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510(k) Data Aggregation

    K Number
    K052544
    Device Name
    PULSE OXIMETER ADAPTER CABLES
    Manufacturer
    AMERICAN I.V. PRODUCTS, INC.
    Date Cleared
    2006-09-29

    (379 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Abbreviated
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K001020,K934959,K993531,K012467,K033304,K991823,K993637,K973147,K971946,K014159,K993383,K021453,K901209,K972502
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    Device Name :

    PULSE OXIMETER ADAPTER CABLES

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

    These devices are intended to be used as replacement accessories to Original Equipment Manufacturer monitors used in the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These systems are used to monitor patients who are either well or poorly perfused, in hospitals, hospital type facilities, intra-hospital transport and home environments.

    Device Description

    AIV's Pulse Oximeter Adapter Cables are direct replacements for similar cables manufactured by the Original Equipment Manufacturers (OEM) for their respective monitors. They use the same type of construction and have the same technological characteristics as the predicate devices (OEM). The adapter cable connects the OEM pulse oximeter sensor with the OEM monitor.

    AI/ML Overview

    This document describes the 510(k) summary for Pulse Oximeter Adapter Cables from American IV Products, Inc. The submission aims to demonstrate substantial equivalence to existing legally marketed predicate devices.

    1. Table of Acceptance Criteria and Reported Device Performance

    For this device, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices, focusing on key characteristics like intended use, construction, and performance. The "reported device performance" reflects that these criteria have been met through testing and comparison.

    Acceptance Criteria (Comparison to Predicate Device)Reported Device Performance
    Intended Use: Connects OEM pulse oximeter sensor with OEM monitor for continuous, non-invasive SpO2 and pulse rate monitoring.Same as predicate devices. The AIV adapter cable connects the OEM pulse oximeter sensor with the OEM monitor for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
    Type of Construction: Flexible, shielded, multi-conductor electrical cable.Same as predicate devices. AIV cables use the same type of construction.
    Connector Design: Adapter cable connectors are keyed to fit the appropriate monitors.Same as predicate devices. Adapter cable connectors are keyed to fit the appropriate monitors.
    Installation into System: Installed between monitor and sensor using keyed connectors.Same as predicate devices. Installed in system between monitor and sensor using keyed connectors.
    Target Patient Population: Patients that are well or poorly perfused.Same as predicate devices.
    Patient Use/Reuse: Reusable.Same as predicate devices.
    Sterility: Non-sterile.Same as predicate devices.
    IEC 60601-1 Testing: Passed Safety Testing.Passed Safety Testing. The company reports conformity to consensus standards relating to Electrical/EMC/Mechanical/Safety.
    IEC 60601-1-2 Testing: Passed or equivalent to OEM adapter cable if OEM system not passing with AIV cable.Passed or shown to be equivalent. When the OEM system did not pass with the AIV cable, the OEM system was tested with the OEM adapter cable to show AIV equivalent to the OEM adapter cable. The company reports conformity to consensus standards relating to Electrical/EMC/Mechanical/Safety.
    Overall Performance: Device performs as intended and does not raise new safety/effectiveness issues or alter fundamental technology.Bench Testing demonstrates that the AIV devices perform as intended. The devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices. This is a conclusion based on the comparison and bench testing.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for the Test Set: Not explicitly stated as a separate "test set" in the context of an AI/algorithm-driven device. For these types of accessories, the testing primarily involves bench testing and comparison to the physical and electrical characteristics of multiple predicate devices. The number of specific AIV part numbers tested is 13, each corresponding to a different OEM part number for various monitor systems.
    • Data Provenance: The testing is primarily retrospective, comparing the AIV cables to existing OEM devices and standards. The data is generated from bench testing within the manufacturer's environment to ensure conformity and equivalence. The country of origin of the data is not specified but is inferred to be the manufacturer's location in the USA (Hanover, MD).

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This type of device (adapter cables) does not typically involve "experts" establishing a "ground truth" for a test set in the way an AI diagnostic algorithm would. Instead, engineering and quality assurance personnel perform instrumental measurements and comparisons. The submission mentions "Director of Regulatory Affairs and Quality Assurance" (Gregory Falk), suggesting that qualified personnel within the company are responsible for overseeing the testing and ensuring compliance. Specific numbers or detailed qualifications of technical experts involved in the bench testing are not provided in this summary.

    4. Adjudication Method for the Test Set

    Not applicable in the context of this device. Adjudication methods (e.g., 2+1) are typically used for interpreting ambiguous cases in diagnostic imaging or similar scenarios where human interpretation is a variable. For adapter cables, compliance is determined by meeting physical, electrical, and performance specifications through direct measurement and comparison, not by consensus among interpreters.

    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 device is an adapter cable, not an AI or diagnostic algorithm, so no MRMC study or AI assistance comparison would be performed.

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

    Not applicable. This device is an adapter cable, not an algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" in this context is established by:

    • Predicate Device Specifications: The technical and performance specifications of the legally marketed OEM pulse oximeter adapter cables.
    • Consensus Standards: International (e.g., IEC 60601-1, IEC 60601-1-2) and national consensus standards for medical electrical equipment safety and electromagnetic compatibility.
    • Functional Intent: The confirmed ability of the AIV cables to perform the intended function of connecting the sensor to the monitor to allow continuous SpO2 and pulse rate monitoring, without degrading the performance of the overall system.

    8. The Sample Size for the Training Set

    Not applicable. There is no "training set" as this is a hardware accessory, not an AI or machine learning algorithm.

    9. How the Ground Truth for the Training Set was Established

    Not applicable. There is no training set or ground truth in the AI/ML sense for this device.

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