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510(k) Data Aggregation
(259 days)
Babyleo TN500 is intended for use with premature babies and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.Neonates are kept warm in the patient with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: - Temperature - Humidity - Oxygen (option)
The device Babyleo TN500 is a medical device used to maintain environmental conditions suitable for preterm babies and neonates. The important features are temperature and humidity. The operational principle is a combination of a neonatal incubator and an open warmer.
Babyleo TN500 can be operated in closed care therapy as an incubator according to IEC60601-2-19 or in open care therapy as a warmer according to IEC60601-2-21. Additionally, an optional x-ray translucent heated mattress is intended to provide sensible heat to the preterm babies and neonates.
The device consists of the following components: Incubator (=bassinet) with a convection heater and closed humidification system for the patient, trolley, radiant warmer, display, mattress, x-ray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package.
This document is a 510(k) Premarket Notification for the Babyleo TN500, a neonatal incubator and radiant warmer. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The information provided heavily focuses on design verification and validation testing, and therefore, does not contain the details on acceptance criteria and study proving performance in the context of an AI/ML medical device that would typically involve clinical studies, multi-reader multi-case studies, and explicit ground truth establishment with expert consensus.
Given the document talks about a physical medical device (neonatal incubator/radiant warmer) and not an AI/ML diagnostic or prognostic tool, the questions posed about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or AUC, multi-reader multi-case studies, expert consensus for ground truth, effect size for human reader improvement with AI assistance, and training/test set sample sizes and provenance for AI/ML models are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this conventional medical device primarily revolve around safety and performance standards, electrical safety, EMC, software verification, biocompatibility, human factors, and reprocessing validation.
Here's how to address the prompt based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document lists compliance with various standards and provides specifications that serve as performance criteria.
| Acceptance Criteria (Standard Compliance / Performance Spec) | Reported Device Performance (Compliance / Value) |
|---|---|
| Electrical Safety: IEC 60601-1, IEC 60601-2-19, IEC 60601-2-21, IEC 60601-2-35 | Device complies with all listed standards. |
| Electromagnetic Compatibility (EMC): IEC 60601-1-2 | Device complies with the standard. |
| Software Verification and Validation: FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (2005) | Software verification and validation testing conducted; documentation provided; considered "major" level of concern. |
| Biocompatibility: ISO 10993, ISO 10993-1, ISO 10993-17, ISO 10993-18 | Evaluation conducted in accordance with FDA guidance; battery of testing included: Integral Test for volatile organic compounds, Photogenic bacteria test, Emission of particles, Material characterization, Toxicological Evaluation, Cytotoxicity, Irritation, Sensitization. |
| Human Factors: FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff, 2016 | Usability evaluation conducted in accordance with FDA guidance. |
| Reprocessing: FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff, 2015 | Reprocessing validation conducted in accordance with FDA guidance. |
| Operating Noise Volume in Patient Compartment | Typically 40 dB(A) (Measured without oxygen application) - (Compared to predicate <49 dB(A), Caleo 47 ± 2 dB(A)) |
| Alarm Volume | 50 to 70 dB(A) (according to IEC 60601-2-19 and IEC 60601-2-21) - (Compared to predicate "according to IEC 60601-2-19") |
| Power Failure Alarm | Yes (65 dB(A), 10 min) - (Compared to predicate "Yes") |
| Maximum Irradiance of Warmer (at 100% power) | 32 mW/cm2 - (Compared to Babytherm 30 mW/cm2) |
| Warm-up Time | 15 to 20 min - (Compared to predicate <50 min, Caleo 20 min) |
| Flow Velocity over Mattress Surface | 10 cm/s (3.94 in/s) (at 36°C) - (Compared to predicate <10 cm/s, Caleo <8 cm/s) |
| Maximum Carbon Dioxide (CO2) concentration in incubator | <0.5 Vol% - (Compared to predicate 0.2 %, Caleo <0.5 Vol%, Babytherm max 0.5 Vol%) |
| Air Temperature Measurement Range | 13 to 45 °C (55.4 to 113 °F) - (Compared to Caleo 13 to 42 °C) |
| Air Temperature Measurement Uncertainty | ± 0.8°C (1.44 °F) - (Compared to Caleo ± 0.8°C) |
| Skin Temperature Measurement Uncertainty (Entire System) | ± 0.3°C (0.54 °F) - (Matches predicate and reference devices) |
| Oxygen Measurement Range (Normal) | 18 to 65 Vol% - (Matches Caleo) |
| Oxygen Measurement Uncertainty | ± 2.5 Vol% (+ 2.5 % of measured value) - (Compared to predicate 5%, Caleo ± 3 Vol%) |
| Humidity Measurement Range (Normal) | 30 to 99 % r. H. - (Matches Caleo) |
| Humidity Measurement Uncertainty | ±10 % - (Matches predicate and Caleo) |
| Heated Mattress Setting Range | Off, 35°C to 39°C, AUTO - (Compared to Babytherm Off, 30°C to 38.5°C) |
| Scale Range | 200 g to 10 kg - (Compared to predicate 300 g to 8 kg, Caleo 250 g to 10 kg, Babytherm 250 g to 8 kg) |
| Scale Resolution | 5 g (OIML) or 1 g (standard version) - (Compared to predicate 10 g or 5 g, Caleo 1 g or 5 g, Babytherm 1 g or 10 g) |
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This is a conventional medical device; performance testing is often conducted on a representative number of units or components, but the "sample size" concept as used in AI/ML clinical studies for a test dataset does not directly apply. The testing mentioned (electrical safety, EMC, software verification, biocompatibility, human factors, reprocessing) would be performed on the device itself or its materials.
- Data Provenance: Not applicable in the sense of patient data. The provenance for the testing data would be from internal lab testing conducted by the manufacturer (Drägerwerk AG & Co. KGaA, Germany) or their designated testing facilities. It's not retrospective or prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of an AI/ML clinical study (e.g., diagnosis of disease) is not relevant for this device. The "ground truth" for this device's performance is established by objective measurements against engineering specifications and recognized international standards. Experts involved would be engineers, quality assurance personnel, and regulatory specialists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling or diagnoses in AI/ML studies. For a physical device, performance is measured against established limits derived from standards or engineering requirements.
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:
- No, not done. This is a physical medical device, not an AI-assisted diagnostic tool. MRMC studies are not relevant for demonstrating the effectiveness of an incubator/warmer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no "algorithm only" performance for a neonatal incubator/radiant warmer as it is not an AI/ML-driven diagnostic or treatment algorithm. Its performance is measured by its ability to maintain specified environmental conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Objective Measurement against Standards and Specifications: The "ground truth" for this device is the adherence to internationally recognized safety and performance standards (e.g., IEC 60601 series, ISO 10993) and the manufacturer's own detailed engineering specifications. For example, the "truth" of the noise level is the scientifically measured sound pressure level, not an expert's subjective assessment.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/ML model for this device. Design and development of the device would involve engineering principles, materials science, and iterative testing, not machine learning model training.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for the device's design and manufacturing is derived from scientific and engineering principles, regulatory requirements, and established medical device standards.
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