(65 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data display and analysis without mentioning AI/ML algorithms.
No.
The device is a glucose monitoring system that provides information to help users understand their glucose levels and how lifestyle impacts them, but it explicitly states that the user is "not intended to take medical action based on the device output without consultation with a qualified healthcare professional," indicating it is for informational purposes rather than direct therapeutic intervention.
Yes
The device is intended to continuously measure, record, analyze, and display glucose values in people, and helps to detect normal and low or high glucose levels, which are functions of a diagnostic device.
Yes
The device is described as a "mobile device application" that receives data from an external iCGM sensor. The description focuses solely on the software's function of receiving, displaying, and analyzing this data. The performance studies listed are software testing, cybersecurity testing, and usability/human factors, all of which are relevant to a software-only device. There is no mention of hardware components or hardware-specific testing for the Signos system itself, only its interaction with the separate iCGM hardware.
Yes, based on the provided information, the Signos Glucose Monitoring System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to "continuously measure, record, analyze, and display glucose values". Glucose measurement is a diagnostic test performed on a biological sample (in this case, interstitial fluid via the iCGM sensor).
- Nature of the Measurement: It is measuring a physiological parameter (glucose) in a biological fluid, which is a hallmark of in vitro diagnostics.
- Comparison to Predicate: The predicate device, the Stelo Glucose Biosensor System (K234070), is also an iCGM system, which are typically classified as IVDs.
While the device also provides information for lifestyle and behavior modification, its core function is the measurement and display of glucose values, which falls under the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Signos Glucose Monitoring System is an over-the-counter (OTC) mobile device application that receives data from an integrated Continuous Glucose Monitor (iCGM) sensor and is intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Signos Glucose Monitoring System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Signos Glucose Monitoring System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursions. This information may be useful in helping users to maintain a healthy weight.
The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.
Product codes
SAF
Device Description
The Signos Glucose Monitoring System is a mobile device application that is paired, via Bluetooth®, with an over-the-counter interoperable continuous glucose monitor (iCGM). The application functions as a primary display for the iCGM by showing the user's glucose reading along with a historic trend every 15 minutes. The system is capable of backfilling missed data and supporting a grace period dictated by the iCGM.
The system's various displays, text, graphs, suggestions, and notifications serve to clearly illustrate the user's past and present glucose readings and their trend direction to assist the user in maintaining a euglycemic state.
The glucose display range is 70 mg/dL to 250 mg/dL.
The Signos System is intended for users over the age of 18 not on insulin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
Over-the-counter use / Home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Testing
Verification testing was conducted to demonstrate that the Signos Glucose Monitoring System functions in a manner consistent with the design inputs. This evaluation demonstrated that the software requirements have been verified and that the data displayed by the Signos Glucose Monitoring System is the same as that which is transmitted by the biosensor and is therefore substantially equivalent to the predicate.
Cybersecurity Testing
A study was conducted to demonstrate that the Signos Glucose Monitoring System was designed and engineered to meet all cybersecurity requirements. This study demonstrated that no unacceptable cybersecurity risks remain for the use of this device.
Usability / Human Factors
A study was conducted to demonstrate that the Signos Glucose Monitoring System user interface was designed and engineered such that use errors that occur during use of the device that could cause harm or degrade device performance are either eliminated or reduced to acceptable levels. This study demonstrated that no unacceptable human factors risks remain for the use of this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
March 21, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, 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.
Signos, Inc. Trevor Denbo VP, Regulatory Affairs and Quality Assurance 30011 Ivy Glenn Drive, Suite 107 Laguna Niguel, California 92677
Re: K250106
Trade/Device Name: Signos Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: SAF Dated: January 13, 2025 Received: January 15, 2025
Dear Trevor Denbo:
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
2
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 OS 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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
2
For comprehensive regulatory information about medical devices and radiation-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,
Image /page/2/Picture/3 description: The image shows the text "Joshua Balsam -S" in a large, sans-serif font. The text is black and appears to be centered. The background is a light blue color, with a faint watermark-like design.
Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K250106
Device Name Signos Glucose Monitoring System
Indications for Use (Describe)
The Signos Glucose Monitoring System is an over-the-counter (OTC) mobile device application that receives data from an integrated Continuous Glucose Monitor (iCGM) sensor and is intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Signos Glucose Monitoring System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Signos Glucose Monitoring System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursions. This information may be useful in helping users to maintain a healthy weight.
The user is not intended to take medical action based on the device output without consultation with a qualified healtheare professional.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the word "SIGNOS" in a sans-serif font. The letters are a dark blue color. The word is horizontally oriented and centered in the image.
Image /page/4/Picture/1 description: The image contains a stylized, circular symbol. The symbol is composed of two curved lines that resemble the letter 'S' or two interlocking hooks. The lines are thick and have a dark blue color. The symbol is enclosed within a dotted circle, which gives it a sense of containment or focus. The background is plain white.
510(k) Summary Prepared: January 14, 2025
| I. | Company | Signos, Inc.
30011 Ivy Glenn Drive, Suite 107
Laguna Niguel, CA 92677 |
|-------|-----------------------------|---------------------------------------------------------------------------------|
| II. | Contact | Trevor J. Denbo
VP, Regulatory Affairs and Quality Assurance
949-424-7607 |
| III. | Product Trade Name | Signos Glucose Monitoring System |
| IV. | Common Name | Glucose Monitoring System |
| V. | Classification Name | Integrated continuous glucose monitoring
system |
| VI. | Regulation Number | 21 CFR 862.1355 |
| VII. | Device Class | Class II |
| VIII. | Classification Product Code | SAF |
| IX. | Predicate Device | K234070, Stelo Glucose Biosensor System |
X. Description
The Signos Glucose Monitoring System is a mobile device application that is paired, via Bluetooth®, with an over-the-counter interoperable continuous glucose monitor (iCGM). The application functions as a primary display for the iCGM by showing the user's glucose reading along with a historic trend every 15 minutes. The system is capable of backfilling missed data and supporting a grace period dictated by the iCGM.
The system's various displays, text, graphs, suggestions, and notifications serve to clearly illustrate the user's past and present glucose readings and their trend direction to assist the user in maintaining a euglycemic state.
The glucose display range is 70 mg/dL to 250 mg/dL.
The Signos System is intended for users over the age of 18 not on insulin.
5
Image /page/5/Picture/0 description: The image shows a white circle with a symbol inside. The symbol is a stylized letter 'S' or two curved arrows facing each other. The symbol is dark blue and appears to be centered within the circle. The circle has a dotted outline.
XI. Indications for Use
The Signos Glucose Monitoring System is an over-the-counter (OTC) mobile device application that receives data from an integrated Continuous Glucose Monitor (iCGM) sensor and is intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Signos Glucose Monitoring System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Signos Glucose Monitoring System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursions. This information may be useful in helping users to maintain a healthy weight.
The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.
XII. Summary of the Technological Characteristics
The fundamental scientific technology, materials of construction, processing methods and mechanism of operation are the same between the subject and predicate devices. Both devices are provided as software systems, designed to display interstitial fluid glucose sensor data and assist the user in understanding how lifestyle and behavior modification, including diet and exercise, impact glucose excursion these levels. The predicate also includes the iCGM, which is the same iCGM used with the subject device. The table below summarizes the comparison of technological characteristics between the subject and predicate devices.
| | Stelo Glucose Biosensor System
(K234070) | Signos Glucose Monitoring System
(Subject Device) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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. | The Signos Glucose Monitoring System is an
over-the-counter (OTC) mobile device
application that receives data from an
integrated Continuous Glucose Monitor
(iCGM) sensor and is intended to
continuously measure, record, analyze, and
display glucose values in people 18 years
and older not on insulin. The Signos Glucose
Monitoring System helps to detect normal
(euglycemic) and low or high (dysglycemic)
glucose levels. The Signos Glucose
Monitoring System may also help the user
better understand how lifestyle and
behavior modification, including diet and
exercise, impact glucose excursions. This
information may be useful in helping users
to maintain a healthy weight.
The user is not intended to take medical
action based on the device output without
consultation with a qualified healthcare
professional. |
| Regulation | 21 CFR 862.1355 | Same |
| Device Class | II | Same |
| Device Code | SAF | Same |
6
| Panel | CH - Clinical Chemistry | Same |
|---|---|---|
| Use Setting | Home use | Same |
| Intended Use | Persons who are not on insulin therapy | |
| age 18 years and older | Same | |
| Software Design | Mobile device application | Same |
| Sensor | Included in clearance. | Not included in clearance. |
| Uses same sensor as cleared in predicate. | ||
| Principle of operation | Mobile device application displaying data | |
| and biosensor: (Amperometric | ||
| measurement of current | ||
| proportional to glucose concentration in | ||
| interstitial) | ||
| fluid via glucose oxidase chemical | ||
| reaction | Mobile device application displaying data | |
| Uses same sensor as cleared in predicate. | ||
| Type of Use | Over-the-counter use | Same |
| Sensor Calibration | ||
| with Application | No | Same |
| Mobile | ||
| Application Host | ||
| Hardware | Android or iOS based mobile device | Same |
| Displayed Range | 70-250 mg/dL | Same |
| Display Device | ||
| Update Interval | Every 15 minutes | Same |
| Glucose Alerts and | ||
| Alarms | Same | |
| Notifications | Various notifications to spur glucose | |
| awareness | Same |
XIII. Discussion of Differences
Indications for Use Comparison
The predicate states that the device "is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended...," while the subject device inserts the words "mobile device application that receives data from an" and "sensor and is" to make the statement read as "is an over-the-counter (OTC) mobile device application that receives data from an integrated Continuous Glucose Monitor (iCGM) sensor and is intended... . " Both the predicate device and the subject device include a mobile device application to display glucose. The predicate includes the iCGM while the subject device is interoperable with that iCGM as an alternative display. The addition of these words to the indications was made to precisely describe the Signos Glucose Monitoring System as the application which uses the iCGM, as opposed to the iCGM itself. The difference is not critical to the intended therapeutic use of the device and does not raise different questions of safety and effectiveness of the device when used as labeled. The predicate also uses a mobile application, and both devices use the iCGM. The intended use of the predicate and the subject device remains in helping "to detect" and "understand" glycemic control.
7
The indications for the Signos Glucose Monitoring System include the statement "this information may be useful in helping users to maintain a healthy weight." The difference is not critical to the intended therapeutic use of the device and does not raise different questions of safety and effectiveness of the device when used as labeled. This is because this change does not change the general function and intent of the device, which is to track and trend glucose data. The intended therapeutic outcome of helping "to detect" and "understand" glycemic control, as found in the predicate indications, is good health which includes a healthy weight.
Numerous studies have demonstrated the association between glucose management and weight management.
XIV. Discussion of the Non-Clinical Testing
Software Testing
Verification testing was conducted to demonstrate that the Signos Glucose Monitoring System functions in a manner consistent with the design inputs. This evaluation demonstrated that the software requirements have been verified and that the data displayed by the Signos Glucose Monitoring System is the same as that which is transmitted by the biosensor and is therefore substantially equivalent to the predicate.
Cybersecurity Testing
A study was conducted to demonstrate that the Signos Glucose Monitoring System was designed and engineered to meet all cybersecurity requirements. This study demonstrated that no unacceptable cybersecurity risks remain for the use of this device.
Usability / Human Factors
A study was conducted to demonstrate that the Signos Glucose Monitoring System user interface was designed and engineered such that use errors that occur during use of the device that could cause harm or degrade device performance are either eliminated or reduced to acceptable levels. This study demonstrated that no unacceptable human factors risks remain for the use of this device.