VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)

K994418 · ETHICON, Inc. · HIH · Jan 24, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K994418
• Device Name: VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
• Applicant: ETHICON, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jan 24, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Loop Electrode is intended for use in gynecologic hysteroscopic electrosurgical procedures.

Device Story

Versapoint Electrosurgery Loop Electrode is a bipolar electrosurgical accessory used with the Scuba Electrosurgical Generator. Device functions as a tool for tissue cutting, removal, and desiccation during gynecologic hysteroscopic procedures. Operated by physicians in clinical settings, the electrode delivers electrical energy to target intrauterine tissues. Output is controlled by the generator, allowing for precise excision of myomas and polyps, lysis of adhesions, incision of septa, and endometrial ablation. Benefits include minimally invasive treatment of benign uterine conditions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Bipolar electrosurgical electrode. Form, fit, and function are identical to the predicate device. Energy source is the Scuba Electrosurgical Generator.

Indications for Use

Indicated for tissue cutting, removal, and desiccation in gynecologic hysteroscopic electrosurgical procedures for treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.

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
• Versapoint Electrosurgery G-VAP Electrode Accessory

Submission Summary (Full Text)

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Attachment 4 – 510(k) Summary

page 1 of 2

K 994418.

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

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## Preclinical testing has been performed to verify that the product meets the Performance Data performance requirements described. It was determined that the device performs safely and effectively. Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) and Conclusion the information provided herein, we conclude that the new device is substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act. Contact Gregory Jones Director Regulatory Affairs - Domestic Gynecare/Ethicon, Inc. Route 22 Somerville New Jersey Date November 4, 1999

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

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Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

JAN 2 4 2000

Gynecare, Inc. c/o Mr. William Goeller Sr. Proiect Manger ETHICON, Inc. P.O. Box 151 Somerville, NJ 08876-0151 Re: K994418

SCUBA System Hysteroscopic Electrosurgery System VRS Angled Loop Electrode Dated: December 28, 1999 Received: December 29, 1999 Regulatory Class: II 21 CFR §884.1690/Procode: 85 HIH 21 CFR §884.4160/Procode: 85 KNF

Dear Mr. Goeller:

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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 Register. Please note: this response to your premarket notification 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.

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): | K994418 |
|---------------------------|---------|

Device Name:

Indications for Use:

Scuba Hysteroscopic Electrosurgery System

Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation.

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

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

| Prescription Use | ✓ |
|------------------|--------------------------------------------------------------------|
| | OR Over The-Counter Use |
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K994418 |
| | (Optional Format 1-2-96) |