(265 days)
The SilverHawk™-R Peripheral Plaque Excision System for Surgical Use is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary, carotid, iliac or renal vasculature.
The SilverHawk-R Peripheral Plaque Excision System for Surgical Use consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk-R Peripheral Catheter and SilverHawk Cutter Driver.
The SilverHawk-R Peripheral Plaque Excision System for Surgical Use is provided sterile for single-use. The catheter is sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 106. The cutter driver is sterilized by Gamma Sterilization Cycle (ANSI/AAMI/ISO 11137), providing a minimum SAL of 108, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1.
This device is an atherectomy system. The provided text is a 510(k) summary for the SilverHawk-R Peripheral Plaque Excision System. It establishes substantial equivalence to a predicate device but does not contain information on acceptance criteria or a study proving that the device meets specific performance criteria.
Therefore, I cannot provide the requested information from the given text. The 510(k) summary focuses on demonstrating equivalence to a previously cleared device based on material, design, indications for use, safety, and efficacy, rather than detailing specific performance targets and studies to meet them for this particular submission.
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K071432 $\beta_{c.j^2}$ $l^p$
FEB 1 2 2008
Special 510(k)
510(K) SUMMARY
Device Name
| Classification Name: | Catheter, Peripheral, Atherectomy21 CFR §870.4875, Class II |
|---|---|
| Common and Usual Name: | Catheter, Peripheral, Atherectomy |
| Proprietary Name: | SilverHawkTM-R Peripheral Plaque Excision System forSurgical Use |
Predicate Device
The SilverHawk Peripheral Plaque Excision System (K061188), currently marketed by FoxHollow Technologies, Inc. (Redwood City, CA).
Summary
This summary of Special 510(k) substantial equivalence is being submitted in accordance with requirements of SMDA 1990.
The SilverHawk-R Peripheral Plaque Excision System for Surgical Use is intended for atherectomy of the peripheral vasculature and is not intended for use in the coronary, carotid, iliac or renal vasculature. The SilverHawk-R Peripheral Plaque Excision System for Surqical Use consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk-R Peripheral Catheter and SilverHawk Cutter Driver.
The SilverHawk-R Peripheral Plaque Excision System for Surgical Use is provided sterile for single-use. The catheter is sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 106. The cutter driver is sterilized by Gamma Sterilization Cycle (ANSI/AAMI/ISO 11137), providing a minimum SAL of 108, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1.
The SilverHawk-R Peripheral Plaque Excision System for Surgical Use is substantially equivalent in material of construction, overall design, indication for 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-R Peripheral Plaque Excision System for Surgical Use with the proposed modifications to facilitate the break down of complex, hard, calcified tissue that may be resistant to conventional treatment, is considered substantially equivalent to the SilverHawk Peripheral Plaque Excision System (K061188).
Contact
Melissa S. Murphy Requlatory Affairs Manager FoxHollow Technologies, Inc. 740 Bay Road Redwood City, CA 94063 Main Tel (650) 421-8400
Date
May 22, 2007
CONFIDENTIAL
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FEB 1 2 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FoxHollow Technologies, Inc. c/o Ms. Melissa Murphy Regulatory Affairs Manager 740 Bay Road Redwood City, CA 94063
Re: K071432
SilverHawk-R Peripheral Plaque Excision System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: MCW Dated: February 7, 2008 Received: February 8, 2008
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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Please be adviscd 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 Biometric's (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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510(k) Number if known: Device Name: SilverHawk™-R Peripheral Plaque Excision System for Surgical Use
INDICATION FOR USE:
Indications for Use: The SilverHawk™-R Peripheral Plaque Excision System for Surgical Use is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary, carotid, iliac or renal 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)
B. Bynum
Air Sign-Off
sion of Cardiovascular Devices
510(k) Number K071432
CONFIDENTIAL
Page 14 of 44
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).