STRYKER HUMMER II MICRODEBRIDER SYSTEM

K972584 · Stryker Endoscopy · ERL · Oct 1, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972584
• Device Name: STRYKER HUMMER II MICRODEBRIDER SYSTEM
• Applicant: Stryker Endoscopy
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Oct 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Hummer II MicroDebrider system, is to be utilized for endoscopic or open plastic, reconstructive, and aesthetic surgery of the Head and Neck. When using the Stryker Hummer II MicroDebrider system, the surgeon has the ability to choose either open or endoscopic viewing and the option to utilize irrigation or vacuum as the surgeon deems necessary. The precise cutting action of the Hummer II Shaver blades allow the surgeon to achieve desired tissue removal, thus minimizing unwanted contour lines, skin discoloration and patient trauma.

Device Story

Stryker Hummer II MicroDebrider system consists of powered instrumentation, disposable irrigated cutters, burs, and tubing sets. Device used in head and neck surgery (endoscopic or open). Surgeon operates system to perform precise tissue removal; selects between open or endoscopic viewing; controls irrigation and vacuum as needed. Cutting action and rotation speed facilitate tissue removal, aiming to minimize contour lines, skin discoloration, and patient trauma. Disposable accessories provided sterile for single use.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993. Electrical safety testing performed per IEC 601-1, UL, and CSA standards. Sterility validation for disposable accessories to an SAL of 10-6.

Technological Characteristics

Powered surgical shaver system. Materials: Biocompatible per ISO 10993. Energy source: Electrical (meets IEC 601-1, UL, CSA). Features: Disposable irrigated cutters, burs, and tubing sets. Sterilization: Sterile (SAL 10-6) for single-use accessories.

Indications for Use

Indicated for patients undergoing endoscopic or open plastic, reconstructive, and aesthetic surgery of the Head and Neck.

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

• Linvatec shaver system
• Xomed shaver system

Submission Summary (Full Text)

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FIXOSCULY

2590 Walsh Avenus Santa Clara, CA 95031 [phone] ( 800 ) (408) 567 25.77 177

Devicc Name:

Classification Name: Common and Usual Name Proprietary Name:

Surgical ENT Drill 874.4250, Class II Electrical Surgical Shaver Stryker Hummer II MicroDebrider System

I

Device Sponsor: Stryker Endoscopy

2590 Walsh Ave. તે રેણે રે જે જે જેવી સુરત કરવામાં આવે છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી ખેતી કરવામાં આવેલું એ તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસ Santa Clara, CA I/DA Registration No. 2936485

## SAFETY AND EFFECTIVENESS SUMMARY:

The Stryker Hummer II MicroDebrider System, consisting of instrumentation which power disposable irrigated cutters and burs, is used in Endoscopic or open plastic, reconstructive and acsthetic surgery of the Head and Neck.

The disposable cutters, burs and tubing sets employed as accessories with the Stryker Hummer II MicroDebrider system, are provided sterile, for single use only, and are validated to an SAL of 10-6. The materials of construction, cutting action, speed of rotation, availability of suction/irrigation and tip configuration are equivalent to Linvatec blades and or the Xomed shaver system, and patient contact materials are demonstrated to be biocompatible per ISO standard 10993. The accessory devices offer no new safety or effectiveness concerns.

The powered instrumentation technology utilized in the device is equivalent to existing marketed devices and is currently cleared for use in Functional Endoscopic Sinus Surgery under K# 952681. This instrumentation is designed to meet TEC 601-1 clectrical standards, as well as UL and CSA requirements.

The Stryker Hummer II MicroDebrider system does not raise any new safety or effectiveness concerns when compared to, and is therefore equivalent to, the Linvatec and Xomed shaver systems.

Carlos Gonzalez

Carlos Gonzalez VP, Regulatory Affairs and Quality Assurance

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Vice President of Regulators and Onalily Vesti res.

CARIOS CONZALI

OCT - 1 1997

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ublic Hearth Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - I

Carlos Gonzalez Vice President, Regulatory Affairs Stryker Endoscopy 2590 Walsh Avenue Santa Clara, CA 95051

Re: K972584 Stryker Hummer II MicroDebrider System Dated: July 7, 1997 Received: July 10, 1997 Regulatory Class: II 21 CFR 874.4250/Procode: 77 ERL

Dear Mr. Gonzalez:

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, 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 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 (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 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 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 question 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,

h.7liau Yu
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page __ 1

510(k) Number (if known):_K # 972584

Device Name: Stryker Hummer II MicroDebrider

## Indications For Use:

The Stryker Hummer II MicroDebrider system, is to be utilized for endoscopic or
es and Neck The Stryker Hummer if MicroDebnoer system, is to a see and Neck.
open plastic, reconstructive, and aesthetic surgery of the Head and Neck.

When using the Stryker Hummer II MicroDebrider system, the surgeon has the
continued the street the survey desenie viewing and the option to utilize When using the Stryker Hummen in MicroDebiading and the option to utilize
ability to choose either open or endoscopic viewing and the opense cutting ability to choose either open of enodscope viewing and the precise cutting
irrigation or vacuum as the surgeon deems necessary. The precise cutting irrigation or vacuum as the surgeon deenls necessary.
action of the Hummer II Shaver blades allow the surgeon to achieve desired action of the Hummer II Shaver blades anow the surgoon in
tissue removal, thus minimizing unwanted contour lines, skin discoloration and patient trauma.

(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_

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Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number