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.

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.

AI/ML Overview

Here's an analysis of the provided information, focusing on acceptance criteria and a study proving device performance, as requested.

Based on the provided 510(k) summary, the device is the Draeger Evita XL continuous ventilator with new software options. This document is a premarket notification for a medical device rather than a detailed study report. Therefore, it does not contain the typical structure of a clinical study with explicitly defined acceptance criteria and performance data in the format you've requested.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This regulatory pathway typically relies on engineering data, performance testing (often bench testing), and risk analysis to show that the new device options are as safe and effective as existing legally marketed devices, rather than a large-scale clinical trial with specific performance metrics like accuracy, sensitivity, or specificity against a ground truth in a clinical setting.

Therefore, many of the specific questions you asked about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance metrics are not addressed or present in this 510(k) summary.

However, I can extract information related to the device's intended performance and the general nature of the validation conducted:

1. A table of acceptance criteria and the reported device performance

As mentioned, the 510(k) summary does not present acceptance criteria and device performance in the typical format of a clinical study (e.g., sensitivity, specificity, AUC). Instead, it states that the improvements are related to "ventilation performance (triggering and patient comfort) through higher leakage compensation and smooth ending of Assistant Spontaneous Breathing (ASB) strokes" and enabling adjustable inspiration termination. The 'acceptance' in this context is based on demonstrating that these software changes function as intended and do not introduce new safety concerns, while maintaining or improving existing performance.

Criterion Type (Inferred)	Stated Performance / Outcome
NIV Plus Option	Improves ventilation performance (triggering and patient comfort) through higher leakage compensation and smooth ending of ASB strokes. Implements Standby Plus (alternative for starting active ventilation in mask ventilation). Detects and reduces flow during disconnection (Anti Air Shower).
Insp. Term. PIF Option	Allows user to adjust inspiration termination criterion (previously fixed level): provides an adjustable stop criterion for pressure support strokes when inspiratory flow falls under a certain level of maximum inspiratory flow.
PPS Option	Assists spontaneous breathing proportionally to breathing effort; degree of support can be set separately according to resistive and elastic components.
Overall (Safety & Effectiveness)	Based on risk analysis and software validation measures, the new software options are "safe and effective and are substantially equivalent to the legally marketed predicate devices."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not explicitly stated in the 510(k) summary. The document refers to "performed software validation measures" and "risk analysis," which would typically involve bench testing and simulations rather than clinical data sets. Therefore, there's no mention of a "test set" in the context of clinical data with human subjects or retrospective/prospective data collection from a specific country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable / Not explicitly stated. Since there is no mention of a clinical test set requiring human expert-established ground truth, this information is not provided. The validation would have involved engineering experts and possibly medical professionals advising on functional requirements and safety.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As no clinical test set requiring expert adjudication is described, this information is absent.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was mentioned or implied. The Evita XL is a ventilator, not an AI-assisted diagnostic imaging device with "human readers." The software options enhance the ventilator's function directly.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is the algorithm/software operating the ventilator. The performance evaluation would be of the ventilator's output and responsiveness as controlled by the new software features. This isn't a "standalone AI" in the sense of a decision support system, but rather the core functionality of the device. The phrase "standalone" might not apply as neatly here, as the software is fundamental to the device's (ventilator's) operation. The validation would have assessed the ventilator's performance with the new software features, ensuring they meet specifications (e.g., accurate flow delivery, appropriate termination).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For software-driven medical devices like ventilators, the "ground truth" for validation is typically defined by engineering specifications, physiological models, and recognized standards for ventilator performance (e.g., accuracy of delivered pressure/volume/flow, response time to patient effort, leakage compensation effectiveness). It's based on objective measurements against these predefined targets, often conducted in a lab or simulation environment. There would likely be no "pathology" or "outcomes data" ground truth in the clinical trial sense for this type of submission.

8. The sample size for the training set

Not applicable / Not explicitly stated. This device is not described as involving machine learning or AI that requires a "training set" of data in the common sense (e.g., for image classification). The software development would follow traditional software engineering principles, with design, implementation, and verification/validation processes.

9. How the ground truth for the training set was established

Not applicable. See point 8.

In summary: The provided 510(k) summary for the Draeger Evita XL ventilator focuses on establishing substantial equivalence for new software features. It indicates that "software validation measures" and "risk analysis" were performed, leading to the conclusion that the new options are safe, effective, and substantially equivalent to predicate devices. However, it does not present detailed clinical study data with specific acceptance criteria, sample sizes, expert involvement, or statistical analyses typical of AI/ML device submissions that rely on extensive clinical datasets.

Summary

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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

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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:

. 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:

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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.

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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.

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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

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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)

Over-The-Counter Use_ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Zase M. Tin

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).