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

Intended 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)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv.

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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

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# 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)

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# 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.

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Comparison of Technological Characteristics with Predicate Devices:

| Specification | Predicate | Predicate | Device Under Review | Comments |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | TI500 Globe-<br>trotter Neonatal<br>Transport Sys-<br>tem<br>(TI500 GT or<br>GT500) | Airborne<br>Life<br>Support<br>Transport Incu-<br>bator<br>Aviator | Globe-Trotter GT5400<br>(GT5400) | |
| Manufacturer | Draeger Medical<br>Systems, Inc. | International Bio-<br>medical | Draeger Medical Sys-<br>tems, Inc. | |
| 510(k) | K001019 | K103527 | | |
| Regulation # | 880.5410 | 880.5410 | 880.5410 | Incubator, Neonatal<br>Transport |
| Product Code | FPL | FPL | FPL | |
| Classification | II | II | II | |
| Intended Use | Intended for the<br>transport of high<br>risk premature,<br>low birth weight,<br>or critically ill<br>newborns be-<br>tween<br>healthcare facili-<br>ties. The means<br>of transportation<br>can be either<br>ground or air-<br>borne (rotary or<br>fixed wing). The<br>system is also<br>suitable for ei-<br>ther transport of<br>stationary care<br>within the hospi-<br>tal. It includes<br>up to three sys-<br>tem compo-<br>nents. These<br>components<br>include a frame<br>which houses<br>the incubator<br>and the pneu-<br>matic module<br>assembly, and a<br>facility for gas<br>cylinder storage.<br>The system is<br>arranged to | The transport in-<br>cubator is intend-<br>ed for use by per-<br>sonnel trained in<br>neonatal care to<br>facilitate the<br>movements of<br>neonates by air or<br>ambulance. | Intended for the<br>transport of newborns<br>weighing up to 10 kg<br>(22 lb.) between health<br>care facilities. It pro-<br>vides a means to con-<br>trol air temperature,<br>deliver oxygen, resusci-<br>tate, provide passive<br>humidification and ven-<br>tilate with active humidi-<br>fication. | The general intend-<br>ed use of the<br>GT5400 has not<br>changed from the<br>predicate TI500GT.<br>The patient weight is<br>linked to the TI500<br>incubator. The<br>TI500 incubator is<br>used in the GT5400<br>and the TI500 GT<br>therefore the patient<br>weight is the same<br>for both devices. |
| Specification | Predicate | Predicate | Device Under Review | Comments |
| Device Name | TI500 Globe-<br>trotter Neonatal<br>Transport Sys-<br>tem<br>(TI500 GT or<br>GT500)<br>plete unit for the<br>care of an infant<br>in need of trans-<br>portation. | Airborne<br>Life<br>Support<br>Transport Incu-<br>bator<br>Aviator | Globe-Trotter GT5400<br>(GT5400) | |
| Indications for<br>Use | Transport of<br>high risk prema-<br>ture, low birth<br>weight or criti-<br>cally ill new-<br>borns. It pro-<br>vides a means<br>to control air<br>temperature and<br>oxygen concen-<br>tration, to add<br>relative humidity<br>and to provide<br>resuscitation. | The transport in-<br>cubator is intend-<br>ed for use by per-<br>sonnel trained in<br>neonatal care to<br>facilitate the<br>movements of<br>neonates by air or<br>ambulance. | Transport of newborns<br>weighing up to 10 kg<br>(22 lb.) between health<br>care facilities. It pro-<br>vides means to control<br>air temperature, deliver<br>oxygen, resuscitate,<br>provide passive humidi-<br>fication, and ventilate<br>with active humidifica-<br>tion.<br>The Globe-Trotter<br>GT5400 neonatal<br>transport system is<br>intended for use by<br>trained health care<br>professionals and it is<br>not intended for home<br>use | Both the GT5400<br>and the TI500GT<br>provide passive<br>humidity. The<br>GT5400 also pro-<br>vides active humidi-<br>fication during venti-<br>lation via the cur-<br>rently marketed<br>NeoPod T System<br>(Humidifier for Neo-<br>natal Transport Ven-<br>tilators) K870173 |
| Target Popula-<br>tion/Patient<br>Population | Newborn infants | Newborn infants | Newly born infants up<br>to 10 kg. (22lbs) | The premise of the<br>population has not<br>changed from the<br>predicates. The<br>weight is now pro-<br>vided as additional<br>information for the<br>user. |
| Environment of<br>Use | Intra-hospital<br>transport as well<br>as transport<br>between health<br>care facilities | Transport between<br>health care facili-<br>ties | Same as T1500 GT | |
| System Speci-<br>fications | | | | |
| Device Classifi-<br>cation | Class I, Type<br>BF, continuous<br>operation | Not found on Mfg.<br>website | Same as T1500 GT | |
| Nominal System<br>length | 129.5 cm (50.9")<br>without cart | UNK | 163.9 cm (64.5 ") | The predicate T1500<br>GT is offered with or<br>without a cart. The. |
| Specification | Predicate | Predicate | Device Under Review | Comments |
| Device Name | TI500 Globe-<br>trotter Neonatal<br>Transport Sys-<br>tem<br>(TI500 GT or<br>GT500) | Airborne<br>Life<br>Support<br>Transport<br>Incu-<br>bator<br>Aviator | Globe-Trotter GT5400<br>(GT5400) | |
| | | | | GT5400 is offered |
| | | | | without a cart. |
| Nominal System<br>Width | 56.5 cm (22") | UNK | 57.8 cm (22.75") | |
| Nominal System<br>Height | 58.4 cm (22.9") | UNK | <42.6 - <58.5 cm<br>(16.8 in - 23 in) | |
| Nominal Weight | 83.9 kg (184.9<br>lb.) or 71.6 kg<br>(157.9 lb.) de-<br>pending on con-<br>figuration | UNK | 80-116 kg (176-254<br>lbs.) depending on<br>options | |
| Infant Weight | Not published | UNK | 10 kg (22 lbs.) | The patient weight is<br>linked to the incuba-<br>tor. Although not<br>previously published<br>the predicate T1500<br>GT and the GT5400<br>are the same. |
| Operating tem-<br>perature (nor-<br>mal) | 10-30 deg C<br>(50-86 deg F) | UNK | Same as T1500 GT | |
| Operating tem-<br>perature (limited<br>use) | 10-40 deg C<br>(50-104 deg F) | UNK | 10-30 deg C (50-86 deg<br>F) | |
| Storage temper-<br>ature | -40 - +70 deg.C<br>(-40 - 158 deg.<br>F)<br>Based on Incu-<br>bator | UNK | -20-+60 deg C (-4-140<br>deg F) | Device packaging is<br>marked with storage<br>temperature re-<br>quirements |
| Relative Humidi-<br>ty Operating<br>Range | 0-95% RH, non-<br>condensing | UNK | 5-95% RH, non-<br>condensing | |
| Altitude Operat-<br>ing Range | As published in<br>the TI500<br>transport incu-<br>bator IFU<br>Sea level to 3<br>km (10000 ft.)<br>non-pressurized<br>ambient; or sea<br>level to 12 km<br>(40,000ft.),<br>pressurized<br>ambient | UNK | Sea level to 3 km<br>(10000 ft.) non-<br>pressurized ambient | There is essentially<br>no difference be-<br>tween the operating<br>altitudes of the pred-<br>icate TI500 GT and<br>the GT5400. The<br>additional statement<br>"or sea level to 12<br>km (40,000ft.), pres-<br>surized ambient"<br>has been removed<br>from the GT5400 as<br>it is understood that<br>you can be at any<br>altitude as long as |
| Specification | Predicate | Predicate | Device Under Review | Comments |
| Device Name | T1500 Globe-<br>trotter Neonatal<br>Transport Sys-<br>tem<br>(T1500 GT or<br>GT500) | Airborne<br>Life<br>Support<br>Transport Incu-<br>bator<br>Aviator | Globe-Trotter GT5400<br>(GT5400) | |
| | | | | pressurized. |
| Environmental | | | | |
| Operating<br>(OP)Temp<br>Range | 10° C to 30° C<br>(50° F to 86° F)<br>ambient (nor-<br>mal)<br>10° C to 40° C<br>(50° F to 104° F)<br>ambient (limited) | UNK | 10° C to 30° C (50° F to<br>86° F) ambient (normal)<br>10° C to 30° C (50° F to<br>86° F) ambient (limited) | |
| OP Relative<br>Humidity Range | 0% RH to 95%<br>RH, non-<br>condensing | UNK | Same as predicate<br>T1500 GT | |
| OP Altitude<br>Range | Not defined | UNK | Sea level to 3km<br>(10,000 ft.) non-<br>pressurized ambient | GT5400 was tested<br>to RTCA DO160<br>which provided the<br>Altitude Range data. |
| Stor-<br>age/Transport<br>(S/T) Temp<br>Range | Not defined | UNK | -20° C to + 60° C (-4° F<br>to +140° F) ambient | No change to prod-<br>uct function |
| Electrical | | | | |
| External Power<br>Requirements | AC 110/120V,<br>50/60 Hz, Six<br>10A breakers-<br><480W worst<br>case (incubator,<br>compressor<br>charger, and<br>monitor) | AC 120V 50-…