OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500

K072412 · Drager Medical AG & Co. Kgaa · CBK · Feb 6, 2008 · Anesthesiology

Device Facts

• Record ID: K072412
• Device Name: OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500
• Applicant: Drager Medical AG & Co. Kgaa
• Product Code: CBK · Anesthesiology
• Decision Date: Feb 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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 or tracheotomized patients. Patients with body weight between 15 and 35 kg (33.1 and 77.8 lbs) must be endotracheally intubated and ventilated with active humidification. The patients should be haemodynamically stable with adequate oxygenation and spontaneous breathing.

Device Story

EvitaXL is a microprocessor-controlled intensive care ventilator; SmartCare/PS option automates weaning process. System monitors spontaneous breathing; maintains patient in "comfortable zone" by adjusting pressure support levels. Used in ICU settings by physicians and respiratory therapists. Device provides automated protocol management; assists clinicians in standardizing weaning; reduces inspiratory support based on patient status. Benefits include standardized weaning process; potential reduction in ventilation duration. Patients 15-35 kg require endotracheal intubation and active humidification.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical design and intended use to the predicate device.

Technological Characteristics

Microprocessor-controlled intensive care ventilator. Features computer-based protocol representation for pressure support management. Supports intubated and tracheotomized patients. Connectivity and specific material standards not detailed.

Indications for Use

Indicated for adults and children (≥15 kg) requiring mechanical ventilation. Used for weaning intubated or tracheotomized patients who are hemodynamically stable with adequate oxygenation and spontaneous breathing. Contraindicated in severe COPD and 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

• EvitaXL with SmartCare Option (K051263)

Submission Summary (Full Text)

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510(k) Summary SmartCare Option for EvitaXL

FEB - 6 2006

510(k) Summa

**Urger**medica
A Dräger and Siemens Company

K072412

| Submitter's Name and Address: | | Dräger Medical AG & Co. KG<br>Moislinger Allee 53-55<br>23542 Lübeck<br>Germany<br>acc. to 21 CFR 807.92 | |
|--------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Contact Person: | | Dr Karin Luebbers<br>Senior Manager Regulatory Affairs | |
| | | Phone:<br>Fax: | + 49 [phone]<br>+ 49 (451) 882-7-5367 |
| Applicant's US Contact Person: | | Ms Kathy Anderson<br>Senior Director Regulatory Affairs | |
| | | Phone:<br>Fax: | [phone]<br>[phone] |
| Date submission was prepared: | | July 31st, 2007 | |
| Device Name: | Common Name:<br>Classification Name:<br>Regulation Number:<br>Class: | Intensive Care Ventilator<br>Continuous Ventilator<br>21 CFR 868.5895<br>2 | |

Legally Marketed Device Identification: EvitaXL with SmartCare Option (K051263)

## Device Description:

The EvitaXL is a time-cycled microprocessor-controlled intensive care ventilator. The option SmartCare™ for the EvitaXL has been developed for assisting physicians and respiratory therapists with the standardization of the weaning process used in intensive care units. The system uses a computerbased representation of a protocol and focusses on the management of pressure support.

Scope of this submission is an extension of claims made in the promotional material, while the itself remains unchanged except for minor modifications that led to non-filing decisions for use, the intended use and the instructions for use also remain unchanged.

## Intended 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 or tracheotomized patients. Patients with body weight between 15 and 35 kg (33.1 and 77.8 lbs) must be endotracheally intubated and ventilated with active humidification. The patients should be haemodynamically stable with adequate oxygenation and spontaneous breathing.

## Predicate Device:

| 510(k) Number | |
|---------------|--|
| K051263 | |

Device Name EvitaXL

Manufacturer Dräger Medical AG & Co. KG

## Substantial Equivalence:

The device and its labelling are identical to the predicate device. Substancial equivalence is claimed on that basis.

| type | release status | effective date | number | organization | page/of |
|----------|----------------|----------------|---------------|-------------------------------|---------|
| TEMPLATE | RELEASED | 30.09.2004 | DMS PQ2160 A4 | Dräger Medical<br>AG & Co. KG | 1/1 |

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA", which is arranged in a circular fashion around the logo.

FEB - 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dräger Medical AG & Co. KG C/O Ms. Kathy Anderson Senior Director, Regulatory Affairs Draeger Medical Systems, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K072412

Trade/Device Name: EvitaXL with Option SmartCare Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: January 18, 2008 Received: January 23, 2008

Dear Ms. Anderson:

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.

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Page 2 - Ms. Anderson

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 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 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.

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):

EvitaXL with Option SmartCare Device Name:

The EvitaXL is a long-term ventilator for intensive care for Indications For Use: adults, children, 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 spontaneous breathing in a "comfortable zone" and to reduce inspiratory support for adults and children with a body weight of at least 15 kg (33 lbs). The patients should be haemodynamically stable with adequate oxygenation and spontaneous breathing. SmartCare can be used for intubated or tracheotomized patients. Patients with body weight between 15 and 35 kq (33.1 and 77.8 lbs) must be endotracheally intubated and ventilated with active humidification.

> SmartCare™/PS is contraindicated in case of severe COPD and severe neurologic disorder that affects the cerebral control mechanism of the spontaneous breathing pattern.

Prescription Use X (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)

Mui Thulul

Division Sign-Off) Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices

KD77417 510(k) Number:

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