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510(k) Data Aggregation

    K Number
    K020386
    Device Name
    INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
    Manufacturer
    INVACARE CORP.
    Date Cleared
    2002-07-02

    (146 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K991722,K990711
    Why did this record match?
    Device Name :

    INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02

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

    The intended function and use of the Invacare Model Platinum Oxygen Concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.

    Device Description

    The Invacare Model Platinum 5 Oxygen Concentrator is an electromechanical, prescription device designed for use in the home, by patients that require supplemental oxygen. Its intended function and use is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve, It is not intended to sustain or support life.

    Oxygen is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula, which are not supplied with the device. A standard humidifier bottle may be used, if desired.

    The front panel of the device contains the controls and indicators. These include a standard barb fitting for attaching the oxygen tubing, the adjustable flow meter, a power light indicator, an elapsed time meter, and a standard on/off rocker type power switch.

    AI/ML Overview

    The provided text describes a 510(k) submission for the Invacare Model Platinum 5 Oxygen Concentrator. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the format requested.

    The document primarily focuses on establishing substantial equivalence to a predicate device (Sunrise Medical Model DeVilbiss 5 Liter Oxygen Concentrator K990711) and confirming that the device was tested to relevant performance requirements.

    Here's an attempt to answer your questions based on the available information, highlighting what is not present:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Inferred from "Required Performance Criteria")Reported Device Performance
    Electrical, Mechanical, and Environmental Performance for home use respiratory devices as set forth in the Anesthesiology and Respiratory Devices Branch's November 1993 document: "Reviewer Guidance for Pre-market Notification Submissions.""In all instances, the device met the required performance criteria and functioned as intended."
    Intended Use: Provide supplemental oxygen to patients with respiratory disorders by separating nitrogen from room air via a molecular sieve. (Note: Not intended to sustain or support life.)The device's description and intended use align with this, and the performance testing indicates it fulfills this function.

    Missing Details: The specific numerical or qualitative thresholds for "electrical, mechanical, and environmental performance" are not detailed in this document. For example, specific oxygen concentration purity, flow rates, noise levels, or operating temperatures are not provided as acceptance criteria.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Sample Size: Not specified. The document only states "The Invacare Model Platinum Oxygen Concentrator was tested..." without detailing the number of units tested.
    • Data Provenance: Not specified, but given Invacare Corporation is based in Elyria, Ohio, USA, it's highly probable the testing was conducted in the USA.
    • Retrospective or Prospective: Not specified. It's likely prospective testing conducted specifically for this submission.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    Not applicable. This type of medical device (oxygen concentrator) does not typically involve expert interpretation for establishing "ground truth" in the way an imaging or diagnostic AI device would. Performance is assessed through objective measurements (e.g., oxygen concentration, flow rate, safety tests) against engineering and regulatory standards.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    Not applicable. See point 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

    Not applicable. This device is an oxygen concentrator, not an AI-powered diagnostic or assistive tool for human readers.

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

    Not applicable. This document describes a physical medical device, not a software algorithm. The "performance" refers to the device's physical operation.

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

    The "ground truth" for this type of device would be objective measurements against established technical standards and specifications (e.g., oxygen purity measured by sensors, flow rate measured by flowmeters, safety compliance with electrical safety standards, environmental testing for durability).

    8. The sample size for the training set

    Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

    Not applicable. See point 8.

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