(30 days)
The IntraTemp Solution Warmer (ITW6L) is designed to warm and maintain the temperature of surgical solutions prior to their use.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "IntraTemp™ Solution Warmer, Model ITW6L." This document establishes that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.
However, the provided text does not contain the specific information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. These details are typically found in the manufacturer's 510(k) submission summary, which is a separate document detailing the technical and performance data used to support the substantial equivalence claim.
Therefore, I cannot populate the table or answer the specific questions because the necessary information is not present in the provided FDA letter. The letter is an approval notification, not a technical performance report.
§ 890.5950 Powered heating unit.
(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.