Who is the manufacturer of Iridex 810 Laser?

Iridex Corporation filed the 510(k) submission for Iridex 810 Laser (K213592).

What is the FDA product code for Iridex 810 Laser?

HQF. It is classified under 21 CFR 886.4390 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for Iridex 810 Laser?

510(k) clearance (submission type: Special).

What are the predicate devices for Iridex 810 Laser?

Iridex 810 Laser (K202760); Iridex MicroPulse P3 Delivery Device (K202760, K162416, K143154).

Who can help prepare an FDA 510(k) submission like Iridex 810 Laser?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Iridex 810 Laser

K213592 · Iridex Corporation · HQF · Mar 23, 2022 · Ophthalmic

Device Facts

Record ID	K213592
Device Name	Iridex 810 Laser
Applicant	Iridex Corporation
Product Code	HQF · Ophthalmic
Decision Date	Mar 23, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 886.4390
Device Class	Class 2
Attributes	Therapeutic

Intended 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 • Nonproliferative Retinopathy • Macular Edema • Proliferative Retinopathy Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments Glaucoma • Primary Open Angle • Closed Angle • Refractory Glaucoma (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 • Choroidal Hemangioma • Choroidal Melanoma • 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 Story

Iridex 810 Laser system; ophthalmic diode laser console; 810 nm treatment beam; 650 nm aiming beam. Used in physician offices, hospitals, and ambulatory surgical centers. System includes console, footswitch, and optical fiber delivery devices (e.g., C-Probe, G-Probe, LIOs). Console transforms electrical power into laser energy; controlled via user interface and footswitch. C-Probe delivery device features RFID tag to communicate with console, restricting operation to Continuous Wave (CW) mode. Healthcare providers use device to perform photocoagulation and cyclophotocoagulation; output affects tissue via thermal laser effects. Benefits include treatment of various retinal and glaucoma conditions. No changes to console technology; addition of C-Probe delivery device for physician preference.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation included electrical safety (IEC 60601-1), laser safety (IEC 60601-2-22, IEC 60825-1), EMI/EMC (IEC 60601-1-2), usability (IEC 60601-1-6), software lifecycle (IEC 62304), and shipping/packaging (ISTA 3A).

Technological Characteristics

810 nm semiconductor laser source; 3 W max power; 0.11 NA. Console includes imaging optics, power supply, control electronics, and microprocessor. Output modes: Continuous-Wave (10 ms-10 s) and MicroPulse (100-1000 µs). Air-cooled. Connectivity: footswitch, touchscreen, knobs, remote control. Compatible with various fiber optic delivery probes. Materials: sheet metal, plastic bezel, standard electronics.

Indications for Use

Indicated for patients requiring retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, or transscleral retinal photocoagulation for conditions including diabetic retinopathy, glaucoma, retinal tears/detachments/holes, lattice degeneration, AMD, intra-ocular tumors, retinopathy of prematurity, sub-retinal neovascularization, and retinal vein occlusion.

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Predicate Devices

Iridex 810 Laser (K202760)
Iridex MicroPulse P3 Delivery Device (K202760, K162416, K143154)

Related Devices

K202760 — Iridex 810 Laser · Iridex Corporation · Oct 21, 2020
K020374 — OCULIGHT SL/SLX · Iridex Corp · May 3, 2002
K023094 — IRIDIS OPHTHALMIC PHOTOCOAGULATOR · Quantel Medical · Dec 17, 2002
K032357 — NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES · Lumenis, Inc. · Oct 9, 2003
K040209 — IRIS MEDICAL IQ 810 PHOTOCOAGULATOR · Iridex Corp · Sep 20, 2004

Submission Summary (Full Text)

{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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. March 23, 2022 Iridex Corporation Bill Hyatt Director of Regulatory Affairs 1212 Terra Bella Ave. Mountain View, California 94043 Re: K213592 Trade/Device Name: Iridex 810 Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: February 18, 2022 Received: February 22, 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 statutes and regulations administered by other Federal agencies. 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 (OS) 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 mediation-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, Ph.D. Acting 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) K213592 Device Name Iridex 810 Laser System #### Indications for Use (Describe) 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 • Nonproliferative Retinopathy • Macular Edema • Proliferative Retinopathy | Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments | |----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | Glaucoma • Primary Open Angle • Closed Angle • Refractory Glaucoma (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 • Choroidal Hemangioma • Choroidal Melanoma • 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. 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, while the other half is made of dots. ## 510(k) SUMMARY; K213592 ## Submitter Information | Company: | Iridex Corporation 1212 Terra Bella Ave Mountain View, CA 94043-1824 Phone: (650) 940-4700 Fax: (650) 355-1305 Establishment Registration No.: 2939653 | |-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Bill Hyatt Director, Regulatory Affairs Phone: (650) 605-8727 Fax: (650) 940-4710 | Date Prepared: March 21, 2022 ## Device Name and Classification | Common Name: | Ophthalmic Laser, Powered Laser Surgical Instrument | |----------------------|-----------------------------------------------------| | Proprietary Name: | Iridex 810 Laser | | Classification Name: | Laser, Ophthalmic | | Product Code: | HQF | | Regulation Number: | 21 CFR 886.4390 | | Device Class: | II | ## Added Compatible Delivery Device: | Company: | Iridex | |----------|-------------------------| | Device: | C-Probe Delivery Device | ## Predicate Device | Laser Console | | |---------------|----------------------------| | Company: | Iridex Corporation | | Device: | Iridex 810 Laser (K202760) | Delivery Device | Company: | | |----------|--| | Device: | | Iridex Corporation MicroPulse P3 Delivery Device (K202760, K162416, K143154) {5}------------------------------------------------ Image /page/5/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 a semi-circle around it. To the right of the circle is the word "IRIDEX" in purple, with each letter capitalized. #### 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 • Nonproliferative Retinopathy • Macular Edema • Proliferative Retinopathy | Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments | | Glaucoma • Primary Open Angle • Closed Angle • Refractory Glaucoma (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 • Choroidal Hemangioma • Choroidal Melanoma • 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 mm 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 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, sans-serif font. The circle is partially filled in with a solid purple color, creating a semi-circular shape. | Compatibility with Iridex 810 Laser (SUBJECT Device) | | | Compatibility with Iridex 810 Laser (PREDICATE Device) | | | | |----------------------------------------------------------------|----------|------------|--------------------------------------------------------------|----------|------------|------------| | Delivery Device | CW-Pulse | MicroPulse | LongPulse* | CW-Pulse | MicroPulse | LongPulse* | | EndoProbe Handpieces | • | • | | • | • | | | G-Probe (cleared under K162416) | | | | | | | | • G-Probe Standard | • | | | • | | | | • G-Probe Illuminate | • | | | • | | | | • TS-600 for Veterinary Use | • | | | • | | | | Laser Indirect Ophthalmoscopes (LIO) | | | | | | | | Iridex LIO Plus (Single-Mirror) | | | | | | | | • Standard 810 nm | • | • | | • | • | | | • Dual 810/532 nm | • | • | | • | • | | | • Large Spot 810 nm | • | | • | • | | • | | TruFocus LIO Premiere (Dual Mirror) | | | | | | | | • Standard 810 nm | • | • | | • | • | | | • Dual 810/532 nm | • | • | | • | • | | | • Large Spot 810 nm | • | | • | • | | • | | MicroPulse P3 (MP3) Probe Family (cleared under K162416) | | • | | | • | | | Operating Microscope Adapter (OMA) | • | | • | • | | • | | Slit Lamp Adapters (SLA) | | | | | | | | • Standard 810 nm | • | • | | • | • | | | • Large Spot 810 nm | • | | • | • | | • | | C-Probe (SUBJECT Compatible Delivery Device) | • | | | | | | ## Delivery Device Compatibility with Iridex 810 Laser * "LongPulse" is a function of Continuous Wave distinguished for marketing purposes to identify Continuous Wave exposure durations in excess of 9 seconds for large spot delivery devices. The proposed Iridex 810 Laser Operator Manual may not identify "LongPulse" but retains and identifies the function through Continuous Wave exposure durations in excess of 9 seconds for large spot delivery devices. {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 a semi-circle around it. To the right of the circle is the word "IRIDEX" in purple, with each letter in a bold, sans-serif font. #### Comparison of Technological Characteristics with the Predicate Device There are no proposed technology/engineering/performance nor materials changes to the currently marketed SUBJECT Laser Console Device. The proposed change to the currently marketed SUBJECT Laser Console that is the subject of this special 510(k) is the following addition of an extended range of compatible delivery devices: - Addition of a compatible delivery device, the Iridex C-Probe Delivery Device, which is a modification to the Iridex MicroPulse P3 Delivery Device. The C-Probe is an identical probe design to the MicroPulse P3 Delivery Device (MP3Probe) but with a unique RFID Tag to allow the laser system to recognize the probe as separate from the MP3 Probe and to inform the laser that the probe is used in Continuous Wave (CW) mode. Additionally, the handle of the C-Probe handle (no potential for patient contact) is the same design and materials as the MP3, but a different color to allow differentiation between the Iridex C-Probe Delivery Device and the MP3. The following table provides a comparison of Technological Characteristics of the SUBJECT device (Iridex 810 Laser) including the SUBJECT compatible delivery device (Iridex C-Probe Delivery Device) to the PREDICATE Devices (Iridex 810 Laser, Iridex MicroPulse P3 Delivery Device). The technological characteristics of the SUBJECT device (laser console and compatible delivery device) are substantially equivalent to those of the PREDICATE device (laser console and compatible delivery device). {8}------------------------------------------------ Image /page/8/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 | Iridex 810 Laser (Predicate Device) | | Iridex 810 Laser (Subject Device) | Bearing on Substantial Equivalence | |----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------| | Intended Use and Indications for Use | 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 system. | | Identical (no change) | Substantially Equivalent | | | Condition | Treatment | | | | | Diabetic Retinopathy • Nonproliferative Retinopathy • Macular Edema • Proliferative Retinopathy | Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments | | | | | Glaucoma • Primary Open Angle • Closed Angle • Refractory Glaucoma (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 | Focal and Grid Laser Treatments | | | | | • Choroidal Hemangioma | Focal and Grid Laser Treatments | | | | | • Choroidal Melanoma | | | | | | • Retinoblastoma | PRP; TSRPC; 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 | | | | Where the device is used | Physician's office, hospital operating room and ambulatory surgical center setting hospital, eye clinic or doctor's exam room | | Identical (no change) | Substantially Equivalent | | Characteristic | Iridex 810 Laser (Predicate Device) | Iridex 810 Laser (Subject Device) | Bearing on Substantial Equivalence | | | Principles of Operation (technology) | | | | | | Technological Characteristics | The light energy delivered for treatment is from an 810 nm semiconductor laser source, with up to 5 W of output power, with an NA of 0.11 The light is delivered to the treatment site with fiber optic treatment probes The power source for the console is standard utility outlets | Identical (no change) | Substantially Equivalent | | | Design/Technological Characteristics | | | | | | Operating Principles | A laser console that plugs into standard utility outlets, connects to a footswitch for activation control and uses a delivery probe attached to the probe port to deliver the light. The console has a user interface to adjust system settings. | Identical (no change) | Substantially Equivalent | | | Design Characteristics | Hardware: A sheet metal enclosure with front bezel and back panel. An approved power supply, control board, diode driver, diode, user interface, power cord and foot switch Repetition rate: < 50 Hz Laser activation: Footswitch Cooling System: Air Cooled | Identical (no change) | Substantially Equivalent | | | Output Mode | Continuous-Wave (including LongPulse duration) and MicroPulse | Identical (no change) | Substantially Equivalent | | | Electrical VAC | 100-240 VAC, 50/60 Hz | Identical (no change) | Substantially Equivalent | | | Electrical Current | < 4 amps | Identical (no change) | Substantially Equivalent | | | User Interface | Touchscreen with Keyboard, Knobs on Laser Console, Remote Control, Footswitch | Identical (no change) | Substantially equivalent | | | Laser Activation | Footswitch | Identical (no change) | Substantially Equivalent | | | Performance | | | | | | Treatment wavelength (Nominal) | 810 nm Infrared (IR) Diode | Identical (no change) | Substantially Equivalent | | | Aiming beam wavelength (Nominal) | 650 nm | Identical (no change) | Substantially Equivalent | | | Maximum treatment laser power | 3 W | Identical (no change) | Substantially Equivalent | | | Continuous Wave duration | 10 ms-10 s | Identical (no change) | Substantially Equivalent | | | MicroPulse duration | 100 $\\\mu$ s – 1000 $\\\mu$ s | Identical (no change) | Substantially Equivalent | | | Characteristic | Iridex 810 Laser (Predicate Device) | Iridex 810 Laser (Subject Device) | Bearing on Substantial Equivalence | | | Compatibility | | | | | | Compatible Delivery Devices | EndoProbe® Handpieces G_Probe® G-Probe Standard G-Probe Illuminate TS-600 for Veterinary Use Laser Indirect Ophthalmoscopes (LIO) Iridex® LIO Plus (Single-Mirror) Standard 810 nm Dual 810/532 nm Large Spot 810 nm TruFocus LIO Premiere® (Dual-Mirror) Standard 810 nm Dual 810/532 nm Large Spot 810 nm MicroPulse P3® Probe Family Operating Microscope Adapter (OMA) Slit Lamp Adapters (SLA) Standard 810 nm Large Spot 810 | Identical with the addition of the Iridex C-Probe Delivery Device | The C-Probe delivery device, which is a modified MicroPulse P3 delivery device, is added. Substantially Equivalent | | | Materials | | | | | | Materials | Sheet metal, approved plastic for the bezel material, standard electronics, laser diode. No liquids or hazardous materials | Identical (no change) | Substantially Equivalent | | | Packaging & Sterilization | | | | | | Packaging & Sterilization | The Iridex 810 Laser Console is supplied non-sterile. Shipping packaging has been designed to safely transport the device to end user facility | Minor change to packaging design and materials validated per ISTA 3A | Substantially Equivalent | | | Comparison of C-Probe and MicroPulse P3 Delivery Devices | | | | | | Characteristic | Iridex MicroPulse P3 Delivery Device (Predicate Device - Compatible Delivery Device) | Iridex C-Probe Delivery Device (Subject Device) | Bearing on Substantial Equivalence | | | C-Probe design compared to MicroPulse P3 Probe design | Compatible with the Iridex 810 Laser Console Handheld fiber optic, Contact plate is concave with no fiber optic protrusion Biocompatible materials RFID Code enables MicroPulse mode | Compatible with Iridex 810 Laser Identical design (including optic and contact plate) Identical materials. Different color handle, which has no potential patient contact. RIFD code enables Continuous Wave mode | Substantially Equivalent Changes made for physician preference to use Continuous Wave Mode and to differentiate between MicroPulse P3 and C-Probe Delivery Devices. | | | Packaging & Sterilization | The compatible MicroPulse P3 Delivery Device is supplied sterile. | Identical (no change) | Substantially Equivalent Changes made for physician preference to use Continuous Wave Mode | | {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. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle on the left side, with a series of dots forming the left half of the circle. To the right of the circle is the word "IRIDEX" in purple, sans-serif font. {11}------------------------------------------------ Image /page/11/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 bold, sans-serif font. The color of the text is also purple, matching the color of the circle. The logo is simple and modern, and the use of purple gives it a sense of sophistication. ### Performance Data The following table summarizes nonclinical testing relevant to the Iridex 810 Laser System (Console and Compatible Delivery Devices) in accordance with the requirements of the design control regulations and established quality assurance procedures. Other than the packaging testing, which is updated to current ISTA 3A guidelines, Verification and Validation method(s) and results are unchanged from those data submitted in K202760; and those data continue to apply to the SUBJECT device. Clinical testing was not required for this product change. | Verification/ Validation Method(s) | Acceptance Criteria | Summary of Results | |----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1 Electrical Safety | Meet appliable clauses of IEC 60601-1 | PASS. Device meets requirements of appliable clauses of IEC 60601-1 | | IEC 60601-2-22 Laser Safety | Meet all appliable IEC 60601-2-22 test items except for EMC, Biocompatibility | PASS. Device meets requirements of appliable clauses of IEC 60601-2-22. | | IEC 60825-1 Laser Safety | Meet appliable IEC 60825-1 requirements | PASS. Device meets IEC 60825-1 Requirements | | IEC 60601-1-2 EMI/EMC | Meet IEC 60601-1-2 Requirements | PASS. The unit met the requirements of appliable clauses of IEC 60601-1-2. | | IEC 60601-1-6:2010, AMD1:2013 (Usability) | Meet the requirements of the appliable clauses IEC 60601-1-6 | PASS. Device meets requirements of appliable clauses of IEC 60601-1-6 | | IEC 62304, Medical device software, Software life-cycle processes | Software lifecycle processes and activities meet requirements of appliable clauses of IEC 62304 | PASS Software lifecycle processes and activities meet IEC 62304 Requirements | | Shipping and Packaging Testing | Meet ISTA 3A Testing and Acceptance Requirements for: • Preconditioning • Atmospheric Conditioning • Shock Test • Random Vibration With and Without Top Load • Random Vibration Under Low Pressure - Truck Portion • Random Vibration Under Low Pressure - Air Portion • Shock Test Meet internal Iridex performance specifications pre- and post-conditioning testing. | PASS. All 5 units passed pre and post ISTA-3A testing (Westpak testing) and Pre-and Post-conditioning Testing (Iridex testing). | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle on the left side, with a series of dots forming the rest of the circle. To the right of the circle is the word "IRIDEX" in a sans-serif font, also in purple. ### Conclusions The Iridex 810 Laser (SUBJECT device) shares identical Intended Use, Indications for Use, Principles of Operation (technology) including energy source, Design/Technological Characteristics, and Performance, as the PREDICATE model of the Iridex 810 Laser, all of which do not raise new questions of safety and effectiveness. There are no design differences between the proposed Iridex C-Probe Delivery Device (SUBJECT compatible device) and the currently marketed Iridex MicroPulse P3 Probe (PREDICATE compatible device), with the exception that a new RFID tag will communicate with the connected laser console to only allow use of the C-Probe in Continuous Wave mode rather than in MicroPulse mode, which is currently the mode used by the MicroPulse P3 delivery device. Since the PREDICATE laser console currently accepts delivery devices that use Continuous Wave mode, the change does not raise new questions of safety and effectiveness. The conclusions drawn from the performance testing of the proposed SUBJECT device (Iridex 810 Laser Console) demonstrate substantial equivalence compared to the legally marketed predicate device.