LogoFDA 510(k) Search
K Number
K050562
Device Name
OCULIGHT GL/GLX
Manufacturer
IRIDEX CORP.
Date Cleared
2005-04-14

(42 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The IRIDEX OcuLight GL/GLx is used in ophthalmic, dermatology, and ear nose and throat (ENT) applications. Specific indications are listed below:
Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy): Retinal Photocoagulation (RPC); Focal and Grid Laser Treatments
Glaucoma (Primary Open Angle, Closed Angle): Laser Trabeculoplasty; Iridotomy, Iridoplasty
Retinal Tears and Detachments: RPC; Focal and Grid Laser Treatments
Lattice Degeneration: RPC; Focal and Grid Laser Treatments
Age-related Macular Degeneration (AMD): RPC; Focal and Grid Laser Treatments
Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma): RPC; Focal and Grid Laser Treatments
Retinopathy of Prematurity: RPC; Focal and Grid Laser Treatments
Sub-Retinal (choroidal) Neovascularization: RPC; Focal and Grid Laser Treatments
Central and Branch Retinal Vein Occlusion: RPC; Focal and Grid Laser Treatments
Dermatology (Pigmented Skin Lesions, Vascular lesions): Focal Laser Treatments
Ear, Nose and Throat (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

Device Description

The OcuLight GL/GLx is a semiconductor-based laser that delivers true continuous wave green laser (532 nm) light for the indication of retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. Visible red (630-650 nm) semiconductor diode laser is used for aiming.

AI/ML Overview

This looks like a 510(k) summary for a medical device seeking clearance, rather than a study proving a device meets acceptance criteria. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, which often relies on demonstrating similar technological characteristics and comparable performance without necessarily conducting extensive de novo clinical studies with predefined acceptance criteria.

Based on the provided document:

  1. A table of acceptance criteria and the reported device performance:

    • The document does not provide a table of acceptance criteria or reported device performance in the way one would see for a clinical study with specific performance metrics (e.g., sensitivity, specificity, accuracy).
    • Instead, it states that the device, IRIS Medical OcuLight GL/GLx, is "substantially equivalent" to legally marketed predicate devices, specifically the OcuLight SL/SLx systems and the Lumenis Novus Spectra (K022327).
    • The basis for this substantial equivalence is primarily rooted in the device's intended use, technological characteristics (wavelength, pulse duration, spot size, energy densities), and the expansion of indications for use not requiring changes to hardware or firmware.
      • Key comparative points mentioned:
        • OcuLight GL/GLx: True continuous wave green laser (532 nm).
        • Lumenis Novus Spectra: Delivers the same 532nm wavelength, pulses of equivalent duration, treatment spots of equivalent size, and equivalent energy densities to the OcuLight GL/GLx.
        • OcuLight SL/SLx: Uses 810 nm wavelength diode laser. The comparison here is largely about the existence of similar devices for ophthalmic and other applications, rather than direct numerical performance comparison for the 532nm device against the 810nm device. The expansion of indications for GL/GLx to include ENT applications is justified by the existence of Lumenis Novus Spectra with similar technology for these applications.

  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • Not applicable. The submission explicitly states "Non-Clinical performance Data: None" and "Clinical performance Data: None." This indicates that no new clinical or non-clinical studies with test sets were conducted for this 510(k) submission to demonstrate performance against specific criteria. The argument for substantial equivalence relies on existing knowledge of the predicate devices and the physical characteristics of the new device.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

    • Not applicable. As no test set performance data was provided, there was no need for experts to establish ground truth for such a set.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not applicable. No test set was used.

  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:

    • Not applicable. This device is a laser system, not an AI-assisted diagnostic tool. No MRMC study was mentioned.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This is a physical laser device, not a standalone algorithm.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • Not applicable. No ground truth data was generated or used in this submission as no new clinical or non-clinical performance studies were conducted.

  8. The sample size for the training set:

    • Not applicable. This is a hardware device; machine learning training sets are not relevant here.

  9. How the ground truth for the training set was established:

    • Not applicable. See point 8.

In summary: The provided document is a 510(k) summary for a laser surgical instrument. It demonstrates substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting new clinical study data with predefined acceptance criteria and performance results. Therefore, most of the requested information regarding study design, sample sizes, and ground truth establishment is not present in this type of submission.

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.