SCUBA SYSTEM

K962482 · Gynecare, Inc. · HIH · Nov 1, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K962482
• Device Name: SCUBA SYSTEM
• Applicant: Gynecare, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Nov 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Scuba is intended to be used for tissue cutting, vaporization and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for excision of intrauterine myomas and polyps, lysis of intrauterine adhesions, and excision of uterine septa.

Device Story

Scuba System is a bipolar electrosurgical device for hysteroscopic surgery. Input: electrical energy from generator; saline fluid environment. Operation: generator provides six waveforms (vaporize, blend, desiccate) at 1-200W; system detects electrode type and auto-adjusts power. Output: tissue cutting, vaporization, and desiccation via Spring, Ball, or Twizzle electrodes. Used in clinical settings by surgeons; generator located outside sterile field, adjusted by staff. Benefits: clear field of view, effective tissue excision/coagulation, reduced safety risks compared to monopolar electrosurgery.

Clinical Evidence

Non-clinical studies included porcine animal models (stomach/skin flap) demonstrating effective tissue vaporization and desiccation. Clinical studies using 10 extirpated uteri compared the Scuba system to monopolar electrosurgery and laser surgery. Results showed Scuba was as effective as comparators in cutting and coagulating tissue, maintained a clear field of view, and showed no significant difference in serosal temperature or histological tissue effects.

Technological Characteristics

Bipolar electrosurgical system. Generator operates at 95-125V/190-250V AC (50/60Hz). Three electrode types (Spring, Ball, Twizzle) for 5 French+ hysteroscopes. Operates in conductive saline environment. Features alphanumeric fluorescent display. Connector cable is steam sterilizable; electrodes are sterile, single-use. System includes automatic electrode detection and power setting adjustment.

Indications for Use

Indicated for gynecologic hysteroscopic electrosurgical procedures including excision of intrauterine myomas and polyps, lysis of intrauterine adhesions, and excision of uterine septa.

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

• Erbotom Generator used with the Karl Storz Hysteroscopic Resectoscopy Accessories

Submission Summary (Full Text)

{0}

NOV - 1 1996
K962482
P192

Gynecare inc.
TM
technology for women's healthcare

235 Constitution Drive
Menlo Park, CA 94025
Telephone: [phone]
Fax: [phone]

# SCUBA SYSTEM 510(k) SUMMARY

## SUMMARY OF SAFETY AND EFFECTIVENESS

GYNECARE, INC.

Company: Gynecare, Inc.
235 Constitution Drive
Menlo Park, CA 94025
Tel: [phone]
Fax: [phone]

Company Representative: Milton McColl, M.D.
Vice President & Medical Director

Date Prepared: June, 1996

Device Name: Scuba System

Generic Name: Hysteroscopic Electrosurgical Device

Classification Name: Obstetrical and Gynecological Surgical Devices

Classification: Class II

The Scuba is a bipolar electrosurgical system designed for hysteroscopic surgical correction of myomas, polyps, intrauterine adhesions, and septate uteri. It consists of an electrosurgical generator, a footswitch, three types of electrodes, and a cable connecting the electrode to the generator. The generator is designed to operate from any voltage source between 95-125V and 190-250V a.c. at 50 or 60Hz. It provides six modes of operation (i.e., six waveforms): three vaporize modes, two blend modes (a combination of vaporization and coagulation) and a desiccate mode similar to the traditional coagulation waveform. The generator controls the power settings from 1 to 200 Watts. A green fluorescent display provides up to 16 characters of alphanumeric information, including the selected mode of operation, the power settings, and other messages related to the operation of the generator. Like other electrosurgical equipment, the generator is designed to be located outside the sterile field, with adjustment of operating settings performed by ancillary operating staff.

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SS&E
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Three electrode configurations are available: the Spring, Ball and Twizzle. The electrodes are identical in construction except for the distal end and are designed for insertion down a 5 French or larger working channel of commercially available hysteroscopes. The electrodes are operated in a conductive (i.e., saline) fluid environment. When connected to the generator via the connector cable, the system detects the type of electrode attached and automatically adjusts the default power settings to the optimal level for each electrode type. The surgeon can change the default power settings as required. The electrodes are provided as sterile, single-use items. The connector cable is steam sterilizable, designed for twenty times reuse.

The Scuba is intended to be used for tissue cutting, vaporization and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for excision of intrauterine myomas and polyps, lysis of intrauterine adhesions, and excision of uterine septa.

Results from non-clinical studies including in vivo studies using the porcine animal model, biocompatibility testing, and clinical studies have shown the Scuba system to be safe and effective in vaporizing and coagulating uterine tissue. In the porcine animal studies using a stomach test model and a skin flap model in live swine, the Scuba device was shown to vaporize and coagulate live tissue. The same electrode used for vaporization was shown to effectively desiccate live tissue and prevent bleeding.

In clinical studies using extirpated uteri, the Scuba system was compared to monopolar electrosurgery and laser surgery. The Scuba system was found to be as effective in cutting and coagulating uterine tissue as the monopolar and laser surgery devices. In one extirpated uteri study using ten uteri, the Scuba and Erbotom Generator were compared side by side in each uterus. Both devices were effective in excising and coagulating uterine tissue. When using the small Scuba electrode the field of view remained clear and all structures were easily visualized. There was no accumulation of debris to obstruct vision. Histological evaluation of the tissue effects showed both devices performed similarly. Serosal temperature measurements recorded throughout the procedure showed no significant difference in uterine temperature for the two devices.

These studies have demonstrated that the Scuba system is substantially equivalent to the Erbotom Generator used with the Karl Storz Hysteroscopic Resectoscopy Accessories (electrodes). Both devices have the same intended use and similar tissue effect. The bipolar features of the Scuba system do not pose new safety questions when compared to currently marketed electrosurgery generators and electrodes. There are actually fewer safety issues with bipolar surgery than with monopolar surgery. Bipolar surgery has been used safely for many surgical procedures, although it is not currently marketed for intrauterine electrosurgery.