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    K Number
    K082758
    Device Name
    PRISMAFLO II
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Date Cleared
    2008-12-19

    (91 days)

    Product Code
    KOC
    Regulation Number
    876.5820
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K020103,K071909
    Why did this record match?
    Device Name :

    PRISMAFLO II

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

    The PRISMAFLO II is for warming dialysis fluid and returning blood flow.

    Device Description

    The PRISMAFLO II is a modified version of the PRISMAFLO covered by K020103. The PRISMAFLO uses water in the heat transfer process. PRISMAFLO II is the same as PRISMAFLO except it is water free.

    The PRISMAFLO II dialysis fluid and blood warmer is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Barkey Prismacomfort 510(K) Number K071909. The PRISMAFLO II blood warmer is used to warm the return blood flow line in order to replace heat lost to the atmosphere and effluent flow during a Prismaflex or PRISMA treatment. The PRISMAFLO II blood warmer consists of one control unit and one sleeve warmer. The control unit (Stihler PRISMAFLO II) controls the sleeve warmer and displays alarm and status messages.

    The PRISMAFLO II blood warmer warns the returning blood flow line by means of a silicon tube heat exchanger which covers the blood return flow line of the Gambro Prismaflex or Prisma system completely. The heat is transferred by the contact of the resistance heating system to the inscried blood return line. The complete enclosure of the returning blood flow line to be warmed ensures that there are no temperature losses to the surroundings. The warmth produced by the sleeve warmer is therefore transferred to the return blood flow at maximum efficiency.

    The sleeve warmer is powered with 22 VDC which is derived from 115 VAC (or where required 230 VAC). 50/60 Hz power supply and is controlled by an on-off switch on the front panel of the control unit Stihler PRISMAFLO II. Above the on-off switch is a display temperature monitor showing actual and set temperature. The temperature of the sleeve warmer and other performance characteristics of the sleeve warmer are controlled electronically, visual and audible alarms as well as cut-offs are hardware realized. Like the blood warmer Barkey Prismacomfort, the sleeve warmer PRISMAFLO II is constructed as a slotted enclosed silicon tube, which can completely enclose inserted blood return flow lines of up to 7.00 mm diameter. The PRISMAFLO II woighs approx 3.9 kg and is equipped with a holder at the rear side of the control unit, which allows mounting on hemodialysis system Gambro Prismatlex and Prisma system. Both products, the PRISMAFLO II and the Barkev Prismacomfort use sleeve warmers made of silicon. The flexibility of this material ensures a nearly complete enclosure of the blood return flow line on Gambro Prismallex and Prisma system.

    Only the water free operation of the PRISMAFLO II differs to the PRISMAFLO.

    AI/ML Overview

    This document describes the PRISMAFLO II blood warmer, a medical device. The information provided heavily emphasizes that the device is a modified version of an existing device (PRISMAFLO) and is substantially equivalent to a predicate device (Barkey Prismacomfort). The "study" described is a nonclinical performance verification.

    Here's an analysis of the provided text in relation to your requested categories:

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

    Acceptance Criteria (Stated Purpose of Tests)Reported Device Performance
    Verify the ability of the system to prevent cooling down of blood return lines on Gambro Prismaflex CRRT system."The following tests were carried out successfully: Verify the ability of the system to prevent cooling down of blood return lines on Gambro Prismaflex CRRT system." (Implies successful heating to prevent cooling, meeting the criterion)
    Verify the ability of the system to protect the patient and to detect and alarm at unsafe operating conditions."The following tests were carried out successfully: Verify the ability of the system to protect the patient and to detect and alarm at unsafe operating conditions." (Implies successful safety mechanisms and alarm functionality, meeting the criterion)
    Compliance with safety standards:"The PRISMAFLO II blood warmer complies with the safety standards below and is therefore safe for the intended use. The device has been thoroughly tested through validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made: DIN EN 60601-1, DIN EN60601-1-2 , UL 2601-1/10.97 , CAN/CSA-C22.2 No. 601.1-M90, ASTM F 2172-02 (USA Standard for Blood and Fluid Warmers)." (Implies successful adherence to all listed standards)

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

    • Sample size used for the test set: Not explicitly stated. The document refers to "the following tests were carried out successfully" but does not give specific numbers of units tested or duration of tests. This is a non-clinical device so "samples" would refer to devices tested, not patient data.
    • Data provenance: The tests were "carried out" by the manufacturer (Stihler Electronic GmbH), presumably in Germany given their address. The data is retrospective in the sense that the tests were completed before submission.

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

    Not applicable. This is a non-clinical device safety and performance verification. "Ground truth" in this context would refer to engineering specifications and regulatory standards, not expert medical opinion on patient data. The tests verify compliance with these objective standards.

    4. Adjudication method for the test set

    Not applicable. There is no mention of adjudication, as there are no human readers or subjective interpretations of results described. The tests are presented as objective measurements against predefined standards.

    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 a medical device (blood warmer), not an AI-powered diagnostic or interpretive tool. There are no human readers involved in its direct operation that would be improved or assisted by AI within the scope of this device.

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

    Not applicable. This is a physical medical device. The "standalone" performance refers to the device's ability to perform its function (warming blood) independently, which is what the non-clinical tests would have assessed. However, the term "algorithm only" is not relevant here as it's not a software-only device.

    7. The type of ground truth used

    The "ground truth" for the non-clinical tests was adherence to:

    • Engineering specifications and design requirements for preventing blood cooling and ensuring safe operation (e.g., set temperature, alarm triggers, cut-off mechanisms).
    • Mandatory and voluntary consensus standards for medical device safety and performance (e.g., DIN EN 60601-1, ASTM F 2172-02).

    8. The sample size for the training set

    Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

    Not applicable, as there is no training set for a physical medical device.

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