(104 days)
The Lullaby The LED Phototherapy System is used for the treatment of indirect hyperbilirubinemia in term and pre-term infants, in a hospital environment - NICUs, PICUs and Well-baby Nurseries - administered by trained, professional medical staff, on the order of a licensed medical practitioner.
The Lullaby 10 LED Phototherapy System is intended for use under the direct supervision of a licensed healthcare practitioner.
The Lullaby The LED Phototherapy System device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.
The Lullaby™ LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, in a hospital. The system can be used for infants in a bassinet, incubator, open bed or radiant warmer. The lamp unit emits blue light, which falls within the phototherapy therapeutic spectrum range. The Lullaby™ LED Phototherapy System consists of a lamp unit with 10 blue LED lamps mounted on a roll stand. The lamp unit consists of a lightweight plastic light enclosure. It can be adjusted vertically and tilted if required. The light enclosure can be tilted up to approximately 90° from the horizontal about it pivot axis. The height of the pedestal can be adjusted to change the vertical position of the lamp unit. The base of the Lullaby™ LED Phototherapy System is designed to slide conveniently under a bassinet, incubator, open bed, or radiant warmer. The lamp unit is designed as a table top style to place directly on the incubator
This 510(k) premarket notification describes the Lullaby™ LED Phototherapy System, a device intended for the treatment of neonatal hyperbilirubinemia.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the proposed Lullaby™ LED Phototherapy System with its predicate device, the Lullaby™ Phototherapy System (K071828), to establish substantial equivalence. The performance factors listed act as the de facto acceptance criteria.
| Performance Factor | Acceptance Criteria (Predicate Device K071828) | Reported Device Performance (Lullaby™ LED Phototherapy System) |
|---|---|---|
| Light Intensity (High Irradiance Mode) | 30 µW.cm⁻².nm⁻¹ | > 45 µW.cm⁻².nm⁻¹ |
| Light Intensity (Low Irradiance Mode) | 20 µW.cm⁻².nm⁻¹ | > 22 µW.cm⁻².nm⁻¹ |
| Light Spectrum | 450-475 nm | 450-465 nm |
| Surface Area Coverage | 50 cm x 30 cm | 60 cm x 30 cm |
| Power Consumption | 100W | 20W |
| Lamp Life | 1000 hours | 50000 hours |
| Lamp Source | CFL tubes | LEDs |
| Overheat Protection | Power cutoff for temp > 85° C | Power cutoff for temperature ≥ 90° C |
Note on "Acceptance Criteria": In the context of a 510(k) for a substantially equivalent device, the "acceptance criteria" are typically met by demonstrating that the new device performs as well as or better than the predicate device for key performance characteristics, or that any differences do not raise new questions of safety or effectiveness. The table above uses the predicate device's performance as the benchmark for these criteria.
2. Sample Size and Data Provenance
The document states: "The subject of this premarket submission, Lullaby™ LED Phototherapy System, did not require clinical studies to support substantial equivalence." Therefore, there is no patient-specific test set or associated sample size for demonstrating clinical performance. The evaluation was based on non-clinical testing and engineering verification.
The data provenance for the non-clinical tests would be internal to Wipro GE Healthcare Private Ltd. and performed during the device's development and testing phases in India (based on the submitter's address).
3. Number and Qualifications of Experts for Ground Truth
Since no clinical studies were conducted and the device's substantial equivalence was based on non-clinical engineering and performance testing, there were no experts used to establish ground truth for a test set in a clinical context. The determination of substantial equivalence was made by the FDA's Office of Device Evaluation based on the provided technical documentation.
4. Adjudication Method
As there was no clinical test set requiring expert interpretation or consensus, there was no adjudication method used in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission explicitly states that clinical studies were not required.
6. Standalone (Algorithm Only) Performance
This device is a physical medical device (phototherapy system), not an algorithm or AI software, therefore, the concept of "standalone (algorithm only) performance" does not apply. The performance evaluation focused on the physical characteristics and functionality of the system itself.
7. Type of Ground Truth Used
The "ground truth" for this submission was established through engineering verification and performance testing. This involved:
- Testing of electrical, mechanical, and safety parameters.
- Reliability testing.
- System design verification protocols.
- Compliance with voluntary standards.
The results of these tests demonstrated that the device met all design requirements and performance claims, allowing it to be deemed substantially equivalent to the predicate.
8. Sample Size for the Training Set
This device is not an AI/ML algorithm that requires a training set. Therefore, there is no training set sample size to report.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is 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).