(141 days)
The GE Datex-Ohmeda Engström family of ventilators (Engström Carestation and Engström Pro) are designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. Optional Neonatal capabilities on Engström family expand the patient range to 0.25 kg.
The GE Datex-Ohmeda Engström family of ventilators are microprocessor based, electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway pressure, spirometry and volume monitoring. Options include an Aerogen Aeroneb nebulizer, data capture accessory and an integrated air compressor. Options available on Engström Carestation only include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling, 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.
Not all features are available with all patient populations.
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 GE Datex-Ohmeda Engström family of ventilators (Engström Carestation and Engström Pro) are flexible, adaptable, and intuitive critical care ventilators. 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 Engström Pro is a defeatured variant of the Engström Carestation.
Both the GE Datex-Ohmeda Engström Carestation and Engström Pro are designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. Optional Neonatal capabilities expand its patient range to 0.25 kg.
The modes of ventilation currently 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)
- Synchronized Intermittent Mandatory Ventilation, Pressure Controlled Volume Guarantee (SIMV-PCVG)
- Bi-level Airway Pressure Ventilation
- Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV)
- Apnea backup (available in SIMV-VC, SIMV-PC, SIMV-PCVG/BiLevel-VG, BiLevel, CPAP/PSV, and VG-PS)
- Non-invasive ventilation (NIV), not available in neonatal mode
- Infant Nasal CPAP (nCPAP), only available in neonatal mode
- Volume Guarantee, Pressure Support (VG-PS), only available in neonatal mode
The GE Datex-Ohmeda Engström Carestation and Engström Pro are microprocessor based, electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulizer control board.
The ventilator consists of two main components: a display and a ventilator unit. The display allows the user to interface with the system and control settings through use of soft keys on the display, a com wheel, and a resistive touch screen. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The Engstrom Carestation also includes a module bay that allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.
The user interface for control of nebulization is provided via the ventilator display unit. The Aerogen Aeroneb Pro Nebulizer board (K021175) is provided standard with the unit. Nebulizers are options for both the Engström Carestation and Engström Pro. Users have the option to configure the system to use an external pneumatic nebulizer in place of the Aerogen.
Optional accessories common to both Engström Carestation and Engström Pro include a trolley/cart, integrated air compressor, support arm, humidifier and water trap mounting brackets, and a data capture accessory. The GE Datex-Ohmeda EV Air Compressor is intended for use as an accessory to provide a dry, filtered, breathable compressed air supply. The compressor has no alarm functions. The Engström Carestation or Engström Pro provides all alarm functions and reactions to a failure of the compressed gas supply. The compressor is installed in the base of the ventilator cart. The compressor is powered from AC mains only. A source of compressed oxygen is required to be connected to Engström Carestation/Engström Pro equipped with the optional compressor. The compressor was cleared in K041775.
Additional optional accessories specific to the Engström Carestation include airway modules, intratracheal pressure sensor, auxiliary electrical outlets, and module bay. Optional functionality specific to the Engström Carestation includes integrated respiratory gas monitoring, capabilities to measure SpiroDynamics via a GE supplied 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 integrated respiratory gas monitoring is provided via the Datex-Ohmeda Gas Modules, M-C, M-CO, M-COV, M-COV, M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, rev 3.2 software and higher (K001814), E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX (K051092), or M-Mini-CO2 Module (K023454) or E-MiniC module (K052582) which are physically integrated into the Engström Carestation, receive electronic power from the Engstrom Carestation and communicate measured values to the Engström Carestation for display on the system display unit.
The provided text describes a 510(k) premarket notification for the GE Datex-Ohmeda Engström Ventilator family (Engström Carestation and Engström Pro). This submission is for an updated version of an existing device, primarily involving software changes.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly provide a table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity) for the device's functions. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and verification.
However, the general acceptance criteria for this type of submission are implied through the testing methods described:
| Acceptance Criteria Category | Reported Device Performance (Summary from Text) |
|---|---|
| Safety and Effectiveness | Demonstrated through verification of specifications, software validation, and compliance with applicable standards. No new questions of safety and effectiveness compared to predicate devices. |
| Functional Equivalence | Operates with updated software primarily adding touch screen functionality and minor changes based on customer feedback (e.g., nuisance alarms). Performs in a substantially equivalent manner to predicate devices. |
| Compliance with Standards | Verification of compliance with applicable standards completed for safe use, including electrical safety and electromagnetic compatibility testing. |
| Intended Use | Continues to provide mechanical ventilation for adults and pediatrics (5kg and above, with optional neonatal capabilities for 0.25kg) with pulmonary impairment. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "Testing on unit level," "Integration testing," "Performance Testing (Verification)," and "Safety Testing (Verification)" but does not specify the number of devices or scenarios used for these tests.
- Data Provenance: The testing appears to be conducted in-house by GE Healthcare/Datex-Ohmeda Inc. as part of their development and verification process. The data is retrospective in the sense that it's based on internal testing conducted on the device prior to submission, rather than prospective clinical trials. There is no mention of data origin by country.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission is for a ventilator, and the testing described is primarily engineering verification and validation against technical specifications and predicate device performance. It does not involve interpretation of medical images or diagnostic outputs that would require clinical expert "ground truth" establishment in the way a diagnostic AI device would. "Simulated Use/User Requirements Testing (Validation)" was performed, implying user involvement, but the number and qualifications of these users/experts are not specified, nor is their role in establishing a "ground truth" defined in the typical diagnostic context.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the testing is against technical specifications and predicate device performance, not against expert-adjudicated ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study was done. The text explicitly states: "The modifications made to the Engstrom ventilator did not require clinical testing."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone medical device (a ventilator), not an algorithm intended for diagnostic interpretation. The software updates were evaluated for their standalone functionality as part of the ventilator system. The non-clinical tests verified and validated the "safety and functionality" of the ventilator with the software changes.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is its adherence to:
- Technical Specifications: The device's design specifications for ventilation parameters, safety features, alarm conditions, etc.
- Predicate Device Performance: The established safety and effectiveness of the previously cleared Engstrom Ventilator (K093886) and Hamilton G5 Ventilator (K070513).
- Applicable Standards: Compliance with relevant medical device standards (e.g., electrical safety, electromagnetic compatibility).
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device (ventilator) with software updates, not an AI/ML algorithm that requires a "training set" in the machine learning sense. The software updates were based on "customer feedback" and "minor changes to bring the product in line with current specifications," but this is not equivalent to a supervised learning training process.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no AI/ML training set in the context described by the question.
§ 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).