(34 days)
The Lullaby™ Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. This device is intended for professional use only by trained clinicians.
The Lullaby™ Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. This device consists of a freestanding lamp that delivers specific wavelength light to the patient positioned below the lamp.
This document describes the GE Healthcare Lullaby™ Phototherapy System, a device intended for the treatment of neonatal hyperbilirubinemia (neonatal jaundice).
Acceptance Criteria and Device Performance:
The document does not explicitly state numerical acceptance criteria for the Lullaby™ Phototherapy System's performance in treating neonatal hyperbilirubinemia. Instead, the acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicit from submission) | Reported Device Performance |
|---|---|---|
| Intended Use | Treatment of neonatal hyperbilirubinemia (neonatal jaundice). | The Lullaby™ Phototherapy System is intended for this specified use. |
| Mode of Action | Delivery of specific wavelength light for neonatal jaundice treatment. | Employs the same mode of action as the predicate device (light therapy). |
| Electrical Safety | Conformance to applicable medical device safety standards. | Evaluated and found to conform to applicable medical device safety standards. |
| Quality Systems | Design and development process conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems. | Manufacturer's process conforms to these standards, with compliance verified through independent evaluation and ongoing factory surveillance. |
| Substantial Equivalence | Demonstrated substantial equivalence to a legally marketed predicate device (Phoenix Neonatal Phototherapy Unit CFL 101, K040853) with respect to safety and effectiveness. | Concluded to be substantially equivalent to the predicate device. |
Study Details:
The document states: "Clinical Tests: None required." This indicates that no specific clinical study was conducted as part of this 510(k) submission to demonstrate the device's performance against specific acceptance criteria. The approval is based on the established safety and effectiveness of the phototherapy treatment modality itself and the device's substantial equivalence to a predicate device.
Therefore, many of the typical study-related questions are not applicable to this submission.
- Sample size used for the test set and the data provenance: Not applicable. No test set from a clinical study was used for performance evaluation since no clinical tests were required.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for a test set was established as no clinical tests were performed.
- Adjudication method for the test set: Not applicable.
- 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. This is a phototherapy device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm. Its performance is inherent in its physical and functional design.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a specific study within this submission. The ground truth for the effectiveness of phototherapy for neonatal hyperbilirubinemia is implicitly based on the long history of safe and effective use established in traditional clinical practice for this type of treatment.
- The sample size for the training set: Not applicable. No training set for an algorithm was used.
- 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).