(84 days)
Not Found
No
The document describes a microprocessor-controlled ventilator with various standard ventilation modes. There is no mention of AI, ML, or any learning algorithms. The "AutoFlow" feature is described as "automatic regulation," which is a common control mechanism in medical devices and does not necessarily imply AI/ML.
Yes
The device is described as a "long-term ventilator" used for "intensive care" of patients, providing various "ventilation modes" to support breathing, which are all therapeutic functions.
No
Explanation: The document describes a ventilator, which is a therapeutic device used for respiratory support, not for diagnosing medical conditions. Its function is to provide ventilation, not to identify diseases or pathologies.
No
The device description explicitly states it is an "Evita 4 / 2 Dura with NeoFlow Option," which is a long-term ventilator. Ventilators are hardware devices that deliver air to patients. The NeoFlow option extends the capabilities of this hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "long-term ventilation" and "inner clinical transport" of patients. This describes a life-support device that directly interacts with the patient's respiratory system.
- Device Description: The description details various ventilation modes and options, all related to providing respiratory support to a patient.
- 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 treatment.
IVD devices are used to perform tests on samples from the body, not to directly provide therapy or life support to the body. This device falls under the category of a therapeutic medical device, specifically a ventilator.
N/A
Intended Use / Indications for 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.
Product codes
CBK
Device Description
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 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 4 for each lung.
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
Adults, children, infants and neonates
Intended User / Care Setting
Intensive care and 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)
Evita 4, Babylog 8000 plus, Servo 300
Reference Device(s)
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
§ 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).
0
7 1998 DEC
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
1
DESCRIPTION OF THE DEVICE:
යි හැකි ව
102
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
息 | |
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
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 4 for each lung. |
2
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.
3
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
4
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
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. |
Page 6 of 6
prescriptions use √
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number
TC