(185 days)
The CARESCAPE Respiratory Modules, (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOVX, E-sCAiOE, E-sCAiOVE) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric patients.
When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy.
These modules are intended for use by qualified medical personnel only.
The CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories measure respiratory parameters (concentrations of Carbon Dioxide, Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate), ventilatory parameters (airway pressure, flow and breathing volumes) and gas exchange parameters (oxygen consumption and carbon dioxide production) of hospital patients.
Parameters measured by the CARESCAPE Respiratory Modules are CO2, N2O, O2, Anesthetic agents, Agent ID, Spirometry, oxygen consumption (VO2) and carbon dioxide production (VCO2) depending on the model used. The CARESCAPE Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPE Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas concentrations. The CARESCAPE Respiratory Modules acquire the signals detected by the module sensors, calculate the parameter values and communicate them to the host device. The CARESCAPE Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system.
The CARESCAPE Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host devices based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.
This 510(k) introduces two new module models in the CARESCAPE Respiratory Modules family: E-sCAiOE and E-sCAiOVE. These new module models include added hardware compared to the modules cleared in K183394. The operation, measured parameters and performance specifications of the E-sCAiOE and E-sCAiOVE is identical to E-sCAiO and E-sCAiOV when used with the current module host devices cleared in the USA. The added modules E-sCAiOE and E-sCAiOVE have the same software as CARESCAPE Respiratory Modules cleared in K183394.
The provided text is a 510(k) Summary for the GE Healthcare CARESCAPE Respiratory Modules. This document describes the device and its claimed substantial equivalence to a predicate device. It does not contain information about an AI/ML-driven device or a study involving human readers or expert ground truth adjudication for image analysis. Therefore, based on the provided text, I cannot answer the questions related to AI/ML device acceptance criteria and study details.
The document focuses on:
- Device Description: Respiratory modules that measure various parameters like CO2, O2, N2O, anesthetic agents, and ventilatory parameters.
- Predicate Device: K183394 CARESCAPE Respiratory Modules.
- Key Change: Introduction of two new module models (E-sCAiOE and E-sCAiOVE) with added hardware (fresh gas sample connector) but identical operation, measured parameters, and performance specifications when used with current host devices.
- Non-Clinical Tests: Bench testing related to software, hardware, and performance, including compliance with various IEC and ISO standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-49, ISO 80601-2-55). Biocompatibility and environmental testing were also conducted. Software was considered "Major" level of concern.
- Clinical Tests: The document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence."
Therefore, I cannot extract the following information that would be relevant to an AI/ML device study:
- Table of acceptance criteria and reported device performance for an AI/ML model.
- Sample size for a test set or data provenance for AI/ML validation.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results or effect size of AI assistance.
- Standalone performance of an algorithm.
- Type of ground truth used (expert consensus, pathology, outcome data).
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to traditional medical device clearance, not an AI/ML device.
§ 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).