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510(k) Data Aggregation

    K Number
    K113525
    Device Name
    ACTIVECARE DVT ACTIVECARE+SFT
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
    Date Cleared
    2012-01-31

    (63 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K023573,K060146
    Why did this record match?
    Reference Devices :

    K023573,K060146

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

    The ActiveCare DVT and ActiveCare+SFT Systems are prescription devices that induce Continuous Enhanced Circulation Therapy of the lower limbs.

    The Systems are intended for use in:

    • Preventing Deep Vein Thrombosis (DVT).
    • Enhancing blood circulation.
    • Diminishing post-operative pain and swelling.
    • Reducing wound-healing time.
    • Treatment and assistance in healing: stasis dermatitis: venous stasis ulcers: arterial and diabetic leg ulcers.
    • Treatment of chronic venous insufficiency.
    • Reducing edema.
    Device Description

    The ActiveCare DVT and ActiveCare+SFT Systems are prescription, pneumatic compression Systems designed to apply sequential compression to the lower limb. The control units of the ActiveCare DVT and ActiveCare+SFT Systems provide the user with several treatment options: compression of the foot - single or double, compression of the call - single or double, compression of the thigh - single or double, and combined compression of any combination of two sleeves. The foot compression program is an intermittent pressure pulse application to a single celled foot sleeve, The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.

    AI/ML Overview

    The provided text describes a 510(k) submission for minor modifications to the ActiveCare DVT and ActiveCare+SFT Systems. This is a premarket notification for a medical device seeking to demonstrate substantial equivalence to a legally marketed predicate device.

    Here's an analysis of the provided information regarding acceptance criteria and studies:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Maintain safety and efficacy after minor modifications."A series of performance testing, including risk analysis, electrical safety, software validation and field testing were performed to demonstrate that the modified ActiveCare DVT and ActiveCare+SFT Systems with the described modifications do not raise any new questions of safety and efficacy."
    Substantial Equivalence to predicate devices (K023573 and K060146)."The ActiveCare DVT and ActiveCare+SFT Systems are substantially equivalent in all aspects, e.q., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available Medical Compression Systems (DBN) Ltd.'s ActiveCare DVT and ActiveCare+SFT Systems, previously cleared under K023573 and K060146, respectively."

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

    The document does not specify the sample size for a "test set" in the context of clinical or performance data for the modified device. The testing described focuses on demonstrating that the modifications themselves do not raise new safety or efficacy concerns, rather than re-proving the device's original clinical effectiveness.

    The document indicates "field testing" was performed, but no details on sample size, data provenance (country of origin, retrospective/prospective), or type of data are provided.

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

    Not applicable. This submission is for modifications to an existing device, and the testing described does not involve establishing ground truth for a diagnostic or predictive algorithm. There's no mention of experts being used in this capacity.

    4. Adjudication method for the test set

    Not applicable. As noted above, this type of testing is not described.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

    No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in this document. The submission focuses on demonstrating the safety and equivalence of minor hardware and software modifications.

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

    Not applicable. The device is a pneumatic compression system, not an AI or algorithm-based diagnostic tool. The "software updates" mentioned are likely related to the control unit's operational logic, not a standalone diagnostic algorithm.

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

    Not applicable. The testing described involves performance, electrical safety, risk analysis, and software validation for the device's functionality, not a diagnostic accuracy assessment against a ground truth.

    8. The sample size for the training set

    Not applicable. This document pertains to modifications of an existing physical medical device, not a machine learning model that would require a training set.

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

    Not applicable, as there is no mention of a training set for a machine learning model.

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