HANDPIECE SHEATH-MODEL #A910

K011929 · Aaron Medical, Inc. · GEI · Sep 18, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K011929
• Device Name: HANDPIECE SHEATH-MODEL #A910
• Applicant: Aaron Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The Aaron 910 handpiece Sheath is intended to be used as an accessory to electrosurgical handpieces. The sheath is placed over the handpiece and provides a barrier to minimize contamination. The Handpiece Sheath is non-sterile and is intended for single patient use only.

Device Story

The Aaron A910 Handpiece Sheath is a non-sterile, disposable cover designed to fit over electrosurgical handpieces. It acts as a physical barrier between the handpiece and the patient to prevent contamination. The device is intended for single-patient use. It is used in clinical settings where electrosurgical procedures are performed. The sheath does not alter the function of the electrosurgical device but serves as an infection control accessory.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and intended use comparisons, supported by hazard analysis.

Technological Characteristics

Non-sterile, disposable sheath. Designed as a physical barrier for electrosurgical handpieces. Materials and construction are equivalent to predicate devices.

Indications for Use

Indicated for use as a protective barrier accessory for electrosurgical handpieces to minimize contamination during single-patient use.

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

• Geiger Medical Technologies Handpiece Sheath (K992149)
• Banta Healthcare Sanitherm Thermometer Sheath (K983406)
• Aspen Laboratories/Conmed Handpiece Sheath (K963088)

Reference Devices

• Aaron Medical High Temperature Replacement Tip drape (K945758)

Submission Summary (Full Text)

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#### AARON MEDICAL , A BOVIE COMPANY AARON A910 HANDPIECE SHEATH

SEP 1 82001

## KO11929

#### 510(k) SAFETY AND EFFECTIVENESS SUMMARY

Trade Name: Common Name: Classification Name:

Aaron A910 Handpiece Sheath Handpiece Sheath Electrosurgical Cutting and Coagulation Devices and Accessories (per 21CFR 878.4400)

The Aaron A910 Handpiece Sheath is a non-sterile, disposable electrosurgical handpiece cover that is designed to fit over an electrosurgical handpiece to provide a barrier between the handpiece and the patient, thus prevent contamination of the handpiece.

The Aaron A910 Handpiece Sheath is substantially equivalent to the Geiger Medical Technologies Handpiece Sheath (K-992149), the Banta Healthcare Sanitherm Thermometer Sheath (K983406), and the Aspen Laboratories/Conmed Handpiece Sheath (K-963088). Additionally, the sheath is of the same design, intended use, materials, method of preparation, and performance claims as Aaron Medical High Temperature Replacement Tip drape (K-945758).

Hazard analysis evaluations were performed on the Aaron A910. There are no new hazards presented with the use of the Aaron A910 as compared with the predicate devices.

In conclusion, the Aaron A910 Handpiece Sheath is substantially equivalent to the named predicate devices in design, methods of operation, intended use, materials, and method of preparation.

Submitted By:

Richard Kozloff Vice-President ; Quality Assurance Aaron Medical 7100 30th Avenue North St. Petersburg, FL 33710

Contact Person: Richard Kozloff Date: June 19, 2001

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SEP 1 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard Kozloff Vice President, Quality Assurance Aaron Medical, Inc. 7100 30th Avenue North St. Petersburg, Florida 33710

Re: K011929

Trade/Device Name: Aaron A910 Handpiece Sheath Regulation Number: 878.4400 Regulatory Class: II Product Code: GEI Dated: June 19, 2001 Received: June 20, 2001

Dear Mr. Kozloff:

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 legally marketed predicate 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 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. Richard Kozloff

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### AARON MEDICAL INDUSTRIES AARON 910 HANDPIECE SHEATH

### INDICATIONS FOR USE

510(k) Number (if known): K 011 9 29

Device Name: Aaron A910 Handpiece Sheath

Indications for Use:

The Aaron 910 handpiece Sheath is intended to be used as an accessory to electrosurgical handpieces. The sheath is placed over the handpiece and provides a barrier to minimize contamination. The Handpiece Sheath is non-sterile and is intended for single patient use only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

SL

(Division Sign-Off) Division of General, Restorative and Neurological Devices

Koll 929 5 i J(k) Number -

(Optional Format 3-10-98)