Who is the manufacturer of GLOBE-TROTTER GT5400?

Draeger Medical Systems, Inc. filed the 510(k) submission for GLOBE-TROTTER GT5400 (K141565).

What is the FDA product code for GLOBE-TROTTER GT5400?

FPL. It is classified under 21 CFR 880.5410 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for GLOBE-TROTTER GT5400?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GLOBE-TROTTER GT5400?

TI500 Globe-trotter Neonatal Transport System (K001019); Airborne Life Support Transport Incubator Aviator (K103527).

Who can help prepare an FDA 510(k) submission like GLOBE-TROTTER GT5400?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GLOBE-TROTTER GT5400

K141565 · Draeger Medical Systems, Inc. · FPL · Sep 10, 2014 · General Hospital

Device Facts

Record ID	K141565
Device Name	GLOBE-TROTTER GT5400
Applicant	Draeger Medical Systems, Inc.
Product Code	FPL · General Hospital
Decision Date	Sep 10, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5410
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Indications for Use

The Globe-Trotter GT5400 (GT5400) is a neonatal transport system intended for the transport of newborns weighing up to 10 kg (22 lb.) between health care facilities. It provides a means to control air temperature, deliver oxygen, resuscitate, provide passive humidification and ventilate with active humidification. The GT5400 can be used for intra-hospital transport as well as between facilities via air or ground. The device is intended to be used by trained health care professionals. It is not intended for home use.

Device Story

The Globe-Trotter GT5400 is a neonatal transport system comprising a transport incubator, modular frame, and life support console. It facilitates intra-hospital and inter-facility transport (air/ground) for newborns up to 10 kg. The system controls air temperature, delivers oxygen, provides passive/active humidification, and supports ventilation. It is operated by trained healthcare professionals. The device integrates various components, including a modified TI500 incubator, blender, mechanical ventilator (MVP10 or CV2i), O2 monitor, and optional infusion pumps, capnographs, and vital signs monitors. It features digital pressure gauges, LED examination lights, and an accessory deck for mounting additional equipment. The system provides a controlled environment for neonates during transit, allowing clinicians to monitor and provide life support, thereby maintaining patient stability during movement between facilities.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, performance verification, and validation activities. Testing included functional/operational testing, biocompatibility assessment, and risk analysis. The device was tested against international standards including IEC 60601-1, IEC 60601-1-2, IEC 62366, ISO 14971, EN 1789, EN 13718-1, EN 13976, and RTCA DO-160 for environmental conditions.

Technological Characteristics

The system consists of a transport incubator, modular frame, and life support console. Materials are biocompatible and previously used in neonatal devices. It operates on AC power (110/120V or 230V) and includes battery backup. Features include digital pressure gauges, LED exam lights, and accessory rails. It is designed for transport environments (air/ground) and complies with IEC 60601-1, IEC 60601-1-2, and RTCA DO-160 standards.

Indications for Use

Indicated for the transport of newborns weighing up to 10 kg (22 lb.) between healthcare facilities. Intended for use by trained healthcare professionals; not for home use.

Regulatory Classification

Identification

A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.

Predicate Devices

TI500 Globe-trotter Neonatal Transport System (K001019)
Airborne Life Support Transport Incubator Aviator (K103527)

Reference Devices

NeoPod T System (K870173)
Biomed Devices Blender (K925982)
Biomed Devices MVP10 (Pre-Amendment)
Biomed Devices CV2i (K942938)
Teledyne Analytical Instruments MX300 (K024155)
B. Braun Perfusor Space Pump (K092313)
Oridion Medical Microcap Capnograph (K981114)
Welch Allyn Propaq LT Monitor (K033378)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Draeger Medical Systems, Incorporated Ms. Gale Winarsky Manager, Regulatory Affairs 3135 Quarry Road Telford, Pennsylvania 18969 Re: K141565 Trade/Device Name: Globe-Trotter® GT5400 Regulation Number: 21 CFR 880.5410 Regulation Name: Neonatal transport incubator Regulatory Class: Class II Product Code: FPL Dated: July 2, 2014 Received: July 3, 2014 Dear Ms. Winarsky: 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. 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. {1}------------------------------------------------ Page 2 - Ms. Winarsky 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerelv. Image /page/1/Picture/8 description: The image shows the FDA logo. The logo is in white and consists of the letters "FDA" in a stylized font. The letters are connected and have a slightly rounded appearance. The background is also white, making the logo appear subtle and almost transparent. Digitally signed by Richard C. Chapman -S Date: 2014.09.10 13:08:06 -04'00' for Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K141565 Device Name Globe-Trotter® GT5400 #### Indications for Use (Describe) The Globe-Trotter GT5400 neonatal transport system is intended for the transport of newborns weighing up to 10 kg (22 lb) between healthcare facilities. It provides means to control air temperature, deliver oxygen, resuscitate, provide passive humidification, and ventilate with active humidification (optional). The Globe-Trotter GT5400 neonatal transport system is intended for use by trained health care professionals and is not intended for home use. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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 Druq 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/0 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 slightly slanted to the right. # 510(k) Summ acc. to 807.91 | Manufacturer Name and Address: | Dräger Medical Systems, Inc. 3135 Quarry Road Telford, PA 18969 | | | | | | | | | | | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------------------|----------------------|-------------------------------|--------------------|-----------------|---------------|-----|--------|----| | Establishment Registration Number: | 2510954 | | | | | | | | | | | | Contact Person: | Gale Winarsky Manager, Regulatory Affairs | | | | | | | | | | | | | <table><tr><td>Phone:</td><td>215-660-2239</td></tr><tr><td>Fax:</td><td>215-721-5424</td></tr></table> | Phone: | 215-660-2239 | Fax: | 215-721-5424 | | | | | | | | Phone: | 215-660-2239 | | | | | | | | | | | | Fax: | 215-721-5424 | | | | | | | | | | | | Date summary was prepared: | 06/09/2014 | | | | | | | | | | | | Device Name: | <table><tr><td>Trade Name:</td><td>Globe-trotter® GT5400</td></tr><tr><td>Classification Name:</td><td>Incubator, Neonatal Transport</td></tr><tr><td>Regulation Number:</td><td>21 CRF 880.5410</td></tr><tr><td>Product Code:</td><td>FLP</td></tr><tr><td>Class:</td><td>II</td></tr></table> | Trade Name: | Globe-trotter® GT5400 | Classification Name: | Incubator, Neonatal Transport | Regulation Number: | 21 CRF 880.5410 | Product Code: | FLP | Class: | II | | Trade Name: | Globe-trotter® GT5400 | | | | | | | | | | | | Classification Name: | Incubator, Neonatal Transport | | | | | | | | | | | | Regulation Number: | 21 CRF 880.5410 | | | | | | | | | | | | Product Code: | FLP | | | | | | | | | | | | Class: | II | | | | | | | | | | | Legally Marketed Device Identification: Substantial equivalence is claimed to the T1500 Globe-Trotter Transport System K001019, Aviator Transport Incubator K103527. #### Intended Use: The Globe-Trotter GT5400 (GT5400) is a neonatal transport system intended for the transport of newborns weighing up to 10 kg between health care facilities. A fully configured system provides means to control air temperature, deliver oxygen, resuscitate, provide passive humidification and ventilate with active humidification. The GT5400 can be used for intra-hospital transport as well as between facilities via air or ground. The device is intended to be used by trained health care professionals. It is not intended for home use. #### Device Description: The GT5400 is a combination of individual currently marketed medical devices without modification of their individual principles of operation. The GT5400 system is comprised of three main parts with standard and optional components. - o Transport Incubator - . Modular Frame - 0 Life Support Console (LCS). Variants - The GT5400 has two variants, Air Vehicle configuration (AV) and Ground Vehicle (GV) configuration. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Dräger" in a stylized, sans-serif font. The color of the text is a vibrant blue. The two dots above the "a" in "Dräger" are prominent and round. The overall design is clean and modern. Comparison of Technological Characteristics with Predicate Devices: | Specification | Predicate | Predicate | Device Under Review | Comments | |--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | TI500 Globe- trotter Neonatal Transport Sys- tem (TI500 GT or GT500) | Airborne Life Support Transport Incu- bator Aviator | Globe-Trotter GT5400 (GT5400) | | | Manufacturer | Draeger Medical Systems, Inc. | International Bio- medical | Draeger Medical Sys- tems, Inc. | | | 510(k) | K001019 | K103527 | | | | Regulation # | 880.5410 | 880.5410 | 880.5410 | Incubator, Neonatal Transport | | Product Code | FPL | FPL | FPL | | | Classification | II | II | II | | | Intended Use | Intended for the transport of high risk premature, low birth weight, or critically ill newborns be- tween healthcare facili- ties. The means of transportation can be either ground or air- borne (rotary or fixed wing). The system is also suitable for ei- ther transport of stationary care within the hospi- tal. It includes up to three sys- tem compo- nents. These components include a frame which houses the incubator and the pneu- matic module assembly, and a facility for gas cylinder storage. The system is arranged to | The transport in- cubator is intend- ed for use by per- sonnel trained in neonatal care to facilitate the movements of neonates by air or ambulance. | Intended for the transport of newborns weighing up to 10 kg (22 lb.) between health care facilities. It pro- vides a means to con- trol air temperature, deliver oxygen, resusci- tate, provide passive humidification and ven- tilate with active humidi- fication. | The general intend- ed use of the GT5400 has not changed from the predicate TI500GT. The patient weight is linked to the TI500 incubator. The TI500 incubator is used in the GT5400 and the TI500 GT therefore the patient weight is the same for both devices. | | Specification | Predicate | Predicate | Device Under Review | Comments | | Device Name | TI500 Globe- trotter Neonatal Transport Sys- tem (TI500 GT or GT500) plete unit for the care of an infant in need of trans- portation. | Airborne Life Support Transport Incu- bator Aviator | Globe-Trotter GT5400 (GT5400) | | | Indications for Use | Transport of high risk prema- ture, low birth weight or criti- cally ill new- borns. It pro- vides a means to control air temperature and oxygen concen- tration, to add relative humidity and to provide resuscitation. | The transport in- cubator is intend- ed for use by per- sonnel trained in neonatal care to facilitate the movements of neonates by air or ambulance. | Transport of newborns weighing up to 10 kg (22 lb.) between health care facilities. It pro- vides means to control air temperature, deliver oxygen, resuscitate, provide passive humidi- fication, and ventilate with active humidifica- tion. The Globe-Trotter GT5400 neonatal transport system is intended for use by trained health care professionals and it is not intended for home use | Both the GT5400 and the TI500GT provide passive humidity. The GT5400 also pro- vides active humidi- fication during venti- lation via the cur- rently marketed NeoPod T System (Humidifier for Neo- natal Transport Ven- tilators) K870173 | | Target Popula- tion/Patient Population | Newborn infants | Newborn infants | Newly born infants up to 10 kg. (22lbs) | The premise of the population has not changed from the predicates. The weight is now pro- vided as additional information for the user. | | Environment of Use | Intra-hospital transport as well as transport between health care facilities | Transport between health care facili- ties | Same as T1500 GT | | | System Speci- fications | | | | | | Device Classifi- cation | Class I, Type BF, continuous operation | Not found on Mfg. website | Same as T1500 GT | | | Nominal System length | 129.5 cm (50.9") without cart | UNK | 163.9 cm (64.5 ") | The predicate T1500 GT is offered with or without a cart. The. | | Specification | Predicate | Predicate | Device Under Review | Comments | | Device Name | TI500 Globe- trotter Neonatal Transport Sys- tem (TI500 GT or GT500) | Airborne Life Support Transport Incu- bator Aviator | Globe-Trotter GT5400 (GT5400) | | | | | | | GT5400 is offered | | | | | | without a cart. | | Nominal System Width | 56.5 cm (22") | UNK | 57.8 cm (22.75") | | | Nominal System Height | 58.4 cm (22.9") | UNK | <42.6 - <58.5 cm (16.8 in - 23 in) | | | Nominal Weight | 83.9 kg (184.9 lb.) or 71.6 kg (157.9 lb.) de- pending on con- figuration | UNK | 80-116 kg (176-254 lbs.) depending on options | | | Infant Weight | Not published | UNK | 10 kg (22 lbs.) | The patient weight is linked to the incuba- tor. Although not previously published the predicate T1500 GT and the GT5400 are the same. | | Operating tem- perature (nor- mal) | 10-30 deg C (50-86 deg F) | UNK | Same as T1500 GT | | | Operating tem- perature (limited use) | 10-40 deg C (50-104 deg F) | UNK | 10-30 deg C (50-86 deg F) | | | Storage temper- ature | -40 - +70 deg.C (-40 - 158 deg. F) Based on Incu- bator | UNK | -20-+60 deg C (-4-140 deg F) | Device packaging is marked with storage temperature re- quirements | | Relative Humidi- ty Operating Range | 0-95% RH, non- condensing | UNK | 5-95% RH, non- condensing | | | Altitude Operat- ing Range | As published in the TI500 transport incu- bator IFU Sea level to 3 km (10000 ft.) non-pressurized ambient; or sea level to 12 km (40,000ft.), pressurized ambient | UNK | Sea level to 3 km (10000 ft.) non- pressurized ambient | There is essentially no difference be- tween the operating altitudes of the pred- icate TI500 GT and the GT5400. The additional statement "or sea level to 12 km (40,000ft.), pres- surized ambient" has been removed from the GT5400 as it is understood that you can be at any altitude as long as | | Specification | Predicate | Predicate | Device Under Review | Comments | | Device Name | T1500 Globe- trotter Neonatal Transport Sys- tem (T1500 GT or GT500) | Airborne Life Support Transport Incu- bator Aviator | Globe-Trotter GT5400 (GT5400) | | | | | | | pressurized. | | Environmental | | | | | | Operating (OP)Temp Range | 10° C to 30° C (50° F to 86° F) ambient (nor- mal) 10° C to 40° C (50° F to 104° F) ambient (limited) | UNK | 10° C to 30° C (50° F to 86° F) ambient (normal) 10° C to 30° C (50° F to 86° F) ambient (limited) | | | OP Relative Humidity Range | 0% RH to 95% RH, non- condensing | UNK | Same as predicate T1500 GT | | | OP Altitude Range | Not defined | UNK | Sea level to 3km (10,000 ft.) non- pressurized ambient | GT5400 was tested to RTCA DO160 which provided the Altitude Range data. | | Stor- age/Transport (S/T) Temp Range | Not defined | UNK | -20° C to + 60° C (-4° F to +140° F) ambient | No change to prod- uct function | | Electrical | | | | | | External Power Requirements | AC 110/120V, 50/60 Hz, Six 10A breakers- <480W worst case (incubator, compressor charger, and monitor) | AC 120V 50-…

GLOBE-TROTTER GT5400

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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GLOBE-TROTTER GT5400

Device Facts

Indications for Use

Device Story

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Indications for Use

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

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