IRIDEX WIRELESS FOOTSWITCH

K062074 · Iridex Corp · HQF · Nov 14, 2006 · Ophthalmic

Device Facts

• Record ID: K062074
• Device Name: IRIDEX WIRELESS FOOTSWITCH
• Applicant: Iridex Corp
• Product Code: HQF · Ophthalmic
• Decision Date: Nov 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2

Intended Use

The IRIDEX Wireless Footswitch is intended for use with compatible IRIDEX Laser Systems operated in hospital or outpatient facilities. The IRIDEX Wireless Footswitch is indicated for use as an accessory to provide input control of laser emission to compatible IRIDEX Laser Systems. This accessory includes a wireless footswitch and a receiver. It is cleared for use for the particular indications of the laser system to which it is attached.

Device Story

Wireless footswitch accessory for IRIDEX laser consoles; replaces cabled footswitch. System comprises two components: footswitch/transmitter and receiver. Receiver connects to laser console via standard wired footswitch port; directly emulates wired footswitch functionality. Used in hospital or outpatient settings by clinicians operating laser systems. Provides remote input control of laser emission; eliminates physical cable constraints. Benefits include improved workspace ergonomics and reduced clutter.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Wireless footswitch/transmitter and receiver pair. Emulates wired footswitch electrical signals. Connects to existing laser console footswitch port. Operates as an accessory to IRIDEX laser systems.

Indications for Use

Indicated for use as an accessory to provide input control of laser emission for compatible IRIDEX Laser Systems in hospital or outpatient facilities. Cleared for the specific indications of the host laser system.

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Predicate Devices

• IRIS Medical OcuLight SL/SLx Laser System (K020374)
• IRIS Medical OcuLight GL/GLx Laser System (K031665, K050562)
• IRIDEX DioLite Laser System (K964074)
• IRIDEX VariLite Laser System (K041930)
• Odyssey 2.4G Diode Laser (K050453)
• Stryker Wireless Universal Footswitch (K033135)
• Linemaster IR Wireless Footswitch (K053510)

Submission Summary (Full Text)

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K062074

# Section 5 - 510(k) Summary or 510(k) Statement

NOW 1 4 2006

#### I. General Information

| Submitter: | IRIDEX Corporation<br>1212 Terra Bella Avenue<br>Mountain View, CA 94043-1824<br>USA |
|---------------------------|--------------------------------------------------------------------------------------|
| Contact Person: | John Jossy<br>Director of Regulatory Affairs and Quality Assurance |
| Summary Preparation Date: | July 17, 2006 |

#### II. Names

| Device Names: | IRIDEX Wireless Footswitch |
|-------------------------------|-----------------------------------------------------------------------------|
| Primary Classification Names: | Accessory for, Laser Powered Surgical Instruments and<br>Lasers, Ophthalmic |

#### III. Predicate Devices

IRIDEX Standard Footswitch - Accessory for:

- IRIS Medical OcuLight SL/SLx Laser System (K020374) .
- IRIS Medical OcuLight GL/GLx Laser System (K031665, K050562) .
- IRIDEX DioLite Laser System (K964074) .
- IRIDEX VariLite Laser System (K041930) .

Ivoclar Vivadent Odyssey 2.4G Pedal -- Accessory for:

- Odyssey 2.4G Diode Laser (K050453) .
Stryker Wireless Universal Footswitch (K033135)

Linemaster IR Wireless Footswitch ( K053510)

#### IV. Product Description

The Wireless Footswitch is an alternate option to the existing cabled footswitch for users of IRIDEX laser consoles. It consists of two discreet parts - a footswitch/transmitter and receiver. The wireless footswitch receiver connects to the laser through the same connector as the current wired footswitch, and operates with the console by directly emulating the functionality of the current wired footswitch.

#### V. Indications for Use

The IRIDEX Wireless Footswitch is intended for use with compatible IRIDEX Laser Systems operated in hospital or outpatient facilities.

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The IRIDEX Wireless Footswitch is indicated for use as an accessory to provide input control of laser emission to compatible IRIDEX Laser Systems. This accessory includes a wireless footswitch and a receiver. It is cleared for the particular indications of the laser system to which it is attached ..

#### VI. Rationale for Substantial Equivalence

The IRIDEX Wireless Footswitch shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

#### VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the IRIDEX Wireless Footswitch is substantially equivalent to the predicate devices.

### VIII. Conclusion

The IRIDEX Wireless Footswitch was found to be substantially equivalent to the predicate devices.

The IRIDEX Wireless Footswitch shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

Page 2/2

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IRIDEX, Corporation % Mr. John Jossy Director, Regulatory Affairs and Quality Assurance 1212 Terra Bella Avenue Mountain View, California 94043-1824

Re: K062074

Trade/Device Name: IRIDEX Wireless Footswitch Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: October 17, 2006 Received: October 19, 2006

Dear Mr. Jossy:

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.

NUV 1 4 2006

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. John Jossy

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/industry/support/index.html.

Sincerely yours,

For
Mark N. Melkerson

DEPU
O.L

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 Statement

K06207 510(k) Number (if known):

IRIDEX Wireless Footswitch Device Name:

Indications for Use:

The IRIDEX Wireless Footswitch is intended for use with compatible IRIDEX Laser Systems operated in hospital or outpatient facilities.

The IRIDEX Wireless Footswitch is indicated for use as an accessory to provide input control of laser emission to compatible IRIDEX Laser Systems. This accessory includes a wireless footswitch and a receiver. It is cleared for use for the particular indications of the laser system to which it is attached.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Melkerson

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

**510(k) Number** K062074 /Page 1 of 1