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510(k) Data Aggregation

    K Number
    K222791
    Device Name
    SafeBreak Vascular
    Manufacturer
    Lineus Medical, LLC
    Date Cleared
    2022-10-16

    (31 days)

    Product Code
    QOI
    Regulation Number
    880.5220
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K212064
    Why did this record match?
    Reference Devices :

    K212064

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

    SafeBreak® Vascular is intended to separate when is exerted across a peripheral IV administration set. When SafeBreak@ Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV catheter. SafeBreak® Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak® Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.

    Device Description

    SafeBreak® Vascular is placed in-line with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device has been shown to reduce the risk of IV catheter failure(s) requiring IV catheter replacement. When SafeBreak® Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient's IV catheter.

    SafeBreak® Vascular is provided sterilized by Ethylene Oxide. The product is single use only and is not designed for reprocessing or re-sterilization by the user.

    The purpose of this special 510(k) is to expand the separation force tolerance of SafeBreak® Vascular to 1-5 lbf.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text, formatted as requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Characteristic)Target / Specification (for K222791)Reported Device Performance (for K222791)
    Separation Force Tolerance1-5 lbf1-5 lbf
    Indication for UseAid in reduction of peripheral IV mechanical complications requiring IV replacement. Used on peripheral IV catheters in adults and adolescent populations (18+) receiving intermittent or continuous infusions with an electronic pump.Identical to target
    MaterialsMakrolon, Polycarbonate, Saint-Gobain, INEOS ABS Lustran, SiliconeIdentical to target
    Environment of UseHospitalIdentical to target
    Principle of OperationConnects to needleless connector and IV administration set via luer. Separates upon tension, valves close to stop fluid/blood flow.Identical to target
    Vascular Access TypePeripheral intravenous catheterIdentical to target
    For Use with Electronic PumpYesIdentical to target
    Single UseYesIdentical to target
    Continuous and Intermittent InfusionYesIdentical to target

    Explanation of the Primary Difference:
    The K222791 device is a special 510(k) to expand the separation force tolerance of SafeBreak® Vascular to 1-5 lbf. The predicate device (DEN190043) had a separation force of "4 ± 1 lbf." The reference device (K212064, Orchid SRV™) supported the expanded pull force range.

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

    The document does not specify the exact sample size used for the performance testing.
    The data provenance is also not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. The testing appears to be primarily mechanical testing.

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

    This information is not provided in the document. The testing described is mechanical performance (Separation Force Testing), which typically does not involve human experts establishing ground truth in the same way clinical studies or image analysis tasks would.

    4. Adjudication Method for the Test Set

    This information is not applicable/provided as the testing described is mechanical performance. Adjudication methods are typically associated with subjective assessments or diagnostic studies.

    5. 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

    An MRMC comparative effectiveness study was not conducted. This device is a mechanical device, not an AI or diagnostic imaging device that involves human readers.

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

    This concept is not applicable as the device is a mechanical IV catheter force-activated separation device, not an algorithm or software. The performance testing was for the mechanical function of the device itself.

    7. The Type of Ground Truth Used

    The ground truth for the performance testing (mechanical testing) was the pre-defined engineering specification for the separation force range (1-5 lbf). The "ground truth" here is the physical measurement against a specified engineering tolerance.

    8. The Sample Size for the Training Set

    This information is not applicable/provided. The device is a mechanical medical device, not a machine learning model, so there is no "training set."

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

    This information is not applicable/provided as there is no training set for a mechanical device.

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