NuBorne Infant Warmer

K173516 · International Biomedical · FMT · Aug 17, 2018 · General Hospital

Device Facts

• Record ID: K173516
• Device Name: NuBorne Infant Warmer
• Applicant: International Biomedical
• Product Code: FMT · General Hospital
• Decision Date: Aug 17, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The NuBorne 500 Infant Warmer is an open care environment used for providing controlled infrared heat to neonates who are physiologically unable to maintain their body temperature or may require external heat to ease the transition from the mother's womb to the external environment. The device is intended to be used in a Labor & Delivery environment for infants immediately after birth, or in a Neonatal Intensive Care Unit for providing premature infants long duration therapy, or in newborn care areas, for providing external heat to low-birth weight infants, and for cases where clinical indications require short/ long duration warming therapy. The device allows access to the infants for various procedures, tilting of the infant and x-ray diagnostics. The device provides three modes of warming: Manual, Skin, and Standby mode for varying care requirements. Also, allows attaching optional accessories on the rail for therapy and monitoring of the infant.

Device Story

Open care radiant warmer for neonates; provides controlled infrared heat via heater head. Operates in Manual, Skin (servo-controlled), and Standby modes. Features include tilting mattress, height adjustment, APGAR timer, x-ray tray, and optional in-bed scale. Used in Labor & Delivery, NICU, and newborn care areas by clinicians. Input includes skin temperature via probe; device transforms input to adjust infrared output to maintain set temperature. Output includes thermal regulation, visual/audible alarms, and patient monitoring data. Benefits include stable thermoregulation for infants unable to maintain body temperature. Clinicians use device to access infants for procedures and diagnostics while maintaining thermal stability.

Clinical Evidence

No clinical data. Evidence consists of bench testing, software verification and validation, biocompatibility testing (cytotoxicity, irritation, sensitization per ISO 10993), human factors/usability engineering, and reprocessing validation. Performance testing confirmed compliance with IEC 60601-1, 60601-1-2, 60601-1-10, 60601-1-8, 60601-1-6, and 60601-2-21.

Technological Characteristics

Radiant warmer; infrared heating element. Materials: Metal (aluminum), molded plastic, cell cast acrylic, textile. Connectivity: Standalone. Power: 115V-230V, 50/60 Hz. Standards: IEC 60601-1, 60601-1-2, 60601-1-10, 60601-1-8, 60601-1-6, 60601-2-21. Features: Servo-controlled skin temperature, manual mode, standby mode, APGAR timer, x-ray tray, optional scale. Software: Embedded firmware for thermal control and alarm management.

Indications for Use

Indicated for neonates, including premature and low-birth weight infants, requiring controlled infrared heat for thermoregulation in Labor & Delivery, NICU, or newborn care areas. Used for short or long duration warming therapy.

Regulatory Classification

Identification

The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.

Special Controls

*Classification.* Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer; (2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and (3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.

Predicate Devices

• Lullaby Warmer (K121625)
• Babyleo TN500 (K162821)

Submission Summary (Full Text)

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August 17, 2018

International Biomedical Amv Pieper Director of Regulatory Affairs 8206 Cross Park Drive Austin, Texas 78754

Re: K173516

Trade/Device Name: NuBorne Infant Warmer Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: Class II Product Code: FMT Dated: July 16, 2018 Received: July 16, 2018

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K173516

Device Name NuBorne Infant Warmer

#### Indications for Use (Describe)

The NuBorne 500 Infant Warmer is an open care environment used for providing controlled infrared heat to neonates who are physiologically unable to maintain their body temperature or may require external heat to ease the transition from the mother's womb to the external environment.

The device is intended to be used in a Labor & Delivery environment for infants immediately after birth, or in a Neonatal Intensive Care Unit for providing premature infants long duration therapy, or in newborn care areas, for providing external heat to low-birth weight infants, and for cases where clinical indications require short/ long duration warming therapy.

The device allows access to the infants for various procedures, tilting of the infant and x-ray diagnostics. The device provides three modes of warming: Manual, Skin, and Standby mode for varying care requirements. Also, allows attaching optional accessories on the rail for therapy and monitoring of the infant.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# K173516 510(k) SUMMARY

#### Submitter Information:

International Biomedical 8206 Cross Park Drive Austin, TX 78754 U.S.A.

Regulatory Affairs Contact:

Amy Pieper Director of Regulatory Affairs [phone] - phone [phone] - fax

Date Summary Prepared: October 27, 2017

## Device Identification:

Trade Name: NuBorne Infant Warmer Common Name: Radiant Warmer Regulatory Class: II Regulation: 880.5130 Product Code: FMT Panel: General Hospital

## Predicate Device:

GE Medical – Lullaby Warmer – k121625 (Primary Predicate) Drager Medical Systems – Babyleo TN500 – k162821 (Supplemental Predicate)

## Device Description:

The NuBorne Infant Warmer is an open care environment used for providing controlled infrared heat to neonates who are physiologically unable to maintain their body temperature or who need external heat to smoothen the transition from the mother's womb to the external environment.

The NuBorne Infant Warmer has three modes of temperature control available – manual temperature mode, skin temperature control mode and standby mode. The device includes a bed that tilts, has height adjustment, side panels, APGAR timer, x-ray tray and an optional inbed scale.

## Indications for Use:

The NuBorne 500 Infant Warmer is an open care environment used for providing controlled infrared heat to neonates who are physiologically unable to maintain their body temperature

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or may require external heat to ease the transition from the mother's womb to the external environment.

The device is intended to be used in a Labor & Delivery environment for warming the infants immediately after birth, or in a Neonatal Intensive Care Unit for providing premature infants long duration thermoregulation therapy, or in newborn care areas, for providing external heat to low-birth weight infants, and for cases where clinical indications require short/long duration warming therapy.

The device allows access to the infants for various procedures, tilting of the mattress, weighing the infant and x-ray diagnostics. The device provides three modes of warming: Manual, Skin, and Standby mode for varying care requirements. Also, allows attaching optional accessories on the rail for therapy and monitoring of the infant.

#### Substantial Equivalence:

The NuBorne Infant Warmer 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 NuBorne Infant Warmer is equivalent to the intended use of the primary predicate k121625. The differences in the indications for use between the predicate devices (k121625 and k162821) and the subject device do not constitute a new intended use. The NuBorne Warmer does not incorporate any incubator indications or functions that are referenced in the supplemental predicate (k162821) – the comparison to the Babyleo predicate is soley based on the infant warmer functionality and indications related to the incubator function are not considered in the substantial equivalence determination.

The Lullaby Warmer (k121625) is identified as the primary predicate because it has comparable indications, functionality and features. The Babyleo (k162821) is identified as a supplemental predicate because it has comparable indications and a comparable standby mode. The differences in technological features between the NuBorne Warmer and Babyleo do not raise new questions of safety and effectiveness.

| | Proposed | Predicate | Predicate |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NuBorne Infant Warmer | K121625 Lullaby Warmer (GE) | K162821 Babyleo TN500 (Drager) |
| Indications for Use | The NuBorne 500 Infant Warmer is an open care<br>environment used for providing controlled infrared<br>heat to neonates who are physiologically unable to<br>maintain their body temperature or may require<br>external heat to ease the transition from the<br>mother's womb to the external environment.<br><br>The device is intended to be used in a Labor &<br>Delivery environment for warming the infants | The Lullaby Warmer is a radiant warmer<br>which provides a microenvironment for<br>a premature, new born baby which<br>otherwise might have very little chance<br>of survival as it will not be able to<br>maintain, by itself, its core body<br>temperature. The Lullaby Warmer<br>provides a means for the care giver to<br>monitor the baby continuously by giving | The Babyleo TN500 is intended for use<br>with premature babies and neonates and<br>can be used as both an incubator and a<br>radiant warmer. When the product is<br>switched between incubator and radiant<br>warmer operation, patients continue to<br>be kept warm during the transition. The<br>device provides a thermally regulated<br>environment for patients with a body |
| | | | |
| | immediately after birth, or in a Neonatal Intensive<br>Care Unit for providing premature infants long<br>duration thermoregulation therapy, or in newborn<br>care areas, for providing external heat to low-birth<br>weight infants, and for cases where clinical<br>indications require short/long duration warming<br>therapy.<br>The device allows access to the infants for various<br>procedures, tilting of the mattress, weighing the<br>infant and x-ray diagnostics. The device provides<br>three modes of warming: Manual, Skin, and<br>Standby mode for varying care requirements. Also,<br>allows attaching optional accessories on the rail for<br>therapy and monitoring of the infant. | timely feedback via the different alarm<br>systems and servo controlled thermal<br>feedback mechanism while maintaining<br>a pre-set temperature and thus ensures<br>that the neonate slowly develops the<br>internal organs to enable it to maintain<br>its body temperature. | weight of up to 5kg( 11lbs) and a height of<br>up to 55cm (22in). The device can be<br>operated as either a closed care unit or an<br>open care unit. As a closed care unit,<br>Babyleo TN500 is an incubator. Neonates<br>are kept warm in the patient<br>compartment with humidifiable air, which<br>can be enriched with oxygen (option). As<br>an open care unit, Babyleo TN500 is a<br>radiant warmer. Babyleo TN500 provides<br>controlled ambient conditions for<br>premature babies and neonates. The<br>following parameters are regulated,<br>according to the intended use:<br>Temperature; Humidity; Oxygen (option). |
| Environment for<br>Use | Hospital or institution | Hospital or institution | Hospital or institution |
| Patient Population | Neonatal | Neonatal | Neonatal |
| Prescriptive | Yes | Yes | Yes |
| Operating Modes | | | |
| Skin Temp Mode | Yes | Yes | Yes |
| Servo Controlled | Yes | Yes | Yes |
| Temperature | | | |
| Monitoring | | | |
| Manual | Yes | Yes | Yes |
| Temperature Mode | | | Yes (AutoThermo Option) |
| Standby Mode | Yes (Standard) | No | |
| PreWarm Mode | Yes | Yes | Yes |
| Operation<br>Parameters and<br>Functions | | | |
| Operating Volume<br>measured in patient<br>bed | 36.2 dB(A) | 38.2 dB(A) | 40 dB(A) |
| Alarm Volume | Adjustable from:<br>54-69 dB(A) | Adjustable from:<br>52-65 dB(A) | Adjustable from:<br>50-70 dB(A) |
| Power Failure<br>Alarm | Continuous audible alarm when power switch is<br>"On" and mains power is disconnected.<br>Cannot be silenced | Continuous audible alarm when switch is<br>"On" and power is disconnected.<br>Cannot be silenced. | Continuous audible alarm when switch is<br>"On" and power is disconnected.<br>Cannot be silenced |
| Air Temperature<br>Measurement<br>Range | This device is an open air radiant warmer.<br>Newborns are warmed by the radiation of the<br>heater head. Air temperature is NOT measured in<br>this type of device. | This device is an open air radiant<br>warmer. Newborns are warmed by the<br>radiation of the heater head. Air<br>temperature is NOT measured in this<br>type of device. | Because this device can be used as both<br>an open radiant warmer and closed<br>convective incubator the air temperature<br>range is during incubator operations is:<br>13-45°C |
| Air Temperature<br>settings and<br>Override | This device is an open air radiant warmer.<br>Newborns are warmed by the radiation of the<br>heater head. Air temperature is NOT measured in<br>this type of device. | This device is an open air radiant<br>warmer. Newborns are warmed by the<br>radiation of the heater head. Air<br>temperature is NOT measured in this<br>type of device. | Because this device can be used as both<br>an open radiant warmer and closed<br>convective incubator the air temperature<br>range that can be set during normal<br>operations is:<br>20-39°C with a confirmation override at<br><28°C and >37°C |
| Oxygen Regulation | This device is an open air radiant warmer. Oxygen<br>delivery can be accomplished by ventilator, nasal<br>prongs or by mask. The warmer does NOT regulate<br>oxygen delivery to the patient, regulation requires<br>different device(s) | This device is an open air radiant<br>warmer. Oxygen delivery can be<br>accomplished by ventilator, nasal prongs<br>or by mask. The warmer does NOT<br>regulate oxygen delivery to the patient,<br>regulation requires different device(s) | An optional accessory to this combination<br>warmer incubator allows oxygen delivery<br>into the closed compartment.<br>Measurement range:<br>Normal range: 18-65 %<br>Extended range: 66-99%<br>Accuracy ± 2.5%<br>When used as an open air radiant<br>warmer, oxygen delivery can be<br>accomplished by ventilator, nasal prongs<br>or by mask. Oxygen delivery to the<br>patient when used as an open air warmer<br>will requires different device(s) NOT<br>controlled by the warmer |
| Radiant Warmer<br>Settings Range in<br>Manual Mode | Single heating element with setting range of:<br>Off-100% in 5% increments<br>Pre-Warm Mode:<br>100% for 10 minutes<br>50% until setting is changed | Single heating element with setting<br>range of:<br>Off-100% in 5% increments<br>Pre-Warm Mode:<br>100% for 12 minutes<br>25% until setting is changed | Two heating elements Setting range:<br>Off, 10% to 100%<br>Pre-Warm Mode:<br>100% for 3 minutes<br>60% for 11.5 minutes<br>30% until setting is changed |
| Radiant Warmer<br>Skin Temperature<br>Regulation Range | 34-38°C<br>A visual symbol appears warning the user if<br>temperature setting<br>>37° C | 30-38°C<br>No visual or confirmation override | 34-38°C<br>A confirmation override required if setting<br>is<br>>37° C |
| Skin Temperature<br>Monitoring Range | 25-40°C | 25-40°C | 13-43°C |
| Warmer Features | | | |
| Maximum<br>Irradiance of<br>Warmer | 25 mW/cm2 (at 100% power) | 22 mW/cm2 (at 100% power) | 32 mW/cm2 (at 100% power) |
| APGAR Timer | Yes (0-60 minutes) | Yes (0-60 minutes) | Yes (0-10 minutes) |
| Trending | Temperature and Weight | No | Temperature and Weight |
| Manual Mode<br>Setting Range | 0 to 100% in 5% increments | 0 to 100% in 5% increments | Off, 10% - 100% |
| Set Temperature<br>Range | 33 to 38 °C (in 0.1 increments) | 30 to 38 °C (in 0.1 increments) | 34 to 38 °C (in 0.1 increments) |
| Heater Hood Swivel | Two Sides | Two Sides | N/A |
| Integrated X-Ray<br>Cassette Tray | Yes | Yes | Yes |
| Bed Tilt Mechanism | Continuous up to 12° | Continuous up to 15° | Continuous up to 13° |
| Storage Drawer<br>Available | Yes | Yes | Yes |
| Access Panels | All side panels are hinged for patient access to<br>support medical procedures and interventions | All side panels are hinged for patient<br>access to support medical procedures<br>and interventions | All side panels are hinged for patient<br>access to support medical procedures and<br>interventions |
| Castors | 4 double castors with locking brakes. | 4 single castors with locking brakes. | 4 double castors with locking brakes. |
| Weighing Scale | 250g - 10kg | N/A | 200g - 10kg…