SmartBolus Calculator
Device Facts
| Record ID | K231824 |
|---|---|
| Device Name | SmartBolus Calculator |
| Applicant | Insulet Corporation |
| Product Code | QRX · Clinical Chemistry |
| Decision Date | Oct 18, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1358 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Therapeutic, Pediatric |
Indications for Use
The SmartBolus Calculator is software intended for the management of diabetes in persons aged 2 and older requiring rapid-acting U-100 insulin. The SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose value (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 SmartBolus Calculator is intended for single patient, home use and requires a prescription.
Device Story
SmartBolus Calculator is a software component of the Omnipod 5 Automated Insulin Delivery System; operates on mobile app platforms (Android/iOS). Inputs include user-entered carbohydrates, CGM sensor glucose values (or manual blood glucose readings), sensor glucose rate of change, insulin on board (IOB), and programmable settings (correction factor, insulin-to-carbohydrate ratio, target glucose). Device processes these inputs via an algorithm to calculate suggested meal or correction insulin bolus doses. Output is displayed to the user, who may accept, modify, or cancel the suggested dose. Used in home settings by patients; facilitates insulin therapy adjustment. Benefits include automated, personalized bolus calculations to assist in glycemic management.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by software verification and human factors validation testing conducted on the Omnipod 5 App (iOS) as part of the broader system evaluation.
Technological Characteristics
Software-only device residing within the Omnipod 5 App. Operates on iOS and Android platforms. Integrates with iCGM systems or manual blood glucose meter inputs. Complies with IEC 62304:2015-05 (software life cycle) and ANSI AAMI ISO 14971:2019 (risk management).
Indications for Use
Indicated for diabetes management in persons aged 2 and older requiring rapid-acting U-100 insulin.
Regulatory Classification
Identification
An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus.
Special Controls
(b) Classification: Class II (special controls). The special controls for this device are - 1. Design verification and validation must include the following: - (i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations. - (ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated. - (iii)Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations. - (iv)A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification. - (v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures. - (vi)Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device. - (vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level. - 2. The device must not be intended for use in implementing automated insulin dosing. - 3. Your 809.10(b) labeling must include: - (i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device. - (ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations. - (iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device. - (iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).
*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following: (i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations; (ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated; (iii) Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations; (iv) A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification; (v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures; (vi) Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device; and (vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level. (2) The device must not be intended for use in implementing automated insulin dosing. (3) Your 21 CFR 809.10(b) labeling must include: (i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device; (ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations; (iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device; and (iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).
Predicate Devices
- SmartBolus Calculator (K222239)
Related Devices
- K203772 — Omnipod 5 SmartBolus Calculator · Insulet Corporation · Jan 27, 2022
- K222239 — SmartBolus Calculator · Insulet Corporation · Aug 19, 2022
