The Babylog intensive care Ventilator (Babylog VN600) is intended for the ventilation of neonates with a body weight of 0.4 kg (0.88 lb) to 10 kg (22 lb) and for pediatric patients with an IBW of 5.2 kg (11.5 lb) to 20.1 kg (44.3 lb).

This device provides mandatory pressure-controlled ventilation modes for supporting spontaneous breathing, and ventilation monitoring.

Device Description

The intensive care ventilators Babylog VN800 and Babylog VN600 were developed and are manufactured by Dräger in Lübeck, Germany.

Babylog VN800 and Babylog VN600 are specified for the ventilation of pediatric patients and neonates. These devices provide mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring.

Babylog VN800 and Babylog VN600 are available in different device variants and can additionally be upgraded by software and hardware options as well as attachable accessories.

Babylog VN800 and Babylog VN600 are available with a basic device configuration that comprises the following:

Trolley with four castors and brakes
Display unit (graphical user interface)
Ventilation unit

The changes have been made in the device design including functional integration of the Infinity series C cockpit into the device by changing "PC based Cockpit technology" to an "Embedded Control Display (ECD) technology" including a visually updated (color) in the graphical user interface. The hardware complexity has been reduced. In addition, a Gas supply Unit has been added as well as the Power supply Unit as an option. The device software and firmware have been redesigned. The functionality and features of Babylog VN800 / VN600 are identical to the predicate device.

AI/ML Overview

It appears the provided text describes a 510(k) premarket notification for a medical device, the Babylog VN800/VN600 ventilator. However, the document focuses on demonstrating substantial equivalence to a predicate device based on technical specifications, intended use, and adherence to consensus standards. It does not present a clinical study to prove the device meets acceptance criteria related to its performance in a clinical setting with human subjects or a clinical outcome.

Specifically, the document lists "Non-clinical Testing" including:

Sterilization
Biocompatibility
Software, including cybersecurity
Electrical safety
Electromagnetic compatibility (EMC)
Alarm Systems in medical electrical equipment
Respiratory gas monitors
Waveforms, including comparisons to the predicate device and performance
Technical System Requirements
Accessories compatibility
Human factors engineering, usability

The "Conclusion" states that "The conclusions drawn from non-clinical tests and the comparison of intended use and technological characteristics with its predicate demonstrate that the new product Babylog VN800 / Babylog VN600 is substantially equivalent to the predicate device... and does not raise new questions of safety or effectiveness."

Therefore, based solely on the provided text, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: The document does not describe specific performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical application. The "performance" mentioned refers to technical performance related to waveforms, not clinical outcomes.
Sample size used for the test set and data provenance: There is no mention of a human test set. The testing described is non-clinical.
Number of experts used to establish the ground truth: Not applicable as there is no clinical test set requiring ground truth established by experts.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable, as this is a physical ventilator device, not an AI algorithm for diagnosis/detection.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable, as this is not an AI/ML-based device requiring a training set in the typical sense.
How ground truth for the training set was established: Not applicable.

The document demonstrates that the device functionally meets standards and is similar to a previously cleared device, but it does not detail a study proving clinical performance against specific acceptance criteria in the way you've outlined for an AI-powered diagnostic or similar product.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

May 16, 2023

Draegerwerk AG & CO KGaA Nataliia Semenova Regulatory Affairs Manager 53/55 Moislinger Allee Luebeck, Schlewsig-Holstein 23542 Germany

Re: K222207

Trade/Device Name: Babylog VN800, Babylog VN600 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: April 17, 2023 Received: April 17, 2023

Dear Nataliia Semenova:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ting Song -S

For James J. Lee, Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K22207

Device Name Babylog VN800 / Babylog VN600

Indications for Use (Describe)

The Babylog intensive care Ventilator (Babylog VN600) is intended for the ventilation of neonates with a body weight of0.4 kg (0.88 lb) to 10 kg (22 lb) and for pediatric patients with an IBW of 5.2 kg (11.5 lb) to 20.1 kg (44.3 lb).

This device provides mandatory pressure-controlled ventilation modes for supporting spontaneous breathing, and ventilation monitoring.

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

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Premarket Notification Summary

Submitter:	Drägerwerk AG & Co. KGaAMoislinger Allee 53-5523542 Lübeck, GermanyEstablishment's registration number: 9611500
Official Correspondent:	Dr. Bettina MoebiusHead of Regulatory Affairs CentralE-Mail: bettina.moebius@draeger.comTelephone: +49 451 882 4100
US Agent:	Darlene ThibodeauHead of Quality Assurance and ComplianceE-mail: darlene.thibodeau@draeger.comTelephone: (978) 773-1060
Date prepared:	16 May 2023
Device Name:	Common name: VentilatorTrade Name: Babylog VN800, Babylog VN600Classification Name: Ventilator, Continuous, Facility UseRegulation Number: 21 CFR §868.5895Product Code: CBKClass: II

Predicate Device: Infinity Acute Care System Workstation Neonatal Care, K093632

Drägerwerk AG & Co. KGaA is submitting a traditional 510(k) premarket notification for a new device, Babylog VN800 / Babylog VN600.

Device Description

The intensive care ventilators Babylog VN800 and Babylog VN600 were developed and are manufactured by Dräger in Lübeck, Germany.

Babylog VN800 and Babylog VN600 are available in different device variants and can additionally be upgraded by software and hardware options as well as attachable accessories.

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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 word is the logo for the Dräger company, which is a German company that makes medical and safety technology.

Babylog VN800 and Babylog VN600 are available with a basic device configuration that comprises the following:

Trolley with four castors and brakes
Display unit (graphical user interface)
Ventilation unit

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Intended Use / Indications for Use

The Babylog intensive care ventilator (Babylog VN800 / Babylog VN600) is intended for the ventilation of neonates with a body weight of 0.4 kg (0.88 lb) to 10 kg (22 lb) and for pediatric patients with an IBW of 5.2 kg (11.5 lb) to 20.1 kg (44.3 lb).

This device provides mandatory pressure-controlled ventilation modes, ventilation modes for supporting spontaneous breathing, and ventilation monitoring.

List of Consensus Standards

Standard Number and Version	Title
ANSI AAMI ES60601-1:2005/(R)2012and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012	Medical electrical equipment - Part 1:General requirements for basic safety andessential performance
IEC 60601-1-2 Edition 4.1 2020-09CONSOLIDATED VERSION	Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - CollateralStandard: Electromagnetic disturbances -Requirements and tests
IEC 60601-1-6 Edition 3.1 2013-10	Medical electrical equipment - Part 1-6:General requirements for basic safety andessential performance - Collateralstandard: Usability
IEC 60601-1-8 Edition 2.1 2012-11	Medical electrical equipment - Part 1-8:General requirements for basic safety andessential performance - CollateralStandard: General requirements, testsand guidance for alarm systems inmedical electrical equipment and medicalelectrical systems
ISO 80601-2-12 First edition 2011-04-15	Medical electrical equipment - Part 2-12:Particular requirements for the safety oflung ventilators - Critical care ventilators[Including: Technical Corrigendum 1(2011)]
ISO 80601-2-55 Second edition 2018-02	Medical electrical equipment - Part 2-55:Particular requirements for the basicsafety and essential performance ofrespiratory gas monitors
ISO 14971 Third Edition 2019-12	Medical devices - Application of riskmanagement to medical devices
IEC 62304 Edition 1.1 2015-06CONSOLIDATED VERSION	Medical device software - Software lifecycle processes
IEC 62366-1 Edition 1.0 2015-02	Medical devices - Part 1: Application ofusability engineering to medical devices
ISO 10993-1 Fifth edition 2018-08	Biological evaluation of medical devices -Part 1: Evaluation and testing within a riskmanagement process
ISO 18562-1 First edition 2017-03	Biocompatibility evaluation of breathinggas pathways in healthcare applications -Part 1: Evaluation and testing within a riskmanagement process
IEC 62133-2 Edition1.0 2017-02	Secondary cells and batteries containingalkaline or other non-acid electrolytes -Safety requirements for portable sealedsecondary cells, and for batteries madefrom them, for use in portable applications- Part 2: Lithium systems
IEC 62133-1 Edition1.0 2017-02	Secondary cells and batteries containingalkaline or other non-acid electrolytes -Safety requirements for portable sealedsecondary cells, and for batteries madefrom them, for use in portable applications- Part 1: Nickel systems
/TR 60601-4-2 Edition 1.0 2016-05	Medical electrical equipment - Part 4-2:Guidance and interpretation -Electromagnetic immunity: performanceof medical electrical equipment andmedical electrical systems

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510(k) Summary

Comparison to Predicate

Topic	Proposed deviceBABYLOG VN800, BABYLOG VN600	Predicate deviceInfinity Acute Care System WorkstationNeonatal Care	Comments
Device Trade Name	Babylog VN800Babylog VN600	Infinity Acute Care System Workstation NeonatalCare	–
Manufacturer	Drägerwerk AG & Co. KGaA	Drägerwerk AG & Co. KGaA	Same
510(k) number	K222207	K093632	–
Regulation number -Classification description	868.5895 - Continuous Ventilator	868.5895 - Continuous Ventilator	Same
Regulatory class	Class II	Class II	Same
Product code	CBK	CBK	Same
Patient population	• Pediatric• Neonate	• Pediatric• Neonate	Same
Topic	Proposed deviceBABYLOG VN800, BABYLOG VN600	Predicate deviceInfinity Acute Care System WorkstationNeonatal Care	Comments
Intended Use /Indications for Use	The Babylog intensive care ventilator (BabylogVN800 / Babylog VN600) is intended for theventilation of neonates with a body weight of 0.4 kg(0.88 lb) to 10 kg (22 lb) and for pediatric patientswith an IBW of 5.2 kg (11.5 lb) to 20.1 kg (44.3 lb).This device provides mandatory pressure-controlledventilation modes, ventilation modes for supportingspontaneous breathing, and ventilation monitoring.	The Infinity Acute Care System WorkstationsNeonatal Care consists of monitoring and controldisplays and additional therapy. They are intendedto be used as integrated, networked, andconfigurable Workstations to provide specifictherapy in neonatal intensive care. The InfinityAcute Care System Workstations Neonatal Careare intended to be used by qualified and trainedmedical personnel.The Infinity CSeries Medical Cockpits, consisting ofthe C500 and and the C700, are monitoring andcontrol displays for the Infinity Acute Care System(IACS). Medical Cockpits are intended to be used tomonitor waveforms, parameter information, andalarms as well as to control settings. The InfinityCSeries Medical Cockpits are intended to be usedin environments where patient care is provided bytrained healthcare Professionals.The Babylog VN500 Ventilation unit of theInfinity Care System is intended for theventilation of neonatal patients from 0.4 kg (0.88lbs) up to 10 kg (22 lbs) and pediatric patientsfrom 5 kg (11 lbs) up to 20 kg (44 lbs)bodyweight. Babylog VN500 offers mandatoryventilation modes for spontaneous breathingsupport and airway monitoring. The BabylogVN500 ventilation unit is intended for use indifferent medical care areas.Babylog VN500 is intended for stationary use inhospitals and medical rooms or for patienttransportation within the hospital.	Similar
Topic	Proposed deviceBABYLOG VN800, BABYLOG VN600	Predicate deviceInfinity Acute Care System WorkstationNeonatal Care	Comments
Intended user	The operating organization must ensure the following:Every user group has the required qualifications (e.g., has undergone specialist training or acquired specialist knowledge through experience). Every user group has been trained to perform the task. Clinical usersThis user group operates the product in accordance with the intended use.Users have medical specialist knowledge in the field of ventilation. Users have knowledge of device monitoring and ventilation care.	The Infinity Acute Care System Workstations Neonatal Care are intended to be used by qualified and trained medical personnel.The Infinity CSeries Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare Professionals.	Similar
Environment of use	The device is intended for stationary use in hospitals and medical rooms or for intrahospital patient transport.Do not use the device in the following environments of use:- Hyperbaric chambers- Magnetic resonance imaging- Together with flammable gases or flammable solutions that can mix with air, oxygen, or nitrous oxide- Areas with danger of explosion- Areas with combustible and highly flammable substances- Rooms with insufficient ventilationDo not operate the device with helium or helium mixtures.	Babylog VN500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.Do not use the device in the following environments:- In hyperbaric chambers- For magnetic resonance imaging (MRI, NMR, NMI)- In conjunction with flammable gases or flammable solutions that can mix with air, oxygen or nitrous oxide- In areas of explosion hazard- In areas with combustible or explosive substances- In rooms without sufficient ventilationDo not operate the device with helium or helium mixtures.	Similar
Topic	Proposed deviceBABYLOG VN800, BABYLOG VN600	Predicate deviceInfinity Acute Care System WorkstationNeonatal Care	Comments
Gas supply	Central gas supply	Central gas supply	Same
	Gas cylinders• Transport supply unit (optional)• Gas cylinder holder (optional)	Gas cylinders• Transport supply unit (optional)• Gas cylinder holder (optional)	Same
	Gas supply unit GS500 (optional)	-	Different
Gas dosage, mixing anddelivery	Dosage of Air/O2 in mixing chamber	Dosage of Air/O2 in mixing chamber	Same
	Inspiratory valve	Inspiratory valve	Same
	Expiratory valve	Expiratory valve	Same
	Pneumatic nebulizer (optional, part of "Nebulizer"option)	Pneumatic nebulizer (optional, part of "Medicationnebulization" option)	Same
Pressure and volumemonitoring	Inspiratory and expiratory pressure	Inspiratory and expiratory pressure	Same
	Inspiratory flow/volume	Inspiratory flow/volume	Same
	Proximal flow/volume	Proximal flow/volume	Same
	2 ambient pressure sensors	1 ambient pressure sensor and user setting altitude	Similar
Oxygen monitoring	Paramagnetic side-stream sensor	Paramagnetic side-stream sensor	Same
	Flow balancing of Air and O2	Flow balancing of Air and O2	Same
Carbon dioxide monitoring	Main-stream sensor usinginfrared absorptionspectroscopy (optional, part of “CO2 monitoring”option)• part no.6871950 MCable - Mainstream CO2• part no. 6873570 CO2 mainstream sensor	Main-stream sensor usinginfrared absorptionspectroscopy (optional, part of “CO2 monitoring”option)• part no.6871950 MCable -Mainstream CO2	Differentoptional component6873570 (K221118)was introduced.
Batteries	Internal battery (NiMH)	Internal battery (NiMH)	Same
Topic	Proposed deviceBABYLOG VN800, BABYLOG VN600	Predicate deviceInfinity Acute Care System WorkstationNeonatal Care	Comments
	Power supply unit PS500 (optional)part no. 8418950 lead-acid part no. 8422900 lithium iron phosphate (LFP)	-	Different
User interface	TFT LCD capacitive touchscreen display Babylog VN800: 18.5 in Babylog VN600: 15.6 in	TFT LCD resistive touchscreen display IACS Medical cockpit C500: 17 in	Similar
	Rotary knob for selecting, adjusting and confirming	Rotary knob for selecting, adjusting and confirming	Same
	Power supply indicators	Power supply indicators	Same
	On/off key	On/off key	Same
	Operation display	Operation display	Same
	Bed coupling (optional)	-	Different
User interface, screendisplays	Waveforms Graphical trends Tabular trends Loops Alarm logbook Logbook Numeric parameters Lists of measured values and set values User-specific list for measured values and set values Smart Pulmonary View (optional)	Curves Graphical trends Numeric trends Loops Alarm history Logbook Numeric parameters Preconfigured lists of measured values and set values Customized lists for measured values and set values Smart Pulmonary View (optional)	Same
General monitoring, alarmprinciples	Optical and acoustical alarm indication	Optical and acoustical alarm indication	Same
	Alarm silence key	Alarm silence key	Same
	High, medium and low alarm priorities	High, medium and low alarm priorities	Same
Topic	Proposed deviceBABYLOG VN800, BABYLOG VN600	Predicate deviceInfinity Acute Care System WorkstationNeonatal Care	Comments
Device monitoring	Downgrading and resetting of defined alarms	Downgrading and resetting of defined alarms	Same
	Alarm logbook	Alarm history	Same
	Nurse call (optional)	Nurse call (optional)	Same
	User-initiated system test	User-initiated system test	Same
	Gas supply	Gas supply	Same
	Power supply	Power supply	Same
	Device temperature	Device temperature	Same
	Mutual Processor Monitoring	Mutual Processor Monitoring	Same
	Connection to display unit	Connection to display unit	Same
Communication protocols	MEDIBUS	MEDIBUS	Same
	MEDIBUS.X	-	Different
	MED.X.Comp	-	Different
Therapy types	Invasive ventilation (Tube)	Invasive ventilation (Tube)	Same
	Non-invasive ventilation (NIV) (optional)	Non-invasive ventilation (NIV) (optional)	Same
	O2 Therapy	O2 Therapy	Same
Type of patient interface	Invasive ventilation (Tube):Endotracheal tube (for pediatric patients and neonates)Tracheostomy cannula (for pediatric patients)	Invasive ventilation (Tube):Endotracheal tube (for pediatric patients and neonates)Tracheostomy cannula (for pediatric patients)	Same
	Non-invasive ventilation (NIV) (optional):NIV mask (for pediatric patients and neonates)Prongs (for pediatric patients and neonates)	Non-invasive ventilation (NIV) (optional):NIV mask (for pediatric patients and neonates)Prongs (for pediatric patients and neonates)	Same
Traditional 510(k)	510(k) Summary	Section 005
Topic	Proposed deviceBABYLOG VN800, BABYLOG VN600	Predicate deviceInfinity Acute Care System WorkstationNeonatal Care	Comments
	O2 Therapy:– Nasal cannula (for pediatric patients andneonates)	O2 Therapy:– Nasal cannula (for pediatric patients andneonates)– Oxygen mask (for pediatric patients andneonates)	Same
Ventilation modes	Pressure Control - Synchronized IntermittentMandatory Ventilation,PC-SIMV	Pressure Control - Synchronized IntermittentMandatory Ventilation,PC-SIMV	Same
	Pressure Control - Assist Control,PC-AC	Pressure Control - Assist Control,PC-AC	Same
	Pressure Control - Controlled MandatoryVentilation,PC-CMV	Pressure Control - Continuous MandatoryVentilation,PC-CMV	Same
	Pressure Control - Airway Pressure ReleaseVentilation,PC-APRV (optional)	Pressure Control - Airway Pressure ReleaseVentilation,PC-APRV (optional)	Same
	Pressure Control - Pressure Support Ventilation,PC-PSV	Pressure Control - Pressure Support Ventilation,PC-PSV	Same
	Pressure Control - Mandatory Minute Ventilation,PC-MMV (optional, part of "Volume ventilation"option)	Pressure Control - Mandatory Minute VolumeVentilation, PC-MMV (optional, part of "Volumeventilation" option)	Same
	Spontaneous - Continuous Positive AirwayPressure, Pressure Support,SPN-CPAP/PS	Spontaneous - Continuous Positive AirwayPressure, Pressure Support,SPN-CPAP/PS	Same
	Spontaneous - Continuous Positive AirwayPressure, Volume Support, SPN-CPAP/VS(optional, part of "Volume ventilation" option)	Spontaneous - Continuous Positive AirwayPressure, Volume Support, SPN-CPAP/VS(optional, part of "Volume ventilation" option)	Same
Topic	Proposed deviceBABYLOG VN800, BABYLOG VN600	Predicate deviceInfinity Acute Care System WorkstationNeonatal Care	Comments
	Spontaneous - Continuous Positive AirwayPressure, SPN-CPAP (optional, part of "Non-invasive ventilation" option)	Spontaneous - Continuous Positive AirwayPressure, SPN-CPAP (optional, part of "Non-invasive ventilation" option)	Same
	Spontaneous - Proportional Pressure Support,SPN-PPS (optional)	Spontaneous - Proportional Pressure Support,SPN-PPS (optional)	Same
Additional settings forventilation	Apnea ventilation	Apnea ventilation	Same
	Trigger	Flow trigger	Same
	Sigh	Sigh	Same
	Volume guarantee (optional, part of "Volumeventilation" option)	Volume Guarantee (optional, part of "Volumeventilation" option)	Same
	ATC (optional)	ATC (optional)	Same
	AutoRelease	AutoRelease	Same
Volume ventilation	Software option which contains PC-MMV and SPN-CPAP/VS and Volume guarantee	Software option which contains PC-MMV and SPN-CPAP/VS and Volume guarantee	Same
Anti-air shower	Reduced flow after detected disconnection untildetected reconnection	Reduced flow after detected disconnection untildetected reconnection	Same
Maneuvers	● Manual insp./inspiration hold● 02/suctioning● Nebulization (optional)	● Manual inspiration/hold● Suction maneuver● Medication nebulization (optional)	Same

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Traditional 510(k)

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Traditional 510(k)

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Image /page/10/Picture/1 description: The image shows the word "Dräger" in a bold, blue font. The "ä" in Dräger has two dots above it. The logo is simple and modern.

Traditional 510(k)

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Traditional 510(k)

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Traditional 510(k)

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Traditional 510(k)

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510(k) Summary

Discussion of Non-clinical Testing

The Babyloq VN800 / Babyloq VN600 ventilator is a new device and has undergone extensive testing to qualify it with e.g., national and international consensus standards, technical system requirements and other requirements. The following verification and validation activities were deemed necessary to establish substantial equivalence to the predicate device and were carried out under well-established methods, their results summarized in Test Summary tables and the evidence included in this submission.

. Sterilization
Biocompatibility
Software, including cybersecurity ●
Electrical safety ●
. Electromagnetic compatibility (EMC)
. Alarm Systems in medical electrical equipment
. Respiratory gas monitors
Waveforms, including comparisons to the predicate device and performance
Technical System Requirements, covering:
- o Risk control measures
- o Technical data
- Essential safety and performance o
. Accessories compatibility
Human factors engineering, usability .

Conclusion

The conclusions drawn from non-clinical tests and the comparison of intended use and technological characteristics with its predicate demonstrate that the new product Babylog VN800 / Babylog VN600 is substantially equivalent to the predicate device Infinity Acute Care System Workstation Neonatal Care K093632 and does not raise new questions of safety or effectiveness.

END -

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).