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.

Device Description

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.

AI/ML Overview

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.

Summary

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GE Healthcare

K 11111

Image /page/0/Picture/25 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has decorative swirls and flourishes around the edges. The logo is presented in black and white, giving it a classic and recognizable appearance.

SEP - 9 2011

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

Premarket Notification 510(k) Summary As required by section 807.92 Engstrom Ventilator

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

COMPANY NAME/ADDRESS/PHONE/FAX:

Datex-Ohmeda, Inc. PO Box 7550 Madison, WI 53707-7550 USA Tel: 608-221-1551 Fax: 608-646-7464

NAME OF CONTACT:

Ms. Monica Morrison Mr. Jim Raskob (alternate)

DATE:

April 19, 2011

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:

21 CFR 868.5895

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

The Engstrom Ventilator is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Engstrom Ventilator (K093886), and the Hamilton G5 Ventilator (K070513).

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

The modes of ventilation currently available include:

1. Volume Controlled (VCV)
1. Pressure Controlled (PCV)
Pressure Controlled, Volume Guaranteed (PCV-VG) 3.
1. Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC)
1. Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC)
Synchronized Intermittent Mandatory Ventilation, Pressure Controlled Volume Guarantee 6. (SIMV-PCVG)
1. Bi-level Airway Pressure Ventilation
1. Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV)
1. Apnea backup (available in SIMV-VC, SIMV-PC, SIMV-PCVG/BiLevel-VG, BiLevel, 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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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 Engstrom ventilator has been updated from the predicate version (K093886). There have been no changes to the intended use or fundamental scientific technology.

The software for the Engstrom ventilator has been updated to include touch screen functionality for navigation to existing Engstrom ventilator functions and menus. Additional minor software updates have been included that are primarily based on customer feedback (such as nuisance alarm conditions) and minor changes to bring the product in line with current specifications.

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

The GE Datex-Ohmeda Engstrom Carestation and Engstrom Pro ventilators have been thoroughly tested through verification of specifications 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, including electrical safety and electromagnetic compatibility testing. 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
Integration testing O
Performance Testing (Verification) o
Safety Testing (Verification) O
Simulated Use/User Requirements Testing (Validation) O

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

The modifications made to the Engstrom ventilator did not require clinical testing. The software changes made to introduce touch screen functionality, as described in this submission, were completely evaluated by non-clinical 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 Engstrom Carestation and Engstrom Pro ventilators as compared to the predicate devices. Based on the performance data, GE Healthcare considers the Engstrom Carestation and Engstrom Pro ventilators with 7.X software to be as safe and effective, and perform in a substantially equivalent manner to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized bird or eagle with three curved lines representing its wings. The symbol is black, and the background is white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MI) 20993-0002

Datex-Ohmeda. Incorporated C/O Ms. Monica Morrison Regulatory Affairs Leader Life Support Solution P.O. Box 7550 3030 Ohmeda Drive Madison. Wisconsin 53707

9 2011

Re: Kill116

Trade/Device Name: Engstrom Carestation Engstrom Pro Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 8, 2011 Received: July 11, 2011

Dear Ms. Morrison:

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 generäl 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 HI (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. Morrison

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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

hu for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K

Device Name: GE Datex-Ohmeda Engström Ventilator

Indications For Use:

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)

L. Schutts

Page 1 of

(Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: 4 11116

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).