LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K962156
    Device Name
    3304 PULSE OXIMETER
    Manufacturer
    BCI INTL., INC.
    Date Cleared
    1996-08-28

    (85 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K020350,K041522,K041644,K041647,K041964,K070732,K971946,K991410
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 3304 provides fast, reliable SpO2, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104° F (0 to 40° C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals

    Device Description

    The new BCI 3304 pulse oximeter is an updated version of existing pulse oximeters legally marketed by BCI International. This updated device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top oximeter with a wall mount charger. The system features an SpO2 probe interface, display of patient data via an LED display (SpO2, Pulse Rate, Pulse Strength), system status LEDs (Probe, Lo Batt, Silence, Alarm, Artifact, Search), and the function keypad area consisting of eight keys (O/I, ID/Clear, Up and Down Arrows, Alarm Select, Alarm Silence, Alarm Volume, Pulse Volume). The oximeter has a printer / pc port that is used for data communication, an optional analog output and an optional digital alarm adapter for a remote location.

    AI/ML Overview

    This document describes the BCI 3304 Pulse Oximeter, an updated version of existing pulse oximeters.

    1. Acceptance Criteria and Reported Device Performance

    The acceptance criteria for pulse oximeters typically relate to the accuracy of SpO2 measurements compared to a reference standard, often expressed as a standard deviation (SD) within specific saturation ranges. While specific predefined acceptance criteria (e.g., "SD must be <= 2.0%") are not explicitly stated in the provided text, the study presents the achieved accuracy.

    Performance MetricAcceptance Criteria (Implicit/Typical for Pulse Oximeters)Reported Device Performance
    SpO2 Accuracy (70-100%)(Implicitly, a low standard deviation is desired, typically < 2% for this range)Standard Deviation = 1.92%
    SpO2 Accuracy (50-69%)(Implicitly, a low standard deviation is desired, typically < 3% for this range)Standard Deviation = 2.31%
    R-squared value(Implicitly, a high R-squared value is desired, approaching 1 for good correlation)0.978 (over the entire range)

    The study aims to demonstrate that the BCI 3304 "accurately displays the patient's blood oxygen level within its accuracy limits as compared to a co-oximeter." The reported standard deviations of 1.92% for 70-100% SpO2 and 2.31% for 50-69% SpO2, along with an R-squared of 0.978, support the accuracy claims and imply that these values meet the unstated acceptance criteria.

    2. Sample Size and Data Provenance

    • Sample Size for Test Set: The document does not explicitly state the number of subjects or data points used in the clinically controlled desaturation studies.
    • Data Provenance: The studies were described as "clinically controlled desaturation studies," which implies a prospective study design. The country of origin of the data is not specified.

    3. Number of Experts and Qualifications for Ground Truth

    The document does not mention the use of experts to establish ground truth for the test set.

    4. Adjudication Method

    Not applicable. The ground truth was established by a co-oximeter, not through expert consensus requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study focuses on the standalone performance of the device against a reference standard.

    6. Standalone Performance Study

    Yes, a standalone performance study was conducted. The device's accuracy was directly compared to a co-oximeter. This is indicated by the statement: "clinically controlled desaturation studies were done to demonstrate that the 3304 accurately displays the patient's blood oxygen level within its accuracy limits as compared to a co-oximeter (OSM-3)."

    7. Type of Ground Truth Used

    The type of ground truth used was comparison to a reference device (co-oximeter). Specifically, an "OSM-3" co-oximeter served as the gold standard for blood oxygen level measurements during the desaturation studies.

    8. Sample Size for the Training Set

    Not applicable. The BCI 3304 Pulse Oximeter is a hardware device (oximeter) and not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

    Not applicable, as there is no training set for this hardware device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1