LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K102737

    Validate with FDA (Live)

    Device Name
    KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
    Manufacturer
    Covidien LLC
    Date Cleared
    2010-10-19

    (27 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K040511
    Predicate For
    K120944,K122499,K142728
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Kendall SCD 700 Sequential Compression System (hereby referenced as "Kendall SCD 700 Series") is designed to apply intermittent pneumatic compression to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.

    The System consists of the controller, the tubing sets (provided with the controller) and singlepatient use garments (purchased separately from this controller). The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression cycle has reached set pressure, the Controller measures the time it takes for the limbs to refill with blood and waits that period of time before the next compression is initiated.

    The use of the Kendall SCD 700 Series Compression System with Leg Sleeves is indicated for:

    • Deep vein thrombosis and pulmonary embolism prophylaxis. .
      The use of the Kendall SCD 700 Series Compression System with Foot Cuffs is indicated for:

    • Circulation enhancement. .

    • Deep vein thrombosis prophylaxis. .

    • Edema Acute. .

    • Edema Chronic. .

    • Extremity pain incident to trauma or surgery. .

    • . Leg Ulcers.

    • Venous stasis / venous insufficiency.. .

    Device Description

    The Kendall SCD™ 700 Sequential Compression controller is an intermittent pneumatic compression device for applying sequential, gradient pressure to a patient's limbs for the prevention of DVT and PE. The controller delivers air though the tubing sets to the pair of disposable garments (one for each limb).

    AI/ML Overview

    Device Acceptance Criteria and Performance Study

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device PerformanceOutcome
    Electric SafetyCompliance with IEC 60601-1 and UL60601-1Testing performed according to specified standards.Passed
    Electromagnetic CompatibilityCompliance with IEC 60601-1-2 and EN55011Testing performed according to specified standards.Passed
    Enclosure ProtectionCompliance with IEC 60529Testing performed according to specified standards.Passed
    General Controller FeaturesVerification and Validation of features to match predicate device.Design Verification and Validation testing performed.Substantially Equivalent
    Compression Cycle OperationVerification and Validation of compression parameters and function to match predicate device.Design Verification and Validation testing performed.Substantially Equivalent
    Controller Alarm and Test ModesVerification and Validation of alarm and test mode functionality to match predicate device.Design Verification and Validation testing performed.Substantially Equivalent
    Battery OperationsVerification and Validation of battery performance and functionality to match predicate device.Design Verification and Validation testing performed.Substantially Equivalent
    BiocompatibilityAll components comprised of materials in accordance with ISO Standard 10993-1.Statement of compliance with ISO Standard 10993-1.Compliant
    Intended UseDevice's intended use matches predicate device: intermittent pneumatic compression for DVT and PE prevention.Device is identical to predicate device in terms of intended use.Identical
    Mode of FunctionDevice's mode of function matches predicate device.Device is identical to predicate device in terms of mode of function.Identical

    Note: The reported device performance indicates that the Kendall SCD™ 700 Controller met all specified criteria, demonstrating substantial equivalence to the predicate device (Kendall SCD Express™ Portable Compression System, K040511).

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

    The provided 510(k) summary does not specify the sample size for the individual tests (Electric Safety, Electromagnetic Compatibility, Enclosure Protection, Design Verification and Validation testing). It only states that "Testing was performed" for each category.

    The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be prospective as they involved performance testing on the proposed Kendall SCD 700 Controller to compare it to the predicate device.

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

    The 510(k) summary does not mention using experts to establish ground truth for the performance testing. The evaluation primarily relies on engineering and technical standards compliance (IEC, UL, EN, ISO) and functional verification against a predicate device.

    4. Adjudication Method for the Test Set

    The 510(k) summary does not describe any adjudication method. Given the nature of the testing (compliance with standards and functional verification), adjudication by multiple external reviewers is typically not applicable in the same way it would be for a clinical trial evaluating diagnostic accuracy.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the purpose of this submission. The device is a physical medical device (sequential compression controller), not an AI-powered diagnostic tool.

    6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

    No, a standalone (algorithm only) performance study was not done. This device is a hardware system, not an algorithm. The "performance data" refers to the device's physical and functional attributes, not algorithmic accuracy.

    7. The Type of Ground Truth Used

    The "ground truth" for the performance testing of the Kendall SCD™ 700 Sequential Compression Controller relies on:

    • Engineering and Safety Standards: Compliance with established international and national standards such as IEC 60601-1, UL60601-1, IEC 60601-1-2, EN55011, and IEC 60529.
    • Predicate Device Performance: The functional behavior (General Controller Features, Compression Cycle Operation, Controller Alarm and Test Modes, Battery Operations) of the legally marketed predicate device (Kendall SCD Express™ Portable Compression System, K040511) serves as the benchmark for substantial equivalence.
    • Biocompatibility Standards: Compliance with ISO Standard 10993-1 for materials.

    No "expert consensus," "pathology," or "outcomes data" in a clinical diagnostic sense was used as ground truth for this device's engineering performance evaluation.

    8. The Sample Size for the Training Set

    This question is not applicable to the Kendall SCD™ 700 Sequential Compression Controller. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

    This question is not applicable for the reasons stated in point 8.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1