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510(k) Data Aggregation
(400 days)
Omnipod 5 SmartBolus Calculator
The Omnipod 5 SmartBolus Calculator is software intended for the management of diabetes in persons aged 6 and older requiring rapid-acting U-100 insulin. The Omnipod 5 SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose reading (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (IOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. The Omnipod 5 SmartBolus Calculator is intended for single patient, home use and requires a prescription.
The Omnipod 5 SmartBolus Calculator is a software device that is a component of the Omnipod 5 Automated Insulin Delivery System. The SmartBolus Calculator exists on the Omnipod 5 App portion of the Omnipod 5 ACE Pump and relies on the user interface of the App.
The Omnipod 5 SmartBolus Calculator receives input parameters and settings from the other components of the system and calculates a suggested bolus amount of insulin to correct an elevated glucose level (a correction bolus) and/or to cover carbohydrates from a meal (meal bolus). The Omnipod 5 SmartBolus Calculator allows users to have the option of populating the current estimated glucose value and trend, which is communicated by the connected iCGM. Users may also manually enter the estimated glucose value or a blood glucose (BG) reading from a blood glucose meter. In addition to glucose, the suggested bolus dose is calculated based on the following parameters: user-entered carbohydrates, rate of change of the sensor glucose (if using a CGM), correction factor, insulin to carbohydrate ratio, target glucose value, and insulin on board (IOB). Once the calculation is complete, the user has the option of delivering the suggested dose of insulin, modifying the amount, or canceling.
The Omnipod 5 SmartBolus Calculator can be used in the Omnipod 5 Automated Insulin Delivery System with both Manual Mode and Automated Mode. When the Omnipod 5 SmartBolus Calculator is used with manually-entered BG readings, it suggests a bolus dose based on the same calculations as the currently cleared Omnipod DASH Insulin Management System (K180045, most recently cleared in K192659).
The document describes the Omnipod 5 SmartBolus Calculator, a software device for diabetes management. Here's a breakdown of the acceptance criteria and the study proving it meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied through the statement that the device meets "Insulin Therapy Adjustment Device special controls and to be safe and effective." The clinical study focused on glycemic control within 4 hours of bolusing. While explicit acceptance criteria for these percentages are not given as strict pass/fail thresholds, the performance observed is presented as evidence of safety and effectiveness, particularly regarding hypoglycemia.
| Glycemic Measure (as measured by CGM) | Acceptance Criteria (Implied: Safety & Effectiveness) | Reported Performance (CGM-Informed SmartBolus Calculator) |
|---|---|---|
| Time in range (70-180 mg/dL) | Expected to maintain time in range within acceptable levels given bolus calculations | 63.8% (SD 15.7) |
| Time spent 180 mg/dL (Hyperglycemia) | Expected to manage hyperglycemia | 34.0% (SD 16.0) |
| Time spent ≥ 250 mg/dL | Expected to manage high hyperglycemia | 9.7% (SD 10.3) |
| Time spent ≥ 300 mg/dL | Expected to manage very high hyperglycemia | 2.6% (SD 3.7) |
*Note: The primary analysis focused on comparing the CGM-informed SmartBolus Calculator with the standard one, and a statistically significant difference was observed for time spent
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