MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300

K061063 · Foxhollow Technologies, Inc. · MCW · May 18, 2006 · Cardiovascular

Device Facts

• Record ID: K061063
• Device Name: MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300
• Applicant: Foxhollow Technologies, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: May 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SilverHawk™ Peripheral Plaque Excision System is intended for use in atherectorny of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.

Device Story

SilverHawk Peripheral Plaque Excision System performs atherectomy in peripheral vasculature. System comprises two components: SilverHawk Peripheral Catheter and SilverHawk Cutter Driver. Used together during atherectomy procedures to excise plaque. Provided sterile for single-use. Catheter sterilized via Ethylene Oxide (ANSI/AAMI/ISO 11135); cutter driver sterilized via Gamma radiation (ANSI/AAMI/ISO 11137). Device operates as a mechanical excision tool. Healthcare providers use the system to remove peripheral arterial plaque, potentially improving blood flow and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and performance comparisons.

Technological Characteristics

Peripheral atherectomy catheter and cutter driver. Biocompatible per ISO-10993-1. Sterilization: Catheter via Ethylene Oxide (ANSI/AAMI/ISO 11135); Cutter Driver via Gamma (ANSI/AAMI/ISO 11137, 25kGy minimum). Single-use.

Indications for Use

Indicated for atherectomy of the peripheral vasculature. Not for use in coronary or carotid vasculature.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• SilverHawk™ Peripheral Plaque Excision System (K053460)

Submission Summary (Full Text)

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# 510(K) SUMMARY

| Classification Name: | Catheter, Peripheral, Atherectomy |
|------------------------|-----------------------------------------------|
| | 21 CFR §870.4875, Class II |
| Common and Usual Name: | Catheter, Peripheral, Atherectomy |
| Proprietary Name: | SilverHawk™ Peripheral Plaque Excision System |

## Predicate Device

The SilverHawk™ Peripheral Plaque Excision System (K053460), currently marketed by FoxHollow Technologies, Inc. (Redwood City, CA).

### Summary

This summary of Special 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.

The SilverHawk™ Peripheral Plaque Excision System is intended for atherectorny of the peripheral vasculature and is not intended for use in the coronary or carotid vasculature. The SilverHawk Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk Peripheral Catheter and SilverHawk Cutter Driver.

The SilverHawk Peripheral Plaque Excision System is provided sterile for single-use. The catheter will be sterilized by Ethylene Oxide (ANSVAAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10°. The cutter driver is sterilized by Gamma Sterilization Cycle (ANSI/AAMI/ISO 11137), providing a minimum SAL of 10°, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1.

The SilverHawk Peripheral Plaque Excision System is substantially equivalent in material of construction, overall design, intended use, and safety and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device.

The SilverHawk Peripheral Plaque Excision System with labeling modifications is considered substantially equivalent to the SilverHawk Peripheral Plaque Excision System (K053460).

Contact Melissa Murphy Senior Regulatory Specialist FoxHollow Technologies, Inc. 740 Bay Road Redwood City, CA 94063 Main Tel [phone]

Date April 14, 2006

www.foxhollowtech.com

740 Sat Rive Redwood City CA 1406 A 1 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 1 : 0 : 10 : 10 :

Image /page/0/Picture/17 description: The image shows the word "FOXHOLLOW" in a stylized, blocky font. The text is white against a black background, creating a high contrast. A horizontal line runs through the middle of each letter, adding a unique design element to the word. The overall effect is bold and eye-catching.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms reaching upwards, enclosed within a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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MAY 1 8 2006

Foxhollow Technologies, Inc. c/o Ms. Melissa Murphy Senior Regulatory Specialist 740 Bay Road Redwood City, CA 94063

Re: K061063

SilverHawk™ Peripheral Plaque Excision System Regulation Number: 21 CFR 870.4875 Regulation Name: Peripheral Atherectomy Catheter Regulatory Class: Class II (Two) Product Code: MCW Dated: April 12, 2006 Received: April 17, 2006

## Dear Ms. Murphy:

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.

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 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 - Ms. Melissa Murphy

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Oma R. Velaner

A 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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510(k) Number if known:

: 2061063

Device Name: SilverHawk™ Peripheral Plaque Excision System

#### INDICATION FOR USE:

Indications for Use: The SilverHawk™ Peripheral Plaque Excision System is intended for use in atherectorny of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.

Prescription Use _ X (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 (ODE)

Duna R. Holmes
(Division Sign-Off)

Division of Cardiovascular Device

510(k) Number_K06106

www.foxhollowtech.com