The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630nm-670mm], IQ 810 [810mm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:

810nm (The IRIDEX Cyclo G6 Laser System)

Ophthalmology:

The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe Illuminate, & MicroPulse® P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse (uP) treatment mode and indicated for the treatment of Glaucoma:

MicroPulse P3 Device: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment (Intended Use): Transscleral Cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: μP

G-Probe & G-Probe Illuminate: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment (Intended Use): Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: CW

Device Description

The Iridex Cyclo G6 is an 810nm (diode) ophthalmic laser comprised of the following main components:

Main console containing the major electrical components, including:
- Control Panel including control knobs (power, interval, duration or software assigned function), treat/standby button, and display;
- Two delivery device fiber-optic connector ports (only one active at a time);
- LIO illumination connection;
- Smart key port for detecting/operating safety filters and/or accessory identification;
- Emergency stop switch;
- Key switch;
- Connector ports for the footswitch, remote control, and power cord;
A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust);
A Wired Remote Control that duplicates the control panel;
Delivery Accessories including G-Probe and MicroPulse P3 probe Handpieces, and the G-Probe Illuminate
Optional Cart/Stand

The laser system automatically enters the "Standby" mode after it is turned on and completes its internal "selftest". Laser emission is not possible until the user attaches the proper delivery device, selects the desired treatment settings, verifies eye safety filter status, places the system into "Ready", and depresses the footswitch.

The system has a primary display screen (power, interval, duration, pulse mode, aiming beam brightness, illumination brightness, treatment/standby toggle, counter reset) and additional screens for ancillary options (system volume, display contrast/brightness, preset selection (user defined/generated), aiming beam settings).

The user may adjust power, treatment duration, treatment interval, type of laser output mode (CW-pulse, MicroPulse), aiming beam brightness, illumination brightness, and reset the laser shot counter. Additionally, for some delivery devices the user may optionally select the on/off operation of the countdown timer on the display screen as well as the on/off function of the voice countdown.

The G-Probe Illuminate that is the subject of this 510(k) is a handheld fiber optic delivery device. It is intended to be used to perform transscleral cyclophotocoagulation of the ciliary processes. It is differentiated from the G-Probe described in earlier submissions by the incorporation of two additional optical fibers to provide white light transillumination of the optic globe. Such transillumination can aid probe placement by revealing the location of internal ocular structures such as the ciliary processes. The incorporation of this transillumination function into a multifunction probe offers the user similar functionality as a separate handheld transilluminator, with a more convenient setup that requires fewer hands or assistants to operate. It is provided as a sterile, single-use device.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Iridex Cyclo G6 Laser System and G-Probe Illuminate. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner one might find for a novel AI/software medical device.

Therefore, the typical acceptance criteria and study design for "device performance" in terms of accuracy, sensitivity, or specificity against a ground truth (e.g., for an AI diagnostic algorithm) are not applicable or present in this document. Instead, the document discusses the equivalence of the proposed device to a legally marketed predicate device based on technical characteristics and safety testing.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

As this is a 510(k) demonstrating substantial equivalence for a physical laser system and its probe (with an added illumination feature), there are no "acceptance criteria" presented in the measurable performance metrics typical for an AI/diagnostic software. Instead, the "performance" is demonstrated through successful completion of various engineering, sterility, and biocompatibility tests, and the "acceptance criterion" is essentially demonstrating that the modified device (Iridex Cyclo G6 Laser System with G-Probe Illuminate) performs safely and effectively at least as well as the predicate device.

The study that "proves" the device meets acceptance criteria is the sum of the conformance to various standards and the comparison of technological characteristics to the predicate.

Acceptance Criteria Category (implied from 510(k) submission)	Reported Device Performance (Summary)
Technological Characteristics Equivalence	The Iridex Cyclo G6 Laser System with G-Probe Illuminate has substantially equivalent technological characteristics to the predicate device (K143154 - Iridex Cyclo G6 Laser System). Key identical characteristics include: - Product Code: General & Plastic Surgery - Regulation: GEX, 21 CFR 878.4810 - Intended Use: Treatment of Glaucoma (Primary Open-Angle, Closed-Angle, Refractory) - Indications for Use: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes - Wavelength: 810nm - Infrared (IR) Diode - Aiming Beam: 630-670 nm - red (nominal) – variable intensity from 0 to < 1.0 mW - Power Watts: 5W - Pulse Duration: CW Pulse 10ms-10S, MicroPulse (µP) 10µs-1000µs - Energy per pulse: Variable, Determined by Power x Time - Output Mode: CW-Pulse, MicroPulse - Repetition rate: <50 Hz - Laser media: 810 nm Diode Laser - User interface: Touch Screen, Knobs on Laser Console, Remote Control, Footswitch - Laser activation: Footswitch - Delivery devices/supply: Ordered with System or separately - Electrical requirements: 100 to 240 VAC @ 50 to 60 Hz Note: The new feature, illumination, is 420-700 nm, which is the distinguishing characteristic from the predicate device that this 510(k) is addressing.
Sterilization	Successfully completed testing to ISO 11135:2014 (Ethylene oxide sterilization).
Biocompatibility	Successfully completed testing to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
Illumination Safety	Successfully completed testing to ISO 15004-2:2007 (Ophthalmic Instruments - Fundamental Requirements and Test Methods - Part 2: Light Hazard Protection).
Shelf Life	Successfully completed testing to ASTM F1980-07:2011 (Accelerated Aging of Sterile Barrier Systems).
Transit Testing	Successfully completed testing to ASTM D4169-14, ASTM D4332-14, ASTM F2096-11, and BS EN ISO 11607-1:2009.
Design Control Compliance	Changes were verified and validated in accordance with Iridex design control procedures.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a clinical performance study with a "test set" in the context of diagnostic performance (e.g., images for an AI algorithm). The "testing" involved engineering and safety validation of the physical device and its components, not an evaluation of diagnostic accuracy using a dataset. Therefore, terms like "sample size for test set" or "data provenance" (country/retrospective/prospective) are not applicable here.

3. 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. As noted above, there is no diagnostic "test set" requiring expert-established ground truth. The assessments are against engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for the same reasons as above.

5. 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 is a laser surgical instrument, not an AI-assisted diagnostic tool for human readers. "Clinical trial data was not required for this product change" as stated in Section VI. Performance Testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" equivalent in this context would be the established international and national standards for medical device safety, sterility, biocompatibility, and illumination (e.g., ISO 11135, ISO 10993 series, ISO 15004-2, ASTM F1980, etc.). The device's performance was compared against the requirements stipulated by these standards and against the technical specifications of its predicate device, rather than against clinical outcomes data or expert consensus on patient cases.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable for the same reasons as above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with a stylized design that suggests flowing hair or water beneath the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 29, 2016

Iridex Corporation Ms. Kathy Maynor Acting VP of Regulatory/Quality 1212 Terra Bella Avenue Mountain View, CA 94043

Re: K162416

Trade/Device Name: Iridex Cyclo G6 Laser System, G-Probe Illuminate Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: GEX Dated: August 27, 2016 Received: August 30, 2016

Dear Ms. Maynor:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Kesia Alexander

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162416

Device Name

Cyclo G6 Laser System with Illumination

Indications for Use (Describe)

810nm (The IRIDEX Cyclo G6 Laser System)

Ophthalmology:

	Condition (Indicated	Treatment (Intended Use)	CW/μP
MicroPulse P3Device	For the treatment ofGlaucoma including:• Primary Open-Angle• Closed-Angle• Refractory	Transscleral Cyclophotocoagulation(TSCPC) of the ciliary processes	μP
G-Probe &G-Probe Illuminate	For the treatment ofGlaucoma including:• Primary Open-Angle• Closed-Angle• Refractory	Transscleralcyclophotocoagulation(TSCPC) of the ciliaryprocesses	CW

Type of Use (Select one or both, as applicable)

[≥] Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 8 - Special 510(k) Summary

I. General Information

Submitter:

Iridex Corporation 1212 Terra Bella Avenue Mountain View, CA 94043

Contact Person: Kathy Maynor kmaynor@iridex.com 352-586-3113

Summary Preparation Date: September 28, 2016

II. Names

Device Name(s): Cyclo G6 Laser System with Illumination

Primary Classification Name(s): Electrosurgical cutting and coagulation device and accessories

Predicate Devices III.

K143154 -Iridex Cyclo G6 Laser System

IV. Product Description

The Iridex Cyclo G6 is an 810nm (diode) ophthalmic laser comprised of the following main components:

. Main console containing the major electrical components, including:
- Control Panel including control knobs (power, interval, duration or software assigned ● function), treat/standby button, and display;
- Two delivery device fiber-optic connector ports (only one active at a time); ●
- . LIO illumination connection;
- Smart key port for detecting/operating safety filters and/or accessory identification; ●
- Emergency stop switch;
- Key switch; ●
- Connector ports for the footswitch, remote control, and power cord;
- A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust); ●
- A Wired Remote Control that duplicates the control panel;
- Delivery Accessories including G-Probe and MicroPulse P3 probe Handpieces, and the ● G-Probe Illuminate
- Optional Cart/Stand

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V. Indications for Use

The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:

810nm (The IRIDEX Cyclo G6 Laser System)

Ophthalmology:

The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe, G-Probe Illuminate, & MicroPulse® P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse (uP) treatment mode and indicated for the treatment of Glaucoma:

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	Condition (Indicated for)	Treatment (Intended Use)	CW/μP
MicroPulse P3Device	For the treatment ofGlaucoma including:• Primary Open-Angle• Closed-Angle• Refractory	Transscleralcyclophotocoagulation(TSCPC) of the ciliaryprocesses	μP
G-Probe &G-Probe Illuminate	For the treatment ofGlaucoma including:• Primary Open-Angle• Closed-Angle• Refractory	Transscleralcyclophotocoagulation(TSCPC) of the ciliaryprocesses	CW

VI. Performance Testing

Clinical trial data was not required for this product change. This product change did not require any additional EMC (electromagnetic compatibility) or IEC 60601 safety testing. There were no software changes to the product.

The product change did require the following tests, which were successfully completed to the relevant standards:

Sterilization:

ISO 11135: 2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices

Biocompatibility:

ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process

ISO 10993-5: 2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity

ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for Irritation and Skin Sensitization

Illumination:

ISO 15004-2:2007 Ophthalmic Instruments -Fundamental Requirements and Test Methods - Part 2: Light Hazard Protection

Shelf Life:

ASTM F1980-07:2011 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Transit Testing:

ASTM D4169-14 Standard Practice for Performance Testing of Shipping Containers

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and Systems

ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or Packing Components for Testing

ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)

BS EN ISO 11607-1: 2009 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems

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VII. Summary of Technological Characteristics

The technological characteristics of the Iridex Cyclo G6 laser are substantially equivalent to those of the predicate device.

		K143154
Characteristic	Iridex Cyclo G6 LaserSystem	Iridex Cyclo G6 Laser System
ProductCode	General & PlasticSurgery	General & Plastic Surgery
Regulation	• GEX, 21 CFR 878.4810	• GEX, 21 CFR 878.4810
IntendedUse	Intended for use for thetreatment of Glaucomaincluding:• Primary Open-Angle• Closed-Angle• Refractory(see section V above)	Intended for use for thetreatment of Glaucomaincluding:• Primary Open-Angle• Closed-Angle• Refractory(see section V above)
Indications forUse	Transscleralcyclophotocoagulation(TSCPC) of the ciliaryprocesses	Transscleralcyclophotocoagulation(TSCPC) of the ciliaryprocesses
Wavelength	810nm - Infrared (IR) Diode	810nm – Infrared (IR) Diode
Aimingbeam	630-670 nm – red(nominal) – variableintensity from 0 to < 1.0mW	630-670 nm - red (nominal) –variable intensity from 0 to< 1.0 mW
PowerWatts	5W	5W
PulseDuration(usec)	CW Pulse 10ms-10SMicroPulse (µP) 10µs-1000µs	CW Pulse 10ms-10SMicroPulse (µP) 10µs-1000µs
		K143154
Characteristic	Iridex Cyclo G6 LaserSystem	Iridex Cyclo G6 Laser System
Energyper pulse(mJ)	Variable: Determined byPower in Watts and time.Calculated by Joule =Watts x Time	Variable: Determined by Powerin Watts and time. Calculatedby Joule = Watts x Time
OutputMode	CW-Pulse, MicroPulse	CW-Pulse, MicroPulse
Repetition rate	<50 Hz	<50 Hz
Lasermedia	810 nm Diode Laser	810 nm Diode Laser
Illumination	420-700 nm	NA
Userinterface	Touch Screen, Knobs onLaser Console, RemoteControl, Footswitch	Touch Screen, Knobs on LaserConsole, Remote Control,Footswitch
Laseractivation	Footswitch	Footswitch
Deliverydevices,howsupplied	Ordered with System orseparately	Ordered with System orseparately
Electricalrequirements	100 to 240 VAC @ 50 to60 Hz	100 to 240 VAC @ 50 to 60 Hz

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VIII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Iridex Cyclo G6 Laser is substantially equivalent to the predicate device and is safe and effective for use for the various indications for use stated.

The changes that are the subject of this 510(k) were verified and validated in accordance with the Iridex design control procedures.

IX. Conclusion

The Iridex Cyclo G6 Laser was found to be substantially equivalent to the predicate device.

The Iridex Cyclo G6 Laser shares identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate device.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.