(123 days)
No
The summary describes a standard transport incubator with temperature control and optional monitoring features. There is no mention of AI/ML algorithms, data training, or performance metrics typically associated with such technologies.
Yes
The device provides heat in a controlled manner, and it can be optionally configured with blue LED phototherapy to treat indirect hyperbilirubinemia, both of which are therapeutic interventions.
No
The device is primarily an incubator providing a controlled environment and warmth for neonates during transport. While it can be optionally configured with a pulse oximeter (which provides diagnostic information), a suction device, and phototherapy, its core function as described is not diagnostic. The provided text emphasizes maintaining a stable environment and temperature, not diagnosing medical conditions.
No
The device description clearly outlines a physical hardware device (incubator) with various integrated hardware components (heating elements, sensors, optional pulse oximeter, suction device, phototherapy, heated mattress). The software controls these hardware functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The NextGen Transport Incubator is designed to provide a controlled thermal environment for neonates during transport. It focuses on maintaining body temperature and supporting vital functions through optional monitoring and airway management equipment.
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens from the neonate. Its function is external to the body and focused on environmental control and physiological support.
The device is a medical device, specifically a transport incubator, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NextGen Transport Incubator is intended for use by personnel care to facilitate the movements of neonates by air or ambulance. The transport incubator provides heat in a controlled manner to neonates through an enclosed temperature controlled environment. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status. The device provides two modes of heat: Manual (operator) controlled or Skin (servo) controlled. All transport incubators may be optionally configured with pulse oximetry, a suction device, and an integrated heated mattress. In addition, the NextGen Incubator may be configured with optional blue LED phototherapy to treat indirect hyperbilirubinemia.
Product codes (comma separated list FDA assigned to the subject device)
FPL
Device Description
The NxtGen Infant Transport Incubator is designed to provide a thermally stable environment for the infant during transport. The incubator is designed to maintain temperatures within desired limits as prescribed by the caregiver.
The NxtGen Infant Transport Incubator has two modes of temperature control available – manual temperature mode and skin temperature control mode (or servo mode). The device includes several optional features including: integrated ambient oxygen monitor, integrated pulse oximeter, integrated phototherapy lighting, integrated electronic suction device, and an integrated heated mattress.
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
Neonates
Intended User / Care Setting
personnel trained in neonatal care / Intra-hospital and transport between healthcare facilities
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)
Performance Testing:
Testing was performed to confirm compliance to the following standards:
- IEC 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety
- IEC 60601-1-2, Medical Electrical Equipment, Part 1-2: General Requirements for Safety Collateral Standard: Electromagnetic Compatibility
- . IEC 60601-1-12, Medical Electrical Equipment, Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
- IEC 60601-1-8, Medical Electrical Equipment, Part 1-8: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-1-6, Medical Electrical Equipment, Part 1-6: General Requirements for Safety – Collateral Standard: Usability
- IEC 60601-2-20, Medical Electrical Equipment, Part 2-20: Particular Requirements for the Basic Safety and Essential Performance of Transport Incubators
- ISO 10079-1, Medical suction equipment - Part 1: Electrically powered suction equipment
- IEC 60601-2-50, Medical electrical equipment Part 2-50: Particular requirements for ● the basic safety and essential performance of infant phototherapy equipment
- IEC 80601-2-35, Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
- IEC 80601-2-55, Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- IEC 80601-2-61, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Bench Testing:
The following additional tests were performed
- Software Verification & Validation Testing
- Software verification and validation testing was conducted and documentation was provided for review.
- Device Validation
- The device was functionally tested to confirm the performance to the essential o requirements of the device, including warming, skin temperature monitoring and alarms.
- Biocompatibility Testing
- The biocompatibility evaluation for the NxtGen Infant Transport Incubator was O conducted in accordance with the FDA guidance on Biocompatibility on the International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The testing included Cytotoxicity, Irritation and Sensitization.
- Human Factor Evaluation
- The usability evaluation for the NxtGen Infant Transport Incubator was O conducted in accordance with the FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff.
- Reprocessing Evaluation
- The reprocessing validation for the NxtGen Infant Transport Incubator was conducted in accordance with the FDA guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff.
Key Results:
In regards to intended use and technology the NxtGen Infant Transport Incubator is substantially equivalent to the listed predicate. Through functional performance testing the subject device has demonstrated substantial equivalence to the predicate device.
Any differences between NxtGen Infant Transport Incubator and the predicate do not raise any new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K141565, K173516, K120168, K771737, K914601, K160238
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
July 15, 2022
International Biomedical Amy Pieper Director of Regulatory Affairs 8206 Cross Park Drive Austin, Texas 78754
Re: K220742
Trade/Device Name: NxtGen Infant Transport Incubator Regulation Number: 21 CFR 880.5410 Regulation Name: Neonatal Transport Incubator Regulatory Class: Class II Product Code: FPL Dated: June 15, 2022 Received: June 17, 2022
Dear Amy Pieper:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paval Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name NxtGen Infant Transport Incubator
Indications for Use (Describe)
The NextGen Transport Incubator is intended for use by personnel care to facilitate the movements of neonates by air or ambulance. The transport incubator provides heat in a controlled manner to neonates through an enclosed temperature controlled environment. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status. The device provides two modes of heat: Manual (operator) controlled or Skin (servo) controlled. All transport incubators may be optionally configured with pulse oximetry, a suction device, and an integrated heated mattress. In addition, the NextGen Incubator may be configured with optional blue LED phototherapy to treat indirect hyperbilirubinemia.
| 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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3
510(k) SUMMARY - K220742
Submitter Information:
Regulatory Affairs Contact:
International Biomedical 8206 Cross Park Drive Austin, TX 78754 U.S.A.
Amy Pieper Director of Regulatory Affairs (512) 873-0033 - phone (512) 873-9090 - fax
Date Summary Prepared: July 8, 2022
Device Identification:
Trade Name: NxtGen Infant Transport Incubator Common Name: Transport Incubator Regulatory Class: II Regulation: 880.5410 Product Code: FPL Panel: General Hospital
Predicate Device:
International Biomedical - Voyager Infant Transport Incubator - K103524
Device Description:
The NxtGen Infant Transport Incubator is designed to provide a thermally stable environment for the infant during transport. The incubator is designed to maintain temperatures within desired limits as prescribed by the caregiver.
The NxtGen Infant Transport Incubator has two modes of temperature control available – manual temperature mode and skin temperature control mode (or servo mode). The device includes several optional features including: integrated ambient oxygen monitor, integrated pulse oximeter, integrated phototherapy lighting, integrated electronic suction device, and an integrated heated mattress.
Indications for Use:
The NxtGen Transport Incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance. The transport incubator provides heat in a controlled manner to neonates through an enclosed temperature controlled environment. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status. The device provides two modes
4
of heat: Manual (operator) controlled or Skin (servo) controlled. All transport incubators may be optionally configured with pulse oximetry, a suction device, and an integrated heated mattress. In addition, the NextGen Incubator may be configured with optional blue LED phototherapy to treat indirect hyperbilirubinemia.
Summary Technological Comparison:
The NxtGen Infant Transport Incubator described in this submission is, in our opinion, substantially equivalent to the predicate devices, in regards to intended use and safety and effectiveness.
The intended use of the NxtGen Infant Transport Incubator is equivalent to the intended use of the predicate K103524. The differences in the intended use do not raise questions about the safety or effectiveness for the subject device.
| System | International Biomedical NXTGEN | International Biomedical | Differences | Discussion of Differences | |
|---|---|---|---|---|---|
| Specification | Transport Incubator | Voyager Transport Incubator | |||
| New Device | Primary Predicate Device | ||||
| Base Model Specifications | |||||
| General | K220742 | K103524 | |||
| Indications | |||||
| for Use | The NxtGen Transport Incubator is | ||||
| intended for use by personnel | |||||
| trained in neonatal care to facilitate | |||||
| the movements of neonates by air or | |||||
| ambulance. The transport incubator | |||||
| provides heat in a controlled manner | |||||
| to neonates through an enclosed | |||||
| temperature controlled | |||||
| environment. The transport | |||||
| incubator is also intended to carry | |||||
| equipment designed for airway | |||||
| management and monitoring of the | |||||
| neonatal infant's status. The device | |||||
| provides two modes of heat: Manual | |||||
| (operator) controlled or Skin (servo) | |||||
| controlled. All transport incubators | |||||
| may be optionally configured with | |||||
| pulse oximetry, a suction device, and | |||||
| an integrated heated mattress. In | |||||
| addition, the NxtGen Incubator may | |||||
| be configured with optional blue LED | |||||
| phototherapy to treat indirect | |||||
| hyperbilirubinemia. | The transport incubator is | ||||
| intended for use by personnel | |||||
| trained in neonatal care to | |||||
| facilitate the movements of | |||||
| neonates by air or | |||||
| ambulance. The transport | |||||
| incubator circulates warmed | |||||
| air at an operator selected | |||||
| and controlled temperature | |||||
| when transporting neonatal | |||||
| infants to hospitals prepared | |||||
| for neonatal infant care. The | |||||
| transport incubator is also | |||||
| intended to carry equipment | |||||
| designed for airway | |||||
| management and monitoring | |||||
| of the neonatal infant's | |||||
| status. | Similar | The intended use of the proposed device and the | |||
| predicate device is for transporting neonatal | |||||
| infants using controlled air temperature. |
Differences involve the addition of servo
temperature control, which is a common
temperature control feature on other transport
incubators on the market, including K141565
(Draeger GT-5400).
Servo (or baby temperature) controlled
temperature is a safe and effective heating
method that is common in infant incubators and
is defined in the safety standard 60601-2-20. | |
| Patient
Population | Neonate | Neonate | Same | N/A | |
| Patient
Weight
(Max) | 10 Kg (22 LBS) | 7.3 Kg (16 LBS.) | Larger
capacity | The only change is a larger capacity patient
weight. Patient weight capacity within the
chamber does not have an effect on safety and
effectiveness of the device and is considered in
the safety testing performed | |
| System | International Biomedical NXTGEN
Transport Incubator
New Device | International Biomedical
Voyager Transport Incubator
Primary Predicate Device | Differences | Discussion of Differences | |
| Specification | | | | | |
| Environment of Use | Intra-hospital and transport between
healthcare facilities. | Intra-hospital and transport
between healthcare facilities. | Same | N/A | |
| Prescriptive | Yes | Yes | Same | N/A | |
| Heating
Technology | Convective Air | Convective Air | Same | N/A | |
| Hood
Design | Double Wall | Double Wall | Same | N/A | |
| Skin Temp
Monitoring | Yes | Yes | Same | N/A | |
| Skin
Temperature Probe
(T1-Primary) | 700-3401 (Disposable)
739-1603 (Reusable) | N/A | New
optional
control
mode
feature | The T1 temperature probe provides feedback on
the patient temperature to the NxtGen system as
a part of the servo control mode. The addition of
servo temperature control, which is a common
temperature control feature on other transport
incubators on the market, including K141565
(Draeger GT-5400) does not raise new questions
of safety and effectiveness and is defined and
tested in FDA recognized standard 60601-2-20. | |
| Temperature Probe
(T2-Reference) | 700-3409 (YSI 400 series compatible) | 700-3409 (YSI 400 series
compatible) | Same | N/A | |
| Infant
Mattress | Cast-coated polyurethane
Polyester - Ventex Recovery 6 | Cast-coated polyurethane
Polyester - Ventex Recovery
6 | Same | The infant mattress is the same mattress used
with the predicate incubator and also the same
cover material as the new optional heated
mattress cover and also the same as the mattress
in the International Biomedical NuBorne Infant
Warmer K173516. | |
| | Operating Mode | | | | |
| Air
Controlled
Mode | Yes | Yes | Same | N/A | |
| Temperature Set Point
Range-Air
Temp | 17.0°C-38.9°C | 17.0°C-38.9°C | Same | N/A | |
| Air
Controlled
Alarm Point | $\pm$ 1.5 °C from Temperature Set Point
Range-Air Temp | $\pm$ 1 °C from Temperature Set
Point Range-Air Temp | Similar | The proposed new device alarm point is still
within the prescribed temperature alarm range in
the 60601-2-20 standard and is more consistent
with current technology. | |
| Servo
Controlled
Mode | Yes | No | New
optional
control
mode | The addition of servo temperature control, which
is a common temperature control feature on
other transport incubators on the market,
including K141565 (Draeger GT-5400) is a safe
and effective heating method and is defined in
the safety standard 60601-2-20. | |
| Temperature Set Point
Range-
Baby Temp | 33°C-37.5°C | N/A | New control
mode
feature | The addition of servo temperature control, which
is a common temperature control feature on
other transport incubators on the market,
including K141565 (Draeger GT-5400) is a safe
and effective heating method and is defined in | |
| System | International Biomedical NXTGEN | International Biomedical | Differences | Discussion of Differences | |
| Specification | Transport Incubator | Voyager Transport Incubator | | | |
| | New Device | Primary Predicate Device | | | |
| Servo
Controlled
Alarm Point | $\pm$ 0.7 °C from Temperature Set Point
Range-Baby Temp | N/A | New control
mode
feature | the safety standard 60601-2-20.
The addition of servo temperature control, which
is a common temperature control feature on
other transport incubators on the market,
including K141565 (Draeger GT-5400) is a safe
and effective heating method and is defined in
the safety standard 60601-2-20. | |
| PreWarm
Mode | Yes | No | New
standby
mode | Pre-Warm mode is simply a stand-by mode
where the incubator can be turned on and
"warmed up" without a patient present. This is
common practice in hospitals so that the
incubator is ready to go when a patient is placed
inside.
Because the device does not run in pre-warm
mode with a patient, the mode has no additional
safety and effectiveness impact. | |
| | Incubator Features | | | | |
| Approximat
e Warm-up
Time | 12 minutes $\pm$ 20% (Low Profile
Chamber)
16 Minutes $\pm$ 20% (XL Chamber) | 20 Minutes | Different
warm-up
time | The warm-up time allows for the device to be
heated sooner compared to the predicate device.
There is no impact to safety and effectiveness. | |
| | Electrical Description | | | | |
| External
Power | AC 100-240 V, 50 -60 Hz. | AC 110/120 V, 50-60 Hz.
AC 230 V, 50-60 H | Same | N/A | |
| Internal
Power | 1-12 V DC, Lead Acid Battery, sealed,
rechargeable.
1-12 V DC, Lithium-Iron Phosphate,
rechargeable | 1-12 V DC, Lead Acid Battery,
sealed, rechargeable. | Same
New battery
option | N/A
Lithium –Iron Phosphate battery is battery
technology most commonly used in medical
devices that offer superior life to the older Lead
Acid type of batteries. Assessed through
performance testing. | |
| Battery Life
Expectance | 4.5 hours | 3 hours | Different | Battery life expectancy is increased compared to
the predicate. This will make long transports
safer as the device will not stop working or
require AC power as quickly. Assessed through
performance testing. | |
| Expected
Battery
Cycles | 200 cycles | 200 cycles | Same | N/A | |
| | Physical Description | | | | |
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Image /page/5/Picture/0 description: The image shows the logo for International Biomedical. The logo consists of a stylized letter "B" on the left, followed by the words "international" in a smaller font and "BIOMEDICAL" in a larger, bolder font. A registered trademark symbol is located to the right of the word "BIOMEDICAL".
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Image /page/6/Picture/5 description: The image shows the logo for International Biomedical. The logo consists of a stylized symbol resembling a beta symbol with a swirl at the top, followed by the words "international" in a smaller font above "BIOMEDICAL" in a larger font. A registered trademark symbol is placed to the right of the word "BIOMEDICAL".
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| System | International Biomedical NXTGEN | International Biomedical | Differences | Discussion of Differences | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Specification | Transport Incubator | Voyager Transport Incubator | ||||||||
| New Device | Primary Predicate Device | |||||||||
| Dimensions | Height | |||||||||
| inches | ||||||||||
| (cm) | Width | |||||||||
| inches | ||||||||||
| (cm) | Depth | |||||||||
| inches | ||||||||||
| (cm) | Weight | |||||||||
| lbs. | ||||||||||
| (kg) | Height | |||||||||
| inches | ||||||||||
| (cm) | Width | |||||||||
| inches | ||||||||||
| (cm) | Depth | |||||||||
| inches | ||||||||||
| (cm) | Weight | |||||||||
| lbs. | ||||||||||
| (kg) | Weight capacity is greater compared to the predicate. | |||||||||
| Incubator | ||||||||||
| without | ||||||||||
| infant | ||||||||||
| chamber or | ||||||||||
| handles | 10.7 | |||||||||
| (27.2) | 32.1 | |||||||||
| (81.5) | 18.4 | |||||||||
| (40.5) | 65 | |||||||||
| (29.5) | 10 | |||||||||
| (25.4) | 37.5 | |||||||||
| (95.2) | 19.2 | |||||||||
| (48.8) | 78 | |||||||||
| (35) | Similar | |||||||||
| Low Profile | ||||||||||
| Infant | ||||||||||
| Chamber | 11.3 | |||||||||
| (28.7) | 30 | |||||||||
| (76.2) | 16.7 | |||||||||
| (42.4) | 18.9 | |||||||||
| (8.6) | 10.75 | |||||||||
| (27.3) | 29 | |||||||||
| (73.7) | 17 | |||||||||
| (43.2) | 17 | |||||||||
| (7.7) | ||||||||||
| XL Infant | ||||||||||
| Chamber | 13.3 | |||||||||
| (33.8) | 30 | |||||||||
| (76.2) | 16.7 | |||||||||
| (42.4) | 21.1 | |||||||||
| (9.6) | 11.25 | |||||||||
| (28.6) | 29 | |||||||||
| (73.7) | 17 | |||||||||
| (43.2) | 20 | |||||||||
| (9.1) | ||||||||||
| Material | ||||||||||
| Material | ||||||||||
| Used for | ||||||||||
| Indirect | ||||||||||
| Patient | ||||||||||
| Contact | Metal (e.g. Aluminum); Molded | |||||||||
| Plastic | Metal (e.g. Aluminum); | |||||||||
| Molded Plastic | Same | N/A | ||||||||
| Material | ||||||||||
| used for | ||||||||||
| direct | ||||||||||
| patient | ||||||||||
| contact | Cell Cast Acrylic; Textile (Ventex | |||||||||
| Recovery 6) | Cell Cast Acrylic; Textile | |||||||||
| (Ventex Recovery 6) | Same | N/A | ||||||||
| Optional Components | ||||||||||
| Heated Mattress | ||||||||||
| Integrated | ||||||||||
| Heated | ||||||||||
| Mattress | Yes | No | New | |||||||
| mattress | ||||||||||
| functionality | The integrated heated mattress is not a new | |||||||||
| technology or item used in neonatal care. Heated | ||||||||||
| mattresses are common in transport incubators | ||||||||||
| already on the market, as can be found in | ||||||||||
| K141565 (Draeger GT-5400). | ||||||||||
| Mattress | ||||||||||
| Dimensions | 31.8 ± 61.0 ± 2.5 cm | 31.8 ± 61.0 ± 2.5 cm | New | |||||||
| mattress | ||||||||||
| feature | The integrated heated mattress and its | |||||||||
| components are compliant with ISO 80601-2-35. | ||||||||||
| For verification of compliance refer to Intertek | ||||||||||
| Safety Report 104427163LAX-005. | ||||||||||
| Mattress | ||||||||||
| Max | ||||||||||
| Temperatu | ||||||||||
| re | 40°C | N/A | New | |||||||
| mattress | ||||||||||
| feature | The integrated heated mattress and its | |||||||||
| components are compliant with ISO 80601-2-35. | ||||||||||
| For verification of compliance refer to Intertek | ||||||||||
| Safety Report 104427163LAX-005. | ||||||||||
| Power | ||||||||||
| Rating | 20 Watt | N/A | New | |||||||
| mattress | ||||||||||
| feature | The integrated heated mattress and its | |||||||||
| components are compliant with ISO 80601-2-35. | ||||||||||
| For verification of compliance refer to Intertek | ||||||||||
| Safety Report 104427163LAX-005. | ||||||||||
| Heated | ||||||||||
| Mattress | ||||||||||
| Element | 738-2409 | N/A | New | |||||||
| mattress | ||||||||||
| feature | The integrated heated mattress and its | |||||||||
| components are compliant with ISO 80601-2-35. | ||||||||||
| For verification of compliance refer to Intertek | ||||||||||
| Safety Report 104427163LAX-005. | ||||||||||
| Heated | ||||||||||
| Mattress | ||||||||||
| Cover | 736-1114 | N/A | New | |||||||
| mattress | ||||||||||
| feature | The integrated heated mattress and its | |||||||||
| components are compliant with ISO 80601-2-35. | ||||||||||
| For verification of compliance refer to Intertek | ||||||||||
| Safety Report 104427163LAX-005. | ||||||||||
| Heated | Cast-coated polyurethane | Cast-coated polyurethane | Same | N/A |
8
Image /page/8/Picture/0 description: The image shows the logo for International Biomedical. The logo consists of a stylized letter "B" with a swirl at the top left, followed by the words "international" in a smaller font and "BIOMEDICAL" in a larger, bolder font. A registered trademark symbol is present to the right of the word "BIOMEDICAL".
| System
Specification | International Biomedical NXTGEN
Transport Incubator
New Device | International Biomedical
Voyager Transport Incubator
Primary Predicate Device | Differences | Discussion of Differences |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------|
| Mattress
Cover
Material | Polyester - Ventex Recovery 6 | Polyester - Ventex Recovery 6 | | |
| Integrated
SpO2 | Yes | Yes | Same | N/A |
| Integrated
O2 Monitor | Yes | Yes | Same | N/A |
| Oxygen
Saturation | 1%-100% | 1%-100% | Same | N/A |
| Pulse Rate | During No Motion Conditions: 25-239 bpm
During Motion Conditions: 47-127 bpm | During No Motion Conditions: 25-239 bpm
During Motion Conditions: 47-127 bpm | Same | N/A |
| Resolution | Oxygen Saturation: 1%
Pulse Rate: 1 bpm | Oxygen Saturation: 1%
Pulse Rate: 1 bpm | Same | N/A |
| Sensor
Peak
Wavelengt
hs | Masimo: 660 nm (red light), 905 nm (infrared light)
Nellcor: 660 nm (red light), 900 nm (infrared light) | Masimo: 660 nm (red light), 905 nm (infrared light)
Nellcor: 660 nm (red light), 900 nm (infrared light) | Same | N/A |
| Sensor
Maximum
Power
Output | Masimo: less than 15 mW (at 50 mA pulsed)
Nellcor: less than 15 mW | Masimo: less than 15 mW (at 50 mA pulsed)
Nellcor: less than 15 mW | Same | N/A |
| Masimo
Sensor
Accuracy | During No Motion Conditions | | Same | N/A |
| | Oxygen
Saturation -
Neonates | $70 - 100% \pm 3%$
0 - 69%
unspecified | Oxygen
Saturation -
Neonates | $70 - 100% \pm 3%$
0 - 69%
unspecified |
| | Oxygen
Saturation -
Pediatrics | $70 - 100% \pm 2%$
0 - 69%
unspecified | Oxygen
Saturation -
Pediatrics | $70 - 100% \pm 2%$
0 - 69%
unspecified |
| | Pulse Rate -
Neonates /
Pediatrics | 25 - 240 bpm
$\pm 3$ bpm | Pulse Rate -
Neonates /
Pediatrics | 25 - 239 bpm
$\pm 3$ bpm |
| | During Motion Conditions | | | |
| | Oxygen
Saturation -
Neonates /
Pediatrics | $70 - 100% \pm 3%$
0 - 69%
unspecified | Oxygen
Saturation -
Neonates /
Pediatrics | $70 - 100% \pm 3%$
0 - 69%
unspecified |
| | Pulse Rate -
Neonates /
Pediatrics | 25 – 240 bpm
$\pm 5$ bpm | Pulse Rate -
Neonates /
Pediatrics | 25 - 239 bpm
$\pm 5$ bpm |
| | Low Perfusion (where 0.02%
Pulse Amplitude and %
Transmission > 5%) | | | |
| | Oxygen
Saturation -
Neonates /
Pediatrics | $\pm 2%$ | Oxygen
Saturation -
Neonates /
Pediatrics | $\pm 2%$ |
| | Pulse Rate -
Neonates /
Pediatrics | $\pm 3$ bpm | Pulse Rate -
Neonates /
Pediatrics | $\pm 3$ bpm |
9
| System | International Biomedical NXTGEN | International Biomedical | Differences | Discussion of Differences | |||
|---|---|---|---|---|---|---|---|
| Specification | Transport Incubator | Voyager Transport Incubator | |||||
| New Device | Primary Predicate Device | ||||||
| Pediatrics | Pediatrics | ||||||
| Nellcor | During No Motion Conditions | During No Motion Conditions | Same | N/A | |||
| Sensor | Oxygen | 70 - 100% ± 2% | Oxygen | 70 - 100% ± 2% | |||
| Accuracy | Saturation - | Saturation - | |||||
| Neonates | Neonates | ||||||
| Oxygen | 60-80% ± 3% | Oxygen | 60-80% ± 3% | ||||
| Saturation - | Saturation - | ||||||
| Neonates | Neonates | ||||||
| Pulse Rate - | 20 - 250 bpm | ||||||
| ± 3 bpm | Pulse Rate - | 20 - 250 bpm | |||||
| ± 3 bpm | |||||||
| Neonates | Neonates | ||||||
| During Motion Conditions | During Motion Conditions | ||||||
| Oxygen | 70 - 100% ± 3% | Oxygen | 70 - 100% ± 3% | ||||
| Saturation - | Saturation - | ||||||
| Neonates | Neonates | ||||||
| Pulse Rate - | 48 – 127 bpm | ||||||
| ± 3 bpm | Pulse Rate - | 48 – 127 bpm | |||||
| ± 3 bpm | |||||||
| Neonates | Neonates | ||||||
| Low Perfusion (where 0.02% | |||||||
| Pulse Amplitude and % | Low Perfusion (where 0.02% | ||||||
| Pulse Amplitude and % | |||||||
| Transmission > 5%) | Transmission > 5%) | ||||||
| Oxygen | ± 2% | Oxygen | ± 2% | ||||
| Saturation - | Saturation - | ||||||
| Neonates / | Neonates / | ||||||
| Pediatrics | Pediatrics | ||||||
| Pulse Rate - | 48 – 250 bpm | ||||||
| ± 3 bpm | Pulse Rate - | 48 - 250 bpm | |||||
| ± 3 bpm | |||||||
| Neonates / | Neonates / | ||||||
| Pediatrics | Pediatrics | ||||||
| Measurem | Ambient Oxygen Monitor | 10.0% to 100% | Same | N/A | |||
| ent Range | 10.0% to 100% | ||||||
| Resolution | 0.1% | 0.1% | Same | N/A | |||
| Response | 40 % | > 40% | Same | N/A | |||
| Light Heat | |||||||
| Output |