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
SIMV
MMV
SB
CPAP
ASB/PSV
PCV+
APRV
Apnea Ventilation
ILV

AI/ML Overview

This is a regulatory submission for a medical device (ventilator) and does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) that would typically be found in a clinical study report or a 510(k) submission for a diagnostic AI/ML device.

The provided document, a 510(k) Summary, primarily focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance against specific clinical acceptance criteria through a dedicated study with experts establishing ground truth.

Therefore, many of the requested fields cannot be extracted directly from this document. I will fill in what can be inferred or stated as "Not applicable/Provided" based on the content.

Here's an analysis based on the provided text:

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

The document does not explicitly state acceptance criteria in a quantitative manner as one would expect for a diagnostic device. Instead, it relies on demonstrating "substantial equivalence" to predicate devices. The "performance" is implicitly deemed acceptable if it is equivalent to the legally marketed predicate devices.

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary of Equivalence)
Classification: Intensive Care Ventilator	Yes
Operating Principle: Time cycled, volume constant, pressure controlled	Yes
Software controlled	Yes
Gas delivery system: Fast "High Pressure Servo Valve", microprocessor controlled	Yes
Intended Use: For adults and children with body weight >= 3 kg	Identical to predicate Evita 4 (K 961687)
Modes of Ventilation	Identical to predicate Evita 4 (K 961687)
Ventilator Settings	Identical to predicate Evita 4 (K 961687)
Flow Trigger Sensitivity	Identical to predicate Evita 4 (K 961687)
Parameter setting	Identical to predicate Evita 4 (K 961687)
Monitors/Indicators	Identical to predicate Evita 4 (K 961687)
Pressure Limitation	Identical to predicate Evita 4 (K 961687)
Alarm Functions	Identical to predicate Evita 4 (K 961687)
Displayed Values	Identical to predicate Evita 4 (K 961687)
Displayed Curves	Identical to predicate Evita 4 (K 961687)
Intermittent PEEP	Identical with Evita 2 dura (K 970165)
Inspiration Hold	Identical with Evita 2 dura (K 970165)
Apnea Ventilation	Identical with Evita 2 dura (K 970165)
Nebulization	Identical with Evita 2 dura (K 970165)
Nebulization in pediatric mode	Identical with Evita 2 dura (K 970165)
Suction Help Mode	Identical with Evita 2 dura (K 970165)
Switch over function	Identical with Evita 2 dura (K 970165)
Leak-Compensation	Identical with Evita 2 dura (K 970165)
Minute Volume-Leak	Identical with Evita 4 (K 961687)
Overall Safety and Efficiency	Substantially equivalent to predicate devices

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

Sample Size: Not applicable/Provided. This document does not describe a clinical study with a "test set" in the context of diagnostic performance evaluation. The substantial equivalence claim is based on comparing technical specifications and intended use.
Data Provenance: Not applicable/Provided. No specific "data" in terms of patient results is discussed. The device is manufactured by Dräger Medizintechnik GmbH, Lübeck, Germany, and sold in the United States.

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)

Number of experts: Not applicable/Provided. This document does not pertain to an AI/ML diagnostic device requiring expert-established ground truth.
Qualifications of experts: Not applicable/Provided.

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

Adjudication method: Not applicable/Provided.

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

MRMC study: No. This is a ventilator, not an AI-assisted diagnostic device for human readers.
Effect size: Not applicable.

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

Standalone performance: Not applicable in the context of an AI/ML algorithm. This device is a ventilator, designed to be used by trained medical professionals. Its "performance" refers to its mechanical and software functions meeting specifications, not an algorithm's diagnostic output.

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

Type of ground truth: Not applicable in the traditional sense of diagnostic device evaluation. The "ground truth" for a ventilator's performance would be its adherence to established electrical, mechanical, and software specifications, and its ability to safely and effectively deliver ventilation as intended, as demonstrated through engineering tests and comparison to legally marketed predicate devices.

8. The sample size for the training set

Sample size for training set: Not applicable/Provided. This document does not describe an AI/ML device that undergoes training on a dataset.

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

Ground truth for training set: Not applicable/Provided.

Summary

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Dräger

4 1888 SEP

file: 510kstate.RTF Date: June, 1998 Author: Frank Clanzett

510(k) SUMMARY Summary of Safety and Effectiveness

K980642

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

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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 VentilationControlled 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 VentilationProcedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options:- PLV- AutoFlow
- MMV	Mandatory Minute Volume VentilationSpontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options:- PLV- AutoFlow
- SB	Spontaneous BreathingSpontaneous breathing at ambient pressure
- CPAP	Continuous Positive Airway PressureSpontaneous breathing with positive airway pressure
- ASB/PSV	Assisted Spontaneous Breathing / Pressure Support VentilationPressure supported spontaneous breathing
- PCV+	Pressure Controlled VentilationPressure controlled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure increase to CPAP level
- APRV	Airway Pressure Release VentilationSpontaneous 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 VentilationSeparate, differentiated, synchronized ventilation with one Evita 4 for each lung

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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 CareVentilator	Yes	Yes	Yes	Yes
Operating Principle: Timecycled, 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, longterm, intensive careventilator for adults andchildren with a bodyweight of at least 3 kg.	like Evita 4 (K 961687)	N.A.	Evita 4 is a time cycled,constant volume, longterm, intensive careventilator for adults andchildren with a bodyweight 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 4510(k) no: K 961687
Ventilator Settings	-	-	-	identical with Evita 4510(k) no: K 961687
Flow Trigger Sensivity	-	-	-	identical with Evita 4510(k) no: K 961687
Parameter setting	-	-	-	identical with Evita 4510(k) no: K 961687
Monitors/Indicators	-	-	-	identical with Evita 4510(k) no: K 961687
Pressure Limitation	-	-	-	identical with Evita 4510(k) no: K 961687
Alarm Functions	-	-	-	identical with Evita 4510(k) no: K 961687
Displayed Values	-	-	-	identical with Evita 4510(k) no: K 961687
Displayed Curves	-	-	-	identical with Evita 4510(k) no: K 961687
Specification	Evita 4 (K 961687)	Evita 2 dura (K 970165)	Servo 300 (K902859)	DrägerEvita 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 4510(k) no. K 961687
Physical Caracteristics

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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

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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.

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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

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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

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).