(131 days)
Not Found
No
The document describes a laser system for ophthalmic treatments. There is no mention of AI or ML in the intended use, device description, or performance studies. The software mentioned is described as "software/embedded firmware," which is typical for controlling hardware and does not imply AI/ML capabilities.
Yes
The device is indicated for various medical conditions of the eye (e.g., Diabetic Retinopathy, Glaucoma, Retinal Tears, tumors) and performs treatments such as Panretinal Photocoagulation and Laser Trabeculoplasty, which are therapeutic interventions.
No
The device is described as a laser system used for treatments such as retinal photocoagulation and laser trabeculoplasty, indicating a therapeutic rather than a diagnostic function.
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 devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- 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 tissues (retina, trabecular meshwork, etc.) to perform procedures like photocoagulation and cyclophotocoagulation.
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens. Its function is to deliver laser energy for treatment.
Therefore, the Iridex 810 Laser falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
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
Product codes (comma separated list FDA assigned to the subject device)
HQF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Retinal, Trabeculoplasty (eye), Cyclophotocoagulation (ciliary body of the eye)
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 in accordance with the requirements of the design control regulations and established quality assurance procedures. Performance testing for the Iridex 810 Laser System (Console and Compatible Delivery Devices) included:
- IEC 60601-1 Electrical Safety: Device meets requirements of applicable clauses.
- IEC 60601-2-22 Laser Safety: Device meets requirements of applicable clauses.
- IEC 60825-1 Laser Safety: Device meets requirements.
- IEC 60601-1-2 EMI/EMC: Unit met the requirements of applicable clauses.
- IEC 60601-1-6:2010, AMD1:2013 (Usability): Device meets requirements of applicable clauses.
- IEC 62304, Medical device software, Software life-cycle processes: Software lifecycle processes and activities meet IEC 62304 Requirements.
- Shipping and Packaging Testing: All 5 units passed pre and post ISTA-3A testing (Westpak testing) and Pre-and Post-conditioning Testing (Iridex testing).
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. Clinical testing was not required for this product change.
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.
Not Found
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.
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: