INTEGRE, MODEL LP581

{0}------------------------------------------------ MAR 1 1 2008 Image /page/0/Picture/1 description: The image shows a logo with the word "ellex" in white letters against a textured, dark circular background. The texture of the background appears to be made up of many small, closely spaced lines or dots, giving it a slightly rough or grainy appearance. The font used for "ellex" is simple and sans-serif, making the word easily readable despite the busy background. 82 Gilbert Street Adelaide SA, 5000 Australia ellex.com +61 3 8104 5200 +61 8 3221 5551 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: Special 510(k) K080423 Ellex Medical Pty. 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 December 13, 2007 Integre LP561 Photocoagulator Ophthalmic Laser Class II, HQF; GEX, Ophthalmic Laser Ellex Integre Duo LP1RG Photocoagulator Ophthalmic Laser Class II, Ophthalmic Laser The Integre LP561 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. The Integre Duo LP1RG device is capable of producing focused pulses of red or green light with wavelengths of 670 nanometres (nm) and 532 nm respectively. The red and green 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 LP561 is essentially the same device with a modification to the laser cavity optical components which results in a vellow (561 nm) treatment laser output. The reason for developing the new device is because the yellow wavelength is characterised by high absorption by melanin in the retinal pigment epithelium and choroids that reduces the {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo for "ellex" inside of a circle. The word "ellex" is written in white, sans-serif font. The circle surrounding the word is black and white and appears to be made of many small lines. The logo is simple and modern. 82 Giberi Street Adelaide SA, 5000 Australia ���������� +61 8 2104 5200 +61 8 8221 5651 penetration depth of the beam in the choroids, high absorption by haemoglobin that facilitates direct treatment for retinal/choroidal neovascularisation and no absorption in macular xanthophylls and higher transmission through cloudy media such as cataract or haze on the cornea. As with the Integre LP1RG, 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 Duo is a ophthalmic photocoagulator laser designed to be used by ophthalmologists for treatment of ocular pathology of the eye. It is expected that the user is trained in operation of the instrument. This is the same intended use as previously cleared for Integre Duo laser 510(k) K052777 The Indications for Use statement can be found in Attachment 2 Refer to the following tables for a comparison of the Integre LP561 with the Integre Duo LP1RG and other commercially available predicate devices ### Intended Use: Comparison of Technological Characteristics: {2}------------------------------------------------ | Characteristic compared | Integre LP561 | Integre Duo LP1RG;<br>510(k) K052777 | Lumenis Novus Varia;<br>510(k) K022181 | Nidek MC-7000;<br>510(k) K974732 | Nidek MC-300;<br>510(k) K042785 | |-----------------------------------------|-------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------| | Laser Type | True CW Diode-Pumped Solid-State (DPSS) | True CW Diode-Pumped Solid-State (DPSS) | Diode-Pumped Solid-State (DPSS) | Diode-Pumped Solid-State (DPSS) frequency-doubled YAG | Diode-Pumped Solid-State (DPSS) frequency-doubled YAG | | Laser Wavelength | 561 nm (yellow) | 532 nm (green)<br>670 nm (red) | 532 nm (green)<br>561 nm (yellow)<br>659 nm (red) | 520.8-530.9 nm (green)<br>568.2 nm (yellow)<br>647.1 nm (red) | 532 nm (green)<br>561 nm (yellow)<br>659 nm (red) | | Laser Power | 50-1500 mW (yellow) | 50-2000 mW (green)<br>50-1500 mW (red) | 50-1500 mW (green)<br>50-600 mW (yellow)<br>50-600 mW (red) | 50-900 mW (green)<br>50-1500 mW (yellow/green)<br>50-1000 mW (red) | 50-2000 mW (green)<br>50-700 mW (yellow)<br>50-700 mW (red) | | 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 3.0 seconds adjustable in variable increments | 0.02 seconds to continuous adjustable in 21 increments | 0.01 to 3.0 seconds adjustable in variable increments | | Repeat mode Intervals | 0.1 to 1.0 seconds | 0.1 to 1.0 seconds | 0.05 to 3.0 | 0.2 to 1.0 seconds | 0.2 to 1.0 seconds | | Laser Safety Class | 4/IV | 4/IV | 4/IV | 4/IV | 4/IV | | Spot Size | 50 to 1000 µm | 50 to 1000 µm | 50 to 1000 µm | 50 to 1000 µm parfocal, 1000 to 2000 um defocused | 50 to 900 µm | す {3}------------------------------------------------ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Gilbert Bireet Adalalde SA, 6000 Australia elleralde SA, 6000 Australia # -ﺴﺎ T, - | Characteristic compared | Comparison Table - Aiming lasers of devices | | | | | |---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Integre LP561 | Integre Duo LP1RG | Lumenis Novus Varia | Nidek MC-7000 | Nidek MC-300 | | Aiming Laser Type | Semi conductor laser diode | Semi conductor laser diode | Semi conductor laser diode | Semi conductor laser diode | Diode pumped solid-state | | Aiming Laser Power | <1 mW | <1 mW | <1 mW | <1 mW | 0.3-0.7 mW Red<br>0.05-0.15 mW Yellow/Green | | Aiming Wavelength | $635 -5/+10$ nm | $635 -5/+10$ nm | 635 nm | 670 nm | 532/561/659 nm | | Laser Safety Class | 2/II | 2/II | 2/II | 2/II | 2/II | | Characteristic compared | Comparison Table - Electrical and Mechanical Characteristics of Devices | | | | | | | Integre LP561 | Integre Duo LP1RG | Lumenis Novus Varia | Nidek MC-7000 | Nidek MC-300 | | Mains Electrical Supply Voltage | 90-240VAC; 250VA | 90-240VAC; 250VA | 100VAC, 120VAC or 230VAC; 880VA | 90-245 VAC, 3 phase | 100/115/230 VAC | | Supply Frequency | 50/60Hz | 50/60Hz | 50/60Hz | 50/60Hz | 50/60Hz | | Weight | console 14.5 kg<br>slit lamp 10.5 kg<br>Console H140 x W280 x D350 mm | console 14.5 kg<br>slit lamp 10.5 kg<br>Console H140 x W280 x D350 mm | 52.2 kg<br>H1020 x W460 x D640mm | 176 kg<br>Console 406 x 990 x 1219 mm | 75 kg<br>Console H780 x W350 x D725 mm | | Operating Temperature Range | +10 C to +40 C; RH 10 to 85% | +10 C to +40 C; RH 10 to 85% | 10 C to 37°C; RH 90% @ 37 C non-condensing | | 15-30°C, RH 30-75% non-condensing | | Transport & Storage Temperature Range | -20 C to +60 C; RH 10% to 85% | -20 C to +60 C; RH 10% to 85% | -10 C to 55°C; RH 90% @ 55°C non-condensing | | 0-50°C, RH 5-95% non-condensing | | Cooling (console) | Air cooled with integrated active thermo-electric cooler | Air cooled with integrated active thermo-electric cooler | Forced air with integrated Thermo Electric Cooler | Internal Water Cooling | Digital control cooling device (internal water cooling) | | | Integre LP561 | Integre Duo LP1RG | Lumenis Novus Varia | Nidek MC-7000 | Nidek MC-300 | | Comparison Table –Delivery Devices & Accessories<br>Delivery Device | | | | | | | Slit Lamp<br>Delivery System<br>(SDS) | Treatment & aiming<br>lasers integrated into<br>slit lamp microscope. | Treatment & aiming<br>lasers integrated into<br>slit lamp microscope. | LaserLink Z and<br>LaserLink Z-1000- slit-<br>lamp delivery adaptors | May be used with;<br>Nidek SL1600, Zeiss<br>SL130, Haag Striet<br>900BQ | May be used with;<br>- Nidek slit lamp<br>delivery unit (SL-1800<br>type)<br>- Nidek attachable slit<br>lamp delivery unit<br>(attachable to SL-<br>1600)<br>- Zeiss slit lamp<br>delivery unit<br>(attachable to 30SL/M<br>type) | | Laser Indirect<br>Ophthalmoscope<br>(LIO) | Ellex LIO. | Ellex LIO. | Keeler, Heine | BIO (Heine or Keeler),<br>MIO (Neitz) | BIO (Keeler) | | Endo Ocular<br>Laser Probe | Not available | Not available | Acculite angled,<br>straight, illuminating<br>and aspirating probes | Endophotocoagulation<br>probe, straight,<br>angled, illuminated &<br>combined | Endophotocoagulation<br>probe, straight,<br>angled, illuminated &<br>combined | | Accessory | Integre LP561 | Integre Duo LP1RG | Lumenis Novus Varia | Nidek MC-7000 | Nidek MC-300 | | Footswitch | Standard footswitch<br>provided as a<br>standard system<br>component.<br>Power control<br>footswitch accessory<br>available. | Standard footswitch<br>provided as a<br>standard system<br>component.<br>Power control<br>footswitch accessory<br>available. | Provided as a<br>standard system<br>component<br>Smart & Powerease<br>footswitch accessory<br>available | Provided as a<br>standard system<br>component | Provided as a<br>standard system<br>component<br>Power Control<br>footswitch accessory<br>available | | Remote Control | Provided as a<br>standard system<br>component. | Provided as a<br>standard system<br>component. | Remote control | Provided as a<br>standard system<br>component | Provided as a<br>standard system<br>component | | Safety Filter | Moveable eye safety<br>filter. | Moveable eye safety<br>filter. | Dual physician filters | Fixed colour balanced<br>safety filter provided as<br>standard system<br>component | Provided as a<br>standard system<br>component | Special 510(k) : 15 {4}------------------------------------------------ Special 510(k) B2 Gilberi Stroet Arielaide SA, 5D00 Australia . . . . . . . : 16 {5}------------------------------------------------ assess of andications for User of Carona Escorts Estatus Estations Comparison - Indications for User of Devices Comparison - Includications for User of Devices Provinces 2 Gilbert Street Dalaide SA, 5000 Austra ntegre LP56 The Ellex Integre is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: - - - - - - - - - - - - - - ും വേണ്ടുവരുന്നു. അവലംബം പുറത്തുവരുന്നു വാഹ്യമായ വരുവന്തും വേണ്ടു. അവലംബം പുറത്തേക്കും അവലംബം പുറത്തേക്കും കാണുക അവലംബം പുരസ്കാരം കോട്ടുകളുടെ കാലാക്കും അവലംബം പ്രശ - dotomy, iridectomy, turelysis and abeculoplastly in angle osuloplasty in angle osure glaucoma and ope glaure glaucoma do Finand Santa and Santa and Sanara and Lumenis Novuss Varia Roomania National Paria Roomania Rasmissioni Rasmiy Rasmiy Roomania Norganization Maria Rasmiy Na Bhotosto avitreal - - - - - សាសនា សាសនា សាសនា សាសនា សាសនា សាសនា សាសនា សាន ស្រុក - - ridotomy, iridectorny and and abeculoplasty in angle close aucoma and open and open angle glaucoma ുക്കുന്നത്. അവലംബം പുറത്തിനു വാഹിത്യ വിശ്വാസിക്കുന്നു. അവലംബം Photocoagulatio Trabeculoplasty or open angle ונים המקום מקום משופיים מוספים מוספים מוסימים של משום של משום של משום של משום של משום של משום של משום של משום של משום של משום של משום של משום של משום של משמעות של משמעות של hotocoagulatii idotomy and rabeculoplasty {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ellex Medical Pty. Ltd. c/o Kevin Howard Senior Regulatory Officer 82 Gilbert Street Adelaide, SA 5000 Australia MAR 1 1 2008 Re: K080423 Trade/Device Name: Integre LP561 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF, GEX Dated: February 13, 2008 Received: February 15, 2008 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, Malina B. Egleston, ind Malvina B. Eydelman, M. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## Indications for Use Statement 510(k) Number (if known): K080423 Device Name: Ellex Integre LP561 ophthalmic laser. Indications for Use: The Ellex Integre 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; - - 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 V AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (OD Dexingler 3/10/2008 510(k) Number K080423