(184 days)
No
The summary does not mention AI, ML, or related terms, and the description of the device's function (detecting trends, tracking patterns, aiding in detection) does not inherently require AI/ML. The performance studies focus on standard software validation, cybersecurity, interoperability, human factors, and bench/clinical testing, without mentioning AI/ML model performance.
Yes.
The device is intended to aid in the detection of euglycemia and hypoglycemia by detecting trends and tracking patterns, which directly supports a medical purpose.
Yes.
The device is an iCGM (integrated continuous glucose monitoring) device that detects trends and tracks patterns of glucose values and aids in the detection of euglycemia and hypoglycemia, which are diagnostic activities.
No
The device description explicitly states that the system consists of a "Sensor which transmits via Bluetooth Low Energy (BLE), and a mobile application Libre Rio App". The Sensor is a hardware component, making the overall system not software-only.
Based on the provided information, the Libre Rio Continuous Glucose Monitoring System is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the system "detects trends and tracks patterns and aids in the detection of euglycemia, and hypoglycemia." This involves analyzing a biological sample (interstitial fluid, from which glucose is measured) to provide information about a person's health status (glucose levels). This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
- Device Description: The system measures glucose values continuously. Glucose measurement is a common type of in vitro diagnostic test.
- Clinical Performance: The document references clinical performance studies and a predicate device (FreeStyle Libre 2 Flash Glucose Monitoring System), which is also a glucose monitoring system and typically classified as an IVD.
While the document doesn't explicitly use the term "IVD," the function and intended use of the device clearly fall under the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
SBH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Back of the upper arm
Indicated Patient Age Range
age 18 and older
Intended User / Care Setting
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)
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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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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).
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) 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 Glucose | ||
| Monitoring System (K222447) | Subject Device: Libre Rio | ||
| Continuous Glucose Monitoring | |||
| System | |||
| Intended use | The System is intended to monitor interstitial fluid | ||
| glucose concentrations and communicate with digitally | |||
| connected devices. | Same | ||
| Device type | Integrated CGM | Same | |
| Principle of | |||
| operation | Amperometric measurement of current proportional to | ||
| glucose concentration in interstitial fluid via glucose | |||
| oxidase chemical reaction | Same | ||
| Test range | 40 to 400 mg/dL | Same | |
| Clinical setting / | |||
| sites of use | Home use | Same | |
| System | |||
| components | On-body sensor | ||
| (User assembles Sensor Applicator and Sensor Pack | |||
| prior to applying the Sensor) | |||
| Compatible Receiver (App or Reader) | Same | ||
| On-body sensor | |||
| (User assembles Sensor Applicator | |||
| and Sensor Pack prior to applying | |||
| the Sensor) | |||
| Compatible Receiver (App) | |||
| Location of | |||
| glucose | |||
| algorithm | Receiver | Same | |
| Data displayed | Current glucose value, current glucose trend, graph | ||
| with recent glucose history, user entered events | Same | ||
| Method of | |||
| Sensor | |||
| activation | Near Field Communication (NFC) | Same | |
| Blood glucose | |||
| meter (BGM) | While using the App, user must have access to a blood | ||
| glucose monitoring system as the App does not provide | |||
| one | Same | ||
| Wireless | |||
| communication | |||
| protocol | NFC: 13.56 MHz RFID | ||
| Bluetooth Low Energy (BLE) | Same | ||
| BLE | |||
| communication | |||
| range | 20 feet unobstructed | Same | |
| Similarities | |||
| Item | Predicate Device: FreeStyle Libre 2 Flash Glucose | ||
| Monitoring System (K222447) | Subject Device: Libre Rio | ||
| Continuous Glucose Monitoring | |||
| System | |||
| Method of | |||
| communication | |||
| and connectivity | |||
| with cloud- | |||
| based | |||
| applications | Can communicate wirelessly to LibreView | Same | |
| Sensor glucose | |||
| algorithm | ADC Glucose Algorithm established for the predicate | ||
| device | Same | ||
| Sensor | |||
| calibration | Factory calibrated | Same | |
| Compatible | |||
| Sensor warmup | |||
| time | 1 hour | Same | |
| Compatible | |||
| Sensor life | Up to 15 days (automatic Sensor shut off) | Same | |
| Anatomical | |||
| Sensor wear | |||
| locations | Back of the upper arm | Same | |
| Sensor | |||
| dimension | 5 mm height / 30 mm diameter | Same | |
| Sensor tail | |||
| dimension | 5.5 mm depth, 0.3 mm width | Same | |
| Sensor power | |||
| supply | Silver oxide battery (not replaceable or rechargeable) | Same | |
| Glucose reading | |||
| update interval | Every 1 minute | Same | |
| Vitamin C | |||
| Inteference | |||
| information | Users can take up 1000 mg of ascorbic acid (Vitamin | ||
| C) per day and use the Sensor readings to make | |||
| treatment decisions | Same | ||
| System Alarms | Replace Sensor, Sensor Ended, App Stopped | Same | |
| Scan-based | |||
| alerts | Scan Error, Sensor Error, Replace Sensor, Sensor | ||
| Ended, Check Sensor | Same | ||
| Method of data | |||
| transfer to | |||
| backfill data gap | |||
| after signal loss | NFC - last 8 hours of historical data transfer upon | ||
| user-initiated scan | Same | ||
| Glucose trend | |||
| arrow | ↑, > +2 mg/dL/min | ||
| ノ, +1 to +2 mg/dL/min | |||
| →, -1 to +1 mg/dL/min | |||
| ↘, -2 to -1 mg/dL/min | |||
| J, |