(267 days)
Celsi Warmer is intended for use in hospitals under a clinician's supervision or at their direction to assist nurses in continuous temperature monitoring and thermal treatment of neonates.
a. Maintain pre-set body temperature as determined by the physician.
b. Celsi Warmer is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg.
c. Monitoring and controlling patient temperature.
The Celsi Warmer is a portable, non-invasive thermal regulating system, indicated for continuous temperature monitoring and thermal treatment of neonates that require extra warmth to maintain normal body temperature. It uses a non-invasive thermometer (using direct mode) that measures the temperature of an infant's skin via a temperature probe placed on their abdomen to provide input into a physiological control loop that controls the mattress temperature. The Celsi Warmer is intended for use in hospitals under a clinician's supervision and is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg. The Celsi Warmer is comprised of the following components:
- Warming Mattress
- Controller Tower
- Celsi Temperature Probe and Celsi Belt
- Power Supply and Cables
I apologize, but the provided text from the FDA 510(k) Clearance Letter for the Celsi Warmer does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria.
The document focuses on:
- Formal FDA clearance: Confirmation of the 510(k) submission, product classification, and general regulatory requirements.
- Device description and indications for use: What the Celsi Warmer is and what it's intended for.
- Comparison to a predicate device: Highlighting similarities in intent, technology, and use environment.
- Summary of non-clinical testing: A list of standards and types of testing performed (Biocompatibility, Software V&V, EMC/Electrical Safety, Usability).
However, it does not include:
- A table of specific acceptance criteria and reported device performance: While it mentions testing, it doesn't provide the quantifiable metrics or the results of those tests.
- Sample sizes for a test set, data provenance, ground truth establishment, or expert details for performance studies.
- Details about MRMC comparative effectiveness studies or standalone algorithm performance.
- Information on training set sample sizes or ground truth for training data.
The 510(k) summary typically provides a high-level overview. Detailed performance data, acceptance criteria, and study methodologies (like those involving expert human readers or specific statistical analyses) are usually found in the full 510(k) submission document, which is not publicly available in this format from the clearance letter.
Therefore, I cannot populate the table or provide answers to the specific questions based solely on the provided text.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).