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 Description

The 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 SmartBolus Calculator receives input parameters and settings from 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 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 sensors qlucose (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 SmartBolus Calculator can be used in the Omnipod 5 Automated Insulin Delivery System with both Manual Mode and Automated Mode.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the SmartBolus Calculator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific acceptance criteria in a quantitative manner for the SmartBolus Calculator's performance. Instead, it states that:

"Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the device is safe for use."
"Through performance testing, the Subject device has been shown to meet the Special Controls and determined to be substantially equivalent to its predicate."
"There was no impact to clinical performance of the SmartBolus Calculator for the design change discussed in this submission."

This implies that the assessment for this 510(k) submission focused on demonstrating that the new iOS version of the SmartBolus Calculator (subject device) performs identically to the predicate Android version (K222239) and meets the same safety and effectiveness standards, rather than establishing new performance metrics.

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for a test set in the context of clinical or performance data for the SmartBolus Calculator itself. The testing mentioned is primarily "software verification and validation testing" and "risk management" activities.

The data provenance is also not explicitly stated as retrospective or prospective clinical data. The testing described appears to be internal software development and validation, rather than a clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The testing described is software-centric, and there's no mention of expert-established ground truth for a test set in a medical diagnostic sense.

4. Adjudication method for the test set

This information is not provided in the document, as it doesn't describe a clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not mentioned or described. The device is an "Insulin Therapy Adjustment Device," not a diagnostic imaging device where MRMC studies are typically conducted. The document focuses on demonstrating substantial equivalence of a new software implementation (iOS) to an existing one (Android).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The SmartBolus Calculator is described as an "Algorithmic software device." Its function is to "calculate a suggested bolus dose." However, it operates as a component of the Omnipod 5 App, and "Once the calculation is complete, the user has the option of delivering the suggested dose of insulin, modifying the amount, or canceling." This indicates it's a human-in-the-loop system, where the user has ultimate control and decision-making power over the suggested dose. Therefore, a purely standalone clinical performance evaluation without human decision-making is not explicitly implied or discussed in this context. The software's calculation itself is standalone, but its application involves a human.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not specify a type of ground truth related to clinical outcomes or expert consensus for its performance evaluation for this particular submission. The "verification activities" and "software verification and validation testing" likely used predefined software requirements, simulated data, and mathematical correctness of calculations as their "ground truth" to ensure the algorithms produced the expected outputs given specific inputs according to the established insulin calculation formulas.

8. The sample size for the training set

The document does not describe a training set in the context of machine learning. The SmartBolus Calculator is an algorithm that computes a bolus dose based on programmable factors and user inputs, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

As there's no mention of a machine learning model or a training set, this information is not applicable.

Summary

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October 18, 2023

Insulet Corporation Maria Brower Senior Specialist Regulatory Affairs 100 Nagog Park Acton, MA 01720

Re: K231824

Trade/Device Name: SmartBolus Calculator Regulation Number: 21 CFR 862.1358 Regulation Name: Insulin Therapy Adjustment Device Regulatory Class: Class II Product Code: QRX Dated: September 19, 2023 Received: September 19, 2023

Dear Maria Brower:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Joshua Balsam -S

Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231824

Device Name SmartBolus Calculator

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K231824 510(K) SUMMARY

Date prepared:	October 16, 2023
Submitter Name:	Insulet Corporation
Submitter Address:	100 Nagog Park, Acton, MA 01720
FDA Establishment Owner/OperatorNumber:	9056196
FDA Establishment RegistrationNumber:	3014585508
Primary Contact PersonPhone:	Maria Brower,Senior Specialist, Regulatory Affairs, Digital Health978-600-7000
Secondary Contact PersonPhone:	Katie Pacheco, Director Regulatory Affairs, DigitalHealth978-600-7000
Fax:	978-600-0120
Device Trade / Proprietary Name:	SmartBolus Calculator
Device Common Name:	Insulin therapy adjustment device
Review Panel (s):	Clinical Chemistry
Product Code(s):	QRX, NDC
Regulation Numbers:	21 CFR 862.1358
Submission Type:	Traditional 510(k)
Device Class:	Class II
Device Predicate:	K222239 (SmartBolus Calculator)

5.1 Purpose of Submission

The SmartBolus Calculator is being modified to be compatible with the iOS version of the Omnipod 5 App component of the Omnipod 5 ACE Pump.

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5.2 Intended 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 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.

5.3 Device Description

The SmartBolus Calculator can be used in the Omnipod 5 Automated Insulin Delivery System with both Manual Mode and Automated Mode.

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Image /page/5/Picture/0 description: The image shows the Insulet logo. The word "Insulet" is written in purple, and below it, the words "maker of Omnipod" are written in gray. The logo is simple and modern.

Summary of Technological Characteristics Compared to Predicate Device 5.4

There is no change to the SmartBolus Calculator that is compatible with the Android version of the Omnipod 5 App. In addition, the SmartBolus Calculations and data inputs are identical to the predicate (K222239). The Subject device (SmartBolus Calculator hosted within the Omnipod 5 App (iOS)) is written in an iOS compatible programming language. The different programming language does not raise different questions about safety and effectiveness because both software items implement the exact same fundamental calculation with no difference in glucose input parameters or calculation.

The differences between predicate and subject device do not raise any different questions about safety and effectiveness, and performance data demonstrates the Omnipod 5 ACE Pump is substantially equivalent to its predicate. Table 5.01 below illustrates the equivalence of the subject device to the predicate.

The user interface for the SmartBolus Calculator is regulated as part of the Omnipod 5 ACE Pump (Omnipod 5 App component) and therefore UI changes are described the concurrent 510(k) submission for the Omnipod 5 ACE Pump.

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Element ofComparison	Subject Device: SmartBolusCalculator	Predicate Device: SmartBolusCalculator (K222239)
Intended use/indications foruse	The SmartBolus Calculator issoftware intended for themanagement of diabetes in personsaged 2 and older requiring rapid-acting U-100 insulin. The SmartBolusCalculator calculates a suggestedbolus dose based on user-enteredcarbohydrates, most recent sensorglucose value (or blood glucosereading if using fingerstick), rate ofchange of the sensor glucose (ifapplicable), insulin on board (IOB),and programmable correction factor,insulin to carbohydrate ratio, andtarget glucose value. The SmartBolusCalculator is intended for singlepatient, home use and requires aprescription.	The SmartBolus Calculator issoftware intended for themanagement of diabetes in personsaged 2 and older requiring rapid-acting U-100 insulin. The SmartBolusCalculator calculates a suggestedbolus dose based on user-enteredcarbohydrates, most recent sensorglucose value (or blood glucosereading if using fingerstick), rate ofchange of the sensor glucose (ifapplicable), insulin on board (IOB),and programmable correction factor,insulin to carbohydrate ratio, andtarget glucose value. TheSmartBolus Calculator is intended forsingle patient, home use and requiresa prescription.
Age Range ofIntended Users	Persons aged 2 and older	Persons aged 2 and older
Device Outputsand InsulinTherapyAdjustmentRecommendations Type	The SmartBolus Calculatorcalculates a suggested bolus doseoutput to the ACE Pump and alsocalculates the insulin-on-board.	The SmartBolus Calculatorcalculates a suggested bolus doseoutput to the iAGC and alsocalculates the insulin-on-board.
Principles ofOperation	Algorithmic software device	Algorithmic software device
ProgrammingLanguage	Android and iOS compatibleprogramming language	Android compatible programminglanguage

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Image /page/7/Picture/0 description: The image shows the Insulet logo. The word "Insulet" is written in a large, purple font. Below the word "Insulet" is the phrase "maker of Omnipod" in a smaller, gray font. The logo is simple and clean, and it is likely used to represent the Insulet Corporation.

5.5 Standards Compliance

The SmartBolus Calculator comply with the following standards in relation to the proposed change within this submission:

Standard	Title	FDARecognition No.
ANSI AAMI ISO14971:2019	Medical devices – Application of RiskManagement to Medical Devices	5-125
IEC 62304:2015-06	Medical Devices Software - (Software life cycleprocesses)	13-79

5.6 Non-Clinical Performance Data

The Omnipod 5 SmartBolus Calculator was designed and developed as part of the Omnipod 5 Automated Insulin Delivery System in accordance with Insulet procedures for Design Control, Software Development, and Risk Management. The information presented in this 510(k) demonstrate the safety and effectiveness of the Omnipod 5 SmartBolus Calculator.

Performance testing was focused primarily on software verification and validation for the SmartBolus Calculator. Human factors validation for the SmartBolus Calculator was done as part of the Omnipod 5 ACE Pump validation (provided in K231826). There was no impact to clinical performance of the SmartBolus Calculator for the design change discussed in this submission.

Performance testing for the addition of an iOS compatible SmartBolus Calculator included the following:

. Risk Management: risk management was completed in accordance with ISO 14971:2019. Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the device is safe for use.
Software Validation: software verification and validation testing were performed in . accordance with IEC 62304:2015 and FDA's guidance document, General

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Principles of Software Validation – Issued January 11, 2002. Software documentation was provided in accordance with FDA guidance Content of Premarket Submissions for Device Software Functions - Issued June 2023.

Special Controls: evaluation of the Special Controls for this device (regulation 21 ● CFR 862.1358) supports the safety and effectiveness of the device.

5.7 Substantial Equivalence Conclusion

The SmartBolus Calculator has the same intended use and indications for use as the predicate device. The difference in technological characteristics (software programming lanquage) of the subject device compared to the predicate device does not raise different questions of safety and effectiveness. Through performance testing, the Subject device has been shown to meet the Special Controls and determined to be substantially equivalent to its predicate.

Regulation Number and Section

§ 862.1358 Insulin therapy adjustment device.

(a)
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.(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; 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).