XPS DRILL SYSTEM

K983224 · Xomed, Inc. · ERL · Oct 21, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K983224
• Device Name: XPS DRILL SYSTEM
• Applicant: Xomed, Inc.
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XPS Drill System is intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck.

Device Story

XPS Drill System is an electric surgical drill for ENT and head/neck surgery. System components include a console, electric motor, interchangeable handpieces, foot pedal, and irrigation accessories. Operates at speeds up to 90,000 RPM with 3.5 oz-in stall torque. Used in clinical settings by surgeons for bone incision or removal. Provides mechanical power to surgical burs/tools; irrigation capability assists in cooling and debris removal. No software or automated processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electric surgical drill system. Components: console, electric motor, interchangeable handpieces, foot pedal, irrigation system. Speed range: 0-90,000 RPM. Stall torque: 3.5 oz-in. No software or electronic control algorithms.

Indications for Use

Indicated for controlled incision or removal of bone in the ear, nose, throat, and other head and neck areas. For prescription use only.

Regulatory Classification

Identification

An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.

Predicate Devices

• K904850
• MPS Powerforma (K960853)

Submission Summary (Full Text)

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OCT 21 1998

Image /page/0/Picture/1 description: The image shows the word "XOMED" in a bold, sans-serif font. To the right of the word is a registered trademark symbol, followed by a circular design with a cross-like shape inside. The cross is made up of four arrow-like shapes pointing towards the center of the circle. The overall design is simple and clean, with a focus on the brand name and logo.

K983224

510k Summary XPS Drill System

### 1.0 Date Prepared

September 10, 1998

# 2.0 Submitter (Contact)

David Timlin Xomed Surgical Products Jacksonville, FL [phone]

## 3.0 Device Name

Proprietary Name: XPS Drill System Electric Surgical Drill System Common Name: ENT electric or pneumatic surgical drill Classification Name:

## 4.0 Device Classification

Currently marketed products of this type have been classified by the Ear, Nose and Throat Panel as follows:

| ENT electric or pneumatic surgical drill | 77ERL | Class II | 874.4250 |
|--------------------------------------------|-------|----------|----------|
| Surgical Instrument Motors and accessories | 79GEY | Class I* | 878.4820 |
| * exempted from premarket notification. | | | |

#### રુ:0 Device Description

The XPS Drill System is made up of a console, electric motor, exchangable handpieces, foot pedal and accessories as described below. It has the ability to operate one handpiece and incorporates irrigation capability. The handpiece speed range is 0 - 90,000 RPM and the stall torque is 3.5 oz-in.

NOTE: There is no software involved with the operation of this device.

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Revised 10/13/98

### Intended Use 6.0

The XPS Drill System is primarily intended for the controlled incision or removal of bonc in the ear, nose, throat and other areas of the head and neck.

#### 7.0 Substantial Equivalence

The new XPS Drill System is the same drill system that was previously cleared by K904850 Xomed now intends to market this system for ENT and Head and Neck surgery. In so doing, we have made some minor changes to the labeling, i.e. the instruction manual and the console None of these changes are significant and are typical of any ENT drill. As an ENT drill, the XPS Drill System is also substantially equivalent to the MPS Powerforma currently marketed by Xomed (K960853). Information from the MPS Powerforma manual was used in modifying the Micro Motors manual for the proposed XPS Drill.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. 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

OCT 21 1998

David M. Timlin Manager, Regulatory Affairs Xomed Surgical Products, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216

Re:

K983224 Xomed XPS Drill System Dated: September 10, 1998 Received: September 14, 1998 Regulatory class: II 21 CFR 874.4250/Procode: 77 ERL

Dear Mr. Timlin:

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 (OS) 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 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 vitn diagnostic devices), please contact the Office of Compliance at (301) 5944613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Complianced [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/cdr/dsmaldsmamain.html".

Sincerely yours,

William Yin

Lillian Yin, Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Revised 10/13/98

510(k) Number (if known): __ K983224 Device Name: XPS Drill System__ Indications for Usc:

The XPS Drill System is intended for the controlled incision or renoval of bone in the ear, nose, throat and other areas of the head and neck.

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

Prescription Use A (Per 21 CFR 801.109)

Oi

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Formal 1-2-96)

Samil A. Sezern

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

49