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510(k) Data Aggregation

    K Number
    K102900
    Manufacturer
    Date Cleared
    2012-03-21

    (538 days)

    Product Code
    Regulation Number
    880.5725
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HEITER 3000 Hyperthermic Perfusion System is intended to raise the temperature of the thoracic or peritoneal cavity to a physician selected target temperature by continuously lavaging the cavity with a sterile circulating, warmed, physiologically compatible solution such as sterile saline or Lactated Ringers.

    Device Description

    The HEITER 3000 is comprised of two components: a portable control console and a single use disposable. The Console consists of a heater, pump, user touch screen, microprocessor, and interface electronics. The primary user interface is a color touch screen display that allows the user to make selections from the operating screen consisting of message display area, main screen area and flow control area. The touch screen also displays operating conditions, flow rate, output fluid temperature, patient temperature, target temperature, alarm and status messages, various timers and auxiliary temperatures. The HEITER 3000 monitors various sensors in the fluid path to ensure safe operation and alerts the user with alarms for out of specification conditions. Independent protection circuits prevent unsafe operation in the event of system software fault. The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The Lavage Procedure Kit is supplied sterile.

    AI/ML Overview

    The provided text describes the HEITER 3000 Hyperthermic Perfusion System and its substantial equivalence to predicate devices, but it does not contain information about a study proving the device meets specific acceptance criteria in the format requested for AI/diagnostic devices.

    Instead, the document details:

    • Software Verification/Validation Testing: A series of internal tests were performed to assess the device's ability to heat/maintain fluid temperature, detect and respond to unsafe conditions, inform users of these conditions, mitigate operator errors, store data, and measure accuracy of temperature, pressure, and flow rates.
    • Human Factors / Non-Clinical Study Testing: A study involving diverse pump users to identify and mitigate safety risks during simulated hyperthermic lavage procedures.
    • Verification of Safety Requirements: Compliance with FDA Recognized Consensus Standards for electrical safety, EMC, biocompatibility, sterility, and packaging.

    The statement "The HEITER 3000 performed within specifications in all of the above tests" indicates that the device met its internal specifications for these technical and safety aspects, but these are not presented as explicit "acceptance criteria" with corresponding "reported device performance" in a comparative table format that would typically be seen for a diagnostic AI algorithm. There are no detailed performance metrics like sensitivity, specificity, or AUC that would be expected for such a request.

    Therefore, many of the requested fields cannot be filled from the provided text because the submission is for a medical device (a physical system) and not an AI or diagnostic algorithm, and the type of evaluation described is typical for hardware and software functionality testing, not clinical comparative effectiveness or standalone algorithm performance.

    Here's an attempt to extract relevant information given the constraints and the nature of the document:


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

    Acceptance Criteria (Implicit from "Tests Carried Out")Reported Device Performance (Summary Statement)
    Ability to heat fluids over the full range of fluid flow rates.Performed within specifications in all tests.
    Ability to maintain fluid temperature over the full range of fluid flow rates.Performed within specifications in all tests.
    Ability to detect and automatically respond to unsafe/ineffective operating conditions (sensor failure, excessive fluid temp/pressure, internal component failures).Performed within specifications in all tests.
    Ability to inform clinical user of unsafe/ineffective conditions via notifications, alerts, alarms, and/or system faults.Performed within specifications in all tests.
    Ability to mitigate against unknown or predictable operator errors.Performed within specifications in all tests.
    Ability to store non-patient, procedure-specific treatment parameters and machine data in non-volatile memory.Performed within specifications in all tests.
    Measurement of temperature accuracy over the full range of fluid flow rates within the operating pressure range.Performed within specifications in all tests.
    Measurement of pressure accuracy over the full range of fluid flow rates within the operating temperature range.Performed within specifications in all tests.
    Measurement of fluid flow rate accuracy over the full range of fluid flow rates within the operating temperature-pressure range.Performed within specifications in all tests.
    Compliance with IEC 60601-1:1998+A1:1991+A2:1995 (Electrical Safety).Complies with and tested to this standard.
    Compliance with IEC 60601-1-2:2001+A1:2004 (EMC).Complies with and tested to this standard.
    Compliance with AAMSI/ANSI/ISO 11135-1:2003(E) (Biological evaluation of medical devices).Complies with and tested to this standard.
    Compliance with AAMSI/ANSI/ISO 10993-1:2007 (Biocompatibility - In vitro cytotoxicity).Complies with and tested to this standard.
    Compliance with AAMSI/AMSI/ISO 10993-7:1995(R)2001 (Biocompatibility - Ethylene Oxide Sterilization Residuals).Complies with and tested to this standard.
    Compliance with AAMSI/ANSI/ISO 10993-10:2002 (Biocompatibility - Irritation and Delayed-type Hypersensitization).Complies with and tested to this standard.
    Compliance with AAMSI/ANSI/ISO 10993-11:2006 (Biocompatibility - Systemic Toxicity).Complies with and tested to this standard.
    Compliance with AAMSI/ANSI/ISO 10993-1:2003(E) (Sterility - Ethylene oxide sterilization).Complies with and tested to this standard.
    Compliance with ASTM D4169-05:2005 (Packaging).Complies with and tested to this standard.
    Mitigation of potential user and patient safety risks identified in human factors study.Results demonstrated task-risks successfully addressed and mitigated.

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

    • Software Verification/Validation & Safety Requirements: No explicit "sample size" is mentioned in terms of patient data or clinical cases. These tests were performed on the device itself ("the HEITER 3000 was tested"). The data provenance is internal testing by the manufacturer.
    • Human Factors Study: The text mentions "diverse groups of pump users" for the non-clinical study. No specific number for the sample size of users is given. This was a prospective simulation study.

    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)

    Not applicable to this device submission. The "ground truth" for a physical medical device's performance is typically its design specifications and recognized standards, which are verified through various engineering and functional tests, not expert consensus on medical images or patient outcomes. The human factors study involved "pump users" but their role was not to establish ground truth in the diagnostic sense, rather to evaluate usability and safety.

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

    Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving interpretation, not for validating the functional performance of a physical medical device.

    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

    No. This is not an AI/diagnostic device. The evaluation focuses on the device's functional performance, safety, and substantial equivalence to predicate devices, not on improving human reader performance.

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

    Not applicable. This is a physical medical system; it's not an algorithm evaluated for standalone performance. The device's "standalone" performance is assessed through its functional tests as described in the software verification/validation section.

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

    The "ground truth" for the device's performance is its design specifications, established engineering principles, and compliance with recognized national and international consensus standards (e.g., IEC 60601 series, ISO 10993 series, ASTM D4169). For the human factors study, the ground truth relates to identified user errors and safety risks being successfully mitigated.

    8. The sample size for the training set

    Not applicable. This is not an AI/machine learning model that requires a training set.

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

    Not applicable. This is not an AI/machine learning model.

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