Iridex 810 Laser

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG" are stacked on top of the word "ADMINISTRATION". October 21, 2020 Iridex Corporation Bill Hyatt Director of Regulatory Affairs 1212 Terra Bella Ave. Mountain View, CA 94043 Re: K202760 Trade/Device Name: Iridex 810 Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF, GEX Dated: September 16, 2020 Received: September 21, 2020 Dear Bill Hyatt: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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. 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You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for LT Charles Chiang Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K202760 Device Name Iridex 810 Laser #### Indications for Use (Describe) The Iridex 810 Laser is indicated for retinal photocoagulation, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the Iridex 810 Laser. #### CONDITION #### TREATMENT | Diabetic Retinopathy<br>• Nonproliferative Retinopathy<br>• Macular Edema<br>• Proliferative Retinopathy | Panretinal Photocoagulation (PRP);<br>Focal and Grid Laser Treatments | |----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | Glaucoma<br>• Primary Open Angle<br>• Closed Angle<br>• Refractory Glaucoma (recalcitrant/uncontrolled) | Laser Trabeculoplasty; Iridotomy;<br>Transscleral Cyclophotocoagulation (TSCPC) | | Retinal Tears, Detachments, and Holes | Transscleral Retinal Photocoagulation (TSRPC);<br>Focal and Grid Laser Treatments | | Lattice Degeneration | PRP; Focal and Grid Laser Treatments | | Age-Related Macular Degeneration (AMD) | Focal and Grid Laser Treatments | | Intra-Ocular Tumors<br>• Choroidal Hemangioma<br>• Choroidal Melanoma<br>• Retinoblastoma | Focal and Grid Laser Treatments | | Retinopathy of Prematurity | PRP; TSRPC; Focal and Grid Laser Treatments | | Sub-Retinal (choroidal) Neovascularization | Focal and Grid Laser Treatments | | Central and Branch Retinal Vein Occlusion | PRP; Focal and Grid Laser Treatments | Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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. 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The emblem features a stylized white flower-like design inside a blue circle with a black border. # 510(k) SUMMARY K202760 ### Submitter Information | Company: | Iridex Corporation<br>1212 Terra Bella Ave<br>Mountain View, CA 94043-1824<br>Phone: (650) 940-4700<br>Fax: (650) 355-1305<br>Establishment Registration No.: 2939653 | | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Contact Person: | Bill Hyatt<br>Director, Regulatory Affairs<br>Phone: (650) 605-8727<br>Fax: (650) 940-4710 | | | Date Prepared: | October 20, 2020 | | | Device Name and Classification | | | | Common Name: | Ophthalmic Laser, Powered Laser Surgical | | | Proprietary Name: | Iridex 810 Laser | | | Classification Name: | Laser, Ophthalmic | | | Common Name: | Ophthalmic Laser, Powered Laser Surgical Instrument | |----------------------|-----------------------------------------------------| | Proprietary Name: | Iridex 810 Laser | | Classification Name: | Laser, Ophthalmic | | Product Code: | HQF, GEX | | Regulation Number: | 21 CFR 886.4390, 21 CFR 886.4810 | | Device Class: | II | ### Predicate Device | Company: | Iridex Corporation | |----------|------------------------------------------| | Device: | OcuLight SL/SLx, Model # 13030 (K020374) | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a blue circle with a white flower-like design inside, followed by the word "IRIDEX" in bold, black letters. The logo is simple and professional, and the use of blue and white gives it a clean and modern look. ### Intended Use (Indications for Use) The Iridex 810 Laser is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the Iridex 810 Laser. | Condition | Treatment | |------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | Diabetic Retinopathy<br>• Nonproliferative Retinopathy<br>• Macular Edema<br>• Proliferative Retinopathy | Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments | | Glaucoma<br>• Primary Open Angle<br>• Closed Angle<br>• Refractory Glaucoma<br>(recalcitrant/uncontrolled) | Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation (TSCPC) | | Retinal Tears, Detachments, and Holes | Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments | | Lattice Degeneration | PRP; Focal and Grid Laser Treatments | | Age-Related Macular Degeneration (AMD) | Focal and Grid Laser Treatments | | Intra-Ocular Tumors<br>• Choroidal Hemangioma<br>• Choroidal Melanoma<br>• Retinoblastoma | Focal and Grid Laser Treatments | | Retinopathy of Prematurity | PRP; TSRPC; Focal and Grid Laser Treatments | | Sub-Retinal (choroidal) Neovascularization | Focal and Grid Laser Treatments | | Central and Branch Retinal Vein Occlusion | PRP; Focal and Grid Laser Treatments | ### Device Description The Iridex 810 Laser system is comprised of a laser console with footswitch and an optical fiber delivery device. The laser console contains two laser diodes (810 nm for Treatment and 650 nm for Aiming beam), imaging optics, power supply, control electronics, and software/embedded firmware (with microprocessor). Lasing can only be initiated from the footswitch. Optical fiber Delivery Devices are provided separately. The following tables shows compatible delivery devices: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for IRIDEX. The logo consists of a circular emblem on the left and the word "IRIDEX" in bold, black capital letters on the right. The emblem features a blue and white floral design inside a blue circle with a thin black border. | Delivery Device | CW-Pulse | MicroPulse | |-----------------------------------------------------------|----------|------------| | Slit Lamp Adapter (SLA) | ● | ● | | Large Spot Slit Lamp Adapter<br>(LS-SLA) | ● | | | TruFocus LIO+ | ● | ● | | Large Spot TruFocus LIO+ | ● | | | Endoprobe Family | ● | ● | | G Probe | ● | | | Operating Microscope Adapter<br>(OMA) | ● | | | MicroPulse P3 (MP3) Family<br>(cleared under K162416) | | ● | | G Probe and G Probe Illuminate<br>(cleared under K162416) | ● | | ### Delivery Device Compatibility with Iridex 810 Laser ### Comparison of Technological Characteristics with the Predicate Device The Iridex 810 Laser (SUBJECT device) is modified from the PREDICATE device to address component obsolescence and to update the user interface to include a color touchscreen (replace LED interface) with a keyboard. Additionally, the range of compatible delivery devices was increased to include delivery devices have been marketed subsequent to the introduction of the PREDICATE device. The following table provides a comparison of Technological Characteristics of the SUBJECT device (Iridex 810 Laser) to the PREDICATE Device (Iris Medical OcuLight SL/SLx). The technological characteristics of the SUBJECT device (Iridex 810 Laser) are substantially equivalent to those of the predicate device. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a blue circular emblem on the left and the word "IRIDEX" in bold, black letters on the right. The emblem features a white floral design with three petals inside a blue circle. | Characteristic | OcuLight SLx<br>(Predicate Device) | Iridex 810 Laser<br>(Subject Device) | Bearing on<br>Substantial<br>Equivalence | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Intended Use and Indications for Use | | | | Intended Use<br>and Indications<br>for Use | Indicated for retinal photocoagulation, laser<br>trabeculoplasty, transscleral cyclophotocoagulation,<br>transscleral retinal photocoagulation, and other diode<br>laser treatments. The following are examples of<br>applications for the Iridex 810 Laser system. | Identical (no change) | Substantially<br>Equivalent | | | Condition | Treatment | | | | Diabetic Retinopathy<br>• Nonproliferative<br>Retinopathy<br>• Macular Edema<br>• Proliferative<br>Retinopathy | Panretinal<br>Photocoagulation (PRP);<br>Focal and Grid Laser<br>Treatments | | | | Glaucoma<br>• Primary Open Angle<br>• Closed Angle<br>• Refractory Glaucoma<br>(recalcitrant/<br>uncontrolled) | Laser Trabeculoplasty;<br>Iridotomy; Transscleral<br>Cyclophotocoagulation<br>(TSCPC) | | | | Retinal Tears,<br>Detachments, and Holes | Transscleral Retinal<br>Photocoagulation<br>(TSRPC); Focal and Grid<br>Laser Treatments | | | | Lattice Degeneration | PRP; Focal and Grid Laser<br>Treatments | | | | Age-related Macular<br>Degeneration (AMD) | Focal and Grid Laser<br>Treatments | | | | Intra-Ocular Tumors<br>• Choroidal Hemangioma<br>• Choroidal Melanoma<br>• Retinoblastoma | Focal and Grid Laser<br>Treatments | | | | Retinopathy of Prematurity | PRP; TSRPC; Focal and<br>Grid Laser Treatments | | | | Sub-Retinal (choroidal)<br>Neovascularization | Focal and Grid Laser<br>Treatments | | | | Central and Branch Retinal<br>Vein Occlusion | PRP; Focal and Grid Laser<br>Treatments | | | Where the<br>device is used | Physician's office, hospital operating room and ambulatory<br>surgical center setting hospital, eye clinic or doctor's exam<br>room | Identical (no change) | Substantially<br>Equivalent | | Characteristic | OcuLight SLx<br>(Predicate Device) | Iridex 810 Laser<br>(Subject Device) | Bearing on<br>Substantial<br>Equivalence | | | Principles of Operation (technology) | | | | Technological<br>Characteristics | The light energy delivered for treatment is from an 810nm<br>semiconductor laser source, with up to 5W of output power,<br>with an NA of 0.11<br><br>The light is delivered to the treatment site with fiber optic<br>treatment probes<br><br>The power source for the console is standard utility outlets | Identical (no change) | Substantially<br>Equivalent | | | Design/Technological Characteristics | | | | Operating<br>Principles | A laser console that plugs into standard utility outlets,<br>connects to a footswitch for activation control and uses a<br>delivery probe attached to the probe port to deliver the light.<br>The console has a user interface to adjust system settings. | Identical (no change) | Substantially<br>Equivalent | | Design<br>Characteristics | Hardware:<br>A sheet metal enclosure with front bezel and back panel. An<br>approved power supply, control board, diode driver, diode,<br>user interface, power cord and foot switch<br><br>Repetition rate: <50Hz<br><br>Laser activation: Footswitch<br><br>Cooling System: Air Cooled | Identical (no change) | Substantially<br>Equivalent | | Output Mode | CW (including LongPulse duration) and MicroPulse | Identical (no change) | Substantially<br>Equivalent | | Electrical VAC | 100-240VAC, 50/50Hz | Identical (no change) | Substantially<br>Equivalent | | Electrical<br>Current | <4amps | Identical (no change) | Substantially<br>Equivalent | | User Interface | Knobs on Laser Console, Remote Control, Footswitch | Touchscreen with<br>Keyboard, Knobs on<br>Laser Console,<br>Remote Control,<br>Footswitch | Addition of a<br>touchscreen is for<br>user convenience, no<br>change to<br>performance.<br><br>Substantially<br>equivalent | | Laser<br>Activation | Footswitch | Identical (no change) | Substantially<br>Equivalent | | Performance | | | | | Treatment<br>wavelength<br>(Nominal) | 810nm Infrared (IR) Diode | Identical (no change) | Substantially<br>Equivalent | | Aiming beam<br>wavelength<br>(Nominal) | 650 nm | Identical (no change) | Substantially<br>Equivalent | | Maximum<br>treatment laser<br>power | 3 W | Identical (no change) | Substantially<br>Equivalent | | Continuous<br>Wave duration | 10ms-10s | Identical (no change) | Substantially<br>Equivalent | | MicroPulse<br>duration | 10us - 1000us | Identical (no change) | Substantially<br>Equivalent | | Characteristic | OcuLight SLx<br>(Predicate Device) | Iridex 810 Laser<br>(Subject Device) | Bearing on<br>Substantial<br>Equivalence | | Compatible<br>Delivery<br>Devices | IR Laser Indirect Ophthalmoscope (LIO)<br>Large Spot (LS) LIO<br>Dual LIO<br>EndoProbes<br>G-Probe / TS-600<br>MicroPulse P3 Family<br>Slit Lamp Adapter (SLA)<br>LS SLA<br>Symphony SLA<br>Symphony 2 SLA<br>Operating Microscope Adapter (OMA) | IR Laser Indirect Ophthalmoscope (LIO)<br>Large Spot (LS) LIO<br>Dual LIO<br>EndoProbes<br>DioPexy Probe<br>G-Probe / TS-600<br>Slit Lamp Adapter (SLA)<br>LS SLA<br>Symphony SLA<br>Symphony 2 SLA<br>Operating Microscope Adapter (OMA) | The MicroPulse P3 Family of probes and the G-Probe<br>Illuminate probes are added, both cleared for use with other Iridex 810 Laser consoles under K162416.<br><br>The DioPexy probe has been discontinued and so the subject device does not identify compatibility to the DioPexy.<br><br>Substantially<br>Equivalent | | Materials | | | | | Materials | Sheet metal, approved plastic for the bezel material, standard electronics, laser diode. No liquids or hazardous materials | Identical (no change) | Substantially<br>Equivalent | | Packaging & Sterilization | | | | | Packaging &<br>Sterilization | The device is supplied non-sterile.<br><br>Shipping packaging has been designed to safely transport the device to end user facility | Identical (no change) | Substantially<br>Equivalent | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a blue and white circular emblem on the left, followed by the word "IRIDEX" in bold, black capital letters. The emblem features a stylized white floral design within a blue circle, surrounded by a thin black border. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a blue circular emblem on the left and the word "IRIDEX" in bold, black letters on the right. The emblem features a stylized white flower with three petals inside a blue circle with a black border. A small "R" in a circle is located at the bottom right of the emblem, indicating a registered trademark. ### Performance Data The following table summarizes nonclinical testing performed on the Iridex 810 Laser System in accordance with the requirements of the design control regulations and established quality assurance procedures. Clinical testing was not required for this product change. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "IRIDEX" in a bold, sans-serif font. To the left of the word is a circular logo with a blue and white flower-like design inside. The logo also includes the registered trademark symbol. | Verification/ Validation<br>Method(s) | Acceptance Criteria | Summary of Results | |-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | IEC 60601-1 Electrical Safety | Meet appliable clauses of IEC 60601-1 | PASS.<br>Device meets requirements of<br>appliable clauses of IEC 60601-1 | | IEC 60601-2-22 Laser Safety | Meet all appliable IEC 60601-2-22 test<br>items except for EMC, Biocompatibility | PASS.<br>Device meets requirements of<br>appliable clauses of IEC 60601-2-22. | | IEC 60825-1 Laser Safety | Meet appliable IEC 60825-1<br>requirements | PASS.<br>Device meets IEC 60825-1<br>Requirements | | IEC 60601-1-2 EMI/EMC | Meet IEC 60601-1-2 Requirements | PASS.<br>The unit met the requirements of<br>appliable clauses of IEC<br>60601-1-2. | | IEC 60601-1-6:2010,<br>AMD1:2013<br>(Usability) | Meet the requirements of the appliable<br>clauses IEC 60601-1-6 | PASS.<br>Device meets requirements of<br>appliable clauses of IEC 60601-1-6 | | IEC 62304,<br>Medical device software,<br>Software life-cycle processes | Software lifecycle processes and<br>activities meet requirements of appliable<br>clauses of IEC 62304 | PASS<br>Software lifecycle processes and<br>activities meet IEC 62304<br>Requirements | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a circular emblem on the left and the word "IRIDEX" in bold, black capital letters on the right. The emblem features a blue and white stylized floral design within a blue circle, with a small "R" in a circle at the bottom. | Verification/ Validation<br>Method(s) | Acceptance Criteria | Summary of Results | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Shipping and Packaging<br>Testing:<br>ISTA 1A Procedure:<br>• Vibration, Fixed Displacement<br>Performed as follows:<br>10-500 Hz<br>30 minutes/axis, three axes<br>• Shock Drop<br>Performed as follows:<br>24" Drop on Corner, Edges (1-<br>3) and Face (1-6)<br>Power measurement (at 50%<br>Duty Cycle), per product release<br>test procedures.<br>Measurement of current, per<br>product release test procedures.<br>Visual Inspection, per product<br>release test procedures.<br>Product functional inspection,<br>per product release test<br>procedures | ISTA 1A Procedure is Performed<br>Measurement of console power (at 50%<br>Duty Cycle) conforms to product release<br>specifications in pre- and post-ISTA 1A<br>Procedure testing.<br>Measurement of console current in<br>system conforms to product release<br>specifications in pre- and post-ISTA 1A<br>Procedure testing and demonstrates no<br>significant change post-1A Procedure<br>testing.<br>Product and packaging appearance<br>conform to product release<br>specifications in pre- and post-ISTA 1A<br>Procedure testing and are not observed<br>to be adversely affected by ISTA 1A<br>Procedure testing.<br>Product functions, including console and<br>footswitch interaction conform to<br>product release specifications in pre-<br>and post-ISTA 1A Procedure testing and<br>are not observed to be adversely affected<br>by ISTA 1A Procedure testing. | PASS.<br>Observed Console Power<br>Measurements, Console Current<br>Measurement, Product and<br>Packaging Appearance and<br>Product Function performed pre-<br>and post- ISTA 1A Procedure<br>Testing passed product release<br>specifications and were not<br>adversely affected by ISTA 1A<br>Procedure testing. | ### Conclusions The Iridex 810 Laser shares identical indications for use and similar design and functional features with the predicate device. The differences between the Iridex 810 Laser and the OcuLight SLx devices do not affect the safety and effectiveness of the Iridex 810 Laser device when used as labeled. Therefore, the Iridex 810 Laser is substantially equivalent to the predicate device.