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510(k) Data Aggregation

    K Number
    K220289
    Device Name
    FridaMom Anti-Nausea Bands
    Manufacturer
    FridaBaby LLC
    Date Cleared
    2022-06-29

    (148 days)

    Product Code
    MVV
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K193374,K041877
    Why did this record match?
    Device Name :

    FridaMom Anti-Nausea Bands

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

    The FridaMom Anti-Nausea Bands are intended to reduce symptoms of nausea which may be experienced due to Travel/ Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).

    Device Description

    The FridaMom Anti-nausea Bands are adjustable wrist bands which apply pressure to the Neiguan (P6) acupressure point to relive symptoms of nausea. The bands consist of an adjustable strap with a hemi-spherical button which applies pressure to the acupressure point.

    AI/ML Overview

    The FridaMom Anti-Nausea Bands do not involve AI; therefore, many of the requested categories are not applicable. The device is a physical acupressure band.

    Here's the information based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Predicate Device K193374)Reported Device Performance (FridaMom Anti-Nausea Bands)
    Intended to reduce symptoms of nausea due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).Intended to reduce symptoms of nausea due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
    Applies pressure to the Neiguan (P6) acupressure point.Applies pressure to the Neiguan (P6) acupressure point.
    Pressure applied: 0.74 lbf (Normal), 0.26 lbf (Loose) (for Primary Predicate)Variable Pressure that ranges from 0.52 lbf to 0.80 lbf.
    Biocompatible materials (e.g., Cloth and Velcro, Medical Grade Stainless Steel).Biocompatible materials (Silicone, ABS). Assessed for biocompatibility per ISO 10993-1, ISO 10993-5, and ISO 10993-10.

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

    • Test Set Sample Size: Not applicable. This device is not an AI/software device that uses a test set in the traditional sense. The "test" involved pre-clinical force measurements on human wrists and biocompatibility testing of materials.
    • Data Provenance: The pre-clinical testing involved measurements on the 1st, 50th, and 99th percentile size female wrists to assess the force applied. The biocompatibility testing followed ISO standards, suggesting laboratory testing. No information on country of origin is specified for these tests. The study is best described as pre-clinical testing for equivalence.

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

    • Not applicable. The ground truth for this device is based on physical properties (force applied, material biocompatibility) and comparison to predicate devices, not expert human assessment of diagnostic output.

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

    • Not applicable. This is not a study that involves human readers or 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:

    • Not applicable. This is not an AI device.

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

    • Not applicable. This is not an AI algorithm.

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

    • The "ground truth" equivalent for acceptability in this submission primarily relies on:
      • Substantial Equivalence: Comparison to legally marketed predicate devices (TumEase Acupressure Bracelets and Acu-strap Travel and Motion Sickness Band) in terms of intended use, technological characteristics (pressure application, materials, dimensions), and safety/efficacy.
      • Pre-clinical Testing Results: Measurements of force applied to the Neiguan (P6) acupressure point on human wrists and biocompatibility testing of the device materials.

    8. The sample size for the training set:

    • Not applicable. This is not an AI/machine learning device that uses a training set.

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

    • Not applicable. This is not an AI/machine learning device that uses a training set.
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