CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400

K991529 · Conway Stuart Medical, Inc. · GEI · Sep 14, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991529
• Device Name: CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400
• Applicant: Conway Stuart Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Conway Stuart Medical Stretta Control Module Model S400 RF generator, in combination with Conway Stuart Medical electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Story

Stretta Control Module Model S400 is an electrosurgical generator delivering controlled low-level radiofrequency (RF) energy for localized tissue coagulation. Device features integrated fluid pump for cooling tissue adjacent to electrodes; controls for maximum temperature, power, energy, and time; and six-channel readouts for impedance, power, and temperature. Operated by qualified medical personnel in clinical settings. System includes AC power cord, single-pedal footswitch, and connecting cables. Output allows physicians to perform precise tissue coagulation; benefits include controlled energy delivery to target sites.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by performance validation testing.

Technological Characteristics

Electrosurgical generator; RF energy source; integrated fluid pump for tissue cooling. Six-channel monitoring for temperature, impedance, and power. Form factor includes front panel connectors for electrodes and foot pedal. Sterilization method not specified.

Indications for Use

Indicated for coagulation of tissue in patients undergoing electrosurgical procedures. Contraindicated when, in the physician's judgment, electrosurgical procedures are contrary to the patient's best interest. Intended for use by qualified medical personnel.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Conway Stuart Medical Model C4

Submission Summary (Full Text)

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| SEP 14 1993 | |
|-----------------------------|---------------------------------|
| Conway Stuart Medical, Inc. | 510(k) Premarket Notification |
| Sunnyvale, CA | Stretta Model S400 RF Generator |
| | |

#### PREMARKET NOTIFICATION 510(k) SUMMARY, TRUTHFUL AND SECTION 8 ACCURATE STATEMENT, INDICATIONS FOR USE

## 8.1 Premarket Notification 510(k) Summary

# 510(k) Summary of Safety and Effectiveness Conway Stuart Medical, Inc. Stretta Control Module Model S400 RF Generator and Accessories

### Intended Use:

The Conway Stuart Medical Stretta Control Module Model S400 RF generator, in combination with Conway Stuart Medical electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

### Submitted by:

Conway Stuart Medical, Inc. 735 Palomar Avenue Sunnyvale, CA 94086 Phone: [phone] Fax: [phone]

### Contact Person:

Thomas C Wehman, Ph.D. Regulatory Affairs Phone: [phone]

### Date Summary Prepared:

April 27, 1999

### Name of Device:

Proprietary Name: Stretta Control Module Model S400 RF Generator and Accessories

Common/Usual Name: Electrosurgical Generator and Accessories

Classification Name: Electrosurgical Device (per 21CFR\$878.4400)

94

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#### Predicate Device:

Conway Stuart Medical Model C4

#### Description:

The Stretta Control Module Model S400 is an electrosurgical generator that is designed to deliver controlled low level radiofrequency energy for localized tissue coagulation. The Stretta generator has controls for maximum temperature, power delivered, energy delivered and time of energy delivered. The unit has readout for total energy delivered, impedance, maximum power and temperature for up to six channels. Connectors located on the front panel include electrode connectors and a foot pedal. A fluid pump is integrated into the Stretta generator to deliver cooling fluid to the surrounding tissue adjacent to the electrode.

System accessories include an AC power cord, a single-pedal footswitch and a connecting cable.

#### Comparison to Predicate Device:

The Stretta Control Model S400 electrosurgical generator and accessories has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, performance validation testing has been done to validate the performance of this device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1999

Thomas C. Wehman, Ph.D. Regulatory Affairs/Ouality Assurance Conway Stuart Medical, Inc. 735 Palomar Avenue Sunnyvale, California 94086

K991529 Re:

> Trade Name: Stretta Control Module Model S400 Radiofrequency Electrosurgical Generator with Pump

Regulatory Class: II Product Code: GEI Dated: July 30, 1999 Received: August 2, 1999

Dear Dr.Wehman :

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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Thomas C. Wehman, Ph.D.

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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Conway Stuart Medical, Inc. Sunnyvale, CA

#### 8.3 Indications for Use

| 510(k) Number: | K 991529 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Conway Stuart Medical Stretta Control Module Model S400<br>Radiofrequency Electrosurgical Generator with Pump |
| Indications for Use: | The Stretta Control Module Model S400 RF electrosurgical<br>generator with pump, in combination with CSM electrodes, is<br>indicated for coagulation of tissue. This device is intended for<br>use by qualified medical personnel, trained in the use of<br>electrosurgery. |
| Contraindications for Use: | The use of the Stretta Control Module Model S400 RF<br>electrosurgical generator with pump is contraindicated when, in<br>the judgment of the physician, electrosurgical procedures would<br>be contrary to the patient's best interest. |

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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Prescription Use (per 21CFR§801.109) OR Over-the-Counter Use (Optional format 1-2-06)

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Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Conway Stuart Medical, Inc.