This 510(k) summary (K030557) is for the VNUS Closure System, an electrosurgical device for treating superficial vein reflux. The summary indicates that the device met acceptance criteria based on in-vitro testing and biocompatibility. However, it does not contain the detailed information necessary to fully answer all of the questions about a typical AI/ML device study. The provided document is from 2003, and the standards for reporting AI/ML device studies were not yet established.

Here's a breakdown of the available information based on the prompt's requirements:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness	Results of in-vitro testing demonstrate that the VNUS Closure System is safe and effective for its intended function.
Biocompatibility	The materials used in the VNUS Closure Catheters have been shown to be biocompatible.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing was "in-vitro," meaning in a laboratory setting, not on human subjects or clinical data in the way an AI/ML device would be tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The testing was in-vitro, and there's no mention of expert-established ground truth in the context of clinical images or data analysis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. As the testing was in-vitro, there's no indication of an adjudication process for a test set in a clinical context.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/provided. This device is not an AI/ML diagnostic or assistive device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. This device is not an algorithm, but a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance appears to be established by the functional results of the in-vitro testing for safety and effectiveness, and biocompatibility testing for material safety. This isn't a "ground truth" in the sense of clinical annotations for a diagnostic algorithm.

8. The sample size for the training set

This information is not applicable/provided. The device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/provided. The device is not an AI/ML algorithm.

Summary

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510 (k) Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: February 11, 2000

510(k) number:	K030557
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MAR 1 1 2003

Applicant Information:

VNUS Medical Technologies, Inc. 2200 Zanker Road, Suite F San Jose, CA 95131

Contact Person:	Sam Nanavati
Phone Number:	(408) 473-1100
Fax Number:	(408) 944-0292

Device Information:

Classification: Class II VNUS® Closure® System Trade Name: Electrosurgical Device and accessories (21 CFR 870.4400) Classification Name:

Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the VNUS Closure System (K982816 and K003092)

Intended Use:

The VNUS Closure System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Test Results:

Performance

Results of in-vitro testing demonstrate that the VNUS Closure System is safe and effective for its intended function.

Biocompatibility

The materials used in the VNUS Closure Catheters have been shown to be biocompatible.

Summary:

Based on the intended use, product, performance and biocompatability information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed and unmodified predicate device.

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Image /page/1/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 design of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 2003

Mr. Sam Nanavati Director, Quality Assurance and Regulatory Compliance VNUS Medical Technologies, Inc. 2200 Zanker Road, Suite F San Jose, California 95131

Re: K030557

Trade/Device Name: VNUS® Closure® System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 19, 2003 Received: February 21, 2003

Dear Mr. Nanavati:

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.

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 - Mr. Sam Nanavati

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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,

Muriam C. Provost

for 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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Indication for Use Statement

510(k) Number (if known):

030557

Device Name:

Closure® System

Indications for Use:

The VNUS Closure System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

(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

(Optional Format 1-2-96)

Miriam C. Provost

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

510(k) Number K030557

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.