(276 days)
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.
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.
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.
§ 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.