STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM

K033135 · Stryker Endoscopy · KNS · Aug 9, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K033135
• Device Name: STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM
• Applicant: Stryker Endoscopy
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Aug 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2

Intended Use

The Stryker Wireless Universal Footswitch System (SWUFS) is indicated for use with compatible endoscopic and general surgery devices. It will utilize a single footswitch to selectively control multiple devices, which typically each have their own dedicated footswitch. The system includes a wireless footswitch and receiver. The SWUFS will be an accessory to and provide footswitch input control for the Stryker Total Performance System, the SERFAS (Stryker Endoscopy Radio Frequency Ablation System) consoles, and the Valleylab Electrosurgical Generator.

Device Story

Wireless footswitch system; provides centralized input control for multiple endoscopic and general surgery devices; replaces individual dedicated footswitches. System consists of wireless footswitch and receiver. Used in operating room; operated by surgical staff. Eliminates floor clutter; improves OR safety and efficiency; reduces setup/cleanup time. Provides input signals to Stryker Total Performance System, SERFAS consoles, and Valleylab Electrosurgical Generator.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-2 standards demonstrated.

Technological Characteristics

Wireless footswitch and receiver system. Complies with IEC 60601-1 (safety), IEC 60601-1-1 (systems), IEC 60601-1-2 (EMC), and IEC 60601-2-2 (high frequency surgical equipment).

Indications for Use

Indicated for use with compatible endoscopic and general surgery devices to provide centralized footswitch control for multiple surgical consoles.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• Stryker Sidne™ System (K022393)
• Stryker SERFAS System (K991960)
• Stryker Total Performance System (K991703)

Submission Summary (Full Text)

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K033135

5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2505 www.stryker.com

## AUG - 9 2004

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Endoscopy

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Device Name

Classification Name:

- . Endoscope and Accessories
- . Bone Cutting Instruments and Accessories
- Electrosurgical Cutting and Coagulation Device and Accessories. .

Common and Usual Name: Wireless Footswitch

Proprietary Name: Stryker Wireless Universal Footswitch System

This 510(k) summary of safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.

The Stryker Wireless Universal Footswitch System (SWUFS) is substantially equivalent in safety and efficacy as the currently marketed Stryker Sidne™ System (K022393), Stryker SERFAS System (K991960), and Stryker Total Performance System (K991703).

The Stryker Wireless Universal Footswitch System (SWUFS) is indicated for use with compatible endoscopic and general surgery devices. It will utilize a single footswitch to selectively control multiple devices, which typically each have their own dedicated footswitch. The system includes a wireless footswitch and receiver. The SWUFS will be an accessory to and provide footswitch input control for the Stryker Total Performance System, the SERFAS (Stryker Endoscopy Radio Frequency Ablation System) consoles, and the Valleylab Electrosurgical Generator. The elimination of numerous wires and multiple footswitches within the Operating Room will improve safety and efficiency by centralizing all footswitch controls, uncluttering the OR floor, and reducing set-up and clean-up time.

The Wireless Universal Footswitch System meets the necessary requirements of the following voluntary standards: IEC 60601-1:1988, A1:1991, A2:1995 Medical Electrical Equipment Part 1: General Requirements for Safety; IEC 60601-1-1:2000 Collateral Standard: Safety Requirements for Medical Electrical Systems; IEC 60601-1-2:2001 Collateral Standard: Electromagnetic Compatibility ~ Requirements and Tests; IEC 60601-2-2:1998 Particular Requirements for the Safety of High Frequency Surgical Equipment.

The technological differences between the Stryker Wireless Universal Footswitch System and the predicate Stryker Sidne™ System, Stryker SERFAS System, and Stryker Total Performance System do not raise new issues of safety and efficacy of the predicate devices. Therefore, the Stryker Wireless Universal Footswitch System is substantially equivalent to the currently marketed devices.

Michael Hilldoerfer Design Engineer Stryker Endoscopy

Date: June 14, 2004

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or waves.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2004

Mr. Michael Hilldoerfer Design Engineer Stryker Endoscopy 5900 Optical Court San Jose, California 95138

Re: K033135 K035153
Trade/Device Name: Stryker Wireless Universal Footswitch System Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS, GCJ, HRX, KOG Dated: July 2, 2004 Received: July 2, 2004

Dear Mr. Hilldoerfer:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premaince nealist in the indications
referenced above and have determined the device is substantially interests a referenced above and nave determined the assessed on the success marketed in interstate for use stated in the encrosule for legally manatinent date of the Medical Device Amendments, or to commerce prior to May 28, 1770, the enabilities of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the PMAN devices that have been recuire approval of a premarket approval application (PMA).)
and Cosmetic Act (Act) that do not require approval of a premarket approval inns of the Ac and Cosment Act (Act) that do not require approvide on trols provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, inerelore, market the device, becycer of the general registration, listing of
general controls provisions of the Act include requirements for annual registration, l general controls of the rist not here not hoseline and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Comtrols) or class III (PMA), it If your device is classified (SCC above) filts existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation ED may be subject to such additional controller Links. Jan 200 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 89B be found in the Code of Pouchal City of Clevice in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a substainments of the requirements of the Act
that FDA has made a determination that your device complies with on Your must that FDA has Inade a delemmation that Jour seee of by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21
comply with all the Act `s requirements, including, but not limited to: est comply with all the Act s requirements, mercesses on the requirements as set CFK Part 807), labeling (21 CFR Part 800); good manat 820); and if applicable, the clectronic
forth in the quality systems (QS) regulation (21 CFR Part 81 GFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Michael Hilldoerfer

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to obgin hakkemig your antial equivalence of your device to a legally premarket notification. The PDA midning of suckantal equice 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), please
s and the many of the comment of the same to the required on aniiled If you desire specific auvice for your act [phone]. Also, please note the regulation entitled, contact the Office of Complance at (39) 377-1471 (21CFR Part 807.97). You may obtain "Misoranding by relective to premained notificances in the Act from the Division of Small other general information on your responsion.com at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its told (demoment) html Manufacturers, International and Combailer Prosses of this main.html

Sincerely yours,

Miriam C Provost

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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## Indications for Use

510(k) Number (if known): K033135

Device Name Stryker Wireless Universal Footswitch System Indications For Use:

The Stryker Wireless Universal Footswitch System (SWUFS) is indicated for use with compatible endoscopic and general surgery devices. It will utilize a single footswitch to selectively control multiple devices, which wpically each have their own dedicated footswitch. The system includes a wireless ceiver. The SWUFS will be an accessory to and provide footswitch input control for the footswitch and Stryker Total Parformance System, the SERFAS (Stryker Endoscopy Radio Frequency Ablation System) consoles, and the Valleylab Electrosurgical Generator.

Prescription) Jse X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE CO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number_K633135