(241 days)
The Versalet 7700 Care Center is a mobile, caster mounted, neonatal device, which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this using radiant or convective heat. Accessories and options to the device permit environmental control and monitoring and may include optional features such as humidification and in-bed scale. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities. This device is not intended for home use.
The Versalet™ 7700 Care Center is a warming device that combines the heating technologies of both incubators and radiant warmers into one product. The Versalet™ 7700 Care Center provides thermal isolation through a convective air system with canopies and side panels forming an enclosure that isolates the air surrounding the infant from the room air, much the same as a traditional infant incubator. The Versalet™ 7700 Care Center offers access to the infant in the incubator mode by allowing the caregiver to open port holes or side panels. If more access is needed, the device can then be transitioned into a radiant warmer device by opening the canopies and raising the over head arm. This allows full access to the infant. The over head arm contains two infrared heaters that provide radiant heat only when the canopies are opened and the over head arm is fully raised. Thus the Versalet™ 7700 Care Center offers the caregiver excellent access while providing good thermal stability. While the device is in the transition mode from incubator to warmer there is a continued supply of convective heat to minimize the heat loss during this period.
The provided text for K053399 states that "The Versalet 7700 Care Center technology is well established in clinical practice, therefore, pre-clinical and clinical testing are not required to establish the performance of the device."
This means that a detailed study proving the device meets specific acceptance criteria, as usually understood in terms of new device performance evaluation, was not performed, nor was it deemed necessary for this 510(k) submission.
Therefore, many of the requested elements about acceptance criteria and study details cannot be directly extracted from this document, as they were not part of the submission's requirements for this particular device.
Here's an attempt to answer based on the provided information, indicating when information is explicitly stated as not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Premarket Testing | Pre-clinical testing to establish performance | Not required (technology well-established) |
| Clinical testing to establish performance | Not required (technology well-established) | |
| Regulatory Compliance | Satisfy requirements of Quality System Regulation Design Controls, including hardware and software verification and validation | Satisfied |
| Safety and Effectiveness | No new questions of safety or effectiveness compared to predicate devices | Deemed substantially equivalent |
| Performance Standards | Compliance with applicable performance standards | None applicable |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable/Not provided. Clinical testing was not required.
- Data provenance: Not applicable/Not provided. Pre-clinical and clinical data were not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided, as formal pre-clinical or clinical testing requiring expert ground truth establishment was not performed.
4. Adjudication method for the test set
- Not applicable/Not provided, as formal pre-clinical or clinical testing requiring adjudication was not performed.
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
- Not applicable. This device is an infant warming device, not an AI-assisted diagnostic tool. No MRMC study was mentioned or performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an infant warming device, not an algorithm. No standalone algorithm performance study was mentioned or performed.
7. The type of ground truth used
- Not applicable/Not provided, as formal pre-clinical or clinical testing requiring ground truth was not performed. The basis for safety and effectiveness primarily relies on substantial equivalence to predicate devices and established technology.
8. The sample size for the training set
- Not applicable/Not provided, as this is not an AI/machine learning device that would typically involve a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided, as this is not an AI/machine learning device.
§ 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).