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510(k) Data Aggregation

    K Number
    K091581
    Device Name
    SUPRA 577.Y LASER
    Manufacturer
    QUANTEL MEDICAL
    Date Cleared
    2009-06-16

    (14 days)

    Product Code
    HQF,HOF
    Regulation Number
    886.4390
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    K071687
    Why did this record match?
    Device Name :

    SUPRA 577.Y LASER

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

    The SUPRA 577.Y Laser is 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 choroids including: Proliferative and nonproliferative diabetic retinopathy, choroidal neovascularization, branch retinal vein occlusion, age-related macular degeneration, retinal tears and detachments, retinopathy of prematurity; Iridotomy, iridectorny and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

    Device Description

    The Quantel SUPRA 577.Y Laser is a semi conductor laser which emits a beam of coherent light The Qualiter SUPRA 577.1 Lase 16 a delivery site(s) via delivery systems/devices.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the Quantel SUPRA 577.Y Laser, a medical device for ophthalmic photocoagulation. The application focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with acceptance criteria and performance data.

    Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance are not available in the provided document. The submission relies on non-clinical data and comparison to the predicate device to establish safety and effectiveness.

    Here's a breakdown of what can be extracted based on your request:

    Acceptance Criteria and Device Performance

    Since this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" in the sense of predefined performance targets for a clinical study are not reported. Instead, the acceptance is based on the device meeting design specifications and demonstrating safety and effectiveness equivalent to a legally marketed predicate device.

    Acceptance Criteria (Implicit for Substantial Equivalence)Reported Device Performance (Non-Clinical Validation)
    Shares "same indications for use" as predicateConfirmed in Section V and Section VI
    Shares "safety compliance" as predicateConfirmed in Section VI
    Shares "similar design features" as predicateConfirmed in Section VI
    Shares "equivalent wavelengths" with predicateConfirmed in Section VI
    Shares "equivalent power" with predicateConfirmed in Section VI
    Shares "equivalent exposure time" with predicateConfirmed in Section VI
    Performs "same indicated surgical procedures"Confirmed in Section VI
    Complies with mandatory and voluntary performance standards (e.g., IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2)Confirmed in Section VII
    Complies with European Medical Directive 93/42/EECConfirmed in Section VII
    Complies with US Federal Performance Standards (21 CFR 1040.10, 21 CFR 1040.11, Laser Notice 50)Confirmed in Section VII
    Complies with 21 CFR Part 820 – Quality System RegulationConfirmed in Section VII
    ISO 9001 and 13485 System CertificationConfirmed in Section VII
    Met all design specificationsConfirmed in "Non clinical Conclusion"

    Study Details

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

      • Not applicable / Not provided. The submission states "No Clinical information is required" (Section VII, Clinical Conclusion). The equivalence is based on non-clinical laboratory testing and comparison of technical specifications to the predicate device.

    2. 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 / Not provided. No clinical test set requiring expert ground truth was performed for this 510(k) submission.

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

      • Not applicable / Not provided. No clinical test set requiring adjudication was performed.

    4. 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. This device is a laser for photocoagulation, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

      • Not applicable. This device is a therapeutic laser operated by a human, not a standalone algorithm. Performance validation relates to its physical output and safety, not an algorithmic assessment.

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

      • For the non-clinical validation, the "ground truth" was adherence to established engineering and medical device standards (e.g., IEC standards, CFR regulations) and validation against the design specifications of the device itself and the predicate device's specifications. No biological or clinical ground truth (like pathology or outcomes data) was used or required for this submission.

    7. The sample size for the training set:

      • Not applicable / Not provided. This is not an AI/machine learning device that requires a training set. The device's design and performance are based on engineering principles and regulatory standards.

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

      • Not applicable / Not provided. As there is no training set, there is no ground truth for it.
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