INTEGRE PRO, MODEL L2RY

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a black circle with the word "ellex." written in white. The word is written in lowercase letters. The dot after the word is also white. 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 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. Special 510(k) JUL - 2 2008 {1}------------------------------------------------ Image /page/1/Picture/14 description: The image shows a black circle with the word "ellex." written in white. The word is written in lowercase letters, and there is a period after the word. The circle is solid black, and the word is centered inside the circle. 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 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. 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: {2}------------------------------------------------ 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)<br>670 nm (red) | 532 nm (green)<br>670 nm (red) | 561 nm (yellow) | | Laser Power | 50-1500 mW (yellow)<br>50-1500 mW (red) | 50-2000 mW (green)<br>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 | ::<br>1 1 - 1 - 1 - 1 - 1 ] T<br> 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 | -<br>: 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.<br>Power control footswitch accessory available. | Collapsible footswitch.<br>Power control footswitch accessory available. | Collapsible footswitch.<br>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 & posterior<br>segments of the eye including:<br>Retinal photocoagulation & pan retinal<br>photocoagulation of vascular & structural<br>abnormalities of the retina & choroid<br>including: proliferative & nonproliferative diabetic<br>retinopathy; choroidal neovascularization; branch retinal vein occlusion; age-related macular degeneration retinal tears & detachments retinopathy of prematurity Iridotomy, iridectomy, suturelysis &<br>trabeculoplasty in angle closure glaucoma<br>& open angle glaucoma | | | | Ellex Integre Duo LP1RG; K052777 | Photocoagulation of both anterior and posterior<br>segments of the eye including:<br>Retinal photocoagulation & pan retinal<br>photocoagulation of vascular & structural<br>abnormalities of the retina & choroid including: proliferative & nonproliferative diabetic<br>retinopathy; choroidal neovascularization; branch retinal vein occlusion; age-related macular degeneration retinal tears & detachments retinopathy of prematurity Iridotomy, iridectomy, suturelysis &<br>trabeculoplasty in angle closure glaucoma and<br>open angle glaucoma | | | | Ellex Integre LP561; K080423 | Photocoagulation of both anterior & posterior<br>segments of the eye including:<br>Retinal photocoagulation & pan retinal<br>photocoagulation of vascular & structural<br>abnormalities of the retina & choroid<br>including: proliferative & nonproliferative diabetic<br>retinopathy; choroidal neovascularization; branch retinal vein occlusion; age-related macular degeneration retinal tears & detachments retinopathy of prematurity Iridotomy, iridectomy, suturelysis &<br>trabeculoplasty in angle closure glaucoma &<br>open angle glaucoma | | | 14 {3}------------------------------------------------ Special 510(l 82 Gi Adela ellex. +61 elle> 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 15 Choice of Ellex Total Solutio Stand Morouslio Systems of Ellex Total Solution Choice of Ellex Total Solution Stand egrated table and sta Fable/stand {4}------------------------------------------------ Special 510(k) Image /page/4/Picture/1 description: The image shows the word "ellex" in white text on a black circle. The word "ellex" is oriented vertically, with the "e" at the bottom and the "x" at the top. The font is sans-serif and appears to be bolded. 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is written in all capital letters and is oriented to follow the curve of the circle. 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. {7}------------------------------------------------ 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 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the words "Special 510(k)". The text is written in a simple, sans-serif font. The background of the image is plain white, which makes the text stand out clearly. 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 ്ലം Page 1 of_____________________________________________________________________________________________________________________________________________________________________