EVITAXL WITH OPTION SMARTCARE

K051263 · Drager Medical AG & Co. Kgaa · CBK · Jul 12, 2005 · Anesthesiology

Device Facts

• Record ID: K051263
• Device Name: EVITAXL WITH OPTION SMARTCARE
• Applicant: Drager Medical AG & Co. Kgaa
• Product Code: CBK · Anesthesiology
• Decision Date: Jul 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The SmartCare/PS system is designed to stabilize the patient's spontaneous breathing in a "comfortable zone" and to reduce inspiratory support. SmartCare can be used for intubated and tracheotomized patients. Patients ventilated with body weight between 15 and 35 kg (33 and 77.5 lbs) must be hemodynamically stable with adequate spontaneous breathing and with active humidification.

Device Story

EvitaXL is a microprocessor-controlled intensive care ventilator. SmartCare/PS is an add-on system (PCB and software) for automated weaning. Inputs: respiratory rate, tidal volume, expiratory CO2 concentration. Operation: system monitors patient data to adjust pressure support (PSupp above PEEP) in CPAP/PS mode; automatically adapts ventilatory assistance, manages weaning strategy, and automates weaning tests. Used in ICU by physicians and respiratory therapists. Output: automated adjustment of pressure support levels. Benefit: standardizes weaning process, reduces inspiratory support, and maintains patient in a 'comfortable zone' during spontaneous breathing.

Clinical Evidence

Effectiveness of the SmartCare protocol was demonstrated via clinical studies comparing the system to the current ventilator standard of care. No specific quantitative metrics (e.g., p-values, sensitivity) are provided in the summary document.

Technological Characteristics

Time-cycled, microprocessor-controlled intensive care ventilator. Hardware addition: printed circuit board for independent calculation/analysis. Connectivity: integrated into EvitaXL platform. Software: automated weaning algorithm. Materials/specs: not specified.

Indications for Use

Indicated for adults, children, and infants (≥3 kg) requiring long-term intensive care ventilation. SmartCare/PS option indicated for hemodynamically stable, intubated or tracheotomized patients (≥15 kg) with adequate spontaneous breathing. Contraindicated in patients with severe COPD or severe neurologic disorders affecting cerebral control of spontaneous breathing.

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, Evita 2dura (K980642)
• Evita 4, Evita 2dura (K983219)
• Evita 4, Evita 2dura (K992608)
• Evita 4, Evita 2dura (K010093)
• Galileo Gold (K040574)
• Servo' (K970839)
• 840 (K021573)

Submission Summary (Full Text)

{0}------------------------------------------------

K05/263

Drägermedical

JUL 1 2 2005

SmartCare / PS Option for EvitaXL

### 510(k) Summary

(Section 3)

A Dräger and Siemens Company

In this section the 510(k) summary acc. to 807.92 is provided.

014

::

...

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for Dräger medical. The word "Dräger" is in bold, with two dots above the "a". The word "medical" is next to it in a thinner font. Below the logo, it says "A Dräger and Siemens Company".

# 510(k) Summary

acc. to 21 CFR 80

| Submitter's Name and Address: | Dräger Medical AG & Co. KGaA<br>Moislinger Allee 53-55<br>23542 Lübeck<br>Germany | | | | | | | | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------------------------|----------------------|-----------------------|--------------------|-----------------|--------|---|
| Contact Person: | Mr Ulrich Schröder<br>Manager Regulatory Affairs | | | | | | | | |
| | <table><tr><td>Phone:</td><td>011 49 [phone]</td></tr><tr><td>Fax:</td><td>011 49 [phone]</td></tr></table> | Phone: | 011 49 [phone] | Fax: | 011 49 [phone] | | | | |
| Phone: | 011 49 [phone] | | | | | | | | |
| Fax: | 011 49 [phone] | | | | | | | | |
| Applicant's US Contact Person: | Ms Monica Ferrante<br>Director Regulatory Affairs | | | | | | | | |
| | <table><tr><td>Phone:</td><td>[phone]</td></tr><tr><td>Fax:</td><td>[phone]</td></tr></table> | Phone: | [phone] | Fax: | [phone] | | | | |
| Phone: | [phone] | | | | | | | | |
| Fax: | [phone] | | | | | | | | |
| Date submission was prepared: | April 15, 2005 | | | | | | | | |
| Device Name: | <table><tr><td>Common Name:</td><td>Intensive Care Ventilator</td></tr><tr><td>Classification Name:</td><td>Continuous Ventilator</td></tr><tr><td>Regulation Number:</td><td>21 CFR 868.5895</td></tr><tr><td>Class:</td><td>2</td></tr></table> | Common Name: | Intensive Care Ventilator | Classification Name: | Continuous Ventilator | Regulation Number: | 21 CFR 868.5895 | Class: | 2 |
| Common Name: | Intensive Care Ventilator | | | | | | | | |
| Classification Name: | Continuous Ventilator | | | | | | | | |
| Regulation Number: | 21 CFR 868.5895 | | | | | | | | |
| Class: | 2 | | | | | | | | |
| | Legally Marketed Device Identification: EvitaXL (K980642, K983219, K992608, K010093) | | | | | | | | |

#### Device Description:

The EvitaXL is a time-cycled microprocessor-controlled intensive care ventilator. Basic difference in the larges granic user The EvitaXL IS a time-cycled inicitorio sono cleared by prematical notifications, is the larger graphic user
cessors Evita 2dura and Evita 4, which have been cleared by prema cessors Evita 2dura and Evita 4, which have been dealer by premainst, and thus feature the identical functionality.

For the EvitaXL a new system called SmartCare™ has been developed for assisting physicians and respiratory For the EvitaXL a new system called onlarcoard in not be care ve care on opinits. The system uses a
therapists with the standardization of the weaning process used in seems therapists with the starbaruization of the weating prococo used in themators of pressure support.

The SmartCare / PS system refers to measured patient data and adjusts the presure support provided by The SmartCare / PS System Telels to measured patient care in strategy that gradually re-EvitaXL for intubated of tractedomized patient's tolerande, while massuring his/her capacity
duces the level of assistance, at a rate that is guided by a patient the develope duces the level of assistance, at a rate that is guided by a naticate (with the stock of the street of 24-hourto breathe without mechaniour abolotanto of the level of assistance.

015

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for Dräger medical. The word "Dräger" is in bold, with two dots above the "a". The word "medical" is in a thinner font. Below the logo, it says "A Dräger and Siemens Company" in a smaller font.

SmartCare / PS essentially uses three parameters measured by EvitaXL:

- respiratory rate
- tidal volume
- expiratory CO2 concentration

It controls the level of pressure (PSupp. above PEEP) during ventilation in CPAP/PS mode.

SmartCare / PS has three main functions:

- automatic adaptation of ventilatory assistance
- automatic weaning strategy
- automation of the weaning test

In order to achieve the above-defined targets, the level of pressure support (PSupp.) is periodically adapted by In order to achieve the above-demed larges, the level of prosours respend in case of bradypnea and low etCO2.

Physically, the SmartCare / PS system has been accomplished by adding a printed circuit board and software.
Industry of the Smarting the start the stars indones indonesday of Physically, the Smartcare / PS system has been accomplished by adding a print.
This makes it possible to run the necessary calculations and analyses independently of the Evit tilation tasks.

#### Intended Use:

The SmartCare/PS system is designed to stabilize the patient's spontaneous breating in a "comfortable zone" The SmartCarerS system is uesigned to stablics the iphoned or tracheotonized patients. Patients
and to reduce inspiratory support. SmartCare can be used for intribated and and to reduce inspiratory support. ShartCare can be ason of the end ventilated and ventilated with body weight between 15 and 35 kg (53.1 and 77.5 b5) must be enable and and many
with active humidification. The patients should be haemodynamically stable with adequate spontaneous breathing.

#### Predicate Devices:

| 510(k) Number | Device Name | Manufacturer |
|---------------|----------------------|------------------------------|
| K980642 | Evita 4, Evita 2dura | Dräger Medical AG & Co. KGaA |
| K983219 | Evita 4, Evita 2dura | Dräger Medical AG & Co. KGaA |
| K992608 | Evita 4, Evita 2dura | Dräger Medical AG & Co. KGaA |
| K010093 | Evita 4, Evita 2dura | Dräger Medical AG & Co. KGaA |
| K040574 | Galileo Gold | Hamilton Medical AG |
| K970839 | Servo' | Maquet Critical Care AB |
| K021573 | 840 | Tyco NPB |

#### Substantial Equivalence:

The intended use of the SmartCare / PS option for the EvitaXL intensive care ventilator is comparable to the The intended use of the SmartCare / PS Uption that use measured respiratory data to directly interact with the predicate devices. All devices offer fullchors that is medical decide or respiratory therapist.
patient and adjust certain parameters without explicity berior within a pregat patient and adjust certain parameters without expilliation of a mouble waried within a predetemined
Nevertheless, parameters that are under control of the ventials and design Nevertheless, parameters that are three continues may solice . The materials and design .
range. Additionally, monitoring functions are still in place and advant are / PS sy range. Additionally, monton's are sint in pace and and elame reistins of the SmartCare / PS system do
are also similar to those predicate devices. The technological care ve are also similar to those predicale devices. The Evital Colical or increar ventilator. Furthermore,
not raise new questions regarding safety or effectiveness of the Evitical not raise new questions regarding salety of Choolvonooo of the Leading State devices.
the labeling associated with SmartCare / PS provides similar information as the predicat

Information provided in the 510(k) submission supports the determination of substantial equivalence. Software Information provided in the 510(K) submission support in FDA guidances and company internal design, development and ventication was penormed uning international, FDA recognized standards and standards. Safety and performance testing was conduction and andysis of results provides
other company internal standards as far as affected The combined and analysis of r other company internal standards as far as anotice. "The ochlined been and is and its intended use.

016

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A minimal and a manufacturer of the many of the many of the many of the many<br>release status | effective date | number<br>number | | page/of |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|----------------|------------------|---------------------------------|---------|
| type<br>TEMPLATE | RELEASED | 30.09.2004 | DMS PQ2160 A4 | Dräger Medical<br>AG & Co. KGaA | 2/3 |

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Dräger medical. The word "Dräger" is in bold, with an umlaut over the "a". The word "medical" is next to it in a lighter font. Below the logo, it says "A Dräger and Siemens Company" in a smaller font.

Effectiveness of the SmartCare protocol has sufficiently been demonstrated by means of clinical studies on Effectiveness of the SmartCare protocol has sunclently been demonstration of the more of the many of the many arison to current ventilator standard of care.

In summary Dräger Medical AG & Co. KGaA has demonstrated the SmartCare system to be as safe and as In summary Dräger Medical AG & Co. KGaA Tas Gellonskaled the SmartCare option is considered to be subeffective as the referenced predical devices which have been reviously effective as the referenced predicate devices. The Evitate which have been previously cleared by FDA.

# 017

type TEMPLATE

:

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and a wavy line representing water beneath it. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the circle's perimeter.

JUL 12 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Drager Medical AG & Co. KGAA c/o Ms. Monica Ferrante Director of Regulatory Affairs Drager Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K051263

Trade/Device Name: EvitaXL with Option SmartCare Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: April 29, 2005 Received: May 16, 2005

Dear Ms. Ferrante:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 - Ms. Monica Ferrante

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Amy Sullivan for
Chiu-Hin, Ph.D.

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

{6}------------------------------------------------

### Indications for Use

510(k) Number (if known): K 051263 EvitaXL with Option SmartCare Device Name: The EvitaXL is a long-term ventilator for intensive care for adults, children, Indications For Use: and infants with a body weight of at least 3 kg (6.6 lbs). With SmartCare™/PS the EvitaXL is intended to stabilize the patient's while onaltouro - n a "comfortable zone" and to reduce inspiratory spontaneous broating hildren with a body weight of at least 15 kg (33 lbs). Support for adults and and mamically stable with adequate oxygenation The patients should be haomes your Care can be used for intubated or and Sportaneous broughtigs Unterwith body weight between 15 and 35 kg traonoothilesu pawents be endotracheally intubated and ventilated with active humidification. SmartCare™/PS is contraindicated in case of severe COPD and severe neurologic disorder that effects the cerebral control mechanism of the spontaneous breathing pattern.

× Prescription Use (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)

Que Sulhom

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

510(k) Number

Page 1 of 1 __________________________________________________________________________________________________________________________________________________________________