(215 days)
Not Found
No
The description focuses on integrating existing technologies (CGM, pen caps, mobile app) and providing dose recommendations based on prescribed settings and glucose data, without mentioning AI or ML algorithms for dose calculation or other functions.
Yes
The device is indicated for diabetes management and provides insulin dose information, which are direct therapeutic interventions for a medical condition.
Yes
The device provides glucose monitoring data and is designed to replace blood glucose testing for diabetes treatment decisions, indicating its role in identifying or characterizing a disease.
No
The device description explicitly states that the system consists of a FreeStyle Libre 2 sensor, two reusable insulin pen caps, and a mobile application. These are hardware components, not solely software.
Based on the provided text, the Bigfoot Unity® Diabetes Management System is an IVD (In Vitro Diagnostic).
Here's why:
- It uses an iCGM sensor (Abbott FreeStyle Libre 2): The device description explicitly states that the system integrates the FreeStyle Libre 2 Flash Glucose Monitoring system, which is an integrated continuous glucose monitor (iCGM). iCGMs are considered IVDs as they measure glucose levels in interstitial fluid, which is a body fluid.
- It provides glucose monitoring data: The intended use states that the system provides glucose monitoring data and is designed to replace blood glucose testing for diabetes treatment decisions. Glucose monitoring is a diagnostic function.
- It generates glucose data: The device description confirms that the device generates glucose data using the FreeStyle Libre 2 sensor.
While the system also provides insulin dose recommendations and management features, its core function relies on obtaining and interpreting glucose data from the iCGM sensor, which falls under the definition of an in vitro diagnostic device.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
QLG, QOG
Device Description
Bigfoot Unity Diabetes Management System ("Bigfoot Unity System") integrates The 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
12 years and older
Intended User / Care Setting
Persons with diabetes mellitus who use disposable pen-injectors for the self-injection of insulin. Requires a prescription. Users manually control therapy decisions. Home Healthcare Environment.
Description of the training set, sample size, data source, and annotation protocol
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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)
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.
- 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, in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and FDA's Draft Guidance, Content of Premarket Submissions for Device Software Functions. 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 support that the Bigfoot Unity software is acceptable for its intended use.
- Human Factors: Human factors and usability testing of the Bigfoot Unity System was conducted to determine whether the user interface design and labeling enabled safe and effective use of the device by the intended user groups. Human factors testing was conducted in accordance with FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices (2016) and ANSI/AAMI/IEC 62366: Medical devices -Application of Usability Engineering to Medical Devices.
- 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 60601-1:2005, 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's guidance, 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.
- Cybersecurity: Cybersecurity risk management was performed including 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.
The following performance characteristics were established for the predicate Bigfoot Unity System in K202145 and are not impacted by the modifications leading to the subject device.
- Interoperability
- Environmental Testing (operating parameters, shock resistance, storage conditions, etc.)
- Biocompatibility
- Analytical and Clinical Performance
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
March 1, 2023
Bigfoot Biomedical, Inc. Kate Lee SVP, Regulatory and Quality 1820 McCarthy Blvd Milpitas. CA 95035
Re: K222280
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: December 7, 2022 Received: December 7, 2022
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 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
1
- 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 (QS) 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.
Digitally signed by Paula Paula Caposino -S Caposino -S Date: 2023.03.01 13:19:34 -05'00'
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K222280 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 reqimens. 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)
区 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 contains the logo for Bigfoot Biomedical. The word "bigfoot" is written in a sans-serif font in blue, with the letters slightly overlapping. Below the word "bigfoot" is the word "BIOMEDICAL" in a smaller, sans-serif font, also in blue. There are three curved lines above the letters "oo" in "bigfoot".
510(k) SUMMARY
Bigfoot Unity® Diabetes Management System
l. Submitter:
| Address: | Bigfoot Biomedical, Inc.
1820 McCarthy Blvd
Milpitas, CA 95035 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Phone: | (408) 716-5600 |
| Contact: | Kate Lee |
| Date Prepared: | February 14, 2023 |
| II. Device: | K222880 |
| 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:
Bigfoot Unity® Diabetes Management System - K202145
IV. Device Description:
Bigfoot Unity Diabetes Management System ("Bigfoot Unity System") integrates The continuous qlucose 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. 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, with the letters gradually changing from a darker to a lighter shade of blue. Above the two "o"s in "bigfoot" are three curved lines that resemble a footprint. Below "bigfoot" is the word "BIOMEDICAL" in a smaller, sans-serif font, also in blue.
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 dosingregimen 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 glucose testing for diabetes treatment decisions, unless otherwise indicated. The device is intended to provide insulin dose information using the available qlucose data to assist persons with diabetes mellitus who use disposable pen-iniectors for the self-iniection 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 glucose 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 expansion to Android OS compatible smartphones. 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 ofsafety or effectiveness. Performance data additionally demonstrates that the Bigfoot Unity System is as safe and effective as its predicate device.
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.
- 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, in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and FDA's Draft Guidance, Content of Premarket Submissions for Device Software Functions. 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 support that the Bigfoot Unity software is acceptable for its intended use.
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BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM 510(K) PREMARKET NOTIFICATION
Image /page/5/Picture/1 description: The image shows the logo for Bigfoot Biomedical. The logo is in blue and features the word "bigfoot" in a stylized font, with a graphic of a footprint above the "oo" in "bigfoot". 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 enabled safe and effective use of the device by the intended user groups. Human factors testing was conducted in accordance with FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices (2016) and ANSI/AAMI/IEC 62366: Medical devices -Application of Usability Engineering to Medical Devices.
- 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 60601-1:2005, 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 Biafoot 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's guidance, 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.
- Cybersecurity: Cybersecurity risk management was performed including 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.
The following performance characteristics were established for the predicate Bigfoot Unity System in K202145 and are not impacted by the modifications leading to the subject device.
- Interoperability .
- Environmental Testing (operating parameters, shock resistance, storage conditions, etc.)
- Biocompatibilitv
- Analytical and Clinical Performance ●
VIII. Conclusion
The Bigfoot Unity System has the same intended use and clinical application as its predicate (the prior version of the 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/accessto 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 subject Bigfoot Unity System provides accurate and reliable dose recommendation based on current standard of care from a healthcare provider. Accordingly, and based on the submitted data, the subject device has been shown to be substantially equivalent to its predicate.