(76 days)
THE SMALL HIGH SPEED DRICE SYSTEM IS INTENDED FOR RAPID DISSEETTON OF BONE, BOPLASTICS AND BIOMATERIALS DURING NEUROSURGICAL, ENT AND MAXILLOFACIAL SURGICAL PROCEDURES
SMALL MIGH SPEED MOTOR DRILL SYSTEMS
This document is a 510(k) premarket notification decision letter from the FDA for a "Small High Speed Motor Drill System." It confirms that the device is substantially equivalent to a legally marketed predicate device.
However, this document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The letter is a regulatory approval document and does not detail the technical performance studies that would have been submitted as part of the 510(k) application. To answer your questions, one would need to access the actual 510(k) submission documentation, which is not provided here.
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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 (301) 594-4659. 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" (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 (800) 638-2041 or (301) 443-6597 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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Page _ of _
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 _
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
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.(b)
Classification. Class II (performance standards).