(134 days)
The Stretta Control Module Model S400 RF electrosurgical generator with pump, in combination with CSM electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel, trained in the use of electrosurgery.
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.
This document does not contain the requested information regarding acceptance criteria, device performance, or study details. It is a 510(k) premarket notification summary for a medical device (Stretta Control Module Model S400 RF Generator) and includes its intended use, description, comparison to a predicate device, and the FDA's clearance letter. It does not provide data from performance studies or specify acceptance criteria for such studies.
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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: (408)733-9910 Fax: (408)522-8699
Contact Person:
Thomas C Wehman, Ph.D. Regulatory Affairs Phone: (408) 733-9910
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)
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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 S400Radiofrequency Electrosurgical Generator with Pump |
| Indications for Use: | The Stretta Control Module Model S400 RF electrosurgicalgenerator with pump, in combination with CSM electrodes, isindicated for coagulation of tissue. This device is intended foruse by qualified medical personnel, trained in the use ofelectrosurgery. |
| Contraindications for Use: | The use of the Stretta Control Module Model S400 RFelectrosurgical generator with pump is contraindicated when, inthe judgment of the physician, electrosurgical procedures wouldbe contrary to the patient's best interest. |
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| 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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.