NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900

K983219 · Drager, Inc. · CBK · Dec 7, 1998 · Anesthesiology

Device Facts

• Record ID: K983219
• Device Name: NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900
• Applicant: Drager, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Dec 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

NeoFlow - Neonatal mode with base flow. The Evita 4 / 2 Dura with NeoFlow Option is a long-term ventilator to be used for intensive care and inner clinical transport of adults, children, infants and neonates with a minimum body weight of 0.5 kg. The device is microprocessor controlled and provides the following ventilation modes: - CMV/assist Controlled Mandatory Ventilation Controlled and assisted volume constant ventilation, with the options: - CPPV Continuous Positive Pressure Ventilation - PLV Pressure Limited Ventilation - AutoFlow For automatic regulation of inspiratory flow - IRV Inversed Ratio Ventilation - SIMV Synchronised 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 Continuos 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, 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 ventilation if breathing stops. - ILV Independent Lung Ventilation Separate, differentiated synchronised ventilation with one Evita 4 / 2 Dura for each lung.

Device Story

Evita 4/2 Dura NeoFlow is a microprocessor-controlled ventilator; provides respiratory support for patients ranging from neonates (min 0.5 kg) to adults. Device delivers various ventilation modes including CMV/assist, SIMV, MMV, SB, CPAP, ASB/PSV, PCV+, APRV, and Apnea Ventilation; features AutoFlow for automatic inspiratory flow regulation. Used in intensive care units and for inner clinical transport; operated by trained healthcare professionals. Provides clinicians with continuous monitoring and automated ventilation control; assists in weaning and maintaining patient minute volume. Benefits include precise pressure/volume delivery tailored to patient size, including neonates, reducing work of breathing and supporting respiratory failure management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Microprocessor-controlled ventilator; supports neonates, infants, children, and adults. Features include AutoFlow for flow regulation, pressure-limited ventilation, and various synchronized/spontaneous modes. Connectivity and specific material standards are not detailed in the provided text. System is designed for long-term intensive care and clinical transport.

Indications for Use

Indicated for intensive care and inner clinical transport of adults, children, infants, and neonates with a minimum body weight of 0.5 kg requiring long-term mechanical ventilation.

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 (K983219)
• Babylog 8000 plus (K983219)
• Servo 300 (K983219)

Submission Summary (Full Text)

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7 1998 DEC

K983219

**Dräger**

file: 510kstate.RTF Date: Aug, 1998 Author: Frank Clanzett

# 510(k) SUMMARY Summary of Safety and Effectiveness

APLICANTS NAME AND ADDRESS:

Drager Medizintechnik GmbH Moislinger Allee 53-55 23542 Luebeck, Germany

APPLICANTS PHONE NUMBER: 49-451-882-3915

APPLICANTS FAX NUMBER: 49-451-882-4351

APPLICANTS CONTACT PERSON: Frank Clanzett Regulatory Affairs Specialist

DATE THE SUMMARY WAS PREPARED: August, 1998

## DEVICE NAME:

Common Name: Classification Name: Evita 4 NeoFlow™ Ventilator, Continuous (per 21 CFR 868.5895)

LEGALLY MARKETED DEVICE TO WHICH DRÄGER IS CLAIMING SUBSTANTIAL EQUIVALENCE:

Evita 4 - Manufactured by Dräger Medizintechnik GmbH, Lübeck, Germany and sold in the United States by Dräger, Inc.

Babylog 8000 plus- Manufactured by Dräger Medizintechnik GmbH, Lübeck, Germany and sold in the United States by Dräger, Inc.

Servo 300 - Sold in the United States by Siemens

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# DESCRIPTION OF THE DEVICE:

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The Evita 4 NeoFlow option extends the patient range of the Evita 4 ventilator to neonates with a minimum weight of 0,5 kg.

The Evita 4 equipped with the NeoFlow option provides the following ventilation modes.

| - CMV/assist | Controlled Mandatory Ventilation<br>Controlled and assisted volume contant ventilation with the<br>options:<br>- CPV Continuous Positive Pressure Ventilation<br>- PLV Pressure Limited Ventilation<br>- AutoFlow For automatic regulation of inspiratory flow<br>- IRV Inversed Ratio Ventilation |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| - SIMV | Synchronized Intermittent Mandatory Ventilation<br>Procedure for weaning patients off the ventilator after they have<br>started spontaneous breathing. With the options:<br>- PLV<br>- AutoFlow |
| - MMV | Mandatory Minute Volume Ventilation<br>Spontaneous breathing with automatic adjustment of mandatory<br>ventilation to the patients minute volume requirement. With the<br>options:<br>- PLV<br>- AutoFlow |
| - SB | Spontaneous Breathing<br>Spontaneous breathing at ambient pressure |
| - CPAP | Continuous Positive Airway Pressure<br>Spontaneous breathing with positive airway pressure |
| - ASB/PSV | Assisted Spontaneous Breathing / Pressure Support Ventilation<br>Pressure supported spontaneous breathing |
| - PCV+ | Pressure Controlled Ventilation<br>Pressure controlled ventilation combined with free spontaneous<br>breathing during the complete breathing cycle, and adjustable<br>pressure increase to CPAP level |
| - APRV | Airway Pressure Release Ventilation<br>Spontaneous breathing on two pressure levels with long time<br>ranges - independently adjustable |
| - Apnea<br>Ventilation | For switching over automatically to volume controlled<br>mandatory ventilation if breathing stops |
| - ILV | Independent Lung Ventilation<br>Separate, differentiated, synchronized ventilation with one<br>Evita 4 for each lung. |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 1998 DEC

Mr. Harald Kneuer Drager, Inc. Critical Care Systems 3136 Quarry Road Telford, PA 18969

Re: K983219 Neoflow Option for Evita 4 and Evita 2 Dura Ventilators Regulatory Class: II (two) Product Code: СВК September 11, 1998 Dated: Received: September 14, 1998

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 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). 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 obliqation 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 requlation (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 qeneral 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Intended Use Statement Drager Evita 4 / 2 Dura NeoFlow Option:

NeoFlow - Neonatal mode with base flow.

The Evita 4 / 2 Dura with NeoFlow Option is a long-term ventilator to be used for intensive care and inner clinical transport of adults, children, infants and neonates with a minimum body weight of 0.5 kg.

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

| - CMV/assist | Controlled Mandatory Ventilation<br>Controlled and assisted volume constant ventilation, with the options:<br>- CPPV Continuous Positive Pressure Ventilation<br>- PLV Pressure Limited Ventilation<br>- AutoFlow For automatic regulation of inspiratory flow<br>- IRV Inversed Ratio Ventilation |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| - SIMV | Synchronised Intermittent Mandatory Ventilation<br>Procedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options:<br>- PLV<br>- AutoFlow |
| - MMV | Mandatory Minute Volume Ventilation<br>Spontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options:<br>- PLV<br>- AutoFlow |
| - SB | Spontaneous Breathing<br>Spontaneous breathing at ambient pressure |
| - CPAP | Continuos Positive Airway Pressure<br>Spontaneous breathing with positive airway pressure |
| - ASB/PSV | Assisted Spontaneous Breathing / Pressure Support Ventilation<br>Pressure supported spontaneous breathing |
| - PCV+ | 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<br>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<br>Separate, differentiated synchronised ventilation with one Evita 4 / 2 Dura for each lung. |

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prescriptions use √

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number

TC