(131 days)
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: Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy), Glaucoma (Primary Open Angle, Closed Angle, Refractory Glaucoma (recalcitrant/uncontrolled)), Retinal Tears, Detachments, and Holes, Lattice Degeneration, Age-Related Macular Degeneration (AMD), Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma), Retinopathy of Prematurity, Sub-Retinal (choroidal) Neovascularization, Central and Branch Retinal Vein Occlusion
TREATMENT: Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments, Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation (TSCPC), Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; TSRPC; Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; Focal and Grid Laser Treatments
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 provided text is a 510(k) summary for the Iridex 810 Laser System. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing related to electrical safety, laser safety, electromagnetic compatibility, usability, and software.
Crucially, this document does not describe a study involving human readers or AI assistance assessing the device's performance in diagnosing or treating conditions. It's about the safety and fundamental performance of a laser device, not an AI diagnostic tool.
Therefore, I cannot provide information on many of the requested points, such as:
- Sample size for the test set and data provenance: Not applicable, as this is a physical device safety and performance evaluation, not a diagnostic accuracy study.
- Number of experts used to establish ground truth & qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
- Stand-alone (algorithm only without human-in-the-loop performance) study: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth here refers to engineering and safety standards, not clinical diagnostic accuracy.
- Sample size for the training set: Not applicable, as this is not an AI/machine learning device being trained.
- How the ground truth for the training set was established: Not applicable.
However, I can extract information related to the acceptance criteria and the summary of non-clinical performance data for the Iridex 810 Laser System as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Verification/Validation Method(s) | Acceptance Criteria | Summary of Results |
|---|---|---|
| IEC 60601-1 Electrical Safety | Meet applicable clauses of IEC 60601-1 | PASS. Device meets requirements of applicable clauses of IEC 60601-1 |
| IEC 60601-2-22 Laser Safety | Meet all applicable IEC 60601-2-22 test items except for EMC, Biocompatibility | PASS. Device meets requirements of applicable clauses of IEC 60601-2-22. |
| IEC 60825-1 Laser Safety | Meet applicable 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 applicable clauses of IEC 60601-1-2. |
| IEC 60601-1-6:2010, AMD1:2013 (Usability) | Meet the requirements of the applicable clauses IEC 60601-1-6 | PASS. Device meets requirements of applicable clauses of IEC 60601-1-6 |
| IEC 62304, Medical device software, Software life-cycle processes | Software lifecycle processes and activities meet requirements of applicable 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 TestMeet 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). |
2. Sample Size Used for the Test Set and Data Provenance:
- For "Shipping and Packaging Testing," the sample size was 5 units.
- For other non-clinical tests (Electrical Safety, Laser Safety, EMI/EMC, Usability, Software), the specific sample size is not explicitly stated within this summary. However, these are typically engineering verification tests performed on a limited number of test units to confirm compliance with international standards.
- Data Provenance: The document does not specify the country of origin for the test data but indicates that the testing was performed internally by Iridex ("Iridex testing") and by a third-party lab ("Westpak testing" for packaging). These are non-clinical engineering tests, not patient studies, so "retrospective or prospective" doesn't directly apply in the clinical sense.
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is the non-clinical performance testing conducted by the manufacturer, Iridex Corporation, and sometimes by accredited third-party testing laboratories. The summary states:
- "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."
This indicates that the "study" demonstrating performance is a series of engineering verification and validation tests against established international standards for medical devices and lasers.
In summary, this document is for a laser device intended for ophthalmic treatments (e.g., retinal photocoagulation). The "acceptance criteria" and "study" described pertain to the device's fundamental safety, electrical performance, laser output characteristics, usability, and software quality, as per relevant international standards, rather than clinical diagnostic accuracy or AI performance improvements.
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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
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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
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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.
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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 Corporation1212 Terra Bella AveMountain View, CA 94043-1824Phone: (650) 940-4700Fax: (650) 355-1305Establishment Registration No.: 2939653 |
|---|---|
| Contact Person: | Bill HyattDirector, Regulatory AffairsPhone: (650) 605-8727Fax: (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)
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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); Focaland 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 LaserTreatments |
| 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 LaserTreatments |
| Sub-Retinal (choroidal)Neovascularization | Focal and Grid Laser Treatments |
| Central and Branch Retinal VeinOcclusion | 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.
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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 withIridex 810 Laser(SUBJECT Device) | Compatibility withIridex 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 VeterinaryUse | • | • | ||||
| Laser IndirectOphthalmoscopes (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) ProbeFamily(cleared under K162416) | • | • | ||||
| Operating MicroscopeAdapter (OMA) | • | • | • | • | ||
| Slit Lamp Adapters (SLA) | ||||||
| • Standard 810 nm | • | • | • | • | ||
| • Large Spot 810 nm | • | • | • | • | ||
| C-Probe (SUBJECTCompatible 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.
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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).
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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 onSubstantialEquivalence | |
|---|---|---|---|---|
| Intended Useand Indicationsfor Use | Indicated for retinal photocoagulation, lasertrabeculoplasty, transscleral cyclophotocoagulation,transscleral retinal photocoagulation, and other diodelaser treatments. The following are examples ofapplications for the Iridex 810 Laser system. | Identical (no change) | SubstantiallyEquivalent | |
| Condition | Treatment | |||
| Diabetic Retinopathy• NonproliferativeRetinopathy• Macular Edema• ProliferativeRetinopathy | PanretinalPhotocoagulation (PRP);Focal and Grid LaserTreatments | |||
| Glaucoma• Primary Open Angle• Closed Angle• Refractory Glaucoma(recalcitrant/uncontrolled) | Laser Trabeculoplasty;Iridotomy; TransscleralCyclophotocoagulation(TSCPC) | |||
| Retinal Tears,Detachments, and Holes | Transscleral RetinalPhotocoagulation(TSRPC); Focal and GridLaser Treatments | |||
| Lattice Degeneration | PRP; Focal and Grid LaserTreatments | |||
| Age-related MacularDegeneration (AMD) | Focal and Grid LaserTreatments | |||
| Intra-Ocular Tumors | Focal and Grid LaserTreatments | |||
| • Choroidal Hemangioma | Focal and Grid LaserTreatments | |||
| • Choroidal Melanoma | ||||
| • Retinoblastoma | PRP; TSRPC; Focal andGrid Laser Treatments | |||
| Retinopathy of Prematurity | PRP; TSRPC; Focal andGrid Laser Treatments | |||
| Sub-Retinal (choroidal)Neovascularization | Focal and Grid LaserTreatments | |||
| Central and Branch RetinalVein Occlusion | PRP; Focal and Grid LaserTreatments | |||
| Where thedevice is used | Physician's office, hospital operating room and ambulatorysurgical center setting hospital, eye clinic or doctor's examroom | Identical (no change) | SubstantiallyEquivalent | |
| Characteristic | Iridex 810 Laser(Predicate Device) | Iridex 810 Laser(Subject Device) | Bearing onSubstantialEquivalence | |
| Principles of Operation (technology) | ||||
| TechnologicalCharacteristics | The light energy delivered for treatment is from an 810 nmsemiconductor laser source, with up to 5 W of outputpower, with an NA of 0.11The light is delivered to the treatment site with fiber optictreatment probesThe power source for the console is standard utility outlets | Identical (no change) | SubstantiallyEquivalent | |
| Design/Technological Characteristics | ||||
| OperatingPrinciples | A laser console that plugs into standard utility outlets,connects to a footswitch for activation control and uses adelivery probe attached to the probe port to deliver thelight. The console has a user interface to adjust systemsettings. | Identical (no change) | SubstantiallyEquivalent | |
| DesignCharacteristics | 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 switchRepetition rate: < 50 HzLaser activation: FootswitchCooling System: Air Cooled | Identical (no change) | SubstantiallyEquivalent | |
| Output Mode | Continuous-Wave (including LongPulse duration) andMicroPulse | Identical (no change) | SubstantiallyEquivalent | |
| Electrical VAC | 100-240 VAC, 50/60 Hz | Identical (no change) | SubstantiallyEquivalent | |
| ElectricalCurrent | < 4 amps | Identical (no change) | SubstantiallyEquivalent | |
| User Interface | Touchscreen with Keyboard, Knobs on Laser Console,Remote Control, Footswitch | Identical (no change) | Substantiallyequivalent | |
| LaserActivation | Footswitch | Identical (no change) | SubstantiallyEquivalent | |
| Performance | ||||
| Treatmentwavelength(Nominal) | 810 nm Infrared (IR) Diode | Identical (no change) | SubstantiallyEquivalent | |
| Aiming beamwavelength(Nominal) | 650 nm | Identical (no change) | SubstantiallyEquivalent | |
| Maximumtreatment laserpower | 3 W | Identical (no change) | SubstantiallyEquivalent | |
| ContinuousWave duration | 10 ms-10 s | Identical (no change) | SubstantiallyEquivalent | |
| MicroPulseduration | 100 $\\mu$ s – 1000 $\\mu$ s | Identical (no change) | SubstantiallyEquivalent | |
| Characteristic | Iridex 810 Laser(Predicate Device) | Iridex 810 Laser(Subject Device) | Bearing onSubstantialEquivalence | |
| Compatibility | ||||
| CompatibleDeliveryDevices | EndoProbe® HandpiecesG_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 FamilyOperating Microscope Adapter (OMA)Slit Lamp Adapters (SLA) Standard 810 nm Large Spot 810 | Identical with the additionof the Iridex C-ProbeDelivery Device | The C-Probe deliverydevice, which is amodified MicroPulseP3 delivery device, isadded.SubstantiallyEquivalent | |
| Materials | ||||
| Materials | Sheet metal, approved plastic for the bezel material,standard electronics, laser diode. No liquids or hazardousmaterials | Identical (no change) | SubstantiallyEquivalent | |
| Packaging & Sterilization | ||||
| Packaging &Sterilization | The Iridex 810 Laser Console is supplied non-sterile.Shipping packaging has been designed to safely transportthe device to end user facility | Minor change to packagingdesign and materialsvalidated per ISTA 3A | SubstantiallyEquivalent | |
| Comparison of C-Probe and MicroPulse P3 Delivery Devices | ||||
| Characteristic | Iridex MicroPulse P3Delivery Device(Predicate Device - Compatible Delivery Device) | Iridex C-ProbeDelivery Device(Subject Device) | Bearing onSubstantialEquivalence | |
| C-Probe designcompared toMicroPulse P3Probe design | Compatible with the Iridex 810 Laser Console Handheld fiber optic, Contact plate is concave with nofiber optic protrusion Biocompatible materials RFID Code enables MicroPulse mode | Compatible with Iridex810 Laser Identical design(including optic andcontact plate) Identical materials.Different color handle,which has no potentialpatient contact. RIFD code enablesContinuous Wave mode | SubstantiallyEquivalentChanges made forphysician preferenceto use ContinuousWave Mode and todifferentiate betweenMicroPulse P3 andC-Probe DeliveryDevices. | |
| Packaging &Sterilization | The compatible MicroPulse P3 Delivery Device is suppliedsterile. | Identical (no change) | SubstantiallyEquivalentChanges made forphysician preferenceto use ContinuousWave Mode |
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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.
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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.
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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 | PASSSoftware 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 TestMeet 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). |
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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.
§ 886.4390 Ophthalmic laser.
(a)
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.(b)
Classification. Class II.