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510(k) Data Aggregation

    K Number
    K161337
    Device Name
    CryoDose H or Similar
    Manufacturer
    NUANCE MEDICAL, LLC
    Date Cleared
    2016-07-12

    (60 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K911420,K924114,K971392,K103310,K990877
    Predicate For
    K233347
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CryoDose H indications for use as follows: CryoDose H is indicated for use in the treatment of actinic keratosis, genital warts, lentigo, mulluscum contagiosum, sebortheic keratosis, skin tags, verruca vulgaris, and verruca plana.

    Device Description

    The proposed device, CryoDose H, is used in the practice of dermatology in the treatment of benign skin lesions using a cryogen spray system. The device consists of an aerosol-filled canister and parts within the canister. The canister is sold within a kit with accessories including: Directions for Use, swabs, and packaging materials. The aerosol is sprayed onto a foam covered cotton swab that is then placed upon the benign lesion (e.g. wart) for 15-40 seconds.

    AI/ML Overview

    The provided document describes the acceptance criteria and study for the Nuance Medical, LLC CryoDose H device.

    Here's the breakdown of the information requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Measured by)Reported Device Performance and Methodology
    Biocompatibility: Absence of cytotoxicity, sensitization, and irritation from patient contact materials (foam-tipped swab applicators). (ISO 10993 Part 1)Biocompatibility testing performed on foam-tipped swab applicators, categorized as external, short-term contact (< 24 hours). Tests included cytotoxicity, sensitization, and irritation. Outcome: Compliant (ensures finished device is biocompatible).
    Chemical Composition: Identical chemical composition of cryogen (95% dimethyl ether, 2% propane, 3% isobutane) to the predicate device.Chemical composition confirmed for the proposed device's aerosol upon receipt from the supplier to ensure it matches the predicate: 95% dimethyl ether, 2% propane, and 3% isobutane.
    Structural and Parts Composition: Canisters, valves, and caps are identical or substantially equivalent to the predicate device.Engineering verification measurements and visual inspections were made to determine that the canisters, valves, and caps were identical or substantially equivalent between the predicate and the proposed device.
    Instructions for Use (Clinical Use) Application and Methodology: Substantial equivalence of instructions for use and product claims to the predicate device.Side-by-side comparison of Instructions for Use from the predicate device and the proposed device. Outcome: No substantial differences exist between the predicate and proposed device's Instructions for Use.
    Cryogen Performance (Output Temperature): Substantially similar output temperature of the cryogen from the canister, on the applicator foam tips, and formation of an "ice ball".Comparative Cryogen Performance testing was conducted. Measures included: 1. Output nozzle exit temperature of the cryogen from the canister. 2. Cryogen-saturated applicator foam tips temperature. 3. Visual confirmation for "ice ball" on neoprene-backed practice pads. Outcome: Practical test assessments determined substantial equivalence to the predicate device.
    Stability and Shelf Life: Maintenance of identity, strength, quality, and purity throughout the labeled dating period.A stability protocol was developed. Testing assessments were conducted under controlled conditions at room temperature and under accelerated conditions. Outcome: Protocol developed to ensure product is maintained throughout its labeled dating period. (Implied successful completion as part of the overall conclusion of safety and effectiveness).

    2. Sample Size Used for the Test Set and the Data Provenance

    • Test Set Sample Size: The document does not explicitly state a specific numerical sample size for each test (e.g., number of foam tips tested for biocompatibility, number of cans for chemical composition, number of devices for temperature testing). The description indicates "Tests were performed" and "Studies were conducted" which implies samples were used.
    • Data Provenance: Not explicitly stated. However, given this is an FDA 510(k) submission, the studies would have been conducted by or for Nuance Medical, LLC, likely in a controlled laboratory setting. There is no mention of country of origin for data, nor if it was retrospective or prospective in a clinical sense, as the studies are primarily bench and lab-based (biocompatibility, chemical, structural, temperature performance).

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    • Number of Experts: Not applicable or not specified. The tests described are primarily objective, bench-top engineering, chemical, and biological assessments, not requiring expert human interpretation of observational data to establish ground truth in the typical clinical sense.
    • Qualifications of Experts: Not applicable or not specified for these types of tests. The tests would be performed by qualified laboratory personnel following established protocols.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not applicable. The tests involve objective measurements (e.g., chemical analysis, temperature readings, visual inspections, biological assay results) and comparisons to predetermined criteria or the predicate device, rather than subjective assessments requiring adjudication.

    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

    • MRMC Study: No. This device is a cryosurgical unit (cryogen spray and applicators), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this submission.

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

    • Standalone Performance: Not applicable. This is a physical medical device for cryosurgical treatment and does not involve an algorithm or AI.

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

    • Type of Ground Truth: The ground truth for this device is primarily established by:
      • Predicate Device Equivalence: The safety and effectiveness of CryoDose H are established by demonstrating substantial equivalence to the legally marketed predicate device, Histofreezer. This means the predicate device's established safety and efficacy serve as the "ground truth" for the new device.
      • Objective Criteria: For specific tests, the ground truth is based on objective, measurable criteria:
        • Biocompatibility: Established ISO 10993 standards and pass/fail criteria for cytotoxicity, sensitization, and irritation.
        • Chemical Composition: Quantitative chemical analysis results matching the specified formula.
        • Structural/Functional Equivalence: Engineering specifications, measurements, and visual inspection confirming identity or substantial equivalence.
        • Temperature Performance: Objective temperature measurements and visual confirmation of physical effects (ice ball).

    8. The sample size for the training set

    • Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the context of algorithm development.

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

    • Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
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