SMALL HIGH SPEED MOTOR DRILL SYSTEM

K030172 · Brasseler USA I, L.P. · HBE · Apr 3, 2003 · Neurology

Device Facts

• Record ID: K030172
• Device Name: SMALL HIGH SPEED MOTOR DRILL SYSTEM
• Applicant: Brasseler USA I, L.P.
• Product Code: HBE · Neurology
• Decision Date: Apr 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

THE SMALL HIGH SPEED DRICE SYSTEM IS INTENDED FOR RAPID DISSEETTON OF BONE, BOPLASTICS AND BIOMATERIALS DURING NEUROSURGICAL, ENT AND MAXILLOFACIAL SURGICAL PROCEDURES

Device Story

Small High Speed Motor Drill System; used for rapid dissection of bone, bioplastics, and biomaterials. Utilized in neurosurgical, ENT, and maxillofacial surgical procedures. Operated by surgeons in clinical/OR settings. Device functions as a powered surgical drill; provides mechanical cutting/abrading action to facilitate surgical access or bone removal. Benefits include efficient tissue/material removal during complex procedures.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device characteristics and intended use.

Technological Characteristics

Powered simple cranial drill system; classified under 21 CFR 882.4310 (Product Code HBE). Mechanical drill system for bone and biomaterial dissection.

Indications for Use

Indicated for patients undergoing neurosurgical, ENT, or maxillofacial surgical procedures requiring rapid dissection of bone, bioplastics, and biomaterials.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 2003

Mr. Anthony V. Rose Regulatory Affairs and Quality Assurance Manager Brasseler USA™ 4837 McGrath Street, Suite J Ventura, California 93003

Re: K030172

Trade/Device Name: Small High Speed Motor Drill System Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBE Dated: January 15, 2003 Received: January 17, 2003

Dear Mr. Rose:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Anthony V. Rose

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), 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) you may obtain. 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

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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510(k) Number (if known): KO30172 Device Name: SMALL MIGH SPEED MOTOR DRILL SYSTEMS Indications For Use:

THE SMALL HIGH SPEED DRICE SYSTEM IS INTENDED FOR RAPID DISSEETTON OF BONE, BOPLASTICS AND BIOMATERIALS DURING NEUROSURGICAL, ENT AND MAXILLOFACIAL SURGICAL PROCEDURES

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Muriam C. Provost

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

长030172 510(k) Number _