XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT

K983025 · Xomed, Inc. · HRX · Nov 6, 1998 · Orthopedic

Device Facts

• Record ID: K983025
• Device Name: XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT
• Applicant: Xomed, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Power Rasp is intended for use as an accessory to the XPS Straight Shot handpiece The Xomed XPS StraightShot Microdebrider System is intended for the cutting and removal of soft and hard tissue or bone in otorhinolaryngology, head and neck, and orthopedic surgery. It is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is needed. These include open spinal surgeries and small and large joint arthroscopic procedures.

Device Story

Mechanical attachment for XPS Straight Shot handpiece; converts rotary motion from collet drive to oscillating (forward/backward) motion. Used to drive cutting bits/rasps for tissue or bone removal. Operated by surgeons in OR settings for orthopedic, ENT, and head/neck procedures. Device facilitates precise tissue resection; benefits patient through minimally invasive access in arthroscopic or spinal surgeries.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical attachment; converts rotary to oscillating motion; compatible with XPS Straight Shot handpiece; non-powered accessory; no software or electronic components.

Indications for Use

Indicated for use with XPS Straight Shot Microdebrider to cut/remove hard and soft tissue or bone in orthopedic, otorhinolaryngology, and head and neck surgery, including open spinal surgeries and small/large joint arthroscopic procedures.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Submission Summary (Full Text)

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# Revised October 1, 1998

K983205 / K983025

## 510(k) Summary

#### 1.0 Date Prepared

August 28, 1998

### 2.0 Submitter (Contact)

Debra B. Cortner Xomed Surgical Products Jacksonville, FL [phone]

#### 3.0 Device Name

Proprietary Name: Xomed FeatherTouch XPS Power Rasp Attachment,

Drill attachment, oscillating attachment Common Name(s):

ENT surgical drill and Surgical instrument motor accessories Classification Name:

#### Device Classification 4.0

Procode 77ERL Class II ; 21 CFR 874.4250 Tier 1 ENT Drill Surgical Motors and Accessories Procode 79GEY Class I ; 21 CFR 878.4820 Tier 1 878.4820 is now exempt from 510(k) notification.

Note: Bur rasp /blade tips to be used with the Power Rasp Attachment are exempted from notification by 21 CFR 874.4140 Ear, Nose and Throat Bur. Surgical motors and accessories are exempt from 510(k) under 21 CFR 878.4820.

#### 5.0 Device Description

The XPS Power Attachment is a mechanical attachment to the collet drive of the XPS Straight Shot handpiece that converts rotary motion to oscillating motion (forward and backward) to drive the cutting bit.

#### 6.0 Intended Use

The Power Rasp is intended for use as an accessory to the XPS Straight Shot handpiece The Xomed XPS StraightShot Microdebrider System is intended for the cutting and removal of soft and hard tissue or bone in otorhinolaryngology, head and neck, and orthopedic surgery. It is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is needed. These include open spinal surgeries and small and large joint arthroscopic procedures.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human figures in profile, with their heads overlapping and facing to the right. The figures are connected by a flowing line that forms the shape of a wave or ribbon. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 NOV

Ms. Debra B. Cortner Senior Regulatory Affairs Specialist Xomed, Inc. 6743 Southpoint Dr. North Jacksonville, Florida 32216

Re: K983025 Trade Name: Xomed FeatherTouch XPS Power Rasp Attachment Regulatory Class: II Product Code: HRX Dated: August 28, 1998 Received: August 31, 1998

Dear Ms. Cortner:

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 (OS) 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.

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 - Ms. Debra B. Cortner

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 K983025: Device Name: FeatherTouch Power Rasp Attachment Indications for Use:

The Power Attachment for cutting blades / rasps is indicated for use with the XPS Straight Shot Microdebrider during surgical procedures to operate these various accessories to cut hard and soft tissue or bone in orthopedic and otorhinolaryngology and head and neck surgery. These include open spinal surgeries and small and large joint arthroscopic procedures.

> (Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Or

Over-the-Counter Use _

(Optional Format 1-2-96)

Ascoeff

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number L983025