(20 days)
Not Found
Not Found
No
The description mentions a "mathematical model" for calculating tracheal pressure, which is a deterministic algorithm, not AI/ML. There are no mentions of AI, ML, or related concepts.
Yes.
The device is described as an "intensive care ventilator," which is a device used to provide life support and respiratory assistance, thus serving a therapeutic function.
No
The device is described as an intensive care ventilator designed to assist with breathing, not to diagnose a condition.
No
The device description explicitly states it is a "time cycled microprocessor-controlled intensive care ventilator," which is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Evita 2 dura and Evita 4 are "time cycled, constant volume, long term, intensive care ventilators." This describes a device used to support breathing in patients, which is a therapeutic function, not a diagnostic one.
- Device Description: The description details the device's function as a ventilator, including features like automatic tube compensation. This further reinforces its role in providing respiratory support.
- Lack of Diagnostic Activities: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status based on such analysis. IVDs are specifically designed for these types of diagnostic tests.
In summary, the Evita 2 dura and Evita 4 are medical devices used for treatment (ventilation), not for diagnosis.
N/A
Intended Use / Indications for Use
The Evita 2 dura and the Evita 4 are time cycled, constant volume, long term, intensive care ventilators for adults and children with a body weight of at least 3 kg.
Intended environment for use of the device
- user facilities ..
- inner clinical transport -
Product codes (comma separated list FDA assigned to the subject device)
73 CBK
Device Description
The Evita 4 or the Evita 2 dura are time cycled microprocessor-controlled intensive care ventilators. Both devices can be equipped with the ATC option. ATC means automatic tube compensation.
This ventilation mode extension provides a compensation of an endotracheal or tracheostomy tube. It calculates and displays the tracheal pressure from a mathematical model on the basis of selected type of tube and tube internal diameter.
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 with a body weight of at least 3 kg.
Intended User / Care Setting
user facilities
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.
Evita 2 dura, Evita 4
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
Image /page/0/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. Above the word "Dräger" is the number "K992608" in a handwritten style. The word "Dräger" is a brand name. The image is in black and white.
AUG 24 1999
file: 510kstate.RTF Date: July 1999 Author: Frank Clanzett
510(k) SUMMARY Summary of Safety and Effectiveness
APPLICANTS NAME AND ADDRESS:
Dräger Medizintechnik GmbH Moislinger Allee 53-55 23542 Lübeck Germany
APPLICANTS CONTACT PERSON:
Mr. Frank Clanzett phone: 011-49-451-882-3915 011-49-451-882-4351 fax: email: frank.clanzett@draeger.com
APPLICANTS CONTACT PERSON IN THE USA
Drager; Inc. Mr. Harald Kneuer phone: 215-721-6917 215-721-6915 fax:
DATE THE SUMMARY WAS PREPARED:
July 1999
DEVICE NAME:
Trade Name: ATC option for Evita 2 dura and Evita 4 Continuous Ventilator Common Name: Classification Name: Ventilator, Continuous (per 21 CFR 868.5895)
LEGALLY MARKETED DEVICE TO WHICH DRÄGER IS CLAIMING SUBSTANTIAL EQUIVALENCE:
- Manufactured by Dräger Medizintechink, Germany Evita 2 dura - Manufactured by Dräger Medizintechinik, Germany Evita 4
DESCRIPTION OF THE DEVICE:
The Evita 4 or the Evita 2 dura are time cycled microprocessor-controlled intensive care ventilators. Both devices can be equipped with the ATC option. ATC means automatic tube compensation.
1
Image /page/1/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The "a" in "Dräger" has an umlaut, which is a diacritical mark consisting of two dots above the letter. The text is black and the background is white.
This ventilation mode extension provides a compensation of an endotracheal or tracheostomy tube. It calculates and displays the tracheal pressure from a mathematical model on the basis of selected type of tube and tube internal diameter.
INTENDED USE
The Evita 2 dura and the Evita 4 are time cycled , constant volume, long term, intensive care ventilators for adults and children with a body weight of at least 3 kg.
Intended environment for use of the device
- user facilities ..
- inner clinical transport -
INFORMATION WERE THE SUBSTANTIALLY EQUIVALENT DECISION IS BASED ON
The devices under review have the same intended use as the predicate devices. The patient range and the intended environment for use of the devices are also identical.
The ATC-option was compared with ventilation modes already existed in the predicate devices and deemed to be substantially equivalent.
The general technology, performance specifications, materials used, dimension operating parameters and other characteristics of the devices under review were compared and are substantially equivalent with those of the predicate devices.
Therefore the devices under review are substantially equivalent to the predicate devices concerning safety, efficiency and intended use.
Jummary
Requiatory Affairs Dräger Medizintechnik GmbH
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they also resemble a bird in flight. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 24 1999
Mr. Harald Kneuer Drager Inc. 3136 Quarry Road Telford, PA 18969
Re: K992608 ATC Option for Evita 2 dura and Evita 4 Regulatory Class: II (two) Product Code: 73 CBK August 2, 1999 Dated: Received: August 4, 1999
Dear Mr. Kneuer:
ー!
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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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 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.
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 leqally 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 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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
K992608 510(k) Number (if known): unk
ATC option for Evita 4 and Device Name: Evita 2 dura
Indication for Use:
The Evita 2 dura and the Evita 4 are time cycled , constant volume, long term, intensive care ventilators for adults and children with a body weight of at least 3 kg.
Intended environment for use of the device
- user facilities -
- inner clinical transport -
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
Joanna A Westershausn
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number _
(Optional Format 3-10-98)
$\downarrow$ PRESCRIPTION USE