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510(k) Data Aggregation

    K Number
    K163170
    Device Name
    Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352
    Manufacturer
    CAPILLUS, LLC
    Date Cleared
    2017-01-31

    (78 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K143199,K150578,K151516,K153618,K122248,K140931
    Why did this record match?
    Reference Devices :

    K143199, K150578, K151516, K153618, K122248, K140931

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

    The Capillus laser domes 82, 202, 272 Pro, 272 OfficePro, 302, 312, and 352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.

    Device Description

    The Capillus272 Pro and Capillus272 OfficePro both consist of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner, and configured for portable use with rechargeable battery and adapter (Capillus272 Pro) and salon/spa use (Capillus272 OfficePro). The Capillus82, Capillus202, Capillus302, Capillus312, and Capillus352 are exactly the same as the Capillus272 Pro with the exception of the number of diodes which are respective of model (e.g. 82 diodes in Capillus82).

    As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (2 short beeps) or ended (one long beep). The portable systems are powered by rechargeable Li-Ion battery cells assembled into a proprietary battery pack. Both the battery are fully compliant to recognized, international standards. The OfficePro is directly powered by the DC charger, which is fully compliant to recognized, international standards.

    AI/ML Overview

    The provided document describes the acceptance criteria and the study conducted for the Capillus laser domes (Capillus 82, 202, 272 Pro, 272 Office Pro, 302, 312, and 352) to support their clearance for Over-the-Counter (OTC) sale.

    Here's the breakdown of the information requested:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Minimum 80% success rate for self-selection (box labeling) in the usability test for OTC classification.94.6% pass rate for self-selection.
    Minimum 80% success rate for comprehension of user instructions, warnings, and precautions in the usability test.90.9% pass rate for user instruction questionnaire.
    Compliance to design specifications as confirmed by performance testing.All functions verified to operate as designed; all acceptance criteria were met.
    Conformity to IEC-60825-2007-03 standard for laser class 3R (AEL of 5 milliWatts maximum).Conforms to IEC-60825-2007-03 (validated for laser class 3R, AEL of 5 milliWatts maximum).
    Charger conformity to IEC 61959.Charger conforms to IEC 61959.
    Absence of reported adverse events for the technology.No reported adverse events for this technology (consistent with predicate devices).

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

    • Sample Size: 55 adult subjects.
    • Data Provenance: Not explicitly stated regarding country of origin, but it describes a study designed to assess "real-world capability of the average adult, 'retail customer'". The study appears to be prospective, designed specifically for this submission.

    3. Number of Experts and Qualifications for Ground Truth:

    • Not Applicable. The study described is a usability test for OTC sales, not a clinical efficacy study requiring expert-established ground truth for a medical condition. The criteria evaluated were self-selection and user instruction comprehension.

    4. Adjudication Method for the Test Set:

    • Not Applicable. As this was a usability test on self-selection and comprehension, not a diagnostic or efficacy study, an adjudication method in the traditional sense (e.g., for medical image interpretation) was not used. The pass rates were objectively determined based on subjects' responses to the test components.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    • No. An MRMC comparative effectiveness study was not done. The study conducted was a usability test for OTC use, not an effectiveness study comparing human readers with and without AI assistance for a diagnostic task.

    6. Standalone (Algorithm Only) Performance Study:

    • No. This device is hardware-based (laser domes) for hair growth and does not involve an "algorithm only" component in the sense of AI or software for diagnosis or analysis. The performance data presented refers to the device's physical and user-interface compliance.

    7. Type of Ground Truth Used:

    • For the usability study, the "ground truth" was established by pre-defined correct responses for self-selection (interpreting box labeling) and user instruction comprehension. This is based on pre-established criteria for user understanding and compliance, not a medical ground truth like pathology or outcomes data.

    8. Sample Size for the Training Set:

    • Not Applicable. There is no mention of a "training set" as this is not an AI or machine learning algorithm requiring training. The document describes a usability study testing the device's instructions and labeling.

    9. How the Ground Truth for the Training Set Was Established:

    • Not Applicable. As no training set for an algorithm was used, this question is not relevant.
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