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510(k) Data Aggregation
(115 days)
Infant Phototherapy Equipment
The BiliTouch™, model Motif Phototherapy Blanket and Infant Phototherapy Equipment, model BT-450 for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home.
The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.
Infant phototherapy equipment is a portable phototherapy light system 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, rechargeable battery and AC/DC power supply. The pad is designed to provide phototherapy treatment from underneath the baby.
Infant phototherapy equipment provides blue LEDs to achieve intensities by two-level with emitting light from blue LEDs (bandwidth 400 - 550 nm used).
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.
This document is an FDA 510(k) Premarket Notification summary for the BiliTouch™ (Motif Phototherapy Blanket) and Infant Phototherapy Equipment (BT-450). It details the device's characteristics and its substantial equivalence to a predicate device, focusing on non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" for an AI/algorithm's performance or "reported device performance" in the typical sense of metrics like accuracy, sensitivity, and specificity for diagnostics. Instead, it describes compliance with various safety and performance standards for a medical device (infant phototherapy equipment).
However, we can infer some "acceptance criteria" and "reported performance" from the "Summary table of technological characteristics of the device compared to the predicate device" and the "SUMMARY OF NON-CLINICAL TESTS" section.
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance (Compliance/Result) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-5 (Cytotoxicity) & ISO 10993-10 (Irritation/Sensitization) for components in contact with user. | Testing was conducted in accordance with FDA Recognition # 2-245, ISO 10993-5:2009, Biological Evaluation of Medical Devices-- Part 5: Tests for In Vitro Cytotoxicity and FDA Recognition # 2-174, ISO 10993-10:2010, Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization. (Implied successful compliance). |
| Electrical Safety | Compliance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012 (IEC 60601-1) & IEC 60601-1-11:2015. | Testing was conducted in accordance with FDA Recognition # 19-4, AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) and FDA Recognition # 19-14, IEC 60601-1-11:2015. (Implied successful compliance). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014. | Testing was conducted in accordance with FDA Recognition # 19-8, IEC 60601-1-2:2014. (Implied successful compliance). |
| Alarm System | Compliance with IEC 60601-1-8: 2006 + AMD1:2012. | Testing was conducted in accordance with FDA Recognition # 5-76. IEC 60601-1-8: 2006 + AMD1:2012. (Implied successful compliance). |
| Infant Phototherapy Equipment Specifics | Compliance with IEC 60601-2-50: 2009/AMD1:2016. | Testing was conducted in accordance with FDA Recognition # 6-387, IEC 60601-2-50: 2009/AMD1:2016. (Implied successful compliance). |
| Software Verification and Validation | Compliance with FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005). | Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005). (Implied successful compliance). |
| Bench Performance Tests (Battery, Light Intensity, Temperature, Alarms) | To demonstrate specifications. | Bench performance tests including testing for battery-powered operating test, light intensity test and testing for temperature on the pad of the device and high temperature alarm were completed to verify that the infant phototherapy equipment demonstrate the specifications. (Implied successful verification). |
| Wavelength | 455~465 nm (matching predicate) | 455~465 nm |
| Light Output (Irradiance) | HIGH: 60±10 µW/cm²/nm; LOW: 30±10 µW/cm²/nm | HIGH: 60±10 µW/cm²/nm; LOW: 30±10 µW/cm²/nm |
| Thermal Safety (PAD Surface) | ≤ 40 °C | Surface of PAD ≤ 40 °C |
| Acoustic Energy | Not explicitly stated an acceptance range, but reported. | 43 ±1 dBA |
| IP Ratings | Control box: IP 21; Pad: IP 23; Power adapter: IP 22 | Control box: IP 21; Pad: IP 23; Power adapter: IP 22 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical data were submitted." This implies that the 'test set' for demonstrating the device's safety and effectiveness was based purely on non-clinical, bench testing and adherence to recognized standards, rather than patient data. Therefore, there is no information on sample size, country of origin, or retrospective/prospective nature of a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is Not Applicable as no clinical data or expert-adjudicated ground truth was used for assessing the device's performance in a diagnostic or AI context. The assessment was based on compliance with device performance standards rather than a clinical ground truth derived from expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is Not Applicable as no clinical data requiring expert adjudication was used.
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
An MRMC study was Not Done. The device is an Infant Phototherapy Equipment, which is a physical device delivering light therapy, not an AI or imaging diagnostic aid that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable as the device is not an algorithm for diagnosis or image interpretation. It is a phototherapy device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the purpose of this 510(k), where "No clinical data were submitted," the "ground truth" for the device's performance is established by its compliance with internationally recognized electrical, mechanical, biocompatibility, and phototherapy-specific safety and performance standards (e.g., IEC 60601 series, ISO 10993) and successful completion of internal bench performance tests.
8. The sample size for the training set
This section is Not Applicable. As stated, "No clinical data were submitted." The device is a physical medical device, not a software algorithm that requires a training set of data.
9. How the ground truth for the training set was established
This section is Not Applicable as there was no training set in the context of an AI/algorithm development.
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