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510(k) Data Aggregation

    K Number
    K082425
    Device Name
    TANDEMHEART TRANSSEPTAL CANNULA- EF 72
    Manufacturer
    CARDIAC ASSIST, INC.
    Date Cleared
    2008-09-18

    (27 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Type
    Special
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K052570,K030398,K872033
    Why did this record match?
    Device Name :

    TANDEMHEART TRANSSEPTAL CANNULA- EF 72

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

    The TandemHeart Transseptal Cannula Set-EF 72 is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

    Device Description

    The TandemHeart Transseptal Cannula Set-EF 72 consists of three main components, a 21 Fr Transseptal Cannula, a 14 Fr Obturator, and a 14/21 Fr Two-stage Dilator which are intended for the drainage of the left atrium during left ventricular bypass.

    AI/ML Overview

    The provided text describes a 510(k) submission for a medical device, the CardiacAssist TandemHeart Transseptal Cannula Set-EF 72. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics as one might find in a full clinical trial report or a study evaluating an AI algorithm.

    Therefore, the requested information elements related to AI/algorithm performance, ground truth, expert consensus, and sample sizes for testing and training sets for an AI device are not applicable to this submission. This document pertains to a medical device's physical and functional characteristics.

    However, I can extract the information that is relevant and map it to the closest corresponding categories where possible.

    Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

    The "acceptance criteria" here are implicitly linked to the performance of the predicate devices. The study performed aims to demonstrate that the new device's performance aligns with or is substantially equivalent to these predicates.

    Acceptance Criteria (Implied by Predicate Performance)Reported Device Performance (TandemHeart Transseptal Cannula Set-EF 72)
    Flow vs. Pressure Drop (HQ) Performance (consistent with predicate THTC-EF cannula over 6 hours)Flow vs. Pressure Drop (HQ) testing indicated a flow performance after six-hour use that was consistent with the longer length and substantially equivalent to the predicate THTC-EF cannula.
    Hemolysis (consistent with predicate devices)Hemolysis testing demonstrated that the THTC-EF 72 cannula was substantially equivalent in performance to the predicate devices.
    Radiopaque Marker Disc Mechanical Integrity (consistent with predicate devices)Radiopaque marker disc testing demonstrated that the THTC-EF 72 cannula was substantially equivalent in performance to the predicate devices.
    Suture Ring Performance (consistent with predicate devices)Suture ring testing demonstrated that the THTC-EF 72 cannula was substantially equivalent in performance to the predicate devices.

    Since this is a 510(k) summary for a physical medical device and not an AI algorithm, the following points are not directly applicable or inferable from the provided text:

    1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device submission. Performance data refers to bench testing rather than patient data.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
    4. 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.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): "Ground truth" in this context would be the measured physical and mechanical properties from the bench tests, compared against the known properties of the predicate devices.
    7. The sample size for the training set: Not applicable.
    8. How the ground truth for the training set was established: Not applicable.
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