XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM

K973499 · Xomed, Inc. · HRX · Jan 30, 1998 · Orthopedic

Device Facts

• Record ID: K973499
• Device Name: XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM
• Applicant: Xomed, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. Orthopedic use is now added to the original intended use for otorhinolaryngology and head and neck 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 spinal and small and large joint arthroscopic procedures.

Device Story

XPS StraightShot Microdebrider System is an AC-powered surgical instrument for tissue/bone resection. System comprises a power control unit, footswitch, reusable handpieces, and interchangeable disposable burs/blades. Operates one or two handpieces (one at a time) with integrated suction and irrigation. Used by surgeons in OR settings for otorhinolaryngology, head/neck, and orthopedic procedures (spinal, joint arthroscopy). Larger handpiece added to original system (K963246) provides increased speed and torque for orthopedic applications. Surgeon controls device via footswitch; output is mechanical cutting/debridement of target tissue. Benefits include precise tissue removal in minimally invasive surgical contexts.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

AC-powered motor system; reusable handpieces; disposable burs/blades. Features suction and irrigation capabilities. System includes power control unit and footswitch. Mechanical cutting/debridement principle. No software-based algorithms or connectivity described.

Indications for Use

Indicated for patients requiring cutting and removal of soft/hard tissue or bone during orthopedic surgical procedures, including spinal 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.

Predicate Devices

• Linvatec Apex
• Stryker SE5
• S&N Dyonics PS3500EP
• S&N Dyonics Arthroscopic MicroDiscectomy (AMD) System
• Sofamor Danek Tissue Resecting System

Submission Summary (Full Text)

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JAN 30 1998

# K973499

### 510(k) Summary

- 1.0 Date Prepared September 15, 1997
- 2.0 Submitter (Contact) David Timlin Xomed Surgical Products Jacksonville, FL [phone]

#### 3.0 Device Name

| Proprietary Name: | XPS StraightShot Microdebrider System or TreBay<br>Shaver System (The proposed product tradename has<br>not been finalized and may be changed at a later date) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name(s): | Electrical surgical shavers, electrical debriders, drill<br>handpieces and cutting blades and burs |
| Classification Name: | Surgical instrument, AC powered motors and<br>accessories / attachments or Arthroscopes and<br>accessories |
| Device Classification | |

## 5.0

Surgical instrument, AC powered motors and accessories / attachments Class II : 21 CFR 878.4820 Tier 1 Procode 87HWE

Arthroscopes and accessories

Class II ; 21CFR 888.1100 Tier 2 Procode 87HRX

#### 6.0 Device Description

The XPS System remains essentially the same as originally described in K963246. There is a Power Control Unit, a footswitch, reusable handpieces and various interchangeable, disposable burs and blades. The system can operate one or two handpieces (one at a time) with suction and irrigation, depending on the handpiece. Xomed now proposes to market the XPS System for the same intended use in orthopedic surgery, including spinal and small and large joint procedures. In order to best meet the needs of the orthopedic surgeons, we have added to the original system, a larger handpiece and additional blades and burs. Other than the larger motor with additional speed and torque, the principle of operation and Power Control Unit remain essentially the same as described in K963246.

64

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#### 7.0 Intended Use

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. Orthopedic use is now added to the original intended use for otorhinolaryngology and head and neck 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 spinal and small and large joint arthroscopic procedures.

#### 8.0 Substantial Equivalence

All of the predicate devices (Linvatec Apex, Stryker SE5, S&N Dyonics PS3500EP, S&N Dyonics Arthroscopic MicroDiscectomy (AMD) System, Sofamor Danek Tissue Resecting System) have similar designs with equivalent characteristics. Most importantly all of the predicate devices are marketed for arthroscopic orthopedic uses. Information on labeling of the predicate devices was included.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol in black, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 1998

Mr. David Timlin Manager, Regulatory Affairs Xomed, Incorporated 6743 Southpoint Drive, North Jacksonville, Florida 32216-0980

K973499 Re:

> Trade Name: XPS StraightShot Microdebrider System or TreBay Shaver System Regulatory Class: II Product Code: HRX Dated: December 1, 1997 Received: December 2, 1997 ..

Dear Mr. Timlin:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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.

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Page 2 - Mr. Timlin

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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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#### K973499 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

# Device Name: XPS StraightShot Microdebrider System

### Indications for Use:

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 spinal 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)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K973499
Or Over-the-Counter Use

Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

revised 3/97