(211 days)
The BiliWrap Phototherapy System is intended for use to treat infants who have been diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The Phototherapy system can be used in a hospital or at home. The device is intended to be used in infants up to the age of 3 months, weighing less than 10 kg.
The BiliWrap Phototherapy System is a portable phototherapy light system that delivers a narrow band of high-intensity blue light via blue light-emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. The device is comprised of a control box and pad including a disposable pad cover and AC/DC power supply. The pad is designed to cover the torso and legs and provide phototherapy treatment on large surface area of the baby.
The BiliWrap Phototherapy System emits light in the spectrum of 450 to 475 nm, a spectrum known as effective to reduce bilirubin concertation in the body of infants. Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using the device can be applied at home or in a hospital.
The provided FDA 510(k) clearance letter for the BiliWrap Phototherapy System (K243372) clearly states: "No clinical data was required for this submission." (Page 11)
Therefore, the device's acceptance criteria and the study proving it meets these criteria are based entirely on non-clinical tests, specifically bench testing and compliance with various recognized consensus standards.
Here's a breakdown of the information requested, based on the provided document:
Acceptance Criteria and Device Performance Study for BiliWrap Phototherapy System (K243372)
The BiliWrap Phototherapy System's acceptance was established through non-clinical performance and safety testing, demonstrating its substantial equivalence to the predicate device (BiliTouch, K210289). No clinical data was required for this submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by compliance with recognized consensus standards and meeting specified performance characteristics that demonstrate substantial equivalence to the predicate device.
| Characteristic | Acceptance Criteria (Target/Standard Compliance) | Reported Device Performance (as demonstrated by testing) |
|---|---|---|
| Intended Use | Treatment of hyperbilirubinemia in infants up to 3 months, weighing 30 μW/cm²/nm) | Low: 30-40 μW/cm²/nm; High: 40-50 μW/cm²/nm - confirmed to achieve recommended irradiance. |
| Light Emitting Area | Sufficient for effective treatment (larger than predicate due to body-shape design) | 1216 cm² (larger than predicate's 420 cm²), designed to provide effective phototherapy. |
| Heat Distribution | Uniform heat distribution, allowing evaporation of heat to prevent overheating | Demonstrated uniform heat distribution with design allowing heat evaporation (5 sections, arms uncovered). |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2 (EMC), IEC 60601-1-11 (Home Healthcare) | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. |
| Biocompatibility | Compliance with ISO 10993-1 for materials in contact with human tissues | Complies with ISO 10993-1; disposable nonwoven polypropylene cover confirmed biocompatible. |
| Photobiological Safety | Compliance with IEC 62471 | Complies with IEC 62471. |
| Software Functionality | Verification and validation in accordance with FDA guidance | Software verification and validation testing completed. |
| Durability | Device maintains functionality over intended lifespan | Durability tests completed. |
| Temperature Control | Device operates within safe temperature limits | Temperature tests completed. |
| Alarm Functionality | Alarms (visual) function as intended | Errors and alarm tests completed (note: visual alarms, no audible alarms, which was deemed acceptable). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No human clinical test set was used. The evaluation was based on bench testing of the device prototypes/production units. The exact number of physical units tested for each non-clinical test (e.g., durability, electrical safety) is not specified but would typically involve a statistically relevant sample as defined by internal quality systems and testing protocols.
- Data Provenance: The data is derived from retrospective (design-stage, in-house) and prospective (final product verification and validation) non-clinical laboratory testing performed by Gerium Medical, Ltd. and/or their contracted testing facilities, as per the listed industry standards. The country of origin of the data is implied to be Israel (where Gerium Medical, Ltd. is located) and potentially international testing laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no clinical test set was used, there was no "ground truth" derived from expert consensus on patient data. The "ground truth" for non-clinical tests is established by:
- Engineering specifications and design requirements.
- Industry consensus standards (e.g., IEC, ISO).
- Predicate device performance characteristics.
The "experts" involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at Gerium Medical, Ltd. and their third-party testing partners, qualified in device design, testing, and regulatory compliance.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring expert adjudication was used. Non-clinical test results are compared against predefined technical acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical data was required for this submission."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to the BiliWrap Phototherapy System. The device is a physical medical device that emits light for phototherapy, not an AI algorithm or software-only diagnostic tool. Its "performance" is its ability to emit light at the specified wavelength and intensity, safely and reliably.
7. The Type of Ground Truth Used
For this device, the "ground truth" is based on:
- Engineering Specifications and Design Requirements: The device must meet its own design specifications (e.g., light intensity, dimensions, weight).
- Compliance with Recognized Consensus Standards: Many standards (e.g., IEC 60601 series for safety, ISO 10993 for biocompatibility) define quantifiable and verifiable criteria.
- Predicate Device Characteristics: Substantial equivalence often relies on demonstrating that the new device performs comparably to a legally marketed predicate device (BiliTouch in this case) on key performance parameters.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device for phototherapy, there is no "training set" in the context of machine learning or AI models. The "training" for such a device is its design, engineering, and manufacturing process.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
§ 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).