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510(k) Data Aggregation

    K Number
    K013760
    Device Name
    DC-3300 LASER DIODE PHOTOCOAGULATOR
    Manufacturer
    NIDEK, INC.
    Date Cleared
    2002-02-11

    (90 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K903639,K913430,K912918
    Why did this record match?
    Device Name :

    DC-3300 LASER DIODE PHOTOCOAGULATOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nidek DC-3300 Laser Diode Photocoagulator is indicated for all retinal photocoagulation procedures, such as limited and pan-retinal, transpupillary laser photocoagulation, endophotocoagulation and transscleral photocoagulation, and glaucoma procedures, such as laser trabeculoplasty and iridotomy. The DC-3300 is used in combination with various delivery systems, such as slit lamps, binocular indirect ophthalmoscopes, endoprobes, and transscleral probes.

    Device Description

    The DC-3300 Laser Diode Photocoagulator is an 808 nm continuous wave device. The DC-3300 consists of a compact, lightweight main console, footswitch and carrying case. The aiming laser of the DC-3300 is a red diode with a wavelength of 633 nm. A number of delivery systems are available with the DC-3300. A Slit Lamp Delivery Unit (Nidek SL-1600) Multipurpose Delivery Unit for the attachment of slit lamps (Nidek SL-1600), Endophotocoagulation Set, Binocular Indirect Ophthalmoscope (Models A and B), and Transscleral Photocoagulation probes.

    AI/ML Overview

    The Nidek DC-3300 Laser Diode Photocoagulator is a device for ophthalmic photocoagulation procedures.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

    Acceptance CriteriaReported Device Performance
    Conformance to IEC 60601-1 (medical electrical equipment general requirements)Device found in conformance.
    Conformance to IEC 60601-1-2 (electromagnetic compatibility)Device found in conformance.
    Conformance to IEC 60601-1-4 (programmable electrical medical systems)Device found in conformance.
    Conformance to IEC 60601-2-22 (safety of surgical, therapeutic and cosmetic laser equipment and accessories)Device found in conformance.
    Conformance to IEC 60825-1 (safety of laser products)Device found in conformance.
    Conformance to UL 2601-1 (medical electrical equipment safety standard)Device found in conformance.
    Performance as intended"The DC-3300 was found to perform as intended." and "The DC-3300 Laser Diode Photocoagulator was found to perform as intended during validation testing."
    Substantial equivalence to predicate devices (Nidek DC-3000 and Iriderm Iris OcuLight SLx)"The DC-3300 is substantially equivalent to the Nidek DC-3000 and Iriderm Iris OcuLight SLx devices." "Product specifications and technical characteristics are within the same range of specifications for the predicate devices."

    2. Sample size used for the test set and the data provenance

    The provided text does not specify a sample size for a test set in the context of clinical performance data for patients. The performance data described relates to compliance with safety standards and functional specifications of the device itself.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    Not applicable. The study is based on engineering and safety standard compliance, not clinical ground truth established by experts.

    4. Adjudication method for the test set

    Not applicable. There is no clinical test set requiring adjudication in the provided information.

    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 is a medical device for laser photocoagulation, not an AI-assisted diagnostic or imaging device requiring human reader assessment.

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

    Not applicable. This is a standalone medical laser device, and its performance is evaluated in terms of its technical specifications and compliance with safety standards, not as an algorithm.

    7. The type of ground truth used

    The "ground truth" for this device's performance is its conformance to established international and national safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, IEC 60825-1, UL 2601-1) and its adherence to product specifications and risk analysis findings.

    8. The sample size for the training set

    Not applicable. This device is not an AI/ML model for which a training set would be required.

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

    Not applicable, as there is no training set for this type of device.

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