(24 days)
The Datex-Ohmeda S/5 Single-width airway module, E-miniC is intended to be used with Datex-Ohmeda S/5 modular monitors: S/5 Anesthesia Monitor, S/5 Compact Anesthesia Monitor, S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor for monitoring CO2 and respiration rate of all hospital patients.
The Datex-Ohmeda S/5 Single-width airway module, E-miniC and accessories is indicated for monitoring CO2 and respiration rate of all hospital patients. E-miniC is indicated for monitoring patients weighing more than 5kg (11 lbs.).
The device is indicated for use by qualified medical personnel only.
The Datex-Ohmeda E-miniC module is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda S/5 E-mini(' module can be used with the following Datex-Ohmeda modular monitors:
- S/50M Anesthesia Monitor (AM) with main software L-ANE02(A)..00 (K021279) or . newer version
- S/5™ Compact Anesthesia Monitor (CAM) with main software L-CANE02(A). 00 . (K022485) or newer version.
- S/5TM Critical Care Monitor (CCM) with main software L-ICU02(A)..00 (K021376) or . newer version
- S/5TM Compact Critical Care Monitor (CCCM) with main software L-CICU02(A). 00 . (K022740) or newer version.
The E-miniC module uses mainly the same accessories as the predicate device, M-miniC (K023454). The main accessories include airway gas sampling lines, mini D-fend water traps and airway adapters. Some supplies have been discontinued, and the Exhaust line for gas return has been redesigned for a new gas return connector. The E-miniC module is a side stream gas analyzer for monitoring the Carbon dioxide (CO2) inhaled and exhaled by the patient by measuring absorbtion of CO2 at 4.2-4.3 mm using narrow band infrared filters/sensors. The EminiC also allows monitoring of the respiration rate. The CO2 is measured and displayed breath by breath. The module is first plugged into the frame of the Monitor. The sampling line is attached to the module connector. The monitor is switched on and the gas sampling line is attached to the airway adapter. The airway adapter is attached between ventilator Y-piece and Heat and moisture exchanger (HME) of the patient's intubation tube. The monitor displays measurements from the E-miniC module in the form of numeric values, CO2 waveform and trends. The waveform size, color and sweep speed can be adjusted. The monitor also generates audible and visual alarms for this module and indicates the priorities and sources of alarms, according to the user interface for alarms in Datex-Ohmeda S/5 patient monitors.
The provided document describes a 510(k) premarket notification for the Datex-Ohmeda S/5™ Single-width Airway Module, E-miniC, and accessories. This submission aims to demonstrate substantial equivalence to a predicate device (Datex-Ohmeda M-miniC).
The document does not contain a detailed study report with specific acceptance criteria and performance metrics for the E-miniC device itself, as would be presented in a clinical validation study. Instead, it focuses on demonstrating equivalence to the predicate device through technological comparisons and adherence to relevant standards.
Therefore, many of the requested points cannot be directly extracted from the provided text. However, based on the information available, here's what can be gathered and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "The Customer and parameter specifications are the same" for the E-miniC and its predicate, M-miniC. It also mentions adherence to standards like ISO 9918:1993 / EN 864:1996 (Medical electrical equipment-Capnometers for use with humans - Particular requirements) and ASTM F-1456: 2001 (Standard Specification for Capnometers). These standards would contain implied acceptance criteria for capnometers. However, specific, quantifiable acceptance criteria and directly reported device performance (e.g., accuracy, precision values) for the new E-miniC are not explicitly detailed in the provided text.
Implied Acceptance Criteria (from standards and equivalence claim):
- Accuracy for CO2 measurement: Must meet the requirements of ISO 9918 and ASTM F-1456.
- Accuracy for Respiration Rate measurement: Must meet the requirements of ISO 9918 and ASTM F-1456.
- Safety: Must conform to IEC 60601-1 and other relevant safety standards.
- Electromagnetic Compatibility (EMC): Must conform to IEC 60601-1-2.
Reported Device Performance:
The document does not explicitly list quantitative performance metrics for the E-miniC. It
states: "The device has been thoroughly tested through validation and verification of specifications." and "The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5™ Single-width airway module, E-miniC as compared to the legally marketed (predicate) Datex-Ohmeda Single-width airway module, M-miniC (K023454)." This implies that the performance is considered equivalent and compliant with applicable standards but doesn't provide specific numerical results.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not describe a specific clinical "test set" or clinical study with patient data to assess the performance of the E-miniC. The testing mentioned is "nonclinical testing" and "validation and verification of specifications" against standards. This suggests laboratory or bench testing rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable, as no clinical test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring adjudication is described.
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 a CO2 gas monitor, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a standalone hardware module for monitoring CO2 and respiration rate. Its performance as a "standalone" device (meaning without human interaction as part of the measurement) is what the non-clinical testing would have evaluated, but the details of this testing (specific results) are not provided. The phrase "algorithm only" is not directly applicable, as it's a sensor-based measurement rather than a complex AI algorithm that produces a diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For capnometers, the ground truth for performance would typically be established using certified calibration gases with known concentrations of CO2 and/or a reference capnometer with known accuracy. The document implicitly states that the device was validated against specifications and standards, which would rely on such established "ground truth" methods in a laboratory setting.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML model that requires a "training set" in the conventional sense. Its function is based on infrared absorption principles, not learned patterns from data.
9. How the ground truth for the training set was established:
Not applicable.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).