(105 days)
The Somnus Model 1000 - Needle Sleeve Bending Tool is intended to change the angle of deployment of the needle for the Model 1000 - Single Needle Coagulating Electrodes by creating a radial bend in the needle sleeve.
This device is intended for use by qualified medical personnel trained in the use of Somnus Tissue Coagulating Electrodes.
The Somnus™ Bendable Tissue Coagulating Electrode is used to deliver radiofrequency (RF) energy for selective thermal ablation of tissues. The needle is deployed from a guide tube. The guide tube can be bent using the Electrode Bending Tool to allow deployment of the needle at angles ranging from 0 to 45°.
The provided text focuses on the 510(k) summary for the Somnus™ Electrode Bending Tool and does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets such criteria with quantitative measures. The document is primarily a regulatory submission for substantial equivalence.
Here's what can be extracted and what information is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in a quantifiable manner within the provided text. The document states "performance validation testing has been done to validate the performance of the device," but the specific criteria are not detailed.
- Reported Device Performance: Not reported with specific metrics. The text only mentions that the tool allows for "deployment of the needle at angles ranging from 0 to 45°" by creating a "radial bend in the needle sleeve." There are no reported numerical outcomes or success rates for this bending function.
Missing Information for this table: Specific, measurable acceptance criteria (e.g., minimum bending angle achieved, precision of bend, tool durability, etc.) and quantitative results from performance validation.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is irrelevant for this device. The Somnus™ Electrode Bending Tool is a mechanical accessory, not a diagnostic or AI-driven device requiring expert interpretation for ground truth establishment. Its performance would be assessed through mechanical engineering tests or usability studies, not through expert consensus on medical images or diagnoses.
4. Adjudication method for the test set
Not applicable, as ground truth establishment by experts for a test set is not relevant for this type of device.
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-driven device, and no human-in-the-loop performance study with or without AI assistance would be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical tool, not an algorithm.
7. The type of ground truth used
Not applicable in the sense of expert consensus, pathology, or outcomes data, as this is a mechanical tool. The "ground truth" for its performance would be defined by engineering specifications and direct measurement of its mechanical function (e.g., measuring the achieved bend angle).
8. The sample size for the training set
Not applicable. This is a physical medical device accessory, not a machine learning model. There is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical tool.
Summary of available information:
The provided document describes the intended use and compares the Somnus™ Electrode Bending Tool to predicate devices, stating that "performance validation testing has been done to validate the performance of the device." However, it does not provide details about the specific acceptance criteria, test methodologies, sample sizes, or quantitative results of these validation tests. The nature of the device (a mechanical accessory) means that many of the requested elements pertaining to AI or diagnostic studies are not applicable.
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510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc.™ Electrode Bending Tool
JUN 18 1997
Intended Use:
The Somnus™ Electrode Bending Tool is an accessory to the Somnus Bendable Tissue Coagulating Electrode. The Bending Tool is intended for use by qualified medical personnel trained in the use of Somnus Tissue Coagulating Electrodes.
Submitted by:
نومبر آهي.
من
Somnus Medical Technologies, Inc. 995 Benecia Avenue 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) 524-6263
Date Summary Prepared:
March 3, 1997
Name of the Device:
Proprietary Name:
Somnus™ Electrode Bending Tool
Common/Usual Name: Electrosurgical Device Accessory
Classification Name:
Electrosurgical Device (per 21 CFR 878.4400)
Classification Panel:
General Surgery Devices
Proprietary Data: This document and the information herein may not be reproduced, used or disclosed without prior written consent of Somnus Medical Technologies, Inc.
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Somnus Medical Technologies, Inc.
Common/Usual Name: Electrosurgical Device Accessory
Electrosurgical Device (per 21 CFR Classification Name: 878.4400)
Classification Panel: General Surgery Devices
Predicate Devices:
Somnus Bendable Tissue Coagulating Electrode, 510(k) Premarket Notification #K961133
Description:
The Somnus™ Bendable Tissue Coagulating Electrode is used to deliver radiofrequency (RF) energy for selective thermal ablation of tissues. The needle is deployed from a guide tube. The guide tube can be bent using the Electrode Bending Tool to allow deployment of the needle at angles ranging from 0 to 45°.
Statement of Intended Use:
The Somnus Model 1000 - Needle Sleeve Bending Tool is intended to change the angle of deployment of the needle for the Model 1000 - Single Needle Coagulating Electrodes by creating a radial bend in the needle sleeve.
The Somnus Bendable Tissue Coagulating Electrodes are intended for use in the coagulation of tissue. The Bending Tool is intended for use by qualified medical personnel trained in the use of Somnus Tissue Coagulating Electrodes.
Comparison to Predicate Devices:
The Somnus Bendable Tissue Coagulating Electrode with Bending Tool 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
Proprietary Data: This document and the information hercin 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 stylized human figure with outstretched arms, representing care and protection. The figure is positioned within a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling the top portion of the circle.
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. 995 Benecia Avenue Sunnyvale, California 94086
Re:
K970809 Trade Name: Somnus™ Electrode Bending Tool Regulatory Class: II Product Code: GEI Dated: May 1, 1997 Received: May 6, 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.
JUN 18 1997
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 - Eve 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 anyertising 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): K970809
Device Name: SOMNUS™ ELECTRODE BENDING TOOL
Indications For Use:
The Somnus Model 1000 - Needle Sleeve Bending Tool is intended to change the angle of deployment of the needle for the Model 1000 - Single Needle Coagulating Electrodes by creating a radial bend in the needle sleeve.
This device is intended for use by qualified medical personnel trained in the use of Somnus Tissue Coagulating Electrodes.
Contraindications for Use:
...'.".
There are no known contraindications for the use of this accessory with the Bendable Tissue Coagulating Electrode.
(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) (Optional Format 1-2-96)
Division of General Restorative Devices
510(k) Number K970809
Proprietary Data: This document and the information herein may not be reproduced,
used or disclosed without prior written consent of Somnus Medical Technologics, Inc
00008
§ 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.