GE DATEX-OHMEDA CENTIVA/5 VENTILATOR

K050860 · Datex-Ohmeda, Inc. · CBK · Jun 21, 2005 · Anesthesiology

Device Facts

• Record ID: K050860
• Device Name: GE DATEX-OHMEDA CENTIVA/5 VENTILATOR
• Applicant: Datex-Ohmeda, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jun 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The GE Datex-Ohmeda Centiva/5 Critical Care Ventilator is designed as a critical care volume, pressure limited ventilator for adult to pediatric patients. It provides volume, bi-level and pressure support ventilation (PSV), Continuous Positive Airway Pressure (CPAP) and PSV with apnea backup ventilation modes. It incorporates volume, peak pressure, PEEP, rate and FIO2 monitoring. 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; provides mechanical ventilation for adult and pediatric patients. Inputs include airway pressure, flow, and volume; monitors FiO2, pressure, flow, and volume. Ventilation modes: Volume Controlled (VCV), SIMV-VC, Bi-level Airway Pressure, CPAP/PSV with apnea backup. Equipped with RS-232 serial interface for Clinical Information Management Systems; pneumatic outlet for drug nebulizers. Used in clinical facilities, including within-facility transport; operated by clinicians. Provides respiratory support to manage pulmonary impairment; output data assists clinicians in adjusting ventilation parameters to optimize patient oxygenation and ventilation.

Clinical Evidence

Bench testing only. Compliance with voluntary standards including UL 2601, ASTM F1100, EN/IEC 60601-1, EN/IEC 60601-1-2, EN 475, CGA V-1, ISO 5145, EN 980, and EN/IEC 60601-2-12.

Technological Characteristics

Microprocessor-based, electronically controlled, pneumatically driven. Includes RS-232 serial interface. Complies with UL 2601, ASTM F1100, IEC 60601-1, IEC 60601-1-2, EN 475, CGA V-1, ISO 5145, EN 980, and IEC 60601-2-12. Form factor includes display/control panel and ventilator unit; optional trolley, support arm, humidifier, and external battery.

Indications for Use

Indicated for adult and pediatric patients with pulmonary impairment ranging from minor to severe requiring mechanical ventilation. Designed for facility use under clinician orders.

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)
• GE Datex-Ohmeda Engstrom Carestation (K041775)

Submission Summary (Full Text)

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## JUN 2 1 2005

K050860

April 1, 2005 Date: 510(k) Summary of Safety and Effectiveness Information Subject: for the GE Datex-Ohmeda Centiva/5 Ventilator GE Datex-Ohmeda Centiva/5 Ventilator Proprietary: Ventilator, Continuous Common: Anesthesiology, 73 CBK, 21 CFR 868.5895 Classification:

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 Centiva/5 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.

GE Datex-Ohmeda Engstrom Carestation --Class II - 21CFR868.5895, which has been the subject of several cleared 510(k)s, most recently with FDA log number K041775.

The Centiva/5 is a flexible, intuitive and simple to operate critical care ventilator. It offers a The Oentivals is a noxible, miality and ventilation power to the hands of the comigurable and compact and, misting is equipped with a RS-232 serial data interface to enable communication with Clinical Information Management Systems.

The GE Datex-Ohmeda Centiva/5 is designed to provide mechanical ventilation for adults and rne GE Butox Online Sky and above having degrees of pulmonary impairment varying from minor to severe. The modes of ventilation are available include:

- Volume Controlled (VCV) .
- Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC) �
- Bi-level Airway Pressure Ventilation .
- Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV) �
- Apnea backup (active in CPAP/PSV) ◆

The GE Datex-Ohmeda Centiva/5 is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, flow and volume phounding. The Centival/5 is equipped with a pneumatic outlet capable of driving standard pneumatic drug nebulizers.

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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 two main components: a display or control panel and a ventilator unit. The ventilator consists of two main ochiponomer a areplier settings. The ventilator unit The usplay allows the user to internation and pneumatic gas flow to and from the patient.

Optional accessories include a trolley/cart, support arm, optional humidifier and an external battery unit.

The GE Datex-Ohmeda Centiva/5 Ventilator 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/EC 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 Centiva/5 Ventilator and the currently marketed device are substantially The GE Datex Onlined Contribution and materials. The GE Datex-Ohmeda Centiva/5 equirator in doorg, volush rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Centiva/5 Ventilator to the standards listed above.

Dan Kosednar, RAC Contact:

... 『

Manager, Regulatory Planning and Submissions

8

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing human services, knowledge, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

JUN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050860

Trade Name: GE Datex-Ohmeda Centiva/5 Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: June 6, 2005 Received: June 8, 2005

Dear Mr. Kosednar:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your over on ind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease, 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). and Cosmotic Pro (110) was the device, subject to the general controls provisions of the Act. The r ou may), and er revisions 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 rr your de reasoned 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.

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

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Page 2 – Mr. Dan Kosednar

comply with all the Act's requirements, including, but not limited to: registration and listing (21 l comply with all the Act s requirements, merialism practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Part 801); good and family and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (Q5) regalances (Sections 531-542 of the Act); 21 CFR 100-1050. product radiation control provisions (Sections 51 - Section in your Section 510(k)
This letter will allow you to begin marketing your device as described in your device to Ac This letter will anow you to ocgin maneemig your antial equivalence of your device to a legally premarket notification. The FDA imaling of substanted by July 2017 11:57
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
s an and and the comments of any and and and and of any of the contined If you desire specific advice for your do 110-11-01-20. Also, please note the regulation entitled, and contact the Office of Complance at [phone] (21CFR Part 807.97). You may obtain "Misbranding by relevence to premarkst noulities. Includes the Act from the Division of Small other general information on your responsion in the loll-free number [phone] or 1941) or Manufacturers, international and Consumer Assistance arovedrh/industry/support/index.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

Enclosure

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## Indications for Use

510(k) Number (if known): K 050860

GE Datex-Ohmeda Centiva/5 Critical Care Ventilator Device Name:

Indications For Use:

The GE Datex-Ohmeda Centiva/5 Critical Care Ventilator is designed as a critical care The GE Datex-Onlineda Ochilieur Online Sontrol, Pressure limited ventifiator for adult to pediaties. In provides SV), Continuous Positive Airway
volume, bi-level and pressure support ventilation (PSV), Continuous Position volume, bl-level and pressure support vontilation (rentilation modes. It incorporates Pressure (CPAP) and FSV with aprica buok up vontant from the volume, peak pressure, PEEP, rate and FIO2 monitoring.

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)

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Ruybulion

(Division Siam Off Division of Anesthesiology, General Hospital. Infection Control, Dental Devices 1050860

510(k) Number: