(123 days)
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.
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.
The document describes the K220742 NxtGen Infant Transport Incubator and its comparison to a predicate device, the International Biomedical Voyager Infant Transport Incubator (K103524). The information provided focuses on the device's technological characteristics, intended use, and compliance with various international standards in lieu of a clinical study.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily discusses substantial equivalence to a predicate device and compliance with established standards. It does not present specific quantitative acceptance criteria and corresponding reported device performance metrics in a single table, as might be seen for diagnostic algorithms. Instead, the "acceptance criteria" are implied by adherence to recognized medical device standards and the device's performance aligning with or improving upon the predicate device's specifications.
Here's a summary of key performance characteristics and how they compare, which can be interpreted as demonstrating the device meets implicit acceptance criteria for functionality and safety based on its predicate and relevant standards:
| Feature/Characteristic | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (NxtGen Infant Transport Incubator) | Discussion of Differences & Justification (for meeting criteria) |
|---|---|---|---|
| Intended Use | Facilitate neonatal transport with controlled heat, airway management, and monitoring. | Similar to predicate, with added servo temperature control, optional pulse oximetry, suction, heated mattress, and blue LED phototherapy. | Differences (servo control, additional options) do not raise new safety/effectiveness questions as they are common features in other market devices (e.g., Draeger GT-5400) and are defined/tested in standard 60601-2-20. |
| Patient Weight (Max) | 7.3 Kg (16 LBS.) (from predicate) | 10 Kg (22 LBS.) | Larger capacity; safety testing performed to account for this change; no effect on safety and effectiveness. |
| Air Controlled Mode Temp Set Point Range | 17.0°C-38.9°C (from predicate) | 17.0°C-38.9°C | Same as predicate. |
| Air Controlled Alarm Point | ± 1 °C from Temperature Set Point Range-Air Temp (from predicate) | ± 1.5 °C from Temperature Set Point Range-Air Temp | Still within the prescribed range of standard 60601-2-20; more consistent with current technology. |
| Servo Controlled Mode | Not present in predicate; common in other incubators (e.g., K141565 Draeger GT-5400) | Yes (new feature) | Safe and effective heating method, defined and tested in standard 60601-2-20. |
| Servo Temp Set Point Range-Baby Temp | Not present in predicate; common in other incubators | 33°C-37.5°C | Safe and effective heating method, defined and tested in standard 60601-2-20. |
| Servo Controlled Alarm Point | Not present in predicate; defined in 60601-2-20 | ± 0.7 °C from Temperature Set Point Range-Baby Temp | Safe and effective heating method, defined and tested in standard 60601-2-20. |
| PreWarm Mode | Not present in predicate | Yes (new standby mode) | Simply a stand-by mode without a patient; no additional safety and effectiveness impact. |
| Approximate Warm-up Time | 20 Minutes (from predicate) | 12 minutes ± 20% (Low Profile); 16 Minutes ± 20% (XL Chamber) | Faster warm-up time; no impact to safety and effectiveness. |
| Internal Power (Battery) | 1-12 V DC, Lead Acid Battery, sealed, rechargeable (from predicate) | 1-12 V DC, Lead Acid Battery, sealed, rechargeable; 1-12 V DC, Lithium-Iron Phosphate, rechargeable (new option) | Lithium-Iron Phosphate is common in medical devices for superior life; assessed through performance testing. |
| Battery Life Expectancy | 3 hours (from predicate) | 4.5 hours | Increased; makes long transports safer; assessed through performance testing. |
| Integrated Heated Mattress | Not present in predicate; common in other incubators (e.g., K141565 Draeger GT-5400) | Yes (new functionality) | Not new technology, common in transport incubators; compliant with ISO 80601-2-35 (per Intertek Safety Report 104427163LAX-005). |
| Phototherapy Light Maximum Irradiance | 27 μW/cm2/nm (predicate) | Low Chamber: 35 μW/cm2/nm; XL Chamber: 22 μW/cm2/nm | Difference due to chamber size; values are within common range for neonatal phototherapy lights (e.g., K120168 GE Healthcare Lullaby Phototherapy System). Compliant with 60601-2-50. |
| Phototherapy Light Effective Irradiated Area | 10 in x 8 in ellipse (predicate) | Low Chamber: 12.3 in x 9.2 in ellipse; XL Chamber: 15.1 in x 10.8 in ellipse | Greater area; increases treatment area; no new safety/effectiveness questions. |
| Integrated Electronic Suction | Not present in predicate | Yes (new option) | Not new technology; common in transport incubators (though typically stand-alone); compliant with ISO 10079-1 (per Intertek Safety Report 104427163LAX-008). |
| Compliance with Standards | Various IEC and ISO standards (e.g., 60601-1, 60601-2-20, 10079-1) | Demonstrated compliance through performance testing. | Confirms safety and essential performance. |
2. Sample Size for the Test Set and Data Provenance:
This document is a 510(k) summary for a medical device (an infant transport incubator), not an AI/ML software as a medical device (SaMD). Therefore, the typical concepts of "test set sample size" and "data provenance" for algorithm performance evaluation do not directly apply in the same way.
The "testing" mentioned in the document primarily refers to bench testing, software verification and validation, biocompatibility testing, human factors evaluation, and reprocessing evaluation to confirm compliance with recognized performance standards (e.g., IEC 60601 series, ISO 10079-1, IEC 80601-2-35/50/55/61).
- Sample Size: The document does not specify a "sample size" of patient cases or data in the context of diagnostic/predictive performance. Instead, testing involves the physical device and its components under various simulated conditions as prescribed by the relevant engineering and safety standards.
- Data Provenance: Not applicable in the context of patient data for algorithm training/testing. The testing involves engineering and performance characteristics of the hardware and software systems.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is not applicable for this type of device submission. There is no mention of "ground truth" established by human experts in the context of diagnostic or predictive performance, as this is a hardware device with integrated functionalities, not an AI diagnostic tool. Expert involvement would be in establishing test protocols, assessing human factors usability, and evaluating compliance with standards by qualified engineers and technical personnel.
4. Adjudication method for the test set:
Not applicable. There is no test set in the context of diagnostic performance requiring adjudication of results based on expert consensus.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
Not applicable. This is not an AI/ML software requiring comparison of human reader performance with and without AI assistance.
6. Standalone (algorithm only without human-in-the-loop performance) study:
Not applicable. This device is an infant transport incubator; it is not a standalone algorithm. The device's functionalities (e.g., temperature control, pulse oximetry, phototherapy, suction) operate autonomously or with human interaction. Testing of these components (e.g., accuracy of temperature sensors, irradiance of phototherapy, suction pressure) would be considered "standalone" in their specific functional performance but not as a diagnostic algorithm.
7. Type of ground truth used:
Not applicable in the context of diagnostic or predictive ground truth. For the NxtGen Infant Transport Incubator, "ground truth" would relate to metrological standards for accuracy (e.g., precise temperature/pressure measurements, calibrated light intensity), and adherence to safety and performance specifications outlined in the referenced standards (e.g., IEC 60601-2-20 for transport incubators, ISO 10079-1 for suction equipment). These are established through validated test equipment and procedures.
8. Sample size for the training set:
Not applicable. This device does not use an AI/ML algorithm that requires a "training set" of data for learning.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML algorithm.
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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
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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
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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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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
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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 | |||
| Indicationsfor Use | The NxtGen Transport Incubator isintended for use by personneltrained in neonatal care to facilitatethe movements of neonates by air orambulance. The transport incubatorprovides heat in a controlled mannerto neonates through an enclosedtemperature controlledenvironment. The transportincubator is also intended to carryequipment designed for airwaymanagement and monitoring of theneonatal infant's status. The deviceprovides two modes of heat: Manual(operator) controlled or Skin (servo)controlled. All transport incubatorsmay be optionally configured withpulse oximetry, a suction device, andan integrated heated mattress. Inaddition, the NxtGen Incubator maybe configured with optional blue LEDphototherapy to treat indirecthyperbilirubinemia. | The transport incubator isintended for use by personneltrained in neonatal care tofacilitate the movements ofneonates by air orambulance. The transportincubator circulates warmedair at an operator selectedand controlled temperaturewhen transporting neonatalinfants to hospitals preparedfor neonatal infant care. Thetransport incubator is alsointended to carry equipmentdesigned for airwaymanagement and monitoringof the neonatal infant'sstatus. | Similar | The intended use of the proposed device and thepredicate device is for transporting neonatalinfants using controlled air temperature.Differences involve the addition of servotemperature control, which is a commontemperature control feature on other transportincubators on the market, including K141565(Draeger GT-5400).Servo (or baby temperature) controlledtemperature is a safe and effective heatingmethod that is common in infant incubators andis defined in the safety standard 60601-2-20. | |
| PatientPopulation | Neonate | Neonate | Same | N/A | |
| PatientWeight(Max) | 10 Kg (22 LBS) | 7.3 Kg (16 LBS.) | Largercapacity | The only change is a larger capacity patientweight. Patient weight capacity within thechamber does not have an effect on safety andeffectiveness of the device and is considered inthe safety testing performed | |
| System | International Biomedical NXTGENTransport IncubatorNew Device | International BiomedicalVoyager Transport IncubatorPrimary Predicate Device | Differences | Discussion of Differences | |
| Specification | |||||
| Environment of Use | Intra-hospital and transport betweenhealthcare facilities. | Intra-hospital and transportbetween healthcare facilities. | Same | N/A | |
| Prescriptive | Yes | Yes | Same | N/A | |
| HeatingTechnology | Convective Air | Convective Air | Same | N/A | |
| HoodDesign | Double Wall | Double Wall | Same | N/A | |
| Skin TempMonitoring | Yes | Yes | Same | N/A | |
| SkinTemperature Probe(T1-Primary) | 700-3401 (Disposable)739-1603 (Reusable) | N/A | Newoptionalcontrolmodefeature | The T1 temperature probe provides feedback onthe patient temperature to the NxtGen system asa part of the servo control mode. The addition ofservo temperature control, which is a commontemperature control feature on other transportincubators on the market, including K141565(Draeger GT-5400) does not raise new questionsof safety and effectiveness and is defined andtested in FDA recognized standard 60601-2-20. | |
| Temperature Probe(T2-Reference) | 700-3409 (YSI 400 series compatible) | 700-3409 (YSI 400 seriescompatible) | Same | N/A | |
| InfantMattress | Cast-coated polyurethanePolyester - Ventex Recovery 6 | Cast-coated polyurethanePolyester - Ventex Recovery6 | Same | The infant mattress is the same mattress usedwith the predicate incubator and also the samecover material as the new optional heatedmattress cover and also the same as the mattressin the International Biomedical NuBorne InfantWarmer K173516. | |
| Operating Mode | |||||
| AirControlledMode | Yes | Yes | Same | N/A | |
| Temperature Set PointRange-AirTemp | 17.0°C-38.9°C | 17.0°C-38.9°C | Same | N/A | |
| AirControlledAlarm Point | $\pm$ 1.5 °C from Temperature Set PointRange-Air Temp | $\pm$ 1 °C from Temperature SetPoint Range-Air Temp | Similar | The proposed new device alarm point is stillwithin the prescribed temperature alarm range inthe 60601-2-20 standard and is more consistentwith current technology. | |
| ServoControlledMode | Yes | No | Newoptionalcontrolmode | The addition of servo temperature control, whichis a common temperature control feature onother transport incubators on the market,including K141565 (Draeger GT-5400) is a safeand effective heating method and is defined inthe safety standard 60601-2-20. | |
| Temperature Set PointRange-Baby Temp | 33°C-37.5°C | N/A | New controlmodefeature | The addition of servo temperature control, whichis a common temperature control feature onother transport incubators on the market,including K141565 (Draeger GT-5400) is a safeand 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 | ||||
| ServoControlledAlarm Point | $\pm$ 0.7 °C from Temperature Set PointRange-Baby Temp | N/A | New controlmodefeature | the safety standard 60601-2-20.The addition of servo temperature control, whichis a common temperature control feature onother transport incubators on the market,including K141565 (Draeger GT-5400) is a safeand effective heating method and is defined inthe safety standard 60601-2-20. | |
| PreWarmMode | Yes | No | Newstandbymode | Pre-Warm mode is simply a stand-by modewhere the incubator can be turned on and"warmed up" without a patient present. This iscommon practice in hospitals so that theincubator is ready to go when a patient is placedinside.Because the device does not run in pre-warmmode with a patient, the mode has no additionalsafety and effectiveness impact. | |
| Incubator Features | |||||
| Approximate Warm-upTime | 12 minutes $\pm$ 20% (Low ProfileChamber)16 Minutes $\pm$ 20% (XL Chamber) | 20 Minutes | Differentwarm-uptime | The warm-up time allows for the device to beheated sooner compared to the predicate device.There is no impact to safety and effectiveness. | |
| Electrical Description | |||||
| ExternalPower | AC 100-240 V, 50 -60 Hz. | AC 110/120 V, 50-60 Hz.AC 230 V, 50-60 H | Same | N/A | |
| InternalPower | 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. | SameNew batteryoption | N/ALithium –Iron Phosphate battery is batterytechnology most commonly used in medicaldevices that offer superior life to the older LeadAcid type of batteries. Assessed throughperformance testing. | |
| Battery LifeExpectance | 4.5 hours | 3 hours | Different | Battery life expectancy is increased compared tothe predicate. This will make long transportssafer as the device will not stop working orrequire AC power as quickly. Assessed throughperformance testing. | |
| ExpectedBatteryCycles | 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 | Heightinches(cm) | Widthinches(cm) | Depthinches(cm) | Weightlbs.(kg) | Heightinches(cm) | Widthinches(cm) | Depthinches(cm) | Weightlbs.(kg) | Weight capacity is greater compared to the predicate. | |
| Incubatorwithoutinfantchamber orhandles | 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 ProfileInfantChamber | 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 InfantChamber | 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 | ||||||||||
| MaterialUsed forIndirectPatientContact | Metal (e.g. Aluminum); MoldedPlastic | Metal (e.g. Aluminum);Molded Plastic | Same | N/A | ||||||
| Materialused fordirectpatientcontact | Cell Cast Acrylic; Textile (VentexRecovery 6) | Cell Cast Acrylic; Textile(Ventex Recovery 6) | Same | N/A | ||||||
| Optional Components | ||||||||||
| Heated Mattress | ||||||||||
| IntegratedHeatedMattress | Yes | No | Newmattressfunctionality | The integrated heated mattress is not a newtechnology or item used in neonatal care. Heatedmattresses are common in transport incubatorsalready on the market, as can be found inK141565 (Draeger GT-5400). | ||||||
| MattressDimensions | 31.8 ± 61.0 ± 2.5 cm | 31.8 ± 61.0 ± 2.5 cm | Newmattressfeature | The integrated heated mattress and itscomponents are compliant with ISO 80601-2-35.For verification of compliance refer to IntertekSafety Report 104427163LAX-005. | ||||||
| MattressMaxTemperature | 40°C | N/A | Newmattressfeature | The integrated heated mattress and itscomponents are compliant with ISO 80601-2-35.For verification of compliance refer to IntertekSafety Report 104427163LAX-005. | ||||||
| PowerRating | 20 Watt | N/A | Newmattressfeature | The integrated heated mattress and itscomponents are compliant with ISO 80601-2-35.For verification of compliance refer to IntertekSafety Report 104427163LAX-005. | ||||||
| HeatedMattressElement | 738-2409 | N/A | Newmattressfeature | The integrated heated mattress and itscomponents are compliant with ISO 80601-2-35.For verification of compliance refer to IntertekSafety Report 104427163LAX-005. | ||||||
| HeatedMattressCover | 736-1114 | N/A | Newmattressfeature | The integrated heated mattress and itscomponents are compliant with ISO 80601-2-35.For verification of compliance refer to IntertekSafety Report 104427163LAX-005. | ||||||
| Heated | Cast-coated polyurethane | Cast-coated polyurethane | Same | N/A |
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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".
| SystemSpecification | International Biomedical NXTGENTransport IncubatorNew Device | International BiomedicalVoyager Transport IncubatorPrimary Predicate Device | Differences | Discussion of Differences |
|---|---|---|---|---|
| MattressCoverMaterial | Polyester - Ventex Recovery 6 | Polyester - Ventex Recovery 6 | ||
| IntegratedSpO2 | Yes | Yes | Same | N/A |
| IntegratedO2 Monitor | Yes | Yes | Same | N/A |
| OxygenSaturation | 1%-100% | 1%-100% | Same | N/A |
| Pulse Rate | During No Motion Conditions: 25-239 bpmDuring Motion Conditions: 47-127 bpm | During No Motion Conditions: 25-239 bpmDuring 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 |
| SensorPeakWavelengths | 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 |
| SensorMaximumPowerOutput | 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 |
| MasimoSensorAccuracy | During No Motion Conditions | Same | N/A | |
| OxygenSaturation -Neonates | $70 - 100% \pm 3%$0 - 69%unspecified | OxygenSaturation -Neonates | $70 - 100% \pm 3%$0 - 69%unspecified | |
| OxygenSaturation -Pediatrics | $70 - 100% \pm 2%$0 - 69%unspecified | OxygenSaturation -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 | ||||
| OxygenSaturation -Neonates /Pediatrics | $70 - 100% \pm 3%$0 - 69%unspecified | OxygenSaturation -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%) | ||||
| OxygenSaturation -Neonates /Pediatrics | $\pm 2%$ | OxygenSaturation -Neonates /Pediatrics | $\pm 2%$ | |
| Pulse Rate -Neonates /Pediatrics | $\pm 3$ bpm | Pulse Rate -Neonates /Pediatrics | $\pm 3$ bpm |
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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 | ||||||
| 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 | < 16 seconds for 90% response | < 16 seconds for 90% response | Same | N/A | |||
| Time | < 25 seconds for 97% response | < 25 seconds for 97% response | |||||
| Accuracy | ± 4.0% over measurement range | ± 4.0% over measurement range | Same | N/A | |||
| Stability | Less than 2% drift over 8 hours atconstant temperature and pressure | Less than 2% drift over 8hours at constanttemperature and pressure | Same | N/A | |||
| Required | Minimal 3cc/minute, 100cc/minute typical | Minimal 3cc/minute, 100cc/minute typical | Same | N/A | |||
| Sample | |||||||
| Flow | |||||||
| Operating | 5°to 40° C (31° - 104° F) | 5°to 40° C (31° - 104° F) | Same | N/A | |||
| Temperatu | |||||||
| re | |||||||
| Observatio | Observation Light | ||||||
| n Light | Yes | Yes | Same | N/A | |||
| Power | 10 Watt | 10 Watt | Same | N/A | |||
| Rating | |||||||
| Audible | < 60 dB | < 60 dB | Same | N/A | |||
| Noise Level | Same | ||||||
| Intensity | 150 Lumens | 150 Lumens | Same | N/A |
{10}------------------------------------------------
Image /page/10/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 size above the word "BIOMEDICAL" in a larger font size. A registered trademark symbol is located to the right of the word "BIOMEDICAL".
| System | International Biomedical NXTGEN | International Biomedical | Differences | Discussion of Differences |
|---|---|---|---|---|
| Specification | Transport Incubator | Voyager Transport Incubator | ||
| New Device | Primary Predicate Device | |||
| (minimum) | ||||
| Light HeatOutput | < 10° C Warmer than ambient | < 0.5 ° C warmer thanambient @ 5" | Documentation Change | The claimed light heat output range wasincreased for the NxtGen system although theelectrical and mechanical specificationscontributing to the light heat output have notbeen changed. The NxtGen Phototherapy lightand its components are in compliance with60601-2-50. For verification of compliance referto 104447422LAX-002 |
| Phototherapy Light | ||||
| IntegratedPhototherapy Light | Yes | Yes - K160238 | Same | N/A |
| PowerRating | 10 Watt | 10 Watt | Same | N/A |
| LightSpectrumRange | 450 - 465 nm | 450 - 465 nm | Same | N/A |
| MaximumIrradianceat mattress | Low Chamber: 35 μW/cm2/nm(Light Bar @ 7.8" above mattress)XL Chamber: 22 μW/cm2/nm(Light Bar @ 9.8" above mattress) | 27 μW/cm2/nm(Light Bar @ 8.8" abovemattress) | Newchambersize | The chamber size difference between the NxtGenand Voyager accounts for the differences inmaximum irradiance values at the mattress. Themaximum irradiance levels for both the Lowchamber and XL chamber are within a commonrange for neonatal phototherapy lights already onthe market as referenced in K120168 (GEHealthcare Lullaby Phototherapy System) |
| EffectiveIrradiatedArea | Low Chamber: 12.3 in 9.2 in ellipseXL Chamber: 15.1 in 10.8 in ellipse | 10 in x 8 in ellipse | Different | The effective irradiated area is greater comparedto the predicate. This will increase thephototherapy treatment area and allow a greateramount of patient's skin will be inside theeffective irradiated area. |
| LightExpectedService Life | 8 years | 8 years | Same | N/A |
| Light Pre-Aging Time | Not Required | Not Required | Same | N/A |
| AudibleNoise Level | < 60dB | < 60 dB | Same | N/A |
| IntensityRatio Ebimin/Ebi max | >40 % | > 40% | Same | N/A |
| Light HeatOutput | < 10° C warmer than ambient | < 0.5 ° C warmer thanambient @ 5" | Documentation change | The claimed light heat output range wasincreased for the NxtGen system although theelectrical and mechanical specificationscontributing to the light heat output have notbeen changed. The NxtGen Phototherapy lightand its components are in compliance with60601-2-50. For verification of compliance referto 104447422LAX-002 |
| Phototherapy LightVariation inIntensity | < 10% | < 10% | Same | N/A |
| System | International Biomedical NXTGEN | International Biomedical | Differences | Discussion of Differences |
| Specification | Transport Incubator | Voyager Transport Incubator | ||
| New Device | Primary Predicate Device | |||
| over5 hrs afterWarm-Up | ||||
| Integratedelectronicsuction | Yes | No | NewElectronicSuctionOption | The integrated electronic suction is not a newtechnology or item used in neonatal care.Electronic suction is common in transportincubators already on the market, but typically asa stand-alone device. Incorporating theelectronic suction into the controls of theincubator make it more easily accessible to theend user. |
| PowerRating | 20 Watt | N/A | NewElectronicSuctionOption | The integrated electronic suction system and itscomponents are compliant with ISO 10079-1. Forverification of compliance refer to Intertek SafetyReport 104427163LAX-008 |
| Airflow atVacuumInlet | 10 LPM | N/A | NewElectronicSuctionOptionComponent | The integrated electronic suction system and itscomponents are compliant with ISO 10079-1. Forverification of compliance refer to Intertek SafetyReport 104427163LAX-008 |
| VacuumMaximumPressure | 150 mmHg(Actual value can be between 108-163 mmHg.) | N/A | NewElectronicSuctionOptionComponent | The integrated electronic suction system and itscomponents are compliant with ISO 10079-1. Forverification of compliance refer to Intertek SafetyReport 104427163LAX-008 |
| VacuumPressureRange | 10-150 mmHg | N/A | NewElectronicSuctionOptionComponent | The integrated electronic suction system and itscomponents are compliant with ISO 10079-1. Forverification of compliance refer to Intertek SafetyReport 104427163LAX-008 |
| VacuumIndicatorAccuracy | ± 5 mmHg | N/A | NewElectronicSuctionOptionComponent | The integrated electronic suction system and itscomponents are compliant with ISO 10079-1. Forverification of compliance refer to Intertek SafetyReport 104427163LAX-008 |
| Noise Level | < 60 dB | N/A | NewElectronicSuctionOptionComponent | The integrated electronic suction system and itscomponents are compliant with ISO 10079-1. Forverification of compliance refer to Intertek SafetyReport 104427163LAX-008 |
| SuctionCanisterVolume (upto 20 degincline) | 800 mL | N/A | NewElectronicSuctionOptionComponent | The integrated electronic suction system and itscomponents are compliant with ISO 10079-1. Forverification of compliance refer to Intertek SafetyReport 104427163LAX-008 |
| SuctionCanister | 738-1701 | N/A | NewElectronicSuctionOptionComponent | The electronic suction canister is already on themarket, as referenced in K771737 (SUCTIONCANISTER). |
| 18" SuctionTubing | 738-1702 | N/A | NewElectronic | The electronic suction tubing is already on themarket, as referenced in K914601 (SUCTION |
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for International Biomedical. The logo consists of a stylized symbol resembling a beta symbol on the left, followed by the words "international" in a smaller font and "BIOMEDICAL" in a larger, bolder font. A registered trademark symbol is placed to the upper right of the word "BIOMEDICAL".
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image shows the logo for International Biomedical. The logo consists of a stylized beta symbol on the left, followed by the words "international" and "BIOMEDICAL" stacked on top of each other. The word "BIOMEDICAL" is in a larger font than "international", and there is a registered trademark symbol to the right of the word "BIOMEDICAL".
| System | International Biomedical NXTGEN | International Biomedical | Differences | Discussion of Differences | ||
|---|---|---|---|---|---|---|
| Specification | Transport Incubator | Voyager Transport Incubator | ||||
| New Device | Primary Predicate Device | |||||
| SuctionOptionComponent | CONNECTING TUBING). | |||||
| 72″ SuctionTubing | 738-2355 | N/A | NewElectronicSuctionOptionComponent | The electronic suction tubing is already on themarket, as referenced in K914601 (SUCTIONCONNECTING TUBING). | ||
| VacuumFilter | 738-1657 | N/A | NewElectronicSuctionOptionComponent | The integrated electronic suction system and itscomponents are compliant with ISO 10079-1. Forverification of compliance refer to Intertek SafetyReport 104427163LAX-008 | ||
| Alarms | ||||||
| Alarms | High TempSet PointAir FlowSkin Temp Fault | High TempSet PointAir FlowSkin Temp Fault | Same | N/A |
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
{13}------------------------------------------------
- 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 ●
- o 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
- o 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.
Conclusion:
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Image /page/14/Picture/1 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. Below the word "international" is the word "BIOMEDICAL" in a larger, bolder font, with the registered trademark symbol to the right.
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.
§ 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).