(136 days)
No
The document describes a microprocessor-based, electronically controlled, pneumatically driven ventilator with various ventilation modes and monitoring capabilities. There is no mention of AI or ML in the intended use, device description, or performance studies sections. The device relies on pre-programmed logic and sensor data for operation.
Yes.
The device is a ventilator designed to provide mechanical ventilation, which is a therapeutic intervention for patients with pulmonary impairment.
No
Explanation: The document explicitly states, "The Engström Carestation is not a pulmonary function calculation device." While it has monitoring capabilities, its primary purpose is mechanical ventilation, not diagnosis.
No
The device is a ventilator system which is described as being microprocessor based, electronically controlled, and pneumatically driven, clearly indicating the presence of hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The GE Datex-Ohmeda Engström family of ventilators are designed to provide mechanical ventilation to patients. They assist with breathing and monitor physiological parameters related to respiration (FiO2, airway pressure, spirometry, volume).
- Lack of Specimen Analysis: The description does not mention the device analyzing any specimens taken from the patient's body. While it monitors parameters of the patient's body, this is not the same as analyzing a sample from the body.
- Intended Use: The intended use is to provide mechanical ventilation for patients with pulmonary impairment, not to diagnose or monitor conditions through the analysis of in vitro samples.
Therefore, the GE Datex-Ohmeda Engström family of ventilators falls under the category of a therapeutic and monitoring medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GE Datex-Ohmeda Engstrom family of ventilators (Engstrom Carestation and Engstrom Pro) are 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 on Engstrom family expand the patient range to 0.25 kg.
The GE Datex-Ohmeda Engstrom family of ventilators are microprocessor based, electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway pressure, spirometry and volume monitoring. Options include an Aerogen Aeroneb nebulizer, data capture accessory and an integrated air compressor. Options available on Engstrom Carestation only include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling, 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 Engstrom 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
CBK
Device Description
The GE Datex-Ohmeda Engstrom family of ventilators (Engstrom Carestation and Engstrom Pro) are flexible, adaptable, and intuitive critical care ventilators. A wide selection of performance options gives the user full control of the system configuration. The Engstrom Carestation is a complete system featuring patient monitoring, patient ventilation, and the capability of interfacing with central information management systems. The Engstrom Pro is a defeatured variant of the Engstrom Carestation.
Both the GE Datex-Ohmeda Engstrom Carestation and Engstrom Pro are 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 its patient range to 0.25 kg.
The modes of ventilation currently available include:
-
- Volume Controlled (VCV)
- Pressure Controlled (PCV) is
- PCV, Volume Guaranteed (PCV-VG)
- Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC) 4.
-
- Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC)
-
- Synchronized Intermittent Mandatory Ventilation, Pressure Controlled Volume Guarantee (SIMV-PCVG)
- Bi-level Airway Pressure Ventilation 7.
- Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV) 8.
- Apnea backup (active in Bi-level and CPAP/PSV)
-
- Non-invasive ventilation (NIV), note that NIV is not available in neonatal mode
-
- Infant Nasal CPAP (nCPAP)
-
- Volume Guarantee, Pressure Support (VG-PS)
The GE Datex-Ohmeda Engstrom Carestation and Engstrom Pro are microprocessor based, electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulizer control board.
The ventilator consists of two main components: a display and a ventilator unit. 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 Engstrom Carestation also includes a module bay that allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.
The user interface for control of nebulization is provided via the ventilator display unit. The Aerogen Aeroneb Pro Nebulizer board (K021175) is provided standard with the unit. Nebulizers are options for both the Engstrom Carestation and Engstrom Pro. Users have the option to configure the system to use an external pneumatic nebulizer in place of the Aerogen.
Optional accessories common to both Engstrom Carestation and Engstrom Pro include a trolley/cart, integrated air compressor, support arm, humidifier and water trap mounting brackets, and a data capture accessory. 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. The Engstrom Carestation or Engstrom Pro provides all alarm functions and reactions to a failure of the compressed gas supply. 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 Carestation/Engstrom Pro equipped with the optional compressor. The compressor was cleared in K041775.
Additional optional accessories specific to the Engstrom Carestation include airway modules, intratracheal pressure sensor, auxiliary electrical outlets, and module bay. Optional functionality specific to the Engstrom Carestation include integrated respiratory gas monitoring, capabilities to measure SpiroDynamics via a GE supplied 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 Out method. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-C, M-COV, M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, rev 3.2 software and higher, (K001814) 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.
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
Adults and pediatrics weighing 5kg and above. Optional Neonatal capabilities expand the patient range to 0.25 kg.
Intended User / Care Setting
Clinician; facility use, including within-facility transport.
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/Engstrom Pro ventilators have been thoroughly tested through verification of specifications and validation, including software validation. Electrical safety and electromagnetic compatibility testing were also completed.
The modifications made to the Engstrom ventilator did not require clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081842, K063404, K041223, K974176
Reference Device(s)
K021175, K041775, K001814, K023454
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
GE Healthcare
Datex-Ohmeda Inc. P.O. Box 7550 Madison, WI 53707-7550 USA
Premarket Notification 510(k) Summary As required by section 807.92 Engstrom Ventilator
. .
MAY -3 2010
GENERAL COMPANY INFORMATION as required by 807.92(a){1}
COMPANY NAME/ADDRESS/PHONE/FAX:
Datex-Ohmeda, Inc. PO Box 7550 Madison, WI 53707-7550 USA Tel: 608-221-1551 Fax: 608-299-2132
NAME OF CONTACT:
Mr. Jim Raskob Ms. Adrienne Lenz (alternate)
DATE:
December 16, 2009
DEVICE NAME as required by 807.92(a)(2)
TRADE NAME:
Engström Carestation Engström Pro
COMMON NAME:
Ventilator, Continuous
CLASSIFICATION NAME:
CBK, ventilator, continuous, facility use
NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as reguired by 807.92(a)(3)
The Engstrom Ventilator is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Engstrom (K081842), Maquet Servo-i (K063404, K041223) and Drager BabyLog 8000 Plus (K974176).
1
DEVICE DESCRIPTION as required by 807.92(a)(4)
The GE Datex-Ohmeda Engström family of ventilators (Engström Carestation and Engström Pro) are flexible, adaptable, and intuitive critical care ventilators. 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 Engström Pro is a defeatured variant of the Engström Carestation.
Both the GE Datex-Ohmeda Engström Carestation and Engstrom Pro are 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 its patient range to 0.25 kg.
The modes of ventilation currently available include:
-
- Volume Controlled (VCV)
- Pressure Controlled (PCV) is
- က် Pressure Controlled, Volume Guaranteed (PCV-VG)
- Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC) 4.
-
- Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC)
-
- Synchronized Intermittent Mandatory Ventilation, Pressure Controlled Volume Guarantee (SIMV-PCVG)
- Bi-level Airway Pressure Ventilation 7.
- Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV) 8.
- Apnea backup (active in Bi-level and CPAP/PSV) ல்
-
- Non-invasive ventilation (NIV), note that NIV is not available in neonatal mode
-
- Infant Nasal CPAP (nCPAP)
-
- Volume Guarantee, Pressure Support (VG-PS)
The GE Datex-Ohmeda Engström Carestation and Engström Pro are microprocessor based, electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulizer control board.
The ventilator consists of two main components: a display and a ventilator unit. 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 Engstrom Carestation also includes a module bay that allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.
The user interface for control of nebulization is provided via the ventilator display unit. The Aerogen Aeroneb Pro Nebulizer board (K021175) is provided standard with the unit. Nebulizers are options for both the Engstrom Carestation and Engstrom Pro. Users have the option to configure the system to use an external pneumatic nebulizer in place of the Aerogen.
Optional accessories common to both Engström Carestation and Engström Pro include a trolley/cart, integrated air compressor, support arm, humidifier and water trap mounting brackets, and a data capture accessory. 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. The Engstrom Carestation or Engstrom Pro provides all alarm functions and reactions to a failure of the compressed gas supply. 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 Carestation/Engström Pro equipped with the optional compressor. The compressor was cleared in K041775.
2
Additional optional accessories specific to the Engström Carestation include airway modules, intratracheal pressure sensor, auxiliary electrical outlets, and module bay. Optional functionality specific to the Engstrom Carestation include integrated respiratory gas monitoring, capabilities to measure SpiroDynamics via a GE supplied 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 Out method. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-C, M-COV, M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, rev 3.2 software and higher, (K001814) or Mini-CO2 Module (K023454) which are physically integrated into the Engstrom Carestation, receive electronic power from the Engström Carestation and communicate measured values to the Engström Carestation for display on the system display unit.
INTENDED USE as required by 807.92(a)(5)
The GE Datex-Ohmeda Engstrom family of ventilators (Engström Carestation and Engström Pro) are designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having decrees of pulmonary impairment varying from minor to severe. Optional Neonatal capabilities on Engstrom family expand the patient range to 0.25 kg.
The GE Datex-Ohmeda Engström family of ventilators are microprocessor based, electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway pressure, spirometry and volume monitoring. Options include an Aerogen Aeroneb nebulizer, data capture accessory and an integrated air compressor. Options available on Engstrom Carestation only include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling, 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 Engstrom 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.
3
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)
The GE Datex-Ohmeda Engstrom has been updated from the predicate version (K081842). There have been no changes to the intended use or fundamental scientific technology.
The software for the Engstrom has been updated to introduce several new features. The significant change to the software includes the addition of a neonatal ventilation mode for volume guarantee - pressure support mode of operation.
This submission also adds the Enqstrom Eview data capture accessory that is optional to either the Engstrom Carestation or Engstrom Pro.
SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as reguired by 807.92(b)(1)(3)
The GE Datex-Ohmeda Engstrom Carestation/Engstrom Pro ventilators have been thoroughly tested through verification of specifications and validation, including software validation. Electrical safety and electromagnetic compatibility testing were also completed.
SUMMARY OF CLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(2)
The modifications made to the Engstrom ventilator did not require clinical testing.
CONCLUSION:
The summary above shows that there are no new questions of safety and effectiveness for the Engstrom Carestation/Engstrom Pro ventilator as compared to the predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jim Raskob Regulatory Affairs Leader Datex-Ohmeda, Incorporated 3030 Ohmeda Drive Madison, Wisconsin 53718-6794
MAY - 3 2010
Re: K093886
Trade/Device Name: GE Datex-Ohmeda Engström Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: April 23, 2010 Received: April 26, 2010
Dear Mr. Raskob:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
Page 2- Mr. Raskob
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.ida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
N-for
Anthony Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K
Device Name: GE Datex-Ohmeda Engström Ventilator
Indications For Use:
The GE Datex-Ohmeda Engström family of ventilators (Engström Carestation and Engström Pro) are 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 on Engström family expand the patient range to 0.25 kg.
The GE Datex-Ohmeda Engström family of ventilators are microprocessor based, electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway pressure, spirometry and volume monitoring. Options include an Aerogen Aeroneb nebulizer, data capture accessory and an integrated air compressor. Options available on Engström Carestation only include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling, 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.
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)
y Schulttus
Page 1 of
Division of Anesthesiology, General Hoapital Infection Control, Dental Devices
510(k) Number: K093886