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510(k) Data Aggregation

    K Number
    K181651
    Device Name
    Radial Medical Compression System
    Manufacturer
    Radial Medical, Inc.
    Date Cleared
    2018-10-12

    (112 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K122609
    Predicate For
    K190976
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Radial Medical Compression System is indicated 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 Radial Medical Compression System (RMCS) is a light weight, mobile, sequential compression device (SCD) placed around the lower leg. The device is designed to provide sequential compression to the calf to augment blood flow. The system includes three components: the Cirvo sequential compression device, an inductive charging cradle and a smart device app (i.e. tablet or smartphone). The RMCS records the amount and duration of compression received during a therapy session as well as compliance with the prescribed therapy. Identified patient data, and compiled, de-identified data will be shared with the treating physician to facilitate clinical decision making.
    The Cirvo uses a mechanical system to sequentially compress the leg utilizing four tension zones tensioned in series. A circumferential sleeve of polyester material is placed around the calf, held in place using hook and loop straps. During the compression cycle, a reduction in the effective circumference of the sleeve exerts a radially inward force on the calf. The device has a compression cycle time of 6 seconds and a physician-determined dwell time between compression cycles. The range of compression cycle pressures of the Cirvo is 40-60 mmHg.

    AI/ML Overview

    The provided text describes the Radial Medical Compression System (RMCS) and its clearance via a 510(k) pathway, demonstrating substantial equivalence to a predicate device. However, the information provided does not include the details typically found in a study proving an AI/device meets acceptance criteria using a test set with ground truth established by experts and adjudication methods, nor does it describe a multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisted by AI.

    The document outlines performance testing for a medical device (a sequential compression system) for therapeutic purposes, not an AI or diagnostic device that would require the establishment of ground truth for a test set, expert consensus, or specific acceptance criteria around diagnostic performance metrics like sensitivity, specificity, or AUC.

    Therefore, I cannot directly answer your prompt's specific requirements regarding acceptance criteria and a study proving an AI device meets those criteria, as the provided text describes a mechanical medical device and its validation for FDA clearance, which focuses on device performance, safety, and substantial equivalence to a predicate.

    However, I can extract the closest analogous information from the provided text regarding the device's performance testing and clinical evaluation.

    Based on the provided text, here's an attempt to extract relevant details, acknowledging that it's for a mechanical device and not an AI/diagnostic system as implied by the prompt's structure:

    The Radial Medical Compression System (RMCS) is a light-weight, mobile, sequential compression device (SCD) designed to provide sequential compression to the calf to augment blood flow. Its clearance was based on demonstrating substantial equivalence to a legally marketed predicate device (Vasculaire Compression System, K122609).

    Acceptance Criteria and Reported Device Performance

    The document does not explicitly present a table of "acceptance criteria" for diagnostic performance (as would be typical for an AI device) but rather functional and safety performance specifications. The "performance" assessment is primarily comparative and related to its intended physiological effect.

    Table 1: Key Performance Attributes and Comparison (Extracted from "Summary Comparison to Predicate" and "Clinical Performance Testing")

    AttributeAcceptance Criteria (Implied / Compared to Predicate)Reported Device Performance (Radial Medical Compression System)
    Pressure DeliveredWithin specified physiological range and comparable to predicate. The predicate delivers 50-150 mmHg.40 – 60 mmHg
    Therapy Delivery ModeSequential compression of calf from caudal to cranial to augment venous flow. Similar to predicate.Mechanical system, four tension zones, tensioned in series. Delivered as sequential compression from caudal to cranial.
    Clinical EffectAugment venous flow (measured as peak venous velocity); comparable or superior to baseline and predicate.- Average 3.5-fold femoral venous flow augmentation (high setting).
    • Radial device (low/high setting) resulted in higher average peak venous velocities compared to baseline and IPC device (p
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