Search Results

The BiliSoft Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly know as neonatal jaundice, during the newborn period in the hospital or home setting. The BiliSoft Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.

The Bili-Soft Phototherapy System is a mobile phototherapy device that delivers high intensity blue light using blue light emitting diodes (LEDs) that transmit light to a fiber optic pad.

The device consists of a light source box and one of two different size fiber optic pads. The light source operates in a single light intensity mode and includes features such as an over temperature indicator with automatic LED shutoff and an hour meter to indicate life. The light source has an automatic universal voltage selection of 90-264 VAC at 47-63 Hz.

Fiber optic pad covers are made of a clear, medical grade, hypoallergenic and latex-free material. The smaller fiber optic pad emits an average output of 35 µW/cm-/nm through a typical snuggly/pad cover, and the larger fiber optic pad emits an average output of 50 µW/cm /nm through a typical snuggly/pad cover. Disposable fiber optic pad covers are available to help comfortably position the baby on the fiber optic pad and to prevent cross contamination of bodily fluids between infants.

LED's have very little light degradation over their lifetime with proper use and care. During normal operating conditions the device is expected to last for approximately 10,000 hours. Once the LED's have reached the end of their life a replaceable LED module is available for purchase. LED's emit no appreciable energy in the ultraviolet (UV) region of the spectrum, so there is no concern for UV exposure to the infant. In addition, LED's emit no significant energy in the infrared (IR) region of the spectrum; therefore there is no concern for excessive warming of the infant due to IR energy.

The provided document K053568 for the BiliSoft Phototherapy System does not contain information about acceptance criteria for a study demonstrating device performance using human subjects, nor does it describe a study involving human readers, training sets, or ground truth establishment in the context of diagnostic performance.

Instead, the document states:

"Since the treatment of neonatal hyperbilirubinemia with phototherapy is a well establish clinical practice, clinical or animal testing to demonstrate safety and effectiveness is not necessary. The product has been subject to extensive bench testing, and the requirement of 21 CFR 820, Subpart C - Design Controls - were satisfied."

Therefore, for the specific questions requested, the answer is that this information is not applicable or not provided in this 510(k) submission. The FDA cleared this device based on substantial equivalence to predicate devices and extensive bench testing, not on a clinical study evaluating diagnostic performance with human readers or AI.

However, I can extract the performance data that was provided in the context of bench testing:

BiliSoft Phototherapy System - Performance Data (Based on Bench Testing and Design Controls)

Since the device is a phototherapy system for treatment (not a diagnostic device being evaluated for a diagnostic algorithm), the following points are not applicable to the information provided in this 510(k):

• Sample sized used for the test set and the data provenance: Not applicable; no clinical test set for diagnostic performance was used.
• 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 diagnostic performance was established.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No; this is a treatment device, not a diagnostic imaging device typically evaluated with MRMC studies.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is a hardware treatment device, not an algorithm.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device