LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K093915
    Device Name
    DEKA TAC DEVICE
    Manufacturer
    DEKA RESEARCH & DEVELOPMENT CORP.
    Date Cleared
    2011-08-23

    (609 days)

    Product Code
    FIG
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K914459,K010888
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DEKA TAC is an automatic tubing clamp device intended for use in a clinical facility as an accessory to a hemodialysis blood circuit to automatically clamp the blood flow in the hemodialysis circuit upon detection of tension in the venous access line in excess of a pre-defined threshold value. The DEKA TAC may be mounted on, or removed from, already assembled hemodialysis blood circuits.

    Device Description

    The DEKA TAC is a multiple-use safety device designed to be used during hemodialysis treatments. The device mounts near the fistula needle on the patient and is designed to clip over the fistula needle tubing. It is designed to occlude the blood flow in the venous blood line should the blood circuit tubing get tangled or tugged or the fistula needle tubing rotated beyond a threshold limit. It will automatically occlude the line once tension, exceeding a pre-established value, is presented to the tubing with a threshold lower than what is required to extract the needle. This occlusion will prevent blood loss should the force on the tubing be great enough to cause the needle to be partially or fully removed from the patient.

    AI/ML Overview

    The DEKA Tension-Activated Clamp (TAC) device is an automatic tubing clamp intended for use in hemodialysis to automatically clamp blood flow upon detection of tension in the venous access line exceeding a pre-defined threshold. The 510(k) summary provides details on the device's performance through in-vitro testing.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Tubing Interface: Ability to interface with standard 5mm outer diameter hemodialysis fistula needle sets.Demonstrated using Baxter Seraflo, Nipro SafeTouch 11, and Medisystem ReadySet needle sets.
    Automatic Activation: Ability to automatically activate based on external conditions, specifically upon tension exceeding a pre-established value on the tubing.Demonstrated through "Actuation Forces Testing Section" where external forces were applied to test force threshold.
    Fluid Occlusion: Ability to fully occlude fluid flow once activated.Demonstrated by testing the effectiveness of the clamp at stopping flow and measuring the leak rate of a closed clamp.
    Response Time:Less than 0.5 seconds
    Force Threshold:Lower than what is required to extract the needle.

    2. Sample Size Used for the Test Set and Data Provenance:

    The document does not explicitly state the exact sample sizes (e.g., number of tubing sets, number of tests for each criterion) for the performance tests. The testing was described as "in-vitro testing," which typically means the data provenance is from a laboratory environment. The country of origin is not specified but implicitly North America given the applicant is a US company and the submission is to the FDA. The tests were retrospective in the sense that they were conducted to demonstrate the device's capabilities prior to submission.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

    This information is not provided. The testing appears to be objective performance measurements against technical specifications rather than relying on expert assessment for ground truth.

    4. Adjudication Method for the Test Set:

    Not applicable, as the tests involved objective measurements of device performance rather than interpretations requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    No MRMC comparative effectiveness study was mentioned. The device is a safety mechanism, and the testing focused on its functional performance rather than comparing its effectiveness in improving human reader performance with or without AI assistance.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

    Yes, the testing described is a standalone performance evaluation of the device. The "Test Results" section details "in-vitro testing" demonstrating the device's ability to:

    • Interface with standard tubing.
    • Automatically activate based on external conditions (tension).
    • Fully occlude fluid flow.
      This confirms that the device's functional capabilities were assessed independently.

    7. Type of Ground Truth Used:

    The ground truth for the performance tests appears to be based on objective technical specifications and measurable physical properties. For example:

    • Tubing Interface: Demonstrated by successful physical attachment and function with specific standard needle sets.
    • Automatic Activation: Ground truth was the pre-established tension threshold met and confirmed by the device's actuation.
    • Fluid Occlusion: Ground truth was the complete cessation of fluid flow and a negligible leak rate.

    8. Sample Size for the Training Set:

    This information is not applicable and not provided. The DEKA TAC is a mechanical device with a fixed actuation mechanism, not an AI/algorithm-driven device that requires training data.

    9. How the Ground Truth for the Training Set Was Established:

    Not applicable, as the device does not involve an AI algorithm with a training set.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1