(87 days)
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.
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.
This 510(k) summary for the Somnoplasty™ System primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information regarding specific acceptance criteria for performance, a formal study proving adherence to those criteria, or the methodology of such a study as one would typically find for AI/ML-based device submissions today.
The document discusses "performance validation testing, including a clinical study," but provides minimal details about the clinical study itself beyond its general purpose.
Therefore, much of the requested information cannot be extracted from the provided text.
Here is the information that can be gleaned and the limitations based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states that "Performance validation testing, including a clinical study, has been done to validate the performance of the device," and that "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." However, specific quantitative acceptance criteria or their corresponding performance results are not detailed.
2. Sample size used for the test set and the data provenance
The document mentions a "clinical study" but does not specify the sample size used for any test set or provide details on data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not available. This document predates the common requirements for AI/ML device submissions, and the nature of this electrosurgical device means ground truth would likely be established through direct clinical observation, patient outcomes, or pathological assessment rather than expert review of data/images in the context of an AI algorithm.
4. Adjudication method for the test set
Not applicable/Not available.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, hence an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device. The device itself performs the therapeutic action, rather than an algorithm providing diagnostic or therapeutic guidance.
7. The type of ground truth used
The device's intended use is for "coagulation (thermal ablation, tissue volume reduction) of soft tissue... and may reduce the severity of snoring in some individuals." Given this, the "ground truth" for its effectiveness and safety in the clinical study would likely have been established through:
- Clinical observation and patient outcomes: Assessment of tissue coagulation/ablation, reduction in snoring severity reported by patients or bed partners, and absence of adverse events.
- Medical imaging/physical examination: Potentially used to verify tissue changes or volume reduction.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
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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)
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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.
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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
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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
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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.
000002
§ 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.