LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM

{0}------------------------------------------------ Pharo Ophthalmic Surgery System/Laser Photolysis System **JUN 2 9 2000** K99315'4 p. 1084 ## 510 (k) Summary Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 Company Name/Contact: Daniel Hoefer ARC Laser Corporation 1832 South 3850 West Salt Lake City, UT 84104 (801) 972-1311, FAX (801) 972-5251 Name of Device: | Trade Name: | 1. Pharo Ophthalmic Surgery System<br>2. Laser Photolysis System | |--------------|-----------------------------------------------------------------------------------| | Common Name: | 1. Anterior and Posterior Segment surgical system<br>2. Phacofragmentation System | Classification name: Phacofragmentation System, per 21 -CFR 886.4670, Vitreous aspiration and cutting device per 21 CFR 886.4150, and Radio frequency Electrosurgery cautery device per 21 CFR 886.4100. HQC, HQE, MXO Product Code: Class II Device Class: Predicate Devices: System is substantially equivalent to the Pharo The following legally marketed devices: The Series 20000 Legacy (K952213) marketed by Alcon Laboratories, Inc., the Premiere Microsurgical System (K89478, K921460, K946227) Alcon marketed by Storz Instrument Company, and the Accuras, marketed by Alcon Laboratories, Inc. The Laser Photolysis System is substantially equivalent to following legally marketed devices: The Premiere the Microsurgical System (K894278, K921460, K946227)marketed by l {1}------------------------------------------------ p. 2074 K 593154 Storz Instrument Company, and the Alcon Series 20000 Legacy marketed by Alcon Laboratories, Inc. ### Description of Device: Pharo Ophthalmic Surgery System is a class The II ophthalmic surgical system intended for use in anterior and/or posterior segment ocular surgery. Functions include Irrigation/Aspiration, Ultrasound phacoemulsification, Bipolar diathermy, pneumatic vitrectomy, pneumatic cutters scissors, air and oil infusion system, and a and illumination. The user interfaces include a foot controller and a touch screen control panel. The vaccuum system utilizes either a venturi or peristaltic pump system. Peripherals include the printer module, cart and trolley. Accessories include an electric or manual infusion pole, cutters in several models, vitrectomes in several models, diathermy forceps and pencils in several models, ultrasound handpieces in either of two models, I/A handpieces in several models, fiber optic cables for illumination in several models, air exchange sets, tubing sets, and collection cassettes. The Photolysis System is intended for use in Laser fragmentation of cataracts. The device consists of a laser console, which delivers energy by fiber optic via a disposable probe. The probe converts the laser light energy into acoustic energy, which is used to fragment the crystalline lens. The system is controlled by push buttons on the front panel and via footswitch. Irrigation/aspiration is provided by the Pharo system. Accessories include the laser photolysis probe and a dedicated irrigation handpiece. #### Intended Use: The Pharo Ophthalmic Surgery System is intended for use in anterior and posterior segment ocular surgery. The Laser Photolysis System is intended for use in fragmentation and removal of the cataractous crystalline lens. # Technological Characteristics/Device Comparison: The Pharo Opthalmcic Surgery System is substantially equivalent to the 20000 Series Legacy marketed by Alcon Laboratories, Inc., the Premiere Microsurgical System manufactured by Storz Instrument Company and the Accuras 2 {2}------------------------------------------------ Photo Ophthalmic Surgery System/Laser Photolysis System A R C. Laser K993/54 p 3 of 4 manufactured by Alcon Laboratories, Inc. Each is intended for anterior and posterior segment op: ******* surgery. Each incorporates an infusion/aspiration syster, sitrasound phacoemulsification via elecronically driven handpieces incorporating piezo-electric transducers, pneumatically driven vitrectomy attachments, and bipolar diathermy. Each allows programming by several surgeons. Re-usable, resterilizable attachments and accessories are available with each system. Both the Pharo and the Accuras utilize viscous fluid control systems for silicone oil infusion during posterior segment surgery. Photolysis System utilizes a photoacoustic The Laser transducer to achieve phacofragmentation. An Nd:YAG laser system fires laser pulses of approximately 7 nanoseconds duration, which are deliverd by fiber optic to a titanium target in the disposable handpiece. Laser energy at a wavelength of 1064 nm is generated at energy levels of 6 to 10 millijoules per pulse, at repetion rates up to 20 Hz. Each pulse of laser energy causes plasma formation within the probe and results in the emission of shock waves from the opening in the probe tip. The shock wave energy is used to fragment the lens. The laser energy emitted from the probe tip places the device in Class one, as defined in 21 CFR 1040.10(b) (5). No health risks have been identified for this level of radiation. The Laser Photolysis System is substantially equivalent to Premiere Microsurqical System Marketed marketed by Storz Instrument Company and the Alcon 20000 Series Legacy marketed by Alcon Laboratories, Inc. - Each device is intended for fragmentation and removal of the cataractous crystalline lens. Each device uses acoustic shock waves to break up the lens, then aspirates the material through the same probe. The materials, warnings, side effects, and methods are all substantially the same. #### Conclusion: The Pharo Ophthalmic Surqical System is substantially equivalent to the 20000 Series Legacy marketed by Alcon Laboratories, Inc., the Accuras marketed by Alcon Laboratores, and the Premiere Microsurgical System marketed by Storz Instrument Company, already legally marketed. The materials, design, intended use, surgical methods, and labeling are all substantially the same, and no new questions of Safety and Effectiveness arise. 3 {3}------------------------------------------------ Pharo Ophthalmic Surgery System/Laser Photolysis System A.R.C. Laser K99 3/54 g. 4 of 4 4 The Laser Photolysis System is substantıarıy equivalent to the 20000 Series Legacy marketed by Alcor an ratories, Inc. and the Premiere Microsurgical Syster → Reted by Storz Instrument Company, already legally marketed. The materials, intended use, surgical methods, and labeling are all substantially the same. The technological difference in the Laser Photolysis System does not raise new questions of Safety and Effectiveness, and/or equivalence is demonstrated by performance data. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the eagle. The text is arranged in a circular fashion around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the bottom and "USA" at the top. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUN 2 9 2000 Mr. Daniel Hoefer Regulatory Affairs Manager A.R.C. Laser Corporation 2417 South 3850 West Salt Lake City, Utah 84120 K993154 Re: > Trade Name: Pharo Ophthalmic Surgery System Laser Photolysis System Regulatory Class: II Product Code: GEX, HQC Dated: April 7, 2000 Received: April 10, 2000 Dear Mr. Hoefer: 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 action. In addition, FDA may publish further announcements 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. {5}------------------------------------------------ Page 2 - Mr. Daniel Hoefer This letter will allow you to begin marketing your device as described in your 510(k) I mis letter will anow you to obja finding of substantial equivalence of your device to a premarket notification. The PDF Intellis 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 If you dosire specific an vitro diagnostic devices), please contact the Office of and additionally 009:10 10. 10. 10. 10. 10. 10. 10. 10. 10. 10. 10. 10. Compliance at (301) 59 ce, please contact the Office of Compliance at (301) 594-4639. advertising of your arregulation entitled, "Misbranding by reference to premarket Anotification" (21 CFR 807.97). Other general information on your responsibilities under the notification (21 OF IC 0077) buision of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Russell Sage Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ - ## 510(K) Number (11 known): K993154 LASER Photolysis System Pharo Ophthalmic Survery System Device Name:_2_ # Indications For Use: - The Laser Photolysis System is indicated for use in 1. The Baser Thocoryous by our the cataractous crystalline lens. - The Pharo Ophthalmic Surgery System is indicated for use 2. The Fiaro Ophunande Bargory bjearactous crystalline lens, in phacorrag. Show posterior ophthalmic surgery. # (Please do not write Below This Line-Continue ON ANOTHER PAGE IF NEEDED) Conourrenoe of CDRH, Office of Devioe Evaluation (ODE) Nureli Jayan (Division Sign-Off) Division of General Restorative Devices 16953154 510(k) Number _ Presoription Use Counter Use (Por 21 CFR 801.100) OR Over-The- (Optional Format