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    K Number
    K041496
    Device Name
    PENTATRASFU BLOOD TRANSFUSION SETS
    Manufacturer
    PENTAFERTE S.P.A
    Date Cleared
    2005-06-30

    (391 days)

    Product Code
    BRZ
    Regulation Number
    880.5440
    Type
    Abbreviated
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K023039,K924721
    Why did this record match?
    Device Name :

    PENTATRASFU BLOOD TRANSFUSION SETS

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

    To Administer Blood to the patient's vascular system.
    To administer Blood and Blood Derivatives into a patient's vascular system

    Device Description

    The PENTATRASFU™ Blood Transfusion Sets are Single Use, Non-toxic, Sterile, Non-Pyrogenic devices used to administer Blood to a patient's vascular system through a Needle or Catheter inserted into a vein.

    AI/ML Overview

    The provided document describes the PENTATRASFU™ Blood Transfusion Sets and their substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML device. Therefore, the information required for this request (AI/ML acceptance criteria, study details, expert involvement, etc.) is not present in the provided text.

    However, I can extract the information related to the performance testing and compliance with standards as described for this medical device.

    Here's the information as best as can be extracted from the provided text, focusing on the performance criteria and testing mentioned for the PENTATRASFU™ Blood Transfusion Sets:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Performance based on ISO 1135-4 Second Edition 1998-03-15 Transfusion Equipment for Medical Use - Part 4 Transfusion Sets for Single UseThe results of the Performance Testing showed that these Blood Transfusion Sets met the testing requirements as described on the ISO 1135-4 Recognized Guidance Document.
    Biocompatibility based on FDA recognized standard 10993Biocompatibility testing of these Blood Transfusion Sets showed the materials to be biocompatible for their intended use.
    SterilityThe device is described as Sterile.
    Non-PyrogenicThe device is described as Non-Pyrogenic.
    Non-toxicThe device is described as Non-toxic.
    Mechanical Properties and FunctioningThe PENTATRASFU™ blood Transfusion Sets have been subjected to performance and safety testing to verify mechanical properties and functioning.
    Substantial Equivalence to Predicate DevicesSubstantially equivalent based on same intended use, instructions, biocompatible materials (PVC tubing, Polyethylene, White PVC, Natural Rubber), similar design, same principle of operation, and no new or different characteristics that affect safety and effectiveness.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    This information is not provided in the document. The document refers to "Performance Testing" but does not specify sample sizes or data provenance.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    This information is not provided in the document. The testing mentioned refers to compliance with a standard (ISO 1135-4) and biocompatibility, which typically involve laboratory testing, not expert-adjudicated ground truth as would be relevant for an AI/ML device.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    This information is not applicable/not provided. The assessment of this medical device is based on compliance with recognized standards and laboratory testing, not a human reader adjudication process.

    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

    This information is not applicable/not provided. This device is a blood transfusion set, not an AI/ML-driven diagnostic or assistive device that would involve human readers or AI assistance.

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

    This information is not applicable/not provided. This device is a physical medical instrument, not an algorithm.

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

    The "ground truth" for this device's performance is established through compliance with recognized international standards (ISO 1135-4 for performance, ISO 10993 for biocompatibility) and direct physical/material testing, rather than clinical outcomes or expert consensus on diagnostic interpretations.

    8. The sample size for the training set

    This information is not applicable/not provided. This device is a physical product and does not have a "training set" in the context of AI/ML.

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

    This information is not applicable/not provided. This device is a physical product and does not have a "training set" or "ground truth" in the context of AI/ML.

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