LASEREX LP1532 PHOTOCOAGULATOR

{0}------------------------------------------------ OCT - 3 1997 # 510 (K) SUMMARY # K972514 This is a 510(K) Summary in accordance with CFR 807.92. #### SUBMITTERS NAME, ADDRESS: 1. Taracan Pty Ltd trading in the USA as Laserex Systems 258 Halifax Street Adelaide, South Australia 5000 AUSTRALIA Corresponding Official: Keith R. Degenhardt Managing Director/CEO 61-8-82236644 Telephone: Facsimile: 61-8-82326277 Signature Date: 616 97 #### 2. DEVICE NAME Laserex Model LP1532. #### 3. PREDICATE DEVICE IDENTIFICATION #### 3.1 Name(s) The predicate devices are: - 1. Alcon Ophthalas 532. - 2. Alcon EyeLite - 3. Iris Occulite - 4. Nidek Prima #### 3.2 Predicate Device Company - 1. Alcon Surgical Inc - 2. Alcon Surgical Inc - 3. Iridex Corporation Inc - 4. Nidek Medical Inc {1}------------------------------------------------ ### INTENDED USES 4. 4.1 The intended uses for this product are; - Retinal Photocoagulation . - Pan Retinal Photocoagulation . - Endophotocoagulation. ● - Photocoagulation for Macular Degeneration . - . Laser Trabeculoplasty #### 4.2 A General Description of these Treatments are; The intended uses for this product are: Retinal treatments, including; - . Retinal Photocoagulation - Pan Retinal Photocoagulation . - Endophotocoagulation . These treatments involve the destruction of neovascular complexes, to obliterate areas of microinfarction or capillary closure. Retinal Photocoagulation will be carried out using principally the Slitlamp Delivery System accessory. Pan Retinal Photocoagulation will be carried out using either of the Laser Indirect Ophthalmoscope or the Slitlamp Delivery System accessory. Endophotocoagulation will be carried out using any one of the three variants of the endoprobe accessories, namely Straight, Curved or Aspirating Endooccular Probes. Photocoagulation for Macular Degeneration involves the destruction of leaking vessels in the macular and paramacular region, and ultimately to produce a chorioretinal adhesion that will resist ongoing vitreoretinal traction. This treatment will be carried out using the slitlamp microscope mounted Slitlamp Delivery System accessory. Laser Trabeculoplasty, the photocoagulation of the trabecular meshwork to create apertures and increase the flow of the aqueous humor in order to treat open-angle glaucoma. This treatment will be carried out using the slitlamp microscope mounted Slitlamp Delivery System accessory. {2}------------------------------------------------ ### DEVICE DESCRIPTION 5. #### 5.1 General The LP1532 is a compact, solid state laser photocoagulator intended for ophthalmic use. It produces laser energy intended to be directed into the eye by a suitably qualified physician, via a range of laser delivery accessories namely; - Laser Endoprobes . - Laser Indirect Ophthalmoscope . - Slitlamp Delivery Systems . The LP1532 is a frequency doubled Nd:YAG Laser operating in the visible green wavelength spectrum ( 532 nanometers ). #### 5.2 Specifications # Size: | Width: | 12" (310 mm) | |---------|----------------| | Length: | 20" (510 mm) | | Height: | 7.5" (190 mm) | | Weight: | 37 lbs (17 kg) | # Power/Electrical Requirements: | Voltage: | 110 or 220 VAC | |-------------------|---------------------| | Frequency: | 50 or 60 Hz | | Electrical power: | 450 Watts | | Insulation class: | Class 1 (UL 2601-1) | # Laser Characteristics: | Treatment laser beam | | |----------------------|---------------------| | Laser class: | Class IV (4) | | Laser wavelength: | 532 nm | | Laser power: | 30 mW min, 2 W max. | ### Aiming laser beam Laser class: Class II (2) Laser wavelength: 635 nm Laser power: 0.05 to 0.95 mW {3}------------------------------------------------ ### Significant Changes/Modifications from Predicate Device 5.3 There are no significant changes or modifications from the predicate products that affect safety, effectiveness, or the intended use of the product. #### 5.4 Accessories The following accessories are intended for use with the LP 1532 laser : - Laser Endo Probes. . - Slitlamp Delivery System. ● - . Laser Indirect Ophthalmoscope. Additional information is provided in the table below | | 510 (K)<br>DEVICE | PREDICATE DEVICE | | | | |------------------------------------|--------------------------------------------|---------------------------------------|---------------------------------------|----------------------------------------|--------------------------------------------| | CHARACTERISTIC<br>COMPARED | LASEREX<br>LP-1532 | ALCON<br>OPHTHALAS<br>532 | IRIS | NIDEK | ALCON<br>EyeLite | | Accessories | | | | | | | Endo Probes | Straight,<br>curved and<br>aspirating | Straight,<br>curved and<br>aspirating | Straight and<br>curved<br>available | Endo<br>Probes<br>available | Straight,<br>curved and<br>aspirating | | Laser Indirect<br>Ophthalmo-scope | Adapted<br>Heine | Adapted<br>Keeler Fison | Adapted<br>Heine | Nidek LIO | Adapted<br>Keeler Fison | | Slitlamp Adaptors | To fit<br>• Zeiss<br>• Haag<br>Streit | To fit<br>• Zeiss<br>• Haag<br>Streit | To fit<br>• Zeiss<br>• Haag<br>Streit | To fit<br>• Zeiss<br>• Haag<br>Streit | To fit<br>• Zeiss<br>• Haag<br>Streit | | | Combo for<br>use with<br>Laserex YAG | Combo for<br>use with<br>Laserex YAG | | Combo for<br>use with<br>NIDEK<br>YAGs | | | Spot Size | 50-500<br>microns | 50-1000<br>microns | 75- 500<br>microns | | | | Operating<br>Microscope<br>Filters | • Zeiss<br>• OPMI-6<br>• Wild<br>• Möeller | | | | • Zeiss<br>• OPMI-6<br>• Wild<br>• Möeller | {4}------------------------------------------------ ### DEVICE LABELS 6. Refer to Appendix A for all device labelling information including; - . Advertising brochure - . Description and directions for use - Product labels (including accessories) . ### COMPARATIVE INFORMATION 7. The following table displays the similarities and differences of the new device to the legally marketed devices to which equivalency is claimed. {5}------------------------------------------------ | | 510(k)<br>DEVICE | PREDICATE DEVICES | | | | |------------------------------------|------------------------------------------------------|-------------------------------------------|----------------------------|---------------------------------|--------------------------------------------------------------------------| | Characteristic<br>Compared | LASEREX<br>LP-1532 | ALCON<br>OPHTHALAS<br>532 | IRIS<br>OCCULITE | NIDEK<br>PRIMA | ALCON<br>EyeLyte | | Laser Power<br>(W) | Up to 2W | Up to 3W | Up to 1.2W | 1.5W | Up to 1.7W | | Laser<br>Wavelength<br>(nm) | 532nm | 532nm | 532nm | 532nm | 532nm | | Laser Class | IV | IV | IV | IV | IV | | Exposure<br>Time (sec) | 0.01 to 2.0<br>sec | 0.01 to 2.0<br>sec and CW | 0.05 to 1.0<br>sec | 0.02 to 3 sec | 0.01 to 2.0<br>sec and CW | | Aiming Laser<br>Type | Red Diode | HeNe | Red Diode | Red Diode | Red Diode | | Aiming Laser<br>Power | 0.05 to 0.95<br>mW<br>continuously<br>variable | 4 intensities<br>selectable up<br>to 1 mw | 0 to1mW | 0.2 to 0.8mW | Continuously<br>variable up to<br>1 mw | | Aiming<br>Wavelength | 635nm | 633nm | set between<br>630 - 650nm | 633nm | 670nm | | Electrical<br>Supply<br>Voltage | 100-120VAC<br>220-250VAC<br>single phase<br>50/60 Hz | 220 VAC<br>single phase | 90-240 VAC<br>50/60 Hz | 100/120/<br>230 VAC<br>50/60 Hz | 100-120 VAC<br>8 A single<br>phase<br>220-240 VAC<br>4 A<br>single phase | | Electrical<br>Power<br>Consumption | 450W | 3K W | 300W | 1500W | 800 W | | Weight | 17Kg | 99Kg | 8.1Kg | 32Kg | 16Kg | | Size | W 31cm<br>D 51cm<br>H 19cm | W 36cm<br>D 81cm<br>H 80cm | W.30cm<br>D 15cm<br>H 30cm | W 30cm<br>D 42cm<br>H 70cm | W 38.7cm<br>D 44.6 cm<br>H 21.8 cm | | Environment | | | | | | | Temperature | 15 - 35<br>degrees C | 15 - 30<br>degrees C | not specified | 5 - 35<br>degrees C | 15 - 35<br>degrees C | | Humidity | Up to 85%<br>RH | Up to 85% RH | not specified | 5 - 95% RH<br>non<br>condensing | Up to 85%<br>RH | {6}------------------------------------------------ | Repeat<br>Interval<br>Duration | Selectable<br>0.1,0.2,0.3,0.5,<br>0.6,0.7,<br>0.8,0.9,1.0<br>sec | Selectable<br>0.2, 0.5, 0.7,<br>0.9 sec | Selectable | 0.2 to 1.0 sec<br>in to 0.1 sec<br>intervals | Selectable<br>0.1, 0.2, 0.3,<br>0.4, 0.5, 0.6,<br>0.8, 0.9,1.0<br>sec | |--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cooling | Air cooled | Internal<br>water<br>cooling<br>system | Air cooled | Internal water<br>cooling<br>system | Air cooled | | Scientific<br>concepts that<br>form the<br>basis for the<br>device | - Green laser source<br>- Generated by means<br>of a laser diode<br>pumped, frequency<br>doubled Yag laser.<br>- Diode pumping<br>configuration very<br>efficient, permitting air<br>cooling<br>- Energy controlled<br>by means of an<br>operator by means of<br>a software driven<br>control system<br>- Energy delivered to<br>target tissue by a<br>range of fiberoptic<br>beam delivery<br>systems | - Green laser source<br>- Generated by means<br>of an arclamp pumped,<br>frequency doubled Yag<br>laser.<br>- Arclamp pumping<br>configuration relatively<br>inefficient, requiring<br>closed loop water<br>cooling<br>- Energy controlled by<br>means of an operator<br>by means of a software<br>driven control system<br>- Energy delivered to<br>target tissue by a range<br>of fiberoptic beam<br>delivery systems | - Green laser source<br>- Generated by<br>means of a laser<br>diode pumped,<br>frequency doubled<br>Yag laser.<br>- Diode pumping<br>configuration very<br>efficient, permitting<br>air cooling<br>- Energy controlled<br>by means of an<br>operator by means of<br>a software driven<br>control system<br>- Energy delivered to<br>target tissue by a<br>range of fiberoptic<br>beam delivery<br>systems | - Green laser source<br>- Generated by means<br>of an arclamp<br>pumped, frequency<br>doubled Yag laser.<br>- Arclamp pumping<br>configuration relatively<br>inefficient, requiring<br>closed loop water<br>cooling<br>- Energy controlled by<br>means of an operator<br>by means of a<br>software driven control<br>system<br>- Energy delivered to<br>target tissue by a range<br>of fiberoptic beam<br>delivery systems | - Green laser source<br>- Generated by means<br>of a laser diode<br>pumped, frequency<br>doubled Yag laser.<br>- Diode pumping<br>configuration very<br>efficient, permitting air<br>cooling<br>- Energy controlled by<br>means of an operator<br>by means of a<br>software driven control<br>system<br>- Energy delivered to<br>target tissue by a range<br>of fiberoptic beam<br>delivery systems | | Intended<br>Uses | Retinal<br>photocoagulation<br>Panretinal<br>photocoagulation,<br>Photocoagulation for<br>Macular Degeneration<br>Trabeculoplasty<br>Endophotocoagulation | Panretinal<br>photocoagulation,<br>Photocoagulation for<br>Macular Degeneration<br>Subretinal<br>neovascularization,<br>Trabeculoplasty,<br>Pneumatic retinopexy,<br>Retinal tears,<br>Retinal detachments,<br>Transscleral<br>cyclophotocoagulation,<br>Endophotocoagulation | Retinal<br>photocoagulation,<br>Anterior segment<br>procedures. | Retinal<br>photocoagulation,<br>Subretinal<br>neovascularization,<br>Closing of retinal<br>arteriols. | Panretinal<br>photocoagulation,<br>Photocoagulation for<br>Macular Degeneration<br>Subretinal<br>neovascularization,<br>Trabeculoplasty<br>Pneumatic retinopexy<br>Retinal tears<br>Retinal detachments<br>Endophotocoagulation | {7}------------------------------------------------ ### BIOCOMPATIBILITY AND STERILIZATION INFORMATION 8. The laser endo probe accessories are the only components of the device that are patient contacting and supplied sterilized. We are sourcing these probes from: Creative Medical Products, Inc 5988 Mld Rivers Mail Drive Suite 236 St Charles MO 63304 Owner/Operator Registration No. 9023612 Establishment Registration No. 1933418 They have provided the following information to us regarding the 510(K) approvals for these probes; - FDA 510(K) approval number #K954307 applies to the straight and curved . probes. - . FDA 510(K) approval number # K954308 applies to the aspirating laser probes. These are the only probes we will be supplying with the device. Additional information provided by Creative Medical Products Inc is contained in Appendix B. {8}------------------------------------------------ ### SOFTWARE VALIDATION & VERIFICATION 9. In accordance with the Reviewer Guidance for Computer Controlled Medical Devices a review of the level of concern for the LP-1532 has been identified to be Minor to Moderate. Operation of the LP-1532 directly affects the patient such that failures or latent design flaws may result in Minor to Moderate patient injury. The software development process has not yet been completed but we believe that an equivalence determination can be made prior to completion. The following data is provided in Appendix C. * - System and software requirements and design . - . Software development - . Verification and validation I certify that in my capacity as Managing Director/CEO of Taracan Pty Ltd, I will ensure that the described processes will be completed and the following will be completed; - Test results and analysis - Software certification Signed:***_*****_**. The text is a signature. Name: Keith R. Degenhardt Position: Managing Director Date: * Derived from 510(K) Memorandum # K91-1 Software Documentation Matrix. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of a human figure with three faces in profile, stacked on top of each other. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" printed around it. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT - 3 1997 Mr. Keith R. Degenhardt Managing Director Laserex Systems 258 Halifax Street Adelaide, South Australia 5000 AUSTRALIA K972514 Re: Laserex LP1532 Photocoagulator Trade Name: Requlatory Class: II Product Code: HOF June 6, 1997 Dated: Received: July 7, 1997 Dear Mr. Degenhardt: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {10}------------------------------------------------ # Page 2 - Mr. Keith R. Degenhardt This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html". Sincerely yours to colle Witten, Ph.D., M.D. a M. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {11}------------------------------------------------ #### 510(k) Number (if known): K972514 # vice Name: LASEREX LP1532 PHOTOCOAGULATOR ### Indications For Use: ### INDICATIONS FOR USE The indication for use for this product are; - · Retinal Photocoagulation - · Pan Retinal Photocoagulation - · Photocoaqulation for Macular Degeneration · Laser Trabeculoplasty - - · Endophotocoagulation. ### A General Description of these Treatments are; The indications for use for this product are: Retinal treatments, including; - Retinal Photocoaqulation . - . Pan Retinal Photocoaqulation - . Endophotocoagulation These treatments involve the destruction of neovascular complexes, to obliterate areas of microinfarction or capillary closure. Retinal Photocoagulation will be carried out using principally the Slittamp Delivery System accessory. Pan Retinal Photocoagulation will be carried out using either of the Laser Indirect Ophthalmoscope or the Slitlamp Delivery System accessory. Endophotocoagulation will be carried out using any one of the endoprobe accessories. namely Straight, Curved or Aspirating Endooccular Probes. Photocoagulation for Macular Degeneration involves the destruction of leaking vessels in the macular and paramacular region, and ultimately to produce a chorioretinal adhesion that will resist ongoing vitreoretinal traction. This treatment will be carried out using the sittlamp microscope mounted Slittlamp Delivery System accessory. Laser Trabeculoplasty, the photocoagulation of the trabecular meshwork to create apertures and increase the flow of the aqueous humor in order to treat open-angle glaucoma: This treatment will be carried out using the slitlamp microscope mounted Slitlamp Delivery System accessory. # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation ( Acseffe (Division Sign-On) Division of General Restorative Devices 510(k) Number K972814 **Prescription Use** (21 CFR 801.109) Over-The-Counter Use