The intensive care ventilator Savina 300 is intended for the ventilation of adults, adolescents, children, and infants starting from 5 kg (11 lbs) body weight. Savina 300 offers mandatory ventilation modes, ventilation modes supporting spontaneous breathing, and airway monitoring. Savina 300 is intended for the following environments of use: - In intensive care wards, in recovery rooms and generally for hospital use - During the transfer of ventilated patients within the hospital

Device Description

Savina 300 is a turbine driven ventilator with a 12.1" color touch screen, providing tube and mask based ventilation capabilities. Air is taken from ambient. O2 can be taken from central gas supply, bottle supply (with appropriated accessories) or from another low pressure oxygen source (LPO). Savina 300 is intended for the ventilation of adults, adolescents, children, and infants starting from 5 kg (11 lbs) body weight in intensive care units, in recovery rooms and generally for hospital use. Savina 300 can also be used during transport of ventilated patients within the hospital. The ventilation unit of the Savina 300 is a microprocessor-controlled ventilator. The Savina 300 provides positive pressure ventilation and adjustable oxygen concentration with pressure- and volume-controlled automatic and spontaneous breathing modes.

AI/ML Overview

Based on the provided text, the device is the Savina 300 intensive care ventilator. The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a rigorous clinical trial proving the device meets those criteria, as one might expect for a new AI/software-as-a-medical-device (SaMD) product.

Therefore, many of the requested elements for a study proving acceptance criteria (like specific metrics, sample sizes for training/test sets, expert adjudication details, MRMC studies, and detailed ground truth establishment for AI performance) are not present in this type of submission. This document describes a traditional medical device (a ventilator) and its modifications, with performance demonstrated through non-clinical testing in conformance with recognized standards.

Here's what can be extracted and what cannot:

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

The document does not explicitly present a table of "acceptance criteria" in the sense of predefined performance thresholds for a clinical study, nor does it report specific performance metrics for the device in a clinical context. Instead, it refers to:

Conformance to FDA recognized standards: This implies that the device's performance meets the requirements outlined in these standards for safety and essential performance.
Non-clinical testing: "Performance data related to each proposed modification has been tested and evaluated." This suggests bench testing and verification activities.
Substantial equivalence: The ultimate "performance" goal stated is that the modifications demonstrate the device is substantially equivalent to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Device meets requirements of recognized consensus standards.	"Verification and validation testing was conducted in conformance to the FDA recognized standards." (List of standards provided on page 8).
New functionalities (ATC, Patient Admission, Leakage Compensation) perform as intended.	"Performance data related to each proposed modification has been tested and evaluated." (No specific numerical performance data is provided in this summary, but it implies successful non-clinical testing results support functionality).
Device is substantially equivalent to the predicate device.	"High level summary reports included in this 510(k) demonstrate that the changes to Savina 300 are substantially equivalent to the predicate device."
Biocompatibility of breathing gas pathways.	"Biocompatibility evaluation for Savina 300 was conducted in accordance with the International Standard ISO 18562..." (implies successful evaluation).
Electromagnetic compatibility.	"The modified Savina 300 has been tested... and has completed a bench-testing which demonstrates electromagnetic immunity test for exposure to radio frequency identification readers." (implies successful testing).

2. Sample size used for the test set and the data provenance:

Sample size: Not applicable/not reported. This was demonstrated through engineering and bench testing, not a clinical study with a patient "test set."
Data provenance: Not applicable. The "data" comes from engineering tests and measurements, not patient data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth as typically understood for AI/diagnostic devices (e.g., expert image review) is not relevant to the type of testing described for this ventilator. Device performance is evaluated against engineering specifications and standard requirements.

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

Not applicable. There was no "test set" in the context of clinical data requiring adjudication.

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. This is not an AI/diagnostic imaging device, and therefore, an MRMC study is not relevant and was not conducted or reported.

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

Not applicable. This device is a ventilator, a mechanical and electronic medical device, not a standalone algorithm.

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

The "ground truth" for this device's performance would be the engineering specifications and requirements of the applicable medical device standards (e.g., ISO 80601-2-12 for critical care ventilators), confirmed through bench testing and validation activities. There is no clinical "ground truth" derived from patient data in this submission summary.

8. The sample size for the training set:

Not applicable. This is a traditional medical device, not a machine learning model, so there is no training set in that context.

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

Not applicable, as there is no training set.

In summary, this 510(k) submission for the Savina 300 ventilator focuses on demonstrating substantial equivalence through non-clinical testing and adherence to recognized standards for device functionality and safety, rather than a clinical study evaluating diagnostic or interpretive performance.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".

January 17, 2019

Dragerwerk AG & CO. KGaA Dr. Bettina Mobius Director Regulatory Affairs Moislinger Allee 53-55 Lubeck, 23558 De

Re: K180779

Trade/Device Name: Savina 300 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: CBK Dated: December 11, 2018 Received: December 17, 2018

Dear Dr. Bettina Mobius:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

James J. Lee -S

Tina Kiang, Ph.D. for Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K180779

Device Name Savina 300

Indications for Use (Describe)

The intensive care ventilator Savina 300 is intended for the ventilation of adults, adolescents, children, and infants starting from 5 kg (11 lbs) body weight.

Savina 300 offers mandatory ventilation modes, ventilation modes supporting spontaneous breathing, and airway monitoring.

Savina 300 is intended for the following environments of use:

In intensive care wards, in recovery rooms and generally for hospital use
During the transfer of ventilated patients within the hospital

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the word "Dräger" in blue font. The font is bold and sans-serif. The two dots above the "a" are also blue. The background is white.

Summary (21 CFFR 807.92)

Applicants / Manufacturer Name and Address:

Drägerwerk AG & KGaA Moislinger Allee 53-55 23558 Lübeck, Germany

Establishment Registration Number: 9611500

Contact Person:

Dr. Bettina Möbius Director Regulatory Affairs

Tel. No.: +49 451 882 4100 Fax No.: +49 451 882 3018 Bettina.moebius@draeger.com

Applicant's US Contact Person

Gale Winarsky Senior Manager Regulatory Affairs

Tel. No.: 215-6602239 Fax No.: 978 3798 335 gale.winarsky@draeger.com

510(k) Number: K180779

Date submission was prepared:

December, 12 2018

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the word "Dräger" in blue font. The font is bold and sans-serif. The two dots above the "a" are also blue. The background is white.

Device Name:

Trade name:	Savina 300 – Classic, Select
Common name:	Intensive Care Ventilator
Classification name:	continuous ventilator, facility use
Regulation Number:	868.5895
Product code:	CBK
Class:	II

Identification of legally Marketed Devices to which Substantial Equivalence is claimed:

510(k) Number	Trade name
K121886	Savina 300	Predicate device
K093633	Infinity Acute Care SystemWork Station Critical Careand Neonatal Care (IACSWS CC)	Predicate device

Device description:

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for Dräger, a German company that manufactures medical and safety technology products. The logo is written in a bold, sans-serif font and is blue in color. The two dots above the 'a' in Dräger are also blue. The logo is simple and modern, and it is easily recognizable.

The ventilation unit of the Savina 300 is a microprocessor-controlled ventilator. The Savina 300 provides positive pressure ventilation and adjustable oxygen concentration with pressure- and volume-controlled automatic and spontaneous breathing modes. Savina 300 provides the following ventilation modes:

Volume-controlled ventilation:

VC-CMV (Volume Control-Continuous Mandatory Ventilation) ●
VC-AC (Volume Control-Assist Control)
VC-SIMV (Volume Control-Synchronized Intermittent Mandatory Ventilation)
VC-MMV (Volume Control-Mandatory Minute Volume Ventilation) ●

Pressure-controlled ventilation:

. PC-SIMV+ (Pressure Control - Synchronized Intermittent Mandatory Ventilation plus)
. PC-APRV (Pressure Control - Airway Pressure Release Ventilation)
PC-AC (Pressure Control - Assist Control)

Support of spontaneous breathing:

SPN-CPAP (Spontaneous-Continuous Positive Airway Pressure) ●
Additionally the ventilation unit features additional settings to complement the ventilation modes. Additional settings:
. Apnea ventilation
. Trigger settings
. Sigh
AutoFlow
. Tube compensation

If breathing of a spontaneously breathing patient stops, apnea ventilation switches over automatically to volume-controlled mandatory ventilation.

With AutoFlow, the inspiration flow is decelerated and thus pressure peaks can be avoided.

The graphical user interface supports simultaneous display of patient waveforms, parameter data, alarm display and annunciation. The Savina 300 produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the word "Dräger" in blue font. The "a" in Dräger has an umlaut, which is two dots above the letter. The font is bold and sans-serif. The background is white.

The Savina 300 can interface with specific Dräger Medical therapeutic and diagnostic equipment, as well as third party devices via a MEDIBUS.X data connection. The following monitors can be connected:

Infinity monitors Delta, Delta XL
. Infinity monitors Kappa, Kappa XLT

Savina 300 provides CO2 measurement as waveform and end tidal CO2 measurement.

Indications for Use:

Savina 300 is intended for the following environments of use:

In intensive care wards, in recovery rooms and generally for hospital use
During the transfer of ventilated patients within the hospital

Summary of Modifications:

The major changes to Savina 300 comprise new functionalities that offer additional options for therapy. These are new patient admission and automatic tube compensation which can be chosen as an option as well as leakage compensation in tube mode.

Automatic Tube Compensation (ATC)

ATC adjusts on-line the pressure to compensate the pressure drop over the tube caused by the current inhaled gas flow of the patient. Thus, under- and overcompensation is avoided. ATC allows for reduced work of breathing based on non-clinical testing.

{7}------------------------------------------------

Savina 300 K180779

Image /page/7/Picture/1 description: The image shows the logo for Dräger, a German company that manufactures medical and safety technology products. The logo is written in a bold, sans-serif font and is colored in blue. The two dots above the 'a' are also blue. The logo is simple and modern, and it is easily recognizable.

Traditional 510(k)

Summary (21 CFFR 807.92)

Patient Admission

The new patient admission of Savina 300 offers two alternative ways to use pre-defined settings for ventilation parameters and alarms. Users admit patients either based on a set patient category (adult, pediatric) or based on the patient height and the resulting ideal body weight..

Leakage compensation in tube mode

In tube mode a leakage flow may impact the ventilation of intubated patients. The ventilator may auto-trigger or the inspiration termination may not be reached due to leakage flow. Leak flow occurs in pediatric ventilation when uncuffed tubes are used. In adult ventilation the cuffed tubes may not be completely tight due to movements or not properly matched cuff pressure and can also lead to undesired leakage flow. To prevent the impact of leak flow for intubated patients the leakage compensation has been enabled for tube application.

The fundamental scientific technology remain unchanged with the modifications to Savina 300. They provide additional functionalities supporting the therapy concepts offered to the patient already in use. The intended use was adjusted to the patient subclasses for pediatric patients.

Summary of non-clinical data:

Verification and validation testing was conducted in conformance to the FDA recognized standards. Performance data related to each proposed modification has been tested and evaluated. High level summary reports included in this 510(k) demonstrate that the changes to Savina 300 are substantially equivalent to the predicate device.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue. The "a" in "Dräger" has an umlaut, which is two dots above the letter.

Summary (21 CFFR 807.92)

AAMI ANSI ES60601-1:2014	Medical electrical equipment - Part 1:General requirements for basic safetyand essential performance
ANSI AAMI IEC 60601-1-2: 2014	Medical electrical equipment - Part 1-2:General requirements for basic safetyand essential performance - Collateralstandard: Electromagnetic compatibility- Requirements and tests
IEC 60601-1-6: 2013	Medical electrical equipment - Part 1-6:General requirements for basic safetyand essential performance - CollateralStandard: Usability
ANSI AAMI IEC 60601-1-8: 2012	Medical electrical equipment - Part 1-8:General requirements for basic safetyand essential performance - Collateralstandard: General requirements, testsand guidance for alarm systems inmedical electrical equipment andmedical electrical systems
ISO 80601-2-12:2011+ COR.1:2011	Medical electrical equipment - Part 2-12:Particular requirements for basic safetyand essential performance of criticalcare ventilators
ISO 80601-2-55:2011 COR:2012	Medical electrical equipment - Part 2-55:Particular requirements for the basicsafety and essential performance ofrespiratory gas monitors
ANSI AAMI ISO 14971: 2007	Medical devices - Application of riskmanagement to medical devices
ANSI AAMI IEC 62304: 2006 AMD1:2015	Medical Device Software - Software LifeCycle Processes
ANSI AAMI ISO 5356-1.2004-05-15	Anaesthetic and respiratory equipment -Conical connectors: Part 1: Cones andsockets
ISO 18562-1, -2, -3	Biocompatibility evaluation of breathinggas pathways in healthcare applications
AIM Standard 7351731 Rev. 2.002017-02-23	Medical Electrical Equipment andSystem Electromagnetic Immunity Testfor Exposure to Radio FrequencyIdentification Readers - An AIMStandard

List of applied standards

December, 12 2018

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue and the background is white. The two dots above the "a" are also blue.

Summary (21 CFFR 807.92)

The modified Savina 300 has been tested in accordance with applicable standards and has completed a bench-testing which demonstrates electromagnetic immunity test for exposure to radio frequency identification readers. The Savina 300 was determined to be substantially equivalent to the predicate device for its intended use.

Biocompatibility

The biocompatibility evaluation for Savina 300 was conducted in accordance with the International Standard ISO 18562 'Biocompatibility evaluation of breathing gas pathways in healthcare applications" part 1 "Evaluation and Testing within a Risk Management Process", part 2 "Test for Emissions of Particulate Matter", part 3 "Tests for Emissions of Volatile Organic Compounds" as recognized by FDA.

Shelf Life

Not applicable. No components have been added that require shelf life data.

Sterilization

Not applicable to Savina 300.

December, 12 2018

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the logo for Dräger, a German company that manufactures medical and safety technology products. The logo is written in a bold, sans-serif font and is blue in color. The two dots above the 'a' in Dräger are also blue. The logo is simple and modern, and it is easily recognizable.

Summary (21 CFFR 807.92)

Conclusion

The fundamental scientific technology of Savina 300 has not been changed. The intended use was changed to clearly state the subgroups adults, adolescents, children, and infants. The comparison with predicate devices and non-clinical testing of the described modifications to Savina 300 demonstrate the Savina 300 is substantially equivalent to the predicate device as the previous cleared in K121886.

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).