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510(k) Data Aggregation
(314 days)
BILI-THERAPY PAD TYPE
The BILI-THERAPY Pad Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.
The BILI-THERAPY Pad Type is a Bili-therapy unit available with large and small pads. The light source can be mounted to the incubator / warmer or an optional stand. The unit provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital / institutional settings. The BILI-THERAPY Pad Type emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia. Light is generated in the light source and conducted to the patient via light guides to the pads are reusable and are intended to be covered with disposable pad covers. Eye masks are recommended for use with this product but are not included in this submission. Reference to commercially available eye masks is provided in the instructions for use.
The provided text describes the BILI-THERAPY Pad Type, a neonatal phototherapy unit, and its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would typically be structured (e.g., using a test set, ground truth established by experts, sample sizes for training/test sets, MRMC studies, or standalone algorithm performance).
Instead, this document (a 510(k) summary) focuses on demonstrating substantial equivalence to an already legally marketed predicate device (Respironics Bili-Tx K070180) based on similarities in intended use, patient population, environment of use, technology, and performance specifications. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence and conforming to relevant safety and performance standards.
Here's a breakdown of the information that is available, formatted to address your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" in this context are primarily the performance and safety standards, and the "reported device performance" are the specifications stated for the BILI-THERAPY Pad Type and compared against the predicate.
| Criterion | Acceptance Criteria (Predicate: Respironics Bili-Tx K070180) | Reported Device Performance (BILI-THERAPY Pad Type) | Notes |
|---|---|---|---|
| Indications for Use | Treatment of hyperbilirubinemia through phototherapy | A phototherapy unit intended for the treatment of neonatal hyperbiliremia. | Stated as having the "same intended use." |
| Patient Population | Neonatal | Neonatal | Stated as having the "same patient population." |
| Environment of Use | Home or hospital/institutional | Hospital or institutional | Similar, with the BILI-THERAPY Pad Type specifically listing "Hospital or institutional" while the predicate also includes "Home." This is considered acceptable for substantial equivalence. |
| Technology | Blue light-emitting diodes (LEDs) | Blue light-emitting diodes (LEDs) | Identical technology. |
| Irradiation Intensity | Neonatal fiber-optic panel: 90 µW/cm²/nm (measured with Joey™ Dosimeter (JD-100)) | High: 53 µW/cm²/nm +/-25% | |
| Medium: 40 µW/cm²/nm +/-25% | |||
| Low: 26.5 µW/cm²/nm +/-25% | |||
| (measurement obtained by BiliBlanket® meter placed on the pad surface without a pad cover) | |||
| Change in irradiance over 6 hours +/- 10% (in effective area) | While numerically different, the comparison implies that the BILI-THERAPY Pad Type's intensities are within acceptable ranges for effective treatment, noting the different measurement methods and variability. A specific range for efficacy is not provided for the predicate. | ||
| Wavelength | Peak between 450 nm and 485 nm | Peak 450 to 480 nm | The BILI-THERAPY Pad Type's wavelength range falls within the predicate's range. |
| Sound Level | 52 dB | 60 dB or less | The BILI-THERAPY Pad Type's sound level is slightly higher but still within generally accepted limits for medical devices and considered substantially equivalent. |
| Compliance with Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50 | IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995 | |
| IEC 60601-1-2: Collateral standard: Electromagnetic Compatibility (Edition 2:2001 with Amendment 1:2004; Edition 2.1) | |||
| IEC 60601-2-50: 2009 Medical Electrical Equipment - Part 2-50 | Both devices declare compliance with the relevant IEC 60601 series standards for medical electrical equipment, including general safety, EMC, and particular requirements for infant phototherapy equipment, indicating compliance with recognized safety and performance benchmarks. The BILI-THERAPY Pad Type specifically lists the versions it complies with. | ||
| Bench Tests | Not explicitly detailed beyond standard compliance, but inferred to be met by predicate approval. | Performed and found to meet all pass/fail criteria, cited standards requirements, and found to be equivalent in comparison to the predicate. | This indicates direct testing of the new device to ensure it performs as expected and meets safety requirements. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or data provenance in the context of an algorithm or clinical performance study. The "testing" mentioned refers to bench tests to verify compliance with engineering specifications and safety standards, as well as a comparison to the predicate device's specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a phototherapy unit, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is hardware, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of an AI/algorithm study. For device performance validation, the "ground truth" would be the engineering specifications and the requirements of the international standards (e.g., IEC 60601 series).
8. The Sample Size for the Training Set
Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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