(150 days)
The bill-hut™ provides phototherapy for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the clinical or home setting.
The bili-hut™ is a modular, portable blue LED-based phototherapy device intended to treat neonatal hyperbilirubinemia, commonly known as infant jaundice. The bili-hut™ consists of the assembled hut (shell with light source, base mattress, base), nest components (nest, nest liner, nest mattress, nest mattress cover), and power supply. It has an optional accessory, the perch, which is a bassinet stand insert. Features include a timer for total LED use and an Environment High Temperature Warning with automatic shutoff. The principle of operation is phototherapy using blue light to break down bilirubin. The device is powered by a 12V medical grade power supply and uses an LED light array. The materials include fabric-based, plastic, metal, and electronic components.
The bili-hut™ device is a phototherapy unit for treating neonatal hyperbilirubinemia (infant jaundice). The provided text describes the acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device, the Ultra Bili Light™ Model 2000 (K974830).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by compliance with recognized standards and performance characteristics comparable to the predicate device. The performance data is primarily non-clinical.
| Acceptance Criteria / Performance Characteristic | bili-hut™ Reported Performance | Predicate Device (Ultra Bili Light™ Model 2000) Performance | Discussion/Compliance |
|---|---|---|---|
| Intended Use | For treatment of neonatal hyperbilirubinemia in clinical or home setting. | For treatment of neonatal hyperbilirubinemia in clinical or home setting (initially Home, later clarified to include Clinical). | Similar. |
| Principle of Operation | Phototherapy with blue light to decrease bilirubin blood levels. | Phototherapy with blue light to decrease bilirubin blood levels. | Similar. |
| Energy Source | Blue light LED | Blue light fluorescent | Different technology, but both deliver therapeutic irradiance above 30 µW/cm²/nm. No new safety/effectiveness questions raised. |
| Light Source Wavelength | 430-490 nm | 430-500 nm | Similar; within AAP recommended range (430-490 nm). |
| Average Irradiance of Intended Treatment Area | 45 µW/cm²/nm | 60 µW/cm²/nm | Similar; both exceed AAP standard for high intensity phototherapy (> 30 µW/cm²/nm). |
| Output Peak Wavelength | 463 nm | Not explicitly stated, implied within 430-500 nm range | Within accepted therapeutic range. |
| Peak Irradiance | 58 µW/cm²/nm | Not explicitly stated, implied by average irradiance. | Consistent with therapeutic requirements. |
| Effective Treatment Area | 170 in² (1097 cm²) | Not explicitly stated. | Adequate for neonatal treatment. |
| Biocompatibility of Patient-Contact Materials | Passed Cytotoxicity, Sensitization (2 methods), Skin Irritation (2 methods) tests per ISO 10993 standards for polypropylene nonwovens (nest liner, nest mattress cover). | Assumed biocompatible, but no publicly available testing data for predicate. | bili-hut™ tested to current ISO 10993 standards. |
| Thermal Safety (Over-temperature shutoff) | Device material contacting newborn non-conductive, fabric-covered foam. LEDs out of reach. Over-temperature shutoff at 43°C (109.4°F) per IEC 60601-2-50. | Heating pad for cold conditions. Thermal protection circuit (beeper, flashing lights, shutoff) for over 98°F (36.7°C). | Both protect from overheating. bili-hut™ does not have a heating feature. bili-hut™ compliant with newer IEC standard, hence different cutoff temperature. No new safety/effectiveness questions raised. |
| Visible Light Radiation Safety | Requires separate eye protection (user-selected protective eye covers or goggles). | Requires BabyFace Shield or eye patches to protect eyes. | Similar; both require external eye protection. |
| Ultraviolet Light Radiation Safety | LED light source emits no UV light. | UV-blocking plastic sheet covers fluorescent bulbs. | Different. bili-hut™ inherently emits no UV; predicate filters it. No new safety/effectiveness questions raised. |
| Electrical Safety Testing | Conformance to AAMI ES60601-1:2005 + A1, IEC 60601-1-6 Ed 3.1 2013, IEC 62366-1 Ed 1.0 2015, IEC 60601-1-11 Ed 2.0 2015, IEC 60601-2-50 Ed 2.1 2016. | No publicly available information for predicate to current standards. | bili-hut™ tested to current, FDA-recognized standards. |
| Electromagnetic Compatibility (EMC) Testing | Conformance to IEC 60601-1-2 Edition 4.0 2014. | No publicly available information for predicate to current standards. | bili-hut™ tested to current, FDA-recognized standards. |
| Usability/Human Factors | Conformance to IEC 60601-1-6 and IEC 62366-1. | Not explicitly stated for predicate device, implied by general design. | bili-hut™ tested to current standards. |
| Device Power, Indicators, LED Performance, System Irradiance, System Light Intensity, Accelerated Lifetime | Bench performance tests completed to verify requirements met. | Implied functional for predicate. | bili-hut™ verified to meet device requirements and specifications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical bench testing.
- Biocompatibility testing: The "sample size" here refers to the materials tested (disposable covers and nest mattress). The studies were likely performed in a laboratory setting by certified testing facilities. The provenance would be the testing lab.
- Electrical Safety, EMC, and Bench Performance tests: These are performed on the device itself. The "sample size" is the device(s) tested. These are laboratory tests, not human data.
There is no mention of a clinical test set or human data used to evaluate the device's performance in treating hyperbilirubinemia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as there was no clinical test set for which ground truth would be established by experts. The performance evaluation was primarily through non-clinical bench testing against established engineering and medical device standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no clinical test set requiring expert adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The bili-hut™ is a phototherapy device, not an AI-assisted diagnostic or interpretative system requiring human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The bili-hut™ is a medical device, not an algorithm. Its performance as a standalone phototherapy unit was assessed via bench testing against engineering and medical device standards, and comparison to a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical and bench performance tests, the "ground truth" or reference points were:
- Recognized international and FDA-recognized standards: (e.g., AAMI ES60601-1, IEC 60601-1-x series, ISO 10993 series).
- American Academy of Pediatrics (AAP) standards: Specifically for therapeutic irradiance (irradiance > 30 µW/cm²/nm) and peak wavelength (430-490 nm).
- Predicate device characteristics: The Ultra Bili Light™ Model 2000 (K974830) served as a benchmark for comparison to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable as this is a medical device, not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 880.5700 Neonatal phototherapy unit.
(a)
Identification. A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.(b)
Classification. Class II (performance standards).