(27 days)
The Iridex® Laser Console (532 model) are solid state lasers that are used to deliver laser energy in either continuous wave pulse (CW-pulse® mode, for ophthalmic applications (532 and 577 models) and for Ear, Nose, and Throat (Otolaryngology) applications (532 model only).
Iridex® 532 Laser
The Iridex® 532 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, ear, nose and throat (ENT)/otolaryngology, and ophthalmology as follows:
Ophthalmology
Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including:
- · Retinal photocoagulation (RPC) for the treatment of
- o Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- o Retinal tears and detachments
- o Lattice degeneration
- o Age-related macular degeneration (AMD)
- o Retinopathy of prematurity
- o Sub-retinal (choroidal) neovascularization
- o Central and branch retinal vein occlusion
- o Diabetic retinopathy, including:
- · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
- o Primary open angle/Closed angle
Ear, Nose, and Throat (ENT)/Otolaryngology
Otosclerotic Hearing loss and/or diseases of the inner ear:
- · Stapedectomy
- · Stapedotomy
- · Myringotomies
- · Lysis of Adhesions
- · Control of Bleeding
- · Removal of Acoustic Neuromas
- · Soft tissue Adhesion in Micro/Macro Otologic Procedures
Iridex® 577 Laser
The Iridex® 577 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialty of ophthalmology as follows:
Ophthalmology
Indicated for use in photocoagulation of both anterior and posterior segments including:
- · Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: o Proliferative and nonproliferative diabetic retinopathy o Choroidal neovascularization o Branch retinal vein occlusion o Age-related macular degeneration (AMD) o Retinal tears and detachments o Retinopathy of prematurity · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma
The Iridex 532/577 Laser consoles are solid state lasers that are used to deliver laser energy in continuous wave and MicroPulse® for ophthalmic applications and (for 532 only) ear, nose, and throat (ENT) / otolaryngology applications. The Iridex® 532 Laser delivers a 532 nm wavelength (green) laser emission, and the Iridex® 577 Laser delivers a 577mm wavelength (true-yellow) laser emission.
The Iridex 532 Laser and the Iridex 577 Laser systems are comprised of a laser console with footswitch and an optical fiber delivery device. Each laser console model contains two laser diodes as follows:
- Iridex 532 Laser: 532 nm for Treatment and 650 nm for Aiming beam ●
- Iridex 577 Laser: 577 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 provided text describes a 510(k) summary for the Iridex® Laser, demonstrating substantial equivalence to a predicate device. The information primarily focuses on non-clinical performance data rather than a detailed clinical study involving human readers and AI assistance.
Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Reported Device Performance
The study primarily evaluates the safety and performance of the Iridex® Laser against established standards and internal specifications, not a comparative effectiveness study with human readers and AI. Thus, the performance is measured against technical and safety benchmarks.
1. Table of Acceptance Criteria and the Reported Device Performance
| Verification/Validation Method(s) | Acceptance Criteria | Summary of Results |
|---|---|---|
| Testing to External Standards | ||
| 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 (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 Test. Meet internal Iridex performance specifications pre- and post-conditioning testing. | PASS. The test unit passed pre and post ISTA-3A testing (Westpak testing) and Pre-and Post-conditioning testing to specification (Iridex testing). |
| Testing to Iridex Internal Specifications | ||
| Treatment Beam Power Output (Measured at 50, 250, 500, 1000, and 2000 mW for both models; 2500 mW for Iridex 532 model only) | Measured Power Output is Power Setting ±20% | PASS |
| Pulse Duration/Interval (MicroPulse Mode) (Measured various combinations of Pulse Duration and Interval settings throughout and beyond claimed range) | Measured Pulse Duration/Interval is Pulse Duration/Interval Setting ±10% | PASS |
| Pulse Duration/Interval (Continuous-Wave Mode) (Measured various combinations of Pulse Duration and Interval settings throughout and beyond claimed range) | Measured Pulse Duration/Interval is Pulse Duration/Interval Setting ±10% | PASS |
| Aiming Beam Power Output (Measured at 0 mW and 0.7 mW setting) | Measured Power Output observable throughout specified power range, ±0.2 mW nominal | PASS |
| Software Verification/Validation (Software development and V&V consistent with IEC 62304; V&V tasks performed at each stage, revisited, or new tasks initiated until acceptance/passing criteria achieved) | Each module within each of the five following Software V&V Domains must pass: 1) Product Info Domain, 2) Essential (Basic) Function Domain, 3) Setting Domain, 4) Specials Domain, 5) Accessories Domain | QUALIFIED. Each module within the five Software V&V Domains passed: 1) Product Info Domain, 2) Essential (Basic) Function Domain, 3) Setting Domain, 4) Specials Domain, 5) Safety Domain. The software performance meets the requirements of the software requirements specification. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical testing was not required for this product change." This indicates that the regulatory submission relies on non-clinical performance and safety data, as well as a comparison to a predicate device. Therefore, there is no test set of clinical images or patient data as would be used in an AI/imaging device. The "test set" here refers to the units of the device itself and its components undergoing engineering validation.
The provenance of this data is from internal Iridex testing and external test houses (e.g., Westpak testing for shipping/packaging). The data is prospective in the sense that the tests were conducted specifically for this regulatory submission on the subject devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Given that this is a non-clinical device performance and safety study, not a diagnostic AI study, there were no clinical experts (e.g., radiologists) involved in establishing ground truth for a test set of images. The ground truth for the device's technical performance (e.g., power output accuracy, pulse duration) would be established by calibrated measurement equipment and engineering standards, not human expert consensus.
4. Adjudication Method for the Test Set
Not applicable. Since there's no clinical test set requiring image interpretation or diagnosis, there's no need for an adjudication method (like 2+1 or 3+1 consensus) for ground truth establishment. Technical performance metrics are typically measured against established engineering tolerances directly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a laser system for treatment, not an AI or diagnostic imaging device. The submission focuses on demonstrating substantial equivalence to a predicate laser device based on technical specifications and safety standards, not on improving human reader performance with AI assistance. Therefore, there is no effect size related to AI improvement for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a therapeutic laser system, not an algorithm, and does not operate as a "standalone" diagnostic or AI tool. Its performance is intrinsic to its hardware and embedded software controlling laser emission.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- International Electrotechnical Commission (IEC) Standards: For electrical, laser, EMI/EMC safety, usability, and software lifecycle processes (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304).
- ISTA Standards: For shipping and packaging integrity (ISTA 3A).
- Internal Iridex Performance Specifications: For parameters like treatment beam power output, pulse duration/interval, and aiming beam power output.
This is a technical and engineering ground truth, established through calibrated measurements and adherence to recognized industry standards, rather than clinical consensus or pathology findings.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not an AI model requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model.
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February 23, 2023
Iridex Corporation Mari Iwamoto, PhD Regulatory Affairs Specialist 1212 Terra Bella Ave. Mountain View. CA 94043
Re: K230228
Trade/Device Name: Iridex® 532 Laser; Iridex® 577 Laser; Iridex® Laser (532 nm and 577 nm models) Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF, GEX Dated: January 24, 2023 Received: January 27, 2023
Dear Mari Iwamoto, PhD:
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.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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-regulatoryinformation/postmarketing-safety-reporting-combination-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-devicereporting-mdr-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,
J Angelo Green -S
Image /page/1/Picture/6 description: The image shows the logo for the Food and Drug Administration (FDA). The logo is in a light blue color and is displayed on a white background. The letters "FDA" are large and bold.
for Tieuvi Nguyen, Ph.D. 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) K230228
Device Name Iridex® 532 Laser Iridex® 577 Laser Iridex® Laser (532 nm and 577 nm models)
Indications for Use (Describe)
The Iridex® Laser Console (532 model) are solid state lasers that are used to deliver laser energy in either continuous wave pulse (CW-pulse® mode, for ophthalmic applications (532 and 577 models) and for Ear, Nose, and Throat (Otolaryngology) applications (532 model only).
Iridex® 532 Laser
The Iridex® 532 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, ear, nose and throat (ENT)/otolaryngology, and ophthalmology as follows:
Ophthalmology
Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including:
- · Retinal photocoagulation (RPC) for the treatment of
- o Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- o Retinal tears and detachments
- o Lattice degeneration
- o Age-related macular degeneration (AMD)
- o Retinopathy of prematurity
- o Sub-retinal (choroidal) neovascularization
- o Central and branch retinal vein occlusion
- o Diabetic retinopathy, including:
- · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
- o Primary open angle/Closed angle
Ear, Nose, and Throat (ENT)/Otolaryngology
Otosclerotic Hearing loss and/or diseases of the inner ear:
- · Stapedectomy
- · Stapedotomy
- · Myringotomies
- · Lysis of Adhesions
- · Control of Bleeding
- · Removal of Acoustic Neuromas
- · Soft tissue Adhesion in Micro/Macro Otologic Procedures
Iridex® 577 Laser
The Iridex® 577 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialty of ophthalmology as follows:
Ophthalmology
Indicated for use in photocoagulation of both anterior and posterior segments including:
- · Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural
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abnormalities of the retina and choroid including: o Proliferative and nonproliferative diabetic retinopathy o Choroidal neovascularization o Branch retinal vein occlusion o Age-related macular degeneration (AMD) o Retinal tears and detachments o Retinopathy of prematurity · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma 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)
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Image /page/4/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle on the left side, which is made up of small dots on the left half and a solid purple color on the right half. To the right of the circle is the word "IRIDEX" in purple, with each letter capitalized.
510(k) SUMMARY; K230228
Submitter Information
| Company: | Iridex Corporation1212 Terra Bella AveMountain View, CA 94043-1824Phone: (650) 940-4700Fax: (650) 940-4710Establishment Registration No.: 2939653 |
|---|---|
| Contact Person: | Mari Iwamoto, PhDSpecialist, Regulatory AffairsPhone: (650) 605-8727Fax: (650) 940-4710 |
- Date Prepared: February 21, 2023
Device Name and Classification
| Common Name: | Ophthalmic Laser, Powered Laser Surgical Instrument |
|---|---|
| Proprietary Name: | Iridex® 532 Laser,Iridex® 577 Laser,Iridex® Laser (532 and 577 nm models) |
| Classification Name: | Laser, OphthalmicPowered Laser Surgical Instrument |
| Product Code: | HQFGEX |
| Regulation Number: | 21 CFR 886.439021 CFR 878.4810 |
| Device Class: | II |
Predicate Device
| Laser Console | |
|---|---|
| Company: | Iridex Corporation |
| Device: | Collectively:Family of IRIDEX IQ® Laser Systems (IQ532, IQ577) (K071687)Individual Models:Iridex IQ 532® Laser System,Iridex IQ 577® Laser System |
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Image /page/5/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle with a dotted outline on the left and the word "IRIDEX" in purple letters on the right. The circle is partially filled in with a solid purple color, while the other half is made up of small dots.
Intended Use (Indications for Use)
The Iridex® Laser Console (532 model and 577 model) are solid state lasers that are used to deliver laser energy in either continuous wave pulse (CW-pulse) or MicroPulse® mode, for ophthalmic applications (532 and 577 models) and for Ear. Nose, and Throat (Otolaryngology) applications (532 model only).
Indications for Use
The Iridex 532 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:
Ophthalmology
Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including:
- Retinal photocoagulation (RPC) for the treatment of ●
- o Diabetic retinopathy, including:
- 트 Nonproliferative retinopathy
- . Macular edema
- 트 Proliferative retinopathy
- Retinal tears and detachments O
- Lattice degeneration o
- Age-related macular degeneration (AMD) O
- Retinopathy of prematurity O
- O Sub-retinal (choroidal) neovascularization
- Central and branch retinal vein occlusion O
- o Diabetic retinopathy, including:
- Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including ●
- Primary open angle/Closed angle O
Ear, Nose, and Throat (ENT)/ Otolaryngology
Otosclerotic Hearing loss and/or diseases of the inner ear:
- Stapedectomy
- Stapedotomy
- Myringotomies
- Lysis of Adhesions
- Control of Bleeding
- Removal of Acoustic Neuromas
- Soft tissue Adhesion in Micro/Macro Otologic Procedures ●
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Image /page/6/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle on the left, with a series of dots forming the left half of the circle. The right half of the circle is filled in with solid purple. To the right of the circle is the word "IRIDEX" in purple, sans-serif font.
The Iridex 577 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialty of ophthalmology as follows:
Ophthalmology
Indicated for use in photocoagulation of both anterior and posterior segments including:
- Retinal photocoagulation, panretinal photocoagulation and intravitreal ● endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and nonproliferative diabetic retinopathy O
- O Choroidal neovascularization
- Branch retinal vein occlusion O
- Age-related macular degeneration (AMD) O
- Retinal tears and detachments O
- Retinopathy of prematurity o
- Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle ● glaucoma
Device Description
The Iridex 532/577 Laser consoles are solid state lasers that are used to deliver laser energy in continuous wave and MicroPulse® for ophthalmic applications and (for 532 only) ear, nose, and throat (ENT) / otolaryngology applications. The Iridex® 532 Laser delivers a 532 nm wavelength (green) laser emission, and the Iridex® 577 Laser delivers a 577mm wavelength (true-yellow) laser emission.
The Iridex 532 Laser and the Iridex 577 Laser systems are comprised of a laser console with footswitch and an optical fiber delivery device. Each laser console model contains two laser diodes as follows:
- Iridex 532 Laser: 532 nm for Treatment and 650 nm for Aiming beam ●
- Iridex 577 Laser: 577 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/7/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle on the left, with a series of dots forming the left half of the circle. The right half of the circle is filled in with solid purple. To the right of the circle is the word "IRIDEX" in purple, sans-serif font.
Delivery Device Compatibility with SUBJECT Iridex® 532 Laser and Iridex® 577 Laser
| Iridex® 532 Laser | Iridex 577® Laser | |||
|---|---|---|---|---|
| Delivery Device | CW-Pulse | MicroPulse | CW-Pulse | MicroPulse |
| EndoProbe | ● | ● | ||
| Laser IndirectOphthalmoscopes (LIO) | ||||
| ● Iridex LIO Plus(Single-Mirror) | ● | ● | ||
| ● TruFocus LIOPremiere(Dual Mirror) | ● | ● | ||
| TxCell™ Scanning LaserDelivery System | ● | ● | ● | ● |
| Slit Lamp Adapters (SLA) | ● | ● | ● | ● |
| ENT Devices |
Comparison of Technological Characteristics with the Predicate Device
The following table provides a comparison of Technological Characteristics of the SUBJECT device (Iridex® 532 Laser and Iridex® 577 models) to the PREDICATE Devices (Iridex IQ 532® Laser System, Iridex IQ 577® Laser System).
The technological characteristics of the SUBJECT device (laser console) 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 | Family of IRIDEX IQ® Laser Systems, IQ532, IQ577 models(PREDICATE Device) | Iridex 532 Laser /Iridex 577 Laser(Subject Device) | Bearing onSubstantialEquivalence |
|---|---|---|---|
| Intended Use and Indications for Use | |||
| Intended Useand Indicationsfor Use | The Iridex® 532 Laser and Iridex® 577 Laser and the hand pieces, delivery devices and accessories that are used with them to deliver laser energy in either CW-pulse or MicroPulse mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of ear, nose and throat (ENT)/otolaryngology, and ophthalmology as follows:532 nmEar, Nose, and Throat (ENT)/ OtolaryngologyOtosclerotic Hearing loss and/or diseases of the inner ear:Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft tissue Adhesion in Micro/Macro Otologic Procedures OphthalmologyIndicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including:Retinal photocoagulation (RPC) for the treatment of: Diabetic retinopathy, including: Nonproliferative retinopathy Macular edema Proliferative retinopathy Retinal tears and detachments Lattice degeneration Age-related macular degeneration (AMD) Retinopathy of prematurity Sub-retinal (choroidal) neovascularization Central and branch retinal vein occlusion Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including Primary open angle/Closed angle 577 nmOphthalmologyIndicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroids including: Proliferative and nonproliferative diabetic retinopathy; Choroidal neovascularization; Branch retinal vein occlusion; Age-related macular degeneration (AMD); Retinal tears and detachments; Retinopathy of prematurity; Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma | Identical (no change) | SubstantiallyEquivalent |
| Characteristic | Family of IRIDEX IQ® Laser Systems, IQ532, IQ577 models(PREDICATE Device) | Iridex 532 Laser /Iridex 577 Laser(Subject Device) | Bearing onSubstantialEquivalence |
| Where thedevice is used | Physician's office, hospital operating room and ambulatory surgicalcenter setting hospital, eye clinic or doctor's exam room | Identical (no change) | SubstantiallyEquivalent |
| Principles of Operation (technology) | |||
| TechnologicalCharacteristics | The light energy delivered for treatment is from a 532 nm (for IQ 532Laser) or 577 nm (for IQ 577 Laser) semiconductor laser source, with upto 5 W of output power.The light is delivered to the treatment site with fiber optic treatmentprobes and accessories. | Identical (no change) | SubstantiallyEquivalent |
| The power source for the console is standard utility outlets | |||
| Design/Technological Characteristics | |||
| OperatingPrinciples | A laser console that plugs into standard utility outlets, connects to afootswitch for activation control and uses a delivery probe/accessoryattached to the probe port to deliver the light. The console has a userinterface to adjust system settings. | Identical (no change) | SubstantiallyEquivalent |
| DesignCharacteristics | Hardware:A sheet metal enclosure with front bezel and back panel. An approvedpower supply, control board, laser module driver, laser module, userinterface, power cord and foot switch.Laser activation: FootswitchCooling System: Air Cooled | Identical (no change) | SubstantiallyEquivalent |
| Output Mode | Continuous-Wave and MicroPulse | Identical (no change) | SubstantiallyEquivalent |
| Electrical VAC | 100-240 VAC, 50/60 Hz | Identical (no change) | SubstantiallyEquivalent |
| ElectricalCurrent | < 3 amps | Updated to meetregulatoryrequirements | SubstantiallyEquivalent |
| User Interface | Touchscreen with Keyboard, Knobs on Laser Console, Remote Control,Footswitch | Identical, but RemoteControl is not plannedto be provided | Substantiallyequivalent |
| LaserActivation | Footswitch | Identical with additionof currently marketedwired footswitches(cleared in 510(k)K151890 andK160549) | SubstantiallyEquivalent |
| Characteristic | Family of IRIDEX IQ® Laser Systems, IQ532, IQ577 models(PREDICATE Device) | Iridex 532 Laser /Iridex 577 Laser(Subject Device) | Bearing onSubstantialEquivalence |
| Performance | |||
| Treatmentwavelength(Nominal) | For the 532 nm Laser:• 532 nmFor the 577 nm Laser:• 577 nm | Identical (no change) | SubstantiallyEquivalent |
| Aiming beamwavelength(Nominal) | 635 nm laser diode. User-adjustable | Identical (no change) | SubstantiallyEquivalent |
| Maximum laserpower | 5 W (treatment) | Reduced MaximumLaser Power to 2.5 W | SubstantiallyEquivalent |
| Treatment laserpower | For the Iridex 532 Laser:50 - 2500 mW (delivered), depending on delivery device.XP Option: 0 - 5000 mW (delivered)For the Iridex 577 Laser:50 - 2000 mW (delivered), depending on delivery device.Option to maximum of 2.5 W | For the Iridex 532Laser:50 - 2500 mW(delivered), dependingon delivery device.For the Iridex 577Laser:50 - 2000 mW(delivered), dependingon delivery device.Option to maximum of2.5 WIdentical, howeverXP Option is notOffered | SubstantiallyEquivalent |
| Maximumaiming beampower | < 1 mW (aiming) | Identical (no change) | SubstantiallyEquivalent |
| ContinuousWave duration | 10 ms – 10000 ms or CW to 60 seconds | Tightened themaximum CW Pulse,which remains withinthe original durationspecification asfollows:10 ms – 3000 ms orCW to 60 seconds | SubstantiallyEquivalent |
| Characteristic | Family of IRIDEX IQ® Laser Systems, IQ532, IQ577 models (PREDICATE Device) | Iridex 532 Laser / Iridex 577 Laser (Subject Device) | Bearing on Substantial Equivalence |
| MicroPulse duration | 0.025 ms – 1.0 ms | Tightened the maximum MicroPulse duration, which remains within the original duration specification as follows:0.05 ms – 1.0 ms | Substantially Equivalent |
| Compatibility | |||
| Compatible Delivery Devices | EndoProbe® HandpiecesLaser Indirect Ophthalmoscopes (LIO) Iridex® LIO Plus (Single-Mirror) Standard 532 nm (IQ 532 Laser) Dual 810/532 nm (IQ 532 Laser) Standard 577 nm (IQ 577 Laser) TruFocus LIO Premiere® (Dual-Mirror) Standard 532 nm (IQ 532 Laser) Dual 810/532 nm (IQ 532 Laser) Standard 577 nm (IQ 577 Laser) Slit Lamp Adapters (SLA)TxCell™ Scanning Laser Delivery SystemENT Devices (IQ 532 Laser only) | Identical (no change) | Substantially Equivalent |
| Packaging & Sterilization | |||
| Packaging & Sterilization | The IQ 532 and IQ 577 Laser Consoles are supplied non-sterile.Shipping packaging has been designed to safely transport the device to end user facility | The Iridex Laser (532 nm and 577 nm models) consoles are supplied non-sterile.Change to packaging design and materials are validated per ISTA 3A | Substantially Equivalent |
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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 and the word "IRIDEX" in purple on the right. The circle is half-filled with solid purple, while the other half is made of dots.
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Image /page/10/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 logo is simple and modern.
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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 purple. The circle is half-filled with a solid purple color, while the other half is made of dots.
Performance Data
The following table summarizes nonclinical testing to standards relevant to the Iridex® Laser (532 and 577 nm models) in accordance with the requirements of the design control regulations and established quality assurance procedures.
Clinical testing was not required for this product change.
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Image /page/12/Picture/0 description: The image shows the logo for Iridex. The logo consists of a purple circle with a dotted outline on the left and the word "IRIDEX" in purple letters on the right. The font is sans-serif and the letters are evenly spaced.
| Verification/ Validation Method(s) | Acceptance Criteria | Summary of Results |
|---|---|---|
| Testing to External Standards (Testing Performed by External Test Houses) | ||
| IEC 60601-1 Electrical Safety | Meet appliable clauses of IEC60601-1 | PASS.Device meets requirements of appliableclauses of IEC 60601-1 |
| IEC 60601-2-22 Laser Safety | Meet all appliable IEC 60601-2-22test items except for EMC,Biocompatibility | PASS.Device meets requirements of appliableclauses of IEC 60601-2-22. |
| IEC 60825-1 Laser Safety | Meet appliable IEC 60825-1requirements | 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 appliableclauses of IEC 60601-1-2. |
| IEC 60601-1-6(Usability) | Meet the requirements of theappliable clauses IEC 60601-1-6 | PASS.Device meets requirements of appliableclauses of IEC 60601-1-6 |
| IEC 62304,Medical device software, Software life-cycle processes | Software lifecycle processes andactivities meet requirements ofappliable clauses of IEC 62304 | PASS.Software lifecycle processes and activitiesmeet IEC 62304 Requirements |
| Shipping and Packaging Testing | Meet ISTA 3A Testing andAcceptance Requirements for:• Preconditioning• Atmospheric Conditioning• Shock Test• Random Vibration With andWithout Top Load• Random Vibration UnderLow Pressure - Truck Portion• Random Vibration UnderLow Pressure - Air Portion• Shock TestMeet internal Iridex performancespecifications pre- and post-conditioning testing. | PASS.The test unit passed pre and post ISTA-3Atesting (Westpak testing) and Pre-andPost-conditioning testing to specification(Iridex testing). |
| Verification/ Validation Method(s) | Acceptance Criteria | Summary of Results |
| Testing to Iridex Internal Specifications | ||
| Treatment Beam Power OutputMeasured power output setting at 50,250, 500, 1000, and 2000 mW (Iridex532 and Iridex 577 models); 2500 mW(Iridex 532 model only) | Measured Power Output is PowerSetting ±20% | PASS |
| Pulse Duration/Interval (MicroPulseMode)Measured various combinations of PulseDuration and Interval settings throughoutand beyond claimed range | Measured Pulse Duration/Interval isPulse Duration/Interval Setting±10% | PASS |
| Pulse Duration/Interval (Continuous-Wave Mode)Measured various combinations of PulseDuration and Interval settings throughoutand beyond claimed range | Measured Pulse Duration/Interval isPulse Duration/Interval Setting±10% | PASS |
| Aiming Beam Power OutputMeasured power output at 0 mW and 0.7mW setting | Measured Power Output observablethroughout specified power range,±0.2 mW nominal | PASS |
| Software Verification/Validation | ||
| Software development and SoftwareVerification and Validation tasks wereperformed consistent with IEC 62304(Medical device software, Softwarelifecycle processes), and were found tomeet the requirements of IEC 62304.Software V&V tasks were performed ateach stage, previous V&V tasks revisited,or new V&V tasks initiated untilacceptance or passing criteria wereachieved for that particular task. | Each module within each of the fivefollowing Software V&V Domainsmust pass:1) Product Info Domain2) Essential (Basic) FunctionDomain3) Setting Domain4) Specials Domain5) Accessories Domain | QUALIFIEDEach module within the five SoftwareV&V Domains passed:1) Product Info Domain2) Essential (Basic) Function Domain3) Setting Domain4) Specials Domain5) Safety DomainThe software performance meets therequirements of the software requirementsspecification. |
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Image /page/13/Picture/0 description: The image shows the word "IRIDEX" in a stylized font. To the left of the word is a semi-circle made of dots, with the right side of the semi-circle filled in with a solid color. The color of the word and the semi-circle is a dark purple. The word is in all capital letters.
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Image /page/14/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, with each letter evenly spaced.
Conclusions
The Iridex Laser (532 nm and 577 nm models) devices (SUBJECT devices) share identical Intended Use, Indications for Use, Principles of Operation (technology) including energy source, Design/Technological Characteristics, and Performance, as the IQ 532 and IQ 577 Laser Systems (PREDICATE device models), all of which do not raise new questions of safety and effectiveness.
The proposed SUBJECT device models are at least as safe and effective as the legally marketed predicate devices.
§ 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.