ENGSTROM CARESTATION, ENGSTROM PRO

• K Number: K081842
• Device Name: ENGSTROM CARESTATION, ENGSTROM PRO
• Manufacturer: DATEX-OHMEDA, INC.
• Date Cleared: 2008-10-03 ( 95 days)
• Product Code: CBK
• Regulation Number: 868.5895
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: K021175 , K041775 , K023454 , K062710 , K063404 , K041223

Intended Use

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.

Device Description

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

AI/ML Overview

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:

1. 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

2. 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.

3. 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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. There was no clinical test set requiring adjudication.

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:

   • 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.

6. 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.

7. 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.

8. 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.

9. 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.

Regulation Number and Section

§ 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).