EVITA 4 (8411900)

K980642 · Drager, Inc. · CBK · Sep 4, 1998 · Anesthesiology

Device Facts

• Record ID: K980642
• Device Name: EVITA 4 (8411900)
• Applicant: Drager, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Sep 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Evita 4 is a time cycled, constant volume, long term, intensive care ventilator for adults and children with a body weight of at least 3 kg. Intended Environment for the device: hospital use inner clinical transport

Device Story

Evita 4 is a microprocessor-controlled, time-cycled, constant-volume intensive care ventilator. It delivers gas via a high-pressure servo valve system. The device supports multiple ventilation modes including CMV/assist, SIMV, MMV, SB, CPAP, ASB/PSV, PCV+, APRV, Apnea Ventilation, and ILV. It is intended for use in hospital settings and during inner-clinical transport by trained clinicians. The device monitors patient respiratory parameters and displays curves and values to assist healthcare providers in managing patient ventilation. It provides features such as AutoFlow, leak compensation, and nebulization to support patient respiratory needs. The software version 3.0 integrates additional functions previously found in the Evita 2 dura, such as inspiration hold and pediatric nebulization, to enhance clinical utility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Microprocessor-controlled, time-cycled, constant-volume ventilator. Features high-pressure servo valve gas delivery. Software version 3.0. Supports multiple ventilation modes (CMV, SIMV, MMV, CPAP, etc.). Designed for hospital and clinical transport use. Connectivity and specific material standards not detailed.

Indications for Use

Indicated for adults and children with a body weight of at least 3 kg requiring long-term intensive care ventilation.

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

• Evita 4 (K961687)
• Evita 2 dura (K970165)
• Servo 300 (K902859)

Submission Summary (Full Text)

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**Dräger**

4 1888 SEP

file: 510kstate.RTF Date: June, 1998 Author: Frank Clanzett

# 510(k) SUMMARY Summary of Safety and Effectiveness

K980642

# APPLICANTS NAME AND ADDRESS:

Drager Inc. Critical Care Systems 3136 Quarry Road Telford , PA 18969

APPLICANTS TELEPHONE NUMBER: (215)-721-6917

APPLICANTS FACSIMILE NUMBER: (215)-721-6915

# APPLICANTS CONTACT PERSON:

Harald Kneuer Regulatory Affairs Manager

DATE THE SUMMARY WAS PREPARED: February, 1998

# DEVICE NAME:

Trade Name: Common Name: Classification Name: Evita 4 Evita 4 Ventilator, Continuous (per 21 CFR 868.5895)

# LEGALLY MARKETED DEVICE TO WHICH DRÄGER IS CLAIMING SUBSTANTIAL EQUIVALENCE:

Evita 4 - Manufactured by Dräger Medizintechnik GmbH, Lübeck, Germany and sold in the United States by Dräger, Inc.

Evita 2 dura- Manufactured by Dräger Medizintechnik GmbH, Lubeck, Germany and sold in the United States by Dräger, Inc.

Servo 300 - Sold in the United States by Siemens

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# DESCRIPTION OF THE DEVICE:

The Evita 4 with the Software version 3.0 is a time cycled, constant volume ventilator The Evita + with the Oct.ware is microprocessor controlled and provides the following ventilation modes:

| - CMV/assist | Controlled Mandatory Ventilation<br>Controlled and assisted volume contant ventilation with the options:<br>- CPV Continuous Positive Pressure Ventilation<br>- PLV Pressure Limited Ventilation<br>- AutoFlow For automatic regulation of inspiratory flow<br>- IRV Inversed Ratio Ventilation |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| - SIMV | Synchronized Intermittent Mandatory Ventilation<br>Procedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options:<br>- PLV<br>- AutoFlow |
| - MMV | Mandatory Minute Volume Ventilation<br>Spontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options:<br>- PLV<br>- AutoFlow |
| - SB | Spontaneous Breathing<br>Spontaneous breathing at ambient pressure |
| - CPAP | Continuous Positive Airway Pressure<br>Spontaneous breathing with positive airway pressure |
| - ASB/PSV | Assisted Spontaneous Breathing / Pressure Support Ventilation<br>Pressure supported spontaneous breathing |
| - PCV+ | Pressure Controlled Ventilation<br>Pressure controlled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure increase to CPAP level |
| - APRV | Airway Pressure Release Ventilation<br>Spontaneous breathing on two pressure levels with long time ranges - independently adjustable |
| - Apnea Ventilation | For switching over automatically to volume controlled mandatory ventilation if breathing stops |
| - ILV | Independent Lung Ventilation<br>Separate, differentiated, synchronized ventilation with one Evita 4 for each lung |

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# Dräger

# tensive Care Ventilator Data Comparison Sheet

| Specification | Evita 4 (K 961687) | Evita 2 dura (K 970165) | Servo 300 (K902859) | Evita 4 SW 3.0 |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Dräger | Dräger | Siemens | Dräger |
| Classification: Intensive Care<br>Ventilator | Yes | Yes | Yes | Yes |
| Operating Principle: Time<br>cycled, volume constant,<br>pressure controlled | Yes | Yes | Yes | Yes |
| Software controlled | Yes | Yes | Yes | Yes |
| Contoll Software: Version 3.0 | No (1.0) | Yes | N.A. | Yes |
| Gas delivery system: Fast<br>"High Pressure Servo Valve",<br>microprocessor controlled | Yes | Yes | Yes | Yes |
| Intended Use | Evita 4 is a time cycled, constant volume, long<br>term, intensive care<br>ventilator for adults and<br>children with a body<br>weight of at least 3 kg. | like Evita 4 (K 961687) | N.A. | Evita 4 is a time cycled,<br>constant volume, long<br>term, intensive care<br>ventilator for adults and<br>children with a body<br>weight of at least 3 kg |
| Specification | Evita 4 (K 961687) | Evita 2 dura (K 970165) | Servo 300 (K902859) | Evita 4 SW 3.0 |
| Modes of Ventilation: | - | - | - | identical with Evita 4<br>510(k) no: K 961687 |
| Ventilator Settings | - | - | - | identical with Evita 4<br>510(k) no: K 961687 |
| Flow Trigger Sensivity | - | - | - | identical with Evita 4<br>510(k) no: K 961687 |
| Parameter setting | - | - | - | identical with Evita 4<br>510(k) no: K 961687 |
| Monitors/Indicators | - | - | - | identical with Evita 4<br>510(k) no: K 961687 |
| Pressure Limitation | - | - | - | identical with Evita 4<br>510(k) no: K 961687 |
| Alarm Functions | - | - | - | identical with Evita 4<br>510(k) no: K 961687 |
| Displayed Values | - | - | - | identical with Evita 4<br>510(k) no: K 961687 |
| Displayed Curves | - | - | - | identical with Evita 4<br>510(k) no: K 961687 |
| Specification | Evita 4 (K 961687) | Evita 2 dura (K 970165) | Servo 300 (K902859) | Dräger<br>Evita 4 SW 3.0 |
| Special Functions | | | | |
| Intermittend PEEP | Yes | Yes | - | identical with Evita 2dura |
| Inspiration Hold | No | Yes | - | identical with Evita 2dura |
| Apnea Ventilation | Yes | Yes | - | identical with Evita 2dura |
| Nebulization | Yes | Yes | - | identical with Evita 2dura |
| Nebulization in pediatric mode | No | Yes | - | identical with Evita 2dura |
| Suction Help Mode | Yes | Yes | - | identical with Evita 2dura |
| Switch over function | Yes | Yes | - | identical with Evita 2dura |
| Leak-Compensation | No | Yes | - | identical with Evita 2dura |
| Minute Volume-Leak | No | Yes | - | identical with Evita 4<br>510(k) no. K 961687 |
| Physical Caracteristics | | | | |

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# INTENDED USE OF THE DEVICE

Evita 4 (SW 3.0) is a time cycled, constant volume, long term, intensive care ventilator for adults and children with a body weight of at least 3kg.

Intended Environment for the device:

- user facilities …
- inner clinical transport -

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES:

The ventilator functions of the Evita 4 with the enhanced software version are substantially equivalent to the Evita 2 dura, the Evita 4 with the former software and the Servo 300 ventilators.

The Evita 4 with enhanced software integrates the same optional functions that are presently performed by the Evita 4 with the former software.

The device fulfils at least the same standards as the Evita 2 dura.

Therefore the device under review is substantial equivalent to the predicate devices concerning safety, efficiency and the intended use.

Flium

Frank Clanzett Regulatory Affairs Dräger Medizintechnik

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Image /page/6/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 with three curved lines representing its wings or feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1998 SEb

Mr. Harald Kneuer Drager Inc. Critical Care Systems 3136 Quarry Road Telford, PA 18969

K980642 Re : Evita 4 Requlatory Class: II (two) Product Code: 73 CBK Dated: June 12, 1998 Received: June 15, 1998

Dear Mr. Kneuer:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Harald Kneuer

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INTENDED USE STATEMENT OF THE EVITA 4, SW 3.0

Fivita 4 is a time cycled, constant volume, long term, intensive care ventilator for adults and children with a body weight of at least 3 kg.

## Intended Environment for the device:

- hospital use
- inner clinical transport

Signature

Frank Clanzep (Regulatory Affairs)

1. September 1998

Mark Kramis

: Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_K980(e4Z

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