VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)

K982738 · Gynecare, Inc. · HIH · Mar 1, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K982738
• Device Name: VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
• Applicant: Gynecare, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Mar 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The G-VAP Electrode is intended for use in gynecologic hysteroscopic electrosurgical procedures. Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa. Excision of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa

Device Story

G-VAP Electrode is a bipolar electrosurgical accessory; used in conjunction with Scuba Electrosurgical Generator. Device performs tissue cutting, removal, and desiccation during gynecologic hysteroscopic procedures. Operated by physicians in clinical settings. Device delivers electrical energy to target intrauterine tissues (myomas, polyps, adhesions, septa) to facilitate surgical treatment. Output is controlled by the generator; provides therapeutic benefit by enabling precise tissue management during hysteroscopy.

Clinical Evidence

Bench testing only. Pre-clinical and bench-top testing performed to verify performance requirements; device determined to be safe and effective.

Technological Characteristics

Bipolar electrosurgical electrode; designed for use with Scuba Electrosurgical Generator. Form, fit, and function are similar to predicate. No specific materials or software algorithms described.

Indications for Use

Indicated for patients undergoing gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, including excision and lysis.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Predicate Devices

• Scuba Electrosurgical System

Submission Summary (Full Text)

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3/1/99

SECTION 7

## 510(k) Summary of Safety and Effectiveness

| Statement | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule “...510(k) Summaries and 510(k) Statements...” (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MODIFIED DEVICE NAME: Versapoint Electrosurgery G-VAP Electrode Accessory |
| | PREDICATE DEVICE NAME: Scuba Electrosurgical System |
| Device Description | The G-VAP Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator. |
| Intended Use | The G-VAP Electrode is intended for use in gynecologic hysteroscopic electrosurgical procedures. |
| Indications Statement | Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa. |
| | Excision of intrauterine myomas |
| | Excision of intrauterine polyps |
| | Lysis of intrauterine adhesions |
| | Incision of uterine septa |
| Technological characteristics | The modified device has the same technological characteristics as the predicate devices. The form, fit, function and method of operation are similar. |

Continued on next page.

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## 510(k) Summary of Safety and Effectiveness, Continued

| Performance<br>Data | Pre-clinical as well as bench top testing has been performed to verify that the<br>product meets the performance requirements described. It was determined<br>that the device performs safely and effectively. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) and<br>the information provided herein, we conclude that the new device is<br>substantially equivalent to the predicate devices under the Federal Food, Drug<br>and Cosmetic Act. |
| Contact | Susan Aloyan<br>Director of Regulatory Affairs and Quality Assurance<br>Gynecare/Ethicon, Inc.<br>235 Constitution Drive,<br>Menlo Park, California 94025-1108 |
| Date | July 31, 1998 |

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MAR 1 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan M. Aloyan GYNECARE, INC. 235 Constitution Drive Menlo Park, CA 94025 Re: K982738 G-VAP Electrodes for Gynecare Scuba System Dated: December 2, 1998 Received: December 3, 1998 Regulatory Class: II 21 CFR 884.1690/Procode: 85HIH 21 CFR 884.4160/Procode: 85 HFG

Dear Ms. Aloyan:

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 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, 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 II (Special Controls) or 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 (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 Recister. 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 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/dsma/dsmamain.html".

Sincerely yours,

J.J.

Capt. Daniel G. Schultz, M.D. Acting 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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## INDICATIONS FOR USE

510(k) Number (if known): ___K982738

Device Name:

Indications for Use:

G-VAP Electrode for use with the SCUBA Hysteroscopic Electrosurgery System

Tissue cutting, removal, and dessication as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the reatment of intrauterine myomas, polyps, adhesions, and septa.

> Excision of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa

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Concurrence of CDRH, Office of Device Evaluation (ODE) 1 Prescription Use OR Over-The-Counter Use

(Optional Format 1-2-9G)

Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Optional Format 1-2-9G