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510(k) Data Aggregation
(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.
Ask a specific question about this device
(136 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 Engstrom 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 (active in Bi-level and CPAP/PSV)
- Non-invasive ventilation (NIV), note that NIV is not available in neonatal mode
- Infant Nasal CPAP (nCPAP)
- Volume Guarantee, Pressure Support (VG-PS)
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. 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 Engstrom Carestation and Engstrom 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 Engstrom Carestation or Engstrom 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 Engstrom 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 Engstrom Carestation include 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 Out method. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-C, M-COV, M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, rev 3.2 software and higher, (K001814) or Mini-CO2 Module (K023454) which are physically integrated into the Engstrom Carestation, receive electronic power from the Engström Carestation and communicate measured values to the Engström Carestation for display on the system display unit.
This document is a 510(k) premarket notification for the GE Datex-Ohmeda Engström Ventilator, seeking substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical data.
Specifically, the document states:
- "The modifications made to the Engstrom ventilator did not require clinical testing."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such clinical study data or acceptance criteria related to a performance study are present in the provided text. The submission focuses on verification of specifications, validation (including software validation), electrical safety, and electromagnetic compatibility testing, rather than a clinical performance study with defined acceptance criteria for AI or a detailed comparison of device performance against a benchmark.
Ask a specific question about this device
(95 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 the Engstrom Family expand the patient range to 0.5 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 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 (Engstrom Carestation and Engstrom 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 Engstrom Pro is a defeatured variant of the Engström Carestation.
Both the GE Datex-Ohmeda Engstrom Carestation and Engstrom 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 its patient range to 0.5 kg.
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)
- . 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 (active in Bi-level and CPAP/PSV)
- . Non-invasive ventilation (NIV), note that NIV is not available in neonatal mode
- . Neonatal Nasal CPAP (nCPAP).
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 nebulizer.
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. 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.
The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.
Optional accessories common to both Engstrom Carestation and Engstrom Pro include a trolley/cart, integrated air compressor, support arm, humidifier and water trap mounting brackets, and auxiliary electrical outlets. 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. All alarm functions and reactions to failure of the compressed gas supply, are provided by the Engstrom Carestation or Engstrom Pro as cleared in K041775. 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 Engstrom Carestation/Engstrom Pro equipped with the optional compressor.
Additional optional accessories specific to the Engstrom Carestation include airway modules, intratracheal pressue sensor, and module bay. Optional functionality specific to the Engstrom Carestation include neonatal use, 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 M-Gas Module (M-C, M-CO, M-COV, M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, (rev 3.2 software and higher) K# 001814) or Mini-CO2 Module (K023454) which are physically integrated into the Engstrom Carestation, receive electronic power from the Engstrom Carestation and communicate measured values to the Engstrom Carestation for display on the system display unit.
Enstrom Pro is a defeatured variant of the Engstrom Carestation. It uses the same hardware and software as the Engstrom Carestation, with the following differences:
- . FRC and Spirodynamics are not available
- Monitoring module is not available .
- . Cart outlets are not available
- . A new cart is provided
- . Aesthetic differentiation
The provided text is a 510(k) Premarket Notification summary for the Engström Ventilator. It describes hardware and software updates to an existing ventilator (Engström Carestation) and introduces a "defeatured variant" (Engström Pro).
Crucially, this document states: "The modifications made to the Engstrom ventilator did not require clinical testing." This means there is no "study that proves the device meets the acceptance criteria" in terms of clinical performance.
Therefore, I cannot provide details on clinical acceptance criteria or studies as the submission itself indicates none were performed or required for the modifications.
However, I can extract information related to non-clinical testing and regulatory compliance, which served as the basis for substantial equivalence for this device.
Here's a breakdown of what the document does provide:
-
A table of acceptance criteria and the reported device performance:
Acceptance Criteria (Non-Clinical/Regulatory Compliance) Reported Device Performance UL 2601 General requirements for Medical Electrical Equipment Verification of compliance made EN/IEC 60601-1: General requirements for Medical Electrical Equipment Verification of compliance made EN/IEC 60601-1-2: 2001 Medical Electrical Equipment Electromagnetic Compatibility Verification of compliance made EN 475 Electrically Generated Alarm Signals Verification of compliance made CGA V-1 ad ISO 5145 Medical Gas Cylinders Threaded Cylinders Verification of compliance made EN 980 Graphical Symbols Verification of compliance made EN/IEC 60601-2-12, Medical Electrical Equipment Critical Care Ventilators Verification of compliance made Software Validation Thoroughly tested through validation Verification of Specifications Thoroughly tested through verification -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable as no clinical testing was performed. The non-clinical testing involved verification against engineering specifications and international standards, which would typically involve testing of device prototypes or production units, not patient data.
- Data Provenance: Not applicable for clinical data. The testing was non-clinical, likely performed internally by the manufacturer during design verification and validation.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth, in a clinical sense, was not established as there was no clinical testing. For non-clinical specification verification, the "ground truth" would be the engineering design specifications and the requirements of the standards themselves, verified by engineers and quality personnel.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical test set requiring adjudication.
-
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. This is a ventilator device, not an AI diagnostic or assistance tool for human "readers." The modifications were to ventilation modes and hardware variants for an established device type.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a medical device (ventilator), not an algorithm or AI system in the typical sense. Its performance is inherent to its mechanical and software operation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical testing, the "ground truth" was compliance with established engineering specifications and international safety and performance standards for medical electrical equipment and critical care ventilators.
-
The sample size for the training set:
- Not applicable. As no clinical testing was done, there was no clinical training set. For software development and verification, there would have been internal testing and validation processes, but these don't typically involve "training sets" in the machine learning sense.
-
How the ground truth for the training set was established:
- Not applicable.
In summary, the 510(k) submission for the Engström Ventilator relies on non-clinical verification and validation against established engineering specifications and international standards to demonstrate substantial equivalence to predicate devices. It explicitly states that clinical testing was not required for the modifications made.
Ask a specific question about this device
(88 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. Optional Neonatal capabilities expand the patient range to 0.5 kg. 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) .
- 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 (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 integrated 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.
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 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 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 integrated 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 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 modules, 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.
This document is a 510(k) summary for the GE Datex-Ohmeda Engstrom Carestation, a continuous ventilator. The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way medical device effectiveness studies for AI/software devices typically do.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices and compliance with voluntary standards for medical electrical equipment.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth type and training set details) are not applicable or not provided in this type of regulatory submission for a physical medical device like a ventilator.
Here's a breakdown based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy) or a comparative performance study against a defined benchmark. Instead, the "acceptance criteria" for a traditional device like this ventilator are implicitly met by:
- Substantial Equivalence: The primary "acceptance" is that the device is substantially equivalent to legally marketed predicate devices.
- Compliance with Voluntary Standards: The device's design and testing demonstrate compliance with recognized industry standards.
| Acceptance Criteria (Implicit) | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence to Predicate Devices | The GE Datex-Ohmeda Engstrom Carestation is substantially equivalent to: |
- GE Datex-Ohmeda Engstrom Carestation (K051895, K060862)
- Drager Evita XL (K051623)
- Drager Babylog 8000 Plus (K974176)
- Siemens Servo-I (K041111223) |
| Compliance with Applicable Voluntary Standards | The device was designed to comply with applicable portions of: - 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 (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) |
| Safety and Effectiveness for Intended Use | Provides mechanical ventilation for adults and pediatrics (5kg and above, optionally 0.5kg for neonates) with varying degrees of pulmonary impairment. |
| Performance of Integrated Components and Optional Accessories | Includes integrated FiO2, airway pressure, spirometry, volume monitoring, Aerogen Aeroneb Pro nebulizer. Options for integrated respiratory gas monitoring (via Datex-Ohmeda M-Gas Module/Mini-CO2 Module), integrated air compressor, SpiroDynamics measurement, and FRC calculation. |
Study Proving Device Meets Acceptance Criteria:
The document states: "The GE Datex-Ohmeda Engström Carestation has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Engström Carestation to the standards listed above."
This "rigorous testing" would likely include:
- Bench testing: To verify technical specifications and performance against design requirements and standards (e.g., airflow accuracy, pressure control, alarm functionality).
- Electrical safety and EMC testing: To comply with UL 2601, EN/IEC 60601-1, and EN/IEC 60601-1-2.
- Software verification and validation: To ensure the microprocessor-based control system functions as intended.
- Materials compatibility testing: For components in contact with gases or patients.
However, the specific details regarding the methodology, results, or quantitative metrics of these internal validation tests are not disclosed in this 510(k) summary. These details would be contained within the full 510(k) submission, which is not publicly available.
Due to the nature of this submission (a 510(k) for a physical ventilator, not an AI/software device), the following items are largely not applicable or not provided in this public summary:
2. Sample size used for the test set and the data provenance: Not applicable in the context of device performance claims made via standards compliance and substantial equivalence to predicate devices. Testing would involve engineering validation and verification, not a clinical "test set" in the sense of patient data for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a ventilator's physical performance is primarily against engineering specifications and industry standards, not expert clinical interpretation of data.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This is for a physical ventilator, not an AI-assisted diagnostic or therapeutic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical ventilator.
7. The type of ground truth used: For a physical device, the "ground truth" would be established by:
* Engineering specifications and design requirements: Ventilator output (pressure, volume, flow) measured against intended values.
* Reference standards and calibrated equipment: For measuring performance parameters.
* Physiological models: For testing performance under simulated patient conditions.
* Clinical consensus on safety parameters: Ensuring the device operates within safe physiological ranges.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
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(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.
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