Circon ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome Resection Electrodes are indicated for use in urology for cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer.

Device Description

CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome™ Resection Electrodes are electrosurgical electrodes used in CIRCON ACMI's resectoscopes utilizing a direct connection between the electrode and the active cord of the electrosurgical generator.

AI/ML Overview

This document, K973820, is a 510(k) Summary for the CIRCON ACMI USA Elite System™ VaporTrode™ Vaporization Electrode and VaporTome™ Resection Electrode. It asserts substantial equivalence to predicate devices and does not present data from a study demonstrating the device meets specific acceptance criteria in the typical contemporary sense of clinical or performance metrics. Instead, "acceptance criteria" here implicitly refer to the regulatory requirements for establishing substantial equivalence.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial Equivalence: Device has similar intended use, technological characteristics, and does not raise new questions of safety or effectiveness compared to predicate devices.	The devices are "substantially equivalent to the Grooved Roller Electrodes marketed by American Cystoscope Makers, Inc." and "Resectoscope Cutting Loops marketed by American Cystoscope Makers, Inc." respectively. These predicate devices are confirmed preamendments devices. The submitter states, "Any differences between these devices do not raise new questions regarding safety or effectiveness."
Intended Use: For cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue, and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer.	The device's intended use is precisely as described in the acceptance criteria: "for use in urology for cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer." This matches existing predicate devices.
Classification: Class II (21 CFR §876.4300) Endoscopic Electrosurgical Unit and Accessories (78FAS)	The device is classified as Class II, matching the established regulatory classification for similar devices.
Operating Principles: Similar to predicate devices.	The submission states that the new devices "employed similar design considerations and operating principles" to the predicate devices.

Study Details:

This 510(k) summary is based on a claim of substantial equivalence, not a performance study in the sense of demonstrating a device meets quantifiable metrics through a clinical trial or extensive bench testing against predefined acceptance criteria (apart from regulatory compliance). The "study" here is the regulatory comparison to predicate devices.

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

No explicit "test set" or sample size is mentioned in the context of a performance study. The evaluation is a comparative review of design, intended use, and technological characteristics against predicate devices. The data provenance is implied to be from the manufacturer's internal assessment comparing their new device to their own previously marketed (preamendments) devices.

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

Not applicable. There was no specific "test set" and thus no ground truth established by experts in the context of a performance study. The ground truth for the comparison is the established regulatory status and characteristics of the predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. No performance test set or adjudication method is described.

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

No, an MRMC comparative effectiveness study was not done. This document is a 510(k) summary for establishing substantial equivalence, not a clinical effectiveness study. There is no mention of human readers or AI assistance.

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

Not applicable. This device is an electrosurgical electrode, not an algorithm or AI system. Its performance is directly tied to its physical interaction with tissue and operation by a medical professional.

7. The Type of Ground Truth Used:

The "ground truth" implicitly used for this submission is the regulatory status and established safety/effectiveness profile of the predicate devices (preamendments devices: Grooved Roller Electrodes and Resectoscope Cutting Loops by American Cystoscope Makers, Inc.). The argument is that the new device is fundamentally the same and therefore equally safe and effective.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary of the "Study" and "Acceptance Criteria" in this context:

The "study" presented in this 510(k) is a comparative analysis of the new device against predicate devices based on:

Intended Use: Identical.
Technological Characteristics: Similar design considerations and operating principles.
Performance: Implied to be equivalent due to similar characteristics, with no new questions of safety or effectiveness.

The "acceptance criteria" are the regulatory requirements for substantial equivalence under 21 CFR §876.4300 and the general provisions of the Federal Food, Drug, and Cosmetic Act. The device "meets the acceptance criteria" by demonstrating that it is substantially equivalent to legally marketed predicate devices, thereby allowing it to proceed to market without premarket approval. The FDA's letter explicitly states, "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent..." This regulatory determination constitutes the fulfillment of the "acceptance criteria" for marketing.

Summary

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8.4/5

973820

PG-1 UF Z

MAY 1 2 1998

510(k) Summary

#K973820

Circon Corporation Submitter: 1) 6500 Hollister Avenue Santa Barbara, CA 93117
Dr. Ronald J. Ehmsen Contact: (805) 961-3290

Date Prepared: May 7, 1998

Name of Device: CIRCON ACMI USA Elite System™ Vapor Trode™ Vaporization 2) Electrode and VaporTomena Resection Electrode
Proprietary/Trade Name: CIRCON ACMI VaporTrode™ Vaporization Electrode and VaporTome™ Resection Electrode

Common/Usual Name: Electrode, Electrosurgical, Active, Urological

Classification: Class II (21 CFR §876.4300)

Classification Name: Endoscopic Electrosurgical Unit and Accessories (78FAS)

3) Names of Predicate or Legally Marketed Devices:

CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes are substantially equivalent to the Grooved Roller Electrodes marketed by American Cystoscope Makers, Inc. (ACMI, a predecessor of CIRCON ACMI Division of Circon Corporation). These devices were confirmed to be preamendments devices in a letter dated August 31, 1995, from Mr. T. Wells of FDA's Office of Compliance. The VaporTome™ Resection Electrodes are substantially equivalent to the Resectoscope Cutting Loops marketed by American Cystoscope Makers, Inc., which are also preamendments devices.

4) Description of Device:

'The term, "substantially equivalent," is intended to reflect a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing on matters relating to patents.

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510(k) Summary #K973820 Circon Corporation Circon ACMI USA Elite System™ Vaporization Electrode and Vapor Tome Resection Electrode May 7, 1998 Page 2

Intended Use of Device: ર)

CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome Resection Electrodes are indicated for use in urology for cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer.

() Comparison of Technological Characteristics:

CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTomeTM Resection Electrodes are substantially equivalent2 to the American Cystoscope Makers, Inc. Grooved Roller Electrodes and Resectoscope Cutting Loops. respectively. Those preamendments devices employed similar design considerations and operating principles. Any differences between these devices do not raise new questions regarding safety or effectiveness.

"The term, "substantially equivalent," is intended to reflect a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing on matters relating to patents.

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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K973820

Circon ACMI USA Elite System™ Vaporization Electrode and VaporTome™ Resection Electrode Dated: March 16, 1998 Received: March 20, 1998 Regulatory Class: II 21 CFR 876.4300/Procode: 78 FAS

Dear Dr. Ehmsen:

MAY 1 2 1998

Ronald J. Ehmsen, Sc.D.

CIRCON Corporation

6500 Hollister Avenue

Vice President, Regulatory Affairs

Santa Barbara, CA 93117-3019

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, 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 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 requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (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/dsmaldsmamain.html".

Sincerely yours.

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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510(k) Number: K973820

Device Name: Circon ACMI USA Elite System™ Vaporization Electrode and VaporTomeTM Resection Electrode

Indications for Use:

Circon ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome™ Resection Electrodes are indicated for use in urology for cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Poler R Sathing
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number K973820

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

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).