characteristics and does not raise any new issues of safety or effectiveness.

J. Non-Clinical Performance Data

The following non-clinical testing was conducted to support a determination of substantial equivalence to the predicate device.

• Visual and Dimensional Verification	• Spiral Blade Functional Testing
• Tensile Testing	• Coating Friction Testing
• Torque Testing	• Biocompatibility
• Guidewire advancement	• In Vitro Simulated Use Testing
• Device Advancement	• Packaging Testing
• Tip Deflection Testing	• Shipping Testing
• Device leak testing	• Shelf Life Testing
• Luer Leak Testing	• Sterility Testing
• Flexibility/Trackability

The above testing confirmed that the Wildcat 5F Guidewire Support Catheter (Kittycat 2) performs according to the stated intended use. All data fell well within pre-determined product specifications and external standard requirements.

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Results of non-clinical testing demonstrated that the Wildcat 5F Guidewire Support Catheter (Kittycat 2) is substantially equivalent to the predicate device

K. Conclusions

for its intended use.

The Avinger Wildcat 5F Guidewire Support Catheter (Kittycat 2) has been carefully compared to a legally marketed device with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the Wildcat 5F Guidewire Support Catheter (Kittycat 2) functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate device for its intended use.

KI12579

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with three lines extending from its head.

1 .

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20995-0002

Avinger, Inc. clo Sevrina Ciucci 400 Chesapeake Dr. Redwood City, CA 94063

OCT - 6 2011

Re: K112579

K 112579
Trade/Device Name: Wildcat 5F Guidewire Support Catheter (Kittycat 2)
1777 177 1978 1978 1978 1959 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: September 2, 2011 Received: September 6, 2011

Dear Ms. Ciucci:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(8) premation in the may markets (for the indications).
referenced above and have determined the device is substant in interstate referenced adove and have ucterinined the acted predicate devices marketed in interstate for use stated in the encrosury maneted provide in the Medical Device Ameridaents, or to commerce pror to May 20, 1970, the enaement and of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the discribed PRAA devices that have been reclassified in accordance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premissions of the Act and Cosmetic Act (Act) that do not require approvince of the general controls provisions of the Act. The You may, therefore, market the device, belyer to the more of the manual registration, listing of general controls provisions of the Fee more of the more of the misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. TTCase note: CDTCP doos nateling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or classion ass be If your device is classified (500 above) in this in the major regulations affecting your device can be finay be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in the Gode of reacting your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised hat i Dri s tissumes of a celebrainments of the requirements of the Act mat i DA has made a determinations administered by other Federal agencies. You must of any I city all the Act's requirements, including, but not limited to: registration and listing (21 Compy with an the Hel Frequirements
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 – Ms. Sevrina Ciucci

device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours.

/CC

fr. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K/ 2579

Wildcat 5F Guidewire Support Catheter (Kittycat 2) Device Name:

Indications for Use:

Prescription Use X

Over-The-Counter Use

(per 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number

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).