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510(k) Data Aggregation

    K Number
    K022140
    Device Name
    WHISPER WEAR BREAST PUMP
    Manufacturer
    WHISPER WEAR
    Date Cleared
    2002-09-30

    (90 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K901344
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Whisper Wear Powered Breast Pump is intended for use by lactating women to express and collect breast milk.

    Device Description

    The Whisper Wear Breast Pump is a self-contained, battery-operated device that is worn under and held in place by everyday clothing. A DC motor imparts motion to a silicone diaphragm that develops a negative pressure that expresses milk from the breast to a collection bag.

    AI/ML Overview

    The provided text describes the Whisper Wear Breast Pump and its regulatory submission, but it does not contain the detailed information requested regarding specific acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/ML-driven device.

    This document is a 510(k) premarket notification for a traditional medical device (a breast pump), and therefore, the typical performance criteria and study designs associated with AI/ML devices are not applicable. The core of this submission is demonstrating substantial equivalence to a predicate device, not establishing novel performance characteristics through a detailed clinical or algorithmic study as would be required for an AI/ML product.

    Here's a breakdown of what the document does provide, and why it doesn't fit the requested format for acceptance criteria and dedicated studies:

    1. Table of Acceptance Criteria and Reported Device Performance:

    • Acceptance Criteria Mentioned: The document states the device "complies with the following standards, practices, and guidances:"
      • 10993-1, Biological Evaluation-Part 1: Guidance on Selection of Tests
      • 10993-5, Biological Evaluation-Part 5: Tests for Cytotoxicity: In Vitro Methods
      • 10993-10, Biological Evaluation-Part 10: Tests for irritation and sensitization
      • UL 1431, Personal Hygiene and Health Care Appliances
      • UL 2601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety
    • Reported Device Performance: The document vaguely states, "This has been demonstrated through a series of bench tests including vacuum and cycle rate performance." It also mentions, "The tissue contact and milk contact materials used to fabricate the Whisper Wear Breast Pump and Collection Bags have a long history of safe usage."
    • Missing from the Request: The document does not provide specific quantitative acceptance criteria (e.g., "vacuum pressure must be > X kPa and < Y kPa") nor does it provide a table with measured performance metrics against such criteria. The "performance" is primarily described as meeting general standards and being "essentially identical to the predicate device."

    2. Sample Size for Test Set and Data Provenance:

    • Not Applicable/Not Provided: This type of information (sample size for a test set, data provenance) is typically associated with studies involving data analysis, often for AI/ML algorithms. For a breast pump, performance is demonstrated through engineering bench tests and material biocompatibility. No "test set" in the context of data is mentioned.

    3. Number of Experts and Qualifications:

    • Not Applicable/Not Provided: This relates to expert review of data for ground truth. Not relevant for a breast pump's physical performance evaluation.

    4. Adjudication Method:

    • Not Applicable/Not Provided: Not relevant for a breast pump's physical performance evaluation.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    • Not Applicable/Not Provided: This is specific to diagnostic or interpretive AI/ML systems where human readers might improve with AI assistance. Not relevant for a breast pump.

    6. Standalone (Algorithm Only) Performance:

    • Not Applicable/Not Provided: There is no algorithm; this is a mechanical device.

    7. Type of Ground Truth Used:

    • Implicitly "Bench Test Standards" and "Predicate Device Characteristics": The "ground truth" for this device's performance would be the specifications and performance of the predicate device (Medela Mini Electric® Breastpump) and compliance with relevant safety and biological standards (ISO, UL). There isn't "ground truth" derived from expert consensus, pathology, or outcomes data in the way it's used for AI/ML models.

    8. Sample Size for Training Set:

    • Not Applicable/Not Provided: No training set for an algorithm is involved.

    9. How Ground Truth for Training Set was Established:

    • Not Applicable/Not Provided: No training set or associated ground truth establishment process is described, as it's not an AI/ML device.

    In summary, the provided document details a 510(k) submission for a non-AI/ML breast pump, focusing on substantial equivalence to a predicate device and compliance with general safety and performance standards. It does not contain the specific types of data and study details that would be present for an AI/ML device seeking regulatory approval.

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