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510(k) Data Aggregation

    K Number
    K221897
    Device Name
    Hydrozid Precise
    Manufacturer
    Date Cleared
    2023-05-30

    (334 days)

    Product Code
    Regulation Number
    878.4350
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Hydrozid Precise contains 1.1.1.2-tetrafluoroethane (also known as R134A, HFC-134a, HFA-134a or fluorocarbon 134a) and is to be used for the treatment of vertuca (warts), including plantar warts, seborrheic keratosis, acrochordon (skin tags), molluscum contagiosum, age spots (lentigo), dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatits, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

    Device Description

    Hydrozid Precise™ is a portable aerosol cryosurgery device intended for the treatment of benign and premalignant skin lesions using a cryogen to freeze cells to induce necrosis (cell destruction). The main device component is the aerosol canister containing cryogen spray. The device is provided in a kit containing a canister, application templates and Instructions for Use. The device is used with non-sterile, single-patient application templates which are disposed after use.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the Hydrozid Precise™ device. The submission aims to establish substantial equivalence to a predicate device, Hydrozid®. The document focuses on demonstrating that the new device is as safe and effective as the predicate, rather than providing detailed acceptance criteria and a study to prove a predetermined performance outcome. The study described is a bench test comparing the thermal profile of the new device to the predicate device.

    Here's an analysis of the available information:

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

    The document does not explicitly state acceptance criteria in terms of numerical thresholds for a specific clinical performance metric (e.g., sensitivity, specificity, accuracy) for Hydrozid Precise™. Instead, the "acceptance criterion" in this context is demonstrating substantial equivalence to the predicate device Hydrozid® in terms of its thermal profile (surface temperature, duration of surface temperature, and ice-ball formation).

    Acceptance Criteria (Implied for Substantial Equivalence)Reported Device Performance (Hydrozid Precise™)
    Capable of reaching the minimum desired temperature for cell destruction and vascular stasis in both minimum and maximum treatment time, equivalent to the predicate device.Confirmed that the cryogen R134a was capable of reaching the minimum desired temperature for cell destruction and vascular stasis in both the minimum and maximum treatment time. Performed equivalently to the predicate device Hydrozid®.
    Thermal profile (surface temperature, duration of surface temperature, and ice-ball) is equivalent to the predicate device.The bench test determined that Hydrozid Precise™ performed equivalently to the predicate device Hydrozid® in terms of its thermal profile.

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

    The document mentions a "bench test" to analyze the thermal profile. For this type of test, "sample size" typically refers to the number of devices or test conditions evaluated. However, the specific sample size used for the bench test is not provided. The data provenance (country of origin, retrospective/prospective) is also not specified, though it is likely a prospective bench study conducted by the manufacturer, BIBAWO Medical A/S, based in Denmark.

    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)

    This information is not applicable as the described study is a non-clinical bench test analyzing the thermal profile of the device, not a study involving human subjects or expert assessment of clinical outcomes. Therefore, no experts were used to establish ground truth in this context.

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

    This information is not applicable as the described study is a non-clinical bench test. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved.

    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

    A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or AI-powered devices involving human interpretation, which is not the case for this cryosurgical unit.

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

    This refers to the performance of an algorithm without human intervention. The Hydrozid Precise™ is a medical device (cryosurgical unit), not an artificial intelligence (AI) algorithm. Therefore, a standalone algorithm performance study was not done. The "standalone" performance here would refer to the device's physical function in the bench test.

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

    For the non-clinical bench test, the "ground truth" would be the measured physical properties (surface temperature, duration of surface temperature, and ice-ball characteristics) of the cryogen (R134a) under controlled experimental conditions, often established using calibrated measurement equipment. These measurements are then compared to the established performance of the predicate device.

    8. The sample size for the training set

    This information is not applicable. Cryosurgical devices are not typically "trained" in the way AI algorithms are. No training set was used.

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

    This information is not applicable as there was no training set.

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