(90 days)
The Somnoplasty™ System is intended for the reduction of the incidence of airway obstructions in patients suffering from UARS or OSAS.
The Somnoplasty " System is intended for the reduction of the incidence of airway obstructions in patients suffering from UARS or OSAS.
The Somnoplasty®" System is intended for the reduction of the incidence of airway obstructions in patients suffering from UARS (Upper Airway Resistance Syndrome) or OSAS (Obstructive Sleep Apnea Syndrome).
The Somnoplasty™ System is comprised of an Electrosurgical (RF) Generator and Tissue Coagulating Electrodes. The RF Generator has controls for target temperature, target energy, power delivered and time of energy delivery. The unit has readouts for total energy delivered, impedance, number of active channels and temperature for up to 3 thermocouples per channel. Connectors on the front panel include connectors for coagulating and dispersive electrodes and a footpedal. The electrodes are provided with various handpiece configurations to facilitate the placement of the needles in the tissue to be ablated.
Accessories included with the generator include a line power cable and single pedal footpedal.
The provided document does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested. The document is a 510(k) summary and related FDA correspondence, primarily focusing on the device's intended use, comparison to predicate devices, and FDA clearance.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about a test set, its sample size, or data provenance.
- Information on the number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance data.
- The type of ground truth used (e.g., pathology, outcomes data).
- The sample size for the training set.
- How ground truth for the training set was established.
The document mentions that "Performance validation testing, including a clinical study, has been done to validate the performance of the device," but it does not provide any specifics or results from that study. It also states the device "is safe and effective in its intended use" based on comparisons and validation results, but no metrics or criteria are elaborated upon.
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NOV 2 1998
510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc.™ Somnoplasty5" System
Intended Use:
The Somnoplasty™ System is intended for the reduction of the incidence of airway obstructions in patients suffering from UARS or OSAS.
Submitted by:
Somnus Medical Technologies, Inc. 285 North Wolfe Road Sunnyvale, CA 94086 Tel: 408.773.9121 Fax: 408.773.9137
Contact Person:
Eve A. Conner, Ph.D. Vice President Clinical and Regulatory Affairs Telephone: (408) 773-9121
Date Summary Prepared:
July 31, 1998
Name of the Device:
| Proprietary Name: | Somnus™ Medical Technologies, Inc.Somnoplasty™ System |
|---|---|
| Common/Usual Name: | Electrosurgical Generator andAccessories |
| Classification Name: | Electrosurgical Device (per 21 CFR878.4400) |
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Predicate Devices:
Somnus Model S2 Electrosurgical Generator Somnus Tissue Coagulating Electrode Models 1000, 1010, 1200, 2000, 2010, 3000, 30XX, 6000
Description:
The Somnoplasty™ System is comprised of an Electrosurgical (RF) Generator and Tissue Coagulating Electrodes. The RF Generator has controls for target temperature, target energy, power delivered and time of energy delivery. The unit has readouts for total energy delivered, impedance, number of active channels and temperature for up to 3 thermocouples per channel. Connectors on the front panel include connectors for coagulating and dispersive electrodes and a footpedal. The electrodes are provided with various handpiece configurations to facilitate the placement of the needles in the tissue to be ablated.
Accessories included with the generator include a line power cable and single pedal footpedal.
Statement of Intended Use:
The Somnoplasty " System is intended for the reduction of the incidence of airway obstructions in patients suffering from UARS or OSAS.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Comparison to Predicate Devices:
The Somnoplasty™ System has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. Performance validation testing, including a clinical study, has been done to validate the performance of the 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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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1998
Eve A. Conner, Ph.D. Vice President Clinical and Regulatory Affairs Somnus Medical Technologies, Inc. 285 North Wolfe Road Sunnyvale, California 94086
K982717 Re: Somnoplastys System Trade Name: Regulatory Class: II Product Code: GEI July 31, 1998 Dated: Received: August 04, 1998
Dear Dr. Conner:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ 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 (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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Page 2 - Dr. Eve A. Conner
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4595. 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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9P27/7
Not Yet Assigned
510(k) Number (if known):
Somnoplasty System Device Name:
Indications for Use:
The Somnoplasty®" System is intended for the reduction of the incidence of airway obstructions in patients suffering from UARS (Upper Airway Resistance Syndrome) or OSAS (Obstructive Sleep Apnea Syndrome).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| OR | Over-The-Counter Use |
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K982717 |
|---|---|
| --------------- | --------- |
Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Somnus Medical Technologies, 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.