Babylog VN800, Babylog VN600

K222207 · Draegerwerk AG & CO Kgaa · CBK · May 16, 2023 · Anesthesiology

Device Facts

• Record ID: K222207
• Device Name: Babylog VN800, Babylog VN600
• Applicant: Draegerwerk AG & CO Kgaa
• Product Code: CBK · Anesthesiology
• Decision Date: May 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Babylog VN800/VN600 are intensive care ventilators for neonates and pediatric patients; provide mandatory and spontaneous ventilation modes; monitor airway pressure, flow, and volume. System comprises trolley, display unit, and ventilation unit. Inputs include central gas supply or cylinders; outputs include controlled gas delivery to patient via endotracheal tube, tracheostomy, or non-invasive masks/prongs. Operated by trained medical personnel in hospitals for stationary use or intrahospital transport. Features include embedded control display (ECD) technology, color GUI, and optional gas/power supply units. Healthcare providers use real-time waveforms, trends, and alarm logs to adjust therapy. Benefits include respiratory support and monitoring for vulnerable patient populations.

Clinical Evidence

Bench testing only. Verification and validation activities included testing against consensus standards for electrical safety (ANSI AAMI ES60601-1), EMC (IEC 60601-1-2), usability (IEC 62366-1), alarm systems (IEC 60601-1-8), respiratory gas monitors (ISO 80601-2-55), and software life cycle (IEC 62304). Performance was verified through technical system requirements, risk control measures, and waveform comparisons to the predicate device.

Technological Characteristics

Ventilator system with embedded control display (ECD) technology. Materials evaluated per ISO 10993-1 and ISO 18562-1. Sensing: paramagnetic side-stream O2 sensor, optional mainstream CO2 infrared absorption sensor. Power: internal NiMH battery, optional lead-acid or LFP power supply unit. Connectivity: MEDIBUS, MEDIBUS.X, MED.X.Comp protocols. Software: redesigned firmware/software per IEC 62304. Form factor: trolley-mounted with 15.6" (VN600) or 18.5" (VN800) capacitive touchscreen.

Indications for Use

Indicated for neonates (0.4-10 kg) and pediatric patients (5.2-20.1 kg IBW) requiring mandatory pressure-controlled ventilation, spontaneous breathing support, and ventilation monitoring.

Regulatory Classification

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.

Predicate Devices

• Infinity Acute Care System Workstation Neonatal Care (K093632)

Reference Devices

• CO2 mainstream sensor (K221118)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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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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<br>Moislinger Allee 53-55<br>23542 Lübeck, Germany<br>Establishment's registration number: 9611500 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Dr. Bettina Moebius<br>Head of Regulatory Affairs Central<br>E-Mail: [e-mail]<br>Telephone: [phone] |
| US Agent: | Darlene Thibodeau<br>Head of Quality Assurance and Compliance<br>E-mail: [e-mail]<br>Telephone: [phone] |
| Date prepared: | 16 May 2023 |
| Device Name: | Common name: Ventilator<br>Trade Name: Babylog VN800, Babylog VN600<br>Classification Name: Ventilator, Continuous, Facility Use<br>Regulation Number: 21 CFR §868.5895<br>Product Code: CBK<br>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.

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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

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.

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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 Version | Title |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI AAMI ES60601-1:2005/(R)2012<br>and A1:2012, C1:2009/(R)2012 and<br>A2:2010/(R)2012 | Medical electrical equipment - Part 1:<br>General requirements for basic safety and<br>essential performance |
| IEC 60601-1-2 Edition 4.1 2020-09<br>CONSOLIDATED VERSION | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and<br>essential performance - Collateral<br>Standard: Electromagnetic disturbances -<br>Requirements and tests |
| IEC 60601-1-6 Edition 3.1 2013-10 | Medical electrical equipment - Part 1-6:<br>General requirements for basic safety and<br>essential performance - Collateral<br>standard: Usability |
| IEC 60601-1-8 Edition 2.1 2012-11 | Medical electrical equipment - Part 1-8:<br>General requirements for basic safety and<br>essential performance - Collateral<br>Standard: General requirements, tests<br>and guidance for alarm systems in<br>medical electrical equipment and medical<br>electrical systems |
| ISO 80601-2-12 First edition 2011-04-15 | Medical electrical equipment - Part 2-12:<br>Particular requirements for the safety of<br>lung ventilators - Critical care ventilators<br>[Including: Technical Corrigendum 1<br>(2011)] |
| ISO 80601-2-55 Second edition 2018-02 | Medical electrical equipment - Part 2-55:<br>Particular requirements for the basic<br>safety and essential performance of<br>respiratory gas monitors |
| ISO 14971 Third Edition 2019-12 | Medical devices - Application of risk<br>management to medical devices |
| IEC 62304 Edition 1.1 2015-06<br>CONSOLIDATED VERSION | Medical device software - Software life<br>cycle processes |
| IEC 62366-1 Edition 1.0 2015-02 | Medical devices - Part 1: Application of<br>usability engineering to medical devices |
| ISO 10993-1 Fifth edition 2018-08 | Biological evaluation of medical devices -<br>Part 1: Evaluation and testing within a risk<br>management process |
| ISO 18562-1 First edition 2017-03 | Biocompatibility evaluation of breathing<br>gas pathways in healthcare applications -<br>Part 1: Evaluation and testing within a risk<br>management process |
| IEC 62133-2 Edition1.0 2017-02 | Secondary cells and batteries containing<br>alkaline or other non-acid electrolytes -<br>Safety requirements for portable sealed<br>secondary cells, and for batteries made<br>from them, for use in portable applications<br>- Part 2: Lithium systems |
| IEC 62133-1 Edition1.0 2017-02 | Secondary cells and batteries containing<br>alkaline or other non-acid electrolytes -<br>Safety requirements for portable sealed<br>secondary cells, and for batteries made<br>from them, for use in portable applications<br>- Part 1: Nickel systems |
| /TR 60601-4-2 Edition 1.0 2016-05 | Medical electrical equipment - Part 4-2:<br>Guidance and interpretation -<br>Electromagnetic immunity: performance<br>of medical electrical equipment and<br>medical electrical systems |

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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.

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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<br>BABYLOG VN800, BABYLOG VN600 | Predicate device<br>Infinity Acute Care System Workstation<br>Neonatal Care | Comments |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Device Trade Name | Babylog VN800<br>Babylog VN600 | Infinity Acute Care System Workstation Neonatal<br>Care | – |
| Manufacturer | Drägerwerk AG & Co. KGaA | Drägerwerk AG & Co. KGaA | Same |
| 510(k) number | K222207 | K093632 | – |
| Regulation number -<br>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<br>• Neonate | • Pediatric<br>• Neonate | Same |
| Topic | Proposed device<br>BABYLOG VN800, BABYLOG VN600 | Predicate device<br>Infinity Acute Care System Workstation<br>Neonatal Care | Comments |
| Intended Use /<br>Indications for Use | The Babylog intensive care ventilator (Babylog<br>VN800 / Babylog VN600) is intended for the<br>ventilation of neonates with a body weight of 0.4 kg<br>(0.88 lb) to 10 kg (22 lb) and for pediatric patients<br>with an IBW of 5.2 kg (11.5 lb) to 20.1 kg (44.3 lb).<br>This device provides mandatory pressure-controlled<br>ventilation modes, ventilation modes for supporting<br>spontaneous breathing, and ventilation monitoring. | The Infinity Acute Care System Workstations<br>Neonatal Care consists of monitoring and control<br>displays and additional therapy. They are intended<br>to be used as integrated, networked, and<br>configurable Workstations to provide specific<br>therapy in neonatal intensive care. The Infinity<br>Acute Care System Workstations Neonatal Care<br>are intended to be used by qualified and trained<br>medical personnel.<br>The Infinity CSeries Medical Cockpits, consisting of<br>the C500 and and the C700, are monitoring and<br>control displays for the Infinity Acute Care System<br>(IACS). Medical Cockpits are intended to be used to<br>monitor waveforms, parameter information, and<br>alarms as well as to control settings. The Infinity<br>CSeries Medical Cockpits are intended to be used<br>in environments where patient care is provided by<br>trained healthcare Professionals.<br>The Babylog VN500 Ventilation unit of the<br>Infinity Care System is intended for the<br>ventilation of neonatal patients from 0.4 kg (0.88<br>lbs) up to 10 kg (22 lbs) and pediatric patients<br>from 5 kg (11 lbs) up to 20 kg (44 lbs)<br>bodyweight. Babylog VN500 offers mandatory<br>ventilation modes for spontaneous breathing<br>support and airway monitoring. The Babylog<br>VN500 ventilation unit is intended for use in<br>different medical care areas.<br>Babylog VN500 is intended for stationary use in<br>hospitals and medical rooms or for patient<br>transportation within the hospital. | Similar |
| Topic | Proposed device<br>BABYLOG VN800, BABYLOG VN600 | Predicate device<br>Infinity Acute Care System Workstation<br>Neonatal Care | Comments |
| Intended user | The operating organization must ensure the following:<br>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<br>This user group operates the product in accordance with the intended use.<br>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.<br>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.<br>Do not use the device in the following environments of use:<br>- Hyperbaric chambers<br>- Magnetic resonance imaging<br>- Together with flammable gases or flammable solutions that can mix with air, oxygen, or nitrous oxide<br>- Areas with danger of explosion<br>- Areas with combustible and highly flammable substances<br>- Rooms with insufficient ventilation<br>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.<br>Do not use the device in the following environments:<br>- In hyperbaric chambers<br>- For magnetic resonance imaging (MRI, NMR, NMI)<br>- In conjunction with flammable gases or flammable solutions that can mix with air, oxygen or nitrous oxide<br>- In areas of explosion hazard<br>- In areas with combustible or explosive substances<br>- In rooms without sufficient ventilation<br>Do not operate the device with helium or helium mixtures. | Similar |
| Topic | Proposed device<br>BABYLOG VN800, BABYLOG VN600 | Predicate device<br>Infinity Acute Care System Workstation<br>Neonatal Care | Comments |
| Gas supply | Central gas supply | Central gas supply | Same |
| | Gas cylinders<br>• Transport supply unit (optional)<br>• Gas cylinder holder (optional) | Gas cylinders<br>• Transport supply unit (optional)<br>• Gas cylinder holder (optional) | Same |
| | Gas supply unit GS500 (optional) | - | Different |
| Gas dosage, mixing and<br>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"<br>option) | Pneumatic nebulizer (optional, part of "Medication<br>nebulization" option) | Same |
| Pressure and volume<br>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<br>infrared absorption<br>spectroscopy (optional, part of “CO2 monitoring”<br>option)<br>• part no.6871950 MCable - Mainstream CO2<br>• part no. 6873570 CO2 mainstream sensor | Main-stream sensor using<br>infrared absorption<br>spectroscopy (optional, part of “CO2 monitoring”<br>option)<br>• part no.6871950 MCable -<br>Mainstream CO2 | Different<br>optional component<br>6873570 (K221118)<br>was introduced. |
| Batteries | Internal battery (NiMH)…