MICROAIRE 1000E SYSTEM

K014060 · Microaire Surgical Instruments, Inc. · HBE · Mar 5, 2002 · Neurology

Device Facts

• Record ID: K014060
• Device Name: MICROAIRE 1000E SYSTEM
• Applicant: Microaire Surgical Instruments, Inc.
• Product Code: HBE · Neurology
• Decision Date: Mar 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The MicroAire® 1000E System is intended for use in surgical procedures requiring the need for cutting, sawing, drilling, reaming, wire driving, pinning, screw driving, decorticating, shaping and manipulation of bone and bone related tissue.

Device Story

MicroAire 1000E System is an electric surgical power system for bone manipulation. Components include electric power supply, power-connecting cables, foot/hand lever activation controls, modular/unitized handpieces, and head assemblies. System operates via electric motors providing variable speed/torque for surgical tasks. Used in OR settings by surgeons across various specialties (ENT, orthopedic, neuro, etc.). Provides mechanical power to attachments for cutting, drilling, and sawing bone. Benefits include precise bone manipulation during surgical procedures. Does not include integrated irrigation; stand-alone irrigation available separately.

Clinical Evidence

No clinical data. Substantial equivalence based on design, performance, and technological characteristics compared to the predicate device.

Technological Characteristics

Class I, Type BF electric power supply (50-60 Hz, 100-230 VAC). Modular/unitized handpieces with electric motors. Foot-controlled throttle mechanisms. Head assemblies for high/medium/low speed drills, oscillating/sagittal/reciprocating saws, and wire/pinning/reaming/drilling chucks. Meets UL, CSA, and IEC safety standards.

Indications for Use

Indicated for cutting, sawing, drilling, reaming, wire driving, pinning, screw driving, decorticating, shaping, and manipulation of bone and bone-related tissue in ENT, maxillofacial, neurological, oral, orthopedic, plastic, podiatric, and spinal surgery.

Regulatory Classification

Identification

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

Predicate Devices

• Stryker® HERMES-Ready™ Total Performance System (TPS™) (K991696)

Submission Summary (Full Text)

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KO14060 1/2 5 2002 MAR

## X . 510(k) Summary

| Date: | December 1, 2001 |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | MicroAire® Surgical Instruments<br>1641 Edlich Drive<br>Charlottesville, VA 22911 |
| Contact Person: | Carl Angles<br>Director of Quality and Regulatory Affairs |
| Telephone:<br>Facsimile: | 434-975-8000<br>434-975-4144 |
| Proprietary Name:<br>Common Name:<br>Classification Name: | MicroAire® 1000E System<br>Electric Surgical System for Cutting and Drilling<br>Powered simple cranial drills, burrs, trephines and<br>their accessories (21 CFR § 882.4310) |

The MicroAire® 1000E System is substantially equivalent to the Stryker® HERMES-Ready™ Total Performance System (TPS™), 510(k) number K991696, predicate device. Although the 1000E system does not integrate irrigation, joint shaving and endoscopy features, the intended use, design, energy, materials, performance, safety, effectiveness, labeling, biocompatibility, and applicable standards are substantially equivalent to the Stryker TPS.

The MicroAire® 1000E System is intended for use in surgical procedures requiring the need for cutting, sawing, drilling, reaming, wire driving, pinning, screw driving, decorticating, shaping and manipulation of bone and bone related tissue.

The MicroAire® 1000E System consists of an electric power supply, powerconnecting cable(s), a foot and/or hand lever power activation control, modular and unitized handpieces, modular head assemblies and accessories.

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## KOLADGO 2/2

## Technological Characteristic Summary - 1000E v. TPS

Power Source: Both sources are Class I, Type BF, electrically powered and controlled devices (50-60 Hz, 100-230 VAC input), which meet the same basic voluntary safety standards (UL, CSA, IEC). However, the TPS system integrates an irrigator pump into the power console while the 1000E does not. MicroAire markets and sells a "stand-alone" irrigation system for those customers that utilize irrigation.

Electric Motors: Both systems contain modular and unitized handpieces that operate at different cycle, speed and/or torque parameters necessary for various surgical procedures.

Foot Control: Both systems utilize foot-controlling throttle mechanisms.

Electric Connecting Cable: Both systems use electric cables to connect the power supply with the handpieces.

Head Assemblies: Both systems have head configurations facilitating high, medium and low speed drills, oscillating, sagittal and reciprocating saws and wire, pinning, reaming and drilling chucks.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 2002 MAR

Mr. Carl Angles Director of Quality and Regulatory Affairs MicroAire Surgical Instruments 1641 Edlich Drive Charlottesville, VA 22911

Re: K014060

Trade/Device Name: MicroAire® 1000E System Regulation Number: 882.4310, 882.4360 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Electric cranial drill motor Regulatory Class: II Product Code: HBE, HBC Dated: December 7, 2001 Received: December 10, 2001

Dear Mr. Angles:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becament be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regard ment date of the Medical Device Amendments, or to conimeres prior to may 20, 1978, the exactions of the Federal Food, Drug, devices that have been rocussion in avere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, merelore, manot and include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your device is classified (over a controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I DTT of local that your device complies with other requirements of the Act that I Dr Hab intatutes and regulations administered by other Federal agencies. You must or any I cacial stututes and regulances including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Far 8077, adoling (21 (QS) regulation (21 CFR Part 820); and if applicable. the electronic for all in the quality byticins (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Carl Angles

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 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,

Miriam C. Provost

for 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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Page 1

KO14060 510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

Device Name:____MicroAire® 1000E System

Indications For Use:

The MicroAire® 1000E System is indicated for use in cutting, sawing, drilling, reaming, wire driving, pinning, screw driving, decorticating, shaping and manipulation of bone and other bone related tissue in a variety surgical procedures. The applications include ENT, maxilliofacial, neurological, oral, orthopedic, plastic, podiatric and spinal surgery.

(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)

Over-The-Counter______________________________________________________________________________________________________________________________________________________________

Muriam C. Provost (Optional Format 1-2-96)

(Division Sign-Offi Division of General, Rentarative and Neurological . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

OR

51 Number K014060