(91 days)
The BILI-THERAPY Spot Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.
The BILI-THERAPY Spot Type is an overhead unit available in two versions: Arm and Stand. The BILI-THERAPY Spot Type phototherapy unit shines a blue light onto the patient for the treatment of hyperbilirubinemia. The unit has no direct contact with the patient.
This document describes the regulatory submission for the BILI-THERAPY Spot Type, a neonatal phototherapy unit. The submission aims to demonstrate substantial equivalence to a predicate device, not to prove clinical effectiveness through a standalone study of the device's diagnostic or therapeutic performance using statistical metrics like sensitivity and specificity. Therefore, many of the requested criteria related to such studies (e.g., sample size for test sets, expert qualifications, HRMR, standalone performance) are not applicable or derivable from this type of regulatory summary.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating substantial equivalence to the predicate device (Respironics Bili-Tx K070180) across various parameters and compliance with recognized standards. The "performance" reported is primarily in relation to these equivalency criteria and bench testing.
| Acceptance Criterion (Compared to Predicate Device & Standards) | Reported Device Performance (BILI-THERAPY Spot Type) |
|---|---|
| Indications for Use | The BILI-THERAPY Spot Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia. (Identical to predicate's intended use according to the summary). |
| Patient Population | Neonatal. (Identical to predicate). |
| Environment of Use | Hospital or institutional. (Identical to predicate's hospital/institutional use, though predicate also permits home use). |
| Prescriptive | Yes. (Identical to predicate). |
| Patient Connection | No. (Equivalent to predicate's overhead unit, but predicate also has a fiber optic panel with patient connection). |
| Technology | Blue light-emitting diodes (LEDs). (Identical to predicate). |
| Dimensions | Arm Type: 1000W x 130D x 450H (mm); Stand Type: 450W x 710D x 1900H (mm). (Varies from predicate's illuminator dimensions, but form factor differs). |
| Weight | Arm Type: approx 2.2 kg; Stand Type: approx 12 kg. (Varies from predicate's 1.3 Kg). |
| Irradiation Intensity | 30-40 µW/cm²/nm (measured at 30 cm). (Comparable to predicate's 32 µW/cm²/nm at 30 cm). |
| Irradiation Area | Effective irradiated area 20 x 30 cm. (Predicate does not specify this directly). |
| Change in Irradiance | After 6 hours +/- 10%. (Predicate does not specify this directly). |
| Wavelength | Peak 450 to 475 nm. (Comparable to predicate's peak between 450 nm and 485 nm). |
| Sound Level | 60 dB or less. (Predicate is 52 dB, but both are within acceptable noise limits for medical devices). |
| Power Supply | Rated, Voltage 120VAC, Power consumption 30VA, frequency 50/60 Hz; Working voltage range 120VAC +/-10%. (Comparable to predicate's 100-240 VAC, 50/60 Hz, 1.0 A input). |
| Operating Temperature | Ambient: 10-30°C; Relative Humidity 30-85% (non-condensing). (Comparable to predicate's 15°C to 35°C). |
| Storage Temperature | Ambient 0-45°C; Relative Humidity 0-90% (non-condensing). (Comparable to predicate's -20°C to 55°C). |
| Mounting Options | Arm or Stand. (Predicate has overhead option with standard IV pole and bracket). |
| Compliance with Standards | Met all pass/fail criteria and cited standards requirements (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50). (Predicate also declared compliance with these standards). |
Details of the Study Proving Acceptance Criteria
The study described is a bench testing program and an equivalency comparison to a predicate device, as typically performed for a 510(k) premarket notification. It is not a clinical study involving patients or diagnostic performance metrics.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. This was a physical device comparison and bench testing, not a study involving patient data.
- Data Provenance: Not applicable, as no patient data was used. The performance data comes from the specific BILI-THERAPY Spot Type device under test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. There was no "ground truth" to establish in the context of clinical outcomes, as this was a bench test and comparison study. The "ground truth" for the technical specifications would be metrology standards and predefined engineering specifications.
4. Adjudication Method for the Test Set:
- Not applicable. There was no clinical data or expert review requiring adjudication in this context. The "adjudication" was based on adherence to engineering specifications and international standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is relevant for comparing human diagnostic performance with and without AI assistance, or comparing different diagnostic methods. This document describes a medical device's technical and safety equivalence to a predicate, not a diagnostic AI or imaging device requiring such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a phototherapy unit, not an algorithm or AI system. Its performance is directly related to its physical properties and light output, not an algorithm's output.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission is established through international safety and performance standards (e.g., IEC 60601 series) and the technical specifications of the predicate device. The BILI-THERAPY Spot Type demonstrates its performance by meeting or being equivalent to these established benchmarks.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of device.
§ 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).