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    K Number
    K152946
    Device Name
    TEMPEDY
    Manufacturer
    SEIRATHERM GMBH
    Date Cleared
    2016-09-15

    (345 days)

    Product Code
    NCX,LGZ
    Regulation Number
    870.5900
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K051873,K080899,K082217,K080908
    Why did this record match?
    Reference Devices :

    K051873

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

    The Seiratherm GmbH tempedy 5000 is intended to deliver cooled or warmed sterile intravenous solutions which may be used to alter the body temperature of adult patients.

    Device Description

    The Seiratherm tempedy System is an adjunct to normalizing the body temperature of adults. It is intended to be used in situations when the patient is hypothermic and requires warming or when the patient is hyperthermic and requires cooling.

    1. It is an intravenous fluid cooling system
    2. It is an intravenous fluid warming system
    3. It is a thermal regulating system with feedback of patient's temperature

    The tempedy System does not deliver drugs. It is not a drug infusion device.
    The tempedy System does not deliver colloids (blood products, plasma, lipids, etc.) It is only for delivery of crystalloids (normal saline, Ringers, etc.).
    The tempedy System includes the following accessories: Power cord, Tubg Set, and Temperature Probe. A list of accessories is on Page 50 of the Instructions for Use Manual.
    Patient contacting parts: The sterile "Tubing Set T0" is a patient contacting part of the system. The Tubing Set TO is a single use part in the tempedy System.
    The GE Healthcare, K051873, M1024231 GP Temperature Probe, Adult YS1 400 compatible temperature probe is also a patient contacting part of the system. It is a manufacturer sterilized, single use part.

    AI/ML Overview

    This document outlines the acceptance criteria and study proving the Seiratherm GmbH tempedy 5000 system meets these criteria.

    The Seiratherm GmbH tempedy 5000 is a thermal regulating system intended to deliver cooled or warmed sterile intravenous solutions to alter the body temperature of adult patients. It was found substantially equivalent to predicate devices in terms of technology, function, and intended use.

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance Criterion (a.c.)Reported Device Performance
    Spillage testing (IEC 60529 - IPX2 Clause 201.11.6.3 and 5)IPX2 compliantPass
    Unintended bolus testing (Clause 201.12.4.4.104)Time to occlusion alarm
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