(272 days)
The Neonatal Phototherapy System, Model: KANGALITE is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates: gestational age ≥38 weeks and weight within 2500-4500 grams. It can be used in the clinical setting or in the home environment. It should be used for neonates whom phototherapy has been prescribed.
The Neonatal Phototherapy System, Model: KANGALITE is a wearable phototherapy system that consists of six components: Light Source with AC Power Cord, Dual Fiber Optic Panels (Standard accessory) /Single Fiber Optic Panel (optional accessory), Swaddle, Strap, Disposable Covers and Table Mounting Clip (optional accessory). The Neonatal Phototherapy System, Model: KANGALITE delivers a narrow band of high-intensity blue light emitting diode (LED), in order to provide phototherapy treatment for neonatal hyperbilirubinemia.
The Neonatal Phototherapy System, Model: KANGALITE Light Source contains a blue LED which emits light in the range 400-500 nm (peak wavelength 455±10 nm). The system gives only one blue light irradiance output level which is not adjustable. This blue light is directed through the optical fiber bundle to the illuminating area of the Fiber Optic Panel where the newborn receives blue light therapy.
The Fiber Optic Panel is inserted into the Disposable Cover and is placed in a soft and comfortable Swaddle, while the baby is wrapped inside to receive phototherapy. Baby is allowed to receive kangaroo care. Besides, compare to conventional phototherapy, no eye protection for the baby is required as blue light will not leak out when properly set up.
The light output (>30 µW/cm²/nm) is sufficient to provide intensive phototherapy which is defined as in the American Academy of Pediatrics (AAP) standard.
Average irradiance for:
Dual Fiber Optic Panels: 50 µW/cm2/nm (±25%);
Single Fiber Optic Panel: 60 uW/cm2/nm (±25%).
The spectrum range of the blue LED light matches with the spectral absorption of bilirubin. Under blue light irradiation, subcutaneous bilirubin absorbs strongly in the blue region of the light spectrum and converts into less lipophilic waste products which can be excreted through the bile or urine without the need for conjugation.
The Neonatal Phototherapy System, Model: KANGALITE can be directly connected to nominal voltages readily available throughout the world as the Light Source is affixed with a wide-range medical adaptor, rated from 100-240 VAC and 50/60 Hz. It converts the power to 15 VDC to power up the Light Source.
The provided text describes a 510(k) premarket notification for a medical device, the Neonatal Phototherapy System, Model: KANGALITE. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel AI/device.
Therefore, many of the requested details regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI models or new clinical devices, are not explicitly provided in this 510(k) submission.
Here's a breakdown of what can be inferred or stated based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of explicit acceptance criteria with numerical performance targets typical for clinical efficacy studies (e.g., sensitivity, specificity, or improvement in bilirubin levels). Instead, the "acceptance criteria" for this 510(k) submission are met by demonstrating substantial equivalence to a previously cleared predicate device (Bili-Tx, K070180) through various non-clinical tests and comparisons of technological characteristics.
The "reported device performance" is largely qualitative, asserting that the device meets relevant safety and performance standards established for such phototherapy systems.
Here's what can be extracted regarding performance and comparison:
| Characteristic | Acceptance Criteria (Implicit for Substantial Equivalence to Predicate) | Reported Device Performance (KANGALITE) |
|---|---|---|
| Intended Use | Treatment of hyperbilirubinemia in neonates (Bili-Tx) | Treatment of unconjugated hyperbilirubinemia in neonates: gestational age ≥38 weeks and weight within 2500-4500 grams |
| Principle of Operation | Blue light phototherapy converting bilirubin to excretable products (Bili-Tx) | KANGALITE uses blue light LEDs (400-500 nm, peak 455±10 nm) for bilirubin conversion |
| Light Intensity (Irradiance) | Standard Panel-Light: 30 µW/cm²/nm; Neonatal Panel-Light: 55 µW/cm²/nm; Overhead Therapy: 30 µW/cm²/nm (Bili-Tx) | Dual Fiber Optic Panels: 50 µW/cm²/nm (±25%); Single Fiber Optic Panel: 60 µW/cm²/nm (±25%). Meets AAP intensive phototherapy standard (>30 µW/cm²/nm). |
| Wavelength | Blue LEDs: 400–550 nm (peak 450–470 nm) (Bili-Tx) | Blue LED: 400-500 nm (peak: 455 ± 10 nm) |
| LED Lifetime | Minimum lifetime of 30,000 hours (Bili-Tx) | Nominal lifetime: >45,000 hours |
| Biocompatibility | Not publicly available for predicate (Bili-Tx) | Passed ISO 10993 for Cytotoxicity, Sensitization, Skin Irritation for patient-contact materials (disposable covers, Swaddle). |
| Electrical Safety | Conforms to IEC 60601-1 (Bili-Tx) | Conforms to ES60601-1 and related amendments. |
| Electromagnetic Compatibility (EMC) | Conforms to EN 60601-1-2 (2nd edition) (Bili-Tx) | Conforms to IEC 60601-1-2 (4th edition) |
| Phototherapy Safety/Performance | Conforms to IEC 60601-2-50 (Bili-Tx) | Conforms to IEC 60601-2-50. |
| Home Use Safety | Intended for home/hospital use (Bili-Tx) | Conforms to IEC 60601-1-11 for home healthcare environment. |
| Water Ingress Protection (Light Source) | IPX0 (Bili-Tx) | IP22 (KANGALITE), fulfills IEC 60601-1-11 requirement for home use. |
| Noise |
§ 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).