POWER TEK II

K020761 · Biomet, Inc. · HRX · Apr 3, 2002 · Orthopedic

Device Facts

• Record ID: K020761
• Device Name: POWER TEK II
• Applicant: Biomet, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Apr 3, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Power Tek II shaver system is a powered instrument for orthopedic applications including abrasion arthroplasty, synovectorny or intra-articular cutting and shaving. The device is intended for use in the knee, shoulder, wrist, temporal-mandibular joint, ankle, and elbow.

Device Story

Power Tek II is an arthroscopic shaver system for orthopedic surgery. System components: control console (microprocessor, shaver driver, mode/speed controls, display), remote control, footswitch, and shaver handpiece. Handpiece operates at 400-12,000 rpm with linear suction for debris aspiration. Used in OR by surgeons for abrasion arthroplasty, synovectomy, and intra-articular cutting/shaving. Surgeon controls device via footswitch or remote control at the surgical field. Microprocessor manages motor speed and operational modes. System facilitates tissue removal and joint debridement, potentially improving surgical efficiency and patient outcomes.

Clinical Evidence

No clinical data provided as a basis of substantial equivalence. Validation relied on bench testing, including IEC 601-1 safety testing, UL certification, electromagnetic compatibility, and software validation.

Technological Characteristics

Powered arthroscopic shaver system. Components: control console with microprocessor, remote control, footswitch, and shaver handpiece. Handpiece speed: 400-12,000 rpm. Features linear suction control. Software-controlled motor operation. Validation standards: IEC 601-1, UL certification.

Indications for Use

Indicated for orthopedic surgical applications including abrasion arthroplasty, synovectomy, or intra-articular cutting and shaving in the knee, shoulder, wrist, temporal-mandibular joint, ankle, and elbow.

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

• Integrated Endoscopy System 1000 (K920800)

Submission Summary (Full Text)

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K020761

## APR 0 3 2002

Image /page/0/Picture/2 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are bold and outlined in black, giving them a three-dimensional appearance. The overall design is simple and modern.

## CORPORATE DOUARTERS H E A

## Summary of Safety and Effectiveness

Applicant or Sponsor:Arthrotek. Inc.

(A wholly owned subsidiary of Biomet, Inc.) 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0578

| Contact Person: | Patricia Sandborn Beres<br>Biomet Orthopedics Inc.<br>Phone: [phone]<br>FAX: [phone] |
|-----------------|----------------------------------------------------------------------------------------------------|
|-----------------|----------------------------------------------------------------------------------------------------|

Proprietary Name: Power Tek II

Arthroscopic shaver console and handpiece Common Name:

Classification Name: Surgical instrument motors and accessories/attachments (21 CFR 878.4820)

Legally Marketed Devices to which Substantial Equivalence is Claimed: The Integrated Endoscopy System 1000 (K920800)

Device Description: The Arthrotek Power Tek II arthroscopic shaver system is intended to provide a shaver unit that will meet the surgeon's needs and patient's needs for abrasion arthroplasty, synovectorny or intra-articular cutting and shaving. The system consists of four pieces. The Control Console houses the microprocessor, shaver driver, mode and speed controls, and operator display. A Remote Control allows the user to access all controls from the surgical field. The Footswitch allows the surgeon easy on/off and forward/reverse/oscillate selection and control. The Shaver Handpiece is capable of running from 400 to 12,000 rpm's, with linear suction control for debris aspiration.

Intended Use: The Power Tek II shaver system is a powered instrument for orthopedic applications including abrasion arthroplasty, synovectomy or intra-articular cutting and shaving. The device is intended for use in the knee, shoulder, wrist, temporal-mandibular joint, ankle, and elbow.

Summary of Technologies: The materials, process and design of the Power Tek II are similar to the predicate device.

Non-Clinical Testing: Validation testing included IEC 601-1 Safety Testing, UL certification, and Electromagnetic Compatibility as well as software validation and clearing and sterilization validation.

Clinical Testing: None provided as a basis of substantial equivalence.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

11

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

일

OFFICE
219.267.6639

FAX [phone]

000137

E-MAIL [e-mail]

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Food and Drug Administration 9200 · Corporate Boulevard Rockville MD 20850

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K020761

Trade/Device Name: Power Tek II Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: March 6, 2002 Received: March 7, 2002

APR 0 3 2002

Dear Ms. Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ms. Patricia Sandborn Beres

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Miriam C. Provost

For Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ KO2O761

Device Name: Power Tek II

Indications For Use:

The Power Tek II shaver system is a powered instrument for orthopedic applications including abrasion arthroplasty, synovectorny or intra-articular cutting and shaving. The device is intended for use in the knee, shoulder, wrist, temporal-mandibular joint, ankle, and elbow.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020761

(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)

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