(276 days)
Not Found
No
The description focuses on standard temperature control modes (Manual, Skin, Standby) and basic device functionalities like tilting, height adjustment, and timers. There is no mention of AI, ML, image processing, or data-driven decision-making beyond basic physiological closed-loop control (as indicated by the IEC 60601-1-10 standard). The performance studies are standard bench testing and compliance evaluations, not AI/ML model validation.
Yes
The device provides controlled infrared heat to neonates to help them maintain body temperature or transition to an external environment, which is a therapeutic intervention. It is used for "long duration therapy" for premature infants and "short/long duration warming therapy" for other infants.
No
The device is an infant warmer, providing controlled infrared heat to neonates. While it assists in caring for infants, its primary function is therapeutic warming, not diagnosis. It allows for X-ray diagnostics, but it doesn't perform the diagnostic function itself.
No
The device description clearly outlines hardware components such as a bed, height adjustment, side panels, and an x-ray tray, and the performance studies include testing related to hardware standards (IEC 60601 series) and physical properties (biocompatibility, reprocessing).
Based on the provided information, the NuBorne 500 Infant Warmer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for providing controlled infrared heat to neonates to maintain their body temperature. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the physical components and functions related to warming and supporting the infant, such as the heating element, bed, tilting mechanism, etc. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Performance Studies: The performance studies listed are related to the safety and functionality of the warming device itself (electrical safety, EMC, usability, reprocessing, etc.), not the accuracy or performance of a diagnostic test.
- Predicate Devices: The predicate devices listed are also infant warmers, which are therapeutic devices, not IVDs.
In summary, the NuBorne 500 Infant Warmer is a medical device used for providing external heat therapy to neonates. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / 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 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.
Product codes
FMT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Neonates, premature infants, low-birth weight infants
Intended User / Care Setting
Hospital or institution, Labor & Delivery environment, Neonatal Intensive Care Unit, newborn care areas.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing 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 60601-1-10, 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:
- Software Verification & Validation Testing: 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 requirements of the device, including warming, skin temperature monitoring and alarms.
- Biocompatibility Testing: The biocompatibility evaluation for the NuBorne Infant Warmer was 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 NuBorne Infant Warmer was conducted in accordance with the FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff.
- Reprocessing Evaluation: The reprocessing validation for the NuBorne Infant Warmer was conducted in accordance with the FDA guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff.
Key results: Any differences between the NuBorne Infant Warmer and the predicates do not raise any new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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:
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
4
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 | ||
| 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 warming the infants | The Lullaby Warmer is a radiant warmer
which provides a microenvironment for
a premature, new born baby which
otherwise might have very little chance
of survival as it will not be able to
maintain, by itself, its core body
temperature. The Lullaby Warmer
provides a means for the care giver to
monitor the baby continuously by giving | The Babyleo TN500 is intended for use
with premature babies and neonates and
can be used as both an incubator and a
radiant warmer. When the product is
switched between incubator and radiant
warmer operation, patients continue to
be kept warm during the transition. The
device provides a thermally regulated
environment for patients with a body |
| | | | |
| | 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. | timely feedback via the different alarm
systems and servo controlled thermal
feedback mechanism while maintaining
a pre-set temperature and thus ensures
that the neonate slowly develops the
internal organs to enable it to maintain
its body temperature. | weight of up to 5kg( 11lbs) and a height of
up to 55cm (22in). The device can be
operated as either a closed care unit or an
open care unit. As a closed care unit,
Babyleo TN500 is an incubator. Neonates
are kept warm in the patient
compartment with humidifiable air, which
can be enriched with oxygen (option). As
an open care unit, Babyleo TN500 is a
radiant warmer. Babyleo TN500 provides
controlled ambient conditions for
premature babies and neonates. The
following parameters are regulated,
according to the intended use:
Temperature; Humidity; Oxygen (option). |
| Environment for
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
Parameters and
Functions | | | |
| Operating Volume
measured in patient
bed | 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 Failure
Alarm | 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 Temperature
Measurement
Range | This device is an open air radiant warmer.
Newborns are warmed by the radiation of the
heater head. Air temperature is NOT measured in
this type of device. | This device is an open air radiant
warmer. Newborns are warmed by the
radiation of the heater head. Air
temperature is NOT measured in this
type of device. | Because this device can be used as both
an open radiant warmer and closed
convective incubator the air temperature
range is during incubator operations is:
13-45°C |
| Air Temperature
settings and
Override | This device is an open air radiant warmer.
Newborns are warmed by the radiation of the
heater head. Air temperature is NOT measured in
this type of device. | This device is an open air radiant
warmer. Newborns are warmed by the
radiation of the heater head. Air
temperature is NOT measured in this
type of device. | Because this device can be used as both
an open radiant warmer and closed
convective incubator the air temperature
range that can be set during normal
operations is:
20-39°C with a confirmation override at
37°C |
| Oxygen Regulation | This device is an open air radiant warmer. Oxygen
delivery can be accomplished by ventilator, nasal
prongs or by mask. The warmer does NOT regulate
oxygen delivery to the patient, regulation requires
different device(s) | This device is an open air radiant
warmer. Oxygen delivery can be
accomplished by ventilator, nasal prongs
or by mask. The warmer does NOT
regulate oxygen delivery to the patient,
regulation requires different device(s) | An optional accessory to this combination
warmer incubator allows oxygen delivery
into the closed compartment.
Measurement range:
Normal range: 18-65 %
Extended range: 66-99%
Accuracy ± 2.5%
When used as an open air radiant
warmer, oxygen delivery can be
accomplished by ventilator, nasal prongs
or by mask. Oxygen delivery to the
patient when used as an open air warmer
will requires different device(s) NOT
controlled by the warmer |
| Radiant Warmer
Settings Range in
Manual Mode | Single heating element with setting range of:
Off-100% in 5% increments
Pre-Warm Mode:
100% for 10 minutes
50% until setting is changed | Single heating element with setting
range of:
Off-100% in 5% increments
Pre-Warm Mode:
100% for 12 minutes
25% until setting is changed | Two heating elements Setting range:
Off, 10% to 100%
Pre-Warm Mode:
100% for 3 minutes
60% for 11.5 minutes
30% until setting is changed |
| Radiant Warmer
Skin Temperature
Regulation Range | 34-38°C
A visual symbol appears warning the user if
temperature setting
37° C | 30-38°C
No visual or confirmation override | 34-38°C
A confirmation override required if setting
is
37° C |
| Skin Temperature
Monitoring Range | 25-40°C | 25-40°C | 13-43°C |
| Warmer Features | | | |
| Maximum
Irradiance of
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
Setting Range | 0 to 100% in 5% increments | 0 to 100% in 5% increments | Off, 10% - 100% |
| Set Temperature
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
Cassette Tray | Yes | Yes | Yes |
| Bed Tilt Mechanism | Continuous up to 12° | Continuous up to 15° | Continuous up to 13° |
| Storage Drawer
Available | Yes | Yes | Yes |
| Access Panels | All side panels are hinged for patient access to
support medical procedures and interventions | All side panels are hinged for patient
access to support medical procedures
and interventions | All side panels are hinged for patient
access to support medical procedures and
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 |
| 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 Priority
Alarms | 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 |
| Electrical
Description | | | |
| Power Supply | 115V – 230V, 50/60 Hz | 115V – 230V, 50/60 Hz | 100V to 240V, 50/60 Hz |
| Power
Consumption | 750W | 600W | 1000W |
| Physical Description | | | |
| Weight (without
options and
accessories) | 105kg | 72kg |