(199 days)
EndoTool SubQ is a software application for use by trained healthcare professionals to calculate and recommend an individual patient's next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with Diabetes Mellitus in both adult and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) (and when indicated a carbohydrate dose) based on the prescribing healthcare provider's nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics.
The EndoTool SubQ is not a substitute for clinical reasoning, but is an aid for trained healthcare professionals to manage patients. The System is based on obtained glucose readings and clinical data entered by the medical staff. Final dose decisions for a patient must be made only after consideration of the full clinical status of the patient. No medical decision should be made based solely on the recommendations provided by this software program.
Monarch Medical Technology's EndoTool SubQ Glucose Management System is a glucose management software solution for healthcare institutions. This system uses proprietary control technology to provide patient-specific glycemic control across a broad population of adult and pediatric patients using basal/bolus insulin therapy. This system is designed to correctly dose subcutaneous insulin (and amount of carbohydrates if and when indicated to treat hypoglycemia) to achieve patient-specific, sustained control with different nutritional and insulin regimens, selected by the patient's physician responsible for glycemic control.
EndoTool SubQ Glucose Management System is designed to be used following a physician order with physician set optional diet, insulin regimen, basal/bolus distribution, initial total daily dose of insulin, and glucose target range. The primary user of the EndoTool SubQ Glucose Management System is the bedside caregiver (e.g. nurse) who will use the system to enter clinical data (e.g. food intake and scheduled blood glucose readings). With confirmation of previous data entered, the system makes the next dose calculation of subcutaneous insulin and the next time for a scheduled glucose determination.
The provided text is a 510(k) summary for the EndoTool SubQ™ device, a software application designed to recommend insulin doses for managing blood glucose levels in diabetic patients. However, the document does not contain explicit acceptance criteria and a detailed study report that proves the device meets specific performance metrics. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and general functionality.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I detail specific study parameters such as sample size, data provenance, expert qualifications, adjudication methods, or effects of AI assistance. The document refers to "Requirements-based testing for all functionality" and "Automated algorithm test case execution" but does not provide the results or details of these tests.
Specifically, the document states:
- Test Summary: "Testing included the following: 1) Requirements-based testing for all functionality. 2) Requirements-based testing for all risk-related requirements. 3) Integration testing to ensure that data flows correctly into and out of the database. 4) Automated algorithm test case execution. 5) Off The Shelf (OTS) software embedded in the application was included in the technical verification protocols. Each OTS component was tested to ensure that it functioned as intended."
- Test Summary Conclusion: "The performance of the EndoTool SubQ Glucose Management System is substantially equivalent to that of the Glytec Glucommander G+ Enterprise System (K113853) and EndoTool IV Glucose Management System (K132547) and raises no new safety or effectiveness issues and performs as well as the predicate."
This indicates that testing was performed, but the results, acceptance criteria, and detailed methodology are not included in this summary.
Therefore, most of the requested information cannot be extracted from this document.
§ 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).