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510(k) Data Aggregation

    K Number
    K965041
    Device Name
    OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
    Manufacturer
    OHMEDA MEDICAL
    Date Cleared
    1997-06-17

    (182 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The APAC is a self-contained, portable and lightweight anesthesia machine that includes the components and accessories necessary to deliver anesthesia.

    Device Description

    The Ohmeda APAC System is a self-contained, portable and lightweight anesthesia machine that includes the components and accessories necessary to deliver anesthesia. It delivers three breathing circuit gases: O2 (cylinder or pipeline), N2O (pipeline only), air (pipeline only). The system includes a Tec 5 Vaporizer and uses a 7800 Ventilator changed to use O2 or air as the pneumatic power source. Safety devices are included to decrease the risk of hypoxic mixtures and complete power or sudden gas supply failures.

    AI/ML Overview

    The Ohmeda APAC (Advanced Portable Anesthesia Care) System is an anesthesia machine. The documentation provided describes its features and safety mechanisms rather than presenting a study with specific acceptance criteria and performance metrics in the format typically seen for diagnostic or AI-driven medical devices.

    Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from the provided text. The document focuses on demonstrating substantial equivalence to a predicate device and compliance with voluntary standards through "rigorous testing," but does not provide the quantitative results of this testing in a comparative manner for specific performance characteristics.

    Here’s a breakdown based on the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Based on the provided text, the acceptance criteria are primarily related to general safety and functional standards, and the "reported device performance" is described qualitatively as compliance.

    Acceptance Criteria CategorySpecific Criteria (Implicitly Accepted by Compliance)Reported Device Performance
    General Anesthesia Machine StandardsCompliance with ASTM F1161-88 for Anesthesia Machine System"The Ohmeda APAC System was designed to comply with the applicable portions of the following voluntary standards: 1. ASTM F1161-88 for the Anesthesia Machine System." "The Ohmeda APAC System has been validated through rigorous testing that, in part, support the compliance of the APAC to the above mentioned standards."
    Electrical Safety/Medical Equipment StandardsCompliance with EN 60601-1-2, IEC 601-1-2 (for 7800 Ventilator)"The Ohmeda APAC System was designed to comply with the applicable portions of the following voluntary standards: 2. EN 60601-1-2, IEC 601-1-2 for the 7800 Ventilator."
    Compliance with EN 60601-1, IEC 601-1 and IEC 601-2-13 (for 7800 Ventilator)"The Ohmeda APAC System was designed to comply with the applicable portions of the following voluntary standards: 3. EN 60601-1, IEC 601-1 and IEC 601-2-13 for the 7800 Ventilator."
    Vaporizer StandardsCompliance with DIN 13252 for Tec 5 Sevoflurane (8%)"The Ohmeda APAC System was designed to comply with the applicable portions of the following voluntary standards: 4. DIN 13252 for the Tec 5 Sevotec 8%."
    Compliance with DIN 13252 for Tec 5 Fluotec (5%)"The Ohmeda APAC System was designed to comply with the applicable portions of the following voluntary standards: 5. DIN 13252 for the Tec 5 Fluotec 5%."
    Compliance with DIN 13252 for Tec 5 Enflurane (5%)"The Ohmeda APAC System was designed to comply with the applicable portions of the following voluntary standards: 6. DIN 13252 for the Tec 5 Enfluratec 5%."
    Compliance with DIN 13252 for Tec 5 Isoflurane (5%)"The Ohmeda APAC System was designed to comply with the applicable portions of the following voluntary standards: 7. DIN 13252 for the Tec 5 Isotec 5%."
    Hypoxic Mixture PreventionO2 concentration > 23% at fresh gas outlet for O2/N2O mixtures"A flow control proportioning system keeps the O2 concentration higher than 23% at the fresh gas outlet for O2 and N2O mixtures."
    N2O flow decreases proportionally with O2 supply decrease"N2O flow decreases proportionally as the O2 supply decreases."
    N2O and air flow stops completely with total O2 supply failure"N2O and air flow stops completely in case of total O2 supply failure."
    Power/Gas Supply Failure ManagementBatteries continue 7800 Ventilator operation during power failure"Batteries continue 7800 Ventilator operation during a power failure."
    Power failure alarms present on Ohmeda ventilators"Ohmeda ventilators have power failure alarms."
    Alarms for low gas supply pressure present on Ohmeda ventilators"Ohmeda ventilators have alarms for low gas supply pressure."
    Alarm for O2 supply pressures
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