(69 days)
The Spacelabs Multigas Module, Model 92518 (Model 92518) is intended to provide a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits. The multigas module is capable of automatically identifying which anesthetic agent(s) is being administered. The 92518 Multigas Module is intended to be used with and controlled by a Spacelabs Healthcare Ultraview-family monitor. The 92518 Multigas Module is intended to be used for monitoring all hospitalized patients, under the direction of qualified medical personnel. Although the 92518 Multigas Module alarms when the duration between breaths exceeds user defined limits, it is not intended to be a primary diagnostic apnea monitor and/or recording device.
The Spacelabs Multigas Module, Model 92518 (Model 92518) is an easy-to-use modular unit in the Spacelabs Healthcare Ultraview-family of monitors (Ultraview). The Module 92518 is inserted into a bay within an Ultraview monitor. The Ultraview monitor is then used to control the Model 92518, and provide the user interface for the Model 92518. The Module 92518 is a sidestream analyzer intended to provide a measurement of the following parameters: Carbon Dioxide (CO2); Oxygen (O2) and Nitrous Oxide (N2O); Anesthetic agents including Desflurane; Enflurane; Halothane; Isoflurane; and Sevorflurane; Respiratory rate; and Calculated MAC and age-dependent MAC values. The Spacelabs Ultraview monitors display information from the Module 92518 and are the user interface for the Model 92518. Ultraview monitors provide a number display for the anesthetic agent concentrations and respiratory rate, and a capnograph waveform display for O2 and CO2. The Module 92518 automatically identifies which anesthetic agent or mixture of anesthetic agents is present, and measures the concentration of the identified agent(s). An alarm is issued if a mixture of more than two anesthetic agents is detected. The Module 92518 is intended to be used primarily in the operating room environment
The Spacelabs Multigas Module, Model 92518, is a sidestream analyzer that measures various gas concentrations (CO2, O2, N2O, and anesthetic agents like Desflurane, Enflurane, Halothane, Isoflurane, Sevoflurane) and respiratory rate. It automatically identifies anesthetic agents and calculates MAC values. The module integrates with Spacelabs Ultraview monitors for control and display of information, including numerical values for gas concentrations and respiratory rate, and capnograph waveforms for O2 and CO2. It is primarily intended for use in the operating room to monitor hospitalized patients and alert clinical personnel to gas concentration deviations.
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Acceptance Criteria and Reported Device Performance:
The provided document does not list specific numerical acceptance criteria for gas measurement accuracy, such as +/- X% of reading or a certain Root Mean Square Error (RMSE). Instead, the performance testing section focuses on compliance with general medical device standards. The "Summary of Performance Testing" indicates that the device "complies with its predetermined specification and with the applicable Standards" for various categories.
Acceptance Criteria Category Reported Device Performance Electrical Safety Compliance with IEC 60601-1: 2005 and UL 60601-1: 2003. Electromagnetic Compatibility (EMC) Compliance with IEC 60601-1-2: 2007. Software Testing Software designed and developed according to a robust software development process, rigorously verified and validated. Compliance with FDA guidance documents on software in medical devices (May 05, Sep 99, Jan 02) and IEC 60601-1-4: 2000. Performance Testing (General) Compliance with internal documentation, IEC 60601-1-8: 2006 (alarm systems), and ISO 21647: 2004 (respiratory gas monitors). The device complies with its predetermined specification and with the applicable Standards. -
Sample Size Used for the Test Set and Data Provenance:
The document does not provide details on the sample size (e.g., number of gas samples, duration of testing) used for the performance tests, nor does it specify the provenance of any data (e.g., country of origin, retrospective/prospective). The testing focused on compliance with specified standards rather than analysis of a distinct patient-derived test set. -
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The described testing involves technical compliance with standards and physical measurements of gas concentrations, not subjective interpretation requiring human expert ground truth. -
Adjudication Method for the Test Set:
Not applicable, as no human expert judgments or interpretations requiring adjudication were involved in the listed performance testing. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or mentioned in the document. The device is a measurement and monitoring tool, not an AI-assisted diagnostic imaging or interpretative system that would typically undergo such a study. -
Standalone (Algorithm-Only) Performance:
The device's performance, as described, is inherently "standalone" in terms of its gas measurement functions. It continuously analyzes gas samples. However, there's no distinction made between an "algorithm-only" performance and the overall device performance, as the device's function is to directly measure and report, not to provide an interpretation that could be assisted by or compared to a human. -
Type of Ground Truth Used:
The "ground truth" for this type of device typically refers to a reference standard against which its measurements are compared. While not explicitly detailed, performance testing for gas analyzers generally involves:- Reference gas mixtures: Using precisely calibrated gas cylinders with known concentrations of CO2, O2, N2O, and anesthetic agents as the "ground truth" to verify the device's accuracy.
- Calibrated flow and pressure sensors: For verifying respiratory rate and flow measurements.
The document states the device complies with "predetermined specification" and "applicable Standards" like ISO 21647, which would inherently require such reference standards.
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Sample Size for the Training Set:
Not applicable. The Spacelabs Multigas Module is a sensor-based device that measures gas concentrations, not a machine learning or AI-driven system that requires a "training set" in the conventional sense. Its underlying technology (infrared for CO2/anesthetics, paramagnetic for O2) is based on established physical principles. -
How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this type of device.
§ 868.1700 Nitrous oxide gas analyzer.
(a)
Identification. A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.(b)
Classification. Class II (performance standards).