IR WIRELESS FOOT SWITCH

K053510 · Linemaster Switch Corp. · GEI · Mar 20, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053510
• Device Name: IR WIRELESS FOOT SWITCH
• Applicant: Linemaster Switch Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The Linemaster wireless foot switch is an accessory that is indicated for use to provide foot switch input control to any medical device that uses a wired foot switch with a switch closure (on/off), to activate said device. The system is intended for use in hospitals, outpatient clinics and physicians offices.

Device Story

System comprises wireless foot switch and receiver; provides remote on/off input control for medical devices typically requiring wired foot switches. Operates via infrared (IR) signals; utilizes unique identification codes programmed into transmitter/receiver pairs to prevent cross-talk between systems. Used in ORs, clinics, and physician offices to replace wired connections; reduces OR floor clutter; improves setup/cleanup efficiency. Healthcare providers operate the switch to activate connected medical equipment. Potential patient benefit includes improved OR safety and efficiency. Warning: Plasma video displays may interfere with IR signal transmission, increasing activation latency or preventing operation.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness demonstrated through risk analysis, verification, and validation testing, including electrical safety (IEC/UL 60601.1, Can/CSA C22.2 No. 60601.1) and electromagnetic compatibility (EN60601-1-2, IEC 1000-4 series, FCC Part 15).

Technological Characteristics

Infrared (IR) wireless transmission system; unique identification code pairing. Complies with IEC/UL 60601.1 (fire, shock, mechanical hazards) and electromagnetic immunity/emissions standards (IEC 1000-4 series, EN 55011, FCC Part 15).

Indications for Use

Indicated for use as an accessory to provide foot switch input control (on/off) for medical devices requiring wired foot switch activation. Intended for use in hospitals, outpatient clinics, and physician offices.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Applied Surgical, LLC, Gemini Surgical and Display System (K051831)
• Stryker wireless universal footswitch (K033135)
• SurgASSIST system with wireless remote control (K020343)
• Megadyne Mega power electrosurgical generator accessories (K050579)
• Valleylab force FXc accessories (K944602)

Submission Summary (Full Text)

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0535/0

Image /page/0/Picture/1 description: The image shows the logo for Linemaster, a company that makes foot switches. The logo features the word "LINEMASTER" in large, bold letters, with a stylized globe behind it. Below the company name is the text "AMERICA'S FOOT SWITCH LEADER".

MAR 2 0 2006

## 510K SUMMARY OF SAFETY AND EFFECTIVENESS DATA

# General Information

#### Manufacturer:

Linemaster Switch Corporation 29 Plaine Hill Road Woodstock, CT 06281 860-974-1000 Phone [phone] Fax

## Establishment Registration Number:

????????????

#### Contact Person:

Michael W. Szostek Components/Safety Engineer [e-mail]

#### Date Prepared:

December 1, 2005

## Classification Name:

Endoscope and Accessories Bone Cutting Instruments and Accessories. Electrosurgical Cutting and Coagulation Device and Accessories. General and Plastic Surgery Any class II device that uses a foot switch as an accessory.

#### Common and Usual Name:

Wireless Foot switch

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Image /page/1/Picture/0 description: The image shows the logo for "LINEMASTER", which is written in large, bold, black letters. Above and below the text is a black and white drawing of the earth. Below the logo is the text "AMERICA'S FOOT SWITCH LEADER".

## Proprietary Name:

IR Wireless Foot Switch

## Predicate Devices:

The Linemaster infrared wireless footswitch is substantially equivalent in function and intended use to the following legally marketed devices: Applied Surgical, LLC, Gemini Surgical and Display System (K051831), Stryker wireless universal footswitch (K033135), SurgASSIST system with wireless remote control (K020343), Megadyne Mega power electrosurgical generator accessories (K050579) and Valleylab force FXc accessories (K944602).

## Device Description:

The Linemaster wireless foot switch will be an accessory to and provide foot switch input control to any medical device that uses a foot switch to control on/off inputs. The system includes a wireless foot switch and a receiver. The wireless foot switches share the same transmission schemes, however each manufacturer will have a unique identification code that is programmed into the transmitter and receiver. This identification code will only allow communication of systems that have been programmed with the same identification code. Systems from different manufacturers will not communicate with each other.

When coupled with a system that uses a wired foot switch the wireless system will function in the same way as the wired version. Apart from the software, the technological characteristics are the same or similar to, those of the predicate wired device where LED-based systems and infrared signals are used to operate the device.

The elimination of wires on the floor of the operating room will improve the safety and efficiency by uncluttering the OR floor and reducing set-up and cleanup time.

## Performance Data:

The infrared wireless foot switch system meets the following standards:

- Classified to IEC/UL 60601.1 Medical electrical equipment by Underwriter's . Laboratories, Inc with respect to fire, shock, and mechanical hazards in accordance with IEC/UL 60601.1.
- Classified with respect to electric shock, fire, mechanical, and other specified . hazards only, in accordance with Can/CSA C22.2 No. 60601.1

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Image /page/2/Picture/0 description: The image shows the logo for Linemaster, which is placed over a graphic of the earth. The text "LINEMASTER" is in bold, black letters. Below the logo is the text "AMERICA'S FOOT SWITCH LEADER".

- EN60601-1-2: 2001 ●
- IEC 1000-4-2: 1995 Electrostatic Immunity
- IEC 1000-4-3: 1995 Radiated Electromagnetic Field Immunity @ 10uv/m .
- IEC 1000-4-4: 1995 Electrical Fast Transients Immunity ●
- . IEC 1000-4-5: 1995 Surge Immunity
- . IEC 1000-4-6: 1996 Conducted RF Immunity
- . IEC 1000-4-8: 1993 Power Frequency Magnetic Field Immunity
- . IEC 1000-4-11: 1994 Voltage Dips and Variations
- . EN 55011: 1998 Radiated and Conducted Emissions, Group 1 Class B
- FCC Part 15 Radiated and Conducted Emissions, Class B .
- . IEC 61000-3-2: 2000 Power Harmonics Class A
- IEC 61000-3-3: 1995 + A1: 2001 Voltage Fluctuation, Section 5 .

The safety and effectiveness of the wireless footswitch described in this submission has been demonstrated through risk analysis, verification, and validation testing.

## Indications for Use:

The Linemaster wireless foot switch will be an accessory to and provide foot switch input control to any medical device that uses a switch closure (on 1001), to activate said device.

## Warnings:

Plasma video displays can seriously affect the operation of infrared devices. The plasma devices can increase switch activation times significantly or gerreest the switch operation altogether.

Do not use in the vicinity of plasma video displays.

## Summary of Technological Characteristics:

The infrared wireless foot switch in this submission is similar with regard to design, operation, and materials and intended use to the predicate devices indicated above. Therefore, no new safety or efficacy issues are created and the wireless foot switch is substantially equivalent to the predicate device

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Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, bold font. The words are stacked on top of each other. The background is white.

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

MAR 2 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Linemaster Switch Corporation c/o Mr. Michael W. Szostek Component/Safety Engineer 29 Plaine Hill Road Woodstock, Connecticut 06281

Re: K053510

Trade/Device Name: IR Wireless Foot Switch Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 10, 2006 Received: March 13, 2006

Dear Mr. Szostek:

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

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Page 2 - Mr. Michael W. Szostek

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. 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 yours,

egree

Mark N. Melkerson Acting 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 : (K053510)

Device Name: IR Wireless Foot Switch

Indications For Use:

The Linemaster wireless foot switch is an accessory that is indicated for use to provide foot switch input control to any medical device that uses a wired foot switch with a switch closure (on/off), to activate said device.

The system is intended for use in hospitals, outpatient clinics and physicians offices.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

elgmdl

(Divis Division of General, Restorative, and Neurological Devices

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510(k) Number_ Kos350