DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)

K971342 · Disk Whisk, Inc. · HWE · Jul 8, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971342
• Device Name: DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)
• Applicant: Disk Whisk, Inc.
• Product Code: HWE · General, Plastic Surgery
• Decision Date: Jul 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The product is indicated for use in endoscopic and nonendoscopic orthopedic procedures, to assist in the removal of fibrous disk material in the spine and for the decortication of bone.

Device Story

The Disk Whisk System is a surgical instrument used by orthopedic surgeons during spinal procedures. It functions as a mechanical tool to assist in the removal of fibrous disk material and the decortication of bone. It is utilized in both endoscopic and nonendoscopic surgical settings. By facilitating the removal of tissue and bone preparation, the device aids the surgeon in performing spinal interventions, potentially improving procedural efficiency and patient outcomes.

Clinical Evidence

No clinical data provided. The determination of substantial equivalence is based on the device's intended use and classification as a Class I device.

Technological Characteristics

Mechanical surgical instrument for orthopedic procedures. No specific materials, energy sources, or software components are described in the provided documentation.

Indications for Use

Indicated for use in endoscopic and nonendoscopic orthopedic procedures to assist in the removal of fibrous disk material in the spine and for the decortication of bone.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rick D. Roberts President and CEO Disk Whisk, Inc. 600 South Rancho Lane, Suite 113 Las Vegas, Nevada 89106

JUL - 8 1997 Re : K971342 Disk Whisk System Requlatory Class: I Product Code: HWE Dated: April 7, 1997 Received: April 10, 1997

Dear Mr. Roberts:

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, qood manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially guivalent 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

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Page 2 - Mr. Rick D. Roberts

comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.

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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9713i42

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Indications For Use: The product is indicated for use in endoscopic and nonendoscopic orthopedic procedures, to assist in the removal of fibrous disk material in the spine and for the decortication of bone.

cello

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971342

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

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