K Number

Device Name

EVITA 2 DURA

Manufacturer

DRAGER, INC.

Date Cleared

1997-08-26

(222 days)

Product Code

CBK

Regulation Number

868.5895

Intended Use

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 started 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

Device Description

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 contant 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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K 961687, K 924930, K902859

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard ventilation modes and microprocessor control, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is a ventilator used for intensive care ventilation, providing various modes to support and control breathing, which directly treats respiratory conditions.

Diagnostic

No
The device description indicates it is a ventilator used for providing respiratory support, not for diagnosing medical conditions. Its modes are for ventilation and breathing assistance, not for disease detection or diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "time cycled, constant volume ventilator" and mentions hardware components like a microprocessor. This indicates it is a physical medical device with integrated software, not a standalone software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Evita 2 dura is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is a "long-term ventilator for the intensive care ventilation of patients." This describes a device that directly interacts with a patient's respiratory system to provide life support.
Device Description: The device description details various ventilation modes and functions related to supporting breathing.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used to perform tests on samples from the body, while the Evita 2 dura is a therapeutic device used on the patient themselves.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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

Product codes (comma separated list FDA assigned to the subject device)

73 CBK

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

patients with a body weight of at least 3 kg up to 200 Kg. (implies age from pediatric to adult)

Intended User / Care Setting

Intensive Care units, Inner clinical transport

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Evita 4, K 961687, Evita, K 924930, Servo 300, K902859

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. Above the word, there is a handwritten number "K970165". The word "Dräger" is prominently displayed, suggesting it is a logo or brand name.

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

AUG 26 1997

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

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

Image /page/1/Picture/0 description: The image contains a few dark, indistinct shapes against a bright white background. The shapes are small and scattered, making it difficult to discern any specific objects or forms. The overall impression is one of minimal detail and high contrast.

Image /page/1/Picture/2 description: The image shows the word "Dräger" in a bold, sans-serif font. The "ä" in the word has two dots above it. The word is in black and the background is white.

Intensive Care Ventilator Data Comparison Sheet

Device	Evita 4	Evita 2 dura	Evita	Servo 300
510 (K) number	K 961687	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	-

Image /page/2/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The "ä" in the word has two dots above it. The word is in black and the background is white.

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,	Yes*2	Yes*2	No	Yes
SIMV and MMV with
AutoFlow
ILV	Yes	Yes	Yes	Yes
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	like Evita 4	0.1 to 2.0 L	0.002 to 4.0 L
Tinsp
I:E-Ratio	0.1 to 2.0 L (Adult Mode)*3
0.1 ... 10 s
not directly adjustable*4	like Evita 4
like Evita 4	not directly adjustable
4:1 to 1:5	10 to 80 % (stepless)
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
PEEP
02-Conc.	0 to 100 cmH2O
0 to 35 cmH2O
21 to 100 Vol.%	like Evita 4
like Evita 4
like Evita 4	0 to 100 cmH2O
0 to 35 cmH2O
21 to 100 Vol.%	10 to 120 cmH2O
0 to 50 cmH2O
21 to 100 Vol.%
Flow Trigger Sensivity
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
Pressure Support	0 to 2 s
0 to 80 cmH2O	like Evita 4
like Evita 4	0 to 2 s
0 to 80 cmH2O	0 to 10 %
0 to 100 cmH2O
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*6	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
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 cmH20	like Evita 4	100 cmH2O	120 cmH20
Inspiratory relief valve	Yes	like Evita 4	Yes	Yes
Device	Evita 4	Evita 2 dura	Servo 300
Alarms
Airway Pressure High /Low	Yes	Yes	Yes
Minute volume High / Low	Yes	Yes	Yes
Apnea	Yes	Yes	Yes
Gas Supply Failure	Yes	Yes	Yes
Power failure	Yes	Yes	Yes
Alarm Silence / Reset	Yes	Yes	Yes
Ventilator Inoperative	Yes	Yes	Yes
Breathing frequency High	Yes	Yes	No
Oxygen concentration High /
Low	Yes	Yes	Yes
Breathing gas temperatur High	Yes	Yes	No
Endexpiratory CO2-
concentration
etCO2 High / Low	Yes	Yes*8 (option)	No
O2 saturation SpO2 High / Low	Yes (option)*9	Yes*9	No
Pulse High / Low	Yes (option) *9	Yes*9	No
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 Ipm	like Evita 4	0 to 99 Ipm	Yes
spont. breath. volume MVspon	0 to 99 Ipm	like Evita 4	0 to 99 Ipm	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
Device	Evita 4	Evita 2 dura	Evita	Servo 300
CO2-production	0 to 999 ml/min	like Evita 4*8	-	No
Seriel 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/I/s	like Evita 4	0 to 99 cmH2O/I/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. C02-concentration FCO2	Yes	like Evita 4*8	-	No
Plethmogram	Yes*9	like Evita 4
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 x 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

Image /page/3/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The "a" in the word has an umlaut, which is a diacritical mark consisting of two dots placed over the letter. The word is in black and the background is white.

Image /page/4/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The "ä" in the word has two dots above it. The text is black and the background is white, creating a high contrast image.

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see explanation of differences

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e explanation of difference

6 of 15

Dräger

Image /page/6/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The "a" in the word has an umlaut, which is a diacritical mark consisting of two dots placed over the letter. The word is in black and the background is white.

Image /page/7/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The "a" in the word has an umlaut, which is a diacritical mark consisting of two dots placed over the letter. The word is black and the background is white.

Image /page/8/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is black and the background is white. The "ä" in Dräger has two dots above it.

(

see explanation of differences

ﺭﻳﺴﻴﺴﻴ

Image /page/9/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The "a" in the word has an umlaut (two dots) above it. The logo is simple and easily recognizable.

Image /page/10/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The "a" in the word has an umlaut, which is a diacritical mark consisting of two dots placed over the letter. The word is black and the background is white, creating a high contrast image.

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