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510(k) Data Aggregation
(314 days)
The BILI-THERAPY Pad Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.
The BILI-THERAPY Pad Type is a Bili-therapy unit available with large and small pads. The light source can be mounted to the incubator / warmer or an optional stand. The unit provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital / institutional settings. The BILI-THERAPY Pad Type emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia. Light is generated in the light source and conducted to the patient via light guides to the pads are reusable and are intended to be covered with disposable pad covers. Eye masks are recommended for use with this product but are not included in this submission. Reference to commercially available eye masks is provided in the instructions for use.
The provided text describes the BILI-THERAPY Pad Type, a neonatal phototherapy unit, and its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would typically be structured (e.g., using a test set, ground truth established by experts, sample sizes for training/test sets, MRMC studies, or standalone algorithm performance).
Instead, this document (a 510(k) summary) focuses on demonstrating substantial equivalence to an already legally marketed predicate device (Respironics Bili-Tx K070180) based on similarities in intended use, patient population, environment of use, technology, and performance specifications. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence and conforming to relevant safety and performance standards.
Here's a breakdown of the information that is available, formatted to address your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" in this context are primarily the performance and safety standards, and the "reported device performance" are the specifications stated for the BILI-THERAPY Pad Type and compared against the predicate.
| Criterion | Acceptance Criteria (Predicate: Respironics Bili-Tx K070180) | Reported Device Performance (BILI-THERAPY Pad Type) | Notes |
|---|---|---|---|
| Indications for Use | Treatment of hyperbilirubinemia through phototherapy | A phototherapy unit intended for the treatment of neonatal hyperbiliremia. | Stated as having the "same intended use." |
| Patient Population | Neonatal | Neonatal | Stated as having the "same patient population." |
| Environment of Use | Home or hospital/institutional | Hospital or institutional | Similar, with the BILI-THERAPY Pad Type specifically listing "Hospital or institutional" while the predicate also includes "Home." This is considered acceptable for substantial equivalence. |
| Technology | Blue light-emitting diodes (LEDs) | Blue light-emitting diodes (LEDs) | Identical technology. |
| Irradiation Intensity | Neonatal fiber-optic panel: 90 µW/cm²/nm (measured with Joey™ Dosimeter (JD-100)) | High: 53 µW/cm²/nm +/-25% | |
| Medium: 40 µW/cm²/nm +/-25% | |||
| Low: 26.5 µW/cm²/nm +/-25% | |||
| (measurement obtained by BiliBlanket® meter placed on the pad surface without a pad cover) | |||
| Change in irradiance over 6 hours +/- 10% (in effective area) | While numerically different, the comparison implies that the BILI-THERAPY Pad Type's intensities are within acceptable ranges for effective treatment, noting the different measurement methods and variability. A specific range for efficacy is not provided for the predicate. | ||
| Wavelength | Peak between 450 nm and 485 nm | Peak 450 to 480 nm | The BILI-THERAPY Pad Type's wavelength range falls within the predicate's range. |
| Sound Level | 52 dB | 60 dB or less | The BILI-THERAPY Pad Type's sound level is slightly higher but still within generally accepted limits for medical devices and considered substantially equivalent. |
| Compliance with Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50 | IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995 | |
| IEC 60601-1-2: Collateral standard: Electromagnetic Compatibility (Edition 2:2001 with Amendment 1:2004; Edition 2.1) | |||
| IEC 60601-2-50: 2009 Medical Electrical Equipment - Part 2-50 | Both devices declare compliance with the relevant IEC 60601 series standards for medical electrical equipment, including general safety, EMC, and particular requirements for infant phototherapy equipment, indicating compliance with recognized safety and performance benchmarks. The BILI-THERAPY Pad Type specifically lists the versions it complies with. | ||
| Bench Tests | Not explicitly detailed beyond standard compliance, but inferred to be met by predicate approval. | Performed and found to meet all pass/fail criteria, cited standards requirements, and found to be equivalent in comparison to the predicate. | This indicates direct testing of the new device to ensure it performs as expected and meets safety requirements. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or data provenance in the context of an algorithm or clinical performance study. The "testing" mentioned refers to bench tests to verify compliance with engineering specifications and safety standards, as well as a comparison to the predicate device's specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a phototherapy unit, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is hardware, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of an AI/algorithm study. For device performance validation, the "ground truth" would be the engineering specifications and the requirements of the international standards (e.g., IEC 60601 series).
8. The Sample Size for the Training Set
Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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(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.
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