(47 days)
The Somnus™ Model 215 Electrosurgical Generator and Accessories are intended for use with the Somnus Tissue Coagulating Electrodes for the coagulation of tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The Somnus Model 215 Electrosurgical Generator, in combination with various Somnus electrodes, is indicated for the coagulation of tissue.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
The SomnusTM Model 215 Electrosurgical Generator is an electrosurgical generator with controls for power delivered, time of energy delivery and in the automatic mode, maximum temperature. 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 electrodes and a footpedal.
Accessories included with the generator include a line power cable, single pedal footpedal an adapter for a dispersive electrode.
The provided text is a 510(k) summary for the Somnus Model 215 Electrosurgical Generator and Accessories.
Based on the provided document, here's an analysis regarding acceptance criteria and a study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document does not provide specific, quantifiable acceptance criteria or reported device performance in the format of a table. It states:
"In addition, performance validation testing 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."
This indicates that internal testing was performed, and the results were deemed satisfactory for substantial equivalence, but the details of those tests, including specific performance metrics and acceptance thresholds, are not included in this publicly available summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for any test set or the data provenance. It only mentions "performance validation testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. The device is an electrosurgical generator, which typically involves objective performance measurements (e.g., power output, impedance, temperature control) rather than subjective interpretation by experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. Given the nature of the device (electrosurgical generator), an adjudication method in the context of expert consensus is unlikely to be relevant in the same way it would be for AI-driven diagnostic imaging devices.
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:
This is not applicable to this device. The Somnus Model 215 Electrosurgical Generator is a medical device for tissue coagulation, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC comparative effectiveness study would not be performed for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable to this device. This is a hardware electrosurgical generator, not an algorithm. The phrase "standalone performance" typically refers to the performance of an AI algorithm independent of human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document does not explicitly state the type of ground truth used. For an electrosurgical generator, "ground truth" would likely relate to objective measurements of electrical output, thermal profiles, and perhaps tissue effects in an experimental setting, rather than pathology or outcomes data in the context of a diagnostic test.
8. The sample size for the training set:
This information is not provided in the document. As an electrosurgical generator, it is a hardware device and does not involve a "training set" in the context of machine learning. Its design and performance are based on engineering principles and validated through physical and electrical testing.
9. How the ground truth for the training set was established:
This information is not provided, and the concept of a "training set" is not applicable to this type of device.
In summary:
The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics, along with "performance validation testing." However, it does not detail the specific acceptance criteria, test methodologies, sample sizes, or expert involvement that would be typically found in a study demonstrating how a device meets specific, quantifiable acceptance criteria, especially for AI or diagnostic devices. The document is typical for a hardware medical device submission where the focus is on safety, effectiveness, and comparison to existing technology.
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JUN 2 4 1997 510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc. TM Model 215 Electrosurgical Generator and Accessories
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Intended Use:
The Somnus™ Model 215 Electrosurgical Generator and Accessories are intended for use with the Somnus Tissue Coagulating Electrodes for the coagulation of tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
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) 617-3424
Date Summary Prepared:
May 6, 1997
Name of the Device:
| Proprietary Name: | Somnus ™ Model 215 ElectrosurgicalGenerator and Accessories |
|---|---|
| Common/Usual Name: | Electrosurgical Generator andAccessories |
| Classification Name: | Electrosurgical Device (per 21 CFR878.4400) |
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.
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Predicate Devices:
Somnus Model 215 Electrosurgical Generator Erbe ICC 200 Erbe ICC 50 VidaMed 50 VidaMed 7205
Description:
The SomnusTM Model 215 Electrosurgical Generator is an electrosurgical generator with controls for power delivered, time of energy delivery and in the automatic mode, maximum temperature. 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 electrodes and a footpedal.
Accessories included with the generator include a line power cable, single pedal footpedal an adapter for a dispersive electrode.
Statement of Intended Use:
The Somnus Model 215 Electrosurgical Generator and Tissue Coagulating Electrodes are intended for use in the coagulation of tissue.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Comparison to Predicate Devices:
The Somnus Model 215 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 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.
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.
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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" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.
JUN 24 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eve A. Conner, Ph.D. Vice President, Clinical and Regulatory Affairs Somnus Medical Technologies, Inc. ........................................................................................................... 285 N. Wolfe Road Sunnyvale, California 94086
Re: K971711
Trade Name: Somnus™ Model 215 Electrosurgical Generator Regulatory Class: II Product Code: GEI Dated: May 6, 1997 Received: May 8, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that. through periodic GMP 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 - Eva A. Conner, 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,
Alan Watts
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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510(k) Number (if known):
K971711 Not Yet Assigned
Device Name:
SOMNUS™ MODEL 215 ELECTROSURGICAL GENERATOR AND ACCESSORIES
Indications For Use:
The Somnus Model 215 Electrosurgical Generator, in combination with various Somnus electrodes, is indicated for the coagulation of tissue.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Contraindications for Use:
The use of the Somnus Model 215 Electrosurgical Generator and Accessories is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interests of the patient.
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971711
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR (Per 21 CFR 801.109)
Over-The-Counter Use
(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.
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§ 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.