EVITE XL

K083050 · Draeger Medical AG & Co. KG · CBK · Dec 29, 2008 · Anesthesiology

Device Facts

• Record ID: K083050
• Device Name: EVITE XL
• Applicant: Draeger Medical AG & Co. KG
• Product Code: CBK · Anesthesiology
• Decision Date: Dec 29, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Long-term ventilator for intensive care. For adults, children, and neonates with a minimum body weight of 3 kg (6.6 lbs). For premature infants with a minimum body weight of 0.5 kg (1.1 lbs) with the NeoFlow option.

Device Story

Evita XL is a time-cycled, microprocessor-controlled intensive care ventilator. It provides continuous ventilation for patients ranging from premature infants to adults. New software options include: NIV Plus (mask ventilation with improved leakage compensation and trigger performance); Insp. Term. PIF (adjustable inspiratory termination criteria based on flow thresholds); and Proportional Pressure Support (PPS) (assists spontaneous breathing proportional to patient effort). The device is used in clinical settings by healthcare professionals. It processes patient respiratory signals to adjust flow and pressure delivery. Outputs are displayed to clinicians to monitor ventilation performance and patient-ventilator synchrony. These features aim to improve patient comfort, optimize trigger sensitivity, and provide tailored respiratory support, potentially reducing work of breathing.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and software validation measures.

Technological Characteristics

Microprocessor-controlled, time-cycled ventilator. Software-based control of ventilation modes (NIV Plus, Insp. Term. PIF, PPS). Features include leakage compensation, flow-based termination criteria, and proportional pressure support. Connectivity and specific material standards are not detailed.

Indications for Use

Indicated for long-term intensive care ventilation in adults, children, and neonates (min weight 3 kg) and premature infants (min weight 0.5 kg with NeoFlow option).

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 XL (K010093; K980642)
• Babylog 8000 plus (K974176)

Submission Summary (Full Text)

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# 510(k) Summary acc. to 21 CFR 807.92

### Applicants Name and Address:

Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany

# Manufacturer Name and Address:

Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany

#### Establishment Registration Number :

9611500

#### Contact Person:

Ulrich Schroeder Head of Regulatory & Clinical Affairs

Tel. No.: + 49 [phone] Fax No : + 49 (451) 882-7-3648

# Applicants US Contact Person

Joyce Kilrov Vice President, Processes, Quality & Regulatory

Tel. No.: [phone] Fax No .: [phone]

# Date submission was prepared:

10/10/2008

# Device Name:

Common Name: Classification Name: Regulation Number: Class:

Evita XL Continuous Ventilator, CBK 21 CFR 868,5895 ll

DEC 2 9 2008

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Image /page/1/Picture/0 description: The image shows the text "K083050" at the top, followed by "P-2 of 3". Below that is the logo for "Dräger medical", with the tagline "A Dräger and Siemens Company" underneath. The text appears to be handwritten and then printed, giving it a slightly rough appearance.

# Legally Marketed Devices to which Substantial Equivalence is claimed:

| 510(k) number | Trade name | Company |
|--------------------|-------------------|-----------------------------|
| K 010093; K 980642 | Evita XL | Draeger Medical AG & Co. KG |
| K 974176 | Babylog 8000 plus | Draeger Medical AG & Co. KG |

# Device Description:

Evita XL is a time-cycled microprocessor-controlled intensive care ventilator intended to provide continuous ventilation for adults, children, neonates and infants with Neoflow option. The device can be also operated in the mask ventilation mode if the according option is installed. Software modification implements these new software options:

- . Option Mask Ventilation Plus (NIV Plus)
- Option Inspiratory Termination Criteria (Insp. Term. PIF) .
- . Option Proportional Pressure Support (PPS)

NIV Plus is a supplement to the existing Mask ventilation option (NIV), which improves ventilation performance (triggering and patient comfort) through higher leakage compensation and smooth ending of Assistant Spontaneous Breathing (ASB) strokes. NIV Plus implements Standby Plus an alternative for starting the active ventilation mode in mask ventilation when the patient takes the first spontaneous breath. Anti Air Shower detects disconnection during mask ventilation if the mask is deliberately removed from the face and reduces the flow supplied for the time of the disconnection.

Insp. Term. PIF is an adjustable stop criterion for pressure support strokes. At the end of the inspiratory phase the delivered inspiratory flow falls under a certain level of the maximum inspiratory flow. The ventilator cycles from inspiration phase to expiration phase when a fixed level was reached. The software modification allows it to adjust this inspiration termination criterion. The device can be configured by the user (adjustable inspiration termination criterion or fixed value is active).

The ventilation mode Proportional Pressure Support (PPS) is a software option for the ventilator Evita XL designed to assist the spontaneous breathing patient. In PPS, the device supports the patient's spontaneous breathing in proportion to the breathing effort. The degree of support in PPS mode can be set separately according to resistive and elastic components directly proportional to the patient effort.

#### Intended Use:

Long-term ventilator for intensive care. For adults, children, and neonates with a minimum body weight of 3 kg (6.6 lbs). For premature infants with a minimum body weight of 0.5 kg (1.1 lbs) with the NeoFlow option.

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Image /page/2/Picture/0 description: The image shows the logo for Dräger medical, with the words "Dräger medical" in a stylized font. Below the logo, it says "A Dräger and Siemens Company". At the top of the image, there is a handwritten note that says "P. 3 of 3".

### Conclusion:

The technological characteristics of the device, the results and conclusions of the performed risk analysis, as well as the performed software validation measures and its results demonstrate that the new software options (NIV Plus; Insp. Term. PIF; PPS) for the critical care ventilator Evita XL are safe and effective and are substantially equivalent to the legally marketed predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 2 9 2008

Dräger Medical AG & Co, KG C/O Joyce Kilroy Vice President, Processes, Quality & Regulatory Draeger Medical System, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K083050

Trade/Device Name: Evita XL Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: November 28, 2008 Received: December 2, 2008

Dear Ms. Kilroy:

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. Kilroy

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Clirs

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 Statement

| 510(k) Number (if known) | K 083050 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Evita XL |
| Indications for Use | Long-term ventilator for intensive care. For adults, children, and neonates with a minimum body weight of 3 kg (6.6 lbs). For premature infants with a minimum body weight of 0.5 kg (1.1 lbs) with the NeoFlow option. |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801. 109)

OR

Over-The-Counter Use_ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Zase M. Tin

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

510(k) Number:________________________________________________________________________________________________________________________________________________________________