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) .

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 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 vertilation, 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 nower, nebulization, and pneumatic gas flow to and from the vehinder ann some 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, Additional optional water trap mounting brackets, and auxiliary electrical outlets. Support ann, mamamor and watcher is provided via the ventilator display unit. The rne ason internate for Nebulizer (K021175) is provided standard with the unit.

AI/ML Overview

The provided text describes a 510(k) submission for the "GE Datex-Ohmeda Engstrom Carestation," a continuous ventilator. This document explicitly states that the device has been validated through "rigorous testing that, in part, supports the compliance" of the device to several voluntary standards.

However, the provided text does not contain specific acceptance criteria or detailed results of a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, or accuracy related to disease detection or diagnosis.

Instead, this document is a regulatory submission demonstrating substantial equivalence to a predicate device and compliance with applicable safety and performance standards for a medical ventilator. The "acceptance criteria" here are compliance with these regulatory and voluntary standards, and the "study" is the rigorous testing mentioned, but the specifics are not detailed in the provided text.

Therefore, I cannot fill out the detailed table and answer the specific questions about sample size, expert ground truth, MRMC studies, or standalone performance as they relate to performance metrics typically expected for AI/diagnostic devices. The information provided is for a traditional medical device (ventilator).

Here's what I can extract from the provided text based on the general nature of the request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Based on described standards)	Reported Device Performance
Regulatory Compliance	Substantial Equivalence to predicate devices (K041775, K023354)	Deemed Substantially Equivalent by FDA (K050597)
	Prescription Use (21 CFR 801 Subpart D)	Indicated for Prescription Use
Voluntary Standards Compliance	UL 2601 General requirements for Medical Electrical Equipment	Device designed to comply with applicable portions.
	ASTM F1100 Particular Requirements for Critical Care Ventilators	Device designed to comply with applicable portions.
	EN/IEC 60601-1: General requirements for Medical Electrical Equipment	Device designed to comply with applicable portions.
	EN/IEC 60601-1-2: 2001 Medical Electrical Equipment Electromagnetic Compatibility	Device designed to comply with applicable portions.
	EN 475 Electrically Generated Alarm Signals	Device designed to comply with applicable portions.
	CGA V-1 ad ISO 5145 Medical Gas Cylinders Threaded Cylinders	Device designed to comply with applicable portions.
	EN 980 Graphical Symbols	Device designed to comply with applicable portions.
	EN/IEC 60601-2-12, Medical Electrical Equipment Critical Care Ventilators	Device designed to comply with applicable portions.
Intended Use	Provide mechanical ventilation for adults and pediatrics weighing 5kg and above.	Device design includes various ventilation modes for this population.
	Provide integrated FiO2, airway pressure, spirometry and volume monitoring.	Device includes these integrated monitoring capabilities.
	Incorporate Aerogen Aeroneb Pro nebulizer.	Device includes this nebulizer.
	Optional integrated respiratory gas monitoring.	Available via Datex-Ohmeda M-Gas Modules and Mini-CO2 Module.
	Optional integrated air compressor.	Available accessory for breathable compressed air supply.
	Designed for facility use, including within-facility transport, under clinician orders.	Stated in Indications for Use.

Regarding the specific questions that relate to AI/Diagnostic studies, the document does not provide the necessary information:

2. Sample sized used for the test set and the data provenance: Not applicable/Provided. This document is for a physical medical device (ventilator), not a diagnostic algorithm. The "testing" refers to verification and validation against engineering specifications and regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. Ground truth, in the context of this device, relates to its ability to meet performance specifications (e.g., deliver set volumes/pressures, maintain alarms accurately), which would be assessed by engineers and testing personnel against pre-defined engineering requirements and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Provided. This is not a study requiring adjudication of diagnostic outputs.

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 device is a ventilator, not an AI or diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a ventilator, not an algorithm being assessed in standalone mode.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for a ventilator's performance would be its adherence to established engineering specifications and physiological parameters (e.g., accuracy of delivered tidal volume, pressure control, alarm functionality) as measured by calibrated equipment and verified against relevant standards (e.g., ISO, ASTM, IEC). The specifics are not detailed here.

8. The sample size for the training set: Not applicable/Provided. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable/Provided.

In summary: The provided document is a 510(k) summary for a ventilator, focusing on its substantial equivalence to predicate devices and compliance with safety and performance standards. It does not contain the detailed study information typically found for AI or diagnostic devices, which is what the individual questions are tailored for. The "acceptance criteria" are the regulatory and voluntary standards, and the "study" is the internal "rigorous testing" conducted by the manufacturer to demonstrate compliance, the specifics of which are not disclosed in this summary document.

Summary

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MAR 2 5 2005

K050597

Date:	March 7th, 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 (rev 3.2 Soltware and higher) Air of Hill of House electronic power from the Engstrom integrated into the Engstrom Ourostation, Techn's Creation for display on the system display unit.

When supplied as an option, the GE Datex-Ohmeda EV Air Compressor is intended for use as When supplied as an option, the GE Datesthable compressed air supply. The compressor has an accessory to provide a ary, merod, broathable of the compressed gas supply,
no alarm functions. All alarm functions and reactions to failure of the many in install no alam functions. All alam fanetis in the some in K041775. The compressor is installed in the base of the Engstom Carocation of Shering Star is powered from AC mains only. A source of in the base of the venthator our. optional compressor.

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

The ventilator consists of three main components: a display, a ventilator unit, and an optional The ventificator consists of three man oon to interface with the system and control settings. The module bay. The display allows nower, nebulization, and pneumatic gas flow to and from the vehinder ann some bay allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.

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.

Contact: Dan Kosednar, RAC

Manager, Regulatory Planning and Submissions

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

MAR 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050597

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: March 8, 2005 Received: March 9, 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 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); 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.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0102. 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 Division 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,

Sytte Mchui Ord.

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

Enclosure

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Indications for Use

510(k) Number (if known): K050597

Device Name: GE Datex-Ohmeda Engstrom Carestation

Indications For Use:

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) .

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)

Page 1 of 1

Ceeu Seleson

Diston Sign Chision of Anesthesiology, General Hospital, Intection Control, Dental Devices

50(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).