GE DATEX-OHMEDA ENGSTROM CARESTATION by DATEX-OHMEDA, INC.

The GE Datex-Ohmeda Engstrom 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 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) .
Bi-level Airway Pressure Ventilation ●
Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV) .
Apnea backup (active in Bi-level and CPAP/PSV) .

Device Description

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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Note: The document provided is a 510(k) summary for a medical device (ventilator). These summaries often focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the manner one might find for a novel diagnostic algorithm. Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, MRMC studies, etc.) are not typically found or disclosed in this type of regulatory filing for this class of device. The "studies" for this device often refer to engineering tests and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standards Compliance)	Reported Device Performance
UL 2601 General requirements for Medical Electrical Equipment	Device was validated through rigorous testing that supports compliance with this standard.
ASTM F1100 Particular Requirements for Critical Care Ventilators	Device was validated through rigorous testing that supports compliance with this standard.
EN/IEC 60601-1: General requirements for Medical Electrical Equipment	Device was validated through rigorous testing that supports compliance with this standard.
EN/IEC 60601-1-2: 2001 Medical Electrical Equipment Electromagnetic Compatibility	Device was validated through rigorous testing that supports compliance with this standard.
EN 475 Electrically Generated Alarm Signals	Device was validated through rigorous testing that supports compliance with this standard.
CGA V-1 ad ISO 5145 Medical Gas Cylinders Threaded Cylinders	Device was validated through rigorous testing that supports compliance with this standard.
EN 980 Graphical Symbols	Device was validated through rigorous testing that supports compliance with this standard.
EN/IEC 60601-2-12, Medical Electrical Equipment Critical Care Ventilators	Device was validated through rigorous testing that supports compliance with this standard.
Substantial Equivalence to Predicate Devices (GE Datex-Ohmeda Engstrom Carestation K041775 and Siemens Mini C Compressor K023354)	The GE Datex-Ohmeda Engstrom Carestation and the currently marketed predicate device are substantially equivalent in design concepts, technologies, and materials. FDA found the device substantially equivalent.
Providing mechanical ventilation for adults and pediatrics weighing 5kg and above with pulmonary impairment from minor to severe, including specified modes of ventilation.	The device is designed for these indications and includes the specified modes of ventilation.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. For this type of device, "testing" primarily refers to engineering verification and validation against performance specifications and recognized standards, not necessarily a "test set" of patient data in the way one would analyze an AI algorithm.
Data Provenance: Not applicable in the context of clinical patient data. The "study" refers to engineering and quality assurance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified or applicable. The ground truth for a ventilator's performance is typically established by metrological standards, engineering specifications, and functional testing, not by expert clinician consensus on a dataset.

4. Adjudication method for the test set

Not specified or applicable. Adjudication methods are typically used for subjective clinical interpretations, which is not the primary assessment method for a ventilator's functional performance in this context.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers (e.g., radiologists, pathologists). The GE Datex-Ohmeda Engstrom Carestation is a standalone mechanical ventilator; it does not involve human "readers" interpreting output with or without AI assistance in this manner.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in essence. The "performance" of the ventilator is "standalone" in that its operation (controlling gases, delivering breaths, monitoring) is independent of human interpretation in the way an AI algorithm might be. The device's integrated measurement capabilities (FiO2, airway pressure, spirometry, volume monitoring) perform their functions autonomously. However, this is not a standalone "algorithm" in the context of an AI-driven diagnostic. It is the core function of the device itself.

7. The type of ground truth used

The "ground truth" for this device's performance is established by:
- Engineering specifications and design requirements: Ensuring the device can deliver specified volumes, pressures, and modes of ventilation accurately.
- Compliance with recognized voluntary standards: (e.g., UL 2601, ASTM F1100, EN/IEC 60601 series). These standards define acceptable performance characteristics and safety criteria.
- Functional tests and calibration: Verifying that components and the overall system operate within specified tolerances.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm trained on a dataset. Its design and validation rely on engineering principles, component testing, and system-level functional verification.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI algorithm.

Summary

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K05/895

SEP 2 7 2005

Date:	July 11, 2005
Subject:	510(k) Summary of Safety and Effectiveness Informationfor the GE Datex-Ohmeda Engstrom Carestation
Proprietary:	GE Datex-Ohmeda Engstrom Carestation
Common:	Ventilator, Continuous
Classification:	Anesthesiology, 73 CBK, 21 CFR 868.5895

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

The GE Datex-Ohmeda Engstrom Carestation is substantially equivalent to the following currently marketed device:

GE Datex-Ohmeda Engstrom Carestation- Class II - 21CFR868.5895, which has been the subject of a cleared 510(k) with FDA log number K041775.

Siemens Mini C Compressor - Class I - 21CFR 868.6250, which has been the subject of a cleared 510(k) with FDK log number K023354

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 ●
Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV) .
Apnea backup (active in Bi-level and CPAP/PSV) .

When supplied as an option, 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,

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(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 intogration and communicate measured values to the Engstrom Carestation for display on the system display unit.

When supplied as an option, 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, no alone in the Engstrom Carestation 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 in mo essed oxygen is required to be connected to Engstrom Carestations equipped with the optional compressor.

The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.

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.

The GE Datex-Ohmeda Engstrom Carestation was designed to comply with the applicable portions of the following voluntary standards;

1. UL 2601 General requirements for Medical Electrical Equipment
1. ASTM F1100 Particular Requirements for Critical Care Ventilators
1. EN/IEC 60601-1: General requirements for Medical Electrical Equipment
1. EN/IEC 60601-1-2: 2001 Medical Electrical Equipment Electromagnetic Compatibility
1. EN 475 Electrically Generated Alarm Signals
1. CGA V-1 ad ISO 5145 Medical Gas Cylinders Threaded Cylinders
1. EN 980 Graphical Symbols
1. EN/IEC 60601-2-12, Medical Electrical Equipment Critical Care Ventilators

The GE Datex-Ohmeda Engstrom Carestation and the currently marketed device are substantially equivalent in design concepts, technologies and materials. The GE Datex-Ohmeda Engstrom Carestation has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Engstrom Carestation to the standards listed above.

Dan Kosednar, RAC Contact:

Manager, Regulatory Planning and Submissions

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SEP 27 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dan Kosednar Manager, Regulatory Planning and Submissions Datex-Ohmeda, Incorportaed Care Business Area P.O. Box 7550 Madison, Wisconsin 53707

Re: K051895

Trade/Device Name: GE Datex-Ohmeda Engstrom Carestation Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: August 30, 2005 Received: August 31, 2005

Dear Mr. Kosednar:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Kosednar

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 mount that I Drimas and regulations and regulations administered by other Federal agencies. or the Free of any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 es results in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality ijon control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) rms reter notification. The FDA finding of substantial equivalence of your device to a premarket nownloade device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you dostro specifical at Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may occare of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony V. Watson per

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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): KO51895

Device Name: GE Datex-Ohmeda Engstrom Carestation

Indications For Use:

The GE Datex-Ohmeda Engstrom Carestation is designed to provide mechanical veriliation for i he GE Datex-Onlineda Engation Ouroclavel is Google from minor to severe. The modes of ventilation are available include:

Volume Controlled (VCV) .
Pressure Controlled (PCV) .
Pressure Controlled, Volume Guaranteed (PCV-VG) .
r ressure Controllent Mandatory Ventilation, Volume Controlled (SIMV-VC) ●
Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC) .
Bi-level Airway Pressure Ventilation .
Bricerol Airway Pressure/Pressure Support Ventilation (CPAP/PSV) ●
Apnea backup (active in Bi-level and CPAP/PSV) .

The GE Datex-Ohmeda Engstrom Carestation is a microprocessor based, electronically The OL Datex Onlinout Engorem othator that includes integrated FiO2, airway pressure, controlled, prieumationing and an Aerogen Aeroneb Pro nebulzier. Options include spirometry and volume monitoring capabilities via various Datex-Ohmeda patient monitoring integrated respiratory goduct labeling and an integrated air compressor.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clim Salion

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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

510(k) Number:_

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).