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

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

The GE Datex-Ohmeda Engström 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 intecrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling, an integrated air compressor, 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.

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 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, capabilities to measure spirodynamics in patients using sized 6.5 tracheal tubes and larger, measurement of functional residual capacity 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.

Additional optional accessories include a trolley/cart, compressor, airway 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.

AI/ML Overview

Here's an analysis of the provided text regarding the GE Datex-Ohmeda Engstrom Carestation:

Important Note: The provided document is a 510(k) summary and FDA clearance letter. It mainly focuses on establishing substantial equivalence to a previously cleared device, not on presenting novel clinical study results with acceptance criteria in the way you might expect for a new, non-substantially equivalent device or a software as a medical device (SaMD). Therefore, many of your requested items, particularly those related to detailed study methodologies, sample sizes for training/test sets, expert ground truth, and comparative effectiveness, are not explicitly present or applicable in this type of submission.

The "study that proves the device meets the acceptance criteria" in this context refers to the rigorous testing mentioned to support compliance with voluntary standards, which is a key part of demonstrating substantial equivalence for hardware devices like ventilators. It's not a clinical trial comparing performance against a clinical endpoint for a diagnostic device.

Here's the breakdown of the information requested, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied/Stated Standards)	Reported Device Performance (Summary from Submission)
UL 2601 General requirements for Medical Electrical Equipment	Validated through rigorous testing that supports compliance.
ASTM F1100 -- Particular Requirements for Critical Care Ventilators	Validated through rigorous testing that supports compliance.
EN/IEC 60601-1: General requirements for Medical Electrical Equipment	Validated through rigorous testing that supports compliance.
EN/IEC 60601-1-2: 2001 Medical Electrical Equipment Electromagnetic Compatibility	Validated through rigorous testing that supports compliance.
EN 475 Electrically Generated Alarm Signals	Validated through rigorous testing that supports compliance.
CGA V-1 ad ISO 5145 Medical Gas Cylinders Threaded Cylinders	Validated through rigorous testing that supports compliance.
EN 980 Graphical Symbols	Validated through rigorous testing that supports compliance.
EN/IEC 60601-2-12, Medical Electrical Equipment Critical Care Ventilators	Validated through rigorous testing that supports compliance.
Substantial Equivalence to Predicate Device (GE Datex-Ohmeda Engstrom Carestation - K051895)	"The GE Datex-Ohmeda Engstrom Carestation and the currently marketed device are substantially equivalent in design concepts, technologies and materials."
Functionality (Mechanical Ventilation modes, Monitoring, Nebulization)	Device provides all listed ventilation modes, integrated monitoring (FiO2, airway pressure, spirometry, volume), and an integrated nebulizer, along with optional respiratory gas monitoring and spirodynamics.
Target Patient Population	Adults and pediatrics weighing 5kg and above with varying degrees of pulmonary impairment.
Intended Use Environment	Facility use, including within-facility transport, under orders of a clinician.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided document. The 510(k) summary states "rigorous testing," which would typically involve engineering and performance testing on the device itself, but specific sample sizes of devices or test conditions are not detailed. This is a hardware device, not a diagnostic algorithm; thus, "test set" in the common AI/ML sense doesn't apply directly.
Data Provenance: Not applicable in the traditional sense for a hardware ventilator. The testing would be conducted in a laboratory or simulated environment, not on a "data set" originating from patients in a specific country. This is a device performance summary, not a data-driven algorithm performance summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable/Not specified. For a hardware ventilator, "ground truth" is typically established by physical measurements, engineering specifications, and established medical standards for ventilator performance, rather than expert consensus on a dataset. Clinical experts would define the requirements but not typically establish "ground truth" for the device's technical performance in a test set.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human-AI studies or for complex diagnostic assessments. For a ventilator's performance testing, the "adjudication" is generally based on objective measurements meeting predetermined engineering specifications and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for diagnostic imaging or other human-in-the-loop AI/ML applications where human readers' performance is being evaluated with and without AI assistance. This document describes a mechanical ventilator (hardware), not a diagnostic AI system, so such a study would not apply.
Effect Size of Human Readers Improve with AI vs without AI: Not applicable for this device.

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

Not applicable in the typical AI/ML sense. While the ventilator itself operates "standalone" in its mechanical functions, the concept of a "standalone algorithm" performance study refers to the isolated performance of a diagnostic or predictive algorithm. The ventilator's performance is intrinsically linked to its hardware and software working together to deliver ventilation. The document states it's a "microprocessor based, electronically controlled, pneumatically driven ventilator," implying algorithms control its function, but their "standalone performance" isn't evaluated separately from the device as a whole.

7. The Type of Ground Truth Used

Engineering Specifications and Voluntary Standards: The primary "ground truth" for a device like this would be established by objective, measurable engineering specifications (e.g., accuracy of delivered tidal volume, pressure control, alarm threshold accuracy) and compliance with the listed voluntary standards (UL, ASTM, EN/IEC). These standards define acceptable performance ranges and safety requirements.

8. The Sample Size for the Training Set

Not applicable/Not specified. This is a hardware device being cleared via substantial equivalence, not an AI/ML algorithm requiring a training set in the conventional sense. The "training" of the device refers to its design, development, and testing against pre-defined specifications and standards.

9. How the Ground Truth for the Training Set was Established

Not applicable/Not specified. As above, the concept of a "training set" ground truth doesn't directly apply here. The "ground truth" for the device's inherent design and functionality would be based on established principles of respiratory physiology, mechanical engineering, electrical engineering, and medical device safety standards.

Summary

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K060862

Date:	March 23, 2006
Subject:	510(k) Summary of Safety and Effectiveness Informationfor the GE Datex-Ohmeda Engstrom Carestation
Proprietary:	GE Datex-Ohmeda Engstrom Carestation
Common:	Ventilator, Continuous	JUN - 5 2006
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 K051895.

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 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, (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

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Carestation 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, are provided by 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 compressed oxygen is required to be connected to Engstrom Carestations equipped with the optional compressor.

A GE supplied tracheal pressure sensor is used to measure spirodynamics.

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

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 of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three abstract human profiles facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the seal in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 5 2006

Datex-Ohmeda, Incorporated C/O Mr. Dan Kosednar Manager, Regulatory Planning and Submission Life Support Solutions PO Box 7550 Madison, Wisconsin 53707

Re: K060862

Trade/Device Name: GE Datex-Ohmeda Engström Carestation . Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator (IPPB) Regulatory Class: II Product Code: CBK Dated: March 23, 2006 Received: March 29, 2006

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 (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.

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 your 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) 276-0120. 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 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,

Snytte Y. M, kain Ons.

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): K

Device Name: GE Datex-Ohmeda Engström 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 t
Constant Positive Airway Pressure Support Ventilation (CPAP/PSV) .
Apnea backup (active in Bi-level and CPAP/PSV) .

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nulf M.L. for AAC 6/6/06

Page 1 of __ 1____

(Division of Anesthesia)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: KD60862

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).