LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K192644
    Device Name
    GM501 SpermAir and GM501 SpermActive
    Manufacturer
    Hamilton Thorne Incorporated
    Date Cleared
    2020-04-23

    (212 days)

    Product Code
    MQL,MOL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K190199
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GM501 SpermAir is intended for the handling and preparation of sperm for use in assisted reproduction procedures. GM501 SpermAir is not intended for use in intrauterine insemination procedures.

    GM501 SpermActive is intended for the handling and preparation of sperm for use in assisted reprocedures. GM501 SpermActive is not intended for use in intrauterine insemination procedures.

    Device Description

    GM501 SpermAir and GM501 SpermActive are ready-to-use solutions for handling and preparation of sperm cells during assisted reproduction procedures. Both devices are aseptically filled into sterilized bottles and sealed. GM501 SpermAir comes in three volumes: 2 ml, 20 ml, and 50 ml. GM501 SpermActive comes in two volumes: 20 ml and 50 ml. Both media have a six-month shelf-life when stored as recommended and can be used for up to seven days after opening.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the GM501 SpermAir and GM501 SpermActive devices, based on the provided FDA 510(k) summary:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    pH7.2-7.5 (GM501 SpermAir/SpermActive)
    Osmolality (mOsm/kg)270-290 (GM501 SpermAir/SpermActive)
    Sterility (per USP <71>)No growth (demonstrated through testing)
    Bacterial Endotoxins (per USP <85>)< 0.25 EU/ml (demonstrated through testing)
    Human Sperm Survival Assay (HSSA)≥ 80% of control motility at 24h (demonstrated through testing)
    Shelf-life6 months (demonstrated through testing for HSSA, sterility, pH, osmolality, and endotoxins)
    Stability after bottle openingDevice specifications met for seven days after opening (HSSA, sterility, pH, osmolality, and endotoxins)
    Aseptic filling informationCompliant with ANSI/AAMI/ISO 13408-1:2008(R)2011, ANSI/AAMI/ISO 13408-2:2003(R)2013
    Simulated shipping and distribution testingDemonstrated (details of outcome not provided, but implies successful testing)

    Additional Study Information:

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

      • The document does not explicitly state the sample sizes for the individual performance tests (pH, osmolality, sterility, endotoxins, HSSA, shelf-life, stability after opening, aseptic filling, shipping).
      • The data provenance is not specified (e.g., country of origin, retrospective/prospective). These were non-clinical performance tests, usually conducted in a controlled laboratory environment.

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

      • This information is not provided as the tests are for objective analytical performance rather than subjective interpretation by experts. For example, pH is measured by a meter, not by expert consensus.

    3. Adjudication method for the test set:

      • Not applicable, as the tests are objective analytical measurements against predefined criteria.

    4. 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:

      • No MRMC study was conducted. This device is a reproductive media for sperm handling, not an AI or imaging device involving human readers.

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

      • Not applicable. This device is a chemical medium, not an algorithm. The performance tests are measurements of its chemical and biological properties.

    6. The type of ground truth used:

      • For most parameters (pH, osmolality, endotoxins, sterility), the ground truth is established by objective analytical measurements using validated laboratory methods and instruments, comparing them to established scientific or regulatory limits (e.g., USP standards).
      • For the Human Sperm Survival Assay (HSSA), the ground truth is based on biological outcomes (sperm motility compared to a control) measured quantitatively.

    7. The sample size for the training set:

      • Not applicable. This is not a machine learning or AI device that requires a training set. The performance studies are conducted to characterize the product's properties.

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

      • Not applicable, as there is no training set for this type of device.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1