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510(k) Data Aggregation

    K Number
    K072308
    Device Name
    D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Date Cleared
    2007-09-12

    (26 days)

    Product Code
    DTM
    Regulation Number
    870.4260
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K063255
    Why did this record match?
    Device Name :

    D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED

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

    The D131 Dideco Kids with 40 micron screen phosphorilcholine (Ph.I.S.I.O.) coated is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filter is used to trap and remove gaseous emboli as well as particulate debris that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

    Device Description

    The D131 Ph.I.S.I.O. is a sterile, non-pyrogenic disposable filter for use in arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 2.5 liters/minute. The D131 Ph.I.S.I.O. is a Infant Arterial Filter with a 40 micron filter screen designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 40 microns from the arterial line agground blood been reduced in the modified in the modified version of the D736 Ph.I.S.I.O. unmodified device resulting in decreased priming volume and surface area of the filtering material. The internal modifications which mainly involve the filter screen geometry, make the new filter essentially a downscaled and simplified version of the D736 Ph.I.S.I.O.. The modifications to some of the external features result in enhanced ergonomics.

    AI/ML Overview

    The provided 510(k) summary (K072308) describes the D131 Ph.I.S.I.O. Dideco Kids Infant Arterial Filter. This document primarily focuses on demonstrating substantial equivalence to a predicate device through in vitro testing, not a clinical study involving human readers or AI. Therefore, several of the requested sections related to AI or human reader studies are not applicable.

    Here's the breakdown of the information that can be extracted:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Established Specifications)Reported Device Performance (D131 Ph.I.S.I.O. vs. D736 Ph.I.S.I.O.)
    Operating Blood VolumeMet established specifications (Implied to be reduced compared to predicate)Reduced priming volume compared to D736 Ph.I.S.I.O.
    Structural IntegrityMet established specificationsComparable to D736 Ph.I.S.I.O.; demonstrated integrity when pressurized over the maximum recommended pressure.
    Pressure IntegrityMet established specificationsPart of the structural integrity assessment, demonstrated integrity when pressurized over the maximum recommended pressure.
    Pressure DropMet established specifications (Implied to be reduced compared to predicate at same max blood flow)Reduced pressure drop at all blood flow rates compared to D736 Ph.I.S.I.O.
    Filter Flow Rate CapacityMet established specificationsEffective filter flow rate capacity at all blood flow rates as compared to D736 Ph.I.S.I.O.
    In vitro Hemolysis/Cell DepletionMet established specificationsComparable to D736 Ph.I.S.I.O. at maximum blood flow.
    Filtration EfficiencyMet established specificationsComparable to D736 Ph.I.S.I.O.; overall mean percent removal greater than 80% for particles equal to the nominal pore size of the filter (40µm).
    LeachingMet established specifications (No evidence of leaching)No analytical evidence of the possibility of leaching of phosphorylcholine coating from the D131 Ph.I.S.I.O. was evidenced during the leaching test.
    Air Handling CharacteristicsMet established specificationsSimilar removal capability for microbubbles as well as air bolus introduced in the circuit at minimum, mean, and maximum blood flow tested compared to D736 Ph.I.S.I.O.

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

    • Sample Size: The document mentions "aged D130 Ph.I.S.I.O. samples (K063255)" for biocompatibility and "sterilized aged devices comparing the D131 Ph.I.S.I.O. vs. the D736 Ph.I.S.I.O." for in vitro tests. Specific numerical sample sizes for these tests are not provided.
    • Data Provenance: The studies were in vitro tests conducted by the manufacturer, Sorin Group Italia S.r.l. in Mirandola, Italy. The tests were performed on aged devices, including one additional year of aging for a "truly worst case." No human or clinical data is presented, so country of origin for patients/data is not applicable. The studies are retrospective of the manufacturing process and device characteristics.

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

    • Not applicable. This was an in vitro device performance study, not a study requiring expert clinical assessment for ground truth. The "ground truth" was established by the physical and chemical properties of the materials and the performance measurements using standardized test methods.

    4. Adjudication method for the test set:

    • Not applicable. This was an in vitro device performance study; there was no subjective assessment or need for adjudication between observers.

    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:

    • Not applicable. This device is an arterial filter for cardiopulmonary bypass circuits, not an AI-powered diagnostic tool requiring human reader studies.

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

    • Not applicable. This device does not involve an algorithm or AI. It is a mechanical filter.

    7. The type of ground truth used:

    • For the in vitro performance tests, the "ground truth" was established by objective measurements and physical/chemical properties of the device under various simulated physiological conditions (e.g., flow rates, pressure). These measurements were compared against established specifications derived from relevant guidance documents (e.g., "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" Final Guidance for Industry, dated November 29, 2000) and the performance of the predicate device (D736 Ph.I.S.I.O.).
    • For biocompatibility, the ground truth was based on the biological response to the materials as assessed through a battery of tests compliant with ISO 10993-1:2002 and FDA guidance, compared against established specifications for biological safety.

    8. The sample size for the training set:

    • Not applicable. This is not an AI/machine learning device that requires a training set. The device itself is the "product" being tested, not an algorithm.

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

    • Not applicable. As noted above, there is no training set for this type of device.
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