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. Optional Neonatal capabilities expand the patient range to 0.5 kg. 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) .
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 (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 integrated 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.

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 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 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 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.

AI/ML Overview

This document is a 510(k) summary for the GE Datex-Ohmeda Engstrom Carestation, a continuous ventilator. The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way medical device effectiveness studies for AI/software devices typically do.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices and compliance with voluntary standards for medical electrical equipment.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth type and training set details) are not applicable or not provided in this type of regulatory submission for a physical medical device like a ventilator.

Here's a breakdown based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy) or a comparative performance study against a defined benchmark. Instead, the "acceptance criteria" for a traditional device like this ventilator are implicitly met by:

Substantial Equivalence: The primary "acceptance" is that the device is substantially equivalent to legally marketed predicate devices.
Compliance with Voluntary Standards: The device's design and testing demonstrate compliance with recognized industry standards.

Acceptance Criteria (Implicit)	Reported Device Performance (as stated in the document)
Substantial Equivalence to Predicate Devices	The GE Datex-Ohmeda Engstrom Carestation is substantially equivalent to: - GE Datex-Ohmeda Engstrom Carestation (K051895, K060862) - Drager Evita XL (K051623) - Drager Babylog 8000 Plus (K974176) - Siemens Servo-I (K041111223)
Compliance with Applicable Voluntary Standards	The device was designed to comply with applicable portions of: - UL 2601 (General requirements for Medical Electrical Equipment) - ASTM F1100 (Particular Requirements for Critical Care Ventilators) - EN/IEC 60601-1 (General requirements for Medical Electrical Equipment) - EN/IEC 60601-1-2 (Medical Electrical Equipment Electromagnetic Compatibility) - EN 475 (Electrically Generated Alarm Signals) - CGA V-1 ad ISO 5145 (Medical Gas Cylinders Threaded Cylinders) - EN 980 (Graphical Symbols) - EN/IEC 60601-2-12 (Medical Electrical Equipment Critical Care Ventilators)
Safety and Effectiveness for Intended Use	Provides mechanical ventilation for adults and pediatrics (5kg and above, optionally 0.5kg for neonates) with varying degrees of pulmonary impairment.
Performance of Integrated Components and Optional Accessories	Includes integrated FiO2, airway pressure, spirometry, volume monitoring, Aerogen Aeroneb Pro nebulizer. Options for integrated respiratory gas monitoring (via Datex-Ohmeda M-Gas Module/Mini-CO2 Module), integrated air compressor, SpiroDynamics measurement, and FRC calculation.

Study Proving Device Meets Acceptance Criteria:

The document states: "The GE Datex-Ohmeda Engström Carestation has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Engström Carestation to the standards listed above."

This "rigorous testing" would likely include:

Bench testing: To verify technical specifications and performance against design requirements and standards (e.g., airflow accuracy, pressure control, alarm functionality).
Electrical safety and EMC testing: To comply with UL 2601, EN/IEC 60601-1, and EN/IEC 60601-1-2.
Software verification and validation: To ensure the microprocessor-based control system functions as intended.
Materials compatibility testing: For components in contact with gases or patients.

However, the specific details regarding the methodology, results, or quantitative metrics of these internal validation tests are not disclosed in this 510(k) summary. These details would be contained within the full 510(k) submission, which is not publicly available.

Due to the nature of this submission (a 510(k) for a physical ventilator, not an AI/software device), the following items are largely not applicable or not provided in this public summary:

2. Sample size used for the test set and the data provenance: Not applicable in the context of device performance claims made via standards compliance and substantial equivalence to predicate devices. Testing would involve engineering validation and verification, not a clinical "test set" in the sense of patient data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a ventilator's physical performance is primarily against engineering specifications and industry standards, not expert clinical interpretation of data.

4. Adjudication method for the test set: Not applicable.

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 is for a physical ventilator, not an AI-assisted diagnostic or therapeutic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical ventilator.

7. The type of ground truth used: For a physical device, the "ground truth" would be established by:
* Engineering specifications and design requirements: Ventilator output (pressure, volume, flow) measured against intended values.
* Reference standards and calibrated equipment: For measuring performance parameters.
* Physiological models: For testing performance under simulated patient conditions.
* Clinical consensus on safety parameters: Ensuring the device operates within safe physiological ranges.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

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

Summary

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Date:	September 7, 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
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, and K060862. Drager Evita XL - Class II - 21CFR868.5895, which has been the subject of a cleared 510(k) with FDA log number K051623 Drager Babylog 8000 Plus - Class II - 21CFR868.5895, which has been the subject of a cleared 510(k) with FDA log number K974176 Siemens Servo-I - Class II - 21CFR868.5895. which has been the subject of a cleared 510(k) with FDA log number K04111223

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 (active in Bi-level and CPAP/PSV)

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Not all features are available with all patient populations.

When supplied as an option, the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-C, M-COV, M-COV, M-CaiO, 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 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.

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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/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol. The seal is black and white and appears to be a simple, stylized design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2006

Datex-Ohmeda, Incorporated Mr. Dan Kosednar Manager, Regulatory Planning and Submissions Life Support Solutions P.O. Box 7550 Madison, Wisconsin 53707

Re: K062710

Trade/Device Name: GE Datex-Ohmeda Engström Carestation Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 8. 2006 Received: September 11, 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) 276-0115. 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.

Chiu-Lin, Ph.D.

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) .
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 (active in Bi-level and CPAP/PSV) .

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number:	K062710

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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).