(90 days)
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.
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.
The provided document is a 510(k) Premarket Notification for the Globe-Trotter® GT5400 neonatal transport system. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy or performance against specific, quantifiable clinical acceptance criteria that might be seen in, for example, an AI/ML device submission.
As such, the document does not contain the specific information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML or diagnostic performance. Instead, it discusses the device's technical specifications and compliance with safety and performance standards.
Here's what can be extracted based on the provided text, and where the requested information is not present:
1. A table of acceptance criteria and the reported device performance
The document provides a comparative table of technological characteristics between the Globe-Trotter GT5400 and its predicate devices (TI500 Globe-trotter Neonatal Transport System and Airborne Life Support Transport Incubator Aviator). This table details specifications like dimensions, weight, operating conditions, electrical requirements, and sub-system features.
The "Comments" column often highlights how the GT5400's specifications align with or relate to the predicate devices. For example:
- Operating temperature: "Same as TI500 GT"
- Infant Weight: "The patient weight is linked to the Incubator. Although not previously published, the predicate TI500 GT and the GT5400 are the same."
- Pressure Gauges: "Testing showed the digital gauge to be functionally equivalent to the analog gauge"
However, these are not "acceptance criteria" in the sense of predefined performance thresholds for a diagnostic or AI/ML device (e.g., sensitivity, specificity, accuracy metrics). They are technical specifications and equivalency statements.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device, and the testing described is primarily non-clinical engineering and performance testing against standards, not clinical data collection on a distinct "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is not a diagnostic device relying on expert-established ground truth from medical images or patient records.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device would be its adherence to established engineering specifications, safety standards (e.g., electrical, environmental, mechanical), and functional performance described in its design. The testing described (performance testing, functional/operation testing, verification and validation) confirms these engineering attributes.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of what the document does provide regarding the device meeting criteria:
The document states:
- "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..." (Page 12)
- "...and was determined to be as safe and effective for its intended use as the predicates." (Page 12)
- "The results of the non-clinical testing, and comparison to the predicate devices show that the modified GT5400 meets the performance requirements of the standards and guidance mentioned above and is substantially equivalent to the predicate devices." (Page 13)
The document lists several international standards and guidance documents that the device was tested against and found to meet, including:
- IEC 60601-1:2005 (General Requirements for Basic Safety and Essential Performance)
- IEC 60601-1-2:2007 (Electromagnetic compatibility)
- IEC 60602-1-6:2010 (Usability)
- IEC 62366:2007 (Application of Usability engineering)
- ISO 14971:2007 (Risk Management)
- EN 1789, EN 13718-1:2008, EN13976-1 (Rescue Systems, Air Ambulances, Transportation of Incubators)
- RTCA DO 160 Environmental Conditions and Test Procedures for Airborne Equipment Section 7 (Operational Shocks and Crash Safety)
- FAR 23/CAR 523 and FAR 29/CAR 529 (Federal Aviation Regulations and Canadian Air Regulations).
Essentially, the "acceptance criteria" here are compliance with these recognized safety and performance standards for neonatal transport incubators, and the "study" proving it involves a comprehensive suite of non-clinical engineering and performance tests, along with a comparison to predicate devices' technological characteristics to demonstrate substantial equivalence.
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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 (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
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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)
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 NeonatalTransport Sys-tem(TI500 GT orGT500) | AirborneLifeSupportTransport Incu-batorAviator | Globe-Trotter GT5400(GT5400) | |
| Manufacturer | Draeger MedicalSystems, Inc. | International Bio-medical | Draeger Medical Sys-tems, Inc. | |
| 510(k) | K001019 | K103527 | ||
| Regulation # | 880.5410 | 880.5410 | 880.5410 | Incubator, NeonatalTransport |
| Product Code | FPL | FPL | FPL | |
| Classification | II | II | II | |
| Intended Use | Intended for thetransport of highrisk premature,low birth weight,or critically illnewborns be-tweenhealthcare facili-ties. The meansof transportationcan be eitherground or air-borne (rotary orfixed wing). Thesystem is alsosuitable for ei-ther transport ofstationary carewithin the hospi-tal. It includesup to three sys-tem compo-nents. Thesecomponentsinclude a framewhich housesthe incubatorand the pneu-matic moduleassembly, and afacility for gascylinder storage.The system isarranged to | The transport in-cubator is intend-ed for use by per-sonnel trained inneonatal care tofacilitate themovements ofneonates by air orambulance. | Intended for thetransport of newbornsweighing up to 10 kg(22 lb.) between healthcare facilities. It pro-vides a means to con-trol air temperature,deliver oxygen, resusci-tate, provide passivehumidification and ven-tilate with active humidi-fication. | The general intend-ed use of theGT5400 has notchanged from thepredicate TI500GT.The patient weight islinked to the TI500incubator. TheTI500 incubator isused in the GT5400and the TI500 GTtherefore the patientweight is the samefor both devices. |
| Specification | Predicate | Predicate | Device Under Review | Comments |
| Device Name | TI500 Globe-trotter NeonatalTransport Sys-tem(TI500 GT orGT500)plete unit for thecare of an infantin need of trans-portation. | AirborneLifeSupportTransport Incu-batorAviator | Globe-Trotter GT5400(GT5400) | |
| Indications forUse | Transport ofhigh risk prema-ture, low birthweight or criti-cally ill new-borns. It pro-vides a meansto control airtemperature andoxygen concen-tration, to addrelative humidityand to provideresuscitation. | The transport in-cubator is intend-ed for use by per-sonnel trained inneonatal care tofacilitate themovements ofneonates by air orambulance. | Transport of newbornsweighing up to 10 kg(22 lb.) between healthcare facilities. It pro-vides means to controlair temperature, deliveroxygen, resuscitate,provide passive humidi-fication, and ventilatewith active humidifica-tion.The Globe-TrotterGT5400 neonataltransport system isintended for use bytrained health careprofessionals and it isnot intended for homeuse | Both the GT5400and the TI500GTprovide passivehumidity. TheGT5400 also pro-vides active humidi-fication during venti-lation via the cur-rently marketedNeoPod T System(Humidifier for Neo-natal Transport Ven-tilators) K870173 |
| Target Popula-tion/PatientPopulation | Newborn infants | Newborn infants | Newly born infants upto 10 kg. (22lbs) | The premise of thepopulation has notchanged from thepredicates. Theweight is now pro-vided as additionalinformation for theuser. |
| Environment ofUse | Intra-hospitaltransport as wellas transportbetween healthcare facilities | Transport betweenhealth care facili-ties | Same as T1500 GT | |
| System Speci-fications | ||||
| Device Classifi-cation | Class I, TypeBF, continuousoperation | Not found on Mfg.website | Same as T1500 GT | |
| Nominal Systemlength | 129.5 cm (50.9")without cart | UNK | 163.9 cm (64.5 ") | The predicate T1500GT is offered with orwithout a cart. The. |
| Specification | Predicate | Predicate | Device Under Review | Comments |
| Device Name | TI500 Globe-trotter NeonatalTransport Sys-tem(TI500 GT orGT500) | AirborneLifeSupportTransportIncu-batorAviator | Globe-Trotter GT5400(GT5400) | |
| GT5400 is offered | ||||
| without a cart. | ||||
| Nominal SystemWidth | 56.5 cm (22") | UNK | 57.8 cm (22.75") | |
| Nominal SystemHeight | 58.4 cm (22.9") | UNK | <42.6 - <58.5 cm(16.8 in - 23 in) | |
| Nominal Weight | 83.9 kg (184.9lb.) or 71.6 kg(157.9 lb.) de-pending on con-figuration | UNK | 80-116 kg (176-254lbs.) depending onoptions | |
| Infant Weight | Not published | UNK | 10 kg (22 lbs.) | The patient weight islinked to the incuba-tor. Although notpreviously publishedthe predicate T1500GT and the GT5400are the same. |
| Operating tem-perature (nor-mal) | 10-30 deg C(50-86 deg F) | UNK | Same as T1500 GT | |
| Operating tem-perature (limiteduse) | 10-40 deg C(50-104 deg F) | UNK | 10-30 deg C (50-86 degF) | |
| Storage temper-ature | -40 - +70 deg.C(-40 - 158 deg.F)Based on Incu-bator | UNK | -20-+60 deg C (-4-140deg F) | Device packaging ismarked with storagetemperature re-quirements |
| Relative Humidi-ty OperatingRange | 0-95% RH, non-condensing | UNK | 5-95% RH, non-condensing | |
| Altitude Operat-ing Range | As published inthe TI500transport incu-bator IFUSea level to 3km (10000 ft.)non-pressurizedambient; or sealevel to 12 km(40,000ft.),pressurizedambient | UNK | Sea level to 3 km(10000 ft.) non-pressurized ambient | There is essentiallyno difference be-tween the operatingaltitudes of the pred-icate TI500 GT andthe GT5400. Theadditional statement"or sea level to 12km (40,000ft.), pres-surized ambient"has been removedfrom the GT5400 asit is understood thatyou can be at anyaltitude as long as |
| Specification | Predicate | Predicate | Device Under Review | Comments |
| Device Name | T1500 Globe-trotter NeonatalTransport Sys-tem(T1500 GT orGT500) | AirborneLifeSupportTransport Incu-batorAviator | Globe-Trotter GT5400(GT5400) | |
| pressurized. | ||||
| Environmental | ||||
| Operating(OP)TempRange | 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 to86° F) ambient (normal)10° C to 30° C (50° F to86° F) ambient (limited) | |
| OP RelativeHumidity Range | 0% RH to 95%RH, non-condensing | UNK | Same as predicateT1500 GT | |
| OP AltitudeRange | Not defined | UNK | Sea level to 3km(10,000 ft.) non-pressurized ambient | GT5400 was testedto RTCA DO160which provided theAltitude Range data. |
| Stor-age/Transport(S/T) TempRange | Not defined | UNK | -20° C to + 60° C (-4° Fto +140° F) ambient | No change to prod-uct function |
| Electrical | ||||
| External PowerRequirements | AC 110/120V,50/60 Hz, Six10A breakers-<480W worstcase (incubator,compressorcharger, andmonitor) | AC 120V 50-400Hz | AC 110/120V, 50/60Hz, 12A max. - Powerconsumption varieswith system configura-tion | The power con-sumption of the In-cubator portion isthe same for boththe predicate TI500GT and the GT5400.The GT5400 hasmore OEM devicesalong with auxiliaryoutlets for other useradded devices.Therefore the designof the GT5400 is 12A instead of 10 A |
| AC 230V,50/60Hz, Six 5Abreakers -<400W worstcase (incubator,compressorcharger, andmonitor) | AC 230V 50-400Hz | AC 230V, 50/60Hz, 8Amax. - Power con-sumption varies withsystem configuration | ||
| Auxiliary PowerSockets | Yes | UNK | Yes | |
| Specification | Predicate | Predicate | Device Under Review | Comments |
| Device Name | TI500 Globe-trotter NeonatalTransport Sys-tem(TI500 GT orGT500) | AirborneLifeSupportTransport Incubator (Aviator) | Globe-Trotter GT5400(GT5400) | |
| Leakage Current | 110/120V - 300 $\mu$ A230V - 500 $\mu$ Aor less | UNK | $\le$ 5 mA (normal condition)$\le$ 10mA (single fault condition) | |
| Physical Specifications | Dimensions Provided are the Maximum | |||
| PublishedLength | 129.5 cm (50.9") | UNK | $\le$ 163.9 cm (64.5") | |
| Published Width | 56.5 cm (22.2") | UNK | $\le$ 57.8 cm (22.75") | |
| PublishedHeight | 58.4 cm(22.9") | UNK | $\le$ 58.5 cm (23 in) | |
| PublishedWeight | 83.9 kg (184.9 lb.) | UNK | $\le$ 101.1 kg (222.9 lb.) | |
| Sub SystemFeatures | ||||
| Transport Incubator | Draeger MedicalSystems, Inc.TI500K001019 | International BiomedicalIncubator as part of the AirborneLifeSupport TransportIncubator (Aviator)K103527 | Draeger Medical Systems, Inc. T1500 for GT5400Modified TI500 Incubator is only sold as part of the GT5400 system | The TI500 incubator is a component of every GT5400 basic system. All GT5400s used during the verification activities included the modified TI500.Modifications for the GT5400 version of the TI500 were tested and showed no impact to the performance of the incubator. |
| Incubator is sold as a stand-alone or as part of the TI500 Globetrotter Neonatal Transport System | Incubator is sold as part of the system | |||
| Incubator Hood | Low or High | UNK | Same as predicate TI500GT | |
| Tubing Support | None Provided | UNK | Provided | Tubing support is commonly used to |
| Specification | Predicate | Predicate | Device Under Review | Comments |
| Device Name | TI500 Globe-trotter NeonatalTransport Sys-tem(TI500 GT or GT500) | AirborneLifeSupportTransportIncubatorAviator | Globe-Trotter GT5400(GT5400) | |
| hold tubing andwires to keep themorganized within anincubator.The GT5400 pro-vides a third partytubing support cur-rently marketed foruse in "any incuba-tor or warming ta-ble". | ||||
| Blender | Biomed DevicesBlenderK925982 | Biomed DevicesBlenderK925982 | Same as predicates | |
| Mechanical Ventilator | Biomed DevicesMVP10Pre-Amendment | Biomed DevicesMVP10Infant TransportVent.Pre-Amendment | Same as predicates | A ventilator is astandard part of theGT5400 basic sys-tem, however theuser may choosebetween the MVP10and CV2i ventilator. |
| N/A | Biomed DevicesCV2i w/ O2 MonitorInfant TransportVent.K942938 | Same as predicateAirborne | ||
| Auxiliary O2Flow Control | Y | UNK | Y | |
| O2 Monitor | Y | Y | Y | GT5400 uses Tele-dyne Analytical In-struments MX300,K024155 - Like theTI500 GT predicate,an O2 Monitor isstandard when |
| Specification | Predicate | Predicate | Device Under Review | Comments |
| Device Name | T1500 Globe-trotter Neonatal Transport System(TI500 GT or GT500) | Airborne Life Support Transport IncubatorAviator | Globe-Trotter GT5400(GT5400) | |
| Modular Frame | Y | Y | Y | MVP10 Ventilator isselectedThe MX300 is mar-keted for use onneonates. |
| Suction | Y | Y | Y | Standard as part ofthe GT5400 basicsystem |
| Infusion Pump | N | B. Braun PerfusorSpace PumpK092313 | Same as used withpredicate Airborne | Optional for GT5400The Perfusor SpacePump is marketedfor use on neonates |
| CO2 Monitor | N | N | Oridion Medical,Microcap CapnographK981114 | Optional for GT5400The Microcap ismarketed for use onneonates |
| Vital Signs Moni-tor | N | Welch AllynPropaq Monitor | Welch Allyn,Propaq LT Monitor w/oRadioK033378 | Optional for GT5400The Propaq LT ismarketed for use onneonates |
| Active Humidifi-cation | N | Y | Westmed Inc. NeopodT System (LavabedSystem)K870173 | Standard as part ofthe GT5400 basicsystemThe Neopod T sys-tem includes thedisposable breathingcircuit for humidifica-tion and is marketedfor use on neonates |
| DisposableBreathing Circuitw/out Humidifi-cation | Y | Y | Biomed DevicesBreathing CircuitPre-Amendment | Circuit provided withinitial shipment ofGT5400.Marketed for use onneonates |
| ResuscitationBag | Y | Y | N | Resuscitation bagsare purchased fromresuscitation suppli-ers by each facility |
| Specification | Predicate | Predicate | Device Under Review | Comments |
| Device Name | TI500 Globe-trotter NeonatalTransport Sys-tem(TI500 GT or GT500) | Airborne LifeSupport TransportIncubatorAviator | Globe-Trotter GT5400(GT5400) | |
| based on their preference. These decisions and purchases are made independent of the transport system, therefore a bag is not provided with the GT5400. | ||||
| ExaminationLight | Y | Y | Y | The exam light for the TI500 GT was incandescent. The exam light for the GT5400 is LED |
| Pressure Gaug-es | Analog | Analog | Digital | Testing showed the digital gauge to be functionally equivalent to the analog gauge |
| Cylinder storage | Y - Static holderwith straps to secure the cylinder. | Y | Y - Movable cylinder tray with straps to secure the cylinder. | |
| Battery | 1 | 1 | 1 or 2 | 1 battery is std. as part of the GT5400. A second battery is optional for the ground vehicle configuration. The 2 battery feature was included in the system configuration during verification. |
| Accessory deckwith mountingrails | N | N | Y | Accessory deck is standard as part of the GT5400 system. It allows the user to add devices of their choosing to the system. Weight limit restriction is identified as 60 lbs. for ground transport and 30 lbs. for air transport. These configurations were tested during the system verification. |
| Specification | Predicate | Predicate | Device Under Review | Comments |
| Device Name | TI500 Globe-trotter NeonatalTransport Sys-tem(TI500 GT orGT500) | AirborneLifeSupportTransport Incu-batorAviator | Globe-Trotter GT5400(GT5400) | |
| Chart/CellPhone Holder | N | UNK | Y | Standard as part ofthe GT5400 system.This feature wasincluded in the sys-tem configurationduring verificationtesting. |
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Discussion of Non-clinical Studies:
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.
Biocompatibility:
The biocompatibility assessment shows that new materials added to the GT5400 with patient contact are currently used in products or legally marketed devices for use with neonates.
Sterilization:
Not applicable
Standards and Guidance:
Performance Standards: None
International Standards:
IEC 60601-1:2005 - Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-2:2007 - Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60602-1-6:2010 - Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
IEC 62366:2007 - Medical devices - Application of Usability engineering to medical devices
ISO 14971:2007 - Medical Devices - Application of Risk Management to Medical Devices
- EN 1789 Rescue Systems Transportation of Incubators Part 1: Interface conditions
EN 13718-1:2008 - Medical Vehicles and Their Equipment - Air Ambulances
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Part 1: Requirements for Medical De-vices Used in Air Ambulances Part 2: Operational and Technical Requirements of Air Ambulances
EN13976-1 - Rescue Systems - Transportation of Incubators Part 1: Interface conditions Part 2: System Requirements
- RTCA DO 160 Environmental Conditions and Test Procedures for Airborne Equipment Section 7 (Operational Shocks and Crash Safety)
FAR 23/CAR 523 FAR 29/CAR 529 - Federal Aviation Regulations (FAR) and Canadian Air Regulations (CAR) sections FAR 23/CAR 523 and FAR 29/CAR 529
Guidance:
Neonatal and Neonatal Transport Incubators - Premarket Notifications 09/18/1998
Draft Guidance: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, 06/22/2011
Conclusion Drawn from Non-Clinical Studies:
The results of the non-clinical testing, and comparison to the predicate devices show that the modified GT5400 meets the performance requirements of the standards and guidance mentioned above and is substantially equivalent to the predicate devices.
§ 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).