The Smith & Nephew TriVex™ System consists of a control unit mounted on a pedestal stand, dual peristaltic pumps, an illuminator, resector handpiece and footswitches.

AI/ML Overview

The Smith & Nephew TriVex™ System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Performance Metric	Reported Device Performance
Biocompatibility requirements (ISO 10993-1)	Meets biocompatibility requirements.
Electrical safety standards for BF type equipment (UL 60601-1 and IEC 60601-1)	Meets electrical safety standards. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Substantial Equivalence to Predicate Devices	The device is deemed "substantially equivalent in Intended Use and Fundamental Scientific Technology" and "substantially equivalent in design, materials, function and intended use" to the predicate devices: Dyonics® Varicose Vein Ablation System (K990723), Subcutaneous Illuminator (K991323), Smith & Nephew Xenon Light Source (K994084), and H.K. Surgical Klein Pump (K012044). No specific numerical performance metrics are provided for the TriVex system's efficacy in vein ablation or resection beyond this statement of equivalence.

2. Sample Size and Data Provenance for Test Set:

The provided document does not contain any information about sample sizes for a test set or the provenance of any clinical data (e.g., country of origin, retrospective or prospective). The submission primarily focuses on substantial equivalence based on technological characteristics and safety standards.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

This information is not provided in the document. As no clinical test set performance data is detailed, information about experts for ground truth establishment is absent.

4. Adjudication Method for Test Set:

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention or describe any MRMC comparative effectiveness study comparing human readers with and without AI assistance. This device is not an AI-powered diagnostic system; it's a surgical tool.

6. Standalone (Algorithm Only) Performance Study:

The document does not describe any standalone algorithm performance, as the device is a physical surgical system, not an algorithm.

7. Type of Ground Truth Used:

Based on the provided text, the "ground truth" for the device's acceptance is based on its compliance with established safety and biocompatibility standards (ISO 10993-1, UL 60601-1, IEC 60601-1) and its substantial equivalence to existing legally marketed predicate devices in terms of intended use, design, materials, and function. There is no mention of clinical outcome ground truth in a study.

8. Sample Size for Training Set:

This information is not applicable and not provided. The TriVex™ System is a medical device, not an AI model requiring a training set in the conventional sense. Its "training" would be through engineering design, material selection, and manufacturing processes, guided by established standards and predicate device characteristics, not data-driven machine learning.

9. How Ground Truth for Training Set Was Established:

This information is not applicable and not provided. The "ground truth" for the development of such a device stems from engineering principles, regulatory compliance requirements, and the established safety and efficacy of the predicate devices it aims to be equivalent to.

In summary:

The acceptance of the Smith & Nephew TriVex™ System by the FDA, as indicated by the 510(k) clearance (K032387), is based on its demonstration of substantial equivalence to existing predicate devices and its compliance with relevant biocompatibility and electrical safety standards. The submission focuses on these aspects rather than detailed clinical performance studies with specific patient or image-based test sets, which are typically required for diagnostic algorithms or novel therapeutic devices requiring extensive clinical validation.

Summary

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Endoscopy Smith & Nephew, Inc 150 Minuteman Road Andover, MA 01810

978 749 1000 978 749 1599 Fax www.smith-nephew.com OCT 2 9 2003

K032387(pg 1 of 2)

SECTION IV

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Date Prepared: July 31, 2003

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

B. Company Contact:

Karen Provencher Regulatory Affairs Specialist Phone: 978-749-1365 Fax: 978-749-1443

C. Device Name

Trade Name:	Smith & Nephew TriVex TM System
Common Name:	Varicose Vein Ablation System
Classification Name:	Stripper, Vein, External

D. Predicate Devices

The Smith & Nephew TriVex™ System is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Dyonics® Varicose Vein Ablation System - K990723, Subcutaneous Illuminator - K991323, Smith & Nephew Xenon Light Source -K994084, and H.K. Surgical Klein Pump - K012044.
Smith & Nephew TriVex™ System Page 29 of 308

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E. Description of Device

The Smith & Nephew TriVex™ System consists of a control unit mounted on a pedestal stand, dual peristaltic pumps, an illuminator, resector handpiece and footswitches.

F. Intended Use

The proposed Smith & Nephew TriVex™ System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.

G. Comparison of Technological Characteristics

The Smith & Nephew TriVex™ System is substantially equivalent in design. materials, function and intended use to the following devices cleared for commercial distribution:

The Dyonics® Varicose Vein Ablation System - K990723
Subcutaneous Illuminator - K991323
Smith & Nephew Xenon Light Source K994084 ●
H.K. Surgical Klein Pump - K012044

G. Summary Performance Data

The Smith & Nephew TriVex™ System meets the biocompatibilty requirements of ISO 10993-1 and electrical safety standards for BF type equipment as stated in UL 60601-1 and IEC 60601-1.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in a sans-serif font.

Public Health Service

OCT 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Provencher Regulatory Affairs Specialist Smith & Nephew , Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

Re: K032387

Trade/Device Name: Smith & Nephew TriVex™ System Regulation Number: 21 CFR 870.4885 Regulation Name: External vein stripper Regulatory Class: II Product Code: DWQ Dated: July 31, 2003 Received: August 4, 2003

Dear Ms. Provencher:

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. Insting 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.

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.

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Page 2 - Ms. Karen Provencher

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

to Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

KC32387

Smith & Nephew TriVex™ System_ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Indicated for use in ambulatory phlebectomy procedures for resection and ablation of varicose veins.

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K632387

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Smith & Nephew TriVex™ System Page 14 of 308

Regulation Number and Section

§ 870.4885 External vein stripper.

(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).