Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 9, 2022 Iridex Corporation Bill Hyatt Director of Regulatory Affairs 1212 Terra Bella Ave. Mountain View, CA 94043 Re: K223132 Trade/Device Name: Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532 nm and 577 nm models) Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HOF Dated: September 23, 2022 Received: October 3, 2022 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 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 {1}------------------------------------------------ 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 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-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 Advice (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, # Anjana Jain -S Anjana Jain, PhD 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) K223132 #### Device Name Iridex PASCAL® 532. Iridex PASCAL® 577, and Iridex PASCAL® (532 nm and 577 nm models) Indications for Use (Describe) Intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: (532nm) - · proliferative and non-proliferative diabetic retinopathy - macular edema - · choroidal neovascularization associated with wet age-related macular degeneration - · age-related macular degeneration - lattice degeneration - retinal tears and detachments #### (577nm) - · proliferative and non-proliferative diabetic retinopathy - · macular edema - choroidal neovascularization associated with wet age-related macular degeneration - · age-related macular degeneration - lattice degeneration - · retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: (532 nm and 577nm) - · iridotomy - · trabeculoplasty | 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. 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle made of dots on the left and the word "IRIDEX" in purple on the right. The circle is half-filled with a solid purple color, and the other half is made of dots. # 510(k) SUMMARY; K223132 ## 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: November 09, 2022 ## Device Name and Classification | Common Name: | Ophthalmic Laser | |-------------------|------------------------------------------| | Proprietary Name: | Iridex PASCAL® 532 | | Proprietary Name: | Iridex PASCAL® 577 | | Proprietary Name: | Iridex PASCAL® (532 nm and 577nm models) | | Classification Name: | Laser, Ophthalmic | |----------------------|-------------------| | Product Code: | HQF | | Regulation Number: | 21 CFR 886.4390 | | Device Class: | II | ## Predicate Device | Laser Console | | |---------------|------------------------------------------------------------------| | Company: | Iridex Corporation | | Device: | PASCAL® Synthesis™ Ophthalmic Scanning Laser System<br>(K123542) | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle made of dots on the left, followed by the word "IRIDEX" in a dark blue sans-serif font. The circle is only half-filled in with purple, and the dots are arranged in a semi-circular pattern. #### Intended Use A laser system console with an integrated slit lamp. The system connects to the slit lamp to enable laser energy to be delivered through the slit lamp illumination path. The system may be used for standard single shot photocoagulation and laser scanning patterns. The system enables the physician to deliver multiple laser spots with a single footswitch depression by automating the emission of laser light. The aiming beam displays the pattern, allowing the physician to place it in the appropriate location. #### Indications for Use Intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: #### (532nm) - proliferative and non-proliferative diabetic retinopathy ● - . macular edema - . choroidal neovascularization associated with wet age-related macular degeneration - . age-related macular degeneration - . lattice degeneration - . retinal tears and detachments #### (577nm) - . proliferative and non-proliferative diabetic retinopathy - macular edema - choroidal neovascularization associated with wet age-related macular degeneration . - age-related macular degeneration . - . lattice degeneration - . retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: #### (532 nm and 577nm) - iridotomy . - trabeculoplasty . {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle on the left side with a dotted outline. To the right of the circle is the word "IRIDEX" in a dark purple sans-serif font. The logo is simple and modern. #### Device Description The Iridex PASCAL® (532 nm and 577 nm models) is an ophthalmic scanning laser system. PASCAL is an acronym for Pattern SCAn Laser. The system can perform single shot photocoagulation as is performed conventionally. In addition, the system is equipped with proprietary laser scanning technology that provides the user with the option to perform laser pattern scanning. This allows the user to place many laser treatment spots in a patient's eye rapidly by performing pattern scan laser photocoagulation. The system will scan user-selectable patterns of laser spots into a patient's eye. The system includes a table for housing the laser module and associated electronics. A slit lamp is also integrated in the table enabling the interface to be at the base of the slit lamp, i.e., no external cabling. The table is smaller in size compared to prior versions to accommodate use in smaller rooms. In addition to single shot and pattern scanning the system also supports the use of a Laser Indirect Ophthalmoscope (LIO) with optical fiber port for connection of a LIO. The system is available with either 532nm or 577nm laser emission. #### Comparison of Technological Characteristics with the Predicate Device A risk management analysis was conducted in accordance with standard EN ISO 14971. The following table provides a comparison of Technological Characteristics of the SUBJECT device (Iridex PASCAL® 532 and Iridex PASCAL® 577) to the PREDICATE Device (PASCAL® Synthesis™ Ophthalmic Scanning Laser System). The technological characteristics of the SUBJECT device (laser console) 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 purple circle on the left, with a series of dots forming the left half of the circle. To the right of the circle is the word "IRIDEX" in purple, with each letter capitalized. | Characteristic | PASCAL® Synthesis™<br>Ophthalmic Scanning Laser System<br>(Predicate Device) | Iridex PASCAL®<br>(532 nm and 577 nm models)<br>(Subject Device) | Bearing on<br>Substantial<br>Equivalence | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------| | | Intended Use and Indications for Use | | | | Intended Use<br>and Indications<br>for Use | <b>Intended Use:</b><br>A laser system console with an integrated slit lamp. The<br>system connects to the slit lamp to enable laser energy to be<br>delivered through the slit lamp illumination path. The system<br>may be used for standard single shot photocoagulation and<br>laser scanning patterns.<br><br>The system enables the physician to deliver multiple laser<br>spots with a single footswitch depression by automating the<br>emission of laser light. The aiming beam displays the pattern,<br>allowing the physician to place it in the appropriate location.<br><br><b>Indications for Use:</b><br>Intended for use in the treatment of ocular pathology in both<br>the posterior and anterior segments.<br><br>Intended for use in the posterior segment to perform retinal<br>photocoagulation, panretinal photocoagulation, focal<br>photocoagulation and grid photocoagulation for vascular and<br>structural abnormalities of the retina and choroid including:<br>(532nm)<br>proliferative and non-proliferative diabetic retinopathy macular edema choroidal neovascularization associated with wet age-<br>related macular degeneration age-related macular degeneration lattice degeneration retinal tears and detachments (577nm) proliferative and non-proliferative diabetic retinopathy macular edema choroidal neovascularization associated with wet age-<br>related macular degeneration age-related macular degeneration lattice degeneration retinal tears and detachments Intended for use in the treatment of ocular pathology in the<br>anterior segment including:<br>(532 nm and 577nm) iridotomy trabeculoplasty | Identical (no change)<br>Note: There is no proposed<br>change with respect to<br>Intended Use and Indications<br>for Use. | Substantially<br>Equivalent | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle with a dotted outline on the left, followed by the word "IRIDEX" in a bold, sans-serif font. The color of the text is also purple, matching the color of the circle. | Characteristic | PASCAL® Synthesis™<br>Ophthalmic Scanning Laser System<br>(Predicate Device) | Iridex PASCAL®<br>(532 nm and 577 nm models)<br>(Subject Device) | Bearing on<br>Substantial<br>Equivalence | | | | | | | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--|--|--|--|--|--| | Where the<br>device is used | Professional Healthcare Facility Environment<br>• Physician offices, clinics, multiple treatment facilities,<br>hospitals except for near active HF surgical equipment<br>and the RF shielded room of an ME system for magnetic<br>resonance imaging, where the intensity of EM<br>disturbances is high | Identical (no change) | Substantially<br>Equivalent | | | | | | | | Design/Technological Characteristics | | | | | | | | | | | Operating<br>Principles | A laser system console with an integrated slit lamp. The system<br>connects to the slit lamp to enable laser energy to be delivered<br>through the slit lamp illumination path. The system may be used for<br>standard single shot photocoagulation and laser scanning patterns<br>The system enables the physician to deliver multiple laser spots with<br>a single footswitch depression by automating the emission of laser<br>light. The aiming beam displays the pattern, allowing the physician<br>to place it in the appropriate location. | Identical (no change) | Substantially<br>Equivalent | | | | | | | | Laser Type | Optically Pumped Semiconductor Laser (OPSL) (Treatment)<br>Laser Diode (Aiming) | Identical (no change) | Substantially<br>Equivalent | | | | | | | | Output<br>Wavelength | • 532 nm or 577 nm (Treatment)<br>• 635 nm (Aiming) | Identical (no change) | Substantially<br>Equivalent | | | | | | | | Output Mode | Continuous-Wave | Identical with addition of<br>MicroPulse® | Substantially<br>Equivalent | | | | | | | | Electrical VAC | 100-240 VAC, 50/60 Hz | Identical (no change) | Substantially<br>Equivalent | | | | | | | | Electrical<br>Current | < 10 Amperes | Identical (no change) | Substantially<br>Equivalent | | | | | | | | User Interface | • Touchscreen LCD Control Panel,<br>• Slit Lamp,<br>• Micro Manipulator (slit lamp),<br>• Power Knob (slit lamp),<br>• 3D Controller (optional),<br>• Footswitch (wired) | Identical with the following<br>changes:<br>• addition of Wireless<br>Footswitch as an optional<br>accessory,<br>• the removal of 3D<br>Controller as an option | Substantially<br>equivalent | | | | | | | | Laser<br>Activation | Footswitch (wired) | Identical with addition of<br>Wireless Footswitch as an<br>optional accessory | Substantially<br>Equivalent | | | | | | | | Performance | | | | | | | | | | | Treatment<br>wavelength<br>(Nominal) | • 532 nm for 532 model<br>• 577 nm for 577 model | Identical (no change) | Substantially<br>Equivalent | | | | | | | | Aiming beam<br>wavelength<br>(Nominal) | 635 nm | Identical (no change) | Substantially<br>Equivalent | | | | | | | | Power Output<br>(mW) | • 0 to 2000 mW (Treatment)<br>• Adjustable 0 to <1 mW (Aiming) | Identical (no change) | Substantially<br>Equivalent | | | | | | | | Duty Cycle | 100% | Enable a variable Duty Cycle<br>with no change to maximum<br>duty cycle (i.e., no change to<br>the maximum percentage of<br>100%) | Substantially<br>Equivalent | | | | | | | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle made of dots on the left, followed by the word "IRIDEX" in purple. The font is sans-serif and the letters are evenly spaced. | Characteristic | PASCAL® Synthesis™<br>Ophthalmic Scanning Laser System<br>(Predicate Device) | Iridex PASCAL®<br>(532 nm and 577 nm models)<br>(Subject Device) | Bearing on<br>Substantial<br>Equivalence | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------| | Pulse duration | 10 ms to 1000 ms | Maintain maximum pulse (1000ms) while enabling the<br>lower end of the pulse range.<br>The enabled exposure time<br>range is 0.05ms -1000ms | Substantially<br>Equivalent | | Pulse Interval | 1, 1.5, 2, 3, 4, 5, 6, 7 and 8 Hz (single spot or LIO) | Identical (no change) | Substantially<br>Equivalent | | Pulse Counter | 0 – 99,999 | Identical (no change) | Substantially<br>Equivalent | | Laser Beam<br>diameter | 50, 100, 200, 400 μm (in air) | 400 μm was replaced with 300 μm | Substantially<br>Equivalent | | Compatibility | | | | | Compatible<br>Delivery<br>Devices | Laser Indirect Ophthalmoscopes (LIO) | Identical (no change) | Substantially<br>Equivalent | | Packaging & Sterilization | | | | | Packaging &<br>Sterilization | • Supplied non-sterile.<br>• Shipping packaging has been designed to safely transport<br>the device to end user facility | Change to packaging design<br>and materials that was<br>validated per ISTA 3B | Substantially<br>Equivalent | #### Performance Data The following table summarizes nonclinical testing relevant to the Iridex PASCAL® 532 and Iridex PASCAL® 577 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 logo for IRIDEX. The logo consists of a purple circle on the left, with a dotted outline. To the right of the circle is the word "IRIDEX" in purple, sans-serif font. | Verification/ Validation 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 appliable clauses of IEC 60601-1 | | IEC 60601-1-2 EMI/EMC | Meet IEC 60601-1-2 Requirements | PASS.<br>The unit met the requirements of appliable clauses of IEC 60601-1-2. | | IEC 60601-1-6 Usability | Meet the requirements of the appliable clauses IEC 60601-1-6 | PASS.<br>Device meets requirements of appliable clauses of IEC 60601-1-6 | | IEC 60601-2-22 Laser Safety | Meet all appliable IEC 60601-2-22 test items except for EMC, Biocompatibility | PASS.<br>Device meets requirements of appliable clauses of IEC 60601-2-22. | | IEC 60825-1 Laser Safety | Meet appliable IEC 60825-1 requirements | PASS.<br>Device meets IEC 60825-1 Requirements | | IEC 62304, Medical device software, Software life-cycle processes | Software lifecycle processes and activities meet requirements of appliable clauses of IEC 62304 | PASS<br>Software lifecycle processes and activities meet IEC 62304 Requirements | | Shipping and Packaging Testing | Meet ISTA 3B Testing and Acceptance Requirements for:<br>• Climatic Conditioning-Package<br>• Climatic Conditioning-Product<br>• Atmospheric Preconditioning<br>• Shock (First Sequence)<br>• Vertical Vibration (Random Vibration with Top Load)<br>• Shock (Second Sequence)<br><br>Meet Iridex performance specifications pre- and post-conditioning testing. | PASS.<br>Test unit passed ISTA-3B conditioning and testing (Westpak testing)<br><br>Test unit passed Iridex performance testing Pre-and Post-conditioning (Iridex testing). | #### Conclusions The Iridex PASCAL® (532 nm and 577 nm models) (SUBJECT device) shares identical Intended Use, Indications for Use, Principles of Operation (technology) including energy source, Design/Technological Characteristics, and Performance, as the PASCAL® Synthesis™ Ophthalmic Scanning Laser System (PREDICATE device), all of which do not raise new questions of safety and effectiveness. The proposed SUBJECT device is at least as safe and effective as the legally marketed predicate device.