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510(k) Data Aggregation
(146 days)
For the treatment of Neonatal Hyperbilirubinemia.
The Olympic Bili-Bassinet has three phototherapy fixtures built into a bassinet.
The two identical overhead fixtures swing and lock in their up position. They are mounted on counter-balanced arms. Thier storage position is recessed into the sides of the bassinet.
The phototherapy pad is a pad/mattress, which is transparent to light. Unlike a fiberoptic pad, which used plastic optical fibers within the pad to transmit the light from the remote light box, the Bili-Bassinet light box is below the pad/mattress and shines through the pad.
All fixtures use conventional blue (type "B") fluorescent phototherapy lamps. "Daylight" and high-intensity (type BB) fluorescent lights are available for use in the overhead fixtures.
The provided document describes the Olympic Bili-Bassinet, a device intended for the treatment of Neonatal Hyperbilirubinemia using phototherapy. The submission aims to establish substantial equivalence to predicate devices rather than proving novel effectiveness. Therefore, the "acceptance criteria" discussed here relate to safety and performance specifications relative to established standards and the predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate/standards) | Reported Device Performance (Olympic Bili-Bassinet) | Study/Section Proving Criterion Met |
|---|---|---|
| Electrical Safety | ||
| Ground Impedance < 0.1 ohm | Less than 0.1 ohm | Electrical Safety Tests (Section 8) |
| Leakage Current < 100 microamperes | Less than 100 microamperes | Electrical Safety Tests (Section 8) |
| Applicable electrical standards met (UL-544, CSA/NRTL, IEC 601-1) | Meets applicable standards | Comparison Chart (Section 7), Electrical Safety Tests (Section 8) |
| Stability | ||
| Meets or exceeds 10° stability (CSA Standard) | Meets or exceeds 10° stability | Tip-over Safety Test (Section 8) |
| Biocompatibility | ||
| Meets guidance document requirements | Meets guidance document requirements | Tripartite Biocompatibility Test (Section 8) |
| Temperature | ||
| Meets applicable standards | Meets applicable standards | Temperature Tests (Section 8) |
| Thermostat performance verified (for over-temperature safety) | Thermostat performance verified | Over Temperature Thermostat Safety Test (Section 8) |
| Mechanical Strength | ||
| Safety Side Latch Strength: Meets 25kg inward and outward force | Meets 25kg inward and outward force test requirement | Safety Side Latch Strength Test (Section 8) |
| Weight Capacity: Passes 4 times capacity | Passes 4 times capacity tests | Weight Capacity Test (Section 8) |
| Fluid Resistance | ||
| Resistant to fluid spills | Passed | Fluid Spill Test (Section 8) |
| Phototherapy Efficacy (Implicit comparator) | ||
| Comparable irradiance to predicate devices | Overhead: 9 "Daylight", 18 "B", 40 "BB" µw/cm²/nmP.T. Pad: 30 Low, 50 Hi µw/cm²/nm | Comparison Chart (Section 7), Light Output (Section 8) |
| Intended Use | ||
| For the treatment of Neonatal Hyperbilirubinemia | For the treatment of Neonatal Hyperbilirubinemia | Intended Use (Section 4), Comparison Chart (Section 7), Indications For Use (Section 8) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The submission is for a phototherapy device and primarily relies on non-clinical engineering and safety tests, and a comparison to predicate devices, rather than a clinical "test set" with patient data.
- Data Provenance: Not applicable in the context of clinical data. The data provenance is internal testing performed by the manufacturer (Olympic Medical) based on engineering standards and comparisons.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This device's evaluation is based on engineering specifications and adherence to recognized standards, not on expert consensus for a clinical "ground truth."
- Qualifications of Experts: Not applicable for establishing clinical ground truth. The "experts" would be the engineers and technicians performing the physical, electrical, and performance tests against established standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no clinical test set or subjective assessment requiring adjudication in this submission. The reported performance is based on objective measurements and compliance with standards.
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
- MRMC Comparative Effectiveness Study: No. This is not an AI-assisted diagnostic device, nor a device that involves "human readers" in its direct function, so an MRMC study is not relevant or performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a medical device, not an algorithm. Its performance is measured directly by its physical, electrical, and optical properties, and its intended effect is through physical light therapy, not by an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this submission is based on:
- Established engineering standards: e.g., UL-544, CSA/NRTL, IEC 601-1 for electrical safety, CSA Standard for stability.
- Guidance documents for biocompatibility.
- Performance specifications of legally marketed predicate devices for comparison, particularly regarding irradiance levels.
- Objective physical measurements: of weight, dimensions, irradiance, electrical characteristics, and mechanical strength.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an algorithm or AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As there is no training set, there is no ground truth establishment for it.
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