(119 days)
No
The description details a calculation based on user-entered parameters and programmable settings, which is a deterministic algorithm, not AI/ML. There is no mention of learning, training data, or adaptive algorithms.
Yes.
The device is intended for the management of diabetes, calculating a suggested bolus dose of insulin. This directly addresses and mitigates a disease state, which is a characteristic of a therapeutic device.
No
The SmartBolus Calculator is a software device that calculates a suggested bolus dose of insulin based on user-entered parameters, but it is not intended to diagnose diabetes or any other medical condition. Its function is to assist in the management of diabetes by providing insulin dosage suggestions.
Yes
The device description explicitly states "The SmartBolus Calculator is a software device". While it is a component of a larger system (Omnipod 5), the submission focuses on the software component and its validation.
Based on the provided information, the SmartBolus Calculator is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The SmartBolus Calculator uses glucose values (either from a sensor or blood glucose meter) as input, but it doesn't examine a specimen itself to provide diagnostic information. It uses the glucose value as one of several parameters to calculate an insulin dose.
- The intended use is for managing diabetes by calculating insulin doses. This is a therapeutic management function, not a diagnostic function.
- The device description focuses on software calculations for insulin delivery. It doesn't describe any process of analyzing biological samples.
While the SmartBolus Calculator relies on glucose data, which is obtained through methods that could be considered part of an IVD process (like a blood glucose meter or CGM), the SmartBolus Calculator itself is a software tool for managing the condition based on that data, not for diagnosing or monitoring the condition through specimen analysis.
N/A
Intended Use / 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.
Product codes
QRX, NDC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
2 and older
Intended User / Care Setting
single patient, home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K222239 (SmartBolus Calculator)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
1
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
2
Indications for Use
510(k) Number (if known) K231824
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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K231824 510(K) SUMMARY
| Date prepared: | October 16, 2023 |
|---|---|
| Submitter Name: | Insulet Corporation |
| Submitter Address: | 100 Nagog Park, Acton, MA 01720 |
| FDA Establishment Owner/Operator | |
| Number: | 9056196 |
| FDA Establishment Registration | |
| Number: | 3014585508 |
| Primary Contact Person | |
| Phone: | Maria Brower, |
| Senior Specialist, Regulatory Affairs, Digital Health | |
| 978-600-7000 | |
| Secondary Contact Person | |
| Phone: | Katie Pacheco, Director Regulatory Affairs, Digital |
| Health | |
| 978-600-7000 | |
| 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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Image /page/4/Picture/0 description: The image shows the Insulet logo. The word "Insulet" is written in a purple sans-serif font. Below the word "Insulet" is the phrase "maker of Omnipod" in a smaller, gray sans-serif font.
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 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.
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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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Image /page/6/Picture/0 description: The image shows the Insulet logo. The word "Insulet" is written in a purple sans-serif font. Below the word "Insulet" is the phrase "maker of Omnipod" in a smaller, gray sans-serif font.
| Element of
Comparison | Subject Device: SmartBolus
Calculator | Predicate Device: SmartBolus
Calculator (K222239) |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use/
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. | 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. |
| Age Range of
Intended Users | Persons aged 2 and older | Persons aged 2 and older |
| Device Outputs
and Insulin
Therapy
Adjustment
Recommendati
ons Type | The SmartBolus Calculator
calculates a suggested bolus dose
output to the ACE Pump and also
calculates the insulin-on-board. | The SmartBolus Calculator
calculates a suggested bolus dose
output to the iAGC and also
calculates the insulin-on-board. |
| Principles of
Operation | Algorithmic software device | Algorithmic software device |
| Programming
Language | Android and iOS compatible
programming language | Android compatible programming
language |
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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 | FDA
Recognition No. |
|-----------------------------|------------------------------------------------------------------------|------------------------|
| ANSI AAMI ISO
14971:2019 | Medical devices – Application of Risk
Management to Medical Devices | 5-125 |
| IEC 62304:2015-06 | Medical Devices Software - (Software life cycle
processes) | 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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Image /page/8/Picture/0 description: The image shows the Insulet company logo. The word "Insulet" is written in a large, purple font. Below the company name, the words "maker of Omnipod" are written in a smaller, gray font.
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.