(243 days)
iSage Rx™ (iSage Rx Basal Insulin Titration) is software indicated for use by adult patients aged 21 and above who have type 2 diabetes and their healthcare providers to titrate basal insulin. iSage Rx is not intended to replace the care and management provided by a healthcare professional trained in the management of diabetes. iSage Rx should not be used by patients with type 2 diabetes who are also using prandial insulin or patients with type 1 diabetes, or patients using an insulin pump.
iSage Rx™ (iSage Rx Basal Insulin Titration) is software
This document does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the iSage Rx device, primarily focusing on the regulatory aspects of substantial equivalence, general controls, and indications for use. It does not include details on the specific performance study conducted to demonstrate the device's efficacy or safety, nor does it specify acceptance criteria for such a study.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).