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510(k) Data Aggregation

    K Number
    K241095
    Device Name
    ARTSMedia Semen Wash Medium
    Manufacturer
    ARTSMedia Denmark ApS
    Date Cleared
    2024-12-18

    (240 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K212410
    Why did this record match?
    Reference Devices :

    K212410

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

    ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).

    Device Description

    ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).

    ARTSMedia Semen Wash Medium consists of physiological salts, energy substrates, buffering agents, Gentamicin Sulphate, and water.

    Furthermore, ARTSMedia Semen Wash Medium is aseptically filtered and provided in a volume of 20 mL. 50 mL. and 100 mL in pre-sterilized glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The ARTSMedia Semen Wash Medium is tested for pH, osmolality, endotoxin, sterility, and sperm toxicity before lot release. The device has a shelf-life of 18 months when stored at 2-8°C and is for single-use only.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called "ARTSMedia Semen Wash Medium." It compares the new device to a predicate device and presents non-clinical performance testing. However, the document does NOT contain information about a study involving an AI/Machine Learning enabled device, human readers, or the establishment of ground truth for such a study. Therefore, I cannot extract the requested information regarding acceptance criteria and study proving device performance for an AI/ML device.

    The document is solely about a reproductive media and supplements device and its substantial equivalence based on physical and chemical properties and biocompatibility, not an AI/ML diagnostic or assistive device.

    Therefore, for all the requested information, the answer will be "Not applicable / No information provided in the given text."

    Here's a breakdown of why based on the input text:

    1. A table of acceptance criteria and the reported device performance: The document provides a table comparing characteristics like pH, Osmolality, Human Sperm Survival Assay, and Endotoxin for the subject and predicate devices. These are "performance" metrics for a biological solution, but not for an AI/ML device's diagnostic accuracy or similar.
    ParameterAcceptance Criteria (from predicate/comparison)Reported Device Performance (ARTSMedia Semen Wash Medium)
    Human Sperm Survival Assay (% motility compared with control after 24 hours)≥ 80%≥ 80%
    Endotoxin (EU/ml)
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