(90 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a combination of existing devices without modification of their principles of operation.
Yes
The device is described as a neonatal transport system that provides means to control air temperature, deliver oxygen, resuscitate, provide passive humidification, and ventilate with active humidification. These functions directly contribute to the medical treatment and care of newborns during transport, fitting the definition of a therapeutic device.
No
Explanation: The device is a neonatal transport system that provides environmental control and life support functions, such as temperature control, oxygen delivery, resuscitation, humidification, and ventilation. These are therapeutic and life-support functions, not diagnostic ones. There is no mention of the device being used to identify or monitor medical conditions.
No
The device description explicitly states it is comprised of hardware components: a transport incubator, modular frame, and life support console.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for transporting newborns and providing life support functions (temperature control, oxygen delivery, ventilation, etc.). This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The description details a combination of medical devices focused on maintaining the physiological well-being of the infant during transport.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to detect diseases, conditions, or infections. The Globe-Trotter GT5400 does not perform such tests.
N/A
Intended Use / Indications for Use
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.
Product codes
FPL
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.
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
newborns, Newly born infants
Intended User / Care Setting
trained health care professionals, intra-hospital transport, between healthcare facilities, air or ground
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 GT5400 was tested in accordance with applicable standards, guidance and internal design control procedures including performance testing, functional/operation testing, verification and validation, biocompatibility assessment, risk analysis and verification of risk control measures and was determined to be as safe and effective for its intended use as the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K870173, K024155, K092313, K981114, K033378, K870173
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5410 Neonatal transport incubator.
(a)
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.(b)
Classification. Class II (performance standards).
0
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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.
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.
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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
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)
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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 | ||||||||||
| Phone:215-660-2239Fax:215-721-5424 | 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: | Trade Name:Globe-trotter® GT5400Classification Name:Incubator, Neonatal TransportRegulation Number:21 CRF 880.5410Product Code:FLPClass:II | 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- | |||
| 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 |