(31 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The device description focuses on mechanical components for plaque excision.
Yes
The device is intended for atherectomy of the peripheral vasculature, which is a procedure to remove plaque buildup and treat conditions like peripheral artery disease, thereby having a therapeutic effect on the patient's condition.
No
Explanation: The device description clearly states its purpose is for "atherectomy of the peripheral vasculature," which is a treatment procedure for removing plaque, not diagnosing conditions.
No
The device description explicitly states it consists of two major components: a catheter and a cutter driver, which are hardware components used in an atherectomy procedure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "atherectomy of the peripheral vasculature." This is a surgical procedure performed in vivo (within the body) to remove plaque from blood vessels.
- Device Description: The device is a "Peripheral Plaque Excision System" consisting of a catheter and a cutter driver. These are tools used for a physical intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information.
IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device is used for treatment (removing plaque), not for diagnosis.
N/A
Intended 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.
Product codes
MCW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The subject device was shown to have substantially equivalent performance when compared to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 (650) 421-8400
Date April 14, 2006
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
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
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 (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 (301) 443-6597 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
3
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