(117 days)
The GE Datex-Ohmeda Engstrom Carestation is designed to provide mechanical ventilation for adults and pediatric patients 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 Engstrom Carestation includes integrated Oxygen, FiO2, airway pressure, spirometry and volume monitoring gas monitoring capabilities via nebulizer. Options include integrating modules listed in the product labeling.
The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.
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 optional Datex-Ohmeda patient monitoring modules.
The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.
The ventilator consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to access and control settings. The ventilator unit controls pneumatic gas flow to and from the patient. The module bay allows integration of various Datex-Ohmeda patient monitoring modules with the ventilator.
Optional accessories include a trolley/cart, airway modules, module bay, support arm, mounting brackets, and auxiliary electrical outlets.
This document is a 510(k) summary for the GE Datex-Ohmeda Engstrom Carestation, a continuous ventilator. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a new, novel AI/software medical device might.
Therefore, many of the requested categories for AI/software device evaluation (like sample sizes for test/training sets, expert qualifications, adjudication, MRMC studies, standalone performance, and detailed ground truth establishment methods) are not applicable or explicitly not found in this type of submission.
The "acceptance criteria" for this conventional device are primarily based on complying with recognized voluntary standards and demonstrating performance comparable to existing, legally marketed predicate devices.
Here's the breakdown based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: Drager Evita 4, Drager Evita 2, Datex-Ohmeda 7900 Ventilator | The GE Datex-Ohmeda Engstrom Carestation is stated to be "substantially equivalent" to these specific predicate devices. The submission asserts that the new device has "similar design and materials" and that its "design has been validated through rigorous testing that, in part, supports the compliance... to the standards listed below." |
| Compliance with Voluntary Standards: | The GE Datex-Ohmeda Engstrom Carestation "was designed to comply with the applicable portions" of the following standards: |
- UL 2601 General requirements for Medical Electrical Equipment
- ASTM F1100 Particular Requirements for Critical Care Ventilators
- EN/IEC 60601-1: General requirements for Medical Electrical Equipment
- EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility
- EN 475 Electrically Generated Alarm Signals
- CGA V-1 ad ISO 5145 Medical Gas Cylinders Threaded Cylinders
- EN 980 Graphical Symbols
- EN/IEC 60601-2-12, Medical Electrical Equipment -- Critical Care Ventilators |
| Intended Use: Mechanical ventilation for patients weighting 5kg and above with varying degrees of pulmonary impairment. | The device provides mechanical ventilation in various modes (VCV, PCV, PCV-VG, SIMV-VC, SIMV-PC, Bi-level, CPAP/PSV, Apnea backup) for the described patient population. |
Study Details (Based on available information in a 510(k) for a conventional medical device)
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Sample size used for the test set and the data provenance:
- N/A (Not Applicable): This document does not describe a "test set" in the context of an AI/software performance study. The evaluation for substantial equivalence relies on design validation and compliance with recognized standards, often involving engineering testing, bench testing, and sometimes animal or human factors testing, but not typically a "test set" of patient data for performance metrics like sensitivity/specificity.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A (Not Applicable): As there is no "test set" of patient data in the AI/software sense, there are no experts establishing ground truth for such a set based on this submission. The "ground truth" for a conventional ventilator often relates to its ability to accurately deliver set parameters, respond to patient needs, and ensure patient safety, which is assessed through engineering and clinical validation testing, not expert consensus on diagnostic images or similar.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A (Not Applicable): Not relevant for this type of device submission.
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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, not applicable: The GE Datex-Ohmeda Engstrom Carestation is a conventional ventilator, not an AI-assisted diagnostic or therapeutic device that involves "human readers." Therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A (Not Applicable): This is a hardware medical device with integrated software for control; it's not an algorithm that operates in a "standalone" fashion to perform a diagnostic or interventional task independent of the physical device or a human operator. The device's performance is inherently tied to its function as a ventilator.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on engineering specifications, established physiological principles, and compliance with performance standards. For example, ground truth for delivered oxygen concentration would be verified against calibrated measurement devices, or ground truth for pressure delivery would be against known pressure sensors. The submission states "rigorous testing" was performed, which implies verification against known accurate measurements and validated methods.
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The sample size for the training set:
- N/A (Not Applicable): This file describes a conventional hardware-based medical device. It does not refer to machine learning model development and therefore does not have a "training set" in that context.
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How the ground truth for the training set was established:
- N/A (Not Applicable): See point 7.
§ 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).