Search Results

The BiliBlanket Plus High Output (67.5 µW/cm²/nm maximum )Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly know as neonatal jaundice, in the hospital or home setting. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.

The BiliBlankel Plus High Output Phototherapy System has two modes of operation: phototherapy, used for the treatment of hyperbilirubinemia; and transillumination, used for a variety of medical procedures such as locating venipuncture sites and detecting pneumothoraces or hydrocephalus. In the phototherapy mode, a fiberoptic cable and blanket are attached to the illuminator box. Phototherapeutic light, which is light in the blue region (42.5 - 475 nm), is transmitted from the illuminator to the blanket via the fiberoptic cable. The blanket is applied to the patient so as to maximize the patient contact with the blanket. The second mode is transillumination. A fiberoptic cable is attached to the illuminator, and the visible light spectrum (white light) appears at the tip of this fiberoptic cable is used for facilitating vascular stick or injections; it is also used for finding pneumothoraces.

Here's a breakdown of the acceptance criteria and study information for the Ohmeda Medical BiliBlanket Plus High Output Phototherapy System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The 510(k) summary primarily focuses on the modification from the predicate device (increased light output) rather than explicit "acceptance criteria" in the traditional sense of a performance study with pass/fail metrics. The "reported device performance" here is essentially the new specification that the modified device achieves. The regulatory submission implies that meeting this increased light output, while adhering to general safety and design controls, is the basis for substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable. No clinical or animal testing was performed.
• Data Provenance: Not applicable, as detailed above.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical or animal testing was performed that would require expert-established ground truth.

4. Adjudication method for the test set:

• Not applicable. No clinical or animal testing was performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC comparative effectiveness study was not performed. The submission explicitly states: "Since treatment of neonatal hyperbilirubinemia with phototherapy is a well established clinical practice, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a medical device, not an AI/algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. No ground truth in the context of clinical accuracy or diagnostic performance was established for this submission. The validation was based on engineering bench testing to confirm the modified light output specifications.

8. The sample size for the training set:

• Not applicable. This device is not an AI/algorithm and does not involve a training set.

9. How the ground truth for the training set was established:

• Not applicable. This device is not an AI/algorithm and does not involve a training set or its associated ground truth establishment.

Summary of the Study and Device Proof:

The submission for the BiliBlanket Plus High Output Phototherapy System is a 510(k) for a modified version of an existing predicate device (Ohmeda - BiliBlanket Plus High Output, K993712).

The "study" that proves the device meets its (new) acceptance criteria is extensive bench testing. The manufacturer, Ohmeda, states that "the product was subject to extensive bench testing, and, to the best of Ohmeda Medical's knowledge, the requirements of 21 CFR 820, Subpart C -- Design Controls -- were satisfied."

The primary modification being documented is an increase in the maximum light output level from the predicate's 18-45 ± 25% µW/cm²/nm to the modified device's 21-50 +35% -25% µW/cm²/nm. The rationale for not conducting clinical or animal testing is that "treatment of neonatal hyperbilirulinemia with phototherapy is a well-established clinical practice." This means the general safety and effectiveness of phototherapy for this indication are already understood, and the modification is primarily an engineering change to the device's performance characteristics, validated through engineering testing.

Ask a specific question about this device