(280 days)
The Bigfoot Unity Diabetes Management System is indicated for the management of diabetes in persons age 12 years and older.
Bigfoot Unity provides glucose monitoring data via the Abbott FreeStyle Libre 2 Flash Glucose Monitoring sensor. The system incorporates real time alarm capabilities and is designed to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The device is intended to provide insulin dose information using the available glucose data to assist persons with diabetes mellitus who use disposable pen-injectors for the self-injection of insulin in implementing health care provider recommended insulin dose regimens. The device is intended for single patient use only and requires a prescription.
Bigfoot Unity is also intended to communicate autonomously with digitally connected medical devices where the user manually controls therapy decisions.
The Bigfoot Unity Diabetes Management System ('Bigfoot Unity System') integrates continuous glucose monitoring with insulin dose recommendations to support people with diabetes mellitus who use disposable insulin pens for self-injection of insulin. The system consists of the Abbott Diabetes Care, Inc.'s FreeStyle Libre 2 Flash Glucose Monitoring System ("FreeStyle Libre 2") integrated continuous glucose monitor (iCGM) sensor, two reusable insulin pen caps (one each for rapid-acting and long-acting insulin pens) and a mobile application. The components communicate via near field communication (NFC) and Bluetooth.
The device generates glucose data using the FreeStyle Libre 2 sensor and displays the data (value and trend) on the rapid-acting insulin pen cap. The rapid-acting pen cap also displays correction and meal insulin doses based upon settings prescribed by the user's healthcare provider and the available glucose data. The long-acting pen cap displays the long-acting insulin dose prescribed by the user's healthcare provider. From the dose recommendations on the pen caps as well as other contextually relevant information such as glucose trend arrows and current exercise status, users determine the doses to take. Users manually select an insulin dose and administer it using the pens according to the insulin manufacturers' instructions. In addition to dose information, both pen caps track the time of insulin doses.
The mobile app provides fixed and configurable system alerts based upon data generated by the FreeStyle Libre 2 sensor. It also enables entry of the healthcare provider prescribed insulin dosing regimen as well as provides system alerts and historical information. In addition, the mobile app manages the secure wireless communication between the system components and enables the transfer of the system data to the cloud.
The Bigfoot Unity Diabetes Management System is an integrated continuous glucose monitor (iCGM) designed to assist individuals with diabetes in managing their insulin doses. It incorporates the Abbott FreeStyle Libre 2 Flash Glucose Monitoring system and provides insulin dose recommendations based on glucose data.
Here's an analysis of the acceptance criteria and supporting studies as described in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding device performance metrics for the Bigfoot Unity System as a complete system beyond the predicate device's performance. Instead, it states that various tests met their respective acceptance criteria, implying successful performance without detailing those criteria quantitatively for this device.
However, it does reference the analytical and clinical performance of the Abbott FreeStyle Libre 2 Flash Glucose Monitor (K193371), which forms a core component of the Bigfoot Unity System. The acceptance criteria for the integrated system are, in part, based on the successful integration and continued performance of this pre-cleared component and the proper functionality of the new elements (pen caps, mobile app, dose recommendations).
Summary of General Performance Claims:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | "Bigfoot Unity System functioned as intended and the results of the testing met the acceptance criteria." |
| Human Factors & Usability | "User interface design and labeling would not impact the performance of the device." |
| Software Verification & Validation | "Software performed in accordance with established specifications... results of the software executed protocols for the Unity System met the acceptance criteria." |
| Biocompatibility | "Determined to be biocompatible per the requirements of ISO 10993-1: 2018." |
| Electromagnetic Compatibility & Electrical Safety | "Comply with the electrical safety and electromagnetic compatibility requirements in IEC 60601-1:2013, IEC/EN 60601-1-2:2014, IEC CISPR 11, and IEC 60601-1-11:2015." |
| Wireless Coexistence | "Demonstrated successful coexistence testing in the presence of common RF interfering devices." |
| Airworthiness | "Successfully demonstrated compliance with airworthiness requirements per the Federal Aviation Administration (FAA) Advisory Circular RTCA/DO-160." |
| Environmental Testing | "Ensured the device specifications for operating temperature, humidity, pressure, impact, vibration, shock, drop, and storage conditions were met." |
| Interoperability | "In alignment with FDA guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices." |
| Cybersecurity | "Appropriate risk mitigation controls have been implemented and tested." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for the Bigfoot Unity System's custom components (e.g., pen caps, mobile app, dose recommendations). It mentions "bench test results," "human factors and usability testing," "software verification and validation testing," and "wireless coexistence and EMC testing," but without numerical details on participants or data points.
For the Abbott FreeStyle Libre 2 Flash Glucose Monitor, its analytical and clinical performance was assessed under K193371. The provenance of this data would be from the studies submitted for that specific 510(k) clearance, which is not detailed in this document. Generally, such studies involve prospective clinical trials to evaluate accuracy against a reference method (e.g., YSI glucose analyzer) in a clinical or home-use setting, typically involving participants from various countries (though often with a significant US cohort).
The data concerning the Bigfoot Unity System's specific new features (dose recommendations, pen caps, mobile app) appears to be from retrospective testing (bench, software V&V, environmental) or prospective limited user testing (human factors) but no details of the number of participants or data origin are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided for the Bigfoot Unity System's specific components. For the Abbott FreeStyle Libre 2 (the iCGM component), the ground truth for its analytical accuracy would have been established using laboratory reference methods (e.g., YSI glucose analyzers) rather than human experts, with the data then statistically compared.
For the human factors testing, "experts" in usability engineering often oversee such studies, but the document does not specify their number or qualifications. The "ground truth" in human factors is often defined by the successful completion of critical tasks without errors, which is assessed against predefined task flows and safety parameters.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for any test sets related to the Bigfoot Unity System beyond the inherent statistical comparisons and validation processes for technical performance. Since no expert concensus or clinical outcome adjudication is explicitly mentioned for the new components, it appears that direct performance against established technical specifications or usability metrics was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The Bigfoot Unity System is an iCGM with dose recommendations, not an imaging device, so an MRMC study would generally not be applicable in this context. There is no information provided regarding the effect size of human readers improving with AI vs. without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not explicitly describe a standalone algorithm-only performance study for the Bigfoot Unity System's dose recommendation functionality. However, the software verification and validation activities would have tested the internal logic and calculations of the algorithm in a standalone manner (i.e., verifying that given specific glucose data and patient settings, the algorithm outputs the correct dose recommendation according to its specifications). The output of the dose recommendation, while displayed to the user for manual action, is a direct algorithmic output. The performance of the FreeStyle Libre 2 sensor itself is a standalone performance of the glucose monitoring component.
7. Type of Ground Truth Used
For the glucose monitoring component (FreeStyle Libre 2), the ground truth is typically laboratory reference methods (e.g., YSI glucose analyzers for blood glucose levels).
For the Bigfoot Unity System's new components:
- Software Verification and Validation: Ground truth is established by pre-defined functional specifications and requirements. The software is verified to produce expected outputs given specific inputs.
- Human Factors: Ground truth is established by safety and usability metrics, where critical tasks are expected to be completed without error, and the interface is easily understandable.
- Bench, Environmental, EMC, Biocompatibility: Ground truth is established by international standards and regulatory requirements (e.g., ISO, IEC).
8. Sample Size for the Training Set
The document does not provide information on the sample size for the training set. The Bigfoot Unity System's dose recommendation functionality is based on a pre-programmed algorithm reflecting healthcare provider prescribed insulin dosing regimens, not a machine learning model that requires a "training set" in the conventional sense of supervised learning. The FreeStyle Libre 2 sensor would have undergone calibration and potentially model training (if AI is used for signal processing/accuracy improvements) but that detail is not provided here.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" for a machine learning model is not explicitly indicated for the Bigfoot Unity System's new components. The system primarily implements established clinical protocols for insulin dosing. Therefore, the "ground truth" for the dose recommendation logic would be based on clinical guidelines and established medical practice for insulin dosing, as prescribed by a healthcare provider. The software validates that it correctly implements these rules.
For the underlying FreeStyle Libre 2 iCGM, if it uses machine learning, the ground truth for any potential sensor calibration/algorithm training would have been established through comparison to laboratory reference glucose measurements (e.g., from YSI devices) from clinical studies.
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May 7, 2021
Bigfoot Biomedical, Inc. Kate Lee SVP, Regulatory & Ouality 1820 McCarthy Blvd Milpitas, CA 95035
Re: K202145
Trade/Device Name: Bigfoot Unity Diabetes Management System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: QLG, QOG Dated: April 9, 2021 Received: April 9, 2021
Dear Kate Lee:
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,
Kellie B. Kelm, Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
K202145
Device Name
Bigfoot Unity Diabetes Management System
Indications for Use (Describe)
The Bigfoot Unity Diabetes Management System is indicated for the management of diabetes in persons age 12 years and older.
Bigfoot Unity provides glucose monitoring data via the Abbott FreeStyle Libre 2 Flash Glucose Monitoring sensor. The system incorporates real time alarm capabilities and is designed to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The device is intended to provide insulin dose information using the available glucose data to assist persons with diabetes mellitus who use disposable pen-injectors for the self-injection of insulin in implementing health care provider recommended insulin dose regimens. The device is intended for single patient use only and requires a prescription.
Bigfoot Unity is also intended to communicate autonomously with digitally connected medical devices where the user manually controls therapy decisions.
Type of Use (Select one or both, as applicable)
Z Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Bigfoot Biomedical. The word "bigfoot" is written in a sans-serif font in blue, with a gradient from light to dark. Above the "oo" in "bigfoot" are two curved lines that resemble footprints. Below "bigfoot" is the word "BIOMEDICAL" in a smaller, sans-serif font, also in blue.
510(k) SUMMARY
Bigfoot Unity™ Diabetes Management System
1. Submitter:
| Address:Phone: | Bigfoot Biomedical, Inc.1820 McCarthy BlvdMilpitas, CA 95035(408) 514-4429 |
|---|---|
| Contact: | Kate Lee |
| Date Prepared: | April 27. 2021 |
II. Device:
| Name of Device: | Bigfoot Unity™ Diabetes Management System |
|---|---|
| Common Name: | Integrated Continuous Glucose Monitor |
| Classification Name: | Integrated Continuous Glucose Monitoring System, Factory Calibrated,Not For Use With Automated Insulin Delivery Systems |
| Regulatory Class: | Class II (21 CFR §862.1355, 21CFR § 880.5860) |
| Product Code: | QLG, QOG |
���. Predicate Device:
Abbott Diabetes Care FreeStyle Libre 2 - K193371
IV. Device Description:
The Bigfoot Unity Diabetes Management System ('Bigfoot Unity System') integrates continuous glucose monitoring with insulin dose recommendations to support people with diabetes mellitus who use disposable insulin pens for self-injection of insulin. The system consists of the Abbott Diabetes Care, Inc.'s FreeStyle Libre 2 Flash Glucose Monitoring System ("FreeStyle Libre 2") integrated continuous glucose monitor (iCGM) sensor, two reusable insulin pen caps (one each for rapid-acting and long-acting insulin pens) and a mobile application. The components communicate via near field communication (NFC) and Bluetooth.
The device generates glucose data using the FreeStyle Libre 2 sensor and displays the data (value and trend) on the rapid-acting insulin pen cap. The rapid-acting pen cap also displays correction and meal insulin doses based upon settings prescribed by the user's healthcare provider and the available glucose data. The long-acting pen cap displays the long-acting insulin dose prescribed by the user's healthcare provider. From the dose recommendations on the pen caps as well as other contextually relevant information such as glucose trend arrows and current exercise status, users determine the doses to take. Users manually select an insulin dose and administer it using the pens according to the insulin manufacturers' instructions. In addition to dose information, both pen caps track the time of insulin doses.
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Image /page/4/Picture/0 description: The image shows the logo for Bigfoot Biomedical. The word "bigfoot" is written in a sans-serif font in blue. Below the word "bigfoot" is the word "BIOMEDICAL" in a smaller sans-serif font, also in blue. The logo is simple and modern.
The mobile app provides fixed and configurable system alerts based upon data generated by the FreeStyle Libre 2 sensor. It also enables entry of the healthcare provider prescribed insulin dosing regimen as well as provides system alerts and historical information. In addition, the mobile app manages the secure wireless communication between the system components and enables the transfer of the system data to the cloud.
V. Intended Use / Indications for Use
The Bigfoot Unity Diabetes Management System is indicated for the management of diabetes in persons age 12 years and older.
Bigfoot Unity provides glucose monitoring data via the Abbott FreeStyle Libre 2 Flash Glucose Monitoring sensor. The system incorporates real time alarm capabilities and is designed to replace blood qlucose testing for diabetes treatment decisions, unless otherwise indicated. The device is intended to provide insulin dose information using the available glucose data to assist persons with diabetes mellitus who use disposable pen-injectors for the self-injection of insulin in implementing health care provider recommended insulin dose regimens. The device is intended for single patient use only and requires a prescription.
Bigfoot Unity is also intended to communicate autonomously with digitally connected medical devices where the user manually controls therapy decisions.
VI. Technological Characteristics
The Bigfoot Unity System has the same intended uses and similar indications, technological characteristics, and principles of operation compared to the predicate device. Bigfoot Unity incorporates the FreeStyle Libre 2 sensor, using the same technology to measure interstitial qlucose and provide real-time qlucose data to the user. The minor technological differences between the Bigfoot Unity System and its predicate device primarily relate to the location of qlucose data display, alert implementation and the inclusion of the HCP-prescribed dose recommendations. These technical differences do not impact the availability of accurate data to support the user in making appropriate dosing decisions. Thus, they do not raise new questions of safety or effectiveness. Performance data additionally demonstrates that the Bigfoot Unity System is as safe and effective as its predicates.
VII. Performance Data
Bench test results support the performance characteristics of the Bigfoot Unity System and show equivalence to the currently marketed predicate device. In all instances, the Bigfoot Unity System functioned as intended and the results of the testing met the acceptance criteria.
Analytical and Clinical Performance:
The analytical and clinical performance of the FreeStyle Libre 2 Flash Glucose Monitor was assessed under K193371.
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Image /page/5/Picture/0 description: The image shows the logo for Bigfoot Biomedical. The word "bigfoot" is written in a blue gradient font, with the top of the letters being a darker blue than the bottom. Above the "oo" in "bigfoot" are three curved lines that resemble a footprint. Below "bigfoot" is the word "BIOMEDICAL" in a smaller, sans-serif font.
Human Factors:
Human factors and usability testing of the Bigfoot Unity System was conducted to determine whether the user interface design and labeling would impact the performance of the device. Human factors testing was conducted in accordance with:
- · FDA Guidance titled Applying Human Factors and Usability Engineering to Medical Devices, dated February 3, 2016
- · ANSI/AAMI/IEC 62366: Medical devices Application of Usability Engineering to Medical Devices
Software Verification and Validation:
Software verification and validation testing was conducted to confirm that the software used in the Bigfoot Unity System performed in accordance with established specifications, and FDA Guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Mav 11, 2005). Verification activities included unit, component, system integration, and system level testing which verified functionality of the device against established software requirements. Results of the software executed protocols for the Unity System met the acceptance criteria and therefore supports that the Bigfoot Unity software is acceptable for its intended use.
Biocompatibility:
The Bigfoot Unity System was determined to be biocompatible per the requirements of ISO 10993-1: 2018, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.
Electromagnetic Compatibility and Electrical Safety:
The Bigfoot Unity System has been tested and shown to comply with the electrical safety and electromagnetic compatibility requirements in IEC 60601-1:2013, Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance. IEC/EN 60601-1-2:2014 and IEC CISPR 11. Additionally, the Bigfoot Unity System complies with IEC 60601-1-11:2015, Medical Electrical Equipment – Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.
Wireless coexistence and EMC testing were performed to confirm that the Bigfoot Unity System remains functional and performs within acceptable limits while in the presence of common radiating electronic devices in accordance with applicable standards as well as FDA Guidance document Radio Frequency Wireless Technology in Medical Devices. The Bigfoot Unity System demonstrated successful coexistence testing in the presence of common RF interfering devices (2.4 GHz frequency band) that are likely to be encountered by users in a home environment.
The Bigfoot Unity System also successfully demonstrated compliance with airworthiness requirements per the Federal Aviation Administration (FAA) Advisory Circular RTCA/DO-160.
Environmental Testing:
Environmental testing on the Bigfoot Unity System was performed in accordance with IEC 60601-1 to ensure the device specifications for operating temperature, operating humidity, operating pressure, impact resistance, vibration resistance, shock resistance, drop resistance, and storage conditions were met.
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Image /page/6/Picture/0 description: The image shows the logo for Bigfoot Biomedical. The word "bigfoot" is written in a sans-serif font in blue, with a gradient from dark to light blue. Above the "oo" in bigfoot, there are three curved arrows pointing to the right. Below the word "bigfoot" is the word "BIOMEDICAL" in a smaller, sans-serif font.
Interoperability:
The Bigfoot Unity System interoperability approach is in alignment with FDA guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (September 6, 2017) and with the iCGM interoperability approach taken by the predicate device.
Cybersecurity:
Cybersecurity risk management was performed included the analysis of confidentiality, integrity, and availability for data, information and software related to the Bigfoot Unity System. Appropriate risk mitigation controls have been implemented and tested.
VIII. Conclusion
The Bigfoot Unity System has the same intended use and clinical application as the predicate device. There are no differences in technological characteristics that raise questions of safety or effectiveness. The Bigfoot Unity System provides significant benefits to users (ease of use/access to insulin dose recommendations based on glucose information where the user manually controls actions for therapy decisions) that outweigh any potential risks associated with manual management of care. Bench testing along with human factors testing demonstrated that the Bigfoot Unity System provides accurate and reliable dose recommendation based on current standard of care from a healthcare provider. Accordingly, based on this and the data provided in this pre-market notification, the subject device and predicate device have been shown to be substantially equivalent.
§ 862.1355 Integrated continuous glucose monitoring system.
(a)
Identification. An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Robust clinical data demonstrating the accuracy of the device in the intended use population.
(ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order (
e.g., an internationally recognized reference material and/or method).(iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device.
(iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period.
(v) Clinical study results in the adult population must meet the following performance requirements:
(A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent.
(B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent.
(C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent.
(D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent.
(E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent.
(H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL.
(I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL.
(J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements.
(K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements.
(vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate.
(vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use.
(2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data.
(3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section.
(4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications.
(5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period.
(6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy.
(7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites (
e.g., abdomen, arm, buttock):(i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL.
(ii) A description of the accuracy of positive and negative rate of change data.
(iii) A description of the frequency and duration of gaps in sensor data.
(iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable.
(v) A description of the observed duration of iCGM life for the device.