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510(k) Data Aggregation

    K Number
    K160814
    Device Name
    Sydney IVF Sperm Cryopreservation Buffer
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY LTD
    Date Cleared
    2016-04-22

    (29 days)

    Product Code
    MQL,MOL
    Regulation Number
    884.6180
    Type
    Special
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K061371
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sydney IVF Sperm Cryopreservation Buffer is intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing.

    Device Description

    Sydney IVF Sperm Cryopreservation Buffer consists of an aqueous solution intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing. The IVF technician will use the buffer to cryopreserve washed spermatozoa, including MESA (microsurgical epididymal sperm aspiration) and TESA (testicular sperm extraction) samples. Sydney IVF Sperm Cryopreservation Buffer contains glycerol as a cryoprotectant, and HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid) as a buffer. This product is used to cryopreserve washed sperm and store them for future use.

    Sydney IVF Sperm Cryopreservation Buffer contains Human Serum Albumin (HSA) (4 mg/mL) and Gentamicin (0.01 mg/mL). The device is available as a 20 mL fill only.

    The Sydney IVF Sperm Cryopreservation Buffer is provided in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of an AI-powered medical device or diagnostic.

    The document is a 510(k) clearance letter from the FDA for a product called "Sydney IVF Sperm Cryopreservation Buffer." This product is a chemical solution, not an AI-powered device or a device that uses algorithms and data analysis in the way implied by the questions (e.g., test sets, training sets, ground truth from experts, MRMC studies).

    Therefore, I cannot populate the table or answer the specific questions about the study design because the document describes a chemical product's regulatory clearance based on "substantial equivalence" to a predicate device, focusing on its formulation, shelf-life, and biological performance (e.g., sperm survival, embryo assay), rather than the performance of an AI algorithm.

    To answer your prompt, I would need a document describing the validation of an AI-powered medical device or a related diagnostic algorithm.

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