(76 days)
K 010093, K 980642
K 974176
No
The description details software modifications that enhance existing ventilation modes and introduce new options based on physiological parameters and user settings. There is no mention of AI or ML algorithms being used for decision-making, pattern recognition, or adaptive learning. The functionalities described are based on pre-programmed logic and adjustable criteria.
Yes
The device is a ventilator, which is used to assist or replace breathing for patients, directly impacting their physiological function to treat a medical condition.
No
Explanation: The device is described as a "Long-term ventilator for intensive care" which provides "continuous ventilation". Its functions relate to providing respiratory support rather than diagnosing conditions.
No
The device description clearly states "Evita XL is a time-cycled microprocessor-controlled intensive care ventilator" and describes software modifications to this existing hardware device. It is not a standalone software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Long-term ventilator for intensive care." This describes a device used to support breathing, which is a physiological function, not a diagnostic test performed on samples from the body.
- Device Description: The description details a ventilator that provides continuous ventilation and various ventilation modes. It focuses on delivering air and managing breathing parameters, not on analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The device is clearly a therapeutic device used to support a patient's respiratory function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CBK
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.
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, neonates, premature infants
Intended User / Care Setting
Not Found
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.
K 010093, K 980642
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.
K 974176
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/0 description: The image shows the Dräger medical logo. Above the logo is the text K083050 and P. 1 of 3. The Dräger medical logo is in bold black font. Below the logo is the text A Dräger and Siemens Company.
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 (451) 882-3648 Fax No : + 49 (451) 882-7-3648
Applicants US Contact Person
Joyce Kilrov Vice President, Processes, Quality & Regulatory
Tel. No.: (215) 660-2626 Fax No .: (215) 721-5424
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
1
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.
2
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.
3
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.
4
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
5
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:________________________________________________________________________________________________________________________________________________________________