The Wildcat 7F Guidewire Support Catheter 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/contrast.

Device Description

The Avinger Wildcat 7F Guidewire Support Catheter (Wildcat 7F) is a sterile, single-use, disposable catheter designed to support steerable guidewires in accessing discrete regions within the peripheral vasculature. The Avinger Wildcat 7F catheter consists of a distal tip, catheter shaft and proximal handle that allows for device manipulation and a means for flushing the catheter lumen. The catheter has a working length of 135 cm and is compatible with 0.035" guidewires. Two key elements of the device define the treatment modality - the distal tip and bilateral wedges. Both elements are visible through fluoroscopy and support steerable guidewires in accessing the discrete region of interest within the peripheral vasculature. Subsequent to conventional guidewire placement, athetercomy devices, PTCA catheters and/or stents may be used to provide therapeutic benefit. The Wildcat 7F catheter in and of itself does not provide any therapeutic benefit beyond simple facilitation of guidewire support.

AI/ML Overview

This 510(k) summary (K083313) for the Avinger Wildcat 7F Guidewire Support Catheter focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through a traditional clinical study with acceptance criteria. Therefore, the information typically requested regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, and MRMC studies is not directly applicable or available in this submission.

Here's a breakdown of the provided information in relation to your request, highlighting what is present and what is absent:

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) based on substantial equivalence, there are no specific "acceptance criteria" presented in terms of clinical performance metrics like sensitivity, specificity, or accuracy. Instead, the device's performance is assessed against established standards and predicate devices.

Performance Aspect	Acceptance Criteria (Implied by Standards/Predicate)	Reported Device Performance
Mechanical Properties	Compliance with ISO10555-1 requirements for sterile, single-use intravascular catheters (tensile, torque strength, coating integrity, device compatibility).	"All data fell well within pre-determined product specifications and external standard requirements."
Biocompatibility	Compliance with ISO 10993 "Biological Evaluation of Medical Devices".	"Biocompatibility testing was conducted according to ISO 10993..." (implies compliance, as no issues were noted).
Functional Equivalence	Ability to support steerable guidewires in accessing discrete regions of the peripheral vasculature; facilitate placement/exchange of guidewires and other interventional devices; and deliver saline/contrast. Functionality similar to predicate devices (Asahi Tornus, GOPHER).	"Design analysis data confirm that the Wildcat device performs according to the stated intended use." "The Avinger Wildcat Guidewire Support Catheter is substantially equivalent to the Asahi Tornus and GOPHER support catheters."
Use Environment	Performance demonstrated in a relevant biological model.	"Device performance was successfully evaluated in a porcine animal model."

2. Sample size used for the test set and the data provenance

Test set sample size: Not applicable/not specified. The nonclinical performance data is based on laboratory testing and an animal model, not a human clinical test set.
Data provenance: Laboratory testing results and data from a porcine animal model. Country of origin for the lab testing is not specified, but the submission is from a US company (Avinger, Inc.). The data is prospective for the specific tests conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As this is not a human clinical study, there was no "test set" requiring expert ground truth in the traditional sense of medical image or clinical outcome assessment. The evaluation relies on engineering and biological testing standards.

4. Adjudication method for the test set

Not applicable. There was no test set requiring expert adjudication.

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

Not applicable. This device is a guidewire support catheter, not an AI-powered diagnostic tool. MRMC studies are not relevant to its regulatory pathway.

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

Not applicable. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" for the nonclinical performance data is based on:
- Engineering specifications and international standards: For mechanical properties (e.g., tensile strength, torque strength, ISO10555-1).
- Biocompatibility standards: For material safety (ISO 10993).
- Physiological observation: In the porcine animal model, demonstrating the catheter's ability to support guidewires and access vessels.
- Comparison to predicate devices: The functional performance is considered "ground truth" by demonstrating equivalence to devices already legally marketed and presumed safe and effective.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

Not applicable. There is no concept of a training set or its ground truth for this device.

Summary

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AVINGER, INC

FEB = 2 2009

SECTION 5: 510(k) SUMMARY (21 CFR §807.92(c))

Submitter:

Avinger, Inc. 400 Chesapeake Dr Redwood City, CA 94063 Phone: 650.216.7400 Fax: 650.216.7406

Contact:

Himanshu Patel President & CEO

Date Summary Prepared: November 7, 2008

DQY

Device Trade Name:

Wildcat 7F Guidewire Support Catheter

Common Name:

Guidewire Support Catheter

Classification Name:

Product Code:

Equivalent Device(s):

Asahi Tornus Support Catheter (K060745) . manufactured by Asahi Intecc Co., Ltd.
Percutaneous Catheter (21 CFR §870.1250)
. GOPHER Support Catheter (K070372) manufactured by Vascular Solutions, Inc.

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Device Description:

The Avinger Wildcat 7F catheter consists of a distal tip, catheter shaft and proximal handle that allows for device manipulation and a means for flushing the catheter lumen. The catheter has a working length of 135 cm and is compatible with 0.035" guidewires. Two key elements of the device define the treatment modality - the distal tip and bilateral wedges. Both elements are visible through fluoroscopy and support steerable guidewires in accessing the discrete region of interest within the peripheral vasculature.

Subsequent to conventional guidewire placement, athetercomy devices, PTCA catheters and/or stents may be used to provide therapeutic benefit. The Wildcat 7F catheter in and of itself does not provide any therapeutic benefit beyond simple facilitation of guidewire support.

Intended Use:

Nonclinical Performance Data:

Design analysis data confirm that the Wildcat device performs according to the stated intended use. Device evaluation consisted of laboratory testing specified in ISO10555-1 Sterile, single-use intravascular catheters - Part I -General Requirements (1995-06-15) and included tensile, torque strength, coating integrity and device compatibility. Biocompatibility testing was conducted according to ISO 10993 "Biological Evaluation of Medical Devices". All data fell well within pre-determined product specifications and external standard requirements. In addition, device performance was successfully evaluated in a porcine animal model.

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Statement of Equivalence:

The Avinger Wildcat Guidewire Support Catheter is substantially equivalent to the Asahi Tornus and GOPHER support catheters. Both the subject device and predicate devices are intended for use with steerable guidewires to access discrete regions of the peripheral vasculature. Additionally, both the subject and predicate devices may be used to facilitate placement and exchange of guidewires and/or other interventional devices. Like the GOPHER catheter, the Avinger device may also be used to infuse/deliver saline or contrast. However, unlike the GOPHER device, the Avinger catheter is indicated for use in the peripheral vasculature only.

The subject and predicate devices are made of similar materials and function according to similar operating principles. Both Gopher and Wildcat devices contain a threaded distal tip which allows for vascular access and guidewire exchange. Additionally, both the subject and predicate devices are compatible with standard guidewires to facilitate peripheral inferventional procedures. All devices are designed to support the guidewire while accessing discrete regions of the vascular anatomy.

Summary: -

Based upon the product technical information, intended use, performance and biocompatibility information provided in this pre-market notification, the Avinger Wildcat Catheter has been shown to be substantially equivalent to currently marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFR = 2 2009

Avinger, Inc. c/o Mr. Himanshu Patel President and CEO 400 Chesapeake Drive Redwood City, CA 94063

Re: K083313

Wildcat 7F Guidewire Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter_ Regulatory Class: Class II Product Code: DQY Dated: November 7, 2008 Received: November 10, 2008

Dear Mr. Patel:

We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the excience)76, 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may of subject to case of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Himanshu Patel

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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Prescription Use

(Per 21 CFR 801 Subpart D)

Over-the-Counter Use

(Per 21 CFR 807 Subpart C)

SECTION 4: INDICATIONS FOR USE STATEMENT

RO83313 510(k) Number if known: 489-Device Name: Wildcat 7F Guidewire Support Catheter Indications for Use:

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 CONFIDENTIAL

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).