(74 days)
Not Found
No
The summary describes an algorithm for converting electrical current to glucose values and calculating rate of change, but there is no mention of AI or ML being used in this process or for the "Insights" feature. The focus is on the hardware, sensor technology, and a redesigned user interface.
No.
The device is a diagnostic tool that measures and displays glucose values, helping users understand how lifestyle impacts glucose. It is explicitly stated that the user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional, indicating it does not provide therapy itself.
Yes
Explanation: The "Intended Use" states that the device "helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels," which is a diagnostic function.
No
The device description explicitly states that the system consists of both a Glucose Sensing Subsystem (GSS) which includes hardware components (sensor applicator, on-body wearable with transmitter, adhesive patch, and sensor) and a Mobile Application Subsystem (MAS). While the MAS is software, the overall system is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is "intended to continuously measure, record, analyze, and display glucose values". Glucose measurement is a diagnostic test performed on a biological sample (interstitial fluid in this case).
- Device Description: The description details how the sensor "converts glucose into electrical current" and how the system "measures and displays estimated glucose values". This is the core function of an in vitro diagnostic device – analyzing a biological sample to provide diagnostic information.
- Mechanism of Action: The device measures glucose in interstitial fluid, which is a biological fluid. This is a key characteristic of an in vitro diagnostic test.
While the device is used by the patient and provides information for them to understand how lifestyle impacts glucose, the fundamental action of measuring glucose in a biological sample places it within the scope of an In Vitro Diagnostic device. The fact that the user is not intended to take medical action without consultation with a qualified healthcare professional doesn't change the nature of the measurement itself being a diagnostic test.
N/A
Intended Use / Indications for Use
The Stelo Glucose Biosensor System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Stelo Glucose Biosensor System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Stelo Glucose Biosensor System may also the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion.
The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.
Product codes (comma separated list FDA assigned to the subject device)
SAF
Device Description
The Stelo Glucose Biosensor system (Stelo System) is an over-the-counter (OTC) interoperable continuous glucose monitoring (iCGM) system.
The Stelo Glucose Biosensor system (Stelo System) is an interoperable connected device that measures and displays estimated glucose values for people who are not on insulin. The Stelo System consists of the following components: the Glucose Sensing Subsystem (GSS) and the Mobile Application Subsystem (MAS). The GSS is comprised of the sensor applicator and on-body wearable, which includes a Bluetooth Low Energy (BLE) molded transmitter, adhesive patch and sensor. The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The transmitter's onboard algorithm converts these measurements into estimated glucose values and calculates the glucose rate of change which are sent every 5 minutes to the MAS is an app that can be downloaded to a compatible smart device and that presents glucose readings and glucose trend to the user every 15 minutes. As such, the most recent displayed glucose value might be up to 15 minutes old. Each sensor session lasts up to 15 days with an extended 12-hour grace period. The grace period allows additional time for the user to change the sensor at a convenient time.
The proposed Stelo System is based on the same mode of operation and mechanism of reaction as the predicate G7 CGM System (K231081), which uses a wire type sensing mechanism that continuously measures interstitial fluid glucose levels and a BLE enabled radio transmitter to wirelessly communicate CGM data to compatible display devices at regular 5-minute intervals. These data are also able to be reliably and securely transmitted to other digitally connected devices, excluding insulin pens and Automated Insulin Dosing (AID) systems.
The Stelo System uses the same hardware design as the predicate G7 CGM System. The Stelo GSS firmware is designed to support a factory-calibrated only device (without calibration inputs), to extend the sensor wear duration from 10 to 15 days while maintaining the accuracy of the device, and to connect to authorized display devices only (i.e., Stelo MAS). The Stelo MAS includes a redesigned user interface (UI) tailored to the Stelo System's user population to simplify the use of the device. The UI includes an app onboarding specific to the Stelo MAS design and its intended use, the most recent glucose value and trend graph which are updated every 15 minutes, a narrowed glucose range display from 70 mg/dL, and an "Insights" feature providing the time in range percentage with suggestions to help users improve their time in range. The UI does not provide any glucose or system alerts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
Over-The-Counter 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)
A clinical study was conducted to evaluate the safety and effectiveness of the Stelo Glucose Biosensor System. The effectiveness of the device was evaluated with respect to reference venous plasma sample YSI measurements across the measuring range throughout a 15-day wear duration with a 12-hour grace period in adult (18 years and older) participants with diabetes. Analysis of the results from the clinical studies show that the subject device meets the iCGM special controls for clinical performance set forth in 21 CFR 862.1355. The safety of the device was evaluated by the incidence of device-related adverse events (AEs) experienced by study subjects. The reported device-related AEs included local irritation (edema), and pain or discomfort. The clinical study demonstrated that the Stelo Glucose Biosensor System is safe and effective for its intended use.
Nonclinical testing results demonstrate that the Stelo Glucose Biosensor System meets pre-defined acceptance criteria and support that the device is acceptable for its intended use. Clinical study results demonstrate that the Stelo Glucose Biosensor System meets the iCGM special controls for clinical performance set forth in 21 CFR 862.1355.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 5, 2024 Dexcom, Inc. Maryam Amini Sr. Manager, Regulatory Affairs 6340 Sequence Drive San Diego, California 92121
Re: K234070
Trade/Device Name: Stelo Glucose Biosensor System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: SAF Dated: December 21, 2023 Received: December 22, 2023
Dear Maryam Amini:
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
2
Indications for Use
510(k) Number (if known) K234070
Device Name Stelo Glucose Biosensor System
Indications for Use (Describe)
The Stelo Glucose Biosensor System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (CCGM) intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Stelo Glucose Biosensor System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Stelo Glucose Biosensor System may also the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion.
The user is not intended to take medical action based on the device output without consultation with a qualified healtheare professional.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Dexcom
510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K234070
Prepared on: 2024-03-05
Contact Details
| Applicant Name | Dexcom, Inc. |
|---|---|
| Applicant Address | 6340 Sequence Dr., San Diego, CA 92121, United States |
| Applicant Contact Telephone | 1(858) 472-5139 |
| Applicant Contact | Neeta Sharma |
| Applicant Contact Email | neeta.sharma@dexcom.com |
| Correspondent Name | Dexcom, Inc. |
| Correspondent Address | 6340 Sequence Dr., San Diego, CA 92121, United States |
| Correspondent Contact | |
| Telephone | 1(949) 258-2365 |
| Correspondent Contact | Maryam Amini |
| Correspondent Contact Email | maryam.amini@dexcom.com |
Device Name and Classification
| Device Trade Name | Stelo Glucose Biosensor System |
|---|---|
| Common Name | Integrated Continuous Glucose Monitoring System |
| Classification Name | Integrated Continuous Glucose Monitor for non-intensive glucose |
| monitoring, Over-The-Counter | |
| Regulation Number | 862.1355 |
| Product Code(s) | SAF |
Legally Marketed Predicate Devices
| Predicate # | K231081 |
|---|---|
| Predicate Trade Name | Dexcom G7 Continuous Glucose Monitoring System |
| Product Code | QBJ |
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Dexcor
Device Description Summary
The Stelo Glucose Biosensor system (Stelo System) is an over-the-counter (OTC) interoperable continuous glucose monitoring (iCGM) system.
The Stelo Glucose Biosensor system (Stelo System) is an interoperable connected device that measures and displays estimated glucose values for people who are not on insulin. The Stelo System consists of the following components: the Glucose Sensing Subsystem (GSS) and the Mobile Application Subsystem (MAS). The GSS is comprised of the sensor applicator and on-body wearable, which includes a Bluetooth Low Energy (BLE) molded transmitter, adhesive patch and sensor. The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The transmitter's onboard algorithm converts these measurements into estimated glucose values and calculates the glucose rate of change which are sent every 5 minutes to the MAS is an app that can be downloaded to a compatible smart device and that presents glucose readings and qlucose trend to the user every 15 minutes. As such, the most recent displayed glucose value might be up to 15 minutes old. Each sensor session lasts up to 15 days with an extended 12-hour grace period. The grace period allows additional time for the user to change the sensor at a convenient time.
The proposed Stelo System is based on the same mode of operation and mechanism of reaction as the predicate G7 CGM System (K231081), which uses a wire type sensing mechanism that continuously measures interstitial fluid qlucose levels and a BLE enabled radio transmitter to wirelessly communicate CGM data to compatible display devices at regular 5-minute intervals. These data are also able to be reliably and securely transmitted to other digitally connected devices, excluding insulin pens and Automated Insulin Dosing (AID) systems.
The Stelo System uses the same hardware design as the predicate G7 CGM System. The Stelo GSS firmware is designed to support a factory-calibrated only device (without calibration inputs), to extend the sensor wear duration from 10 to 15 days while maintaining the accuracy of the device, and to connect to authorized display devices only (i.e., Stelo MAS). The Stelo MAS includes a redesigned user interface (UI) tailored to the Stelo System's user population to simplify the use of the device. The UI includes an app onboarding specific to the Stelo MAS design and its intended use, the most recent glucose value and trend graph which are updated every 15 minutes, a narrowed glucose range display from 70 mg/dL, and an "Insights" feature providing the time in range percentage with suggestions to help users improve their time in range. The Ul does not provide any glucose or system alerts.
INTENDED USE/INDICATIONS FOR USE
The Stelo Glucose Biosensor System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, and display glucose values in people 18 years and older not on insulin. The Stelo Glucose Biosensor System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Stelo Glucose Biosensor System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion. The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.
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INDICATIONS FOR USE COMPARISON
The differences between the indications for use of the predicate (G7 CGM System) and subject (Stelo Gluose Biosensor System) devices are not critical to the intended use of the device for managing a disease or condition related to glvcemic control.
TECHNOLOGICAL COMPARISON
The Stelo System shares identical hardware, material, chemical composition, principle of operation and energy source with the predicate device. Design differences between the Stelo Glucose Biosensor System and the predicate device does not constitute a new intended use. The Stelo Glucose Biosensor System is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.
Non-Clinical and/or Clinical Tests Summary and Conclusions
The following supportive performance characteristics were established through nonclinical testing of the predicate device and are applicable to the Stelo Glucose Biosensor System in this 510(k):
- . Biocompatibilitv
- . Chemical/Material Characterization (not Biocompatibility-related)
- Sterilization Validation •
- Electrical and Mechanical Performance •
- . Operating Environmental Conditions Testing
- . Wireless Coexistence
- . Electrical Safety and Electromagnetic Compatibility
- . Packaging Validation
- . Interoperability
The following performance characteristics were verified or validated through studies conducted on the subject device, Stelo Glucose Biosensor System:
- . Electrical and Mechanical Performance (session dependent testing): Performance testing was performed to ensure the device specifications for sensor sensitivity, linearity, and fatigue, as well as wearable battery life and current leakage were met.
- Operating Environmental Conditions Testing: Environmental testing was performed on the Stelo Glucose Biosensor System to ensure the device specifications for operational robustness, operating conditions (evaluation of performance under various operational temperatures and humidity conditions), and chemical robustness (evaluation of performance when subject to soap water) were met.
- Shelf-Life:
Shelf-life testing was performed to evaluate the stability of Stelo Glucose Sensing Subsystem under real time anticipated storage conditions and supported its useful life to be up to 10 months. The test results for the Stelo Glucose Sensing Subsystem met specifications.
6
Human Factors:
Human factors and usability testing of the Stelo Glucose Biosensor System was conducted to determine whether users can appropriately self-identify themselves as appropriate users using the information on the device's pre-purchase labeling and whether the intended user population can safely use the system under representative conditions. Human factors testing was conducted in accordance with:
- . Design considerations for Devices intended for Home Use, Guidance to FDA Staff and Industry, November 24, 2014
- . Applying Human Factors and Usability Engineering to Medical Devices, Guidance to FDA Staff and Industry, February 3, 2016
- IEC 62366-1:2015/AMD 1:2020: Medical devices Part 1: Application of Usability Engineering . to Medical Devices
- . ANSI/AAMI HE75:2009/(R) 2018 – Human Factors Engineer, Design of Medical Devices
The critical, essential and frequently performed tasks were evaluated to demonstrate safe and effective use of the Stelo System and were identified through a use-related risk analysis (URRA), which identified critical tasks solely based on the Severity of harm and included tasks resulting from known-use problems and hazards analysis. An analysis of hazards and risks was conducted on the Stelo Glucose Biosensor System to determine safety risks associated with use of the human factors study support that the general population (lay users) can correctly self-identify themselves as appropriate users and that the intended users can use the Stelo Glucose Biosensor System safely and effectively.
-
. Software Verification and Validation:
Software verification and validation testing was conducted to confirm that the software used in the Stelo Glucose Biosensor System performed in accordance with established specifications, IEC 62304 and FDA Guidance document "Guidance for the Content of Premarket Submissions for Device Software Functions," June 14, 2023. Evaluation activities included code review, unit, system integration, and system level testing which verified functionality of the device against established software requirements. Results of the software executed protocols for the Stelo Glucose Biosensor System are acceptable for their intended use. -
. Cybersecurity:
Dexcom has provided cybersecurity risk management documentation for the Stelo Glucose Biosensor System that includes analysis of confidentiality, integrity, and availability for data, information and software related to the Stelo Glucose Biosensor System in accordance with the FDA Guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (September 27, 2023). For each identified threat and vulnerability risk event scenario, risk assessment of impact to confidentiality, integrity, and availability was performed and documented within the cybersecurity risk management documentation. Appropriate risk mitigation controls have been implemented and tested. In addition, Dexcom has controls and processes in place to ensure continued support for keeping the device secure and to ensure that the device firmware, software and components are malware free. Additional controls are also in manufacturing through distribution to ensure that the medical device firmware and software are malware free from point of origin to the hands of the end user.
A clinical study was conducted to evaluate the safety and effectiveness of the Stelo Glucose Biosensor System. The effectiveness of the device was evaluated with respect to reference venous plasma sample YSI measurements across the measuring range throughout a 15-day wear duration with a 12-hour grace period in
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Dexcom
adult (18 years and older) participants with diabetes. Analysis of the results from the clinical studies show that the subject device meets the iCGM special controls for clinical performance set forth in 21 CFR 862.1355. The safety of the device was evaluated by the incidence of device-related adverse events (AEs) experienced by study subjects. The reported device-related AEs included local irritation (edema), and pain or discomfort. The clinical study demonstrated that the Stelo Glucose Biosensor System is safe and effective for its intended use.
Nonclinical testing results demonstrate that the Stelo Glucose Biosensor System meets pre-defined acceptance criteria and support that the device is acceptable for its intended use. Clinical study results demonstrate that the Stelo Glucose Biosensor System meets the iCGM special controls for clinical performance set forth in 21 CFR 862.1355. The clinical data of the Stelo Glucose Biosensor System were also compared to that of the predicate device to support a substantial equivalence decision.