(178 days)
The SilverHawk™ Peripheral Plaque Excision System 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™ 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 will be provided sterile for singleuse. 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 106, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1.
The SilverHawk™ Peripheral Plaque Excision System with the additional clinical contraindication statement is identical in material of construction, overall design, intended use, and safety and efficacy to the predicate device.
The provided text is a 510(k) summary for the SilverHawk™ Peripheral Plaque Excision System. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study demonstrating the device meets such criteria.
The document states: "The SilverHawk™ Peripheral Plaque Excision System with the additional clinical contraindication statement is identical in material of construction, overall design, intended use, and safety and efficacy to the predicate device." This indicates that the new device's safety and efficacy are established by its similarity to the already-approved predicate device (K053460), rather than a new standalone study with specific acceptance criteria.
Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them because this information is not present in the provided text. The submission relies on substantial equivalence to a predicate device, which typically means a new clinical study to establish acceptance criteria for the new device is not required or presented in the 510(k) summary.
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K06//88
OCT 2 3 2006
510(k) SUMMARY
Device Name
Classification Name:
Common and Usual Name: Proprietary Name:
Catheter, Peripheral, Atherectomy 21 CFR 8870.4875, Class II Catheter, Peripheral, Atherectomy 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™1 Peripheral Plaque Excision System is intended for atherectomy of the peripheral vasculature and is not intended for use in the coronary, carotid, iliac or renal 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 will be provided sterile for singleuse. 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 106, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1.
The SilverHawk™ Peripheral Plaque Excision System with the additional clinical contraindication statement is identical in material of construction, overall design, intended use, and safety and efficacy to the predicate device.
The SilverHawk™ Peripheral Plaque Excision System with the additional clinical contraindication statement is considered substantially equivalent to the SilverHawk™ Peripheral Plaque Excision System (K053460).
Contact:
Date:
Melissa Murphy Regulatory Compliance Manger FoxHollow Technologies, Inc. 740 Bay Road Redwood City, CA 94063 (650) 421-8579
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2006
FoxHollow Technologies, Inc. c/o Ms. Melissa Murphy Senior Regulatory Specialialist 740 Bay Road Redwood City, CA 94063
Re: K061188
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: October 11, 2006 Received: October 13, 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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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
sama R. Lackines
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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Indications for Use
510(k) Number (if known): . K061188
Device Name: SilverHawk™ Peripheral Plaque Excision System
Indications For Use:
The SilverHawk™ Peripheral Plaque Excision System 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
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Duana R. bochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_406 1188
Page 1 of 1
§ 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).