(68 days)
The GE Datex-Ohmeda Engström 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 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 t
- Constant Positive Airway Pressure Support Ventilation (CPAP/PSV) .
- Apnea backup (active in Bi-level and CPAP/PSV) .
The GE Datex-Ohmeda Engström 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 intecrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling, an integrated air compressor, capabilities to measure SpiroDynamics via an intratracheal pressure sensor in patients using sized 6.5 tracheal tubes and larger, and calculation of functional residual capacity of mechanically ventilated patients using Nitrogen Wash In/Wash Out method.
The Engström Carestation is not a pulmonary function calculation device.
The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.
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, capabilities to measure spirodynamics in patients using sized 6.5 tracheal tubes and larger, measurement of functional residual capacity 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.
Additional optional accessories include a trolley/cart, compressor, airway module bay, support arm, humidifier and water trap mounting brackets, and auxiliary electrical outlets. The user interface for control of nebulization is provided via the ventilator display unit. The Aerogen Aeroneb Pro Nebulizer (K021175) is provided standard with the unit.
Here's an analysis of the provided text regarding the GE Datex-Ohmeda Engstrom Carestation:
Important Note: The provided document is a 510(k) summary and FDA clearance letter. It mainly focuses on establishing substantial equivalence to a previously cleared device, not on presenting novel clinical study results with acceptance criteria in the way you might expect for a new, non-substantially equivalent device or a software as a medical device (SaMD). Therefore, many of your requested items, particularly those related to detailed study methodologies, sample sizes for training/test sets, expert ground truth, and comparative effectiveness, are not explicitly present or applicable in this type of submission.
The "study that proves the device meets the acceptance criteria" in this context refers to the rigorous testing mentioned to support compliance with voluntary standards, which is a key part of demonstrating substantial equivalence for hardware devices like ventilators. It's not a clinical trial comparing performance against a clinical endpoint for a diagnostic device.
Here's the breakdown of the information requested, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied/Stated Standards) | Reported Device Performance (Summary from Submission) |
|---|---|
| UL 2601 General requirements for Medical Electrical Equipment | Validated through rigorous testing that supports compliance. |
| ASTM F1100 -- Particular Requirements for Critical Care Ventilators | Validated through rigorous testing that supports compliance. |
| EN/IEC 60601-1: General requirements for Medical Electrical Equipment | Validated through rigorous testing that supports compliance. |
| EN/IEC 60601-1-2: 2001 Medical Electrical Equipment Electromagnetic Compatibility | Validated through rigorous testing that supports compliance. |
| EN 475 Electrically Generated Alarm Signals | Validated through rigorous testing that supports compliance. |
| CGA V-1 ad ISO 5145 Medical Gas Cylinders Threaded Cylinders | Validated through rigorous testing that supports compliance. |
| EN 980 Graphical Symbols | Validated through rigorous testing that supports compliance. |
| EN/IEC 60601-2-12, Medical Electrical Equipment Critical Care Ventilators | Validated through rigorous testing that supports compliance. |
| Substantial Equivalence to Predicate Device (GE Datex-Ohmeda Engstrom Carestation - K051895) | "The GE Datex-Ohmeda Engstrom Carestation and the currently marketed device are substantially equivalent in design concepts, technologies and materials." |
| Functionality (Mechanical Ventilation modes, Monitoring, Nebulization) | Device provides all listed ventilation modes, integrated monitoring (FiO2, airway pressure, spirometry, volume), and an integrated nebulizer, along with optional respiratory gas monitoring and spirodynamics. |
| Target Patient Population | Adults and pediatrics weighing 5kg and above with varying degrees of pulmonary impairment. |
| Intended Use Environment | Facility use, including within-facility transport, under orders of a clinician. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The 510(k) summary states "rigorous testing," which would typically involve engineering and performance testing on the device itself, but specific sample sizes of devices or test conditions are not detailed. This is a hardware device, not a diagnostic algorithm; thus, "test set" in the common AI/ML sense doesn't apply directly.
- Data Provenance: Not applicable in the traditional sense for a hardware ventilator. The testing would be conducted in a laboratory or simulated environment, not on a "data set" originating from patients in a specific country. This is a device performance summary, not a data-driven algorithm performance summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable/Not specified. For a hardware ventilator, "ground truth" is typically established by physical measurements, engineering specifications, and established medical standards for ventilator performance, rather than expert consensus on a dataset. Clinical experts would define the requirements but not typically establish "ground truth" for the device's technical performance in a test set.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human-AI studies or for complex diagnostic assessments. For a ventilator's performance testing, the "adjudication" is generally based on objective measurements meeting predetermined engineering specifications and regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is relevant for diagnostic imaging or other human-in-the-loop AI/ML applications where human readers' performance is being evaluated with and without AI assistance. This document describes a mechanical ventilator (hardware), not a diagnostic AI system, so such a study would not apply.
- Effect Size of Human Readers Improve with AI vs without AI: Not applicable for this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Not applicable in the typical AI/ML sense. While the ventilator itself operates "standalone" in its mechanical functions, the concept of a "standalone algorithm" performance study refers to the isolated performance of a diagnostic or predictive algorithm. The ventilator's performance is intrinsically linked to its hardware and software working together to deliver ventilation. The document states it's a "microprocessor based, electronically controlled, pneumatically driven ventilator," implying algorithms control its function, but their "standalone performance" isn't evaluated separately from the device as a whole.
7. The Type of Ground Truth Used
- Engineering Specifications and Voluntary Standards: The primary "ground truth" for a device like this would be established by objective, measurable engineering specifications (e.g., accuracy of delivered tidal volume, pressure control, alarm threshold accuracy) and compliance with the listed voluntary standards (UL, ASTM, EN/IEC). These standards define acceptable performance ranges and safety requirements.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This is a hardware device being cleared via substantial equivalence, not an AI/ML algorithm requiring a training set in the conventional sense. The "training" of the device refers to its design, development, and testing against pre-defined specifications and standards.
9. How the Ground Truth for the Training Set was Established
- Not applicable/Not specified. As above, the concept of a "training set" ground truth doesn't directly apply here. The "ground truth" for the device's inherent design and functionality would be based on established principles of respiratory physiology, mechanical engineering, electrical engineering, and medical device safety standards.
§ 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).