The provided text describes the 510(k) premarket notification for the VNUS® ClosureFAST™ Catheter. However, it does not include detailed information regarding acceptance criteria, a specific study proving device performance against those criteria, or the methodology typically associated with such studies (sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

Instead, the submission focuses on establishing substantial equivalence to a predicate device.

Here's an attempt to answer your questions based only on the provided text, highlighting what is implicitly or explicitly stated and what is missing:

Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of quantitative metrics or thresholds.	"Performance is substantially equivalent to the predicate device and effective for its intended function."
Specific functional or clinical endpoints with predefined success rates are not provided.	Biocompatibility: "The materials used in the VNUS ClosureFAST Catheters have been shown to be biocompatible."
Bench test results or clinical study outcomes against specific criteria are not detailed in the summary.	The device's technological characteristics and principles of operation are considered substantially equivalent to the predicate device, relying on RF energy delivery to heat a blood vessel to a specific temperature.

Missing Information: The document does not provide explicit numerical acceptance criteria (e.g., "The device must achieve X% vein closure rate" or "Temperature control must be within Y degrees"). The primary "acceptance" is based on substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. (The submission does not detail any specific clinical or in-vitro tests that would involve a "test set" in the context of algorithm evaluation).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable/Not specified. This information is typically relevant for studies involving human interpretation or expert review, which is not described as part of the evidence provided in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable/Not specified. (Likely not relevant as no expert consensus or ground truth establishment based on human review is described).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document makes no mention of an MRMC study or any comparison of human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable/Not specified. The device is a physical catheter, not an AI algorithm, so the concept of "standalone performance" for an algorithm doesn't apply here. The performance evaluation is implicitly around the device's physical and functional capabilities, as compared to a predicate device.

7. The Type of Ground Truth Used

The "ground truth" for the device's functional performance is implicitly established by the performance of the predicate device (VNUS® ClosurePlus™ Catheter, K030557) and the underlying scientific understanding of RF energy's effect on blood vessels for coagulation. There's no mention of pathology, outcomes data, or expert consensus being specifically used as "ground truth" in new studies for this 510(k). The focus is on substantial equivalence.

8. The Sample Size for the Training Set

Not applicable/Not specified. This concept applies to algorithms that learn from data, which is not the case for this device.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not specified, as there is no training set mentioned.

Summary of Device and Evidence Presented:

The VNUS® ClosureFAST™ Catheter's acceptance criteria and proof of effectiveness are primarily based on its substantial equivalence to an existing, legally marketed predicate device (VNUS® ClosurePlus™ Catheter, K030557). The 510(k) summary states:

"The subject device is substantially equivalent in intended use and/or method of operation to the VNUS® ClosurePlus™ Catheter (K030557)."
"The technological characteristics and principals of operation of the VNUS ClosureFAST catheter are substantially equivalent to the noted predicate devices rely on the delivery of RF energy to an intravascular catheter that heats a blood vessel to a specific temperature to achieve the intended use."
"Performance is substantially equivalent to the predicate device effective for its intended function."
Biocompatibility of materials was confirmed.

Therefore, the "study" for acceptance is an argument for substantial equivalence, rather than a detailed presentation of new clinical trial data against novel, explicit acceptance criteria. The FDA agreed with this assessment, stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..."

Summary

{0}------------------------------------------------

KOLI373

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.

15 May 2006 Date Prepared:

510(k) number:

AUG 0 1 2006

Applicant Information:

VNUS Medical Technologies, Inc. 5799 Fontanoso Way San Jose, CA 95138

Contact Person:	Carelle Karimimanesh
Phone Number:	(408) 360-7261
Fax Number:	(408) 365-8480

Device Information:

Classification:	Class II
Trade Name:	VNUS® ClosureFAST™ Catheter
Classification Name:	Electrosurgical Device (21 CFR §878.4400)

Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the VNUS® ClosurePlus™ Catheter (K030557).

The technological characteristics and principals of operation of the VNUS ClosureFAST catheter are substantially equivalent to the noted predicate devices rely on the delivery of RF energy to an intravascular catheter that heats a blood vessel to a specific temperature to achieve the intended use.

Intended Use:

The VNUS® ClosureFAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Test Results:

Performance

r orrormants Nostantially equivalent to the predicate device effective for its intended function.

Biocompatibility

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

Summary:

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

{1}------------------------------------------------

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 eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VNUS Medical Technologies, Inc. % Carelle Karimimanesh Director, Regulatory Affairs 2200 Zanker Road, Suite F San Jose, California 95131

Re: K061373

Trade/Device Name: VNUS® ClosureFAST™ Regulatory Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 15, 2006 Received: May 17, 2006

AUG 0 1 2006

Dear Carelle Karimimanesh:

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 gencral 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.

{2}------------------------------------------------

Page 2 – Carelle Karimimanesh

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) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Bnechuk

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Device Name: VNUS® ClosureFAST™ Catheter

510(k) Number: K061373

Indications for Use:

The VNUS® ClosureFAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

$\sqrt{ }$

Prescription Use: (21 CFR §801 Subpart D) or

Over the Counter Use: (21 CFR §801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Hubera Buclian

(Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number K061573

CONFIDENTIAL

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.