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    K Number
    K961717
    Device Name
    NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS
    Manufacturer
    NALTIAC MEDICAL, INC.
    Date Cleared
    1996-07-18

    (77 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K880103
    Why did this record match?
    Device Name :

    NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS

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

    The NMI Retrograde Cardioplegia Cannulae-RCCS are intended for use in perfusing blood or Cardioplegia solutions via the coronary sinus during cardiopulmonary surgery.

    Device Description

    The NMI Retrograde Cardioplegia Cannulae are fabricated with polyvinyl chloride bodies (PVC) and polyurethane balloon cuffs, polycarbonate/polyethylene stopcocks, polypropylene clamps, PVC female luer connectors, and stainless steel guidewires. The features of the device include: self-inflating cuff, pressure monitoring port with 3-way stopcock on jumen extension, suture ing. and 14 French size. The cannulae are placed in the coronary sinus in order to infuse cardioplegia in a retrograde fashion to the myocardium. This practice both arrests the heart and preserves metabolic function during surgery.

    AI/ML Overview

    The provided document, K961717, describes the NMI Retrograde Cardioplegia Cannula-RCCS and its substantial equivalence to the Research Medical, Inc. Retrograde Cardioplegia Cannula # K880103. The study detailed is primarily focused on bench testing and material performance rather than clinical efficacy involving human readers or sophisticated algorithms. Therefore, many of the requested fields related to clinical studies, human readers, ground truth, and AI performance are not applicable.

    Here's the information derived from the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are generally demonstrated by the NMI cannulae's performance being comparable to or better than the RMI cannulae or by meeting specific physical/material standards.

    Acceptance Criteria (What is considered acceptable)Reported Device Performance (NMI Retrograde Cardioplegia Cannula-RCCS)
    Pressure Drop / Saline (4°C): Consistent performance compared to predicate at varying flow rates (100-500 ml/min).NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 11 to 76 mmHg at 4°C (Predicate: 7 to 97 mmHg)
    Pressure Drop / Saline (40°C): Consistent performance compared to predicate at varying flow rates (100-500 ml/min).NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 6 to 60 mmHg at 40°C (Predicate: 6 to 97 mmHg)
    Pressure Drop / Bovine Blood (25% Hematocrit, 4°C): Consistent performance compared to predicate at varying flow rates (100-500 ml/min).NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 22 to 121 mmHg at 4°C (Predicate: 14 to 127 mmHg)
    Pressure Drop / Bovine Blood (25% Hematocrit, 40°C): Consistent performance compared to predicate at varying flow rates (100-500 ml/min).NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 11 to 77 mmHg at 40°C (Predicate: 12 to 91 mmHg)
    Pressure Monitoring Port: Accurate pressure readings (0.5 to 0.9 mmHg) for downstream pressures of 10 to 80 mmHg.NMI cannulae 0.5 to 0.9 mmHg for downstream pressures of 10 to 80 mmHg (Predicate: 0.6 to 0.9 mmHg)
    Balloon Burst: Greater than 130 mmHg.Greater than 130 mmHg
    Guide Collapse: Less than predicate device.Less than predicate device
    Balloon Device (Performance): Greater than predicate device.Greater than predicate device
    Leak Test Requirements: No leaks at 10 psi air on NMI Device @ 4°C and 40°C.No leaks at 10 psi air on NMI Device @ 4°C and 40°C
    Tubing Bond Strength: Exceeds 0.4 lb tensile strength @ 4°C and 40°C.Exceeds 0.4 lb tensile strength @ 4°C and 40°C
    Luer Connections: Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings.Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings
    Package Integrity: Passed burst test in accordance with ASTM F1140-88.Tyvek/Mylar passed burst test in accordance with ASTM F1140-88
    Shipping & Distribution Testing: Passed Distribution Simulation Test per ASTM 40169 Standard.Passed Distribution Simulation Test per ASTM 40169 Standard
    Accelerated Aging: No affects on performance after one year.One year - No affects on performance
    Biocompatibility: Fluid contact materials comply with Tripartite Biocompatibility Guidance for external devices, blood path direct, short term use.Fluid contact materials of construction comply with Tripartite Biocompatibility Guidance for external devices, blood path direct, short term use
    Sterilization: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶.Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶
    Pyrogenicity: Non-Pyrogenic per USP Pyrogen test (LAL).Non-Pyrogenic per USP Pyrogen test (LAL)

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

    • Sample Size: Not explicitly stated as a numerical sample size. The testing appears to involve a limited number of manufactured devices for functional testing and material analysis.
    • Data Provenance: The data is generated from retrospective bench testing of manufactured devices, comparing the NMI cannulae to a predicate device (Research Medical, Inc. Retrograde Cardioplegia Cannula # K880103). The country of origin of the data is not specified but is implicitly associated with Naltiac Medical, Inc. in Dallas, TX, USA.

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

    • Not Applicable. This study does not involve human expert interpretation of data to establish a ground truth. It focuses on physical and material performance metrics evaluated through laboratory testing.

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

    • Not Applicable. There is no adjudication method described as the study involves objective physical measurements and material tests, not subjective interpretations.

    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 is not a study involving human readers or AI assistance. It's a medical device bench testing and substantial equivalence submission.

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

    • Not Applicable. There is no algorithm or AI component to this medical device.

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

    • Objective Measurement Standards / Predicate Device Performance: The "ground truth" or reference for performance is established by objective engineering and safety standards (e.g., ANSI/HIMA MD70.1-1983, ASTM F1140-88, ASTM 40169, USP Pyrogen test, Tripartite Biocompatibility Guidance) and by the functional performance ranges observed in the predicate device.

    8. The sample size for the training set

    • Not Applicable. There is no "training set" in the context of an algorithm or AI. The device is a physical medical instrument.

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

    • Not Applicable. As there is no training set for an algorithm, there is no ground truth established for one.
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