USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE

K973820 · Circon Corp. · FAS · May 12, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K973820
• Device Name: USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
• Applicant: Circon Corp.
• Product Code: FAS · Gastroenterology, Urology
• Decision Date: May 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Electrosurgical electrodes for use with resectoscopes; direct connection to active cord of electrosurgical generator. Used by urologists in clinical settings for cutting, coagulation, and vaporization of soft tissue (prostate/bladder). Device facilitates surgical treatment of BPH and bladder cancer by delivering electrical energy to target tissue.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and operating principle comparison to preamendments predicate devices.

Technological Characteristics

Electrosurgical active electrodes for use with resectoscopes; direct connection to electrosurgical generator active cord. Class II device (21 CFR 876.4300).

Indications for Use

Indicated for urological soft tissue cutting, coagulation, and vaporization, including prostatic and bladder tissue, for treatment of benign prostatic hyperplasia (BPH) and bladder cancer.

Regulatory Classification

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.

Predicate Devices

• Grooved Roller Electrodes (ACMI)
• Resectoscope Cutting Loops (ACMI)

Submission Summary (Full Text)

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# 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: [phone]

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:

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.

^'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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)