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510(k) Data Aggregation

    K Number
    K140841
    Device Name
    TABLO CARTRIDGE
    Manufacturer
    HOME DIALYSIS PLUS
    Date Cleared
    2014-09-11

    (162 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K120823
    Predicate For
    K190793,K193670
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Tablo™ Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Tablo™ Cartridge is compatible only with the Tablo™ Hemodialysis System.

    Device Description

    The Tablo™ Cartridge comprises a single-use, sterile Blood Tubing Set attached to an Organizer. The Organizer ensures proper placement of the Blood Tubing Set with the Tablo Hemodialysis System. The Blood Tubing Set consists of an arterial line, a venous line, an adaptor to connect the two lines, a saline line, a pressure transducer protector, a venous drip chamber, an arterial pressure pod, and a heparin syringe line. The Tablo Cartridge is developed exclusively for use with the Tablo Hemodialysis System. It is single-use, offered in one configuration, and provided sterile.

    AI/ML Overview

    This document is a 510(k) summary for the Tablo™ Cartridge, a blood tubing set used for hemodialysis. It does not present a study proving the device meets acceptance criteria in the way one might expect for a clinically-oriented AI/software device. Instead, it describes performance testing to demonstrate substantial equivalence to a predicate device for a hardware medical device.

    Therefore, many of the requested fields (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance for AI, and training set details) are not applicable to this type of submission.

    Here's a breakdown based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be common for AI/software devices. Instead, it lists types of performance testing and a general conclusion of compliance.

    Acceptance Criteria CategoryReported Device Performance
    Functional TestingMet all performance specifications. The minor differences in technological characteristics (organizer, inner diameter of blood pump segment, access point configuration, pressure measuring component) did not raise new or different questions of safety or effectiveness.
    Biocompatibility TestingDemonstrated to be safe and did not raise new or different questions of safety or effectiveness.
    Packaging and Shelf Life TestingDemonstrated to be safe and did not raise new or different questions of safety or effectiveness.
    Sterilization ValidationDemonstrated to be safe and did not raise new or different questions of safety or effectiveness.
    Pyrogenicity Testing (for blood fluid path)Demonstrated to be safe and did not raise new or different questions of safety or effectiveness.
    Applicable Standards and FDA Guidance DocumentsComplies with applicable standards and FDA Guidance Documents.
    Substantial EquivalenceDetermined to be substantially equivalent to the Fresenius Blood Tubing Set (K120823).

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

    This information is Not Applicable to this document as it describes testing of a physical medical device (blood tubing set) rather than an AI/software device with a distinct "test set" of data. The testing mentioned would involve laboratory and engineering tests on physical devices.

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

    This information is Not Applicable. Ground truth, in the context of expert review for medical images or data, is not relevant for the performance testing described for a blood tubing set.

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

    This information is Not Applicable. Adjudication methods are typically used for expert consensus on ambiguous cases in the context of diagnostic AI/software.

    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

    This information is Not Applicable. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a physical device like a blood tubing set.

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

    This information is Not Applicable. There is no algorithm discussed for standalone performance.

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

    This information is Not Applicable. The "ground truth" for the performance of a blood tubing set would be established by validated engineering specifications, material standards, and functional requirements rather than medical expert consensus or pathology.

    8. The sample size for the training set

    This information is Not Applicable. Training sets are relevant for machine learning algorithms, which are not described in this submission for a physical medical device.

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

    This information is Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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