(76 days)
The GE Datex-Ohmeda Engstrom Carestation is designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. The modes of ventilation are available include:
- Volume Controlled (VCV) .
- Pressure Controlled (PCV) .
- Pressure Controlled, Volume Guaranteed (PCV-VG) ●
- Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC) ●
- Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC) .
- Bi-level Airway Pressure Ventilation ●
- Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV) .
- Apnea backup (active in Bi-level and CPAP/PSV) .
The Engström Ventilator (EV) is a flexible, adaptable, and intuitive critical care ventilator. A wide selection of performance options gives the user full control of the system configuration. The Engström Carestation is a complete system featuring patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.
The GE Datex-Ohmeda Engstrom Carestation is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulzier. Options include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling and an integrated air compressor.
The ventilator consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The module bay allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
Note: The document provided is a 510(k) summary for a medical device (ventilator). These summaries often focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the manner one might find for a novel diagnostic algorithm. Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, MRMC studies, etc.) are not typically found or disclosed in this type of regulatory filing for this class of device. The "studies" for this device often refer to engineering tests and compliance with recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| UL 2601 General requirements for Medical Electrical Equipment | Device was validated through rigorous testing that supports compliance with this standard. |
| ASTM F1100 Particular Requirements for Critical Care Ventilators | Device was validated through rigorous testing that supports compliance with this standard. |
| EN/IEC 60601-1: General requirements for Medical Electrical Equipment | Device was validated through rigorous testing that supports compliance with this standard. |
| EN/IEC 60601-1-2: 2001 Medical Electrical Equipment Electromagnetic Compatibility | Device was validated through rigorous testing that supports compliance with this standard. |
| EN 475 Electrically Generated Alarm Signals | Device was validated through rigorous testing that supports compliance with this standard. |
| CGA V-1 ad ISO 5145 Medical Gas Cylinders Threaded Cylinders | Device was validated through rigorous testing that supports compliance with this standard. |
| EN 980 Graphical Symbols | Device was validated through rigorous testing that supports compliance with this standard. |
| EN/IEC 60601-2-12, Medical Electrical Equipment Critical Care Ventilators | Device was validated through rigorous testing that supports compliance with this standard. |
| Substantial Equivalence to Predicate Devices (GE Datex-Ohmeda Engstrom Carestation K041775 and Siemens Mini C Compressor K023354) | The GE Datex-Ohmeda Engstrom Carestation and the currently marketed predicate device are substantially equivalent in design concepts, technologies, and materials. FDA found the device substantially equivalent. |
| Providing mechanical ventilation for adults and pediatrics weighing 5kg and above with pulmonary impairment from minor to severe, including specified modes of ventilation. | The device is designed for these indications and includes the specified modes of ventilation. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. For this type of device, "testing" primarily refers to engineering verification and validation against performance specifications and recognized standards, not necessarily a "test set" of patient data in the way one would analyze an AI algorithm.
- Data Provenance: Not applicable in the context of clinical patient data. The "study" refers to engineering and quality assurance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified or applicable. The ground truth for a ventilator's performance is typically established by metrological standards, engineering specifications, and functional testing, not by expert clinician consensus on a dataset.
4. Adjudication method for the test set
- Not specified or applicable. Adjudication methods are typically used for subjective clinical interpretations, which is not the primary assessment method for a ventilator's functional performance in this context.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers (e.g., radiologists, pathologists). The GE Datex-Ohmeda Engstrom Carestation is a standalone mechanical ventilator; it does not involve human "readers" interpreting output with or without AI assistance in this manner.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in essence. The "performance" of the ventilator is "standalone" in that its operation (controlling gases, delivering breaths, monitoring) is independent of human interpretation in the way an AI algorithm might be. The device's integrated measurement capabilities (FiO2, airway pressure, spirometry, volume monitoring) perform their functions autonomously. However, this is not a standalone "algorithm" in the context of an AI-driven diagnostic. It is the core function of the device itself.
7. The type of ground truth used
- The "ground truth" for this device's performance is established by:
- Engineering specifications and design requirements: Ensuring the device can deliver specified volumes, pressures, and modes of ventilation accurately.
- Compliance with recognized voluntary standards: (e.g., UL 2601, ASTM F1100, EN/IEC 60601 series). These standards define acceptable performance characteristics and safety criteria.
- Functional tests and calibration: Verifying that components and the overall system operate within specified tolerances.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm trained on a dataset. Its design and validation rely on engineering principles, component testing, and system-level functional verification.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of an AI algorithm.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).