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510(k) Data Aggregation

    K Number
    K213210
    Device Name
    Oxygen Concentrator, Model JAY-5AW
    Manufacturer
    LONGFIAN SCITECH CO., LTD.
    Date Cleared
    2022-12-08

    (435 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K131968
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Longfian Oxygen Concentrator, Model JAY-5AW is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model JAY-5AW, can be used at home or healthcare environments. The Longfian Oxygen Concentrator, Model JAY-5AW, does not nor is it intended to sustain or support life. The device is intended for use in adults.

    Device Description

    The Longfian Oxygen Concentrator, Model JAY-5AW adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method.

    The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The weight of Jay-5AW is around 16kg (~351bs). There is no influence on indoor oxygen percent during the generator operating.

    The biocompatibility contact classification of the device is as permanent contact externally communicating with dry and humified gas pathway.

    The life-time/use life of the oxygen concentrator is set at 5 years or 20.000 hours after the product is sold, whichever comes first.

    The reusable components:

    • Intake air filter (two pieces, part number:GL-01)
    • Secondary filter (one piece, part number:GL-02)
    • nasal oxygen tube and
    • humidifier.

    JAY-5AW medical oxygen concentrator contains the following items:

    • One (1) JAY-5AW Oxygen Concentrator Unit
    • One (1) AC Power Supply
    • One (1) Nasal Oxygen Tube
    • One (1) Firesafe Cannula Valve
    • One (1) Humidifier
    • One (1) Operation Manual
    AI/ML Overview

    The provided document is a 510(k) premarket notification for an Oxygen Concentrator, Model JAY-5AW. It details the device's technical specifications, indications for use, and a comparison to a predicate device. However, it does not contain information about a study proving the device meets acceptance criteria related to AI or a "human-in-the-loop" performance study of the type usually associated with the questions asked.

    The document discusses "acceptance criteria" and "device performance" in the context of non-clinical bench testing for safety and performance (e.g., biocompatibility, electrical safety, EMC, software verification, and oxygen concentration/flow performance), not for an AI-driven diagnostic or assistive device that would involve human readers, ground truth establishment by experts, or MRMC studies.

    Therefore, I cannot populate the table or answer the specific questions related to AI-driven device performance, sample sizes for test sets, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment in that context.

    The document focuses on demonstrating substantial equivalence to a predicate device through engineering and safety testing of a physical medical device (an oxygen concentrator), not a software-based AI system.

    Here's what can be extracted regarding the "acceptance criteria" and "device performance" as presented in this document for the Oxygen Concentrator:

    Acceptance Criteria and Reported Device Performance (Based on the provided document for an Oxygen Concentrator):

    Acceptance Criteria CategorySpecific Acceptance Criteria (from document)Reported Device Performance (from document)
    Oxygen Concentration93% ± 3% (at 0-5 L/min flow)93% ± 3% (Consistent with predicate device. Performance testing confirmed oxygen production capacity meets design requirements after 8 hours continuous max output.)
    Oxygen Flow0-5 L/min0-5 L/min (Consistent with predicate device. Performance testing confirmed oxygen production capacity meets design requirements after 8 hours continuous max output.)
    Input PowerPredicate: 500WSubject Device: 460W (Difference noted, but validated for safety and effectiveness through testing.)
    Outlet Pressure40-70 kPa40-70 kPa (Consistent with predicate device)
    Noise≤ 53 dB(A)≤ 53 dB(A) (Consistent with predicate device)
    FusePredicate: T6.3AL/250VSubject Device: F5AL/250V (Difference noted, but electrical safety testing conducted.)
    Operating Temperature10-40 ℃10-40 ℃ (Meets specified conditions)
    Operating Relative Humidity30%-85%30%-85% (Meets specified conditions)
    Operating Atmospheric Pressure700-1060 hPa700-1060 hPa (Meets specified conditions)
    Transportation/Storage TemperaturePredicate: -20-45 ℃Subject Device: -40-45 ℃ (Broader range, but within acceptable limits.)
    Transportation/Storage Relative Humidity≤ 95%≤ 95% (Meets specified conditions)
    Transportation/Storage Atmospheric PressurePredicate: 500-1060 hPaSubject Device: 700-1060 hPa (Different range, but implied to be acceptable.)
    BiocompatibilityCompliance with ISO18562-1, -2, -3, ISO10993-5, -10, -17Testing conducted in accordance with specified ISO standards.
    Electrical SafetyCompliance with IEC 60601-1, -1-2, -1-8, -1-11, and ISO 80601-2-69System complies with specified IEC and ISO standards.
    Electromagnetic Compatibility (EMC)Compliance with IEC 60601-1-2System complies with specified IEC standard.
    Software Verification & ValidationAdherence to FDA Guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). Moderate Level of Concern.Testing conducted, and documentation provided as recommended. (No specific performance metrics for software stated, just compliance with V&V process).
    Basic Safety & Essential PerformanceBased on ISO 80601-2-69Evaluated based on ISO 80601-2-69.

    Responses to Specific Questions (based on the provided document and its scope):

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

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

      • The document describes bench testing of a physical device (oxygen concentrator prototypes/production samples), not a study involving patient data or AI algorithm validation with a "test set" in the common sense of AI/diagnostic imaging.
      • Therefore, no information on sample sizes of patient data or data provenance (country, retrospective/prospective) is provided or relevant to the type of testing detailed in this document. The testing describes electrical, functional, and biocompatibility tests performed on the physical device itself.

    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 document is for an oxygen concentrator, not an AI diagnostic device. There is no concept of "ground truth" derived from expert interpretation of medical images or data from a patient population, nor a need for radiologists or similar experts in this context. The "truth" for this device's performance is determined by meeting engineering and safety standards.

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

      • Not applicable. There is no "adjudication method" involved as there are no expert interpretations to be reconciled.

    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. No MRMC study was performed as this is not an AI-assisted diagnostic device.

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

      • Not applicable. This is a physical medical device (oxygen concentrator), not an algorithm. The software mentioned (software verification and validation) pertains to the embedded control software of the device itself, not a standalone diagnostic algorithm.

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

      • The "ground truth" for this device's performance is adherence to established international and national standards (e.g., IEC 60601 series, ISO 80601 series, ISO 18562 series, ISO 10993 series) and its stated design specifications (e.g., oxygen concentration, flow rate). These are technical performance metrics, not clinical diagnostic "ground truth."

    8. The sample size for the training set:

      • Not applicable. There is no "training set" as this is not a machine learning/AI model.

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

      • Not applicable. No training set exists for this type of device submission.
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