KOMET XK-95 PERFORATOR MOTOR (MI-102)

K991625 · Komet Medical · HBB · Jul 30, 1999 · Neurology

Device Facts

• Record ID: K991625
• Device Name: KOMET XK-95 PERFORATOR MOTOR (MI-102)
• Applicant: Komet Medical
• Product Code: HBB · Neurology
• Decision Date: Jul 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4370
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XK-95 Perforator Motor is intended to be used in conjunction with various cranial perforators and an adapter for cranial perforations.

Device Story

The Komet Medical Xk-95 Perforator Motor is a powered surgical instrument designed for use in neurosurgical procedures. It functions as a motor drive unit that connects to compatible cranial perforators via an adapter to facilitate the creation of burr holes in the skull. The device is intended for use by surgeons in an operating room environment. By providing controlled rotational power, it assists the clinician in performing cranial access, thereby supporting surgical workflows. The device is operated by a physician or surgical staff to ensure precise bone penetration during craniotomy or related procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motor-driven surgical handpiece for cranial perforation; includes adapter for compatibility with cranial perforators; powered system; class II device.

Indications for Use

Indicated for use in cranial perforation procedures requiring a motor-driven perforator system.

Regulatory Classification

Identification

A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Komet Medical c/o Mr. Courtney S. Paradice 2188 Knoll Drive Ventura, California 93003

K991625 Re:

Trade Name: Komet Medical Xk-95 Perforator Motor Regulatory Class: II Product Code: HBB Dated: May 3, 1999 Received: May 11, 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 (OS) 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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899/6025

## INDICATION OF USE

The XK-95 Perforator Motor is intended to be used in conjunction with various cranial The XX-95 I criorator Motor adapter for cranial perforations.

vision Sign-Off

(Division Sign-Off)
Division of General Restorative Devices 14991625
510(k) Number

Prescription Use ***_*****_**
(Per 21 CFR 801.109)