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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the NuBorne Infant Warmer, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific, predefined performance criteria through a traditional clinical study with human patients. As such, information regarding sample sizes, ground truth establishment for AI, human reader studies, and training sets (common in AI/software device submissions) is not applicable to this type of device and submission. This device is a hardware medical device, not an AI or software-as-a-medical-device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are derived from compliance to recognized medical device standards and functional performance compared to predicate devices. The "reported device performance" reflects how the NuBorne Infant Warmer meets these standards and compares to its predicates.

Acceptance Criterion (Standard/Characteristic)	Reported Device Performance (NuBorne Infant Warmer)
Indications for Use	Matches or is substantially equivalent to predicate devices (GE Medical Lullaby Warmer, Drager Medical Systems Babyleo TN500 - for warmer functions). Designed for neonates requiring controlled infrared heat for thermoregulation in L&D, NICU, and newborn care.
Operating Modes (Skin Temp, Manual, Standby, Pre-Warm)	All modes (Skin Temp, Manual, Standby, Pre-Warm) are functional ("Yes"). Standby mode is standard.
Operating Volume measured in patient bed	36.2 dB(A)
Alarm Volume	Adjustable from 54-69 dB(A)
Power Failure Alarm	Continuous audible alarm when power switch is "On" and mains power is disconnected. Cannot be silenced. (Meets common safety practice).
Air Temperature Measurement/Settings	Not measured as it's an open-air radiant warmer. (Consistent with predicate K121625).
Oxygen Regulation	Does not regulate oxygen delivery; requires separate devices. (Consistent with predicate K121625).
Radiant Warmer Settings Range in Manual Mode	Off-100% in 5% increments. Pre-Warm Mode: 100% for 10 minutes, then 50%.
Radiant Warmer Skin Temperature Regulation Range	34-38°C. Visual warning if setting >37°C.
Skin Temperature Monitoring Range	25-40°C
Maximum Irradiance of Warmer	25 mW/cm2 (at 100% power)
APGAR Timer	Yes (0-60 minutes)
Trending	Temperature and Weight
Manual Mode Setting Range	0 to 100% in 5% increments
Set Temperature Range	33 to 38 °C (in 0.1 increments)
Heater Hood Swivel	Two Sides
Integrated X-Ray Cassette Tray	Yes
Bed Tilt Mechanism	Continuous up to 12°
Storage Drawer Available	Yes
Access Panels	All side panels are hinged for patient access.
Castors	4 double castors with locking brakes.
Weighing Scale	250g - 10kg (optional accessory)
High Priority Alarms	High skin temp, Low skin temp, Check Baby, Max temp, Skin temp probe disconnected, Skin temp probe failure.
Medium/Low Priority Alarms	N/A (Unlike K162821 which has several specific medium priority alarms)
Power Supply	115V – 230V, 50/60 Hz
Power Consumption	750W
Weight (without options/accessories)	105kg
Height (mm)	1800 – 2000
Width (mm)	850
Length (mm)	1170
Mattress Height from Floor (mm)	900-1100
Mattress Size (mm)	450 x 650
Material Used for Indirect Patient Contact	Metal (e.g., Aluminum); Molded Plastic
Material Used for Direct Patient Contact	Cell Cast Acrylic; Textile (Wiman)
Bisphenol A (BPA)	BPA free in-patient compartment
Latex	Latex Free
IEC 60601-1 (General Safety for Medical Electrical Equipment)	Pass
IEC 60601-1-2 (EMC)	Pass
IEC 60601-1-6 (Usability)	Pass
IEC 60601-1-8 (Alarm Systems)	Pass
IEC 60601-1-10 (Physiological Closed-Loop Controllers)	Pass
IEC 60601-2-21 (Infant Radiant Warmers Specific)	Pass
Software Verification & Validation Testing	Conducted and documentation provided as recommended by FDA.
Device Validation (Functional Performance)	Tested to confirm performance to essential requirements: warming, skin temperature monitoring, alarms.
Biocompatibility Testing	Conducted per ISO-10993 (Cytotoxicity, Irritation, Sensitization).
Human Factor Evaluation	Conducted per FDA guidance.
Reprocessing Evaluation	Conducted per FDA guidance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. This is a hardware medical device, not an AI/software device that uses a "test set" of data in the sense of classification or diagnostic performance. Performance was evaluated through bench testing and compliance with standards.
Data Provenance: Not applicable. The "data" here refers to direct measurements and observations during engineering and safety testing of the device itself, rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. The "ground truth" for a hardware device like an infant warmer is established through engineering specifications, regulatory standards, and physical measurements (e.g., temperature accuracy, noise levels, safety features). This does not typically involve expert radiologists or similar medical specialists establishing a "ground truth" for classification tasks.
Qualifications of Experts: N/A for establishing "ground truth" in this context. However, engineering and regulatory experts would have overseen the testing and documentation.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This is a hardware device; thus, there is no "test set" that requires adjudication by human readers for diagnostic or classification concordance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This type of study is relevant for diagnostic imaging devices or AI-powered clinical decision support systems where human reader performance is being evaluated with and without AI assistance. The NuBorne Infant Warmer is a therapeutic/supportive care device.
Effect Size: Not applicable.

6. Standalone Performance Study (Algorithm Only)

Standalone Performance Study: No. This concept is for AI algorithms. The NuBorne Infant Warmer is a physical device with embedded software controlling its functions, but it's not an "algorithm only" device in the sense implying standalone diagnostic or predictive performance. Its performance is its standalone performance as a medical device.

7. Type of Ground Truth Used

Type of Ground Truth: For this device, the "ground truth" is defined by:
- Engineering Specifications: Designed parameters and tolerances for temperature, noise, physical dimensions, etc.
- International and National Medical Device Standards (e.g., IEC 60601 series): These standards define acceptable safety, electrical, mechanical, and performance characteristics.
- Internal Validation and Verification Protocols: Procedures to confirm the device operates according to its design and specifications.
- Biocompatibility Standards (ISO-10993): Defining acceptable biological response of materials.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not use machine learning or AI that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device type.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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 (512) 873-0033 - phone (512) 873-9090 - 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:

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 careenvironment used for providing controlled infraredheat to neonates who are physiologically unable tomaintain their body temperature or may requireexternal heat to ease the transition from themother's womb to the external environment.The device is intended to be used in a Labor &Delivery environment for warming the infants	The Lullaby Warmer is a radiant warmerwhich provides a microenvironment fora premature, new born baby whichotherwise might have very little chanceof survival as it will not be able tomaintain, by itself, its core bodytemperature. The Lullaby Warmerprovides a means for the care giver tomonitor the baby continuously by giving	The Babyleo TN500 is intended for usewith premature babies and neonates andcan be used as both an incubator and aradiant warmer. When the product isswitched between incubator and radiantwarmer operation, patients continue tobe kept warm during the transition. Thedevice provides a thermally regulatedenvironment for patients with a body

	immediately after birth, or in a Neonatal IntensiveCare Unit for providing premature infants longduration thermoregulation therapy, or in newborncare areas, for providing external heat to low-birthweight infants, and for cases where clinicalindications require short/long duration warmingtherapy.The device allows access to the infants for variousprocedures, tilting of the mattress, weighing theinfant and x-ray diagnostics. The device providesthree modes of warming: Manual, Skin, andStandby mode for varying care requirements. Also,allows attaching optional accessories on the rail fortherapy and monitoring of the infant.	timely feedback via the different alarmsystems and servo controlled thermalfeedback mechanism while maintaininga pre-set temperature and thus ensuresthat the neonate slowly develops theinternal organs to enable it to maintainits body temperature.	weight of up to 5kg( 11lbs) and a height ofup to 55cm (22in). The device can beoperated as either a closed care unit or anopen care unit. As a closed care unit,Babyleo TN500 is an incubator. Neonatesare kept warm in the patientcompartment with humidifiable air, whichcan be enriched with oxygen (option). Asan open care unit, Babyleo TN500 is aradiant warmer. Babyleo TN500 providescontrolled ambient conditions forpremature babies and neonates. Thefollowing parameters are regulated,according to the intended use:Temperature; Humidity; Oxygen (option).
Environment forUse	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
OperationParameters andFunctions
Operating Volumemeasured in patientbed	36.2 dB(A)	38.2 dB(A)	40 dB(A)
Alarm Volume	Adjustable from:54-69 dB(A)	Adjustable from:52-65 dB(A)	Adjustable from:50-70 dB(A)
Power FailureAlarm	Continuous audible alarm when power switch is"On" and mains power is disconnected.Cannot be silenced	Continuous audible alarm when switch is"On" and power is disconnected.Cannot be silenced.	Continuous audible alarm when switch is"On" and power is disconnected.Cannot be silenced
Air TemperatureMeasurementRange	This device is an open air radiant warmer.Newborns are warmed by the radiation of theheater head. Air temperature is NOT measured inthis type of device.	This device is an open air radiantwarmer. Newborns are warmed by theradiation of the heater head. Airtemperature is NOT measured in thistype of device.	Because this device can be used as bothan open radiant warmer and closedconvective incubator the air temperaturerange is during incubator operations is:13-45°C
Air Temperaturesettings andOverride	This device is an open air radiant warmer.Newborns are warmed by the radiation of theheater head. Air temperature is NOT measured inthis type of device.	This device is an open air radiantwarmer. Newborns are warmed by theradiation of the heater head. Airtemperature is NOT measured in thistype of device.	Because this device can be used as bothan open radiant warmer and closedconvective incubator the air temperaturerange that can be set during normaloperations is:20-39°C with a confirmation override at<28°C and >37°C
Oxygen Regulation	This device is an open air radiant warmer. Oxygendelivery can be accomplished by ventilator, nasalprongs or by mask. The warmer does NOT regulateoxygen delivery to the patient, regulation requiresdifferent device(s)	This device is an open air radiantwarmer. Oxygen delivery can beaccomplished by ventilator, nasal prongsor by mask. The warmer does NOTregulate oxygen delivery to the patient,regulation requires different device(s)	An optional accessory to this combinationwarmer incubator allows oxygen deliveryinto the closed compartment.Measurement range:Normal range: 18-65 %Extended range: 66-99%Accuracy ± 2.5%When used as an open air radiantwarmer, oxygen delivery can beaccomplished by ventilator, nasal prongsor by mask. Oxygen delivery to thepatient when used as an open air warmerwill requires different device(s) NOTcontrolled by the warmer
Radiant WarmerSettings Range inManual Mode	Single heating element with setting range of:Off-100% in 5% incrementsPre-Warm Mode:100% for 10 minutes50% until setting is changed	Single heating element with settingrange of:Off-100% in 5% incrementsPre-Warm Mode:100% for 12 minutes25% until setting is changed	Two heating elements Setting range:Off, 10% to 100%Pre-Warm Mode:100% for 3 minutes60% for 11.5 minutes30% until setting is changed
Radiant WarmerSkin TemperatureRegulation Range	34-38°CA visual symbol appears warning the user iftemperature setting>37° C	30-38°CNo visual or confirmation override	34-38°CA confirmation override required if settingis>37° C
Skin TemperatureMonitoring Range	25-40°C	25-40°C	13-43°C
Warmer Features
MaximumIrradiance ofWarmer	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 ModeSetting Range	0 to 100% in 5% increments	0 to 100% in 5% increments	Off, 10% - 100%
Set TemperatureRange	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-RayCassette Tray	Yes	Yes	Yes
Bed Tilt Mechanism	Continuous up to 12°	Continuous up to 15°	Continuous up to 13°
Storage DrawerAvailable	Yes	Yes	Yes
Access Panels	All side panels are hinged for patient access tosupport medical procedures and interventions	All side panels are hinged for patientaccess to support medical proceduresand interventions	All side panels are hinged for patientaccess to support medical procedures andinterventions
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
High Priority Alarms
	1. High skin temp	1. High skin temp	1. Check Baby
	2. Low skin temp	2. Low skin temp	2. Max temp
	3. Check Baby	3. Check Baby	3. Scale defective
	4. Max temp	4. max Temp
	5. Skin temp probe disconnected	5. Temp probe failure
	6. Skin temp probe failure
Medium PriorityAlarms	N/A	N/A	1. Skin mode not confirmed
			2. Skin temp not confirmed
			3. Kangaroo mode not confirmed
			4. Air mode not confirmed
			5. Manual mode not confirmed
			6. Radiant Power not confirmed
			7. Skin temp probe defective
			8. Skin temp probe disconnected
			9. High skin temp
			10. Low skin temp

Low Priority Alarms	N/A	N/A	N/A
ElectricalDescription
Power Supply	115V – 230V, 50/60 Hz	115V – 230V, 50/60 Hz	100V to 240V, 50/60 Hz
PowerConsumption	750W	600W	1000W
Physical Description
Weight (withoutoptions andaccessories)	105kg	72kg	<140kg
Height (mm)	1800 – 2000	1800	1850 - 2250
Width (mm)	850	655	690
Length (mm)	1170	1120	1154
Mattress Heightfrom Floor (mm)	900-1100	880 - 1020	700 – 1100
Mattress Size (mm)	450 x 650	462 x 640	450 x 690
Material
Material Used forIndirect PatientContact	Metal (e.g. Aluminum); Molded Plastic	Metal (e.g. Aluminum); Molded Plastic	Metal (e.g. Aluminum); Synthetic material(e.g. TPE)
Material used fordirect patientcontact	Cell Cast Acrylic; Textile (Wiman)	Textile; Acrylic	Textile (Vowalon Medilind)
Bisphenol A (BPA)	BPA free in-patient compartment	Unknown or not stated in literature	BPA free in-patient compartment
Latex	Latex Free	Unknown or not stated in literature	Latex Free
PerformanceTesting
IEC 60601-1	Pass	Pass	Pass
IEC 60601-1-2	Pass	Pass	Pass
IEC 60601-2-21	Pass	Pass	Pass

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Performance Testing:

Testing was performed to confirm compliance to the following standards:

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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 60601-1-10, Medical Electrical Equipment, Part 1-10: Requirements for the Development of Physiological Closed-Loop Controllers
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 60601-2-21, Medical Electrical Equipment, Part 2-21: Particular Requirements for the Basic Safety and Essential Performance of Infant Radiant Warmers

Bench Testing:

The following additional tests were performed

Software Verification & Validation Testing
- o Software verification and validation testing was conducted and documentation was provided as recommended by FDA.
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 NuBorne Infant Warmer was conducted O 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 NuBorne Infant Warmer was conducted in O 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 NuBorne Infant Warmer was conducted in accordance with the FDA guidance: Reprocessing Medical Devices in Health

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Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff.

Conclusion:

In regards to intended use and technology the Nuborne Infant Warmer is substantially equivalent to the listed predicates.

Any differences between the NuBorne Infant Warmer and the predicates do not raise any new questions of safety and effectiveness.

Regulation Number and Section

§ 880.5130 Infant radiant warmer.

(a)
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.(b)
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.