Retinal photocoagulation and pan retinal photocoagulation 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, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Device Description

The Integre Pro L2RY is an addition to the Ellex range of ophthalmic photocoagulators. The Integre family are designed for use by ophthalmologists in a clinic or outpatient facility, or in the Retinal Specialist's office.

It is capable of producing focused pulses of red or yellow light with wavelengths of 670 nanometres (nm) and 561 nm respectively. The red and vellow beams may be used for the same treatments, but the red gives increased penetration of haemorrhaging tissue and fluids, and may also be used to treat ocular melanomas.

The Integre Pro L2RY is based upon the Integre Duo LP1RG with a modification to the laser cavity optical components which results in a yellow (561 nm) treatment laser output.

As with the Integre Duo, the laser pulses are accurately positioned on a structure within the patient's eye with the aid of a delivery device. The delivery device is an integrated slit-lamp microscope. An optional Laser Indirect Ophthalmoscope (LIO) can also be used.

The Integre Pro is an ophthalmic photocoagulator laser designed to be used by ophthalmologists for treatment of ocular pathology of the eye.

AI/ML Overview

The provided text describes the Ellex Integre Pro L2RY ophthalmic laser, a modified version of the Ellex Integre Duo LP1RG. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for validation studies of diagnostic or AI-driven devices.

Instead, the document is a 510(k) Summary submitted to the FDA for market clearance. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria.

Therefore, many of the requested information points (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training sets) cannot be extracted from this document as these types of studies were not conducted or reported for this device's 510(k) submission.

The document primarily compares the technical characteristics and intended uses of the new device (Integre Pro L2RY) with its predicate devices (Integre Duo LP1RG and Integre LP561) to establish substantial equivalence.

Here's a breakdown of what can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or a pass/fail threshold. Instead, it demonstrates "substantial equivalence" based on similar technological characteristics and identical intended uses to predicate devices. The "performance" reported is therefore a comparative table of specifications.

Characteristic compared	Ellex Integre Pro L2RY (Proposed)	Predicate Device 1 (Ellex Integre Duo LP1RG; K052777)	Predicate Device 2 (Ellex Integre LP561; K080423)
Laser Type	True CW Diode-Pumped Solid-State (DPSS)	True CW Diode-Pumped Solid-State (DPSS)	True CW Diode-Pumped Solid-State (DPSS)
Laser Wavelength	561 nm (yellow), 670 nm (red)	532 nm (green), 670 nm (red)	561 nm (yellow)
Laser Power	50-1500 mW (yellow), 50-1500 mW (red)	50-2000 mW (green), 50-1500 mW (red)	50-1500 mW (yellow)
Exposure time settings (pulse duration)	0.01 to 4.0 seconds adjustable in variable increments	0.01 to 4.0 seconds adjustable in variable increments	0.01 to 4.0 seconds adjustable in variable increments
Repeat mode intervals	0.1 to 1.0 seconds	0.1 to 1.0 seconds	0.1 to 1.0 seconds
Laser Safety Class	4/IV	4/IV	4/IV
Spot Size	50 to 1000 µm	50 to 1000 µm	50 to 1000 µm
Aiming Laser	Semi conductor laser diode	Semi conductor laser diode	Semi conductor laser diode
Aiming Laser Wavelength	635 -5/+10 nm	635 -5/+10 nm	635 -5/+10 nm
Clinical Versatility	Being able to offer most treatment capabilities with just two clinically proven wavelengths, red and yellow, with sufficient power.	(Implied similar for its wavelengths)	(Implied similar for its wavelength)
Integrated Design Platform	Yes	Yes	Yes
Flexibility (Adaption to slit lamps/delivery systems)	Yes	Yes	Yes
Intended Use	Identical to predicate devices (Photocoagulation of both anterior & posterior segments of the eye for various ocular pathologies listed).	Identical to predicate devices (Photocoagulation of both anterior & posterior segments of the eye for various ocular pathologies listed).	Identical to predicate devices (Photocoagulation of both anterior & posterior segments of the eye for various ocular pathologies listed).

The acceptance criterion for this 510(k) submission is that "modification to the predicate device... does not adversely affect the intended use, technological characteristics or safety and effectiveness." The study proving this is the comparison of technological characteristics and intended uses against the predicate devices, showing they are substantially equivalent.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable / Not provided. This is a hardware device modification, not a diagnostic algorithm undergoing validation on a test set of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable / Not provided. There is no "ground truth" derived from experts for a test set in this context. The determination of device characteristics is based on engineering specifications and testing.

4. Adjudication Method:

Not applicable / Not provided.

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 / Not provided. This device is an ophthalmic laser for treatment, not an AI-assisted diagnostic tool.

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

Not applicable / Not provided. This is a standalone laser system for treatment, not an AI algorithm.

7. The Type of Ground Truth Used:

Not applicable / Not provided for patient data. The "ground truth" here is the engineering specifications and performance of the device itself (e.g., accurate wavelength, power output, exposure time). This is established through internal testing and measurement against design specifications, not clinical "outcomes data" or "expert consensus" related to patient diagnoses.

8. The Sample Size for the Training Set:

Not applicable / Not provided. There is no "training set" as this is not a machine learning device.

9. How the Ground Truth for the Training Set was Established:

Not applicable / Not provided.

Summary

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82 Gilbert Street Adelaide SA, 5000 Australia ellex.com +61 8 8104 5200 +61 8 8221 5651

Attachment 5: 510(k) Summary

*Submitter's Name:

Submitter's Address:

Contact Person:

Contact Details:

Date Summary Prepared:

Trade Name of Modified Device: (For which this Special 510(k) is being submitted)

Common Name of Modified Device: (For which this Special 510(k) is being submitted)

Classification of Device:

Trade Name of Predicate Device:

Common of Predicate Device:

Classification of Device:

Description of the Device:

KO81565

Ellex Medical Ptv. Ltd. *Manufacturing and packaging.

82 Gilbert Street Adelaide, South Australia, 5000 AUSTRALIA

Kevin Howard, Senior Regulatory Officer

Tel +61 8 8104 5200 Fax +61 8 8221 5645 Email: khoward@ellex.com

May 27, 2008

Integre Pro

Photocoagulator Ophthalmic Laser

Class II, HQF; GEX, Ophthalmic Laser

Ellex Integre Duo LP1RG

Photocoagulator Ophthalmic Laser

Class II, Ophthalmic Laser

The Integre Pro L2RY is based upon the Integre Duo LP1RG with a modification to the laser cavity optical components which results in a yellow (561 nm) treatment laser output.

Special 510(k)

JUL - 2 2008

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82 Gilbert Street Adelaide SA, 5000 Australia ellex.com +61 8 8104 5200 +61 8 8221 5651

The principle reasons for modifying the current model Integre Duo and creating the Integre Pro are for the following;

Clinical versatility. That is, being able to offer most treatment capabilities with just two clinically proven wavelengths, red and yellow with sufficient power to treat not only the macular but also wherever green laser is indicated.
Fully integrated design platform
Flexibility, integrated design but still allows for adaption to a variety of slit lamps and delivery systems

The Integre Pro is an ophthalmic photocoagulator laser designed to be used by ophthalmologists for treatment of ocular pathology of the eye. It has identical intended uses as the previously cleared Integre Duo LP1RG, 510(k) K052777 and Integre LP561, 510(k) K080423.

The Indications for Use statement can be found in Attachment 2

Refer to the following tables for a comparison of the Integre Pro with the Integre Duo LP1RG and other commercially available predicate devices

Intended Use:

Comparison of Technological Characteristics:

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Image /page/2/Picture/7 description: The image contains the word "ellex" in a circular logo. The word is written vertically and rotated 90 degrees counterclockwise. The logo is black and white, with the word "ellex" in white against a black background.

82 Gilbert Street
Adelaide SA, 5000 Australia
ellex.com
+61 8 8104 5200
+61 8 8104 5200
+61 8 8221 5651

+61 8 8221 5651

Treatment Lasers dermatology

Characteristic compared	Ellex Integre Pro L2RY	Ellex Integre Duo LP1RG; K052777	Ellex Integre LP561; K080423
Laser Type	True CW Diode-Pumped Solid-State (DPSS)	True CW Diode-Pumped Solid-State (DPSS)	True CW Diode-Pumped Solid-State (DPSS)
Laser Wavelength	561 nm (yellow)670 nm (red)	532 nm (green)670 nm (red)	561 nm (yellow)
Laser Power	50-1500 mW (yellow)50-1500 mW (red)	50-2000 mW (green)50-1500 mW (red)	50-1500 mW (yellow)
Exposure time settings (pulse duration)	0.01 to 4.0 seconds adjustable in variable increments	0.01 to 4.0 seconds adjustable in variable increments	0.01 to 4.0 seconds adjustable in variable increments
Repeat mode intervals	0.1 to 1.0 seconds	0.1 to 1.0 seconds	0.1 to 1.0 seconds
Laser Safety Class	4/IV	4/IV	4/IV
Spot Size	50 to 1000 µm	50 to 1000 µm	50 to 1000 µm
Characteristic compared and a compared			Ellex Integre Pro L2RY - - - Ellex Integre Duo LP1RG, - - - - - - - - - - - - - Ellex Integre LP561, - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
	Semi conductor laser diode	Semi conductor laser diode	::1 1 - 1 - 1 - 1 - 1 ] T Semi conductor laser diode
			ining Laser Power ____________________________________________________________________________________________________________________________________________________________
CONSULTIONS CONSULTION CONSULTION CONSULTION CONSULTION COMMENT COMMENT COLLECT COLLECT COLLECT COLLE	635 -5/+10 nm	1635 -5/+10 nr	-: 635 -5/+10 nm
are a market a millio a minima and series and some and comments and comments a manus a la caller comments a	2/1	, 2/11	ar was an an an an an and an and an and and and and and on the manus and and in the manus and comments of the many comments of the many comments of the many comments of the m
Characteristic compared	Ellex Integre Pro L2RY	Ellex Integre Duo LP1RG; K052777	Ellex Integre LP561; K080423
Mains Electrical Supply Voltage	100-240VAC; 800VA	100-240VAC; 800VA	100-240VAC; 800VA
Supply Frequency	50/60Hz	50/60Hz	50/60Hz
Weight	32 kg (un-packed system w/out stand) (proposed)	32 kg (un-packed system w/out stand)	32 kg (un-packed system w/out stand)
Size	Console/table top H100 x W834 x D436 mm (proposed)	Console H123 x W434 x D512 mm	Console H123 x W434 x D512 mm
Operating Temperature Range	+10 C to +40 C; RH 35 to 85%	+10 C to +40 C; RH 10 to 85%	+10 C to +40 C; RH 10 to 85%
Transport & Storage Temperature Range	-10 C to +55 C; RH 35 to 85%	-10 C to +55 C; RH 10 to 85%	-10 C to +55 C; RH 10 to 85%
Cooling (console)	Air cooled with integrated active thermo-electric cooler (TEC)	Air cooled with integrated active thermo-electric cooler (TEC)	Air cooled with integrated active thermo-electric cooler (TEC)
Comparison Table -Delivery Devices	Ellex Integre Pro L2RY	Ellex Integre Duo LP1RG; K052777	Ellex Integre LP561; 510(k) K080423
Delivery Device
Slit Lamp Delivery System (SDS)	Treatment & aiming lasers integrated into slit lamp microscope or optional slit lamp adaptors.	Treatment & aiming lasers integrated into slit lamp microscope.	Treatment & aiming lasers integrated into slit lamp microscope.
Laser Indirect Ophthalmoscope (LIO)	Ellex LIO.	Ellex LIO.	Ellex LIO.
Comparison Table - Standard Accessories
Accessory	Ellex Integre Pro L2RY	Ellex Integre Duo LP1RG; K052777	Ellex Integre LP561; 510(k) K080423
Footswitch	Collapsible footswitch.Power control footswitch accessory available.	Collapsible footswitch.Power control footswitch accessory available.	Collapsible footswitch.Power control footswitch accessory available.
Remote Control Unit (RCU)	Colour LCD model.	Monochrome LCD model.	Monochrome LCD model.
Safety Filter	Fixed eye safety filter. Moveable eye safety filter as an accessory.	Moveable eye safety filter.	Moveable eye safety filter.

Comparison - Indications for Use of Devices
Ellex Integre Pro L2RY	Photocoagulation of both anterior & posteriorsegments of the eye including:Retinal photocoagulation & pan retinalphotocoagulation of vascular & structuralabnormalities of the retina & choroidincluding: proliferative & nonproliferative diabeticretinopathy; choroidal neovascularization; branch retinal vein occlusion; age-related macular degeneration retinal tears & detachments retinopathy of prematurity Iridotomy, iridectomy, suturelysis &trabeculoplasty in angle closure glaucoma& open angle glaucoma
Ellex Integre Duo LP1RG; K052777	Photocoagulation of both anterior and posteriorsegments of the eye including:Retinal photocoagulation & pan retinalphotocoagulation of vascular & structuralabnormalities of the retina & choroid including: proliferative & nonproliferative diabeticretinopathy; choroidal neovascularization; branch retinal vein occlusion; age-related macular degeneration retinal tears & detachments retinopathy of prematurity Iridotomy, iridectomy, suturelysis &trabeculoplasty in angle closure glaucoma andopen angle glaucoma
Ellex Integre LP561; K080423	Photocoagulation of both anterior & posteriorsegments of the eye including:Retinal photocoagulation & pan retinalphotocoagulation of vascular & structuralabnormalities of the retina & choroidincluding: proliferative & nonproliferative diabeticretinopathy; choroidal neovascularization; branch retinal vein occlusion; age-related macular degeneration retinal tears & detachments retinopathy of prematurity Iridotomy, iridectomy, suturelysis &trabeculoplasty in angle closure glaucoma &open angle glaucoma

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Special 510(l

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82 Gilbert Street
Adelaide SA, 5000 Austral ellex.com
+61 8 8104 5200
+61 8 8221 5651

omparison Table - Electrical and Mechanical Characteristics of Devic

Choice of Ellex Total Solutio
Stand

Morouslio Systems of Ellex Total Solution
Choice of Ellex Total Solution
Stand

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Fable/stand

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Special 510(k)

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82 Gilbert Street
Adelaide SA, 5000 Australia
ellex.com
· +61 8 8104 5200
· +61 8 8104 52000
· +61 8 8104 52000
· +61 8 8221 5651

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Image /page/5/Picture/0 description: The image shows the word "ellex" in white font on a black circular background. The font is sans-serif and appears to be bolded. The letters are closely spaced together, and the dot on the "i" is connected to the "x".

82 Gilbert Street Adelaide SA. 5000 Australia ellex.com +61 8 8104 5200 +61 8 8221 5651

Conclusion:

Ellex Medical has demonstrated by its evaluation of the Integre Pro L2RY that modification to the predicate device, the Integre Duo LP1RG, does not adversely affect the intended use, technological characteristics or safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2008

Ellex Medical Pty. Ltd. c/o Kevin Howard, Senior Regulatory Officer 82 Gilbert Street Adclaide, South Australia, 5000 AUSTRALIA

Re: K081565

Trade/Device Name: Integre Pro, Model L2 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: May 27, 2008 Received: June 4, 2007

Dear Mr. Howard:

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 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.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Malvina Eggleston, und

Malvina B. Evdelman, M.I 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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Image /page/8/Picture/1 description: The image shows a logo with the word "ellex" in white letters against a black circular background. The letters are stylized and appear to be in a sans-serif font. The background has a textured or grainy appearance, giving it a slightly distressed look. The logo is simple and modern, with a focus on the brand name.

82 Gilbert Street Adelaide SA, 5000 Australia ellex.com +61 8 8104 5200 * +61 8 8221 5651

Attachment 2

Indications for Use Statement

510(k) Number (if known):

K081565

Device Name: Ellex Integre Pro L2RY ophthalmic faser.

Indications for Use:

The Integre family of Ophthalmic laser and Delivery Devices are intended to be used in the treatment of ocular pathology.

The Ellex Integre Pro L2RY is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:

Retinal photocoagulation and pan retinal photocoagulation of vascular and structural � abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy: -
- choroidal neovascularization; ー
- branch retinal vein occlusion;
- age-related macular degeneration;
- retinal tears and detachments: -
- retinopathy of prematurity;
Iridotomy, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open . angle glaucoma

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

Bruce Drum

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Page 1 of_____________________________________________________________________________________________________________________________________________________________________

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.