MEDNEXT 1000 DRILL

K972308 · Mednext, Inc. · GEY · Aug 20, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972308
• Device Name: MEDNEXT 1000 DRILL
• Applicant: Mednext, Inc.
• Product Code: GEY · General, Plastic Surgery
• Decision Date: Aug 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

To provide power to operate various accessories to cut hard tissue, bone, soft tissue.

Device Story

Med"ext 1000 Surgical Drill is a powered surgical instrument designed to drive various accessories for cutting hard tissue, bone, and soft tissue. Used in clinical/surgical settings by physicians; device provides mechanical power to surgical attachments. Output is rotational force/torque applied to cutting accessories to facilitate tissue resection or bone drilling. Benefits include efficient tissue/bone removal during surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered surgical drill; intended for cutting hard tissue, bone, and soft tissue. Class I device (Product Code: GEY).

Indications for Use

Indicated for use in surgical procedures requiring the cutting of hard tissue, bone, and soft tissue.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

Thomas J. Mickel, Ph.D. Executive Vice President Med"ext Inc. .... .. .. 5490 Dexter Way West Palm Beach, Florida 33407

AUG 20 1997

Re: K972308 Trade Name: Med"ext 1000 Surgical Drill Regulatory Class: I Product Code: GEY Dated: June 18, 1997 Received: June 20, 1997

Dear Dr. Mickel:

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 requirements , 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.

Image /page/0/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing movement or connection.

{1}------------------------------------------------

## Page 2 - Thomas J. Mickel, Ph.D.

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 vour 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,

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

{2}------------------------------------------------

Intended Use Statement

510 (k) Number (if known):

Device Name: .................................................................................................................................................................

Indications for Use:

..............................................................................................................................................................................

. (

To provide power to operate various accessories to cut hard tissue, bone, soft tissue.

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

Concurrence of CDRH, Office of Device Evaluation (OQE)

bcolleto

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number: K972308

Prescription Use
(Per 21CFR 801.109)

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

.