(56 days)
The Geiger Electrosurgical Handpiece Sheath is intended to be placed over an electrosurgical handpiece and act as a non-sterile barrier.
The Geiger Electrosurgical Handpiece Sheath is a non-sterile, clear plastic, disposable, electrosurgical handpiece cover, designed to be used over an electrosurgical handpiece to limit contamination.
The provided text is a 510(k) summary for the Geiger Electrosurgical Handpiece Sheath. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study.
Therefore, most of the requested information regarding acceptance criteria and performance study details cannot be extracted from the provided text.
Here's what can be stated based on the given information:
1. Table of acceptance criteria and the reported device performance:
This information is not present in the provided text. The submission is a 510(k) for substantial equivalence, which primarily relies on comparing the new device to existing legally marketed predicate devices, not on a new performance study with explicit acceptance criteria.
2. Sample size used for the test set and the data provenance:
This information is not present in the provided text. No specific test set or data provenance for performance evaluation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not present in the provided text. No ground truth establishment for a test set is discussed.
4. Adjudication method for the test set:
This information is not present in the provided text. No adjudication method for a test set is discussed.
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 information is not present in the provided text. The device is an electrosurgical handpiece sheath, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present in the provided text. The device is a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.
7. The type of ground truth used:
This information is not present in the provided text. The submission relies on substantial equivalence to predicate devices, not on establishing ground truth for a new performance claim.
8. The sample size for the training set:
This information is not present in the provided text. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established:
This information is not present in the provided text. There is no mention of a training set or ground truth establishment for such.
In summary: The provided document is a 510(k) submission for a non-sterile, clear plastic, disposable electrosurgical handpiece cover. It establishes substantial equivalence to predicate devices (ConMed Non-Sterile Handpiece Sheath, ConMed Sterile Handpiece Sheath K963088, and Banta Healthcare Products Sanitherm Oral Thermometer Sheaths K983406) based on design, operation, intended use, materials, method of preparation, and performance claims, rather than presenting performance data from a specific study against predefined acceptance criteria.
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AUG 19 1999
Image /page/0/Picture/1 description: The image shows the logo for Geiger Medical Technologies. The word "GEIGER" is in large, bold, sans-serif font at the top. Below it, the words "medical technologies" are in a smaller, sans-serif font, set against a black rectangle. A registered trademark symbol is to the right of the word Geiger.
Page 36 of 36
K 992149
510(k) SAFETY AND EFFECTIVENESS SUMMARY
TRADE NAME: COMMON NAME: CLASSIFICATION NAME: (878.4400)
Geiger Electrosurgical Handpiece Sheath Geiger Electrosurgical Handpiece Sheath Device, Electrosurgical, Cutting & Coagulation & Accessories,
The Geiger Electrosurgical Handpiece Sheath is a non-sterile, clear plastic, disposable, electrosurgical handpiece cover, designed to be used over an electrosurgical handpiece to limit contamination.
The Geiger Electrosurgical Handpiece Sheath is substantially equivalent to the ConMed Non-Sterile Handpiece Sheath (510(k) clearance information unknown), and to the ConMed Sterile Handpiece Sheath, FDA-cleared under K963088. The Geiger Electrosurgical Handpiece Sheath is substantially equivalent to the listed devices in design, operation, intended use, materials, method of preparation, and performance claims.
The Geiger Electrosurgical Handpiece Sheaths are also identical in design, materials, method of preparation and performance claims to the Banta Healthcare Products Sanitherm Oral Thermometer Sheaths, FDA-cleared under K983406.
In conclusion, the Geiger Electrosurgical Handpiece Sheaths are substantially equivalent to the predicate devices in methods of operation, intended use, and results derived from operation.
Submitted By: John Bottjer President Geiger Medical Technologies, Inc. 24040 Camino del Avion, A-195 Monarch Beach, CA 92629 (949) 240-7584
Contact Person: John Bottjer Date: June 22, 1999
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG , 9 1990
Mr. John Bottier President Geiger Medical Technologies, Inc. 24040 Camino Del Avion Suite A-195 Monarch Beach, California 92629
Re: K992149
Trade Name: Geiger Electrosurgical Handpiece Sheath Regulatory Class: II Product Code: GEI Dated: June 22, 1999 Received: June 24, 1999
Dear Mr. Bottjer:
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 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 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 - Mr. John Bottjer
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,
Sir
Russell Sage
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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2 of 36 Page
510(k) NUMBER (IF KNOWN) : GEIGER ELECTROSURGICAL HANDPIECE SHEATH DEVICE NAME:
INDICATIONS FOR USE :
The Geiger Electrosurgical Handpiece Sheath is intended to be placed over an The Gelger Ellectrosurgical handpiece and act as a non-steriive barrier.
electrosurgical handpiece and act as a non-sterials and historial in tho The electrosurgical handpress and act as a non becalled processions of the marketplace.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Russell S. Payne for J2P
(Division Sign-Off) Division of General Restorative Devices 510(k) Number ...
§ 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.