(24 days)
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.
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 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 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 qlucose 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.
The information provided focuses on the substantial equivalence of the SmartBolus Calculator to a predicate device, specifically regarding the expansion of its age range of intended users. The document details the clinical study performed to support this expanded indication, rather than a general acceptance criteria study for the device's core functionality.
Here's an analysis of the provided information based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria in a tabular format for the SmartBolus Calculator's overall performance. Instead, the "acceptance criteria" can be inferred from the clinical study's primary objective, which was to evaluate safety based on glucose metrics. The study aimed to show that the use of the SmartBolus Calculator in the expanded age group (2.0-5.9 years) did not significantly worsen these safety metrics compared to manual entry of blood glucose values.
| Acceptance Criteria (Inferred from Study Objective) | Reported Device Performance |
|---|---|
| Safety Metrics (4-hour post bolus period): | |
| Mean % time Blood Glucose < 70 mg/dL (Phase 2 vs Phase 1) | Mean decrease of 1.13% in Phase 2 (4.03%) vs. Phase 1 (5.16%). (P = 0.6250, not statistically significant) |
| Mean % time Blood Glucose > 180 mg/dL (Phase 2 vs Phase 1) | Mean decrease of 2.03% in Phase 2 (33.2%) vs. Phase 1 (35.2%). (P = 1.0000, not statistically significant) |
| Number of deaths | 0 |
| Number of serious adverse events | 0 |
| Number of unanticipated adverse device effects (UADE) | 0 |
| Number of non-serious adverse events | 1 (prolonged hyperglycemia) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 5 subjects in the preschool cohort (aged 2.0-5.9 years).
- Data Provenance: The study was a "single-arm, multi-center, prospective clinical study" conducted across "2 US clinical sites." Therefore, the data is prospective and from the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. The clinical study collected glucose metrics directly from the subjects, which served as the primary data for evaluation.
4. Adjudication Method for the Test Set
The document does not mention an explicit adjudication method for the clinical study's data. Clinical study data, particularly objective metrics like blood glucose levels, typically do not require adjudication in the same way imaging or subjective diagnostic interpretations might. Safety events would be reviewed by the study investigators and reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This study was a clinical trial evaluating the safety and effectiveness of the device in a specific patient population, not a comparative study of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This study was a human-in-the-loop study. The SmartBolus Calculator is a software device that recommends a bolus dose, but the user "has the option of delivering the suggested dose of insulin, modifying the amount, or canceling." The clinical study evaluated the device's performance when used by patients/caregivers in Manual Mode.
7. The Type of Ground Truth Used
The ground truth for the clinical study was based on objective clinical outcomes data (glucose metrics and adverse events) directly measured from the study participants during the two phases of the study (Manual Mode with manual BG entry vs. Manual Mode with SmartBolus Calculator use).
8. The Sample Size for the Training Set
The document does not provide information on the sample size for the training set used to develop the SmartBolus Calculator. The submission focuses on the clinical validation of the device's expanded indication, not its initial development.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established.
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August 19, 2022
Insulet Corporation Alexander Hamad Sr. Regulatory Affairs Specialist 100 Nagog Park Acton, MA 01720
Re: K222239
Trade/Device Name: SmartBolus Calculator Regulation Number: 21 CFR 862.1358 Regulation Name: Insulin Therapy Adjustment Device Regulatory Class: Class II Product Code: QRX, NDC Dated: July 26, 2022 Received: July 26, 2022
Dear Alexander Hamad:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Paula Caposino, Ph.D. Acting Deputy Director 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) K22239
Device Name SmartBolus Calculator
Indications for Use (Describe)
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.
| 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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K222239 - 510(K) SUMMARY
| Date Prepared: | August 19, 2022 |
|---|---|
| Submitter Name: | Insulet Corporation |
| Submitter Address: | 100 Nagog Park, Acton, MA, 01720 |
| FDA Establishment Owner/OperatorNumber: | 9056196 |
| FDA Establishment RegistrationNumber: | 3014585508 |
| Contact Person: | Alexander HamadSr. Regulatory Affairs Specialist |
| Phone: | 978-600-2432 |
| 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: | K203772 (SmartBolus Calculator) |
5.1 Purpose of Submission
The purpose of this submission is to modify the legally marketed SmartBolus Calculator to expand the age range in the devices' indications for use from 6 years and older to 2 years and older.
5.2 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.
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The 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 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 qlucose 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.
5.3 Summary of Technological Characteristics Compared to Predicate Device
The technological characteristics of the subject device are identical to the predicate device cleared in K203772. There have been no modifications to the design or software of the device.
There are no changes to the device's intended use, however, the indications for use is being modified to lower the age range from 6 years and older to 2 years and older.
5.4 Indications for Use:
The table below provides the indications for use for the SmartBolus Calculator subject device as compared to the predicate.
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Table 5.01: SmartBolus Calculator Substantial Equivalence Comparison
| Element ofComparison | Subject Device:SmartBolus Calculator | Predicate Device:SmartBolus Calculator(K203772) | Comparison |
|---|---|---|---|
| Indicationsfor Use | The SmartBolus Calculator issoftware intended for themanagement of diabetes inpersons aged 2 and olderrequiring rapid-acting U-100insulin. The SmartBolusCalculator calculates asuggested bolus dose basedon user-enteredcarbohydrates, most recentsensor glucose value (orblood glucose reading if usingfingerstick), rate of change ofthe sensor glucose (ifapplicable), insulin on board(IOB), and programmablecorrection factor, insulin tocarbohydrate ratio, and targetglucose value. TheSmartBolus Calculator isintended for single patient,home use and requires aprescription. | The Omnipod 5 SmartBolusCalculator is softwareintended for the managementof diabetes in persons aged 6and older requiring rapid-acting U-100 insulin. TheOmnipod 5 SmartBolusCalculator calculates asuggested bolus dose basedon user-enteredcarbohydrates, most recentsensor glucose value (orblood glucose reading if usingfingerstick), rate of change ofthe sensor glucose (ifapplicable), insulin on board(IOB), and programmablecorrection factor, insulin tocarbohydrate ratio, and targetglucose value. The Omnipod5 SmartBolus Calculator isintended for single patient,home use and requires aprescription. | Same, except for theage indication(minimum agelowered from 6 to 2) |
| Age Range ofIntendedUsers | Persons aged 2 and older | Persons aged 6 and older | Difference in ageindication (proposedchange per this 510ksubmission) |
5.5 Standards Compliance
The SmartBolus Calculator complies with the following standards in relation to the proposed change within this submission:
- 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 ●
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to Medical Devices
- ANSI AAMI ISO 14155:2011 Clinical investigation of medical devices for human . subjects - Good clinical practice
5.6 Non-Clinical Performance Data
To demonstrate the safety and effectiveness of the commercial Omnipod 5 Automated Insulin Delivery System user interface, Insulet executed a comprehensive Human Factors formative and validation testing process that followed and complied with the FDA recognized standards 62366-1 and HE75. This process is in-line with the Agency's current thinking regarding iterative design and Human Factors testing methodologies as described in their most recent guidance: Applying Human Factors and Usability Engineering to Medical Devices. The validation test was simulated and structured to mimic actual use, utilized an equivalent to production version of the system, and was designed to be sufficiently sensitive to capture use related problems, if they existed. The study was conducted to ensure sufficient data collection for the "Caregivers of Children with Diabetes" user group, with specific focus on caregivers of young children (aged 2-5.9 years). In total, 16 participants were included in the study.
The Omnipod 5 System has been found to be substantially equivalent to the predicate for the intended users, uses, and use environments. Any additional modifications to the user interface related to the safety critical tasks (including the device, training, and labeling) would not further reduce risk, are not possible or not practical, and the remaining residual use-related risks are outweighed by the benefits derived from use of the device.
5.7 Clinical Performance Data
The following clinical data were provided in support of the substantial equivalence determination for the expansion of the indications for the SmartBolus Calculator. These data supplement the existing performance data presented in the 510(k) submissions for the predicate device (K203772).
A clinical study was performed on the SmartBolus Calculator within the Omnipod 5 System per ISO 14155:2011 with the objective to assess the safety and effectiveness of the device for use in patients aged 2.0-5.9 years with type 1 diabetes during Manual Mode operation.
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This single-arm, multi-center, prospective clinical study enrolled 5 subjects across 2 US clinical sites. The study used the Omnipod 5 System in Manual Mode and consisted of two outpatient phases - 7 days of Omnipod 5 System use in Manual Mode without a connected CGM using manual entry of BG values to deliver boluses (Phase 1), followed by 7 days of Omnipod 5 System use in Manual Mode with a connected CGM using the SmartBolus Calculator to deliver boluses (Phase 2).
The primary objective of this study was to evaluate the safety of the SmartBolus Calculator using glucose metrics of percentage of time < 70 mg/dL and percentage of time > 180 mg/dL during the 4-hour post bolus period from Phase 1 as compared to Phase 2. The mean percentage of time blood glucose levels were < 70 mg/dL for the preschool cohort (aged 2.0 to 5.9 years) from Phase 1 was 5.16% as compared to 4.03% in Phase 2 resulting in non-statistically significant decrease of 1.13% (P = 0.6250). The mean percentage of time blood qlucose levels were > 180 mg/dL for the preschool cohort from Phase 1 was 35.2% as compared to 33.2% in Phase 2, a decrease of 2.03% that was not statistically significant (P = 1.0000).
In the 5 subjects enrolled in the preschool cohort of 2.0-5.9 years, there were zero (0) deaths, zero (0) serious adverse events, and zero (0) unanticipated adverse device effects (UADE) reported. There was one (1) non-serious adverse event reported (prolonged hyperglycemia).
In summary, the results of this study indicate the SmartBolus Calculator is substantially equivalent to the predicate and performed as expected when used to deliver boluses in Manual Mode by entering a manual reading or using the CGM value in the bolus calculator, during both the day and night, in preschool subjects aged 2.0-5.9 years with type 1 diabetes. Results demonstrated similar glucose metrics with the use of the SmartBolus Calculator (Phase 2) as compared to manual entry of blood glucose values for the delivery of boluses (Phase 1) for the preschool cohort. No safety concerns were reported during the study.
5.8 Substantial Equivalence Conclusion
The subject device, the SmartBolus Calculator, has the same intended use and similar indications for use as the predicate device. There are no technological differences between the subject and predicate device, only a difference in the age range within the indications for
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use. The difference in indications for use between the subject and predicate device do not raise new questions of safety and effectiveness. Clinical validation successfully demonstrates that the SmartBolus Calculator has been found to be substantially equivalent to the predicate for the intended users, uses, and use environments. Therefore, the SmartBolus Calculator is substantially equivalent to the predicate device.
§ 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).