(334 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.
Yes
The device is a mechanical ventilator designed to provide ventilation for patients with pulmonary impairment, which is a therapeutic intervention.
No
The device is primarily a mechanical ventilator for providing respiratory support. While it includes integrated monitoring of physiological parameters (FiO2, airway pressure, spirometry, and volume), and optional gas monitoring and FRC calculation, its core function as described is to provide ventilation, not diagnose conditions. The text also explicitly states, "The Engström Carestation is not a pulmonary function calculation device."
No
The device is described as a microprocessor-based, electronically controlled, pneumatically driven ventilator with integrated hardware components like FiO2, airway pressure, spirometry, and volume monitoring, as well as optional hardware accessories.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mechanical ventilation for patients with pulmonary impairment. 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 airflow and pressure to assist breathing. While it includes monitoring of physiological parameters like FiO2, airway pressure, spirometry, and volume, these are measurements of the patient's respiratory function in vivo, not diagnostic tests on in vitro samples.
- Lack of IVD Characteristics: The text does not mention any components, processes, or intended uses related to analyzing biological samples (blood, urine, tissue, etc.) outside of the body to diagnose diseases or conditions.
Therefore, the GE Datex-Ohmeda Engström Carestation and Engström Pro are medical devices, specifically ventilators, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GE Datex-Ohmeda 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 Carestation and Engström Pro expand the patient range to 0.25 kg.
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. 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.
Product codes
CBK
Device Description
The GE Datex-Ohmeda Engström Carestation and Engström Pro are flexible, and intuitive, critical care ventilators. A wide selection of performance options gives the user full control of the system configuration. The Engström Carestation and Engström Pro feature patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.
Both the GE Datex-Ohmeda 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 allow the Engström Carestation and Engström Pro to be used with patients weighing 0.25 kg and above.
The modes of ventilation currently 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) 5.
-
- Synchronized Intermittent Mandatory Ventilation, Pressure Controlled Volume Guarantee (SIMV-PCVG)
-
- Bi-level Airway Pressure Ventilation
- Constant Positive Airway Pressure Support Ventilation (CPAP/PSV) 8.
- Apnea backup (available in SIMV-VC, SIMV-PC, SIMV-PCVG/BiLevel-VG, BiLevel, 9. CPAP/PSV, and VG-PS)
-
- Non-invasive ventilation (NIV), not available in neonatal mode
-
- Infant Nasal CPAP (nCPAP), only available in neonatal mode
-
- Volume Guarantee. Pressure Support (VG-PS), only available in neonatal mode
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 through use of soft keys on the display, a com wheel, and a resistive touch screen. The Engström 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 standard nebulizer board is provided with both the Engström Carestation and Engström Pro variants. Users have the option to configure the system to use an external pneumatic nebulizer in place of the standard nebulizer.
The optional medical air compressor is intended for use as an accessory to provide a dry, filtered, breathable compressed air 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 Engström Carestation/Engström Pro equipped with the optional compressor. The use of an integrated air compressor was first cleared in K050597.
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. 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 Engström Carestation includes 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 Gas Modules, M-C. M-COV. M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, rev 3.2 software and higher (K001814), E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX (K051092), or M-Mini-CO2 Module (K023454) or E-MiniC module (K052582) which are physically integrated into the Engström Carestation, receive electronic power from the Engström Carestation and communicate measured values to the Engström 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
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
The GE Datex-Ohmeda Engstrom Carestation and Engström Pro ventilators with the integrated compressor have been thoroughly tested through verifications and validation. including software validation. Verification of compliance with applicable standards has also been completed to ensure safe use of the device in its intended use environment. The following quality assurance measures were applied during the development of the Engstrom ventilator system:
- o Risk Analysis
- Requirements/Specification Reviews O
- Design Reviews O
- Testing on unit level O
- o Integration testing
- Performance Testing (Verification) o
- Safety Testing (Verification) o
The modifications made to the Engström ventilator did not require clinical testing. The compressor improvements as described in this submission were completely evaluated by nonclinical tests to verify and validate the safety and functionality of the ventilator.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K050597, K001814, K051092, K023454, K052582
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are black and are arranged in a way that suggests depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2015
Datex-Ohmeda, Inc. Ms. Trishia Dwyer Regulatory Affairs Leader Post Office Box 7550 Madison, WI 53707
Re: K140575
Trade/Device Name: GE Datex-Ohmeda Engström Carestation and Engström Pro Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 29, 2014 Received: December 31, 2014
Dear Ms. Dwyer:
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.
1
Page 2 - Ms. Dwyer
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known): K140575
Device Name: GE Datex-Ohmeda Engström Carestation and Engström Pro
Indications For Use:
The GE Datex-Ohmeda 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 Carestation and Engström Pro expand the patient range to 0.25 kg.
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. 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 IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
3
Image /page/3/Picture/0 description: The image shows the logo for GE Healthcare. The text is in a light gray color. The words "GE Healthcare" are written in a simple, sans-serif font.
Datex-Ohmeda Inc. 3030 Ohmeda Drive P.O. Box 7550 Madison, WI 53707-7550 USA
Premarket Notification 510(k) Summary As required by section 807.92 Engström Carestation and Engström Pro
GENERAL COMPANY INFORMATION as required by 807.92(a)(1)
COMPANY NAME/ADDRESS/PHONE/FAX:
Datex-Ohmeda, Inc. 3030 Ohmeda Drive PO Box 7550 Madison, WI 53707-7550 USA Tel: 608-221-1551 x 500-3260 Fax: 608-646-6488
NAME OF CONTACT:
Ms. Trishia Dwyer Ms. Monica Morrison (alternate)
DATE:
March 5, 2014
DEVICE NAME as required by 807.92(a)(2)
TRADE NAME:
Engström Carestation Engström Pro
COMMON NAME:
Ventilator, Continuous
CLASSIFICATION NAME:
ventilator, continuous, facility use
CDRH PRODUCT CODE:
СВК
REGULATION NUMBER:
CBK: 21 CFR 868.5895
Image /page/3/Picture/21 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has four decorative flourishes extending outward, resembling droplets or stylized flames. The logo has a metallic, silver appearance, suggesting a polished or reflective surface.
4
NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EOUIVALENCE IS MADE as required by 807.92(a)(3)
The Engström Ventilator is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Engström Ventilator (K111116).
DEVICE DESCRIPTION as required by 807.92(a)(4)
The GE Datex-Ohmeda Engström Carestation and Engström Pro are flexible, and intuitive, critical care ventilators. A wide selection of performance options gives the user full control of the system configuration. The Engström Carestation and Engström Pro feature patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.
Both the GE Datex-Ohmeda 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 allow the Engström Carestation and Engström Pro to be used with patients weighing 0.25 kg and above.
The modes of ventilation currently 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) 5.
-
- Synchronized Intermittent Mandatory Ventilation, Pressure Controlled Volume Guarantee (SIMV-PCVG)
-
- Bi-level Airway Pressure Ventilation
- Constant Positive Airway Pressure Support Ventilation (CPAP/PSV) 8.
- Apnea backup (available in SIMV-VC, SIMV-PC, SIMV-PCVG/BiLevel-VG, BiLevel, 9. CPAP/PSV, and VG-PS)
-
- Non-invasive ventilation (NIV), not available in neonatal mode
-
- Infant Nasal CPAP (nCPAP), only available in neonatal mode
-
- Volume Guarantee. Pressure Support (VG-PS), only available in neonatal mode
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 through use of soft keys on the display, a com wheel, and a resistive touch screen. The Engström 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 standard nebulizer board is provided with both the Engström Carestation and Engström Pro variants. Users have the option to configure the system to use an external pneumatic nebulizer in place of the standard nebulizer.
The optional medical air compressor is intended for use as an accessory to provide a dry, filtered, breathable compressed air supply. The compressor is installed in the base of the ventilator cart. The
5
compressor is powered from AC mains only. A source of compressed oxygen is required to be connected to Engström Carestation/Engström Pro equipped with the optional compressor. The use of an integrated air compressor was first cleared in K050597.
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. 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 Engström Carestation includes 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 Gas Modules, M-C. M-COV. M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, rev 3.2 software and higher (K001814), E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX (K051092), or M-Mini-CO2 Module (K023454) or E-MiniC module (K052582) which are physically integrated into the Engström 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 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 Carestation and Engström Pro expand the patient range to 0.25 kg.
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. 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.
6
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)
The GE Datex-Ohmeda Engström ventilator has been updated from the predicate version (K111116). There have been no changes to the intended use or fundamental scientific technology.
This 510(k) requests clearance to add an alternate integrated air compressor to the Engstrom Carestation and Engstrom Pro accessory list. The alternate air compressor, the EV air differs from the predicate (cleared under K050597) in that it contains improvements in acoustics, vibration, and thermal dissipation.
The EVair compressor was designed specifically for the Engström family of products (Engström Carestation and Engström Pro). It fits in the back of the Engström cart and acts as a source of compressed air. The EVair is not available as a stand-alone compressor; it is only available as an accessory to the Engström Carestation and Pro. The new integrated compressor, EVair is manufactured by IMTMedical. The addition of the alternate compressor. EVair, does not affect the safe or effective use of the ventilator as the compressor interfaces with the ventilator in the same manner, and performs in an equivalent manner. There is no change to the Engstrom performance as a result of this change. Additionally, the EVair compressor performs in a functionally equivalent manner to the predicate, EVair03.
| | Engstrom Carestation,
Engstrom Pro 7.x software
(K111116) | Engstrom Carestation and
Engstrom Pro
(this 510(k)) | Comments/Equivalence | | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 Carestation and
Engström Pro expand the
patient range to 0.25 kg. | Identical to Engstrom 7.X
(K111116) Indications for
Use. Only change is to
reference to product
name, Engstrom
Carestation and Engstrom
Pro instead of Engstrom
family of ventilators. | | |
| | | 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 | | 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. Options
include an Aerogen Aeroneb
nebulizer, data capture
accessory, and an integrated
air compressor. Options | |
| | | Engstrom Carestation,
Engstrom Pro 7.x software
(K111116) | | Engstrom Carestation and
Engstrom Pro
(this 510(k)) | Comments/Equivalence |
| | | 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. | | 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. | | Not all features are available
with all patient populations. | |
| | | The Engström Carestation is
not a pulmonary function
calculation device. | | 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. | | The system is designed for
facility use, including within-
facility transport, and should
only be used under the orders
of a clinician. | |
| | Ventilation
Modes | 1. Volume Controlled (VCV),
2. Pressure Controlled (PCV),
3. Pressure Controlled,
Volume Guaranteed (PCV-
VG),
3. Pressure Controlled,
Volume Guaranteed (PCV-
VG),
4. Synchronized Intermittent
Mandatory Ventilation,
Volume Controlled (SIMV-
VC),
5. Synchronized Intermittent
Mandatory Ventilation,
Pressure Controlled (SIMV-
PC),
6. Synchronized Intermittent
Mandatory Ventilation,
Pressure Controlled Volume
Guarantee (SIMV-PCVG),
7. Bi-level Airway Pressure
Ventilation
8. Constant Positive Airway
Pressure/Pressure Support | | 1. Volume Controlled (VCV),
2. Pressure Controlled (PCV),
3. Pressure Controlled,
Volume Guaranteed (PCV-
VG),
3. Pressure Controlled,
Volume Guaranteed (PCV-
VG),
4. Synchronized Intermittent
Mandatory Ventilation,
Volume Controlled (SIMV-
VC),
5. Synchronized Intermittent
Mandatory Ventilation,
Pressure Controlled (SIMV-
PC),
6. Synchronized Intermittent
Mandatory Ventilation,
Pressure Controlled Volume
Guarantee (SIMV-PCVG),
7. Bi-level Airway Pressure
Ventilation
8. Constant Positive Airway
Pressure/Pressure Support | Identical to Engstrom 7.X
(K111116). No change to
the ventilation modes. |
| | | Engstrom Carestation,
Engstrom Pro 7.x software
(K111116) | | Engstrom Carestation and
Engstrom Pro
(this 510(k)) | Comments/Equivalence |
| | | Ventilation (CPAP/PSV),
9. Apnea backup (available in
SIMV-VC, SIMV-PC, SIMV-
PCVG/BiLevel-VG, BiLevel,
CPAP/PSV, and VG-PS),
10. Non-invasive ventilation
(NIV),
11. Nasal CPAP (nCPAP).
12. Volume Guaranteed,
Pressure Support (VG-PS)
Note: NIV is not available in
neonatal mode. VG-PS and
nCPAP are only available in
neonatal mode. | | Ventilation (CPAP/PSV),
9. Apnea backup (available in
SIMV-VC, SIMV-PC, SIMV-
PCVG/BiLevel-VG, BiLevel,
CPAP/PSV, and VG-PS),
10. Non-invasive ventilation
(NIV),
11. Nasal CPAP (nCPAP).
12. Volume Guaranteed,
Pressure Support (VG-PS)
Note: NIV is not available in
neonatal mode. VG-PS and
nCPAP are only available in
neonatal mode. | |
| | Engstrom
Ventilator
System
Software | Version 7.X | | Version 7.X | Substantially equivalent.
Minor software updates
only have been made with
no change to the features
or function of the
ventilator. |
| | Optional
Integrated
Air
Compressor | Integrated Air Compressor
option available (called
EVair03) | | Integrated Air Compressor
option available (called EVair) | Functionally equivalent to
Engstrom 7.X (K111116).
Verification has
demonstrated that the
EVair compressor is
functionally equivalent to
the predicate EVair03
compressor. |
| | Air
Compressor:
Transition to
backup air
supply for
Engstrom | Pneumatic control to switch
from standby to reserve air
supply. Backup operation
begins when pipeline pressure
drops below 250 kPa (36.3 psi). | | Software control to switch
from standby to reserve air
supply. Backup operation
begins when pipeline pressure
drops below 280 kPa (40.6 psi),
this is a factory set-point
but can be adjusted by trained
service personnel. | The backup operation of
the EVair is substantially
equivalent to the
predicate EVair03.
Pressure values still fall
within the Engstrom
ventilator specifications.
No functional change to
the Engstrom Ventilator,
the EVair has been
verified to be functionally
equivalent to the EVair03
compressor. |
Please see the table below for a comparison of the predicate Engstrom Carestation and Engstrom Pro (K11116) compared to the modifications proposed in this 510(k):
7
8
9
SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)
The GE Datex-Ohmeda Engstrom Carestation and Engström Pro ventilators with the integrated compressor have been thoroughly tested through verifications and validation. including software validation. Verification of compliance with applicable standards has also been completed to ensure safe use of the device in its intended use environment. The following quality assurance measures were applied during the development of the Engstrom ventilator system:
- o Risk Analysis
- Requirements/Specification Reviews O
- Design Reviews O
- Testing on unit level O
- o Integration testing
- Performance Testing (Verification) o
- Safety Testing (Verification) o
SUMMARY OF CLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(2)
The modifications made to the Engström ventilator did not require clinical testing. The compressor improvements as described in this submission were completely evaluated by nonclinical tests to verify and validate the safety and functionality of the ventilator.
CONCLUSION:
The summary above demonstrates that there are no new questions of safety and effectiveness for the Engström Carestation and Engström Pro ventilators as compared to the predicate devices. Based on the performance data, GE Healthcare considers the Engström Carestation and Engström Pro ventilators to be as safe and effective, and perform in a substantially equivalent manner to the predicate devices.