XK-95 HIGH SPEED MOTOR DRILL SYSTEM

K984035 · Komet Medical · HBE · Jun 3, 1999 · Neurology

Device Facts

• Record ID: K984035
• Device Name: XK-95 HIGH SPEED MOTOR DRILL SYSTEM
• Applicant: Komet Medical
• Product Code: HBE · Neurology
• Decision Date: Jun 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

High Speed Drall Syst પ્રાહ-95 for use during neurological to provide power to ope proc or attachments acı assurili

Device Story

The XK-95 High Speed Motor Drill System is a powered surgical instrument used in neurological procedures. It provides rotational power to various surgical attachments or instruments. The device is intended for use by surgeons in an operating room environment. It functions as a motor-driven system to facilitate bone cutting, drilling, or other surgical tasks required during neurosurgery. The system assists the surgeon in performing precise mechanical actions, potentially reducing procedure time and improving surgical outcomes.

Clinical Evidence

Bench testing only.

Technological Characteristics

High-speed motor-driven system; powered surgical instrument; intended for neurological applications; Class II device (Product Code HBE).

Indications for Use

Indicated for use during neurological procedures to provide power to operating instruments or attachments.

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

3 1999 JUN

Mr. Courtney S. Paradice Komet Medical 1679 Kellogg Springs Drive Atlanta, Georgia 30338

Re: K984035 Trade Name: XK-95 High Speed Motor Drill System Regulatory Class: II Product Code: HBE Dated: March 2, 1999 Received: March 5, 1999

Dear Mr. Paradice:

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.

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## Page 2 - Mr. Courtney S. Paradice

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,

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

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510(k) Number (if known): 984035

Device Name:

FDA's Statement of the Indications For Use for device:

High Speed Drall Syst પ્રાહ-95 for use during neurological to provide power to ope proc or attachments acı assurili

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Over-The-Counter Use

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