The Cobra Hand Piece presented in this submission is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hvperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

Device Description

The Cobra Hand Piece delivers the energy from the VidaMed TUNA System RF Generator. The Cobra Hand Piece contains two needle electrodes which are deployed at an angle of 90°. The needles can be deployed at 4 preset lengths which vary between 10-22mm. The needles are insulated at the base to protect the urethra during ablation of the prostatic tissue. The disposable Cobra Cartridge is attached to a reusable handle, containing the mechanism for the needle deployment and retraction. The Cobra Hand Piece only works with the VidaMed TUNA System RF Generator.

AI/ML Overview

The provided text describes a 510(k) submission for the VidaMed Cobra Hand Piece, which is a modification to an existing electrosurgical device for treating benign prostatic hyperplasia (BPH).

Based on the provided text, a formal study proving the device meets specific acceptance criteria is not explicitly detailed. The submission focuses on demonstrating "Substantial Equivalence" to previously cleared devices. This means that instead of new clinical trials with acceptance criteria, the regulatory approval is based on the new device (Cobra Hand Piece) being similar enough in intended use, technological characteristics, safety, and effectiveness to a predicate device (VidaMed's TUNA System and RF Generator) that has already been approved.

Therefore, the information you requested about acceptance criteria, study details, sample sizes, ground truth, and expert adjudication for a prospective study is largely not applicable (N/A) in this specific context, as the approval route is substantial equivalence rather than a new clinical efficacy study.

However, I can extract the relevant information regarding the device's intended use, which would implicitly define its performance domain.

Here's a breakdown of the requested information based only on the provided text:

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

Since this is a 510(k) submission based on substantial equivalence, explicit quantitative acceptance criteria for this new device and reported performance for this specific device from a standalone clinical trial are not presented. The "performance" is implicitly tied to the predicate device's established performance, assuming the modifications do not negatively impact it.

Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Implied by Substantial Equivalence to Predicate)
Effective treatment of symptoms due to urinary outflow obstruction secondary to BPH.	Capable of treating symptoms due to urinary outflow obstruction secondary to BPH.
Safe use in men over the age of 50 with prostate sizes between 20 and 50 cc.	Safe for use in men over the age of 50 with prostate sizes between 20 and 50 cc.
Delivers RF energy from the VidaMed TUNA System RF Generator as intended.	Delivers RF energy from the VidaMed TUNA System RF Generator as intended.
Needles deploy at 90° for ablation.	Needles deploy at 90° for ablation at 4 preset lengths (10-22mm).
Needles insulated at the base to protect the urethra.	Needles are insulated at the base to protect the urethra.

2. Sample size used for the test set and the data provenance

Sample size for test set: N/A (No specific test set for efficacy or performance described in this 510(k) summary for the Cobra Hand Piece itself; relies on substantial equivalence to predicate device's prior approvals).
Data provenance: N/A (Not specified for a new clinical study. The existing TUNA System would have had data from its prior approvals, but not detailed here for the Cobra Hand Piece).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: N/A
Qualifications of experts: N/A

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

Adjudication method: N/A

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

MRMC study done: No. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are not relevant to its approval.
Effect size: N/A

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

Standalone study done: N/A. This is a medical instrument, not an algorithm.

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

Type of ground truth: N/A (Relies on the established safety and effectiveness of the predicate device).

8. The sample size for the training set

Sample size for training set: N/A (No algorithm or machine learning training set mentioned).

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

Ground truth for training set established: N/A (No algorithm or machine learning training set mentioned).

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

The provided document describes a 510(k) submission based on "Substantial Equivalence." This regulatory pathway does not typically involve a new clinical study with explicit acceptance criteria for the new device itself. Instead, the submission argues that the Cobra Hand Piece is a modification to an already legally marketed device (VidaMed's TUNA System and RF Generator) and shares similar features and functions.

The "proof" that the Cobra Hand Piece meets acceptance criteria stems from the fact that its predicate device, the TUNA System, has already been cleared for the treatment of symptomatic BPH in several prior 510(k)s. The current submission for the Cobra Hand Piece asserts that the modifications do not raise different questions of safety and effectiveness compared to the predicate device. Therefore, the device meets its intended use and is deemed substantially equivalent, implying it will perform similarly to the previously approved predicate. No new clinical trials, expert consensus, or specific dataset analyses (as would be typical for AI/diagnostic devices) are detailed in this summary for the Cobra Hand Piece itself.

Summary

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510(k) Summary of Safety and Effectiveness

k 973344 142

NOV 26 1997

September 4, 1997

Submitted by:	VidaMed, Inc.46107 Landing ParkwayFremont, CA 94538
Contact:Phone:FAX:	Robin Bush(510) 492-4930(510) 413-1538
Product:	Cobra Hand Piece
Common Name:	Electrosurgical Device

Intended Use

Device Description

Technological Characteristics

VidaMed currently markets the TUNA Catheter as a disposable device. The Cobra Hand Piece represents a modification to the existing TUNA Catheter by creating a disposable cartridge that fits on the reusable handle. The cartridge will be manufactured with materials that are used currently in the TUNA device. The handle will be made of stainless steel, and is reusable to facilitate cleaning and sterilization.

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K973366
2+2
VidaMed Cobra Hand Piece

Sterilization

The Cobra Cartridge is provided sterile and ready to assemble into the handle. The Cobra Handle is provided non-sterile and must be sterilized prior to use. The handle may sterilized by a variety of methods.

Substantial Equivalence

VidaMed's TUNA System and RF Generator have been cleared for the treatment of symptomatic BPH in several 510(k)s. The Cobra Hand Piece is a modification to the existing TUNA Cathether Hand Piece and shares similar features and function with corresponding devices distributed by VidaMed.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with its wings outstretched.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1997

Robin Bush, RAC Vice President, Regulatory and Clinical Affairs VIDAMED 46107 Landing Parkway Fremont, CA 94538

Re: K973366 VidaMed Cobra Hand Piece Dated: September 4, 1997 Received: September 8, 1997 Regulatory Class: II 21 CFR 876.4300/Procode: 78 KNS

Dear Ms. Bush:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W.Liliau Yu
Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological 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): ____________________________________________________________________________________________________________________________________________________ N/A

Device Name:

Cobra Hand Piece

Indication for Use:

The Cobra Hand Piece presented in this submission is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973366
Prescription Use ✗ OR Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

ો રો રે (){

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).