GE DATEX-OHMEDA ENGSTROM CARESTATION

K041775 · Datex-Ohmeda, Inc. · CBK · Oct 26, 2004 · Anesthesiology

Device Facts

• Record ID: K041775
• Device Name: GE DATEX-OHMEDA ENGSTROM CARESTATION
• Applicant: Datex-Ohmeda, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Oct 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

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/Pressure Support Ventilation (CPAP/PSV) . Apnea backup (active in Bi-level and CPAP/PSV) . The Engstrom Carestation includes integrated Oxygen, FiO2, airway pressure, monitoring and an integrated Aerogen Aeroneb Pro nebulizer. Options include integrating spirometry and volume monitoring gas monitoring capabilities via modules listed in the product labeling. The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.

Device Story

Microprocessor-based, electronically controlled, pneumatically driven critical care ventilator. Inputs: respiratory gas, airway pressure, FiO2, and spirometry data via integrated monitoring modules. Operation: provides various ventilation modes (VCV, PCV, PCV-VG, SIMV-VC, SIMV-PC, Bi-level, CPAP/PSV) with apnea backup. Output: mechanical ventilation and real-time respiratory monitoring data displayed on integrated screen. Used in clinical facilities and for within-facility transport; operated by clinicians. System integrates patient monitoring, ventilation, and central information management interfacing. Benefits: provides flexible, adaptable respiratory support for patients with pulmonary impairment; enables clinician control via intuitive interface.

Clinical Evidence

Bench testing only. Compliance with voluntary standards (UL 2601, ASTM F1100, IEC 60601-1, IEC 60601-1-2, EN 475, CGA V-1, ISO 5145, EN 980, IEC 60601-2-12) used to validate safety and performance.

Technological Characteristics

Microprocessor-based, electronically controlled, pneumatically driven. Integrated monitoring for O2, FiO2, airway pressure, spirometry. Standards: UL 2601, ASTM F1100, IEC 60601-1, IEC 60601-1-2, EN 475, CGA V-1, ISO 5145, EN 980, IEC 60601-2-12. Modular design with display, ventilator unit, and module bay. Connectivity: interfaces with central information management systems.

Indications for Use

Indicated for mechanical ventilation of adult and pediatric patients weighing 5kg and above with pulmonary impairment ranging from minor to severe. Contraindications not specified.

Regulatory Classification

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.

Predicate Devices

• Drager Evita 4 (K992608)
• Drager Evita 2 (K970165)
• Datex-Ohmeda 7900 Ventilator (K023366)

Submission Summary (Full Text)

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K\$\phi\$41775

## OCT 2 6 2004

| Date: | September 21, 2004 |
|-----------------|--------------------------------------------------------------------------------------------------------|
| Subject: | 510(k) Summary of Safety and Effectiveness Information<br>for the GE Datex-Ohmeda Engstrom Carestation |
| Proprietary: | GE Datex-Ohmeda Engstrom Carestation |
| Common: | Ventilator, Continuous |
| Classification: | Anesthesiology, 73 CBK, 21 CFR 868.5895 |

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

The GE Datex-Ohmeda Engstrom Carestation is substantially equivalent to the following currently marketed device:

Drager Evita 4- Class II - 21CFR868.5895, which has been the subject of a cleared 510(k) with FDA log number K992608.

Drager Evita 2- Class II - 21CFR868.5895, which has been the subject of a cleared 510(k) with FDA log number K970165.

Datex-Ohmeda 7900 Ventilator –Class II - 21CFR868.5895, which has been the subject of several cleared 510(k)s, most recently with FDA log number K023366

The Engström Ventilator (EV) is a critical care ventilator that is flexible and physically adaptable r no Engottom Yorklass ( ( work environments and has an intuitive user interface that is common to many to a vancity of work of monto selection of performance options gives the user full control of Datex Onmoda production. 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 r no QE Bater bring 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) .

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The GE Datex-Ohmeda Engstrom Carestation is a microprocessor based, electronically The GE Datex-Onmeda Lingston Oursettion is a negrated FiO2, anway pressure,
controlled, pneumatically driven ventilator that includes integrated fright controlled, pheuriatically differ ventilator that instals and stars of respiratory gas monitoring Spirometry and volume monik-only diameda patient monitoring modules.

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 The ventiliator Consists of thee main oonlyonomer of the system and control settings. The module bay. The display allows the acon to increase and pneumatic gas flow to and from the ventiator unit controls election policity nowledged, or various Datex-Ohmeda patient monitoring modules with the ventilator.

modules with the vehilator.
Optional accessories include a trolley/care, airway modules, module bay, support arm, Optional accounter than a ting brackets, and auxiliary electrical outlets.

The GE Datex-Ohmeda Engstrom Carestation was designed to comply with the applicable portions of the following voluntary standards;

- 1. UL 2601 General requirements for Medical Electrical Equipment
- 2. ASTM F1100 Particular Requirements for Critical Care Ventilators
- 3. EN/IEC 60601-1: General requirements for Medical Electrical Equipment
- 4. EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility
- 5. EN 475 Electrically Generated Alarm Signals
- 6. CGA V-1 ad ISO 5145 Medical Gas Cylinders Threaded Cylinders
- 7. EN 980 Graphical Symbols
- 8. EN/IEC 60601-2-12, Medical Electrical Equipment -- Critical Care Ventilators

The GE Datex-Ohmeda Engstrom Carestation and the currently marketed device are substantially The OE Datex Onlineda Light Child Light and materials. The GE Datex-Ohmeda Engstrom equiration has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Engstrom Carestation to the standards listed above.

Dan Kosednar, RAC Contact:

Manager, Regulatory Planning and Submissions

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Image /page/2/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized symbol that resembles three overlapping lines or stripes, with a wavy line at the bottom. The symbol is black, and the background of the seal is white.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 6 2004

Mr. Dan Kosednar Manager, Regulatory Planning and Submissions Datex-Ohmeda, Incorporated CARE Business Area P.O. Box 7550 Madison, Wisconsin 53707

Re: K041775

Trade/Device Name: GE Datex-Ohmeda Engstrom Carestation Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 27, 2004 Received: September 28, 2004

Dear Mr. Kosednar:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becaled by (2) [2] [2] [2] [2]
referenced above and have determined the device is substantially equivalent (for the referenced above and have decemined are to legally marketed predicate devices marketed in indications for use stated in the environment date of the Medical Device mensiale conmitetee prior to may 20, 1978, consided in accordance with the provisions of Amendinens, of to devrees that have o Act (Act) that do not require approval of a premarket the Federal Pood, Drug, and Oometry, therefore, market the device, subject to the general approval application (1 Mirr). I The general controls provisions of the Act include controls provisions of a - a - annual registration, listing of devices, good manufacturing practice, requirements for uibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classinod (oos associations) controls. Existing major regulations affecting (FMA), it may of subject to backs and the mail.
your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the Sous nouncements concerning your device in the Federal Register.

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Page 2 - Mr. Kosednar

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA \$ Issualice of a substantes with other requirements
mean that FDA has made a determination that your device the Federal accepted mean that FDA has made a decermination that your and inistered by other Federal agencies.
of the Act or any Federal statutes and regulations administed to sectimited to posit of the Act or any rederal statutes and regulations, but not limited to: registration You must comply with an the Fect 3 requirements and 10 mm.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gED Box 800); and i and listing (21 CJTK I all 6077, laooming (21 CFR Pat 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your device to a This letter will anow you to begin mailering your antial equivalence of your device to a premarket nonification. THC FDA miang or clossification 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), If you desire specific acritor for your as at [phone]. Also, please note the regulation
and contact the Office of Compliance at [phone]. Also, please of a V prease contact the Other of Ochipinal premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may other general mioninations international and Consumer Assistance at its toll-free Division of Binas 2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

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## Indications for Use

510(k) Number (if known): K

Device Name: GE Datex-Ohmeda Engstrom Carestation

Indications For Use:

The GE Datex-Ohmeda Engstrom Carestation is designed to provide mechanical The GE Datex-Onmeda Engetrom Surviving 5kg and above having degrees of vehiliation for adults and poulutines working beginning and are available include:

- Volume Controlled (VCV) .
- Pressure Controlled (PCV) .
- Pressure Controlled, Volume Guaranteed (PCV-VG) .
- 1 1035410 Controllern Mandatory Ventilation, Volume Controlled . (SIMV-VC)
- (Synchronized Intermittent Mandatory Ventilation, Pressure Controlled . (SIMV-PC)
- Bi-level Airway Pressure Ventilation .
- Constant Positive Airway Pressure/Pressure Support Ventilation . (CPAP/PSV)
- Apnea backup (active in Bi-level and CPAP/PSV) .

The Engstrom Carestation includes integrated Oxygen, FiO2, airway pressure, The Engstron? Oursetal.ornitoring and an integrated Aerogen Aeroneb Pro spironelly and volume monitoring gas monitoring capabilities via nebuilter. Options inolade integraxing modules listed in the product labeling.

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)

Cim for AAG

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510(k) Number:_大马当门 7 S

⁽Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices