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510(k) Data Aggregation

    K Number
    K210862
    Device Name
    Hemafuse System
    Manufacturer
    Sisu Global Health
    Date Cleared
    2021-07-29

    (128 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Hemafuse System

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

    The HEMAFUSE™ System is indicated for the collection of whole blood shed during a surgical procedure in which blood can be collected from the surgical field during periods of significant hemorrhage for purpose of reinfusion. It should only be used when performing surgery in remote military and austere military environments, when other sources of blood or autotransfusion are unavailable or thought inadequate for the need. Each Hemafuse System unit is indicated for a period of use no greater than 5 minutes.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Hemafuse System. It primarily outlines the regulatory approval for the device and its indications for use. Crucially, it does NOT contain the acceptance criteria or details of a study proving the device meets those criteria, specifically concerning AI/ML performance.

    The information requested in your prompt (acceptance criteria, device performance, sample sizes, expert qualifications, ground truth methods, MRMC studies, etc.) is typically found in the summary of safety and effectiveness (SSED) or clinical study reports that are part of the 510(k) submission, but this letter itself does not provide that level of detail. It only states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent."

    Therefore, based solely on the provided text:

    I cannot create the table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 regarding the study specifics. This letter is a regulatory approval document, not a performance study report.

    The Hemafuse System, as described, is an autotransfusion apparatus, which is a physical device used to collect and reinfuse blood during surgery. It is not an AI/ML-based device that would typically have the kind of acceptance criteria, ground truth establishment, or human reader enhancement studies you are asking about (e.g., for diagnostic imaging AI).

    If you have a document that details the performance study for the Hemafuse System, please provide it, and I would be happy to analyze it according to your requested criteria.

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