(300 days)
The Fanem Infant Phototherapy Bilitron Sky 5006 is intended to treat neonatal hyperbilirubinemia by providing phototherapeutic light to the body of the patient. It is intended for use on the recommendation and under the supervision of healthcare professionals.
The Fanem Infant Phototherapy Billtron Sky 5006 is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, in a hospital. They system can be used for infants in bassinets, incubators, open beds or radiant warmers. The lamp unit emits blue light, which falls within the phototherapy therapeutic spectrum. The Infant Phototherapy Bilitron Sky 5006 consists of a lamp unit and can be hood mounted or trolley mounted.
This document is a 510(k) summary for the Fanem Infant Phototherapy Bilitron Sky 5006. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device, the NanoBlu 500 by Drager.
Here's an analysis of the provided text in the context of acceptance criteria and a study to prove it:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with corresponding reported device performance values. Instead, it compares the subject device's features to those of its predicate device, implying that meeting the predicate device's characteristics constitutes acceptance.
Here's a summary of the comparative features, which act as de facto acceptance criteria based on substantial equivalence:
| Feature | Acceptance Criteria (Predicate Device: NanoBlu 500) | Reported Device Performance (Subject Device: Bilitron Sky 5006) |
|---|---|---|
| Intended Use | For the treatment of neonatal hyperbilirubinemia | For the treatment of neonatal hyperbilirubinemia |
| Target Population | Neonates | Neonates |
| Type | Freestanding device | Freestanding device |
| Mounting Hardware | Roll stand, 3 legs w/casters, 3 locking | Roll stand, 3 legs w/casters |
| Light Attachment | Lights mounted in enclosure | Lights mounted in enclosure |
| Light Source | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) |
| Wavelength | 400-550 nm | 400-550 nm |
| Operating Voltage | 90 VAC to 240 VAC | 100-240V |
| Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50 | IEC 60601-1, IEC 60601-1-2:2001, IEC 60601-2-50 |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing for the Infant Phototherapy Bilitron Sky 5006. However, it does not specify any "test set" in the context of clinical studies, nor does it provide details about sample sizes, data provenance (country of origin), or whether data was retrospective or prospective. The testing mentioned appears to be related to engineering and safety standards rather than clinical performance data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The submission is for a medical device (phototherapy unit), and the "ground truth" concept usually refers to a diagnostic or prognostic performance in AI/clinical studies. For this device, regulatory approval is based on equivalence to existing technology and adherence to recognized standards, not on diagnostic accuracy established by expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. There's no mention of a clinical test set or adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or conducted. This type of study is typically used for diagnostic devices or AI algorithms where human interpretation plays a significant role and the goal is to measure the impact of the new technology on reader performance. The Fanem Infant Phototherapy Bilitron Sky 5006 is a therapeutic device, not a diagnostic one.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study (algorithm only) was not mentioned or conducted. This concept is relevant for AI algorithms or automated diagnostic systems. The Fanem device is a physical phototherapy unit.
7. Type of Ground Truth Used
The concept of "ground truth" as typically understood in AI models (e.g., pathology, outcomes data, expert consensus) is not directly applicable to this submission. The "truth" for this device is its adherence to specified physical and electrical characteristics and its ability to emit light within the therapeutic spectrum, validated through non-clinical testing and comparison to an established predicate device. The efficacy of phototherapy itself for neonatal hyperbilirubinemia is a well-established medical principle.
8. Sample Size for the Training Set
There is no mention of a training set or its sample size. This is a medical device, not an AI model, so the concept of a training set is not pertinent.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this information 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).