(662 days)
The UroSurge UroTherm™ Fluid Warming System is intended to varm sterile irrigating solutions to normothermic temperatures (37°C) for use in medical/surgical procedures. Not for use with blood or blood products.
UroSurge UroTherm™ Fluid Warning System
The provided text is a 510(k) Pre-market Notification letter from the FDA, which primarily confirms that the UroSurge UroTherm Fluid Warming System is substantially equivalent to a legally marketed predicate device. This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided text.
The document focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study 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.