(64 days)
The K.M.I. SSW Sterile Solution Warmer is intended for the administration of sterile solutions at a controlled temperature drawn from containers using K.M.I. DIK system administration set. The "K" pump is also used in conjunction with this device.
Not Found
This is a 510(k) premarket notification letter from the FDA to Kolster Methods, Incorporated, regarding their SSW-Sterile Solution Warmer. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. It is a regulatory approval letter based on a declaration of substantial equivalence, not a detailed study report.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them from the provided text.
§ 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.