SmartBolus Calculator

K222239 · Insulet Corporation · QRX · Aug 19, 2022 · Clinical Chemistry

Device Facts

• Record ID: K222239
• Device Name: SmartBolus Calculator
• Applicant: Insulet Corporation
• Product Code: QRX · Clinical Chemistry
• Decision Date: Aug 19, 2022
• 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

Software component of Omnipod 5 Automated Insulin Delivery System; resides on Omnipod 5 App. Inputs: user-entered carbohydrates, sensor glucose value (iCGM) or manual blood glucose (BG) reading, sensor glucose rate of change, programmable correction factor, insulin-to-carbohydrate ratio, target glucose, and insulin on board (IOB). Operation: calculates suggested bolus dose for correction or meal coverage; user reviews, modifies, or cancels delivery. Used in home environment by patients or caregivers. Output: suggested insulin bolus dose. Benefits: assists in insulin dosing for diabetes management in pediatric population (aged 2+).

Clinical Evidence

Single-arm, multi-center, prospective study (n=5) in subjects aged 2.0-5.9 years with type 1 diabetes. Compared manual bolus entry (Phase 1) vs. SmartBolus Calculator (Phase 2). Primary endpoints: % time <70 mg/dL and >180 mg/dL post-bolus. Results: % time <70 mg/dL was 5.16% (Phase 1) vs 4.03% (Phase 2, p=0.6250); % time >180 mg/dL was 35.2% (Phase 1) vs 33.2% (Phase 2, p=1.0000). Zero deaths or serious adverse events reported.

Technological Characteristics

Software-only device residing within the Omnipod 5 App. Operates as a glycemic controller (iAGC) using inputs from iCGM or manual blood glucose meters. Connectivity via mobile device integration. Complies with standards including ANSI AAMI IEC 62366-1 (usability), ANSI AAMI HE75 (human factors), and ANSI AAMI ISO 14971 (risk management).

Indications for Use

Indicated for management of diabetes 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 (K203772)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

INSTRUMENT ONLY

## I Background Information:

A 510(k) Number

K222239

B Applicant

Insulet Corporation

C Proprietary and Established Names

SmartBolus Calculator

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QRX | Class II | 21 CFR 862.1358 - Insulin Therapy Adjustment Device | CH - Clinical Chemistry |
| NDC | Class II | 21 CFR 868.1890 - Predictive pulmonary-function value calculator | CH - Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission:

Modification to a cleared device to expand the age indication (from ≥6 years old to ≥2 years old)

B Type of Test:

Continuous glucose monitor informed insulin dose calculator

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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## III Intended Use/Indications for Use:

### A Intended Use(s):
See Indications for Use below.

### B Indication(s) 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.

### C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only

This device resides in the Omnipod 5 App and requires the App to function. The SmartBolus Calculator works with the following rapid-acting U-100 insulins: NovoLog® (insulin aspart), Humalog® (insulin lispro), and Admelog® (insulin lispro).

## IV Device/System Characteristics:

### A Device Description:
The SmartBolus Calculator is a software device that resides in the Omnipod 5 App. It requires input parameters and settings from the SmartAdjust™ Technology, a glycemic controller (iAGC) and glucose values from a compatible integrated continuous glucose monitoring system (iCGM) or blood glucose (BG) values from a blood glucose meter to calculate suggested insulin bolus doses. The SmartBolus Calculator can be used in both open-loop (manual mode) and closed-loop (automated mode). When used with a compatible iCGM, the SmartBolus Calculator can use the sensor glucose values and trend information to calculate a suggested bolus dose. When the 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 bolus calculator (K180045, K192659).

### B Instrument Description Information:

1. Instrument Name: SmartBolus Calculator
2. Specimen Identification: Not applicable
3. Specimen Sampling and Handling: Not applicable

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4. Calibration: Not applicable
5. Quality Control: Not applicable

V Substantial Equivalence Information:

A Predicate Device Name(s): Omnipod 5 SmartBolus Calculator

B Predicate 510(k) Number(s): K203772

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K222239 | K203772 |
| --- | --- | --- |
| Device Trade Name | SmartBolus Calculator | OmniPod 5 SmartBolus Calculator |
| General Device Characteristic Similarities | | |
| Indications For Use | The SmartBolus Calculator is software intended for the management of diabetes in persons 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 | Same |

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| | use and requires a prescription. | |
| --- | --- | --- |
| General Device Characteristic Differences | | |
| User Age | Ages 2 and older | Persons aged 6 and older |

VI Standards/Guidance Documents Referenced:

- FDA Guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device” dated October 25, 2017
- FDA Guidance “Deciding When to Submit a 510(k) for a Software Change to an Existing Device” dated October 25, 2017
- FDA Guidance “Applying Human Factors and Usability Engineering to Medical Devices” dated February 3, 2016
- ANSI AAMI IEC 62366-1:2015 – Medical Devices – Part 1: Application of Usability Engineering
- ANSI AAMI HE75:2009/(R)2018 – Human Factors Engineering – Design of Medical Devices
- ANSI AAMI ISO 14971:2019 – Medical devices – Application of Risk Management to Medical Devices

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

The SmartBolus Calculator is a software-only device, therefore the following analytical performance characteristics are not applicable.

1. Precision/Reproducibility:
Not applicable.

2. Linearity:
Not applicable.

3. Analytical Specificity/Interference:
Not applicable.

4. Accuracy (Instrument):
Not applicable.

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5. Carry-Over:

Not applicable.

B Other Supportive Instrument Performance Characteristics Data:

1. Clinical Testing:

**CGM-Informed Bolus Calculator Study: Preschool Cohort**

A single-arm, multicenter, prospective clinical study was conducted to evaluate the performance of the SmartBolus Calculator in patients with type 1 diabetes during Manual Mode (open-loop) operation. The study enrolled 5 evaluable subjects aged 2.0-5.9 years old across two clinical sites, and consisted of two 7-day outpatient phases of Omnipod 5 use:

- Phase 1: 7 days of Omnipod 5 use in Manual Mode without a connected CGM using manual entry of BG values to deliver boluses
- Phase 2: 7 days of Omnipod 5 use in Manual Mode with a connected CGM using the SmartBolus calculator to deliver boluses.

The primary objective of the study was to evaluate the safety of the CGM-informed bolus calculator using glucose metrics of percentage of time &lt; 70 mg/dL and percentage of time &gt; 180 mg/dL during the 4-hour post bolus period from Phase 2 as compared to Phase 1. Data from the clinical study is presented in the table below.

There were no deaths, unanticipated adverse device effects (UADE) or serious adverse events (SAE) reported in this study. One (1) non-serious adverse event of prolonged hyperglycemia was reported which resolved after a Pod change with appropriate subcutaneous insulin coverage during the transition and appeared likely related to an infusion site issue rather than the SmartBolus calculator itself.

Comparison of Glycemic Measures from Phase 1 (Standard SmartBolus Calculator) and Phase 2 (CGM-Informed SmartBolus Calculator) for the 4 hours After any Bolus (n=5)

| Percent time in glucose range as measured by CGM | Standard SmartBolus Calculator (Phase 1) | CGM-Informed SmartBolus Calculator (Phase 2) | Change* |
| --- | --- | --- | --- |
| 70-180 mg/dL | 59.6 (7.1) | 62.8 (15.5) | 3.15 (16.72) |
| <70 mg/dL | 5.16 (4.99) | 4.03 (3.28) | -1.13 (4.09) |
| <54 mg/dL | 1.47 (1.88) | 0.81 (0.91) | -0.66 (1.39) |
| >180 mg/dL | 35.2 (10.3) | 33.2 (18.5) | -2.03 (18.72) |
| ≥250 mg/dL | 9.4 (5.7) | 7.9 (6.4) | -1.55 (5.95) |
| ≥300 mg/dL | 2.33 (2.69) | 1.99 (2.05) | -0.34 (1.83) |

Results presented as average (standard deviation)
*Change is calculated as per-subject time in specified glycemic range during Phase 2 minus per-subject time in specified glycemic range during Phase 1.

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2. In Silico Testing:

Simulations of possible input and output combinations were run to supplement information collected in the Clinical Study. These simulations evaluated additional types and/or ranges of variables in order to assess that different scenarios (including different bolus timing and miscalculated carbohydrate content) do not affect safety of the device in the intended user population.

3. Human Factors Testing:

The SmartBolus Calculator is a component of the Omnipod 5 System. Human factors validation testing was conducted with the Omnipod 5 App installed on a compatible mobile device. Human Factors validation study on the Omnipod 5 System as a whole was performed with 16 representative participants (i.e., caregivers of children 2-5.9 years old) and described in the Decision Summary for K220394.

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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