WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S

K102022 · Avinger, Inc. · DQY · Aug 6, 2010 · Cardiovascular

Device Facts

• Record ID: K102022
• Device Name: WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S
• 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 6F 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

The Wildcat 6F Guidewire Support Catheter is an over-the-wire device designed for peripheral vascular access. It features a 6F catheter shaft, a proximal handle assembly, and an atraumatic distal tip with articulation capabilities. The device is compatible with 0.035" guidewires and is available in 110 cm or 135 cm lengths. Operated by clinicians in an interventional setting, the catheter is inserted into the vasculature to provide support for steerable guidewires, facilitate the exchange of interventional tools, and serve as a conduit for saline or contrast delivery. The device is single-use and sterilized via irradiation. By providing a stable platform for guidewire navigation, it assists physicians in reaching discrete vascular regions, potentially improving the efficiency and success of interventional procedures.

Clinical Evidence

Bench testing only. Evaluation included tensile strength, torque strength, coating integrity, and device compatibility per ISO 10555-1. Biocompatibility testing was performed according to EN ISO 10993-1. All results met pre-determined product specifications and external standard requirements.

Technological Characteristics

6F sheath, 0.035" guidewire compatible, over-the-wire catheter. Features proximal handle, locking luer connector, and articulated distal tip. Available in 110 cm or 135 cm lengths. Sterilized via irradiation. Testing conducted per ISO 10555-1 and EN ISO 10993-1.

Indications for Use

Indicated for use in patients requiring peripheral vasculature access to support steerable guidewires, facilitate placement/exchange of interventional devices, and deliver saline or contrast media.

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)

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K102022 page 1 of

6 2010

AVINGER, INC.

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

| Submitter: | Avinger, Inc.<br>400 Chesapeake Drive | |
|------------------------|-------------------------------------------------|-----|
| | Redwood City, CA 94063 | |
| Contact: | Himanshu Patel<br>Chief Technology Officer | AUG |
| Date Summary Prepared: | 15 July 2010 | |
| Device Trade Name: | Wildcat 6F 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 6F Guidewire Support Catheter is a 6F sheath and 0.035" guidewire compatible over-thewire device. It consists of a catheter shaft with handle assembly at the proximal end an atraumatic distal tip. The catheter is available in two sizes with a working length of either 110 cm or 135 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 6F 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 6F 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. Biocompatibility testing was

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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.

### Comparison with Cleared Device:

The Avinger 6F 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 three primary differences between the modified and cleared devices. First, the modified device has a smaller profile (6F as opposed to 7F) as compared to the cleared device. Second, the distal tip has been modified to allow for articulation. Lastly, the 6rd clevice will be offered in two working lengths to accommodate various access procedures.

#### Summary:

Based upon the product technical information, intended use, and performance data provided in this premarket notification, the Avinger 6F catheter has been shown to be equivalent to the currently marketed Avinger 7F catheter.

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

AUG - 6 2010

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

Re: K102022

Trade/Device Name: Wildcat 6F Guidewire Support Catheter Regulation Number: 21 CFR§ 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: July 16, 2010 Received: July 19, 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, 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.

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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); 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/CDRH/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

una R. Laline

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

Enclosure

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AVINGER, INC.

# Section 1: Statement of Indications for Use

510(k) Number if known: TBD KIO 2022

Device Name: Wildcat 6F Guidewire Support Catheter

AUG - 6 2010

Indications for Use:

The Wildcat 6F 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.

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

AND/OR

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

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Concurrence of CDRH, Office of 욕ூர்ட்டி நடிப்பூர்மடும்

(Division Sign-Off)

CONFIDENTIAL

DIVISION OF OCT OF Childing Security Devisor

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510(k) Number K 102022