INTEGRE, MODEL LP581
Device Facts
| Record ID | K080423 |
|---|---|
| Device Name | INTEGRE, MODEL LP581 |
| Applicant | Ellex Medical Pty, Ltd. |
| Product Code | HQF · Ophthalmic |
| Decision Date | Mar 11, 2008 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 886.4390 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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
Device Story
Integre LP561 is an ophthalmic photocoagulator laser; modification of Integre Duo LP1RG. Device uses diode-pumped solid-state (DPSS) laser to produce 561 nm (yellow) light pulses. Yellow wavelength provides high absorption by melanin in retinal pigment epithelium/choroids and hemoglobin; facilitates treatment for retinal/choroidal neovascularization; allows transmission through cloudy media (cataracts/corneal haze). Used by ophthalmologists in clinics or retinal specialist offices. Laser pulses delivered via integrated slit-lamp microscope or optional Laser Indirect Ophthalmoscope (LIO). Physician positions laser using aiming beam; triggers pulses via footswitch. Output affects ocular tissue via photocoagulation to treat specified pathologies. Benefits include improved penetration of hemorrhaging tissue and fluids compared to green/red lasers.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.
Technological Characteristics
True CW Diode-Pumped Solid-State (DPSS) laser; 561 nm wavelength; 50-1500 mW power; 0.01-4.0s pulse duration. Integrated slit-lamp microscope delivery system. Air-cooled with active thermo-electric cooler. Class 4/IV laser. Aiming laser: semiconductor diode, <1 mW, 635 nm. Electrical: 90-240VAC, 50/60Hz. Dimensions: console 140x280x350 mm, 14.5 kg.
Indications for Use
Indicated for patients requiring photocoagulation of anterior and posterior eye segments, including those with proliferative/nonproliferative diabetic retinopathy, choroidal neovascularization, branch retinal vein occlusion, age-related macular degeneration, retinal tears/detachments, retinopathy of prematurity, and angle closure or open angle glaucoma.
Regulatory Classification
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.
Predicate Devices
- Ellex Integre Duo LP1RG (K052777)
Reference Devices
Related Devices
- K081565 — INTEGRE PRO, MODEL L2RY · Ellex Medical Pty, Ltd. · Jul 2, 2008
- K063297 — LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR · Lightmed Corp. · Sep 20, 2007
- K111643 — OPTO MITRA YELLOW LASER · Opto Electronica SA · Nov 3, 2011
- K042785 — MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 · Nidek, Inc. · Dec 14, 2004
- K052777 — LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D · Ellex Medical Pty, Ltd. · Mar 16, 2006
Submission Summary (Full Text)
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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
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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:
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| 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 |
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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
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Special 510(k)
B2 Gilberi Stroet
Arielaide SA, 5D00 Australia
. . . . . . .
: 16
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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
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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.
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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,
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
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## 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
