Omnipod 5 SmartBolus Calculator

K203772 · Insulet Corporation · QRX · Jan 27, 2022 · Clinical Chemistry

Device Facts

• Record ID: K203772
• Device Name: Omnipod 5 SmartBolus Calculator
• Applicant: Insulet Corporation
• Product Code: QRX · Clinical Chemistry
• Decision Date: Jan 27, 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 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.

Device Story

Software-based bolus calculator residing in Omnipod 5 App; used for diabetes management in home settings by patients. Inputs: user-entered carbohydrates, iCGM sensor glucose or manual blood glucose (BG) readings, glucose rate-of-change, insulin-on-board (IOB), and programmed settings (correction factor, insulin-to-carbohydrate ratio, target glucose). Operation: calculates suggested insulin bolus dose in both open-loop (manual) and closed-loop (automated) modes. Output: suggested bolus dose displayed to user. Clinical impact: assists patients in determining insulin dosing to improve glycemic control; reduces time spent in hypoglycemia (<70 mg/dL) compared to manual BG entry methods.

Clinical Evidence

Prospective, single-arm, multicenter study (N=25, ages 6-70) compared manual BG entry (Phase 1) vs. CGM-informed bolus calculation (Phase 2). Primary endpoint: safety via time in glucose ranges post-bolus. Results showed CGM-informed bolus calculator reduced time <70 mg/dL (2.1% vs 2.8%, p-value not specified). Zero deaths or UADEs reported. Supplemented by in silico simulations of edge cases to ensure safe output recommendations.

Technological Characteristics

Software-only device; resides in Omnipod 5 App. Interoperable with iCGM systems. Uses algorithmic calculation based on user-defined insulin parameters and real-time glucose data. Complies with IEC 62304 (software lifecycle), ISO 14971 (risk management), and IEC 62366 (usability).

Indications for Use

Indicated for diabetes management in patients aged 6+ requiring rapid-acting U-100 insulin. Intended for single-patient, home use via prescription.

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

• DreaMed Advisor Pro (K201476)

Reference Devices

• Omnipod DASH Insulin Management System (K180045, K192659)

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

K203772

B Applicant

Insulet Corporation

C Proprietary and Established Names

Omnipod 5 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:

New device

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 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.

### 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 Omnipod 5 SmartBolus 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 Omnipod 5 SmartBolus Calculator is a software device that resides in the Omnipod 5 App. It requires input parameters and settings from the SmartAdjust Technology, an interoperable automated glycemic (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 Omnipod 5 SmartBolus Calculator can be used in both open-loop (manual mode) and closed-loop (automated mode). When used with a compatible iCGM, the Omnipod 5 SmartBolus Calculator can use the sensor glucose values and trend information to calculate a suggested bolus dose. 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 bolus calculator (K180045, K192659).

### B Instrument Description Information:

1. Instrument Name: Omnipod 5 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): DreaMed Advisor Pro
B Predicate 510(k) Number(s): K201476
C Comparison with Predicate(s):

| Device & Predicate Device(s): | K203772 | K201476 |
| --- | --- | --- |
| Device Trade Name | Omnipod 5 SmartBolus Calculator | DreaMed Advisor Pro |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Same | Software intended for the management of diabetes |
| Principle of operation | Same | Algorithmic software device |
| Age Range of Intended Users | Same | 6 years and older |
| Glucose Data Sources | Same | Sensor glucose data from a compatible integrated continuous glucose monitor (iCGM) and/or self-monitoring blood glucose (SMBG) meter values |
| General Device Characteristic Differences | | |
| Device Outputs | The Omnipod 5 SmartBolus Calculator calculates a suggested bolus dose output and calculates the insulin-on-board. | Insulin therapy adjustment recommendations including basal rate, carbohydrate ratio (CR), correction factors |

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VI Standards/Guidance Documents Referenced:

- 21 CFR 862.1358 (Special controls established under DEN170043)
- IEC 62366:2015; Medical Devices – Park 1: Application of Usability Engineering
- HE75:2009, Human Factors Engineering – Design of Medical Devices
- ISO 14971:2007; Medical devices – Application of Risk Management to Medical Devices
- IEC 62304 Ed. 1.1 2015; Medical device software – Software life cycle processes
- FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” dated May 11, 2005
- FDA Guidance “Applying Human Factors and Usability Engineering to Medical Devices” dated February 3, 2016

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

This is a software only device for insulin bolus dose calculation. 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.

5. Carry-Over:
Not applicable.

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# B Other Supportive Instrument Performance Characteristics Data:

## Summary of Clinical Testing:

A single-arm, multicenter, prospective clinical study was conducted to evaluate the Omnipod 5 SmartBolus Calculator in patients with type 1 diabetes during Manual Mode operation. The study enrolled 25 evaluable subjects aged 6-70 years across 3 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, followed by;
- Phase 2: 7 days of Omnipod 5 use in Manual Mode with a connected CGM using the CGM-informed bolus 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 1 as compared to Phase 2. Data from the clinical study is presented in the tables below. In the 25 subjects enrolled in the combined age cohort of 6.0-70.0 years, there were zero (0) deaths and zero (0) unanticipated adverse device effects (UADE) reported. One (1) serious adverse event (SAE) was reported that occurred in the aged 18.0-70.0 years cohort and was indicated as not related to the study procedures or study device. There were no non-serious adverse events reported.

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=25)

| Percent time in glucose range as measured by CGM | Standard SmartBolus Calculator | CGM-Informed SmartBolus Calculator | Difference |
| --- | --- | --- | --- |
| 70-180 mg/dL | 65.1% | 63.8% | -1.3% |
| | (15.4) | (15.7) | |
| < 70 mg/dL | 2.8% | 2.1% | -0.6%* |
| | (2.7) | (2.0) | |
| < 54 mg/dL | 0.5% | 0.3% | -0.2% |
| | (1.0) | (0.7) | |
| > 180 mg/dL | 32.1% | 34.0% | 1.9% |
| | (15.7) | (16.0) | |
| ≥ 250 mg/dL | 8.2% | 9.7% | 1.4% |
| | (6.9) | (10.3) | |
| ≥ 300 mg/dL | 2.0% | 2.6% | 0.6% |
| | (2.6) | (3.7) | |

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 potential edge cases (including physiologically improbable edge cases) will produce either a safe output (e.g., bolus recommendation), or an error alerting the user to an unsafe condition.

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Human Factors:
The Omnipod 5 SmartBolus Calculator is a component of the Omnipod 5 System. Human Factors validation study was conducted on the Omnipod 5 System as a whole and described in the Decision Summary for K203774.

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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