NAVILAS Laser System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 22, 2016 Judy Gordon, D. V. M. Regulatory Affairs Consultant ClinReg Consulting Services, Inc. 733 Bolsana Drive Laguna Beach, CA 92651 Re: K162191 Trade/Device Name: Navilas® Laser System 577s Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and In Dermatology Regulatory Class: Class II Product Code: GEX, HKI, NFF, NFG Dated: October 17, 2016 Received: October 18, 2016 Dear Dr. Gordon: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device {1}------------------------------------------------ related adverse events) (21 CFR 803); 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. If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Kesia Alexander for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K162191 Device Name Navilas® Laser System 577s #### Indications for Use (Describe) The Navilas Laser System 577s is indicated for use: - In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser). Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Latice Degeneration, Retinal Tears and Detachments (Laser Retinopexy). - For the imaging (capture, display, storage and manipulation) of the retina of the eve, including via color and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye. - In Laser Trabeculoplasty for Primary Open Angle Glaucoma, as well as Iridotomy and Iridoplasty for Closed Angle Glaucoma. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | <div style="display:inline-block;"><span> </span><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:inline-block;"><span> </span><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | APPLICANT: | OD-OS GmbH<br>Warthestr. 21<br>14513 Teltow<br>Germany<br>Phone: +49 3328 312 82-100<br>Fax: +49 3328 312 82-999 | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | OFFICIAL<br>CORRESPONDENT: | Judy F. Gordon, D.V.M.<br>Regulatory Consultant to OD-OS GmbH<br>733 Bolsana Drive<br>Laguna Beach, CA 92561<br>Tel: (949) 715-0609<br>Fax: (949) 715-0610<br>judy@clinregconsulting.com | | DATE PREPARED: | October 17, 2016 | | TRADE NAME: | Navilas® Laser System 577s | | COMMON NAME: | Photocoagulator with a Digital Fundus Camera | | DEVICE<br>CLASSIFICATION: | Laser Instrument, Surgical, Powered<br>Class II, per 21 CFR §878.4810<br>Camera, Ophthalmic<br>Class II, per 21 CFR §886.1120<br>Device, Storage, Images, Ophthalmic<br>Class I per 21 CFR §892.2010<br>Device, Communication, Images, Ophthalmic<br>Class I per 21 CFR §892.2020 | | PRODUCT CODES: | GEX; HKI, NFF, NFG | {4}------------------------------------------------ ### SUBSTANTIAL EQUIVALENCE The Navilas Laser System 577s is substantially equivalent to the Navilas Laser System 577+ cleared under K141851. This laser model is functionally identical to the predicate Navilas laser, the same scientific technology as well as same intended use, with the exception of the elimination of the fluorescein angiography imaging capability of the predicate laser system. This model will also include hardware design improvements for manufacturability, including: - A new graphical user interface monitor and display format - Relocation of the scanner controls to inside the optical head and conversion from . motorized to manual base height adjustment - . Designation of table as an optional accessory - Inclusion of a combination objective element that can be used with commercially ● available macular, peripheral and gonioscopic contact lenses As with the predicate device, the Navilas Laser 577s is intended to aid in the diagnosis and treatment of ocular pathology of the eye. ### DESCRIPTION OF THE DEVICE The Navilas Laser 577s is a laser photocoagulator with an integrated digital fundus camera. The Navilas 577s Laser System combines imaging technologies (fundus live imaging, and infra-red imaging) with established laser photocoagulation treatment methods by providing the doctor a system for imaging and treatment planning prior to the photocoagulation. The Navilas Laser 577s is comprised of: - A semiconductor laser source that operates at 577nm. The semiconductor laser . source for the Navilas 577s is identical to the laser source used with the Navilas 577+ cleared under K141851. - An integrated delivery system that directs the laser beam through an ● ophthalmoscope using motorized mirrors. - A digital camera that provides continuous real-time imaging in color with white light illumination of the fundus, or in monochrome using infrared illumination. - A software platform intended to be used to capture display, store and manipulate . images captured by the fundus camera. The Navilas Laser System 577s supports the user during multiple steps of a laser treatment procedure with digital imaging, image storage, planning and laser treatment options including: {5}------------------------------------------------ Digital imaging as provided by a color image with white light, supporting mydratic and non-mydratic image acquisition (with and without dilated pupils), or a monochrome IR image. Images are presented using a digital display. An illumination mode is selected where images are acquired and either stored or discarded after viewing on the touch sensitive digital display. Image Storage - Captured images can be digitally stored in the Navilas Laser System 577s database along with other patient related data to create a complete patient record for future reference. Images from other devices may also be imported and stored. Planning - Areas identified on acquired or imported images by the user that are selected for future treatment consideration can be marked through the use of treatment planning tools available. The physician has the ability to highlight areas on acquired images (called Points of Interest). These locations are created and manipulated using the touch sensitive digital display. Laser Treatment - Treatment options are also unchanged from the predicate device with Single Pulse Mode. Repeat Mode and Scanned Pattern Mode available on all Navilas laser models. Pre-positioning of the aiming beam onto locations which are selected by the physician during planning is also facilitated. The position of the aiming beam can be monitored on the real-time image that is displayed on the touch sensitive digital display. Report generation - Information collected in the database includes images obtained before, during and after treatment. This information may be used for the generation of patient reports for documentation purposes. The Navilas Laser 577s can emit a 577 nm wavelength beam for photocoagulation with power up to 2000 milliwatt and pulse duration up to 4000 milliseconds. More characteristics of the device are given in the table for substantial equivalence below. The software platform is based on an embedded Windows operating system. ### INDICATION FOR USE The Navilas 577s Laser System is indicated for use: - . In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser), Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Lattice Degeneration, Retinal Tears and Detachments (Laser Retinopexy). - . For the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye. - In Laser Trabeculoplasty for Primary Open Angle Glaucoma, as well as Iridotomy and Iridoplasty for Closed Angle Glaucoma. {6}------------------------------------------------ BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE The technological characteristics of the Navilas Laser 577s are substantially equivalent to those of the predicate device | COMPARISON OF THE NAVILAS LASER PHOTOCOAGULATION TECHNOLOGY TO THE PREDICATE DEVICE | |-------------------------------------------------------------------------------------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | FEATURES AND<br>CHARACTERISTICS | OD-OS<br>NAVILAS LASER SYSTEM 577S<br>(PROPOSED) | OD-OS<br>NAVILAS LASER SYSTEM 577+<br>(K141851) | COMPARISON | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Field of Use | Ophthalmology | Ophthalmology | Same | | Laser Type | Retinal photocoagulating laser | Retinal photocoagulating laser | Same | | Indications for Use | The Navilas 577s is indicated for use:<br>In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser), Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Lattice Degeneration, Retinal Tears and Detachments (Laser Retinopexy). For the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye. | The Navilas 577+ is indicated for use:<br>In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser), Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Lattice Degeneration, Retinal Tears and Detachments (Laser Retinopexy). For the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography and infrared imaging; and for aiding in the diagnosis and treatment of ocular | No, the fluorescein angiography functionality is not offered with the proposed laser model | | FEATURES AND<br>CHARACTERISTICS | OD-OS<br>NAVILAS LASER SYSTEM 577S<br>(PROPOSED) | OD-OS<br>NAVILAS LASER SYSTEM 577+<br>(K141851) | COMPARISON | | | In Laser Trabeculoplasty for Primary<br>Open Angle Glaucoma, as well as<br>Iridotomy and Iridoplasty for Closed<br>Angle Glaucoma. | pathology in the posterior segment<br>of the eye. In Laser Trabeculoplasty for Primary<br>Open Angle Glaucoma, as well as<br>Iridotomy and Iridoplasty for Closed<br>Angle Glaucoma. | | | Laser medium | Optically pumped semiconductor laser<br>source operating at 577 nm | Optically pumped semiconductor laser<br>source operating at 577 nm | Same | | Wavelength(s) | 577 nm yellow | 577 nm yellow | Same | | Laser Output | Continuous-wave | Continuous-wave | Same | | Treatment Power | < 2000 mW | < 2000 mW | Same | | Treatment Pulse<br>Duration | 10 ms – 4000 ms<br>0.050 to 0.500 ms | 10 ms – 4000 ms<br>0.050 to 0.500 ms | Same | | Repeat Mode | Yes | Yes | Same | | Pulse Interval Time | 160 ms – 4000 ms<br>Short pulse: 0.050 to 2.000 ms | 160 ms – 4000 ms<br>Short pulse: 0.050 to 2.000 ms | Same | | Retinal Spot size | 50 μm – 500 μm | 50 μm – 500 μm | Same | | Laser Class | IV | IV | Same | | Aiming Laser Type | Semiconductor laser visible red diode | Semiconductor laser visible red diode | Same | | Wavelength | 635 nm | 635 nm | Same | | Maximum Avg.<br>Power | Adjustable to less than 1mW | Adjustable to less than 1mW | Same | | Laser Class | II | II | Same | | Power Supply | 115/230 VAC | 115/230 VAC | Same | {7}------------------------------------------------ # 510(K) SUMMAR {8}------------------------------------------------ # 510(K) SUMMAR {9}------------------------------------------------ ### PERFORMANCE DATA Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the Navilas 577s Laser System. This was accomplished by software and hardware verification & validation testing, along with system level bench testing of the Navilas Laser 577s. Software was tested in accordance with the Level of Concern (LOC) for the Navilas system software which is considered to be "major." In accordance with http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ uc m089543.htm, a Major LOC is defined as any device where a malfunction of the software of the device could result in a death or serious injury. All necessary bench testing was conducted on the Navilas Laser System 577s to support a determination of substantial equivalence to the predicate devices. The tests performed include: - . Illumination Safety - ISO 15004-2 Ophthalmic Instruments - Fundamental Requirements and Test Methods - Part 2: Light Hazard Protection - IEC 62304 Medical Device Software Software Life Cycle Process . - . Human Factors and Usability - - · Medical devices Part 1: Application of Usability Engineering to Medical Devices, IEC 62366 - · Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability, IEC 60601-1-6 - Laser Product Safety Testing -. - · Medical Electric Equipment, Part 1: General requirements for safety, IEC 60601-1 - • Medical Electrical Equipment Part 1-2: General requirements for safety (Collateral standard: electromagnetic compatibility - requirements and tests). IEC 60601-1-2 - Medical Electrical Equipment, Part 2: Particular requirements for the safety and diagnostic and therapeutic laser equipment. IEC 60601-2-22. - · Safety of Laser Products, Part 1: Equipment classification and requirements, IEC 60825-1Laser Bench testing to verify spot and patter placement accuracy. - Software Verification and Validation All criteria for this testing were met and results demonstrate that laser photocoagulation performed with the Navilas Laser 577s meets all performance specifications and requirements.