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.

Device Description

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 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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are black and are arranged in a way that suggests depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 3, 2015

Datex-Ohmeda, Inc. Ms. Trishia Dwyer Regulatory Affairs Leader Post Office Box 7550 Madison, WI 53707

Re: K140575

Trade/Device Name: GE Datex-Ohmeda Engström Carestation and Engström Pro Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 29, 2014 Received: December 31, 2014

Dear Ms. Dwyer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Dwyer

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K140575

Device Name: GE Datex-Ohmeda Engström Carestation and Engström Pro

Indications For Use:

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.

Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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Datex-Ohmeda Inc. 3030 Ohmeda Drive P.O. Box 7550 Madison, WI 53707-7550 USA

Premarket Notification 510(k) Summary As required by section 807.92 Engström Carestation and Engström Pro

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

COMPANY NAME/ADDRESS/PHONE/FAX:

Datex-Ohmeda, Inc. 3030 Ohmeda Drive PO Box 7550 Madison, WI 53707-7550 USA Tel: 608-221-1551 x 500-3260 Fax: 608-646-6488

NAME OF CONTACT:

Ms. Trishia Dwyer Ms. Monica Morrison (alternate)

DATE:

March 5, 2014

DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

Engström Carestation Engström Pro

COMMON NAME:

Ventilator, Continuous

CLASSIFICATION NAME:

ventilator, continuous, facility use

CDRH PRODUCT CODE:

СВК

REGULATION NUMBER:

CBK: 21 CFR 868.5895

Image /page/3/Picture/21 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has four decorative flourishes extending outward, resembling droplets or stylized flames. The logo has a metallic, silver appearance, suggesting a polished or reflective surface.

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NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EOUIVALENCE IS MADE as required by 807.92(a)(3)

The Engström Ventilator is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Engström Ventilator (K111116).

DEVICE DESCRIPTION as required by 807.92(a)(4)

The modes of ventilation currently available include:

1. Volume Controlled (VCV)
1. Pressure Controlled (PCV)
1. Pressure Controlled, Volume Guaranteed (PCV-VG)
1. Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC)
Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC) 5.
1. Synchronized Intermittent Mandatory Ventilation, Pressure Controlled Volume Guarantee (SIMV-PCVG)
1. Bi-level Airway Pressure Ventilation
Constant Positive Airway Pressure Support Ventilation (CPAP/PSV) 8.
Apnea backup (available in SIMV-VC, SIMV-PC, SIMV-PCVG/BiLevel-VG, BiLevel, 9. CPAP/PSV, and VG-PS)
1. Non-invasive ventilation (NIV), not available in neonatal mode
1. Infant Nasal CPAP (nCPAP), only available in neonatal mode
1. Volume Guarantee. Pressure Support (VG-PS), only available in neonatal mode

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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 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.

INTENDED USE as required by 807.92(a)(5)

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.

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The GE Datex-Ohmeda Engström ventilator has been updated from the predicate version (K111116). There have been no changes to the intended use or fundamental scientific technology.

This 510(k) requests clearance to add an alternate integrated air compressor to the Engstrom Carestation and Engstrom Pro accessory list. The alternate air compressor, the EV air differs from the predicate (cleared under K050597) in that it contains improvements in acoustics, vibration, and thermal dissipation.

The EVair compressor was designed specifically for the Engström family of products (Engström Carestation and Engström Pro). It fits in the back of the Engström cart and acts as a source of compressed air. The EVair is not available as a stand-alone compressor; it is only available as an accessory to the Engström Carestation and Pro. The new integrated compressor, EVair is manufactured by IMTMedical. 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. Additionally, the EVair compressor performs in a functionally equivalent manner to the predicate, EVair03.

	Engstrom Carestation,Engstrom Pro 7.x software(K111116)	Engstrom Carestation andEngstrom Pro(this 510(k))	Comments/Equivalence
Indicationsfor Use	The GE Datex-OhmedaEngström family of ventilators(Engström Carestation andEngström Pro) are designed toprovide mechanical ventilationfor adults and pediatricsweighing 5kg and abovehaving degrees of pulmonaryimpairment varying fromminor to severe. OptionalNeonatal capabilities onEngström family expand thepatient range to 0.25 kg.	The GE Datex-OhmedaEngström Carestation andEngström Pro are designed toprovide mechanical ventilationfor adults and pediatricsweighing 5kg and abovehaving degrees of pulmonaryimpairment varying fromminor to severe. OptionalNeonatal capabilities onEngström Carestation andEngström Pro expand thepatient range to 0.25 kg.	Identical to Engstrom 7.X(K111116) Indications forUse. Only change is toreference to productname, EngstromCarestation and EngstromPro instead of Engstromfamily of ventilators.
		The GE Datex-OhmedaEngström family of ventilatorsare microprocessor based,electronically controlled,pneumatically drivenventilators that includeintegrated FiO2, airwaypressure, spirometry andvolume monitoring. Optionsinclude an Aerogen Aeronebnebulizer, data captureaccessory and an integrated aircompressor. Options availableon Engström Carestation only		The GE Datex-OhmedaEngström Carestation andEngström Pro aremicroprocessor based,electronically controlled,pneumatically drivenventilators that includeintegrated FiO2, airwaypressure, spirometry, andvolume monitoring. Optionsinclude an Aerogen Aeronebnebulizer, data captureaccessory, and an integratedair compressor. Options
		Engstrom Carestation,Engstrom Pro 7.x software(K111116)		Engstrom Carestation andEngstrom Pro(this 510(k))	Comments/Equivalence
		include integrated respiratorygas monitoring capabilities viavarious Datex-Ohmeda patientmonitoring modules listed inthe product labeling,capabilities to measureSpiroDynamics via anintratracheal pressure sensor inpatients using sized 6.5tracheal tubes and larger, andcalculation of functionalresidual capacity ofmechanically ventilatedpatients using Nitrogen WashIn/Wash Out method.		available on EngströmCarestation only includeintegrated respiratory gasmonitoring capabilities viavarious Datex-Ohmeda patientmonitoring modules listed inthe product labeling,capabilities to measureSpiroDynamics via anintratracheal pressure sensor inpatients using sized 6.5tracheal tubes and larger, andcalculation of functionalresidual capacity ofmechanically ventilatedpatients using Nitrogen WashIn/Wash Out method.
		Not all features are availablewith all patient populations.		Not all features are availablewith all patient populations.
		The Engström Carestation isnot a pulmonary functioncalculation device.		The Engström Carestation isnot a pulmonary functioncalculation device.
		The system is designed forfacility use, including within-facility transport, and shouldonly be used under the ordersof a clinician.		The system is designed forfacility use, including within-facility transport, and shouldonly be used under the ordersof a clinician.
	VentilationModes	1. Volume Controlled (VCV),2. Pressure Controlled (PCV),3. Pressure Controlled,Volume Guaranteed (PCV-VG),3. Pressure Controlled,Volume Guaranteed (PCV-VG),4. Synchronized IntermittentMandatory Ventilation,Volume Controlled (SIMV-VC),5. Synchronized IntermittentMandatory Ventilation,Pressure Controlled (SIMV-PC),6. Synchronized IntermittentMandatory Ventilation,Pressure Controlled VolumeGuarantee (SIMV-PCVG),7. Bi-level Airway PressureVentilation8. Constant Positive AirwayPressure/Pressure Support		1. Volume Controlled (VCV),2. Pressure Controlled (PCV),3. Pressure Controlled,Volume Guaranteed (PCV-VG),3. Pressure Controlled,Volume Guaranteed (PCV-VG),4. Synchronized IntermittentMandatory Ventilation,Volume Controlled (SIMV-VC),5. Synchronized IntermittentMandatory Ventilation,Pressure Controlled (SIMV-PC),6. Synchronized IntermittentMandatory Ventilation,Pressure Controlled VolumeGuarantee (SIMV-PCVG),7. Bi-level Airway PressureVentilation8. Constant Positive AirwayPressure/Pressure Support	Identical to Engstrom 7.X(K111116). No change tothe ventilation modes.
		Engstrom Carestation,Engstrom Pro 7.x software(K111116)		Engstrom Carestation andEngstrom Pro(this 510(k))	Comments/Equivalence
		Ventilation (CPAP/PSV),9. Apnea backup (available inSIMV-VC, SIMV-PC, SIMV-PCVG/BiLevel-VG, BiLevel,CPAP/PSV, and VG-PS),10. Non-invasive ventilation(NIV),11. Nasal CPAP (nCPAP).12. Volume Guaranteed,Pressure Support (VG-PS)Note: NIV is not available inneonatal mode. VG-PS andnCPAP are only available inneonatal mode.		Ventilation (CPAP/PSV),9. Apnea backup (available inSIMV-VC, SIMV-PC, SIMV-PCVG/BiLevel-VG, BiLevel,CPAP/PSV, and VG-PS),10. Non-invasive ventilation(NIV),11. Nasal CPAP (nCPAP).12. Volume Guaranteed,Pressure Support (VG-PS)Note: NIV is not available inneonatal mode. VG-PS andnCPAP are only available inneonatal mode.
	EngstromVentilatorSystemSoftware	Version 7.X		Version 7.X	Substantially equivalent.Minor software updatesonly have been made withno change to the featuresor function of theventilator.
	OptionalIntegratedAirCompressor	Integrated Air Compressoroption available (calledEVair03)		Integrated Air Compressoroption available (called EVair)	Functionally equivalent toEngstrom 7.X (K111116).Verification hasdemonstrated that theEVair compressor isfunctionally equivalent tothe predicate EVair03compressor.
	AirCompressor:Transition tobackup airsupply forEngstrom	Pneumatic control to switchfrom standby to reserve airsupply. Backup operationbegins when pipeline pressuredrops below 250 kPa (36.3 psi).		Software control to switchfrom standby to reserve airsupply. Backup operationbegins when pipeline pressuredrops below 280 kPa (40.6 psi),this is a factory set-pointbut can be adjusted by trainedservice personnel.	The backup operation ofthe EVair is substantiallyequivalent to thepredicate EVair03.Pressure values still fallwithin the Engstromventilator specifications.No functional change tothe Engstrom Ventilator,the EVair has beenverified to be functionallyequivalent to the EVair03compressor.

Please see the table below for a comparison of the predicate Engstrom Carestation and Engstrom Pro (K11116) compared to the modifications proposed in this 510(k):

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SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

The GE Datex-Ohmeda Engstrom Carestation and Engström Pro ventilators with the integrated compressor have been thoroughly tested through verifications and validation. including software validation. Verification of compliance with applicable standards has also been completed to ensure safe use of the device in its intended use environment. The following quality assurance measures were applied during the development of the Engstrom ventilator system:

o Risk Analysis
Requirements/Specification Reviews O
Design Reviews O
Testing on unit level O
o Integration testing
Performance Testing (Verification) o
Safety Testing (Verification) o

SUMMARY OF CLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(2)

The modifications made to the Engström ventilator did not require clinical testing. The compressor improvements as described in this submission were completely evaluated by nonclinical tests to verify and validate the safety and functionality of the ventilator.

CONCLUSION:

The summary above demonstrates that there are no new questions of safety and effectiveness for the Engström Carestation and Engström Pro ventilators as compared to the predicate devices. Based on the performance data, GE Healthcare considers the Engström Carestation and Engström Pro ventilators to be as safe and effective, and perform in a substantially equivalent manner to the predicate devices.

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).