(87 days)
Somnus Model 215 Electrosurgical Generator, Somnus Tissue Coagulating Electrode Models 1000, 2000
Not Found
No
The device description focuses on standard electrosurgical components (RF generator, electrodes) and controls (power, time, impedance, temperature). There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies validate substantial equivalence to predicate devices using standard clinical outcomes, not AI/ML performance metrics.
Yes
The device is intended for the coagulation (thermal ablation, tissue volume reduction) of soft tissue, including tissue in the uvula/soft palate, to reduce the severity of snoring, which directly addresses a health condition.
No
The device is intended for coagulation (thermal ablation, tissue volume reduction) of soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is comprised of an Electrosurgical (RF) Generator and Tissue Coagulating Electrodes, which are hardware components.
Based on the provided information, the Somnoplasty™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the coagulation (thermal ablation, tissue volume reduction) of soft tissue within the body (uvula/soft palate) to reduce snoring. This is a therapeutic procedure performed directly on a patient.
- Device Description: The device is an electrosurgical system that delivers RF energy to tissue. This is a common type of surgical device used for tissue modification in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The Somnoplasty™ System is a surgical device used for treatment.
N/A
Intended Use / Indications for Use
The Somnoplasty™ System is intended for the coagulation (thermal ablation, tissue volume reduction) of soft tissue, including tissue in the uvula/soft palate and may reduce the severity of snoring in some individuals. The system is intended for use by qualified medical personnel trained in the use of RF tissue ablation.
Product codes
GEI
Device Description
The SomnoplastyTM System is comprised of an Electrosurgical (RF) Generator and Tissue Coagulating Electrodes. The RF Generator has controls for 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 6 thermocouples. 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, single pedal footpedal and an adapter plug to accommodate dispersive electrodes from various manufacturers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uvula/soft palate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel trained in the use of RF tissue ablation.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Somnus Model 215 Electrosurgical Generator, Somnus Tissue Coagulating Electrode Models 1000, 2000
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUL 1 7 1997
510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc. TM Somnoplasty™ System
Intended Use:
The Somnoplasty™ System is intended for the coagulation (thermal ablation, tissue volume reduction) of soft tissue, including tissue in the uvula/soft palate and may reduce the severity of snoring in some individuals. The system is intended for use by qualified medical personnel trained in the use of RF tissue ablation.
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 8, 1997
Name of the Device:
Somnus™ Medical Technologies, Inc. Proprietary Name: SomnoplastyTM System
Common/Usual Name: Electrosurgical Generator and Accessories
Electrosurgical Device (per 21 CFR Classification Name: 878.4400)
1
Predicate Devices:
Somnus Model 215 Electrosurgical Generator Somnus Tissue Coagulating Electrode Models 1000, 2000
Description:
The SomnoplastyTM System is comprised of an Electrosurgical (RF) Generator and Tissue Coagulating Electrodes. The RF Generator has controls for 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 6 thermocouples. 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, single pedal footpedal and an adapter plug to accommodate dispersive electrodes from various manufacturers.
Statement of Intended Use:
The SomnoplastyTM System is intended for coagulation of soft tissue, including the uvula/soft palate and may reduce the severity of snoring in some individuals.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Comparison to Predicate Devices:
The SomnoplastyTM 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eve A. Conner, Ph.D. Vice President Clinical/Regulatory Affairs Somnus Medical Technologies, Inc. 285 N. Wolfe Road Sunnyvale, California 94086
JUL 17 1997
Re: K971450 Trade Name: Somnoplasty™ System Regulatory Class: II Product Code: GEI Dated: April 17, 1997 Received: April 21, 1997
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 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 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
3
Page 2 - Eve A. Conner. Ph.D.
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.
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
4
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K#971450 |
|---|---|
| --------------------------- | ---------- |
SOMNOPLASTY™ SYSTEM Device Name:
Indications For Use:
The Somnoplasty System is intended for coagulation (thermal ablation, tissue volume reduction) of soft tissue, including the uvula/soft palate and may reduce the severity of snoring in some individuals.
(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 |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K971450 |
(Optional Format 1-2-96)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.