(30 days)
No
The summary describes a laser system with standard components and software/firmware for control, with no mention of AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly lists various conditions like Diabetic Retinopathy, Glaucoma, Retinal Tears, etc., and the treatments provided by the device (e.g., Panretinal Photocoagulation; Laser Trabeculoplasty), all of which are medical interventions aimed at treating or alleviating diseases.
No.
The Iridex 810 Laser is indicated for retinal photocoagulation and other diode laser treatments, which are therapeutic procedures, not diagnostic ones. The "Intended Use / Indications for Use" section lists conditions and treatments but does not describe any diagnostic capabilities.
No
The device description explicitly states it is comprised of a laser console with footswitch and an optical fiber delivery device, which are hardware components. While it includes software/embedded firmware, it is not solely software.
Based on the provided information, the Iridex 810 Laser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Iridex 810 Laser Function: The Iridex 810 Laser is a therapeutic device that uses laser energy to treat various eye conditions. It directly interacts with the patient's tissue (retina, sclera) to perform procedures like photocoagulation.
- Lack of Specimen Examination: The device description and intended use clearly indicate that the Iridex 810 Laser does not examine specimens derived from the human body. It is a treatment device, not a diagnostic one.
Therefore, the Iridex 810 Laser falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Iridex 810 Laser is indicated for retinal photocoagulation, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the Iridex 810 Laser.
CONDITION: Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy) TREATMENT: Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments
CONDITION: Glaucoma (Primary Open Angle, Closed Angle, Refractory Glaucoma (recalcitrant/uncontrolled)) TREATMENT: Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation (TSCPC)
CONDITION: Retinal Tears, Detachments, and Holes TREATMENT: Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments
CONDITION: Lattice Degeneration TREATMENT: PRP; Focal and Grid Laser Treatments
CONDITION: Age-Related Macular Degeneration (AMD) TREATMENT: Focal and Grid Laser Treatments
CONDITION: Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma) TREATMENT: Focal and Grid Laser Treatments
CONDITION: Retinopathy of Prematurity TREATMENT: PRP; TSRPC; Focal and Grid Laser Treatments
CONDITION: Sub-Retinal (choroidal) Neovascularization TREATMENT: Focal and Grid Laser Treatments
CONDITION: Central and Branch Retinal Vein Occlusion TREATMENT: PRP; Focal and Grid Laser Treatments
Product codes (comma separated list FDA assigned to the subject device)
HQF, GEX
Device Description
The Iridex 810 Laser system is comprised of a laser console with footswitch and an optical fiber delivery device. The laser console contains two laser diodes (810 nm for Treatment and 650 nm for Aiming beam), imaging optics, power supply, control electronics, and software/embedded firmware (with microprocessor). Lasing can only be initiated from the footswitch.
Optical fiber Delivery Devices are provided separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Retina, eye (specifically relating to conditions like diabetic retinopathy, glaucoma, retinal tears, AMD, intra-ocular tumors, retinopathy of prematurity, sub-retinal neovascularization, central and branch retinal vein occlusion).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician's office, hospital operating room and ambulatory surgical center setting hospital, eye clinic or doctor's exam room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was performed on the Iridex 810 Laser System. Clinical testing was not required.
Verification/Validation Methods and Summary of Results:
- IEC 60601-1 Electrical Safety: PASS. Device meets requirements of applicable clauses of IEC 60601-1.
- IEC 60601-2-22 Laser Safety: PASS. Device meets requirements of applicable clauses of IEC 60601-2-22.
- IEC 60825-1 Laser Safety: PASS. Device meets IEC 60825-1 Requirements.
- IEC 60601-1-2 EMI/EMC: PASS. The unit met the requirements of applicable clauses of IEC 60601-1-2.
- IEC 60601-1-6:2010, AMD1:2013 (Usability): PASS. Device meets requirements of applicable clauses of IEC 60601-1-6.
- IEC 62304, Medical device software, Software life-cycle processes: PASS. Software life-cycle processes and activities meet IEC 62304 Requirements.
- Shipping and Packaging Testing (ISTA 1A Procedure - Vibration, Fixed Displacement; Shock Drop): PASS. Observed Console Power Measurements, Console Current Measurement, Product and Packaging Appearance and Product Function performed pre- and post- ISTA 1A Procedure Testing passed product release specifications and were not adversely affected by ISTA 1A Procedure testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG" are stacked on top of the word "ADMINISTRATION".
October 21, 2020
Iridex Corporation Bill Hyatt Director of Regulatory Affairs 1212 Terra Bella Ave. Mountain View, CA 94043
Re: K202760
Trade/Device Name: Iridex 810 Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF, GEX Dated: September 16, 2020 Received: September 21, 2020
Dear Bill Hyatt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for LT Charles Chiang Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202760
Device Name Iridex 810 Laser
Indications for Use (Describe)
The Iridex 810 Laser is indicated for retinal photocoagulation, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the Iridex 810 Laser.
CONDITION
TREATMENT
| Diabetic Retinopathy
• 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 blue circular emblem on the left and the word "IRIDEX" in bold, black, sans-serif font on the right. The emblem features a stylized white flower-like design inside a blue circle with a black border.
510(k) SUMMARY K202760
Submitter Information
| Company: | Iridex Corporation
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: | October 20, 2020 | |
| Device Name and Classification | | |
| Common Name: | Ophthalmic Laser, Powered Laser Surgical | |
| Proprietary Name: | Iridex 810 Laser | |
| Classification Name: | Laser, Ophthalmic | |
| Common Name: | Ophthalmic Laser, Powered Laser Surgical Instrument |
|---|---|
| Proprietary Name: | Iridex 810 Laser |
| Classification Name: | Laser, Ophthalmic |
| Product Code: | HQF, GEX |
| Regulation Number: | 21 CFR 886.4390, 21 CFR 886.4810 |
| Device Class: | II |
Predicate Device
| Company: | Iridex Corporation |
|---|---|
| Device: | OcuLight SL/SLx, Model # 13030 (K020374) |
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Image /page/5/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a blue circle with a white flower-like design inside, followed by the word "IRIDEX" in bold, black letters. The logo is simple and professional, and the use of blue and white gives it a clean and modern look.
Intended Use (Indications for Use)
The Iridex 810 Laser is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the Iridex 810 Laser.
| Condition | Treatment |
|---|---|
| Diabetic Retinopathy | |
| • 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 nm for Treatment and 650 nm for Aiming beam), imaging optics, power supply, control electronics, and software/embedded firmware (with microprocessor). Lasing can only be initiated from the footswitch.
Optical fiber Delivery Devices are provided separately. The following tables shows compatible delivery devices:
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Image /page/6/Picture/0 description: The image contains the logo for IRIDEX. The logo consists of a circular emblem on the left and the word "IRIDEX" in bold, black capital letters on the right. The emblem features a blue and white floral design inside a blue circle with a thin black border.
| Delivery Device | CW-Pulse | MicroPulse |
|---|---|---|
| Slit Lamp Adapter (SLA) | ● | ● |
| Large Spot Slit Lamp Adapter | ||
| (LS-SLA) | ● | |
| TruFocus LIO+ | ● | ● |
| Large Spot TruFocus LIO+ | ● | |
| Endoprobe Family | ● | ● |
| G Probe | ● | |
| Operating Microscope Adapter | ||
| (OMA) | ● | |
| MicroPulse P3 (MP3) Family | ||
| (cleared under K162416) | ● | |
| G Probe and G Probe Illuminate | ||
| (cleared under K162416) | ● |
Delivery Device Compatibility with Iridex 810 Laser
Comparison of Technological Characteristics with the Predicate Device
The Iridex 810 Laser (SUBJECT device) is modified from the PREDICATE device to address component obsolescence and to update the user interface to include a color touchscreen (replace LED interface) with a keyboard. Additionally, the range of compatible delivery devices was increased to include delivery devices have been marketed subsequent to the introduction of the PREDICATE device.
The following table provides a comparison of Technological Characteristics of the SUBJECT device (Iridex 810 Laser) to the PREDICATE Device (Iris Medical OcuLight SL/SLx). The technological characteristics of the SUBJECT device (Iridex 810 Laser) are substantially equivalent to those of the predicate device.
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Image /page/7/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a blue circular emblem on the left and the word "IRIDEX" in bold, black letters on the right. The emblem features a white floral design with three petals inside a blue circle.
| Characteristic | OcuLight SLx
(Predicate Device) | Iridex 810 Laser
(Subject Device) | Bearing on
Substantial
Equivalence |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intended Use and Indications for Use | | |
| 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
• 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 | |
| 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 | OcuLight SLx
(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 810nm
semiconductor laser source, with up to 5W 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: