(53 days)
The SilverHawk Peripheral Plaque Excision System is intended for use in atherectomy 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 will be provided sterile for single-use.
The SilverHawk Peripheral Plaque Excision System is a medical device intended for atherectomy of the peripheral vasculature. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device. Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth for a de novo study is not directly available in this summary.
However, based on the provided text, here's what can be inferred and stated:
1. Table of Acceptance Criteria and Reported Device Performance
Strict acceptance criteria and detailed performance metrics are not explicitly stated in this 510(k) summary, as the submission is based on demonstrating substantial equivalence to a predicate device rather than a de novo approval requiring a set of performance benchmarks. The "performance" reported is primarily in the context of being substantially equivalent to the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (ReFORM Peripheral Catheter System (K024243)) in material, design, intended use, safety, and efficacy. | The SilverHawk Peripheral Plaque Excision System was shown to have "substantially equivalent performance" when compared to the predicate device. The FDA concurred with this determination. |
| Biocompatibility | The device is biocompatible per ISO-10993-1. |
| Sterility Assurance Level (SAL) for catheter | Validated to a SAL of 10-6 for Ethylene Oxide sterilization. |
| Sterility Assurance Level (SAL) for cutter driver | Validated to a minimum SAL of 10-6 by Gamma Sterilization Cycle (VDmax method, minimum dose of 25kGy). |
| Ethylene Oxide residuals | Limits for Ethylene Oxide residuals were met during sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not detail a specific clinical test set for the SilverHawk Peripheral Plaque Excision System. The "performance" is assessed based on comparison to the predicate device, which would involve engineering, bench, and potentially animal testing data, but the specific sample sizes for these tests are not provided. The data provenance is not mentioned as this is a regulatory submission rather than a clinical study report.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As this is a 510(k) submission based on substantial equivalence, the "ground truth" for device performance is largely established through comparison to the predicate device's known performance characteristics and regulatory clearances, not through expert consensus on a new clinical test set for the SilverHawk device itself in this document.
4. Adjudication Method for the Test Set
Not applicable. There is no described "test set" in the context of a prospective clinical trial requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not describe a MRMC comparative effectiveness study involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is not an AI algorithm. It is a physical medical device (atherectomy catheter system). Therefore, the concept of "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness profile of the predicate device (ReFORM Peripheral Catheter System, K024243), as determined by its previous FDA clearance and market performance. The goal of this 510(k) is to demonstrate that the SilverHawk system is "substantially equivalent" to this established ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI algorithm.
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Ko43555
SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
Classification Name:
Common and Usual Name: Proprietary Name:
Catheter, Peripheral, Atherectomy 21 CFR §870.4875, Class II Catheter, Peripheral, Atherectomy SilverHawk Peripheral Plaque Excision System
Predicate Device
The ReFORM Peripheral Catheter System (K024243), 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 atherectomy 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 atherectorny procedures. The two components are the SilverHawk Peripheral Catheter and SilverHawk Cutter Driver.
The SilverHawk Peripheral Plaque Excision System will be provided sterile for single-use. The catheter will be sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10th. 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 is considered substantially equivalent to the ReFORM Peripheral Catheter System (#K024243).
Contact:
December 22, 2004 Date:
Melissa Murphy Regulatory Specialist FoxHollow Technologies, Inc. 300 Saginaw Drive Redwood City, CA 94063 (650) 421-8579
::.223, 1.054" WATER BACKUP
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FoxHollow Technologies, Inc. c/o Ms. Melissa Murphy Regulatory Specialist 300 Saginaw Drive Redwood City, CA 94063
Re: K043553
Trade Name: Catheter, Peripheral, Atherectomy Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: December 22, 2004 Received: December 27, 2004
Dear Ms. Murphy:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your Section 310(x) premaince is substantially equivalent (for the indications for use stated in the enclosure) the devices marketed predicate devices marketed in interstate for tise stated in the encrosure, to regary manatise in the Medical Device American walls of the land Food. Drug commerce provide to May 20, 1978, the excordance with the provisions of the Federal Food, Drug. devices may nave occh recuired in asses approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require subject to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the fiel 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 If your device ts classified (soc aborto) als. Existing major regulations affecting your device can thay be subject to suell additional controlions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous ceements 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 Please be advised fill IDA's issualled of a subscription with other requirements of the Act
that FDA has made a determination that your device complies with of any must that FDA nas made a delectimation administered by other Federal agencies. You must as and list or any Federal statutes and regulations daminding, but not limited to: registration and listing (2) comply with all the Act 3 requirements, merces and acturing practice requirements as set CFR Part 807), labeling (21 CFR Part 801), good manart 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections of Concerned in your device as described in your Section 5 10(k) I his letter will anow you to ocgin maneting of substantial equivalence of your device to a legally premarket nothleation. The PDA maing of bactuation 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 If you desire specific advice for your ac not and and and the regulation entitled, Colliact the Office of Complance at (216) 21 (21CFR Part 807.97). You may obtain "Misbranding by relevelec to premance notifications in the Act from the Division of Small other general miorination on your responsibility of the toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sinccrelv yours,
Dina R. Vochner
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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): ____________________________________________________________________________________________________________________________________________________
SilverHawk Peripheral Plaque Excision System Device Name:
Indications For Use:
The SilverHawk Peripheral Plaque Excision System is intended for use in atherectorny of the the Siren awn i enphord i chiphord is not intended for use in the coronary or carotid vasculature.
The intended use of the SilverHawk Peripheral Plaque Excision System is identical to the The Intended use of the Gilver lawn Peripheral Catheter System which was found to be approved indication for the Re. only of Peripheral Atherocath (K871011, K874706, K881088 substantially equivalent to the SilverHawk Peripheral Plaque Excision System and the ReForm and KooJJ40). Don't the Oliver latin't exphonal Friday of the peripheral vasculature and neither device is intended for use in the coronary or carotid vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)
Dunia R. Vollmer
(Division Sian-Off) Division of Cardiovascular Devices
510(k) Number_K043553
§ 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).