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510(k) Data Aggregation

    K Number
    K101538
    Device Name
    HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)
    Manufacturer
    PHILIPS ELECTRONICS UK LIMITED
    Date Cleared
    2010-11-05

    (155 days)

    Product Code
    HGY,HGW
    Regulation Number
    884.5150
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K052047,K823591,K828340
    Why did this record match?
    Reference Devices :

    K052047, K823591

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

    The Philips Avent Manual Breast Pump is intended to express and collect milk from the breasts of a lactating woman.

    Device Description

    The Philips Avent Manual Breast Pump expresses and collects milk from the breast of a lactating woman. The device is designed to be reusable by a single user. The pump diaphragm is activated by a manual pivoting handle. The duckbill valve closes to prevent backflow and seal the device under negative pressure as the handle is depressed. The valve then relaxes to allow milk flow into the bottle between pump actuations. Pumping can only be performed on one breast at a time. The vacuum level can be adjusted to comfort by varying the speed and travel of the manual handle. The device is comprised of the manual breast pump parts and feeding bottle. The Philips Avent Manual Breast Pump operates in one mode - manual. In the manual mode, the user controls the frequency and level of vacuum by varying the stroke/cycle of the control handle lever. All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.

    AI/ML Overview

    This document is a 510(k) summary for the Philips Avent Manual Breast Pump, seeking to establish substantial equivalence to predicate devices. The study conducted is a performance test comparing the subject device to existing predicate devices, focusing on vacuum pressure levels.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implicit)Reported Device Performance (Philips Avent Manual Breast Pump)
    Maximum pressure under normal use should be comparable to predicate devices and generally fall within approximately -240 to -300 mmHg. (Inferred from predicate device performance.)Average: -249 mmHg; Top Outlier: -258.9 mmHg
    Maximum pressure under worse-case use should not exceed 350 mmHg. (Stated directly.)Average: -328 mmHg; Top Outlier: -338.8 mmHg
    Biocompatibility: Materials should not be cytotoxic, irritating, or a dermal sensitizer.Not cytotoxic, irritating, or a dermal sensitizer

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

    • Sample Size:
      • For vacuum pressure testing: Not explicitly stated as a number of devices tested, but it mentions "All devices were tested" for the subject device and the two predicate devices. This implies at least one of each device was tested, but more details like replicates are not provided.
      • For biocompatibility: Not specified in terms of sample size of materials or tests.
    • Data Provenance: The document does not specify the country of origin for the data. The study appears to be a prospective performance test specifically conducted for this 510(k) submission, comparing the new device against existing ones under controlled conditions.

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

    • This information is not applicable. This study is a technical performance test (measuring vacuum pressure and biocompatibility), not a study requiring expert interpretation of diagnostic images or clinical outcomes to establish ground truth. The "ground truth" here is the physical measurement of pressure and the results of standardized biocompatibility tests.

    4. Adjudication Method for the Test Set

    • This information is not applicable. As this is a technical performance test rather than a clinical trial requiring subjective assessments, there is no mention of an adjudication method.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

    • No, an MRMC comparative effectiveness study was not done. This device is a manual breast pump, and the study focuses on its physical performance characteristics (vacuum pressure and biocompatibility) compared to predicate devices, not on human reader performance with or without AI assistance.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

    • This information is not applicable. This device is a physical, non-electronic medical device (a manual breast pump) and does not involve an algorithm or AI.

    7. The Type of Ground Truth Used

    • Vacuum Pressure: The ground truth used was direct physical measurement of vacuum pressure (in mmHg) under specified operating conditions (recommended use and worse-case use).
    • Biocompatibility: The ground truth was established by standardized laboratory tests for cytotoxicity, irritation, and dermal sensitization, which provide objective results based on established protocols (e.g., ISO10993).

    8. The Sample Size for the Training Set

    • This information is not applicable. This is not an AI/ML device, so there is no training set in the typical sense.

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

    • This information is not applicable. As there is no training set, there is no ground truth established for one.
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