LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K014016
    Device Name
    ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
    Manufacturer
    MINNTECH CORP.
    Date Cleared
    2002-02-01

    (58 days)

    Product Code
    DWC
    Regulation Number
    870.4250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K791550
    Why did this record match?
    Device Name :

    ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

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

    The Minntech Corporation's EnGUARD™ CHC Dual Reservoir Cardioplegia Heater/Cooler is intended to be used as a self-contained temperature control device designed to deliver cooled or heated water to a cardioplegia heat exchanger in the cardiopulmonary bypass circuit.

    Device Description

    The Minntech EnGUARD ™ CHC Dual Reservoir Cardioplegia Heater/Cooler is a portable heating and cooling circulation system with mechanical controls for delivery of warm or cool water to flow through type water pathway cardioplegia heat exchanger devices.

    AI/ML Overview

    The provided text describes the Minntech EnGUARD™ CHC Dual Reservoir Cardioplegia Heater/Cooler, a medical device. However, it does not include detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the way described in the prompt's request (e.g., using AI, test sets, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance).

    The document is a 510(k) summary for a medical device submitted to the FDA, focusing on substantial equivalence to a predicate device for market clearance. The "Performance Testing" section is very high-level and only lists the types of tests conducted, not the specific criteria or results.

    Therefore, I cannot provide the requested information. The document states:

    • "The following performance testing was conducted to determine device effectiveness as a cardioplegia heater/cooler: Heating and Cooling Systems performance, Electrical Safety Testing and Water Bath Management."

    This statement does not contain:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size for test sets or data provenance.
    3. Number of experts, their qualifications, or adjudication methods for ground truth.
    4. Information about MRMC comparative effectiveness studies or human reader improvement with AI.
    5. Information about standalone algorithm performance.
    6. The type of ground truth used (e.g., pathology, outcomes data).
    7. Sample size for the training set or how its ground truth was established.

    The document primarily focuses on a comparison of technological characteristics to a predicate device, as shown in this table:

    1. Table of Acceptance Criteria and Reported Device Performance

    Not explicitly stated in the document as acceptance criteria. The table below represents a comparison of features and ranges between the proposed device and its predicate, which implicitly serves as meeting "acceptance" by demonstrating substantial equivalence.

    CharacteristicAcceptance Criteria (Predicate Device Specification)Reported Device Performance (EnGUARD™ CHC)
    Reservoirs/constructionDual/plasticDual/plastic
    Power requirements100, 115, 240 VAC100, 115, 240 VAC
    Reservoir Capacity (Cool)7.6 liters8 liters
    Reservoir Capacity (Heat)5.7 liters6 liters
    Fluid Heating Range25°C to 42°C25°C to 42°C
    Fluid Cooling Range32°C to 3°CIce Water temperatures
    Connections1/2" Hansen Fittings1/2" Hansen Fittings
    Hi Limit Temperature Control44°C43°C

    Further Breakdown of Requested Information (Not Available in Document):

    1. Sample size used for the test set and the data provenance: Not specified. The document refers to "Performance Testing" but does not detail the sample size or source of data for these tests.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. This is a medical device, not an AI/diagnostic software. Ground truth in this context would refer to instrument calibration and measurement accuracy, not expert consensus on images or diagnostic outcomes.
    3. Adjudication method for the test set: Not applicable/specified.
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating diagnostic performance with human readers, typically in the context of imaging or AI assistance. This document describes a physical medical device (heater/cooler).
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
    6. The type of ground truth used: Not specified. For a heater/cooler, "ground truth" would likely refer to calibrated thermometers and flow meters to verify temperature and flow accuracy.
    7. The sample size for the training set: Not applicable. There is no mention of an algorithm or training set for this physical device.
    8. How the ground truth for the training set was established: Not applicable.

    In summary, the provided text is a 510(k) summary for a physical medical device (a heater/cooler), which follows a different regulatory pathway and testing paradigm than the AI/diagnostic software performance evaluation outlined in your prompt questions. Therefore, most of the requested information regarding AI-specific criteria, expert adjudication, and ground truth establishment is not present or applicable.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1