WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500

K101647 · Avinger, Inc. · DQY · Aug 6, 2010 · Cardiovascular

Device Facts

• Record ID: K101647
• Device Name: WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500
• Applicant: Avinger, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 6, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Wildcat 5F Guidewire Support Catheter is intended 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 Story

Wildcat 5F Guidewire Support Catheter; 5F sheath, 0.014" guidewire compatible over-the-wire device. Consists of catheter shaft, proximal handle assembly, locking luer connector, and atraumatic distal tip. Used in peripheral vasculature to support steerable guidewires, facilitate device exchange, and deliver saline/contrast. Operated by clinicians in interventional settings. Smaller profile (5F) and single-part distal tip with exposed wedges distinguish it from 7F predicate. Single-use; sterilized via irradiation.

Clinical Evidence

Bench testing only. Evaluation included tensile, torque strength, coating integrity, and device compatibility per ISO 10555-1 and EN ISO 10993-1. Performance successfully evaluated in a porcine animal model representing a discrete vascular bed in coronary arteries under GLP-like conditions.

Technological Characteristics

5F sheath, 140 cm working length, 0.014" guidewire compatible. Single-part distal tip with exposed wedges. Materials evaluated per EN ISO 10993-1. Sterilized via irradiation. Single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring support for steerable guidewires to access discrete regions of the peripheral vasculature, including facilitation of guidewire/interventional device placement and exchange, and delivery of saline or contrast.

Regulatory Classification

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.

Predicate Devices

• Wildcat 7F Guidewire Support Catheter (K083313)

Submission Summary (Full Text)

{0}------------------------------------------------

AVINGER

# Section 2: 510(k) Summary (21 CFR § 807.92)

| Submitter: | Avinger; Inc. | AUG 0,6 2010 |
|------------------------|-------------------------------------------------|--------------|
| | 400 Chesapeake Drive | |
| | Redwood City, CA 94063 | |
| Contact: | Himanshu Patel | |
| | Chief Technology Officer | |
| Date Summary Prepared: | 12 July 2010 | |
| Device Trade Name: | Wildcat 5F Guidewire Support Catheter | |
| Common Name: | Guidewire Support Catheter | |
| Classification Name: | Percutaneous Catheter (21 CFR § 870.1250) | |
| Product Code: | DQY | |
| Cleared Device: | Wildcat 7F Guidewire Support Catheter (K083313) | |

## Device Description:

The Wildcat 5F Guidewire Support Catheter is a 5F sheath and 0.014" guidewire compatible over-thewire device. It consists of a catheter shaft with handle assembly at the proximal end an atraumatic distal tip. The catheter has a working length of 140 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.

### Intended Use:

The Wildcat 5F Guidewire Support Catheter is intended 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.

## Nonclinical Performance Data:

Design verification testing was conducted. Such testing confirms that the Wildcat 5F device performs according to the stated intended use. Device evaluation consisted of laboratory testing specified in 10555-1 "Sterile, single-use intravascular catheters – Part 1 – General Requirements" and included tensile, torque strength, coating integrity and device compatibility testing was conducted according to EN ISO 10993-1 "Biological Evaluation of Medical Devices". All data fell well within pre-determined product specifications and external standard requirements. In addition, device

{1}------------------------------------------------

performance was successfully evaluated in a porcine animal model. The test model represented a discrete vascular bed in the coronary arteries under GLP-like conditions.

#### Comparison with Cleared Device:

The Avinger 5F catheter is very similar to the Avinger 7F catheter. Both devices are intended for use with steerable guidewires to access discrete regions of the peripheral vasculature. Additionally, both devices may be used to facilitate placement and exchange of conventional guidewires and to deliver saline or contrast. Both devices are comprised of similar materials and function according to similar operating parameters. There are two primary differences between the modified and cleared devices. First, the modified device is smaller (5F as opposed to the cleared device: Secondly, the distal tip of the modified device is comprised of a single part with atraumatic exposed wedges as opposed to the retractable wedges contained in the larger device.

### Summary:

Based upon the product technical information, intended use, performance and biocompatibility data provided in this premarket notification, the Avinger 5F catheter has been shown to be equivalent to the currently marketed Avinger 7F catheter.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 0 6 2010

Avinger, Inc c/o Mr. Himanshu Patel Chief Technology Officer 400 Chesapeake Drive Redwood City, CA 94063

Re: K101647

Trade/Device Name: Wildcat 5F Guidewire Support Catheter Regulation Number: 21 CFR§ 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 14, 2010 Received: July 15, 2010

Dear Mr Patel:

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. Ilsting 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.

{3}------------------------------------------------

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); medical device reporting (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); 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/CDRHOffices/ucm115809.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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

una R. Vi. hiner

VBram D. Zuckerman, M.D. -Director

Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

AVINGER, INC.

## Section 1: Statement of Indications for Use

510(k) Number if known: 780-> K10 (k) 1 1 7

Device Name: Wildcat 5F Guidewire Support Catheter

AUG 0 6 2010

Indications for Üse:

The Wildcat 5F Guidewire Support Catheter is intended 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.

ಸ Prescription Use: (Per 21 CFR § 801, Subpart D)

AND/OR

Over-the-Counter Use _ (Per 21 CFR §807, Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (Division Sign-Jevices Page 2 CONFIDENTIAL

510(k) Number_