The VNUS RF Generator, model RFG2 is a bipolar, high frequency electronic, microprocessor and software controlled instrument. It allows the user to set Power, Temperature and Time (Set-points and measured values) as well as measured impedance and user messages. It is provided non-sterile. The model RFG2 is compatible only with the disposable RF delivery devices (e.g., catheters) marketed by VNUS Medical Technologies under separate clearance(s). The instrument cable connects the disposable device to the RF generator. The Instrument Cable is provided non-sterile and is user sterilizable by autoclave. It has been validated to eliminate multiple steam sterilization cycles. If the disposable device has an integrated cable, a separate instrument cable is not necessary.

AI/ML Overview

The provided 510(k) notification for the VNUS Radiofrequency Generator, Model RFG2, does not include detailed acceptance criteria or a comprehensive study demonstrating direct quantitative performance against such criteria in the way a modern AI/device submission would. Instead, it relies on substantial equivalence to predicate devices and general performance claims based on in-vitro testing.

Here's a breakdown of the information that can and cannot be extracted from the provided document, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety for intended use	"Results of in-vitro testing will demonstrate that the VNUS Radiofrequency Generator is safe..."
Effectiveness for intended use	"...and effective for its intended use."
Substantial Equivalence to Predicate Devices (VNUS RF Generator models RF-110 and RF-220)	"Based upon the design, materials, functioning performed by VNUS, it is concluded that the VNUS Radiofrequency Generator...is substantially equivalent to predicate devices in safety and effectiveness."
Bipolar RF energy delivery efficiency	"The efficiency of bipolar RF energy delivery allows systems to be used at lower power compared with monopolar systems." (This is a general claim about bipolar technology, not a specific performance metric for this device)
Compatibility with disposable RF delivery devices	"The model RFG2 is compatible only with the disposable RF delivery devices...marketed by VNUS Medical Technologies under separate clearance(s)."
Sterilizability of instrument cable (if separate)	"The instrument cable is provided non-sterile and user sterilizable by autoclave. It has been validated to eliminate multiple steam sterilization cycles."

Limitations from the document:

The document does not provide specific, quantitative acceptance criteria for metrics like accuracy, sensitivity, specificity, or objective performance benchmarks.
The "reported device performance" are general statements that the device is "safe and effective" and "substantially equivalent." There are no numerical results or performance statistics presented.
The document mentions "in-vitro testing" but does not provide any details about the methodology, results, or how these results specifically demonstrate safety and effectiveness against explicit criteria.

Given the nature of this submission (a 510(k) from 2004 for an electrosurgical generator, focusing on substantial equivalence), much of the requested information regarding AI-specific studies, ground truth establishment, expert adjudication, and large-scale clinical trials in the context of diagnostic/AI performance is not applicable or present in this document.

Here's an assessment of the other requested information based on the document:

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

Sample Size: Not applicable/not specified. The document refers to "in-vitro testing" but provides no details on sample size, types of samples, or specific tests conducted. This is not a study involving a "test set" of patient data in the way an AI algorithm would be evaluated.
Data Provenance: Not applicable. The "testing" mentioned is in-vitro, meaning likely bench testing or laboratory experiments, not patient data from a specific country or collected retrospectively/prospectively.

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

Not applicable. This device is an electrosurgical generator, not a diagnostic imaging or AI device that requires expert-established ground truth for a test set. The validation would likely involve engineering and electrical performance testing.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a "test set" or adjudication in the context of expert review for this device.

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

No. This is not an AI device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported.

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

Not applicable. This device is an electrosurgical generator, not an algorithm. Its operation inherently involves a human operator.

7. The Type of Ground Truth Used

Not applicable in the context of clinical "ground truth" (e.g., pathology, outcomes data). For an electrosurgical generator, "ground truth" for performance would be based on engineering specifications, electrical safety standards, and functional performance in in-vitro models (e.g., tissue impedance, temperature control, power output). The document states "Results of in-vitro testing will demonstrate that the VNUS Radiofrequency Generator is safe and effective."

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a "training set" in the machine learning sense.

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

Not applicable. As this is not an AI device, there is no training set or ground truth establishment relevant to machine learning.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states: "Results of in-vitro testing will demonstrate that the VNUS Radiofrequency Generator is safe and effective for its intended use." It further concludes based on "the design, materials, functioning performed by VNUS" and "comparison with currently marketed devices" that the device is "substantially equivalent to predicate devices in safety and effectiveness."

Key points regarding the "study":

The "study" is described as in-vitro testing. No details about the specific tests, methodologies, or results are provided in this summary.
The primary mechanism for demonstrating compliance is substantial equivalence to previously cleared predicate devices (VNUS RF Generator models RF-110 and RF-220, cleared under K0033547). This means the device relies on demonstrating that it is as safe and effective as a legally marketed device, often by showing it has the same technological characteristics, intended use, and performs similarly in relevant (often non-clinical) tests.
The document implies that the in-vitro testing would have assessed factors like the generator's ability to deliver bipolar RF energy, maintain set power/temperature, and operate safely, consistent with the technological characteristics and principle of operation of the predicate devices.

Summary

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Page 1 of
510(k) Notification

JUN - 7 2004

SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k)-safety and effectiveness information is being submitted in This summary of JTO(K)-Salety and SRSCR 3390 and 21 CFR 807.92.
accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: March 1, 2004

KO40638 510(k) number: _______________________________________________________________________________________________________________________________________________________________

Applicant Information: VNUS Medical Technologies, Inc. 2200 Zanker Avenue, Suite F San Jose, CA 95131

FDA Registration Number: 2953189

Contact Person

Sam Nanavati
Phone Number:	(408) 473-1140
Fax Number:	(408) 944-0292

Device Information:

Classification:	Class II
Trade Name:	VNUS Radiofrequency Generator, Model RFG2
Classification Name:	Electrosurgical Device

Predicate Device(s)

Predicate Device(s)
VNUS RF Generator models RF-110 and RF-220 cleared as a part of the VNUS "Closure" VNUS RF Generator models NF-110 and Kr -1 -226 cloulou and Tissue Coagulation System (K0033547)

Device Description:

Device Description.
The VNUS RF Generator, model RFG2 is a bipolar, high frequency electronic, The VNDS RT Generator, model instrument. It allows the user to set Power, microprocessor 7 Soltware - outrolies user displays of Power, Temperature and Time Temperature and measured values) as well as measured impedance and user messages. (Sel-politis and measured values) as won to the during use, and is provided non-sterile.

The model RFG2 is compatible only with the disposable RF delivery devices (e.g., The model Tr Oz 13 oompatible only marketed by VNUS Medical Technologies under separate clearance(s).

The instrument cable connects the disposable device to the RF generator. The Instrument The instrument cable connoots the user sterilizable by autoclave. It has been validated to Cable Is provided norms of the cable events of the cable are identical to eliminate multiple steam stemization cyoles. " Beth one on integrated cable, a separate instrument cable is not necessary.

Intended Use:

The VNUS Radiofrequency Generator is intended for use with VNUS radiofrequency devices intended for vessel and tissue coagulation.

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Page 2 of 2

510(k) Notification

Intended Use of Predicate Devices

Intended Use of Predicate Devices
The specified predicate devices are indicated for "coagliation" The specified predicale devices are indicated for "obagana" and tissue coagulation" (VNUS Vessel and Tissue Coagulation System).

Technological Comparison

Technological Comparison
The RF energy is widely used in electrosurgical equipment for many is a lise use of The RF energy is widely used in electrosuryisal oquipments of intended uses. The use of
efficacy of such devices has been well established for a variety of intended uses. The efficacy of such devices has been well outliked over monopolar systems. North bipolar RF energy delivery has potential advantages over it tassue is minimized, is minimized, i
grounding pads are required, and the potential for damage to adjacent of hind grounding pacs are required, and the preenter cash current. The efficiency of bipolar RF
as the patient is no longer the return path for electrical case at lower as the patient is no longer the return path for Novation to be used at lower energy delivery allows byetents on compared with monopolar systems.

The technological characteristics and principals of operation of the VNUS RF Generator, The technological characteristially equivalent to the noted predicate devices.

Test Results:

Performance

Penormance
Results of in-vitro testing will demonstrate that the VNUS Radiofrequency Generator is safe and effective for its intended use.

Summary of Safety and Effectiveness

Summally of Salety and Enooth ontended use, comparison with currently Based upon the design, materials, tunenting performed by VNUS, it is concluded that the the marketed devices and the non official tooling Porcerary name: TBD) is substantially v NOS Radionequoney Ocherate devices in safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the logo is a stylized image of an eagle, with its wings spread and its head turned to the left. The eagle is made up of three curved lines, and it appears to be in flight.

JUN - 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040638

Ro40050
Trade/Device Name: VNUS Radiofrequency Generator, Model RFG2 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 8, 2004 Received: March 10, 2004

Dear Mr. Nanavati:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bectoril 3 re(s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or to connineres prior to May 20, 1978, are econdance with the provisions of the Federal Food, Drug, devices marc Act (Act) that do not require approval of a premarket approval application (PMA). and Costine real (11ct) market the device, subject to the general controls provisions of the Act. The 1 ou may, merciole, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 is clubbined (too as 2017). Existing major regulations affecting your device can may be subject to sach addresses regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous overning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I DTF Blocantes own device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must bil ally it cut all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Ace 31equirements) 01); good manufacturing practice requirements as set CFK Fart 607), adocing (21 CFR Part 820), and if applicable, the electronic forul in the quality systems (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) I his letter will anow you to ogin maneting of substantial equivalence of your device to a legally premarket notification: "The PDF miding of casion 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 ion your ac (301) 594-4659. Also, please note the regulation entitled, Comact the Office of Complanes at (Set , 21 (Set Part 807.97). You may obtain Milsorating by reference to premaironibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Mandracturers, International and Goless http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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):	K040638
---------------------------	---------

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The VNUS Radiofrequency Generator is intended for use with VNUS
Children and the characted of for usessel and tissue coagulation The VNUS Radiofrequency Generator is intended for version in the virus of experience

Prescription Use(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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Miriam C. Provost
(Division Sign-Off)
	Division of General, Restorative, and Neurological Devices
Page	of ______

VNUS Medical Technologies	510(k) Number	K040638
---------------------------	---------------	----------------

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.