(334 days)
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 on Engström Carestation and Engström Pro expand the patient range to 0.25 kg.
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. 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 Carestation and Engström Pro are flexible, and intuitive, critical care ventilators. A wide selection of performance options gives the user full control of the system configuration. The Engström Carestation and Engström Pro feature patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.
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 allow the Engström Carestation and Engström Pro to be used with patients weighing 0.25 kg and above.
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 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 Engström 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 standard nebulizer board is provided with both the Engström Carestation and Engström Pro variants. Users have the option to configure the system to use an external pneumatic nebulizer in place of the standard nebulizer.
The optional medical air compressor is intended for use as an accessory to provide a dry, filtered, breathable compressed air 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 use of an integrated air compressor was first cleared in K050597.
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. 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-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 Engström Carestation and communicate measured values to the Engström Carestation for display on the system display unit.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Datex-Ohmeda Engström Carestation and Engström Pro ventilators.
This 510(k) submission (K140575) is primarily for the addition of an alternate integrated air compressor (EVair) to the existing GE Datex-Ohmeda Engström Carestation and Engström Pro ventilators, which were previously cleared under K111116. The submission states "There have been no changes to the intended use or fundamental scientific technology." and "The addition of the alternate compressor, EVair, does not affect the safe or effective use of the ventilator as the compressor interfaces with the ventilator in the same manner, and performs in an equivalent manner. There is no change to the Engstrom performance as a result of this change." Consequently, the acceptance criteria and studies focus specifically on the new compressor and its functional equivalence, rather than a broad re-evaluation of the entire ventilator system.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) (adding an alternate component), the acceptance criteria are framed around functional equivalence and safety of the new EVair compressor compared to the predicate EVair03.
| Acceptance Criteria Category | Specific Criteria (Expected Performance) | Reported Device Performance (Engström Carestation and Engström Pro with EVair) |
|---|---|---|
| Intended Use | Identical to the predicate device (Engstrom 7.x - K111116): Mechanical ventilation for adults and pediatrics (5kg+), optional neonatal (0.25kg+). Microprocessor-based, electronically controlled, pneumatically driven. Integrated FiO2, airway pressure, spirometry, volume monitoring, Aerogen Aeroneb nebulizer, data capture accessory, integrated air compressor. Integrated respiratory gas monitoring (Carestation only), SpiroDynamics, FRC calculation (Carestation only). For facility use. | Confirmed to be identical to the predicate Engstrom 7.x (K111116) Indications for Use, with only a textual change in reference to the product name. No change to the intended use. |
| Ventilation Modes | Identical to the predicate device (Engstrom 7.x - K111116) list of 12 ventilation modes, including VCV, PCV, PCV-VG, SIMV-VC, SIMV-PC, SIMV-PCVG, Bi-level, CPAP/PSV, Apnea backup, NIV, Infant Nasal CPAP, and Volume Guarantee/PS. | Confirmed to be identical to the predicate Engstrom 7.x (K111116). No change to the ventilation modes. |
| Ventilator System Software | Minor software updates only, with no change to the features or function of the ventilator. (Version 7.X) | Version 7.X. Minor software updates only have been made with no change to the features or function of the ventilator. Considered substantially equivalent. |
| Optional Integrated Air Compressor Functionality | Functionally equivalent to the predicate (EVair03) such that it does not affect the safe or effective use of the ventilator. | Verification has demonstrated that the EVair compressor is functionally equivalent to the predicate EVair03 compressor. The compressor interfaces with the ventilator in the same manner. This results in no change to the Engstrom performance. |
| Air Compressor: Transition to Backup Air Supply | Pneumatic control to switch from standby to reserve air supply. Backup operation begins when pipeline pressure drops below 250 kPa (36.3 psi) [for predicate EVair03]. Pressure values should fall within the Engstrom ventilator specifications. | Software control to switch from standby to reserve air supply. Backup operation begins when pipeline pressure drops below 280 kPa (40.6 psi), which is a factory set-point but can be adjusted by trained service personnel. The backup operation of the EVair is substantially equivalent to the predicate EVair03. Pressure values still fall within the Engstrom ventilator specifications. No functional change to the Engstrom Ventilator; the EVair has been verified to be functionally equivalent to the EVair03 compressor. |
| Safety and Performance (New Compressor) | Compliance with applicable standards (e.g., electrical safety, EMC, performance standards for ventilators), risk analysis, software validation. The compressor should exhibit improvements in acoustics, vibration, and thermal dissipation compared to the predicate. | Thoroughly tested through verifications and validation, including software validation. Verification of compliance with applicable standards has been completed. Risk Analysis, Requirements/Specification Reviews, Design Reviews, Testing on unit level, Integration testing, Performance Testing (Verification), and Safety Testing (Verification) were applied. The EVair compressor contains improvements in acoustics, vibration, and thermal dissipation. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes nonclinical testing only.
- Sample Size: The document does not specify a quantitative "sample size" in terms of units tested for the compressor, nor does it refer to patient data. Testing appears to be on developmental units of the EVair compressor integrated with the Engström ventilators.
- Data Provenance: The testing was "nonclinical," meaning it did not involve human patients. It was conducted by the manufacturer, Datex-Ohmeda, Inc. (GE Healthcare). There is no mention of country of origin for specific test data, but the company is based in Madison, WI, USA. The testing is prospective in the sense that it evaluates a newly designed component (EVair compressor) before its market release.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The concept of "ground truth established by experts" is not directly applicable here as this is a nonclinical engineering and functional equivalence study for a medical device component.
- The ground truth for this type of evaluation is typically defined by engineering specifications, regulatory standards (e.g., ISO, IEC for medical electrical equipment), and the performance characteristics of the legally marketed predicate device.
- The "experts" involved would be the manufacturer's engineers, quality assurance personnel, and regulatory specialists who designed, tested, and evaluated the device against these objective criteria. Their qualifications would stem from their professional expertise in medical device development, testing, and regulatory requirements.
4. Adjudication Method for the Test Set
- Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human observers (e.g., radiologists interpreting images) where consensus or a tie-breaking mechanism is needed to establish a "true" label.
- This submission describes nonclinical engineering testing. Therefore, such adjudication methods are not applicable. The results of the tests (e.g., pressure measurements, acoustic levels, vibration, thermal performance, software function) are objective, quantitative data compared against predefined specifications and predicate performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done.
- MRMC studies are clinical studies designed to evaluate the diagnostic performance of human readers, often comparing performance with and without an AI-assisted device.
- This 510(k) submission is for an alternate component (air compressor) of a ventilator, not a diagnostic AI device. The submission explicitly states: "The modifications made to the Engström ventilator did not require clinical testing."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is framed for AI/algorithm-based devices. The Engström Carestation and Engström Pro are physical medical devices (ventilators) with microprocessor control, not standalone AI algorithms.
- The "standalone performance" of the EVair compressor itself was evaluated during its design and verification to meet engineering specifications (acoustics, vibration, thermal dissipation) and then its integrated performance with the ventilator system was verified. This can be considered the equivalent of a "standalone" functional test for the component.
7. The Type of Ground Truth Used
- For this nonclinical submission, the ground truth is based on:
- Engineering Specifications: Detailed technical requirements for component performance (e.g., pressure ranges, flow rates, alarm thresholds, acoustic limits, vibration levels, thermal profiles).
- Regulatory Standards: Compliance with relevant national and international standards for medical devices, particularly continuous ventilators (e.g., 21 CFR 868.5895, ISO, IEC standards).
- Predicate Device Performance: The demonstrated safe and effective performance of the previously cleared predicate device (Engstrom Ventilator K111116 and its EVair03 compressor). The new EVair compressor was evaluated against the functional performance of the EVair03.
8. The Sample Size for the Training Set
- This question is relevant for machine learning or AI models.
- Not applicable. This submission is for a physical medical device and its component, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for an AI model in this submission.
§ 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).