NxtGen Infant Transport Incubator

K220742 · International Biomedical · FPL · Jul 15, 2022 · General Hospital

Device Facts

• Record ID: K220742
• Device Name: NxtGen Infant Transport Incubator
• Applicant: International Biomedical
• Product Code: FPL · General Hospital
• Decision Date: Jul 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5410
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

NxtGen Infant Transport Incubator provides thermally stable environment for neonates during air or ambulance transport. Device features convective air heating with two modes: Manual (operator-controlled) and Skin (servo-controlled). Optional configurations include integrated pulse oximetry, electronic suction, heated mattress, and blue LED phototherapy. Input data includes skin temperature (via probe) and ambient temperature; device transforms inputs via servo-control logic to maintain set-point temperature. Output includes thermal regulation, monitoring data, and phototherapy. Used in intra-hospital and inter-facility transport by trained neonatal care personnel. Healthcare providers monitor infant status via integrated displays; output informs clinical decisions regarding thermal support and respiratory/phototherapy needs. Benefits include stable neonatal environment during transit, reducing risk of hypothermia/hyperthermia.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including functional performance testing (warming, skin temperature monitoring, alarms), software verification and validation, biocompatibility testing (ISO 10993), human factors/usability evaluation, and reprocessing validation. Compliance with IEC 60601-1, 60601-1-2, 60601-1-12, 60601-1-8, 60601-1-6, 60601-2-20, 60601-2-50, 80601-2-35, 80601-2-55, 80601-2-61, and ISO 10079-1 confirmed.

Technological Characteristics

Convective air heating; double-wall hood; servo or manual control modes. Materials: Aluminum, molded plastic, cell cast acrylic, polyester/polyurethane mattress. Power: AC 100-240V or internal rechargeable battery (Lead Acid or Lithium-Iron Phosphate). Connectivity: Integrated pulse oximetry, O2 monitor, suction, phototherapy. Standards: IEC 60601-2-20 (incubators), ISO 80601-2-35 (heated mattresses), ISO 10079-1 (suction), IEC 60601-2-50 (phototherapy).

Indications for Use

Indicated for neonates requiring transport by air or ambulance. Used by trained neonatal care personnel to provide a thermally stable, temperature-controlled environment. Supports airway management and patient monitoring. Optional features include pulse oximetry, suction, heated mattress, and blue LED phototherapy for indirect hyperbilirubinemia.

Regulatory Classification

Identification

A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.

Predicate Devices

• Voyager Infant Transport Incubator (K103524)

Reference Devices

• Draeger GT-5400 (K141565)
• International Biomedical NuBorne Infant Warmer (K173516)
• GE Healthcare Lullaby Phototherapy System (K120168)
• SUCTION CANISTER (K771737)
• SUCTION CONNECTING TUBING (K914601)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K220742

#### 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) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px">☐</span> 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 [phone] - phone [phone] - 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 | | | |
| Indications<br>for Use | The NxtGen Transport Incubator is<br>intended for use by personnel<br>trained in neonatal care to facilitate<br>the movements of neonates by air or<br>ambulance. The transport incubator<br>provides heat in a controlled manner<br>to neonates through an enclosed<br>temperature controlled<br>environment. The transport<br>incubator is also intended to carry<br>equipment designed for airway<br>management and monitoring of the<br>neonatal infant's status. The device<br>provides two modes of heat: Manual<br>(operator) controlled or Skin (servo)<br>controlled. All transport incubators<br>may be optionally configured with<br>pulse oximetry, a suction device, and<br>an integrated heated mattress. In<br>addition, the NxtGen Incubator may<br>be configured with optional blue LED<br>phototherapy to treat indirect<br>hyperbilirubinemia. | The transport incubator is<br>intended for use by personnel<br>trained in neonatal care to<br>facilitate the movements of<br>neonates by air or<br>ambulance. The transport<br>incubator circulates warmed<br>air at an operator selected<br>and controlled temperature<br>when transporting neonatal<br>infants to hospitals prepared<br>for neonatal infant care. The<br>transport incubator is also<br>intended to carry equipment<br>designed for airway<br>management and monitoring<br>of the neonatal infant's<br>status. | Similar | The intended use of the proposed device and the<br>predicate device is for transporting neonatal<br>infants using controlled air temperature.<br><br>Differences involve the addition of servo<br>temperature control, which is a common<br>temperature control feature on other transport<br>incubators on the market, including K141565<br>(Draeger GT-5400).<br>Servo (or baby temperature) controlled<br>temperature is a safe and effective heating<br>method that is common in infant incubators and<br>is defined in the safety standard 60601-2-20. | |
| Patient<br>Population | Neonate | Neonate | Same | N/A | |
| Patient<br>Weight<br>(Max) | 10 Kg (22 LBS) | 7.3 Kg (16 LBS.) | Larger<br>capacity | The only change is a larger capacity patient<br>weight. Patient weight capacity within the<br>chamber does not have an effect on safety and<br>effectiveness of the device and is considered in<br>the safety testing performed | |
| System | International Biomedical NXTGEN<br>Transport Incubator<br>New Device | International Biomedical<br>Voyager Transport Incubator<br>Primary Predicate Device | Differences | Discussion of Differences | |
| Specification | | | | | |
| Environment of Use | Intra-hospital and transport between<br>healthcare facilities. | Intra-hospital and transport<br>between healthcare facilities. | Same | N/A | |
| Prescriptive | Yes | Yes | Same | N/A | |
| Heating<br>Technology | Convective Air | Convective Air | Same | N/A | |
| Hood<br>Design | Double Wall | Double Wall | Same | N/A | |
| Skin Temp<br>Monitoring | Yes | Yes | Same | N/A | |
| Skin<br>Temperature Probe<br>(T1-Primary) | 700-3401 (Disposable)<br>739-1603 (Reusable) | N/A | New<br>optional<br>control<br>mode<br>feature | The T1 temperature probe provides feedback on<br>the patient temperature to the NxtGen system as<br>a part of the servo control mode. The addition of<br>servo temperature control, which is a common<br>temperature control feature on other transport<br>incubators on the market, including k141565<br>(Draeger GT-5400) does not raise new questions<br>of safety and effectiveness and is defined and<br>tested in FDA recognized standard 60601-2-20. | |
| Temperature Probe<br>(T2-Reference) | 700-3409 (YSI 400 series compatible) | 700-3409 (YSI 400 series<br>compatible) | Same | N/A | |
| Infant<br>Mattress | Cast-coated polyurethane<br>Polyester - Ventex Recovery 6 | Cast-coated polyurethane<br>Polyester - Ventex Recovery<br>6 | Same | The infant mattress is the same mattress used<br>with the predicate incubator and also the same<br>cover material as the new optional heated<br>mattress cover and also the same as the mattress<br>in the International Biomedical NuBorne Infant<br>Warmer K173516. | |
| | Operating Mode | | | | |
| Air<br>Controlled<br>Mode | Yes | Yes | Same | N/A | |
| Temperature Set Point<br>Range-Air<br>Temp | 17.0°C-38.9°C | 17.0°C-38.9°C | Same | N/A | |
| Air<br>Controlled<br>Alarm Point | $\pm$ 1.5 °C from Temperature Set Point<br>Range-Air Temp | $\pm$ 1 °C from Temperature Set<br>Point Range-Air Temp | Similar | The proposed new device alarm point is still<br>within the prescribed temperature alarm range in<br>the 60601-2-20 standard and is more consistent<br>with current technology. | |
| Servo<br>Controlled<br>Mode | Yes | No | New<br>optional<br>control<br>mode | The addition of servo temperature control, which<br>is a common temperature control feature on<br>other transport incubators on the market,<br>including K141565 (Draeger GT-5400) is a safe<br>and effective heating method and is defined in<br>the safety standard 60601-2-20. | |
| Temperature Set Point<br>Range-<br>Baby Temp | 33°C-37.5°C | N/A | New control<br>mode<br>feature | The addition of servo temperature control, which<br>is a common temperature control feature on<br>other transport incubators on the market,<br>including K141565 (Draeger GT-5400) is a safe<br>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<br>Controlled<br>Alarm Point | $\pm$ 0.7 °C from Temperature Set Point<br>Range-Baby Temp | N/A | New control<br>mode<br>feature | the safety standard 60601-2-20.<br>The addition of servo temperature control, which<br>is a common temperature control feature on<br>other transport incubators on the market,<br>including K141565 (Draeger GT-5400) is a safe<br>and effective heating method and is defined in<br>the safety standard 60601-2-20. | |
| PreWarm<br>Mode | Yes | No | New<br>standby<br>mode | Pre-Warm mode is simply a stand-by mode<br>where the incubator can be turned on and<br>"warmed up" without a patient present. This is<br>common practice in hospitals so that the<br>incubator is ready to go when a patient is placed<br>inside.<br>Because the device does not run in pre-warm<br>mode with a patient, the mode has no additional<br>safety and effectiveness impact. | |
| | Incubator Features | | | | |
| Approximat<br>e Warm-up<br>Time | 12 minutes $\pm$ 20% (Low Profile<br>Chamber)<br>16 Minutes $\pm$ 20% (XL Chamber) | 20 Minutes | Different<br>warm-up<br>time | The warm-up time allows for the device to be<br>heated sooner compared to the predicate device.<br>There is no impact to safety and effectiveness. | |
| | Electrical Description | | | | |
| External<br>Power | AC 100-240 V, 50 -60 Hz. | AC 110/120 V, 50-60 Hz.<br>AC 230 V, 50-60 H | Same | N/A | |
| Internal<br>Power | 1-12 V DC, Lead Acid Battery, sealed,<br>rechargeable.<br>1-12 V DC, Lithium-Iron Phosphate,<br>rechargeable | 1-12 V DC, Lead Acid Battery,<br>sealed, rechargeable. | Same<br>New battery<br>option | N/A<br>Lithium –Iron Phosphate battery is battery<br>technology most commonly used in medical<br>devices that offer superior life to the older Lead<br>Acid type of batteries. Assessed through<br>performance testing. | |
| Battery Life<br>Expectance | 4.5 hours…