(134 days)
Babyleo TN500 is intended for use with premature babies and neonates 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 requlated 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 compartment 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 tray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package. The subject of this submission is the addition of the optional Touch time function, which can be activated in order to stabilize the thermal environment in the patient compartment when the hand ports are opened. It supports users during routine tasks (e.g. changing diapers, washing the baby, checking sensors). Additionally, the scale resolution is changed from 5q to 10g.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Babyleo TN500 (Neonatal Incubator and Radiant Warmer)
Reason for Submission: Addition of optional "Touch time" function and change in scale resolution.
Acceptance Criteria and Reported Device Performance
Since this 510(k) submission is for modifications to an already cleared device (K162821), the core performance specifications of the Babyleo TN500 remain unchanged and are considered the acceptance criteria based on the predicate device. The changes are specifically for the "Touch time" feature and the scale resolution.
The table below focuses on the elements changed or directly impacted by the submission. For other parameters, the document states "Identical" meaning the performance meets the existing criteria from the predicate device (K162821).
| Feature | Acceptance Criteria (from K162821) | Reported Device Performance (K182859) |
|---|---|---|
| Touch time Function | N/A (New feature in this submission) | The optional Touch time function can be activated in order to stabilize the thermal environment in the patient compartment when the hand ports are opened. It also increases air circulation and disables audio signals of certain alarms for a maximum of 20 minutes. |
| Scale Resolution | 5 g (OIML) or 1 g (standard version) | 10 g (OIML) or 1 g (1 oz) (Changed from 5g to 10g for OIML) |
| Risk Analysis | Acceptable risks identified and mitigated according to ISO 14971 for the original device. | Risks for the "Touch time" modification were identified and mitigated according to ISO 14971, ensuring risk acceptability criteria have been met. |
| Conformity to Standards | IEC 60601-1; 60601-1-2; 60601-2-19; 60601-2-21 | Testing was performed according to applicable Standards IEC 60601-1-2; 60601-2-19; and 60601-2-21 for the Touch time feature. Verification and validation testing were conducted in conformance to FDA recognized standards. |
Study Information
The provided document describes a verification and validation (V&V) testing approach for the modifications, not a typical clinical study with patient data, ground truth establishment, or human reader involvement. This is common for modifications that do not significantly alter the intended use or fundamental technological characteristics of a device.
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Sample size used for the test set and the data provenance:
- Test Set Size: Not explicitly stated as individual "samples" in terms of patient data. The testing was focused on the device's functionality and safety regarding the "Touch time" feature and scale resolution. This likely involved engineering bench testing or simulated use cases.
- Data Provenance: Not specified. Given the nature of V&V testing for a medical device modification, it would be laboratory-based data generated during manufacturing and development, likely in Germany (Drägerwerk AG & Co. KGaA is in Luebeck, Germany) with adherence to international standards. It is prospective testing specific to the modifications.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was not a study requiring expert-established ground truth in the clinical sense (e.g., diagnosis). The ground truth for device performance features like temperature regulation, alarm functionality, and scale accuracy is typically against engineering specifications and validated test equipment.
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Adjudication method for the test set:
- Not applicable. The V&V testing would involve comparing device performance against predetermined engineering specifications and international standards, rather than expert adjudication of clinical outcomes.
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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. This is not an AI-assisted device and therefore no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is not an algorithm-only device. The V&V testing evaluated the functional performance of the device and its new feature.
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The type of ground truth used:
- Engineering Specifications and International Standards: The performance of the device and its new features were evaluated against established engineering specifications for the device and compliance with recognized international standards (IEC 60601-1-2, 60601-2-19, and 60601-2-21). This is the "ground truth" for demonstrating safety and effectiveness of device functions.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 880.5400 Neonatal incubator.
(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).