LogoFDA 510(k) Search
K Number
K222207
Device Name
Babylog VN800, Babylog VN600
Manufacturer
Draegerwerk AG & CO KGaA
Date Cleared
2023-05-16

(295 days)

Product Code
CBK
Regulation Number
868.5895
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

K093632

Not Found

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware and software redesign without mentioning AI/ML capabilities.

Yes
The device is a ventilator, which provides respiratory support, directly treating or alleviating a medical condition (ventilation of neonates and pediatric patients).

No

This device is a ventilator, designed to provide mandatory pressure-controlled ventilation and support spontaneous breathing. While it performs "ventilation monitoring," this is a function of delivering therapy rather than diagnosing a medical condition. Its primary purpose, as stated in the "Intended Use," is for "ventilation of neonates and pediatric patients," which is a treatment, not a diagnostic, function.

No

The device description explicitly states it includes hardware components such as a trolley, display unit, ventilation unit, gas supply unit, and power supply unit.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for the "ventilation of neonates and pediatric patients." This describes a therapeutic and monitoring function related to breathing, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
  • Device Description: The description focuses on the mechanical aspects of ventilation, including mandatory and supportive ventilation modes, monitoring, and hardware components like a trolley, display unit, and ventilation unit. There is no mention of analyzing biological samples.
  • Lack of IVD Keywords: The text does not contain keywords typically associated with IVD devices, such as "specimen," "sample," "assay," "reagent," "analyte," "diagnosis," or "laboratory."
  • Performance Studies: The performance studies listed are related to the safety and functionality of a ventilator (sterilization, biocompatibility, software, electrical safety, EMC, alarms, waveforms, technical requirements, accessories, human factors). These are not the types of studies conducted for IVD devices, which would focus on analytical and clinical performance related to the detection or measurement of substances in biological samples.

In summary, the Babylog intensive care Ventilator is a medical device used for respiratory support and monitoring, not for performing in vitro diagnostic tests on biological specimens.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

CBK

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.

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

Pediatric, Neonate

Intended User / Care Setting

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 users: This 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.

Environment of use: The device is intended for stationary use in hospitals and medical rooms or for intrahospital patient transport.

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)

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 .

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.

K093632

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.

Not Found

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 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

1

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

2

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)

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 a bold, sans-serif font. The word is blue. The two dots above the "a" are also blue.

510(k) Premarket Notification Summary

| Submitter: | Drägerwerk AG & Co. KGaA
Moislinger Allee 53-55
23542 Lübeck, Germany
Establishment's registration number: 9611500 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Dr. Bettina Moebius
Head of Regulatory Affairs Central
E-Mail: bettina.moebius@draeger.com
Telephone: +49 451 882 4100 |
| US Agent: | Darlene Thibodeau
Head of Quality Assurance and Compliance
E-mail: darlene.thibodeau@draeger.com
Telephone: (978) 773-1060 |
| Date prepared: | 16 May 2023 |
| Device Name: | Common name: Ventilator
Trade Name: Babylog VN800, Babylog VN600
Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: 21 CFR §868.5895
Product Code: CBK
Class: 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 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.

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 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

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.

5

Image /page/5/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is written in blue. The two dots above the "a" are also blue. The word is horizontally oriented and centered.

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 VersionTitle
ANSI AAMI ES60601-1:2005/(R)2012
and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012Medical electrical equipment - Part 1:
General requirements for basic safety and
essential performance
IEC 60601-1-2 Edition 4.1 2020-09
CONSOLIDATED VERSIONMedical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-1-6 Edition 3.1 2013-10Medical electrical equipment - Part 1-6:
General requirements for basic safety and
essential performance - Collateral
standard: Usability
IEC 60601-1-8 Edition 2.1 2012-11Medical electrical equipment - Part 1-8:
General requirements for basic safety and
essential performance - Collateral
Standard: General requirements, tests
and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
ISO 80601-2-12 First edition 2011-04-15Medical electrical equipment - Part 2-12:
Particular requirements for the safety of
lung ventilators - Critical care ventilators
[Including: Technical Corrigendum 1
(2011)]
ISO 80601-2-55 Second edition 2018-02Medical electrical equipment - Part 2-55:
Particular requirements for the basic
safety and essential performance of
respiratory gas monitors
ISO 14971 Third Edition 2019-12Medical devices - Application of risk
management to medical devices
IEC 62304 Edition 1.1 2015-06
CONSOLIDATED VERSIONMedical device software - Software life
cycle processes
IEC 62366-1 Edition 1.0 2015-02Medical devices - Part 1: Application of
usability engineering to medical devices
ISO 10993-1 Fifth edition 2018-08Biological evaluation of medical devices -
Part 1: Evaluation and testing within a risk
management process
ISO 18562-1 First edition 2017-03Biocompatibility evaluation of breathing
gas pathways in healthcare applications -
Part 1: Evaluation and testing within a risk
management process
IEC 62133-2 Edition1.0 2017-02Secondary cells and batteries containing
alkaline or other non-acid electrolytes -
Safety requirements for portable sealed
secondary cells, and for batteries made
from them, for use in portable applications
  • Part 2: Lithium systems |
    | IEC 62133-1 Edition1.0 2017-02 | Secondary cells and batteries containing
    alkaline or other non-acid electrolytes -
    Safety requirements for portable sealed
    secondary cells, and for batteries made
    from 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: performance
    of medical electrical equipment and
    medical electrical systems |

6

Image /page/6/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.

7

Image /page/7/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue. The two dots above the "a" are also blue.

510(k) Summary

Comparison to Predicate

| Topic | Proposed device
BABYLOG VN800, BABYLOG VN600 | Predicate device
Infinity Acute Care System Workstation
Neonatal Care | Comments |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Device Trade Name | Babylog VN800
Babylog VN600 | Infinity Acute Care System Workstation Neonatal
Care | – |
| 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 device
BABYLOG VN800, BABYLOG VN600 | Predicate device
Infinity Acute Care System Workstation
Neonatal Care | Comments |
| 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. | The Infinity Acute Care System Workstations
Neonatal Care consists of monitoring and control
displays and additional therapy. They are intended
to be used as integrated, networked, and
configurable Workstations to provide specific
therapy in neonatal intensive 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, consisting of
the C500 and and the C700, are monitoring and
control displays for the Infinity Acute Care System
(IACS). Medical Cockpits are intended to be used to
monitor waveforms, parameter information, and
alarms as well as to control settings. The Infinity
CSeries Medical Cockpits are intended to be used
in environments where patient care is provided by
trained healthcare Professionals.
The Babylog VN500 Ventilation unit of the
Infinity Care System is intended for the
ventilation of neonatal patients from 0.4 kg (0.88
lbs) up to 10 kg (22 lbs) and pediatric patients
from 5 kg (11 lbs) up to 20 kg (44 lbs)
bodyweight. Babylog VN500 offers mandatory
ventilation modes for spontaneous breathing
support and airway monitoring. The Babylog
VN500 ventilation unit is intended for use in
different medical care areas.
Babylog VN500 is intended for stationary use in
hospitals and medical rooms or for patient
transportation within the hospital. | Similar |
| Topic | Proposed device
BABYLOG VN800, BABYLOG VN600 | Predicate device
Infinity Acute Care System Workstation
Neonatal 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 users
This 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 ventilation
    Do 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 ventilation
    Do not operate the device with helium or helium mixtures. | Similar |
    | Topic | Proposed device
    BABYLOG VN800, BABYLOG VN600 | Predicate device
    Infinity Acute Care System Workstation
    Neonatal 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 and
    delivery | 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 "Medication
    nebulization" option) | Same |
    | Pressure and volume
    monitoring | 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 using
    infrared absorption
    spectroscopy (optional, part of “CO2 monitoring”
    option)
    • part no.6871950 MCable - Mainstream CO2
    • part no. 6873570 CO2 mainstream sensor | Main-stream sensor using
    infrared absorption
    spectroscopy (optional, part of “CO2 monitoring”
    option)
    • part no.6871950 MCable -
    Mainstream CO2 | Different
    optional component
    6873570 (K221118)
    was introduced. |
    | Batteries | Internal battery (NiMH) | Internal battery (NiMH) | Same |
    | Topic | Proposed device
    BABYLOG VN800, BABYLOG VN600 | Predicate device
    Infinity Acute Care System Workstation
    Neonatal 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, screen
    displays | 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, alarm
    principles | 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 device
    BABYLOG VN800, BABYLOG VN600 | Predicate device
    Infinity Acute Care System Workstation
    Neonatal 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 device
    BABYLOG VN800, BABYLOG VN600 | Predicate device
    Infinity Acute Care System Workstation
    Neonatal Care | Comments |
    | | O2 Therapy:
    – Nasal cannula (for pediatric patients and
    neonates) | O2 Therapy:
    – Nasal cannula (for pediatric patients and
    neonates)
    – Oxygen mask (for pediatric patients and
    neonates) | Same |
    | Ventilation modes | Pressure Control - Synchronized Intermittent
    Mandatory Ventilation,
    PC-SIMV | Pressure Control - Synchronized Intermittent
    Mandatory Ventilation,
    PC-SIMV | Same |
    | | Pressure Control - Assist Control,
    PC-AC | Pressure Control - Assist Control,
    PC-AC | Same |
    | | Pressure Control - Controlled Mandatory
    Ventilation,
    PC-CMV | Pressure Control - Continuous Mandatory
    Ventilation,
    PC-CMV | Same |
    | | Pressure Control - Airway Pressure Release
    Ventilation,
    PC-APRV (optional) | Pressure Control - Airway Pressure Release
    Ventilation,
    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 Volume
    Ventilation, PC-MMV (optional, part of "Volume
    ventilation" option) | Same |
    | | Spontaneous - Continuous Positive Airway
    Pressure, Pressure Support,
    SPN-CPAP/PS | Spontaneous - Continuous Positive Airway
    Pressure, Pressure Support,
    SPN-CPAP/PS | Same |
    | | Spontaneous - Continuous Positive Airway
    Pressure, Volume Support, SPN-CPAP/VS
    (optional, part of "Volume ventilation" option) | Spontaneous - Continuous Positive Airway
    Pressure, Volume Support, SPN-CPAP/VS
    (optional, part of "Volume ventilation" option) | Same |
    | Topic | Proposed device
    BABYLOG VN800, BABYLOG VN600 | Predicate device
    Infinity Acute Care System Workstation
    Neonatal Care | Comments |
    | | Spontaneous - Continuous Positive Airway
    Pressure, SPN-CPAP (optional, part of "Non-
    invasive ventilation" option) | Spontaneous - Continuous Positive Airway
    Pressure, 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 for
    ventilation | Apnea ventilation | Apnea ventilation | Same |
    | | Trigger | Flow trigger | Same |
    | | Sigh | Sigh | Same |
    | | Volume guarantee (optional, part of "Volume
    ventilation" option) | Volume Guarantee (optional, part of "Volume
    ventilation" 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 until
    detected reconnection | Reduced flow after detected disconnection until
    detected reconnection | Same |
    | Maneuvers | ● Manual insp./inspiration hold
    ● 02/suctioning
    ● Nebulization (optional) | ● Manual inspiration/hold
    ● Suction maneuver
    ● Medication nebulization (optional) | Same |

8

Image /page/8/Picture/1 description: The image shows the word "Dräger" in blue font. The "ä" in the word has two blue dots above it. The font is bold and sans-serif.

Traditional 510(k)

9

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

Traditional 510(k)

10

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)

11

Image /page/11/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue. The two dots above the "a" are also blue.

Traditional 510(k)

12

Image /page/12/Picture/1 description: The image shows the word "Dräger" in blue font. The word is written in a bold, sans-serif font. The two dots above the "a" are also blue. The background is white.

Traditional 510(k)

13

Image /page/13/Picture/1 description: The image shows the word "Dräger" in a bold, blue font. The two dots above the "a" are also blue. The word is centered in the image and takes up most of the space.

14

Image /page/14/Picture/1 description: The image shows the word "Dräger" in a bold, blue font. The two dots above the "a" are also blue. The word is the logo for the Dräger company, which specializes in medical and safety technology.

Traditional 510(k)

15

Image /page/15/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is in blue color. The two dots above the "a" are also blue. The logo is simple and modern.

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 -