TRITON HUDSON CHUCK ATTACHMENT

K983092 · Mednext, Inc. · HBB · Nov 6, 1998 · Neurology

Device Facts

• Record ID: K983092
• Device Name: TRITON HUDSON CHUCK ATTACHMENT
• Applicant: Mednext, Inc.
• Product Code: HBB · Neurology
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4370
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use during surgical procedures to cut hard tissue, bone and soft tissue and to hold cranial perforators that have a standard Hudson fitting.

Device Story

Hudson Chuck for Mednext TRITON Handpiece is a surgical accessory; functions as a mechanical interface/chuck to hold cranial perforators with standard Hudson fittings; used by surgeons during surgical procedures to facilitate cutting of hard tissue, bone, and soft tissue; device operates as a mechanical coupling mechanism; provides secure attachment for surgical cutting instruments; enables effective tissue resection; used in clinical surgical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical surgical chuck; designed for standard Hudson fitting compatibility; manual operation; non-powered accessory.

Indications for Use

Indicated for use during surgical procedures requiring the cutting of hard tissue, bone, and soft tissue, and for holding cranial perforators with a standard Hudson fitting.

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

6 1998 NOV

Dr. Stewart Willason President Mednext, Inc. 5490 Dexter Way West Palm Beach, Florida 33407

Re: K983092 Trade Name: Hudson Chuck for Mednext TRITON Handpiece Regulatory Class: II Product Code: HBB Dated: September 02, 1998 Received: September 03, 1998

Dear Dr. Willason:

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.

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.

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Page 2 - Dr. Stewart Willason

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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## Appendix E - Statement of Intended Use

## Intended Use Statement

983072 510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________ Automa

Hudson Chuck for Mednext TRITON Handpiece Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

For use during surgical procedures to cut hard tissue, bone and soft tissue and to hold cranial perforators that have a standard Hudson fitting.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21CFR 801.109)

OR

Over-the-Counter Use

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**Division Sign-Off**

Division of General Restorative Devices
510(k) Number K983092