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510(k) Data Aggregation

    K Number
    K011606
    Device Name
    PURESPERM BUFFER
    Manufacturer
    NIDACON INTERNATIONAL AB
    Date Cleared
    2001-07-12

    (49 days)

    Product Code
    MQL,REP
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K980814,K984172,K000621
    Why did this record match?
    Device Name :

    PURESPERM BUFFER

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

    The product is intended to be used for diluting PureSperm® (K980814 and K984172) sperm separation medium to prepare the different layers of a density gradient. PureSperm® Buffer has been formulated to optimize the function of the original PureSperm®.

    Device Description

    PureSperm® Buffer is supplied as a sterile (autoclaved SAL 10-3) isotonic salt solution. It is optimised for the dilution of PureSperm® or PureSperm® 100 in the preparation of density centrifugation gradients for separating and purifying human sperm. Two layers are commonly used for the gradient: 40% and 80%. This system effectively isolates the best sperm from lymphocytes, epithelial cells, abnormal or immature sperm, cell debris and bacteria. PureSperm® Buffer is CE marked in countries of the European Union. It is supplied in 100 and 250 ml bottles.

    AI/ML Overview

    This document is a 510(k) summary for the PureSperm® Buffer, a medical device used in assisted reproduction. The information provided heavily emphasizes the substantial equivalence of the device to a predicate device rather than detailing specific performance criteria or a comprehensive study report in the way a contemporary AI/ML device submission would.

    Therefore, many of the requested points regarding acceptance criteria, performance metrics, and study design are not applicable or not provided in this 2001 510(k) submission. This is typical for device submissions from this era, especially for reproductive media which are generally considered lower risk than software-as-a-medical-device.

    Here is the information extracted and formatted to the best of what's available in the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Stated or Implied)Reported Device Performance
    Safety and Effectiveness"The results of clinical trials and comparative testing against predicate product indicates that the new device is as safe and effective as the predicate device."
    Intended Use"The intended use of the product is the same [as the predicate device]."
    Composition Similarity"Based on the similarity of composition..."
    Product Testing Results"...product testing results..." (Specific results not detailed in this summary.)

    Note: The submission relies on "substantial equivalence" to a predicate device (K000621, SpermRinse™) rather than setting and meeting de novo acceptance criteria. Specific quantitative performance metrics are not specified in this summary.

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

    • Sample Size: Not specified.
    • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "clinical trials and comparative testing," but no details are provided.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    • Number of Experts: Not specified.
    • Qualifications of Experts: Not specified.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not specified. Given the nature of the device (reproductive media) and the era of the submission, formal adjudication methods like 2+1 or 3+1 are highly unlikely to have been part of the assessment for this type of product.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

    • MRMC Study: No, an MRMC study was not done. This type of study is primarily relevant for imaging-based diagnostic devices where human readers are interpreting data, which is not the case for this reproductive media.
    • Effect Size: Not applicable.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

    • Standalone Study: Not applicable. This device is a biochemical solution, not an algorithm or AI.

    7. The Type of Ground Truth Used

    • Type of Ground Truth: Not explicitly stated. The submission primarily relies on "comparative testing" against a predicate device and "clinical trials." For reproductive media, ground truth would likely be established through in-vitro biological assays (e.g., sperm viability, motility, morphology post-processing) and potentially in-vivo outcomes data (e.g., fertilization rates, pregnancy rates in clinical use), but these details are not present in this 510(k) summary.

    8. The Sample Size for the Training Set

    • Sample Size: Not applicable. This device is a biochemical solution, not an AI/ML algorithm that requires a training set.

    9. How the Ground Truth for the Training Set was Established

    • Ground Truth Establishment: Not applicable. This device is a biochemical solution, not an AI/ML algorithm.
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