(111 days)
Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog.
Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetes related healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, and evaluation of patient data in order to support effective diabetes management.
Insulia Diabetes Management Companion includes a basal calculator intended to provide direction to the patient in response to blood glucose and health events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments, similar to the directions provided to patients as a part of routine clinical practice.
Insulia Diabetes Management Companion intended for use on commercially available mobile platforms, personal computers, in the home or in professional healthcare settings, and uses generally available networks and communication protocols.
Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Insulia Diabetes Management Companion is a mobile and web based diabetes management system for adult type 2 diabetes patients and their healthcare team. Insulia Diabetes Management Companion includes three components:
- . A mobile medical application for use by patients on commercially available smartphones (iPhones and Android phones) and tablets.
- . A web-based application for use by patients in their home on their personal computer and on their mobile device, or by HCPs in professional healthcare settings through a compatible web browser on a personal computer.
- . A secure database hosted in a private cloud environment and used to securely store patient data.
Insulia Diabetes Management Companion provides secure capture, storage and transmission of blood glucose data and other diabetes-related healthcare information to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of patient data in order to support effective diabetes management.
Insulia Diabetes Management Companion includes a Basal Calculator intended to provide directions to the patient in response to blood glucose measurements and other diabetesrelated events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments. The guidance is similar to the directions provided to patients as a part of routine clinical practice.
Insulia Diabetes Management Companion provides educational coaching messages based on blood glucose values.
Insulia Diabetes Management Companion is only indicated for use with insulin detemir (Levemir® U-100) once or twice daily, insulin degludec (Tresiba® U-100) once daily, and insulin glargine (Basaglar® U-100. Lantus® U-100. and Toujeo® U-300) once daily.
Insulia Diabetes Management Companion should not be used for:
- basal dose recommendations for intermediate-acting insulin (NPH Neutral Protamine Hagedorn);
- " premixed insulin.
Insulia Diabetes Management Companion should not be used in the following populations:
- = pregnant women;
- non-adult patients:
- patients that are treated with a basal-plus or a basal-bolus regimen (i.e multiple mealtime insulin injections per day or insulin pump therapy).
I cannot provide a table of acceptance criteria and reported device performance or information about sample size, expert ground truth, adjudication methods, MRMC studies, standalone studies, or how ground truth was established for this device.
The provided document is an FDA 510(k) clearance letter and associated 510(k) summary for the "Insulia Diabetes Management Companion." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific performance metrics against acceptance criteria.
Here's why I can't fulfill your request based solely on the provided text:
- No detailed performance data: The document states, "Design verification and validation testing, clinical evidence, and updated Human Factors evaluation on the modification of Insulia Diabetes Management Companion demonstrated that the device meets the performance requirements for its intended use." However, it does not present any specific performance metrics, acceptance criteria, or study results (e.g., accuracy, sensitivity, specificity, or effect size) in numerical form.*
- Focus on Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This often involves demonstrating that technological characteristics are similar and that any differences do not raise new questions of safety or effectiveness. It doesn't typically require a full-scale clinical trial proving net positive clinical benefit from scratch.
- Limited "Clinical Evidence" Description: The document mentions "Clinical evidence provided supported that the addition Tresiba U-100 and Basaglar to the list of insulin analogs compatible with Insulia conforms to the general principles and rules identified in the previous analysis of the standard of care performed for the cleared device." This suggests a review of existing clinical knowledge and principles rather than a new comparative effectiveness study on the device's performance itself against a defined outcome.
Based on the provided text, the device was cleared because it was determined to be substantially equivalent to a previously cleared device (K170669), and the modifications (adding compatibility for two new insulin analogs) were assessed through design verification, validation, and risk management activities, without raising new issues of safety or effectiveness.
To get the information you asked for (acceptance criteria, specific performance metrics, sample sizes, expert details, etc.), you would typically need to refer to more detailed clinical study reports, scientific publications, or internal validation documentation for the device, which are not included in this FDA 510(k) summary.
§ 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).