GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405

K992149 · Geiger Medical Technologies, Inc. · GEI · Aug 19, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992149
• Device Name: GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405
• Applicant: Geiger Medical Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The Geiger Electrosurgical Handpiece Sheath is intended to be placed over an electrosurgical handpiece and act as a non-sterile barrier.

Device Story

The Geiger Electrosurgical Handpiece Sheath is a disposable, clear plastic cover designed to fit over electrosurgical handpieces. It functions as a non-sterile barrier to prevent contamination of the handpiece during use. The device is intended for clinical settings where electrosurgical equipment is utilized. It is applied by the clinician or staff prior to the procedure. The sheath does not interfere with the operation of the electrosurgical handpiece, allowing the physician to perform cutting and coagulation as intended while maintaining a barrier between the device and the environment.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Non-sterile, clear plastic disposable sheath. Form factor is a sleeve designed to fit over an electrosurgical handpiece. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a protective barrier over electrosurgical handpieces to limit contamination during clinical procedures.

Regulatory Classification

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.

Predicate Devices

• ConMed Non-Sterile Handpiece Sheath (510(k) clearance information unknown)
• ConMed Sterile Handpiece Sheath (K963088)

Reference Devices

• Banta Healthcare Products Sanitherm Oral Thermometer Sheaths (K983406)

Submission Summary (Full Text)

{0}------------------------------------------------

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 [phone]

Contact Person: John Bottjer Date: June 22, 1999

{1}------------------------------------------------

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.

{2}------------------------------------------------

## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{3}------------------------------------------------

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 ...