EVITA 2 DURA

K970165 · Drager, Inc. · CBK · Aug 26, 1997 · Anesthesiology

Device Facts

• Record ID: K970165
• Device Name: EVITA 2 DURA
• Applicant: Drager, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Aug 26, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Evita 2 dura is a long term ventilator for the intensive care of patients with a body weight of at least 3 Kg up to 200 Kg. The device is microprocessor controlled and provides the following ventilation modes: - CMV Controlled Mandatory Ventilation - SIMV Synchronized Intermittent Mandatory Ventilation - MMV Mandatory Minute Volume Ventilation - CPAP Continuous Positive Airway Pressure - PCV+ Pressure Controlled Ventilation, combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure support from CPAP level. - APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable. - Apnea ventilation For switching over automatically to volume controlled ventilation if breathing stops. - ILV Independent Lung Ventilation Separate, differentiated, synchronised ventilation with one Evita 2 dura unit for each lung. Application range - Intensive Care units - Inner clinical transport

Device Story

Evita 2 dura is a microprocessor-controlled, time-cycled, constant-volume ventilator for intensive care and intra-hospital transport. It delivers mechanical ventilation via a high-pressure servo valve system. The device supports multiple modes including CMV, SIMV, MMV, CPAP, PCV+, APRV, and ILV. It features AutoFlow for volume-controlled modes and apnea ventilation for automatic backup. Operators (clinicians) configure settings via a front panel with keys, rotary knobs, and 7-segment/LCD displays. The device monitors airway pressure, flow, volume, and optional CO2/SpO2, providing visual (LED/display) and audible alarms. Output data assists clinicians in managing patient respiratory status and weaning. Benefits include flexible ventilation strategies tailored to patient needs, from pediatric to adult populations.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and functional comparisons to predicate devices.

Technological Characteristics

Microprocessor-controlled, time-cycled, constant-volume ventilator. Gas delivery via high-pressure servo valve. Features 7-segment displays and LCD/TFT options for monitoring. Connectivity includes optional CO2 and SpO2 modules. Power supply 100-240V AC, optional 12/24V DC, and internal lead-acid battery. Dimensions 530x290x420 mm, weight 27 kg. Operating temperature 10-40°C.

Indications for Use

Indicated for long-term intensive care ventilation of patients weighing 3 kg to 200 kg.

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 (K924930)
• Servo 300 (K902859)

Submission Summary (Full Text)

{0}

K970165
Drager

Datei: Summary.RTF
Date: 19.12.1996
Author: Frank Clanzett

# 510(k) SUMMARY
## Summary of Safety and Effectiveness

**APPLICANTS NAME AND ADDRESS:**
Drager Inc.
Critical Care Systems
4101-100 Pleasant Valley Road
Chantilly, VA 20151

**APPLICANTS TELEPHONE NUMBER:**
(703)-817-0100

**APPLICANTS FACSIMILE NUMBER:**
(703)-817-0101

**APPLICANTS CONTACT PERSON:**
Harald Kneuer
Regulatory Affairs Manager

**DATE THE SUMMARY WAS PREPARED:**
November 11, 1996

**DEVICE NAME:**
Trade Name: Evita 2 dura
Common Name: Evita 2 dura
Classification Name: Ventilator, Continuous
(per 21 CFR 868.5895)

AUG 26 1997

**LEGALLY MARKETED DEVICE TO WHICH DRAGER INC. IS CLAIMING SUBSTANTIAL EQUIVALENCE:**

Evita 4 - Manufactured by Dragerwerk AG, Lubeck, Germany and sold in the United States by Drager Inc.

Evita - Manufactured by Dragerwerk AG, Lubeck, Germany and sold in the United States by Drager Inc.

Servo 300 - Sold in the United States by Siemens

Page 1 of 15

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Dräger

# Intensive Care Ventilator Data Comparison Sheet

| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| --- | --- | --- | --- | --- |
| 510 (K) number | K 961687 | | K 924930 | K902859 |
| Manufacturer | Dräger | Dräger | Dräger | Siemens |
| Classification | Intensive Care Ventilator | Intensive Care Ventilator | Intensive Care Ventilator | Intensive Care Ventilator |
| Working Principle | time cycled, volume constant, pressure controlled. | like Evita 4
like Evita 4 | time cycled, volume constant, pressure controlled. | time cycled, volume constant, pressure controlled. |
| Software controlled | Yes | Yes | Yes | Yes |
| Gas delivery system | Fast "High Pressure Servo Valve", microprocessor controlled | like Evita 4 | Fast "High Pressure Servo Valve", microprocessor controlled | Fast "High Pressure Servo Valve", microprocessor controlled |
| Voltage for gas delivery system | 12 V DC | like Evita 4 | 12 V DC | - |

* see explanation of differences

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| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| --- | --- | --- | --- | --- |
| Pneumatic Unit | Partnumber 84 12 360 | like Evita 4 | | |
| Software for Pneumatic Unit | Partnumber 84 11 742 | like Evita 4 | | |
| Electronic Unit | Partnumber 84 12 835 | like Evita 4 | | |
| Software for Electronic Unit | Partnumber 84 11 741 | like Evita 4 | | |
| Modes of Ventilation: | | | | |
| CMV | Yes | Yes | Yes | Yes |
| SIMV | Yes | Yes | Yes | Yes |
| CPAP | Yes | Yes | Yes | Yes |
| ASB | Yes | Yes | Yes | Yes |
| Assist Control | Yes | Yes | Yes | Yes |
| MMV | Yes | Yes | Yes | No |
| PCV+ (BIPAP) | Yes*1 | Yes*1 | Yes | Yes |
| APRV | Yes | Yes | Yes | No |
| CMV, Assist Control, SIMV and MMV with AutoFlow | Yes*2 | Yes*2 | No | Yes |
| ILV | Yes | Yes | Yes | |

* see explanation of differences

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| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| --- | --- | --- | --- | --- |
| Ventilator Settings | | | | |
| Rate | 0.5 to 100 bpm | like Evita 4 | 5 to 60 bpm for CMV
0.5 to 20 bpm for SIMV | 5 to 150 bpm for CMV
0.5 to 40 bpm for SIMV |
| Vt | 0.02 to 0.3 L (Pediatric Mode)*3
0.1 to 2.0 L (Adult Mode)*3 | like Evita 4 | 0.1 to 2.0 L | 0.002 to 4.0 L |
| Tinsp | 0.1 ... 10 s | like Evita 4 | not directly adjustable | 10 to 80 % (stepless) |
| I:E-Ratio | not directly adjustable*4 | like Evita 4 | 4:1 to 1:5 | not directly adjustable |
| Flow | 6 to 30 lpm (Paediatric Mode)*3
6 to 120 lpm (Adult Mode)*3 | like Evita 4 | 6 to 120 lpm | not directly adjustable |
| Pmax | 0 to 100 cmH2O | like Evita 4 | 0 to 100 cmH2O | 10 to 120 cmH2O |
| PEEP | 0 to 35 cmH2O | like Evita 4 | 0 to 35 cmH2O | 0 to 50 cmH2O |
| O2-Conc. | 21 to 100 Vol.% | like Evita 4 | 21 to 100 Vol.% | 21 to 100 Vol.% |
| Flow Trigger Sensitivity | | | | |
| for CMV assist | 0.3 to 15 lpm*5 | like Evita 4 | 0.5 to 5.0 cmH2O | 0 to 17 cmH2O P. trigger |
| for SIMV | 0.3 to 15 lpm*5 | like Evita 4 | 0.7 cmH2O fixed trigger | 0 to 17 cmH2O P. trigger |
| for ASB (pressure support) | 0.3 to 15 lpm | like Evita 4 | 1 to 15 lpm | 0 to 17 cmH2O P. trigger |
| for CPAP | 0.2 cmH2O fixed trigger | like Evita 4 | 0.2 cmH2O fixed trigger | |
| Pinsp | 0 to 80 cmH2O | like Evita 4 | 10 to 100 cmH2O | 0 to 100 cmH2O |
| Rise time | 0 to 2 s | like Evita 4 | 0 to 2 s | 0 to 10 % |
| Pressure Support | 0 to 80 cmH2O | like Evita 4 | 0 to 80 cmH2O | 0 to 100 cmH2O |

* see explanation of differences

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Dräger

| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| --- | --- | --- | --- | --- |
| Parameter setting
Main ventilation settings | with 10.4" Color TFT-LC-display, Touch screen and central | With keys, 7-Seg. Display rotary knob and central rotary dial knob for selecting and confirming* | rotary knob for every parameter | rotary knob for every parameter |
| further settings | With 10.4" Color TFT-LC-Display, Touch screen and central rotary knob | Via menu | menu via hardkeys | - |
| Monitors/Indicators
Power ON | TFT-LC-Display (Color) | LC-Display (monochrom) or TFT (Color) | LC-Display | LED |
| Dimension of Display | 21.1cm x 15.8cm
640 x 480 dots | 12.5cm x 9.5cm
640 x 480 dots | 9.8cm x 7.9cm
128 x 240 dots | |
| Alarm Condition | red LED and TFT-LC-Display | red LED and TFT or LC-Display | red LED and LC Display | red LED and LED Display |
| Warnings | yellow LED and TFT-LC-Display | yellow LED and LC or TFT | yellow LED and LC-Display | |
| Messages | TFT-LC-Display | LCD-or TFT-Display | LC-Display | LED-Display |
| Curves | TFT-LC-Display | LCD-or TFT-Display | LC-Display | no |

* see explanation of differences

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| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| --- | --- | --- | --- | --- |
| Measured values | TFT-LC-Display | LC-or TFT Display | LC-Display and 7-Segment-Display | several LED-Displays |
| Adjusted values | TFT-LC-Display | 7-Segment Display and LC- or TFT- Display | Scale of potentiometer and LC-Display | Scale of potentiometer and LED-Display |
| Audible Alarm | Yes | Yes | Yes | Yes |
| Alarm sound level | adjustable | adjustable | fixed | adustable |
| Pressure Limitation | | | | |
| adjustable Pmax | 0 to 100 cmH2O | like Evita 4 | 0 to 100 cmH2O | 10 to 100 cmH2O |
| Safety Valve | 100 cmH2O | like Evita 4 | 100 cmH2O | 120 cmH2O |
| Inspiratory relief valve | Yes | like Evita 4 | Yes | Yes |

* see explanation of differences
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| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| --- | --- | --- | --- | --- |
| Alarms | | | | |
| Airway Pressure High / Low | Yes | Yes | Yes | Yes |
| Minute volume High / Low | Yes | Yes | Yes | Yes |
| Apnea | Yes | Yes | Yes | Yes |
| Gas Supply Failure | Yes | Yes | Yes | Yes |
| Power failure | Yes | Yes | Yes | Yes |
| Alarm Silence / Reset | Yes | Yes | Yes | Yes |
| Ventilator Inoperative | Yes | Yes | Yes | Yes |
| Breathing frequency High | Yes | Yes | Yes | No |
| Oxygen concentration High / Low | Yes | Yes | Yes | Yes |
| Breathing gas temperatur High | Yes | Yes | Yes | No |
| Endexpiratory CO2-concentration | | | | |
| etCO2 High / Low | Yes | Yes*8 (option) | No | No |
| O2 saturation SpO2 High / Low | Yes (option)*9 | Yes*9 | No | No |
| Pulse High / Low | Yes (option) *9 | Yes*9 | No | No |

* see explanation of differences

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Dräger

| Device | Evita | Evita 2 dura | Evita | Servo 300 |
| --- | --- | --- | --- | --- |
| Displayed Values | | | | |
| max. airway pressure Ppeak | 0 to 99 cmH2O | like Evita 4 | 0 to 99 cmH2O | Yes |
| Plateau pressure | 0 to 99 cmH2O | like Evita 4 | 0 to 99 cmH2O | Yes |
| PEEP | 0 to 99 cmH2O | like Evita 4 | 0 to 99 cmH2O | Yes |
| mean airway pressure | 0 to 99 cmH2O | like Evita 4 | 0 to 99 cmH2O | Yes |
| min. airway pressure | 0 to 99 cmH2O | like Evita 4 | 0 to 99 cmH2O | No |
| insp. oxygen concentration | 15 to 100 Vol.-% | like Evita 4 | 5 to 99 Vol.-% | Yes |
| Minute volume MV | 0 to 99 lpm | like Evita 4 | 0 to 99 lpm | Yes |
| spont. breath. volume MVspon | 0 to 99 lpm | like Evita 4 | 0 to 99 lpm | No |
| Tidal volume VT | 0 to 3999 ml | like Evita 4 | 0 to 3999 ml | Yes |
| spont. tidal volume VTspon | 0 to 3999 ml | like Evita 4 | 0 to 3999 ml | No |
| breathing frequency f | 0 to 150 bpm | like Evita 4 | 0 to 80 bpm | Yes |
| spont. breathing frequency fspon | 0 to 150 bpm | like Evita 4 | 0 to 80 bpm | No |
| breathing gas temperatur | 18 to 51°C | like Evita 4 | 18 to 51°C | No |
| endexp. CO2-concentration etCO2 | 0 to 13.3 Vol.% | like Evita 4 *8 | - | No |

* see explanation of differences

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Dräger

| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| --- | --- | --- | --- | --- |
| CO2-production | 0 to 999 ml/min | like Evita 4*^{8} | - | No |
| Serial dead space Vds | 0 to 999 ml | like Evita 4*^{8} | - | No |
| Dead Space Ventilation Vds/VT | 0 to 999 ml | like Evita 4*^{8} | - | - |
| etCO2 | 0 to 13.3 Vol% | like Evita 4*^{8} | - | - |
| Compliance C (calculated value) | 0 to 250 ml/cmH2O | like Evita 4 | 0 to 250 ml/cmH2O | No |
| Resistance R (calculated value) | 0 to 99 cmH2O/l/s | like Evita 4 | 0 to 99 cmH2O/l/s | No |
| Pulse Rate | 20 to 250 bpm (option*9) | like Evita 4*^{9} | - | No |
| SpO2 | 0 - 100 %*^{9} | like Evita 4*^{9} | - | - |
| Displayed curves | | | | |
| Airway pressure Paw (t) | Yes | like Evita 4 | Yes | No |
| Flow (t) | Yes | like Evita 4 | Yes | No |
| Exsp. CO2-concentration | Yes | like Evita 4*^{8} | - | No |
| FCO2 | | | | |
| Plethmogram | Yes*^{9} | like Evita 4 | - | - |

* see explanation of differences

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Dräger

| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| --- | --- | --- | --- | --- |
| Special Functions | | | | |
| Intermittend PEEP | Yes | like Evita 4 | Yes | No |
| Inspiration Hold | Yes | like Evita 4 | Yes | Yes |
| Apnea Ventilation | Yes | like Evita 4 | Yes | Yes |
| Nebulization | Yes | like Evita 4 | Yes | Yes |
| Suction Help Mode | Yes | like Evita 4 | Yes | No |
| Switch over function | Yes | like Evita 4 | Yes | Yes |
| Physical Characteristics | | | | |
| Dimensions WxHxD | 530 x 290 x 450 mm | 530 x 290 x 420 mm | 530 x 270 x 420 mm | 242 x 360 240 mm
(pneumatics) 427 x 110
321 mm (front panel) |
| Weight | 27 kg | like Evita 4 | 27 Kg | 23.2 kg |
| Operation Temperature | 10 to 40°C | like Evita 4 | 15 to 40°C | |
| Storage Temperature | -20 to 60°C | like Evita 4 | -20 to 60°C | |

* see explanation of differences
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| Device | Evita 4 | Evita 2 dura | Evita | Servo 300 |
| --- | --- | --- | --- | --- |
| Power Supply | | | | |
| AC-Power connection range | 100V to 240 V, 50/60 Hz | like Evita 4 | 100V to 127 V, 220 V
to 240 V, 50/60 Hz | 100, 120, 220 and 240
V AC, 50/60 Hz |
| Power consumption | approximately 125 W | like Evita 4 | approximately 125 W | 40 W |
| DC-connection | Option, range 12 or 24V
DC*^{10} | like Evita 4 | No | 24 V DC |
| Internal battery | Option *^{10} | like Evita 4 | No | Yes |
| Operating time with battery | > 10 min *^{10} | like Evita 4 | No | Approx. 30 min |
| Typ of internal batterie | lead, free of maintenance | like Evita 4 | - | lead, free of
maintenance |
| Recharge time | < 1.5 hours | like Evita 4 | - | 10 hours |

* see explanation of differences

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Dräger

# Explanation of Differences

1. Evita 2 dura and Evita 4 uses the name PCV+ instead of the name BIPAP for the same ventilation mode. This pressure controlled ventilation mode is combined with free spontaneous breathing during the complete breathing cycle.
2. Evita 2 dura and Evita 4 uses extra setting AutoFlow for all volume controlled ventilation modes (CMV, SIMV, and MMV) instead of a separate mode (Pressure regulated volume controlled of the serve 300).
3. Evita 2 dura and Evita 4 distinguishes between an Adult and a Pediatric Mode, which can be selected by the user after switching on.
4. Evita 2 dura and Evita 4 uses instead of an I:E-adjustment the adjustment of the Inspiratory Time Tinsp
5. Evita 2 dura and Evita 4 uses the Flow Trigger for the adjustment of the trigger sensitivity in all ventilation modes
6. Evita 2 dura uses a different operating concept:
- 11 ventilation parameter, for example VT is adjusted as follows:
By pressing a key the parameter the adjusted parameter is selected. After that the yellow LED on the key is activated.
- Turn the central rotary knob = adjust the value
- Press the central rotary knob = confirm the value
- The yellow LED is switched off.
- The value is displayed by a 7-Segement-Display.
7. In Evita 2 dura for adjusting of the parameters are no potentiometer used. The adjusted value is displayed by 7-Segment-displays (each 11 parameters have an own 7-segment-display).
8. Evita 2 dura can be equipped with an built-in monitoring for the expiratory CO2 concentration. The basic version of Evita 4 is equipped with this feature.
9. Evita 2 dura and Evita 4 can be equipped optional with an oxygen saturation measurement
10. Evita 2 dura and Evita 4 can be equipped with a DC power supply

* see explanation of differences
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Dräger

# DESCRIPTION OF THE DEVICE:

The Evita 2 dura is a time cycled, constant volume ventilator for long term use in intensive care and inner clinical transport. The device is microprocessor controlled and provides the following ventilation modes:

- CMV/assist
Controlled Mandatory Ventilation
Controlled and assisted volume contact ventilation with the options:
- CPV Continuous Positive Pressure Ventilation
- PLV Pressure Limited Ventilation
- AutoFlow For automatic regulation of inspiratory flow
- IRV Inversed Ratio Ventilation

- SIMV
Synchronized Intermittent Mandatory Ventilation
Procedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options:
- PLV
- AutoFlow

- MMV
Mandatory Minute Volume Ventilation
Spontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options:
- PLV
- AutoFlow

- SB
Spontaneous Breathing
Spontaneous breathing at ambient pressure

- CPAP
Continuous Positive Airway Pressure
Spontaneous breathing with positive airway pressure

- ASB/PSV
Assisted Spontaneous Breathing / Pressure Support Ventilation
Pressure supported spontaneous breathing

- PCV+
Pressure Controlled Ventilation
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
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
Separate, differentiated, synchronized ventilation with one Evita 2 dura for each lung

Page 13 of 15

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Dräger

# INTENDED USE OF THE DEVICE:

The Evita 2 dura is a long term ventilator for the intensive care of patients with a body weight of at least 3 Kg up to 200 Kg.

The device is microprocessor controlled and provides the following ventilation modes:

- CMV Controlled Mandatory Ventilation
- SIMV Synchronized Intermittent Mandatory Ventilation
- MMV Mandatory Minute Volume Ventilation
- CPAP Continuous Positive Airway Pressure
- PCV+ Pressure Controlled Ventilation, combined with free spontaneous breathing during the complete breathing cycle and adjustable pressure support from CPAP level.
- APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges - independently adjustable.
- Apnea ventilation For switching over automatically to volume controlled ventilation if breathing stops.
- ILV Independent Lung Ventilation Separate, differentiated, synchronised ventilation with one Evita 2 dura unit for each lung.

Application range - Intensive Care units
- Inner clinical transport

Page 14 of 15

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Dräger

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

The ventilator functions of the Evita 2 dura are substantially equivalent to the Evita 4, the Evita and the Servo 300 ventilators.

The Evita 2 dura integrates the optional functions for CO2 and SpO2 that are presently performed by the Evita 4.


Frank Clanzett
Regulatory Affairs Specialist

Page 15 of 15

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DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

Mr. Harald Kneuer
Drager, Inc.
Critical Care Systems
4101 Pleasant Valley Road, Suite 100
Chantilly, Virginia 20151

AUG 26 1997

Re: K970165
Evita 2 Dura
Regulatory Class: II (two)
Product Code: 73 CBK
Dated: May 27, 1997
Received: May 28, 1997

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 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 Regulations, 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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/dsmamain.html".

Sincerely yours,


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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Product: Evita 2 dura
Dräger

# Intended use of the product

Evita 2 dura is a long-term ventilator for the intensive care ventilation of patients with a body weight of at least 3 kg up to 200 Kg.

The device is microprocessor-controlled and provides the following ventilation modes :

- CMV : Intermittent Positive Pressure Ventilation
Controlled and assisted volume-constant ventilation

- SIMV : Synchronized Intermittent Mandatory Ventilation
Procedure for weaning patients off the ventilator after they have stayed spontaneous breathing

- MMV : Mandatory Minute Volume Ventilation
Spontaneous breathing with automatic adjustment of mandatory ventilation to the patient's minute volume requirement.

- CPAP : Continuous Positive Airway Pressure
Spontaneous breathing with positive airway pressure and adjustable pressure support.

- PCV+ : Pressure Controlled Ventilation
Pressure-controlled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure support from CPAP level.

- APRV : Airway Pressure Release Ventilation
Spontaneous breathing on two pressure levels with long time ranges - independently adjustable.

Furthermore Evita 2 dura offers the following special ventilation modes :

- Apnea ventilation : For switching over automatically to volume-controlled ventilation if breathing stops.

- ILV : Independent Lung Ventilation, optional
Separate, differentiated, synchronised ventilation with one Evita 3 unit for each lung.

## Application range

- Intensive care units

- Inner-clinical transport

Beier
(Project Manager)


CE_4_FDA.RTF