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

532 nm:

Dermatology:
· Pigmented Skin Lesions
· Vascular Lesions

Ear, Nose, and Throat (ENT)/ Otolaryngology

Otosclerotic Hearing loss and/or diseases of the inner ear:

· Stapedectomy
· Stapedotomy
· Myringotomies
· Lysis of Adhesions
· Control of Bleeding
· Removal of Acoustic Neuromas
· Soft tissue Adhesion in Micro/Macro Otologic Procedures

Ophthalmology:

Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including:

· Retinal photocoagulation (RPC) for the treatment of
Diabetic retinopathy, including:
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
· Retinal tears and detachments
Lattice degeneration
Age-related macular degeneration (AMD)
Retinopathy of prematurity
Sub-retinal (choroidal) neovascularization
Central and branch retinal vein occlusion
· Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
Primary open angle/Closed angle

577nm

Dermatology:

· Treatment of Vascular and pigmented lesions
Ophthalmology:

Indicated for use in photocoagulation of both anterior and posterior segments including:

· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including :

Proliferative and nonproliferative diabetic retinopathy;
Choroidal neovascularization;
Branch retinal vein occlusion;
Age-related macular degeneration
Retinal tears and detachments
Retinopathy of prematurity
· Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

630 - 670nm

Ophthalmology:

Indicated for use in photocoagulation of both anterior and posterior segments including:
· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
Proliferative and non-proliferative diabetic retinopathy;
Choroidal neovascularization:
Branch retinal vein occlusion;
Age-related macular degeneration
Retinal tears and detachments
Retinopathy of prematurity
· Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma

810nm

Ophthalmology:

Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples:

· Retinal photocoagulation for the treatment of:
· Diabetic retinopathy, including:
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
· Retinal Tears, Detachments and Holes
· Lattice degeneration
· Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
· Retinopathy of prematurity
· Sub-retinal (choroidal) neovascularization
· Central and Branch Retinal Vein Occlusion
· Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:
Primary open angle
Closed angle
Refractory Glaucoma (recalcitrant/uncontrolled)

Device Description

The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope is a light combination and reflection viewing system used with the Iridex IQ/GL/SL/TX laser system families. The LIO combines a laser treatment beam from an Iridex laser source with the illumination beam of a Heine binocular indirect ophthalmoscope into a mixed optical beam used by a physician with a handheld ophthalmic examination (condensing) lens to enter a patient's pupil and to collect and view reflections by a patient's retina returned through the same pupil. It provides a portable alternative to patients who cannot be examined or treated with a fixed slit lamp adapter. The LIO is supplied non-sterile and is intended for reuse and worn on the physician's head to view and treat the patient's retina. The device can be used to evaluate and treat patients of all ages, including infants, in an office, operating room and ambulatory surgical center setting.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical performance studies for a novel AI/software-driven medical device. Therefore, much of the requested information regarding AI model performance, ground truth establishment, training sets, and expert adjudication cannot be extracted from this document, as it pertains to a different type of device and regulatory pathway.

This document describes hardware modifications to an existing device and updates to its operating manual. The performance data presented is "simulated use" validation testing for the physical device, not an AI or software algorithm.

However, I can provide the information that is present in the document.

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

The document does not present acceptance criteria in a formal table with reported device performance in the manner typically seen for clinical effectiveness of a new AI/software feature. Instead, it describes a "simulated use" validation test.

Acceptance Criteria (Inferred from Test Design)	Reported Device Performance
The user could properly align and operate the device (e.g., the illumination and aiming/treatment beams would pass through the 20-diopter condensing lens and concentrically enter the simulated pupil plane using a pupil size of 6 mm in diameter, and achieve proper alignment of the internal illumination and aiming/treatment beam mirrors as well as illumination and aiming beam travel within the binocular field of view by using the adjustment control knobs) when following the updated operator manual.	"All units passed the simulated use test." This indicates that for all tested devices, the users were able to properly align and operate the device according to the updated manual and observe the expected beam alignments and travel.

Acceptance Criteria (Inferred from Test Design)

Reported Device Performance

The user could properly align and operate the device (e.g., the illumination and aiming/treatment beams would pass through the 20-diopter condensing lens and concentrically enter the simulated pupil plane using a pupil size of 6 mm in diameter, and achieve proper alignment of the internal illumination and aiming/treatment beam mirrors as well as illumination and aiming beam travel within the binocular field of view by using the adjustment control knobs) when following the updated operator manual.

"All units passed the simulated use test." This indicates that for all tested devices, the users were able to properly align and operate the device according to the updated manual and observe the expected beam alignments and travel.

2. Sample size used for the test set and the data provenance

Sample size for the test set: 25 modified TruFocus LIO Premiere devices.
Data provenance: Not directly applicable in the sense of patient data. The "test set" consists of the physical devices themselves undergoing simulated use. The testing was conducted as part of a 510(k) submission, implying it was contemporary to the submission date (August 3, 2018). It is not specified if the testing was retrospective or prospective in relation to patient treatment, as it was a simulated use test of the device's functionality. The country of origin of the data (testing location) is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The "ground truth" for this simulated use test was whether the device could be properly operated and aligned physically according to its design specifications using the updated manual, not a clinical diagnosis or outcome. The validation involved verifying the physical alignment and functionality of the device, likely a pass/fail assessment based on engineering specifications, rather than an expert clinical determination. The risk assessment was performed by a "qualified cross-functional team," but their role was in assessing risks, not establishing a clinical ground truth for a test set.

4. Adjudication method for the test set

Not applicable and not provided. The test was a simulated use validation, which likely involved a technical assessment of physical alignment and function, not a consensus-based adjudication of clinical findings.

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

No. This document does not mention an MRMC study or any AI component. The device is a laser indirect ophthalmoscope, a hardware device, not an AI-assisted diagnostic tool.

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

No. This is a hardware device, not an algorithm.

7. The type of ground truth used

The "ground truth" was the physical functionality and alignment of the device as per its design specifications when operated by a user following the updated manual. This is a technical/engineering ground truth based on the device's intended operation, not a clinical "expert consensus" or "pathology/outcomes data."

8. The sample size for the training set

Not applicable. This device does not involve a training set for an AI algorithm.

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

Not applicable. There is no AI algorithm with a distinct training set described in this document.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

September 5, 2018

Iridex Corporation Edward Sinclair Vice President, Regulatory and Ouality Affairs 1212 Terra Bella Avenue Mountain View, California 94043-1824

Re: K181662

Trade/Device Name: Iridex TruFocus LIO Premiere 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 3, 2018 Received: August 6, 2018

Dear Edward Sinclair:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Alexander Beylin -S 2018.09.05 18:03:14 -04'00'

for Malvina 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) K181662

Device Name TruFocus LIO Premiere

Indications for Use (Describe)

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

532 nm:

Dermatology:
· Pigmented Skin Lesions
· Vascular Lesions

Ear, Nose, and Throat (ENT)/ Otolaryngology

Otosclerotic Hearing loss and/or diseases of the inner ear:

· Stapedectomy
· Stapedotomy
· Myringotomies
· Lysis of Adhesions
· Control of Bleeding
· Removal of Acoustic Neuromas
· Soft tissue Adhesion in Micro/Macro Otologic Procedures

Ophthalmology:

Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including:

· Retinal photocoagulation (RPC) for the treatment of
Diabetic retinopathy, including:
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
· Retinal tears and detachments
Lattice degeneration
Age-related macular degeneration (AMD)
Retinopathy of prematurity
Sub-retinal (choroidal) neovascularization
Central and branch retinal vein occlusion
· Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
Primary open angle/Closed angle

577nm

Dermatology:

· Treatment of Vascular and pigmented lesions
Ophthalmology:

Indicated for use in photocoagulation of both anterior and posterior segments including:

· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including :

Proliferative and nonproliferative diabetic retinopathy;

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Choroidal neovascularization;
Branch retinal vein occlusion;
Age-related macular degeneration
Retinal tears and detachments
Retinopathy of prematurity
· Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

630 - 670nm

Ophthalmology:

Indicated for use in photocoagulation of both anterior and posterior segments including:
· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
Proliferative and non-proliferative diabetic retinopathy;
Choroidal neovascularization:
Branch retinal vein occlusion;
Age-related macular degeneration
Retinal tears and detachments
Retinopathy of prematurity
· Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma

810nm

Ophthalmology:

Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples:

· Retinal photocoagulation for the treatment of:
· Diabetic retinopathy, including:
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
· Retinal Tears, Detachments and Holes
· Lattice degeneration
· Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
· Retinopathy of prematurity
· Sub-retinal (choroidal) neovascularization
· Central and Branch Retinal Vein Occlusion
· Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:
Primary open angle
Closed angle
Refractory Glaucoma (recalcitrant/uncontrolled)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/5/Picture/1 description: The image shows the logo for IRIDEX. The logo consists of a circular emblem on the left and the word "IRIDEX" in bold, sans-serif font on the right. The emblem features a stylized floral design within a blue circle.

510(k) SUMMARY

Submitter Information

Company:	Iridex Corporation1212 Terra Bella AveMountain View, CA 94043-1824Phone: (650) 940-4700Fax: (650) 355-1305Establishment Registration No.: 2939653
Contact Person:	Edward J. SinclairVice President, Regulatory and Quality AffairsPhone: (650) 940-4700Fax: (650) 355-1305
Date Prepared:	August 3, 2018
Device Name and Classification
Common Name:	Laser Indirect Ophthalmoscope
Proprietary Name:	Iridex TruFocus LIO Premiere™
Classification Name:	Laser Powered Surgical Instruments (and Accessories
Product Code:	GEX
Regulation Number:	21 CFR§ 878.4810
Device Class:	II
Predicate Device
Company:	Iridex Corporation

Intended Use (Indications For Use)

The intended use of the modified device, as described in its labeling, has not changed as a result of the modifications. The indications for use are described below:

The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630mm-670mm], IQ 810 [810nm]), 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: 532 nm:

Dermatology:

• Pigmented Skin Lesions

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Image /page/6/Picture/2 description: The image contains the word "IRIDEX" in a bold, sans-serif font. To the left of the word is a circular logo with a blue border. Inside the border is a white design that resembles a snowflake or a stylized flower with three intersecting lines in the center.

· Vascular Lesions
Ear, Nose, and Throat (ENT)/ Otolaryngology

Otosclerotic Hearing loss and/or diseases of the inner ear:

· Stapedectomy
· Stapedotomy
· Myringotomies
· Lysis of Adhesions
· Control of Bleeding
· Removal of Acoustic Neuromas
Soft tissue Adhesion in Micro/Macro Otologic Procedures

Ophthalmology:

Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including:

· Retinal photocoagulation (RPC) for the treatment of
- Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
· Retinal tears and detachments
- Lattice degeneration
- Age-related macular degeneration (AMD)
- Retinopathy of prematurity
- Sub-retinal (choroidal) neovascularization
- Central and branch retinal vein occlusion
· Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including - Primary open angle/Closed angle

577mm:

Dermatology:

· Treatment of Vascular and pigmented lesions
Ophthalmology:

Indicated for use in photocoagulation of both anterior and posterior segments including: · Retinal photocoagulation, panretinal photocoagulation and intravitreal

endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:

Proliferative and nonproliferative diabetic retinopathy;
Choroidal neovascularization:
Branch retinal vein occlusion;
Age-related macular degeneration
Retinal tears and detachments
Retinopathy of prematurity

· Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

630 - 670nm:

Ophthalmology:

Indicated for use in photocoagulation of both anterior and posterior segments including:

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Image /page/7/Picture/2 description: The image shows the logo for IRIDEX. The logo consists of a circular emblem on the left and the word "IRIDEX" in bold, black letters on the right. The emblem features a stylized flower-like design with a blue border and a complex geometric pattern inside.

· Retinal photocoagulation, panretinal photocoagulation and intravitreal
endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
Proliferative and non-proliferative diabetic retinopathy;
Choroidal neovascularization;
Branch retinal vein occlusion;
Age-related macular degeneration
Retinal tears and detachments
Retinopathy of prematurity
· Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma

810mm:

Ophthalmology:

Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral

cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples:

· Retinal photocoagulation for the treatment of:
· Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
· Retinal Tears, Detachments and Holes
· Lattice degeneration
· Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
Retinopathy of prematurity
Sub-retinal (choroidal) neovascularization
· Central and Branch Retinal Vein Occlusion
· Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:
- Primary open angle
- Closed angle
- Refractory Glaucoma (recalcitrant/uncontrolled)

Device Description

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Image /page/8/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a blue circular emblem on the left and the word "IRIDEX" in bold, black letters on the right. The emblem features a white floral design with three stylized petals inside a blue circle.

There are five models of the TruFocus LIO Premiere available that differ in the laser wavelength to be delivered, spot size, and the type of LIO-to-laser console connector, as listed in the table below.

Product No.(Model)	Description	Iridex Laser ConsoleCompatibility	Spot Size	ConnectorType
87300	TruFocus LIO Premiere, 532/810	OcuLight GL, TX, SL, SLx, IQ532	350 µm	Resistive
87301	TruFocus LIO Premiere, 810	OcuLight SL, SLx	350 µm	Resistive
87302(Large Spot)	TruFocus LIO Premiere, 810 LS	OcuLight SL, SLx	1400 µm	Resistive
87303	TruFocus LIO Premiere, 532	IQ 532	350 µm	RFID
87304	TruFocus LIO Premiere, 577	IQ 577	350 µm	RFID

Each LIO includes:

· Accessory Kit (PN 87526) comprised of a carry case (PN 87284), headband-mounted rechargeable battery (PN 87287), and a plug-in transformer (PN 87286). These accessories are also available for individual purchase.
· LIO instructions are provided in the form of an Operator Manual.
· Heine Omega 500 BIO instructions are included.
· Zero-diopter and Two-diopter lenses are included.

Other available options include:

· Extension cord for plug-in transformer
· Wall-mounted charging cradle

Key Functional Components

The TruFocus LIO Premiere contains the following hardware components:

Adjustable headband
Headband-mounted rechargeable battery
Headband-mounted optics unit
· Fiber-optic cable with connector (resistive or RFID)
· Zero-diopter and Two-diopter lenses
Plug-in transformer and extension cord
· Wall-mounted charging cradle
· Replaceable LED illumination bulb
· Standard carry case

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Comparison of Technological Characteristics with the Predicate Device

The TruFocus LIO Premiere subject device is substantially equivalent to the TruFocus LIO Premiere predicate device (cleared by FDA in K170718 on May 3, 2017). The intended use, mechanism of action, and key components remain the same. There were no changes in the technological characteristics. A comparison of the significant technological characteristics, which are identical, is provided in the table below:

Characteristic	Iridex TruFocus LIO PremiereLaser Indirect Ophthalmoscope(Subject Device)	Iridex TruFocus LIO PremiereLaser Indirect Ophthalmoscope(Predicate device cleared by K170718)
Type/Design	Indirect Ophthalmoscope Binocular(Headband mounted)	Indirect Ophthalmoscope Binocular(Headband mounted)
TreatmentWavelength	532nm, 577nm, 810nm	532nm, 577nm, 810nm
Eye Filter OD	6 @ 532 nm & 577nm, 2 @ 810 nm	6 @ 532 nm & 577nm, 2 @ 810 nm
WorkingDistance	370mm +/- 10mm	370mm +/- 10mm
Fiber Length	13'8"	13'8"
Aerial Spot Size	Standard LIO spot size: 1.1mm(0.043in) ±10%Large LIO spot size: 4.0mm (0.157in)±10%	Standard LIO spot size: 1.1mm(0.043in) ±10%Large LIO spot size: 4.0mm (0.157in)±10%
IlluminationSource	LED Illumination light source standardwith optional Halogen bulb	LED Illumination light source standardwith optional Halogen bulb
Cooling System	Air Cooled	Air Cooled
Electrical	Heine rechargeable battery. Operateson 100-240VAC, 50/50Hz. Optionalwall plug in charger.	Heine rechargeable battery. Operateson 100-240VAC, 50/50Hz. Optionalwall plug in charger.
Weight	≤ 1000gm (2.2 lbs.) with batteryinstalled	≤ 1000gm (2.2 lbs.) with batteryinstalled

Description of Changes

The Operator Manual (Instructions For Use) has been updated in order to (a) provide additional illustrations and clarification of the various adjustment controls, (b) clarify the patient treatment instructions showing how to position the illumination and aiming beams within the binocular field of view and how to position the condenser lens along the axis of the aiming beam, and (c) establish a separate section to provide instructions for use of the binocular indirect ophthalmoscope (BIO) mode.

The submission also describes minor changes including a dimensional increase of a portion of the fiber optic cable assembly to improve attachment to molded clips at the top of the headband, an improved manufacturing process and new adhesive to enhance the bond reliability of the glass dust cover and cover frame used to shield the optics, and improvements to the aiming beam adjustment control cam surface finish resulting in a smoother actuation "feel" to the user.

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Image /page/10/Picture/0 description: The image contains the logo for IRIDEX. To the left of the company name is a circular logo with a blue border. Inside the border is a white design that resembles a snowflake or a stylized flower with three intersecting lines.

K181662

Risk Analysis

A risk analysis was used to assess the impact of the cumulative effect of each device modification and the proposed modifications to the Operator Manual. The risk assessment methods comply with EN ISO 14971:2012 "Medical devices – Application of risk management to medical devices." The device and labeling changes described in this 510(k) submission were assessed for risk by reviewing the current Risk Management documentation for the TruFocus LIO Premiere device. The Hazard Analysis was reviewed and it was determined that no new hazards were introduced. The FMEA documents were reviewed to determine whether any risks were increased, reduced, or whether new risks were introduced as a result of the change (i.e., any difference in the occurrence or detectability of potential failure modes, or any new failure modes/potential causes). This assessment was performed by a qualified cross-functional team. The potential hazards were found to be sufficiently mitigated through the modified user instructions, device design, and change verification and validation to an acceptable level of risk. The potential benefits to patients outweigh the low residual risk of the modifications to the device and labeling.

Performance Data

In addition to verification and validation testing of the individual device changes, performance testing was conducted to validate the cumulative effect of device modifications and changes to the Operator Manual (the user instructions). A test procedure was developed to subject a sample size of 25 modified TruFocus LIO Premiere devices to a "simulated use" validation test following the modified Operator Manual. This test was designed to verify that when following the updated operator manual, the user could properly align and operate the device (e.g., the illumination and aiming/treatment beams would pass through the 20-diopter condensing lens and concentrically enter the simulated pupil plane using a pupil size of 6 mm in diameter, and achieve proper alignment of the internal illumination and aiming/treatment beam mirrors as well as illumination and aiming beam travel within the binocular field of view by using the adjustment control knobs). All units passed the simulated use test.

Conclusions

The modified TruFocus LIO Premiere device is as safe and effective as, and is 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.