(108 days)
The Drager NanoBlu 500 LED Phototherapy Light 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. Additionally, this product can be used with an underbaby phototherapy light to increase patient coverage.
The Dräger NanoBlu 500 is an LED phototherapy light. It consists of an LED module with 5 LEDs and a fan, a microprocessor controller, and an alphanumeric display and keyboard. The display and keyboard are used to program the functions of the light. The Dräger NanoBlu 500 is available in two versions, the hood mount and the trolley mount. The hood mount version has suction cups on the bottom that are used when placed on the top of an incubator. The trolley mount version is mounted on a rolling trolley to allow use above an incubator or radiant warmer. The trolley consists of a base supported by three 2 in (5.08 cm) castors. A column, with an adjustable and articulating arm, connects them. Both of these features allow the light to be positioned for optimum light over the patient. There are no single-use components or accessories for the NanoBlu™ 500.
The provided text is a 510(k) summary for the Dräger NanoBlu™ 500 Phototherapy Light, which is a device intended to treat neonatal hyperbilirubinemia.
Here's an analysis of the acceptance criteria and the study as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly present a table of "acceptance criteria" in the way a clinical study might define primary and secondary endpoints. Instead, the "acceptance criteria" are implied by the performance characteristics compared to the predicate device and compliance with relevant standards. The "reported device performance" refers to the NanoBlu 500's specifications as stated in the submission.
| Feature | Acceptance Criteria (Implied by Predicate/Standards) | NanoBlu™ 500 Reported Performance |
|---|---|---|
| Intended Use | Treat neonatal hyperbilirubinemia | Treat neonatal hyperbilirubinemia |
| Target Population | Neonates | Neonates |
| Light Source | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) |
| Wavelength | 400-550 nm | 400-550 nm |
| Intensity | Similar to predicate (35 ± 3.5 μW/cm²·nm @ High) | Minimum 40 μW/cm²·nm |
| Electrical Safety | IEC 60601-1, UL 60601-1, CSA/CAN C22.2 601.1 | Compliant with these standards |
| EMC | IEC 60601-1-2 | Compliant with this standard |
| Infant Phototherapy Specific Safety | IEC 60601-2-50 | Compliant with this standard |
2. Sample size used for the test set and the data provenance
The document describes nonclinical testing of "prototype devices" and does not refer to a "test set" in the context of patient data or clinical samples. It focuses on engineering and performance testing. Therefore, there is no patient-based sample size mentioned, nor is there data provenance in terms of country of origin or retrospective/prospective status for a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the submission describes nonclinical testing, not a clinical study involving ground truth established by experts.
4. Adjudication method for the test set
This information is not applicable as the submission describes nonclinical testing, not a clinical study requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a phototherapy light, not an AI-assisted diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The NanoBlu 500 is a hardware device for phototherapy, not an algorithm, and the testing described is of its physical and performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical testing described, the "ground truth" would be established by reference standards, engineering specifications, and the specified requirements of the medical device standards (e.g., IEC, UL). There is no clinical ground truth (like expert consensus, pathology, or outcomes data) mentioned as this was a nonclinical submission.
8. The sample size for the training set
This information is not applicable as no "training set" in the context of machine learning or clinical data is mentioned. The testing involved prototype devices and compliance checks.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as above. There was no training set.
Summary of the Study:
The study described in this 510(k) summary is a nonclinical performance and safety evaluation of the NanoBlu™ 500 Phototherapy Light. The "study" involved:
- Testing prototype devices to specifications: This likely involved verifying manufacturing tolerances, functionality, and specific performance metrics.
- Spectral characterization of the LED light source: Measuring the actual light output spectrum (wavelengths) to ensure it falls within the therapeutic range (400-550 nm).
- Analysis of the potential optical radiation hazard: Assessing the safety of the light output to ensure it does not pose undue risks to patients or users.
- Compliance testing against international and national standards:
- IEC 60601-1 (General Safety for Medical Electrical Equipment)
- UL 60601-1 (General Safety for Medical Electrical Equipment, US specific)
- IEC 60601-1-2 (Electromagnetic Compatibility - EMC)
- IEC 60601-2-50 (Particular Safety Requirements for Infant Phototherapy Equipment)
The purpose of these tests was to demonstrate substantial equivalence to a predicate device (Natus® Blue Light Phototherapy) by showing similar intended use, operating principles, hardware configuration, and comparable performance and safety characteristics. The conclusion was that the device meets expectations and raises no new safety or effectiveness issues based on this nonclinical testing. No clinical studies were conducted or deemed necessary for this 510(k) submission.
§ 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).