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 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.

AI/ML Overview

This document describes the IRIDEX Wireless Footswitch, seeking clearance as an accessory for existing IRIDEX laser systems. As an accessory that emulates the functionality of a wired footswitch, the submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria.

Therefore, the requested information fields related to clinical efficacy studies, expert ground truth, and training data are largely not applicable in the context of this 510(k) submission. The FDA clearance is based on the device's functional similarity to predicate devices and its adherence to general controls for safety and effectiveness.

Here's an attempt to populate the table and answer the questions based on the provided text, indicating "Not Applicable" where the information is not present or relevant to a substantial equivalence submission for an accessory device:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an accessory (wireless footswitch) demonstrating substantial equivalence to wired and other wireless footswitches, the "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity or specificity. Instead, acceptance is based on functional equivalence and safety to predicate devices. The document implies functional equivalence to existing wired and wireless footswitches as the primary criterion.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Functional Equivalence	The wireless footswitch must directly emulate the functionality of the current wired footswitch of IRIDEX laser consoles. It must provide input control of laser emission to compatible IRIDEX Laser Systems in the same manner as the wired footswitch. Its use should be cleared for the particular indications of the laser system to which it is attached.	"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."
Indications for Use	The device's indications for use must be similar to or the same as predicate devices and compatible with the existing IRIDEX laser systems.	"The IRIDEX Wireless Footswitch shares the same indications for use... with, and thus is substantially equivalent to, the predicate devices."
Safety and Effectiveness	The device must be demonstrated to be substantially equivalent to predicate devices in terms of technical characteristics and operation, implying it meets the same safety and effectiveness standards as those devices. This includes general controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration). Compliance with applicable standards is usually demonstrated.	"The review of the indications for use and technical characteristics provided demonstrates that the IRIDEX Wireless Footswitch is substantially equivalent to the predicate devices."
Design Features	The design features (e.g., wireless transmission) should be similar to other legally marketed wireless footswitches.	"The IRIDEX Wireless Footswitch shares... similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices."

Study Details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission is for substantial equivalence of an accessory device (wireless footswitch) based on functional emulation and comparison to predicate devices, not requiring a clinical performance study with a test set of patient data. The documentation does not mention such a study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No clinical test set or ground truth validation by experts is mentioned or required for this type of 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a hardware accessory (wireless footswitch), not an AI-powered diagnostic tool. MRMC studies are irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware accessory, not an algorithm. Performance is assessed based on its ability to emulate the wired footswitch function and comply with relevant standards (though not explicitly detailed in this summary).
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Not a clinical diagnostic device requiring ground truth for clinical performance. The "ground truth" for this device's functionality would be the successful and consistent control of the laser system, as performed by the wired equivalent.
The sample size for the training set
- Not Applicable. This is a hardware accessory, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established
- Not Applicable. No training set for an algorithm.

Summary

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K062074

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

NOW 1 4 2006

I. General Information

Submitter:	IRIDEX Corporation1212 Terra Bella AvenueMountain View, CA 94043-1824USA
Contact Person:	John JossyDirector 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 andLasers, 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

V. Indications for Use

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

Page 1/2

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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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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.

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

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
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.(b)
Classification. Class II.