(68 days)
No
The document describes a microprocessor-based, electronically controlled, pneumatically driven ventilator with standard monitoring and optional modules. There is no mention of AI, ML, or related concepts in the intended use, device description, or other sections.
Yes
The device is a ventilator designed to provide mechanical ventilation for patients with pulmonary impairment, which is a therapeutic intervention.
No
The device is explicitly stated as "not a pulmonary function calculation device" and its primary function is mechanical ventilation, including monitoring of vital parameters related to ventilation (FiO2, airway pressure, spirometry, volume). While it collects data, its intended use is to provide support, not to diagnose a condition.
No
The device description explicitly states it is a "microprocessor based, electronically controlled, pneumatically driven ventilator" and details hardware components like a display, ventilator unit, and module bay, indicating it is a physical device with integrated software, not software-only.
Based on the provided text, the GE Datex-Ohmeda Engström Carestation is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed to provide mechanical ventilation for patients. This is a life support and therapeutic function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a ventilator system that controls gas flow, monitors physiological parameters (FiO2, airway pressure, spirometry, volume), and can integrate with patient monitoring modules. These are all related to supporting and monitoring a patient's respiratory function in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the GE Datex-Ohmeda Engström Carestation is a medical device for respiratory support and monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CBK
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.
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The GE Datex-Ohmeda Engstrom Carestation is designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above.
Intended User / Care Setting
The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K# 001814, K023454, K041775, K021175
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
| Date: | March 23, 2006 | |
|---|---|---|
| Subject: | 510(k) Summary of Safety and Effectiveness Information | |
| for 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 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 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)
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.
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
1
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 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.
The GE Datex-Ohmeda Engstrom Carestation was designed to comply with the applicable portions of the following voluntary standards:
-
- 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: 2001 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
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
2
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.
3
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
4
Indications for Use
510(k) Number (if known): K
Device Name: GE Datex-Ohmeda Engström Carestation
Indications For Use:
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.
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