GE Healthcare U(

SEP
- ~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

GENERAL COMPANY INFORMATION as required by 807.92(a)h(1)

COMPANY NAME/ADDRESS/PHONE/FAX:

Datex-Ohmeda, Inc.
P0 Box 7550
Madison, WI 53707-7550 USA
Tel: 608-221-1551
Fax: 608-646-7464

NAME OF CONTACT:

Ms. Monica Morrison

Mr. Jim Raskob (alternate)

DATE:

April 19, 2011

DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

Engstr6mn Carestation
Engstr6m Pro

COMMON NAME:

Ventilator, Continuous

CLASSIFICATION NAME:

ventilator, continuous, facility use

CDRI- PRODUCT CODE:

CBK

REGULATION NUMBER:

21 CFR 868.5895

GE Engstrom 7TX Special 510(k) Page 22 of 3155

 NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL
EOULIVALENCE IS MADE as required by 807.92(a)(3)

The Engstrom Ventilator is substantially equivalent in safety and effectiveness -to the legally
marketed (predicate) Engstrom Ventilator (K093886), and the Hamilton G5 Ventilator (K0705 13).

DEVICE DESCRIPTION as required by 807.92(a)(4)

The GE Datex-Ohmeda Engstrtim family of ventilators (Engstrdm Carestation and Engstr6m Pro)
are flexible, adaptable, and intuitive critical care ventilators. A wide selection of performance
options gives the user fuill control of the system configuration. The Engstrbm Carestation is a
complete system featuring patient monitoring, patient ventilation, and the capability of interfacing
with central information management systems. The Engstrdm Pro is a defeatured variant of the
Engstriim Carestation.

Both the GE Datex-Obmeda Engstriin Carestation and Engstrdm 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:

I. Volume Controlled (VCV)
2. Pressure Controlled (PCV)
3. Pressure Controlled, Volume Guaranteed (PC V-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
(SIM V-PC VG)
7. Bi-level Airway Pressure Ventilation
8. Constant Positive Airway Pressure/Pressure Support 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), not available in neonatal mode
11. Infant Nasal CPAP (nCPAP), only available in neonatal mode
12. Volume Guarantee, Pressure Support (VG-PS), only available in neonatal mode

The GE Datex-Ohmeda Engstr6m Carestation and Engstr6m 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
comn wheel, and a resistive touch screen. 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-Ohmieda 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 (K021 175) is provided standard with the unit. Nebulizers
are options for both the Engstr6m Carestation and Engstrdm Pro. Users have the option to
configure the system to use an external pneumatic nebulizer in place of the Aerogen.

GE Engstrom 7.X Special 510(k) Page 23 of 3155

 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/Engstrdm Pro equipped with the optional
compressor. The compressor was cleared in K04 1775.

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 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 calculationof functional residual capacity of mechanically ventilated
patients using Nitrogen Wash In/Wash Out method. The integrated respiratory gas monitoring is
provided via the Datex-Ohmeda Gas Modules, M-C, M-CO, 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 (KOS51092), or M-Mini-C02 Module (K023454) or E-MiniC module
(K052582) 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.

INTENDED USE as required by 807.92(a)(5)

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 InWash 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.

GE Engstrom 7.X Special 510(k) Page 24 of 3155

 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO THE
PREDICATE DEVICE as required by 807.92(a)(6)

The GE Datex-Ohmeda Engstrom ventilator has been updated from the predicate version
(K093886). There have been no changes to the intended use or fundamental scientific technology.

The software for the Engstrom ventilator has been updated to include touch screen functionality for
navigation to existing Engstrom ventilator functions and menus. Additional minor software updates
have been included that are primarily based on customer feedback (such as nuisance alarm
conditions) and minor changes to bring the product in line with current specifications.

SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as

required by 807.92(b)(1)(3)

The GE Datex-Ohmeda Engstrom Carestation and Engstrom Pro ventilators have been thoroughly
tested through verification of specifications 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, including electrical safety and electromagnetic
compatibility testing. The following quality assurance measures were applied during the
development of the Engstrom ventilator system:
o Risk Analysis
o Requirements/Specification Reviews
" Design Reviews
o Testing on unit level
o Integration testing
o Performance Testing (Verification)
o Safety Testing (Verification)
o, Simulated Use/User Requirements Testing (Validation)

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. The software
changes made to introduce touch screen functionality, as described in this submission, were
completely evaluated by non-clinical 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 Engstrom Carestation and Engstrom Pro ventilators as compared to the predicate devices.
Based on the performance data, GE Healthcare considers the Engstrom Carestation and Engstrom
Pro ventilators with 7.X software to be as safe and effective, and perform in a substantially
equivalent manner to the predicate devices.

GE Engstrom 7.X Special 510(k) Page 25 of 3155

DEPARTMENT OF HEALTH & HUMAN SERVICES rPublic I linIth Ser vice

]oo(, d 1lruv A iStt1h(I(.'

1090)3 Sc''I[-Cirushire A veii tic
Iiocimncil Control Room -\VU66-6609
Silver Sprig. NIL) 20993-0002

Dite Ohmliedla. Inlcorporated

C/O M/s. Monica Morrison
Regulatory Affairs Leader
Life Su)ppert SoIlution
P1.0. Box 7350 QP
3030 Ohm11eda Drive
Mvadison. Wisconsin 53707

Re: K[11t116
Trade/Device Name: Lnrgstrom Carestat ion Fngstrom j) r
Regulationl INumlber: 2 1 CFR 868.5895
Regulation Name: Continuou0Ls Ven1tilator
Regu latory Class: 11
ProdcLIt CodeC: CBK
Dated: July 8, 20l1I
Received: July I1I1.20 11

Dear N/fs. Morrison:

We have reviewed yoUr Section 5 10(k) premarket notifBeat ion of internt to mrarket the device
referenced above and have determined the device is suibstantially equivalent (for the
indications for Use stated in the enlosure) to legally marketed predicate devices marketed inl
interstate commerce pr ior to M/ay 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, Drug1. and Cosmetic Act (Act) that do not require approval of a premarket
approval application (PNMA). 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 annoual registration, listing of dlevices, good marfu factUri ng practice,
labeling, and prohibitions ag-ainst misbranding and adcl teratio. Please note: CD RI-I does
not eval nate in formation related to contract l iabili ty warranties. We remind you, however.
that device labeling mu1Lst be tru.th ful and not mnislead irc

If yourl device is classified (see above) into either class If(Special Controls) or class IlI
(P1N4A). it may be subject to additional controls. Existing maj or reouilations a ffecti ng your
device canl be founod inl the Code of Federal Regtlatib 1S. Title 21 I [arts 800 to 898. Inl
addition. FDA may publish further announ1cemrents concernino your device inl the Federal
Re ' ste r.
Plage 2 - Nws. M\,orriison

Please be advised that FDA's issuance of a substantial eq tivalence dleterinlation does not
mecan that FDA ha s madec a determination that \'otir[ device comnpies with other reqluirments
of the Act or any FeCderal statts an1d regulilations administered by 01ther Federal aglencies.
YOU mu~st comIply with all the Acts requiremnts. including, but not limited to: registration
and listing (21 I R Part 807); labeling (21 CF R Part 801); mnedical device reportingi
(reporting ofimedical device-related adverse events) (2! CFR 803); good manufacturing
practice reqCuiremnents as Set forth inl the quality systems (QS) regulation (21I CFR Part 820);
and if applicable, the electronic product radiation control provisions (Sections 531 -542 of
the Act); 21 CFR 1000- 1050.

If y;oul desire specific advice for your device on our labeling regulation (21 CFR Part 801),
please go to hittu://www. fdacL-,(gov/Ab)ottFDA/Cetes~f'fices/CRII-/CDRZl-O ffices
/LicmII 115809.kmi for the Center for Devices and Radiological Health's (CD RI-Is) 01Nice of
Compliance. Also, please note the regulation entitled: "Misbranding by ref'erence to
premnarket notification" (21 C.FR Part 807.97). For questions regarding the reporting of'
adverse events under the N'IDR re-ulation (21 CI7R I'art 803)), please go to
htt://wx~~fd~go\'/
cc icl DvicesSaftv/epotaPro lemd aul o the CD RI-Is
ot
Office of Surveillance and Biomectri cs/D ix'ision of Postmarket StrveilIlance.

YOU miay dobtain other genera! in formation on your responsi biIi ties tinder the Aect fromr the
Division of Smrall M/al1Ufa'cttircrs. International arid Co1stimer Assistance at its toll-fre
num111ber (800) 638-2041 or (301) 796-7 100 or at its Internet address
Iittp://wwv\%. fda,..go\v/M\'ed icalIDevices/ReSOur-CSf'orYOLI/I[ICdLStrv%/defauiilitill.

Sincerely yoLurs.

Anthony D. Watson, B.S., M.S., M.B.A.

Director
Division of Anesthesiology, General H-ospital,
Infection Control and Dental Devices
0111ice of [Device Evaluation
Center for Devices and
Radiological Health

En1closure
 Indications for Use

5 10(k) Number (if known): K

Device Name: GE Datex-Obmeda Engstr~m Ventilator

Indications For Use:

The GE Datex-Ohmeda Engstrbm family of ventilators (EngstrSm Carestation and Engstrdm 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 Engstr6m family expand the patient range to 0.25 kg.

The GE Datex-Ohmeda Engstrdm 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 Engstrdm 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 Engstr6m 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 AND/OR Over-The-Counter Use ___

(Part 21 CFRROI Subpart D) (21 CFR807 SubpartC)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

IENEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lila PagelIofI_
(Division Sign-Oft)
Division of Anesthesiology, General Hospital
Infection Control, Dentai Devices

51 0(k) Number:_t 1Il

GE Engstrom 7.X Special 510(k) Page 20 of 3155