(197 days)
Not Found
No
The document describes a standard microprocessor-controlled ventilator with various ventilation modes. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections.
Yes
The device is a ventilator, which is used to provide respiratory support and treat patients, fitting the definition of a therapeutic device.
No
The device description indicates it is a ventilator, which is a therapeutic device, not a diagnostic one. Its function is to provide respiratory support, not to diagnose medical conditions.
No
The device description clearly states it is a ventilator, which is a hardware device controlled by software. The summary does not indicate the submission is for the software component alone.
Based on the provided information, the Evita 4 ventilator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Evita 4 Function: The description clearly states that the Evita 4 is a ventilator. Its function is to assist or control breathing for patients. It does not perform any tests on bodily samples.
- Intended Use: The intended use is for providing ventilation to patients, not for diagnostic testing.
- Device Description: The description focuses on ventilation modes and control mechanisms, not on analytical or testing capabilities.
Therefore, the Evita 4 falls under the category of a life support or therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
Evita 4 is a time cycled, constant volume, long term, intensive care ventilator for adults and children with a body weight of at least 3 kg.
Intended Environment for the device:
- hospital use
- inner clinical transport
Product codes (comma separated list FDA assigned to the subject device)
73 CBK
Device Description
The Evita 4 with the Software version 3.0 is a time cycled, constant volume ventilator. The Evita 4 with the Software is microprocessor controlled and 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 and children
Intended User / Care Setting
user facilities
hospital use
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Dräger
4 1888 SEP
file: 510kstate.RTF Date: June, 1998 Author: Frank Clanzett
510(k) SUMMARY Summary of Safety and Effectiveness
APPLICANTS NAME AND ADDRESS:
Drager Inc. Critical Care Systems 3136 Quarry Road Telford , PA 18969
APPLICANTS TELEPHONE NUMBER: (215)-721-6917
APPLICANTS FACSIMILE NUMBER: (215)-721-6915
APPLICANTS CONTACT PERSON:
Harald Kneuer Regulatory Affairs Manager
DATE THE SUMMARY WAS PREPARED: February, 1998
DEVICE NAME:
Trade Name: Common Name: Classification Name: Evita 4 Evita 4 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.
Evita 2 dura- Manufactured by Dräger Medizintechnik GmbH, Lubeck, Germany and sold in the United States by Dräger, Inc.
Servo 300 - Sold in the United States by Siemens
1
DESCRIPTION OF THE DEVICE:
The Evita 4 with the Software version 3.0 is a time cycled, constant volume ventilator The Evita + with the Oct.ware is microprocessor controlled and 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
Dräger
tensive Care Ventilator Data Comparison Sheet
| Specification | Evita 4 (K 961687) | Evita 2 dura (K 970165) | Servo 300 (K902859) | Evita 4 SW 3.0 |
|---|---|---|---|---|
| Manufacturer | Dräger | Dräger | Siemens | Dräger |
| Classification: Intensive Care | ||||
| Ventilator | Yes | Yes | Yes | Yes |
| Operating Principle: Time | ||||
| cycled, volume constant, | ||||
| pressure controlled | Yes | Yes | Yes | Yes |
| Software controlled | Yes | Yes | Yes | Yes |
| Contoll Software: Version 3.0 | No (1.0) | Yes | N.A. | Yes |
| Gas delivery system: Fast | ||||
| "High Pressure Servo Valve", | ||||
| microprocessor controlled | Yes | Yes | Yes | Yes |
| Intended Use | Evita 4 is a time cycled, constant volume, long | |||
| term, intensive care | ||||
| ventilator for adults and | ||||
| children with a body | ||||
| weight of at least 3 kg. | like Evita 4 (K 961687) | N.A. | Evita 4 is a time cycled, | |
| constant volume, long | ||||
| term, intensive care | ||||
| ventilator for adults and | ||||
| children with a body | ||||
| weight of at least 3 kg | ||||
| Specification | Evita 4 (K 961687) | Evita 2 dura (K 970165) | Servo 300 (K902859) | Evita 4 SW 3.0 |
| Modes of Ventilation: | - | - | - | identical with Evita 4 |
| 510(k) no: K 961687 | ||||
| Ventilator Settings | - | - | - | identical with Evita 4 |
| 510(k) no: K 961687 | ||||
| Flow Trigger Sensivity | - | - | - | identical with Evita 4 |
| 510(k) no: K 961687 | ||||
| Parameter setting | - | - | - | identical with Evita 4 |
| 510(k) no: K 961687 | ||||
| Monitors/Indicators | - | - | - | identical with Evita 4 |
| 510(k) no: K 961687 | ||||
| Pressure Limitation | - | - | - | identical with Evita 4 |
| 510(k) no: K 961687 | ||||
| Alarm Functions | - | - | - | identical with Evita 4 |
| 510(k) no: K 961687 | ||||
| Displayed Values | - | - | - | identical with Evita 4 |
| 510(k) no: K 961687 | ||||
| Displayed Curves | - | - | - | identical with Evita 4 |
| 510(k) no: K 961687 | ||||
| Specification | Evita 4 (K 961687) | Evita 2 dura (K 970165) | Servo 300 (K902859) | Dräger |
| Evita 4 SW 3.0 | ||||
| Special Functions | ||||
| Intermittend PEEP | Yes | Yes | - | identical with Evita 2dura |
| Inspiration Hold | No | Yes | - | identical with Evita 2dura |
| Apnea Ventilation | Yes | Yes | - | identical with Evita 2dura |
| Nebulization | Yes | Yes | - | identical with Evita 2dura |
| Nebulization in pediatric mode | No | Yes | - | identical with Evita 2dura |
| Suction Help Mode | Yes | Yes | - | identical with Evita 2dura |
| Switch over function | Yes | Yes | - | identical with Evita 2dura |
| Leak-Compensation | No | Yes | - | identical with Evita 2dura |
| Minute Volume-Leak | No | Yes | - | identical with Evita 4 |
| 510(k) no. K 961687 | ||||
| Physical Caracteristics |
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5
INTENDED USE OF THE DEVICE
Evita 4 (SW 3.0) is a time cycled, constant volume, long term, intensive care ventilator for adults and children with a body weight of at least 3kg.
Intended Environment for the device:
- user facilities …
- inner clinical transport -
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES:
The ventilator functions of the Evita 4 with the enhanced software version are substantially equivalent to the Evita 2 dura, the Evita 4 with the former software and the Servo 300 ventilators.
The Evita 4 with enhanced software integrates the same optional functions that are presently performed by the Evita 4 with the former software.
The device fulfils at least the same standards as the Evita 2 dura.
Therefore the device under review is substantial equivalent to the predicate devices concerning safety, efficiency and the intended use.
Flium
Frank Clanzett Regulatory Affairs Dräger Medizintechnik
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 SEb
Mr. Harald Kneuer Drager Inc. Critical Care Systems 3136 Quarry Road Telford, PA 18969
K980642 Re : Evita 4 Requlatory Class: II (two) Product Code: 73 CBK Dated: June 12, 1998 Received: June 15, 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 Requlations, 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 Requlation (QS) for Medical Devices: General regulation (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 requlation may result in regulatory 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 obligation 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.
7
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 regulation (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 general 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. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
INTENDED USE STATEMENT OF THE EVITA 4, SW 3.0
Fivita 4 is a time cycled, constant volume, long term, intensive care ventilator for adults and children with a body weight of at least 3 kg.
Intended Environment for the device:
- hospital use
- inner clinical transport
Signature
Frank Clanzep (Regulatory Affairs)
- September 1998
Mark Kramis
: Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_K980(e4Z
/ Prescription Use