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510(k) Data Aggregation

    K Number
    K171828
    Device Name
    ETCO2 Sensor
    Manufacturer
    Orantech Inc.
    Date Cleared
    2018-05-31

    (345 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K042601
    Why did this record match?
    Device Name :

    ETCO2 Sensor

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

    The intended use of the ETCO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.

    Device Description

    The ETCO2 Sensor is comprised of three main components, a sensor with photo detector and light emitter, cable and connector, The CO2 Sensor incorporates an infrared light source, of specified wavelength, and an infrared detector. The photo detector and light emitter end of the CO2 sensor is connected to an airway adapter. The airway adapter is connected between the patient airway and the respirator. As the patient completes an expiratory breath the sensor measures the CO2 levels in the expiratory breath and sends that data to the compatible CO2 monitor. The monitor then reads the data and converts the data so it can be displayed on screen.

    AI/ML Overview

    This document is a 510(k) premarket notification for an ETCO2 Sensor (Model CTM-RP01), not a study report detailing specific acceptance criteria and performance of an AI/ML device. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is not present in this document.

    The document focuses on demonstrating substantial equivalence to a predicate device (Capnostat 5 CO2 sensor, K042601) based on similar technological characteristics and performance specifications for a carbon dioxide gas analyzer.

    Here's what can be extracted and what is not available based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    The document provides the performance specifications of the subject device (ETCO2 Sensor, Model CTM-RP01) and compares them to the predicate device. These specifications serve as de facto "acceptance criteria" through the lens of substantial equivalence.

    Acceptance Criteria (from Predicate Device Specifications)Reported Device Performance (ETCO2 Sensor, Model CTM-RP01)Comments
    CO2 Measurement Range: 0 to 150 mmHg, 0 to 19.7%0 to 150 mmHg, 0 to 19.7%Same
    CO2 Resolution: 0.1 mmHg 0 to 69 mmHg; 0.25 mmHg 70 to 150 mmHg0.1 mmHg 0 to 69 mmHg; 0.25 mmHg 70 to 150 mmHgSame
    CO2 Accuracy:Same
    0 - 40 mmHg ± 2 mmHg0 - 40 mmHg ± 2 mmHg
    41 - 70 mmHg ± 5% of reading41 - 70 mmHg ± 5% of reading
    71 - 100 mmHg ± 8% of reading71 - 100 mmHg ± 8% of reading
    101 - 150 mmHg ± 10% of reading101 - 150 mmHg ± 10% of reading
    Above 80 breath per minute ± 12% of readingAbove 80 breath per minute ± 12% of reading
    *NOTE: Gas temperature at 25°C*NOTE: Gas temperature at 25°C
    Respiration Rate Range: 0 to 150 breaths per minute (bpm)0 to 150 breaths per minute (bpm)Same
    Respiration Rate Accuracy: ± 1 breaths per minute (bpm)± 1 breaths per minute (bpm)Same
    Voltage Requirements: 5.0 VDC ±5%5.0 VDC ±5%Same
    Interconnection: Lemo Redel 8-pin plasticLemo Redel 8-pin plasticSame
    Operating Temperature/Humidity: 0-45°C, 10-90% RH, non-condensing0-40°C, 15-85% RH, non-condensingSimilar
    Storage Temperature/Humidity: -40-70°C,
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