(184 days)
The Libre Rio Continuous Glucose Monitoring System is an over-the-counter (OTC) integrated continuous glucose monitoring (iCGM) device indicated for non-insulin using persons age 18 and older. The System detects trends and tracks patterns and aids in the detection of euglycemia, and hypoglycemia. The System is also intended to autonomously communicate with digitally connected devices.
The Libre Rio Continuous Glucose Monitoring System (herein referred to as the 'System') is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to facilitate calculation of glucose values accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The System is intended for over-the-counter use in a home setting. The System consists of the following components: a Sensor which transmits via Bluetooth Low Energy (BLE), and a mobile application Libre Rio App that is downloaded to a compatible smartphone running iOS and Android operating system.
Here are the details regarding the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the Libre Rio Continuous Glucose Monitoring System. It primarily focuses on the device's substantial equivalence to a predicate device and summarizes various performance testing categories. The "Reported Device Performance" for each category usually states that acceptance criteria were met, without detailing the specific metrics or thresholds.
However, based on the type of testing mentioned and common practices for CGM devices, we can infer some general areas where acceptance criteria would have been established and reportedly met:
| Area of Performance Testing | Implied Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|---|
| Software Verification & Validation | Adherence to IEC 62304 and FDA guidance for software functions, no critical bugs, software performs as intended. | "Results of executed protocols met the acceptance criteria and therefore support that the System software is acceptable for its intended use." |
| Cybersecurity | Adherence to FDA guidance for cybersecurity in medical devices, identification and mitigation of threat/vulnerability risks, protection of confidentiality, integrity, and availability of data. | "Appropriate risk mitigation controls have been implemented and tested." |
| Interoperability | Compliance with FDA guidance for interoperable medical devices, successful communication with digitally connected devices. | Approach "developed in alignment with FDA guidance," implying successful implementation. |
| Human Factors | Adherence to ANSI/AAMI/IEC 62366, IEC 60601-1-6, and FDA guidance for human factors, demonstrating usability and safety for intended users. | "The analysis and the study performed demonstrated that the changes implemented for the subject device meet the usability requirement for its intended use." |
| Bench Testing (CT, MRI, X-ray compatibility) | Device maintains functionality and accuracy under specific CT, MRI, and X-ray conditions; no adverse effects. | "The test results showed all functionality testing acceptance criteria was met." |
| Biocompatibility, Sterility, Shelf Life, Packaging, Electrical Safety, EMC, Mechanical Design, Clinical Performance | Each established for the predicate device, implying they met relevant standards and criteria. | "The Libre Rio Sensor is identical to the predicate FreeStyle Libre 2 Sensor and no design changes were introduced to allow compatibility to the Libre Rio App. Therefore, the following supportive performance characteristics established for the predicate device (K222447) is applicable to the subject device and is not impacted." These were implicitly met by the predicate and thus deemed met for the subject device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the test sets used in the listed performance tests. It mentions "studies" and "testing" but does not quantify the number of participants or data points.
The data provenance is not explicitly mentioned for the reported tests. However, the study is for the Libre Rio Continuous Glucose Monitoring System, which appears to be a new device (or an updated version) from Abbott Diabetes Care, Inc., located in Alameda, CA, USA. This suggests the data would likely be generated in the USA, and primarily from prospective testing conducted specifically for this submission, especially for areas like human factors, bench testing for new contraindications, and software validation. The clinical performance data is stated to be derived from the predicate device (K222447), which would have its own provenance details.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any of the mentioned test sets. It broadly refers to "studies" and "testing" but does not detail the methodology of ground truth establishment for specific components like software, cybersecurity, or human factors.
4. Adjudication Method for the Test Set
The document does not specify any adjudication methods (e.g., 2+1, 3+1, none) used for establishing ground truth in the performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, the document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is a continuous glucose monitoring system, which typically involves direct measurement and user interaction, not interpretation by multiple human readers of clinical cases. The "Human Factors" testing mentioned focuses on usability and user interface, not on comparative effectiveness with human interpretation of readings.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicit in the description of the device and testing, especially for "Software Verification and Validation" and the "Sensor glucose algorithm," is that standalone algorithm performance testing was conducted. The device's "Sensor glucose algorithm" is stated to be the "ADC Glucose Algorithm established for the predicate device," which would have undergone rigorous standalone validation. The "Libre Rio App" is designed to autonomously receive and display glucose data, suggesting the algorithm operates independently of immediate human intervention for value generation. The bench testing of the sensor's compatibility with CT, MRI, and X-ray would also involve objective measurements without human interpretation in the loop to assess the sensor's function.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for each specific test. However, based on the nature of the device and the tests:
- Clinical Performance (inherited from predicate): For CGM devices, the gold standard for ground truth is typically blood glucose measurements obtained from a laboratory reference method (e.g., YSI analyzer) at various glucose levels.
- Software Verification and Validation: Ground truth would be based on functional specifications and expected outputs for given inputs.
- Cybersecurity: Ground truth involves adherence to security protocols and identified risk mitigations.
- Human Factors: Ground truth is established through user task completion rates, error rates, and subjective feedback against predefined usability goals and safety requirements.
- Bench Testing (CT, MRI, X-ray): Ground truth would be based on physical and electrical performance standards and expected device behavior under specific environmental conditions, potentially using calibrated instruments to verify sensor output accuracy.
8. The Sample Size for the Training Set
The document does not provide information about the sample size for the training set. Given that the sensor glucose algorithm is "ADC Glucose Algorithm established for the predicate device," the training data would be associated with the development of that original algorithm, not necessarily new training for the Libre Rio specifically (unless modifications were made, which is not indicated for the algorithm itself).
9. How the Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for the training set (for the inherited "ADC Glucose Algorithm") was established. For glucose monitoring algorithms, ground truth for training data is typically established through paired comparisons with laboratory reference methods (e.g., YSI blood glucose measurements) across a diverse range of glucose values, patient populations, and physiological conditions.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
June 7, 2024
Abbott Diabetes Care, Inc. Arul Sterlin Director Regulatory Affairs & Program Management 1360 South Loop Road Alameda, California 94502
Re: K233861
Trade/Device Name: Libre Rio Continuous Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter Regulatory Class: Class II Product Code: SBH Dated: December 5, 2023 Received: December 6, 2023
Dear Arul Sterlin:
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).
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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
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Indications for Use
510(k) Number (if known) K233861
Device Name
Libre Rio Continuous Glucose Monitoring System
Indications for Use (Describe)
The Libre Rio Continuous Glucose Monitoring System is an over-the-counter (OTC) integrated continuous glucose monitoring (iCGM) device indicated for non-insulin using persons age 18 and older. The System detects trends and tracks patterns and aids in the detection of euglycemia, and hypoglycemia. The System is also intended to autonomously communicate with digitally connected devices.
Type of Use (Select one or both, as applicable)
| Production Use (Part 21 CFR 211 Subpart D) |
|---|
| Compounding Use (21 CFR 211 Subpart J) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract shape on the left, followed by the text "Abbott" in bold black font on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold black font. The logo is clean and professional, likely used for branding purposes by Abbott Diabetes Care.
510(k) Summary 5.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: New Application
5.1 Submitter:
Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502
Contact: Arul Sterlin Title: Director Regulatory Affairs & Program Management Phone: (510) 219-9737
Date Prepared: June 4, 2024
5.2 Device Names and Classification:
| Name of Device: | Libre Rio Continuous Glucose Monitoring System |
|---|---|
| Common Name: | Integrated continuous glucose monitor for non-intensive glucose management, over-the-counter |
| Regulatory Section: | 21 CFR 862.1355 |
| Classification: | Class II |
| Product Code(s): | SBH |
| Review Panel: | Clinical Chemistry |
5.3 Predicate Device
Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (K222447)
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Image /page/4/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract shape on the left, followed by the text "Abbott" in bold, black letters on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.
Indications for Use 5.4
The Libre Rio Continuous Glucose Monitoring System is an over-the-counter (OTC) integrated continuous glucose monitoring (iCGM) device indicated for non-insulin using persons age 18 and older.
The System detects trends and tracks patterns and aids in the detection of euglycemia, hyperglycemia, and hypoglycemia. The System is also intended to autonomously communicate with digitally connected devices.
Contraindication
Diathermy: Remove all parts of your System before high-frequency electrical heat (diathermy) treatment. The effect of diathermy on the System hasn't been tested. The exposure may damage the Sensor, which could impact proper device function and cause inaccurate readings.
ર્સ્ટ Device Description
The Libre Rio Continuous Glucose Monitoring System (herein referred to as the 'System') is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to facilitate calculation of glucose values accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The System is intended for over-the-counter use in a home setting.
The System consists of the following components: a Sensor which transmits via Bluetooth Low Energy (BLE), and a mobile application Libre Rio App that is downloaded to a compatible smartphone running iOS and Android operating system.
Libre Rio Sensor
- . The Sensor is single use, disposable, and powered by a silver oxide battery. The Sensor is provided through a Sensor Applicator (which includes an electron beam sterilized sub-component) which is used to apply the Sensor to the back of the user's arm. The Sensor continuously measures glucose concentration in interstitial fluid and has an eight (8) hour memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 15 days.
Libre Rio App
- When downloaded to a compatible smartphone, the Libre Rio App uses Near Field Communication (NFC) to start new Sensor and uses Bluetooth Low Energy (BLE) to receive glucose data from the Sensor. The user can view real-time glucose information, trend information, and historical information on the App. As a mobile application, the Libre Rio App allows connectivity with cloud-based applications. The App is distributed using the App Store and Google Play Store and a list of compatible devices is accessible in the App via the Help feature or product website.
The Libre Rio Continuous Glucose Monitoring System is compatible with the Libre Data
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Image /page/5/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue letter "a" on the left, followed by the words "Abbott" and "Diabetes Care" in black text on the right. The word "Abbott" is in a larger, bolder font than "Diabetes Care," which is positioned directly below it.
Sharing API cleared under K223537. The display device of the connected Libre Rio System, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data.
5.6 Substantial Equivalence
The similarities and differences between the subject and the predicate device are highlighted in the tables below.
| Similarities | |||
|---|---|---|---|
| Item | Predicate Device: FreeStyle Libre 2 Flash GlucoseMonitoring System (K222447) | Subject Device: Libre RioContinuous Glucose MonitoringSystem | |
| Intended use | The System is intended to monitor interstitial fluidglucose concentrations and communicate with digitallyconnected devices. | Same | |
| Device type | Integrated CGM | Same | |
| Principle ofoperation | Amperometric measurement of current proportional toglucose concentration in interstitial fluid via glucoseoxidase chemical reaction | Same | |
| Test range | 40 to 400 mg/dL | Same | |
| Clinical setting /sites of use | Home use | Same | |
| Systemcomponents | On-body sensor(User assembles Sensor Applicator and Sensor Packprior to applying the Sensor)Compatible Receiver (App or Reader) | SameOn-body sensor(User assembles Sensor Applicatorand Sensor Pack prior to applyingthe Sensor)Compatible Receiver (App) | |
| Location ofglucosealgorithm | Receiver | Same | |
| Data displayed | Current glucose value, current glucose trend, graphwith recent glucose history, user entered events | Same | |
| Method ofSensoractivation | Near Field Communication (NFC) | Same | |
| Blood glucosemeter (BGM) | While using the App, user must have access to a bloodglucose monitoring system as the App does not provideone | Same | |
| Wirelesscommunicationprotocol | NFC: 13.56 MHz RFIDBluetooth Low Energy (BLE) | Same | |
| BLEcommunicationrange | 20 feet unobstructed | Same | |
| Similarities | |||
| Item | Predicate Device: FreeStyle Libre 2 Flash GlucoseMonitoring System (K222447) | Subject Device: Libre RioContinuous Glucose MonitoringSystem | |
| Method ofcommunicationand connectivitywith cloud-basedapplications | Can communicate wirelessly to LibreView | Same | |
| Sensor glucosealgorithm | ADC Glucose Algorithm established for the predicatedevice | Same | |
| Sensorcalibration | Factory calibrated | Same | |
| CompatibleSensor warmuptime | 1 hour | Same | |
| CompatibleSensor life | Up to 15 days (automatic Sensor shut off) | Same | |
| AnatomicalSensor wearlocations | Back of the upper arm | Same | |
| Sensordimension | 5 mm height / 30 mm diameter | Same | |
| Sensor taildimension | 5.5 mm depth, 0.3 mm width | Same | |
| Sensor powersupply | Silver oxide battery (not replaceable or rechargeable) | Same | |
| Glucose readingupdate interval | Every 1 minute | Same | |
| Vitamin CInteferenceinformation | Users can take up 1000 mg of ascorbic acid (VitaminC) per day and use the Sensor readings to maketreatment decisions | Same | |
| System Alarms | Replace Sensor, Sensor Ended, App Stopped | Same | |
| Scan-basedalerts | Scan Error, Sensor Error, Replace Sensor, SensorEnded, Check Sensor | Same | |
| Method of datatransfer tobackfill data gapafter signal loss | NFC - last 8 hours of historical data transfer uponuser-initiated scan | Same | |
| Glucose trendarrow | ↑, > +2 mg/dL/minノ, +1 to +2 mg/dL/min→, -1 to +1 mg/dL/min↘, -2 to -1 mg/dL/minJ, < -2 mg/dL/min | Same | |
| Similarities | |||
| Item | Predicate Device: FreeStyle Libre 2 Flash GlucoseMonitoring System (K222447) | Subject Device: Libre RioContinuous Glucose MonitoringSystem | |
| Situations wherefingerstick test isrequired toconfirm sensorreading | The user's symptoms do not match the glucose values displayed by the device. The device does not show a glucose value During the first 12 hours of wear during which the check blood glucose icon is displayed | Same | |
| Compatibilitywith connecteddevices | Compatible with digitally connected devices | Same | |
| Compatibleoperatingsystems andhardwareplatform | App is compatible with:iOS operating system and Apple iPhone Android operating system and Android-enabled phone | Same | |
| ApplicationProgrammingInterfaces(APIs) | Enables users to share their glucose data with authorized client software.Can communicate iCGM data wirelessly and securely to and from digitally connected devices (client software) through a cloud-based communication method, the Libre Data Sharing API. | Same |
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Image /page/6/Picture/0 description: The image shows the Abbott Diabetes Care logo. The logo consists of a blue abstract shape on the left and the words "Abbott Diabetes Care" on the right. The word "Abbott" is in bold, while "Diabetes Care" is in a smaller, regular font.
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| Differences | |||
|---|---|---|---|
| Item | Predicate Device: FreeStyle Libre 2Flash Glucose Monitoring System(K222447) | Subject Device: Libre Rio ContinuousGlucose Monitoring System | |
| Indications for use | The FreeStyle Libre 2 Flash GlucoseMonitoring System is a continuousglucose monitoring (CGM) device withreal time alarms capability indicatedfor the management of diabetes inpersons age 2 and older. It is intendedto replace blood glucose testing fordiabetes treatment decisions, unlessotherwise indicated.The System also detects trends andtracks patterns and aids in the detectionof episodes of hyperglycemia andhypoglycemia, facilitating both acuteand long-term therapy adjustments.Interpretation of the System readingsshould be based on the glucose trendsand several sequential readings overtime. | The Libre Rio Continuous GlucoseMonitoring System is an over-the-counter(OTC) integrated continuous glucosemonitoring (iCGM) device indicated for non-insulin using persons age 18 and older.The System detects trends and tracks patternsand aids in the detection of euglycemia,hyperglycemia, and hypoglycemia. TheSystem is also intended to autonomouslycommunicate with digitally connecteddevices. |
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Image /page/8/Picture/7 description: The image contains the logo for Abbott Diabetes Care. On the left is a blue, stylized letter 'a'. To the right of the logo is the text 'Abbott' in bold, black letters, with the text 'Diabetes Care' underneath in a smaller, non-bold font.
| Differences | ||
|---|---|---|
| Item | Predicate Device: FreeStyle Libre 2Flash Glucose Monitoring System(K222447) | Subject Device: Libre Rio ContinuousGlucose Monitoring System |
| The System is also intended toautonomously communicate withdigitally connected devices, includingautomated insulin dosing (AID)systems. The System can be used aloneor in conjunction with these digitallyconnected devices for the purpose ofmanaging diabetes. | ||
| Intended use population | Persons with diabetes age 2 and older | Non-insulin using persons age 18 and older |
| Device use | Prescription use | Over the counter |
| Contraindications againstMRI/diathermy/CT | MRI, Diathermy and CT | Diathermy |
| Caution and warningagainst X-ray | Yes | No |
| Compatible Sensor | FreeStyle Libre 2 Sensor | Libre Rio Sensor |
| Primary display device | FreeStyle Libre 2 Reader or FreeStyleLibre 2 App | Libre Rio App |
| Navigation | Side panel navigation | Bottom bar navigation menu |
| App Stopped alert | iOS only | iOS and Android |
| Optional alarms | Glucose Alarms: Low Glucose Alarm,High Glucose AlarmSystem Alarm: Signal Loss Alarm | Not Applicable |
| Mandatory glucose alarm | Urgent Low Glucose Alarm | Not Applicable |
| Method to displaycurrent glucose resultand trend arrow | BLE for glucose data transfer. User-initiated scan via NFC required todisplay glucose data. | Bluetooth Low Energy (BLE). Dataautomatically transfers and displays glucosedata without user-initiated scan (streamingdata).A user-initiated scan can also be performed todisplay real-time glucose data and historical |
5.7 Comparison of Technological Characteristics with the Predicate Device
Amperometric measurement of glucose concentration (via glucose oxidase chemical reaction) in the interstitial fluid is the technological principle for both the subject and predicate devices. The Sensor is held in place with an adhesive pad and incorporates a subcutaneously implanted sensor component and associated electronics. The electrochemical sensor component uses glucose oxidase enzyme to oxidize glucose and transfer electrons to an electrode, producing a current. The strength of the current is proportional to the amount of glucose present in the subcutaneous space. The electrical current signal is converted a glucose value (in mg/dL) for display to the user on the App.
At a high-level, the subject and predicate devices are based on the following technological
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Image /page/9/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue square with a stylized "a" inside, followed by the words "Abbott" in bold black letters on the top line and "Diabetes Care" in regular black letters on the bottom line. The logo is simple and modern, and the colors are clean and professional.
elements:
- . Compatibility with system-specific Sensor
- Use of NFC interface for starting new Sensors
- Use of BLE interfaces for wireless communication with the Sensor ●
- Use of software algorithm for conversion of the raw glucose measurements from the ● Sensor to calculate glucose results
- Ability to display of glucose results from Sensors after a user-initiated scan via NFC.
- Inclusion of App software interface to wirelessly communicate with cloud-based ● application.
- Libre Data Sharing API to communicate iCGM data with authorized client software for ● specific and permitted use cases in accordance with the cleared intended use environments.
The following major technological differences exist between the subject and predicate devices:
- . The subject device Libre Rio App allows automatic display of glucose results from the Libre Rio Sensor without a user-initiated scan. The predicate FreeStyle Libre 2 App required a user initiated scan to display glucose results.
- The subject device Libre Rio App does not issue glucose alarms or signal loss alarm . whereas the predicate device issues the below listed alarms:
- Optional alarms Low Glucose Alarm, High Glucose Alarm, Signal Loss o Alarm
- Mandatory glucose alarm Urgent Low Glucose Alarm o
- The subject device labeling removes the contraindications against CT scan and MRI. ● The Libre Rio Sensor is labeled MR conditional.
- The subject device labeling removes the caution and warning against X-ray. .
Summary of Performance Testing 5.8
The following performance characteristics were evaluated to support substantial equivalence:
- Software Verification and Validation Software verification and validation testing and ● evaluation was conducted in accordance with IEC 62304 and documentation was provided as recommended by FDA Guidance "Content of Premarket Submissions for Device Software Functions" issued June 14, 2023, and FDA Guidance "Multiple Function Device Products: Policy and Considerations", dated July 29, 2020. Results of executed protocols met the acceptance criteria and therefore support that the System software is acceptable for its intended use.
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- Cybersecurity ADC has provided cybersecurity risk management documentation for ● the System that includes analysis of confidentiality, integrity, and availability for data, information and software related to the System accordance with FDA guidance document, "Cybersecurity in Medical Devices: Ouality System Considerations and Content of Premarket Submissions" issued Sept 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.
- Interoperability - The subject device incorporated an approach for interoperability developed in alignment with FDA guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices" issued September 6, 2017.
- Human Factors ADC conducted a risk analysis of the design and user interface in ● accordance with ANSI/AAMI/IEC 62366, IEC 60601-1-6 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices". The analysis and the study performed demonstrated that the changes implemented for the subject device meet the usability requirement for its intended use.
- Bench Testing - The subject device underwent additional safety and compatibility performance testing for the sensors to support removal of contraindications against computerized tomography (CT) scans, the modification of the magnetic resonance imaging (MRI) contraindication to magnetic resonance (MR) conditional, and the removal of the caution and warning against X-ray. The test results showed all functionality testing acceptance criteria was met.
The Libre Rio Sensor is identical to the predicate FreeStyle Libre 2 Sensor and no design changes were introduced to allow compatibility to the Libre Rio App. Therefore, the following supportive performance characteristics established for the predicate device (K222447) is applicable to the subject device and is not impacted.
- Biocompatiblity ●
- Sterility
- Shelf Life Stability
- Packaging Integrity/Shipping Integrity ●
- Electrical Safety and Electromagnetic Compatibility ●
- Mechanical Design Testing
- Clinical Performance
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Image /page/11/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue abstract shape on the left, followed by the text "Abbott" in bold, black letters. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.
5.9 Conclusion
The Libre Rio Continuous Glucose Monitoring System has the same intended use and clinical application as the predicate device. There are no differences in the technologal characteristics that raise different questions of safety and effectiveness. Based on the performance testing and data provided in this pre-market notification, the subject device and predicate device have been shown to be substantially equivalent.
§ 862.1355 Integrated continuous glucose monitoring system.
(a)
Identification. An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Robust clinical data demonstrating the accuracy of the device in the intended use population.
(ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order (
e.g., an internationally recognized reference material and/or method).(iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device.
(iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period.
(v) Clinical study results in the adult population must meet the following performance requirements:
(A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent.
(B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent.
(C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent.
(D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent.
(E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent.
(H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL.
(I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL.
(J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements.
(K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements.
(vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate.
(vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use.
(2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data.
(3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section.
(4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications.
(5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period.
(6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy.
(7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites (
e.g., abdomen, arm, buttock):(i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL.
(ii) A description of the accuracy of positive and negative rate of change data.
(iii) A description of the frequency and duration of gaps in sensor data.
(iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable.
(v) A description of the observed duration of iCGM life for the device.