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510(k) Data Aggregation

    K Number
    K033179
    Device Name
    MEDELA CLARIO HOME CARE PUMP
    Manufacturer
    MEDELA AG
    Date Cleared
    2003-10-15

    (14 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Type
    Abbreviated
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K983552,K862569,K941961,K932031
    Why did this record match?
    Reference Devices :

    K983552, K862569, K941961, K932031

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

    The Medela Clario Home Care Pump is intended for use in the medical field for suctioning secretions, bodily fluids and foreign objects in the nasal, pharyngeal and tracheal areas.

    The Medela CLARIO Suction Pumps are indicated for aspiration and removal of secretions, bodily fluids and foreign objects from a patient's airway or respiratory support system in the nasal, pharyngeal and tracheal areas.

    Device Description

    The Clario suction pump consists of three parts: drive unit, SafetyChamber (valve block) and canister set.

    The DC motor and gear, drive electronics, LED light (indicating battery status), the on/off switch and, in the AC/DC version, a rechargeable battery are housed in the drive unit.

    The valve block is attached to the drive unit with a turning motion. Two valve discs in the block are responsible for building up the vacuum in the suction canister.

    On the top of the valve block the vacuum level can be adjusted by the user by means of a rotating knob, selecting one of the three air bleeding orifice sizes.

    The canister set consists of canister, lid and swimmer. The canister plugs directly into the valve block.

    For operation off the mains supply a medical grade AC/DC adapter is included.

    AI/ML Overview

    The provided text is a 510(k) summary for the Medela® CLARIO™ Home Care Pump, a powered suction pump. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and detailed study designs in the way that new, higher-risk devices might.

    Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in this document because it is not required for a 510(k) submission of this nature.

    Here's a breakdown of what can be extracted and what cannot:

    1. Table of Acceptance Criteria and Reported Device Performance

    • Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics with pass/fail thresholds. For a 510(k) for a device like this, the "acceptance criteria" is primarily demonstrating substantial equivalence to existing predicate devices in terms of intended use, technological characteristics, and safety/effectiveness. This is a qualitative assessment made by the FDA.
    • Reported Device Performance: The document states: "The technology of the Clario Home Care Pump is identical to the predicate devices and there are no technical differences which would raise new aspects regarding safety and effectiveness." This is the core "performance" claim for a 510(k) in this context – its performance is equivalent to established, safe, and effective devices.
    Acceptance Criteria (Implied for 510(k))Reported Device Performance
    Substantial equivalence to predicate devices (K983552, K862569, K941961, K932031) in terms of intended use, technological characteristics."The technology of the Clario Home Care Pump is identical to the predicate devices and there are no technical differences which would raise new aspects regarding safety and effectiveness."
    Safe and effective for its intended use."Based upon the information presented above, it is concluded that the proposed Medela CLARIO Home Care Pump is safe and effective for the intended use and is substantially equivalent to the predicate devices."

    2. Sample size used for the test set and the data provenance

    • Not Applicable / Not Provided: 510(k) submissions for devices like this typically rely on comparison to predicate devices, engineering analyses, and performance bench testing rather than clinical "test sets" with patient samples in the way a diagnostic AI might. No specific test set sample size or provenance is mentioned.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Not Applicable / Not Provided: See point 2. There's no mention of a "test set" requiring ground truth established by experts.

    4. Adjudication method for the test set

    • Not Applicable / Not Provided: See point 2 and 3.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • No: This device is a powered suction pump, not an AI or imaging diagnostic device. MRMC studies are not relevant to this product.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • No: This device is a powered suction pump, not an algorithm or AI.

    7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

    • Not Applicable / Not Provided: The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices and the demonstration that the new device is technologically equivalent, thus inheriting that "truth."

    8. The sample size for the training set

    • Not Applicable / Not Provided: This is not an AI or machine learning device requiring a training set.

    9. How the ground truth for the training set was established

    • Not Applicable / Not Provided: See point 8.
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