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510(k) Data Aggregation

    K Number
    K161540
    Device Name
    Advanced Breast Template System
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Date Cleared
    2016-10-20

    (139 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K023220
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Advanced Breast Template System is intended for use for cancer treatment of the breast or chest wall using high dose rate HDR Brachytherapy.

    Device Description

    The Advanced Breast Template System is an applicator for interstitial Brachytherapy. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.

    The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. This device is used on male and female patients.

    The Advanced Breast Template System is compatible with the following afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™.

    The Advanced Breast Template System is CT compatible.

    AI/ML Overview

    The provided document describes the 510(k) submission for the Advanced Breast Template System, a remote controlled radionuclide applicator system used for HDR Brachytherapy in breast cancer treatment. This device is not an AI/ML powered device, therefore no information is available with respect to acceptance criteria or studies that prove an AI/ML device meets criteria.

    However, the document does contain information regarding non-clinical performance data provided in support of the substantial equivalence determination for this device.

    1. Table of acceptance criteria and the reported device performance:

    Since this is not an AI/ML device, the concept of typical 'acceptance criteria' for AI model performance (like sensitivity, specificity, AUC) does not apply. Instead, the device met various performance and safety standards for medical devices.

    Acceptance Criteria (Standards/Tests)Performance/Finding
    Biocompatibility Testing:
    ISO 10993-1, ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization, Irritation)Components categorized as medical device, surface device in contact with breached or compromised surfaces, prolonged contact duration (>24h to 30d). All tests performed.
    In accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1 for: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subacute Toxicity, ImplantationAll tests conducted, implying compliance with these standards for biocompatibility.
    Sterilization Testing:
    Validation/Efficacy Testing of Cleaning, Disinfection, Sterilization CyclesPerformed to assess effectiveness of provided procedures.
    Evaluation of components after sterilization cycles (up to stated use life) for performance and damagePerformed and evaluated, implying satisfactory performance and no significant damage affecting safety or effectiveness.
    Mechanical Testing:
    CT Compatibility Tests and AnalysisDevice is stated to be CT compatible, implying successful testing.
    Declaration of Conformity:
    ISO 10993-1, ISO 10993-5, ISO 10993-10, AAMI ANSI ST-79, AAMI ANSI ST-81, AAMI TIR-12, AAMI TIR-30, IEC 62366, EN ISO 17664Declared conformity to all listed standards, indicating adherence to relevant safety and performance requirements.

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

    • Not Applicable. This is a medical device (hardware) submission, not an AI/ML software submission. Therefore, there are no "test sets" in the context of data for model evaluation. The "tests" refer to laboratory and engineering tests on the physical device and its materials.

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

    • Not Applicable. As this is not an AI/ML device, there are no test sets requiring expert ground truth establishment.

    4. Adjudication method for the test set:

    • Not Applicable. No test sets requiring adjudication for ground truth.

    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 not an AI assistant and therefore no MRMC studies comparing human readers with and without AI assistance were conducted.

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

    • Not Applicable. This is a physical medical device, not an algorithm.

    7. The type of ground truth used:

    • Not Applicable. No ground truth in the context of AI/ML performance evaluation was used. The "ground truth" for this device's safety and effectiveness comes from adherence to established engineering, material, and medical device standards (e.g., biocompatibility standards, sterilization efficacy, mechanical integrity).

    8. The sample size for the training set:

    • Not Applicable. This is a physical medical device, not an AI/ML model, so there is no training set.

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

    • Not Applicable. No training set was used.
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