(53 days)
No
The summary describes a mechanical atherectomy system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for atherectomy of the peripheral vasculature, which is a therapeutic medical procedure to remove plaque causing blockages.
No
The device is described as an "atherectomy system" intended for "plaque excision," which are therapeutic procedures, not diagnostic ones.
No
The device description clearly states it consists of a catheter and a cutter driver, which are hardware components.
Based on the provided information, the SilverHawk Peripheral Plaque Excision System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "atherectomy of the peripheral vasculature." This is a surgical procedure performed in vivo (within the living body) to remove plaque from blood vessels.
- Device Description: The description details a system used during a procedure, consisting of a catheter and a cutter driver. These are instruments used directly on the patient's anatomy.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information about a patient's health status. The SilverHawk system does not perform this function.
Therefore, the SilverHawk Peripheral Plaque Excision System is a surgical device used for an interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
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.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device was shown to have substantially equivalent performance when compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K871011, K874706, K881088, KooJJ40
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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.
2
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
Image /page/2/Picture/5 description: The image contains a handwritten symbol that resembles a cursive letter 'e' or a number '3' with a loop at the top. The symbol is slightly tilted to the left. It is drawn with a thin line, and the overall impression is simple and minimalist.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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