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510(k) Data Aggregation

    K Number
    K981776
    Device Name
    ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1998-08-03

    (75 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K941984
    Why did this record match?
    Device Name :

    ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X

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

    Replacement battery for Sabretek 6060 Homerun Volumetric Infusion Pump (K941984) (and other non-rechargeable 8.4 volt (9-volt) applications).

    This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

    Device Description

    MC146X is a 8.4 volt/800 mAh battery pack which replaces Sabretek 6060 Homerun Volumetric Infustion Pump (K941984) and other 8.4 volt (9-volt) (K941984). applications battery

    AI/ML Overview

    This document pertains to a 510(k) premarket notification for a battery, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, MRMC studies, standalone performance, training set, and ground truth establishment is not applicable to this submission.

    The document is primarily focused on demonstrating substantial equivalence of the "Alexander Manufacturing Company battery Part Number MC146X" to a legally marketed predicate device (Sabretek 6060 Homerun Part Number Volumetric Infusion Pump battery K941984, and other 8.4-volt applications batteries).

    The key elements discussed are:

    • Device Description: MC146X is an 8.4 volt/800 mAh battery pack.
    • Intended Use: Replacement battery for the Sabretek 6060 Homerun Volumetric Infusion Pump (K941984) and other non-rechargeable 8.4-volt (9-volt) applications.
    • Substantial Equivalence: Claimed equivalence to the Sabretek 6060 Homerun Volumetric Infusion Pump battery (K941984) and other 8.4 volt (9-volt) applications batteries.
    • Compliance: Alexander Manufacturing Company operates under 21 CFR Part 820 Good Manufacturing Practice for Medical Devices (GMP) and is ISO 9001 registered.
    • Testing: "Testing data is located in Appendix C" (though Appendix C is not provided in the prompt). The document mentions the MC146X meets "all US Government ANSI/NEDA specs."

    Without Appendix C, specific performance data or acceptance criteria related to battery function (e.g., voltage, capacity, cycle life, safety standards) cannot be detailed. However, the existing information does not describe an AI/ML-driven device or a study involving human readers or ground truth as typically understood in AI/ML performance evaluation.

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