Libre Rio Continuous Glucose Monitoring System

K233861 · Abbott Diabetes Care · SBH · Jun 7, 2024 · Clinical Chemistry

Device Facts

• Record ID: K233861
• Device Name: Libre Rio Continuous Glucose Monitoring System
• Applicant: Abbott Diabetes Care
• Product Code: SBH · Clinical Chemistry
• Decision Date: Jun 7, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1355
• Device Class: Class 2

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.

Device Story

System consists of a single-use, disposable, factory-calibrated subcutaneous sensor and a mobile application (Libre Rio App). Sensor measures interstitial fluid glucose via amperometric glucose oxidase reaction; transmits data via Bluetooth Low Energy (BLE) to a smartphone. App displays real-time glucose values, trend arrows, and historical graphs. Used in home settings by patients; no fingerstick calibration required. System autonomously communicates with digitally connected devices via Libre Data Sharing API. Output aids users in tracking glucose patterns and detecting hypo/euglycemia/hyperglycemia. Device is MR conditional; diathermy is contraindicated.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by bench testing, software verification/validation (IEC 62304), cybersecurity risk management, interoperability testing, and human factors/usability engineering (ANSI/AAMI/IEC 62366). Performance characteristics for the sensor (biocompatibility, sterility, shelf life, electrical safety) are leveraged from the predicate device (K222447).

Technological Characteristics

Amperometric glucose oxidase sensor; silver oxide battery; BLE/NFC connectivity. Sensor dimensions: 5mm height, 30mm diameter; tail 5.5mm depth, 0.3mm width. Software: mobile app (iOS/Android). Sterilization: electron beam. Connectivity: cloud-based via Libre Data Sharing API. MR conditional.

Indications for Use

Indicated for non-insulin using persons age 18 and older. Contraindicated for patients on dialysis or who are critically ill. Not for use during diathermy treatment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• FreeStyle Libre 2 Flash Glucose Monitoring System (K222447)

Reference Devices

• Libre Data Sharing API (K223537)

Submission Summary (Full Text)

{0}

FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY AND INSTRUMENT

## I Background Information:

A 510(k) Number

K233861

B Applicant

Abbott Diabetes Care, Inc.

C Proprietary and Established Names

Libre Rio Continuous Glucose Monitoring System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| SBH | Class II | 21 CFR 862.1355 - Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter | CH - Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission:

New Device

B Measurand:

Blood glucose from interstitial fluid.

C Type of Test:

Quantitative, amperometric assay (Glucose Oxidase).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

K233861 - Page 2 of 8

## III Intended Use/Indications for Use:

### A Intended Use(s):
See Indications for Use below.

### B Indication(s) 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.

### C Special Conditions for Use Statement(s):
OTC - Over The Counter

**Contraindication**

**Diathermy:** Remove all parts of your Libre Rio Continuous Glucose Monitoring 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.

Do not use the Libre Rio Continuous Glucose Monitoring System if you are on dialysis or critically ill. It is not known how different conditions or medications common to these populations may affect performance of the System.

Only apply the Libre Rio Continuous Glucose Monitoring System Sensor to the back of the upper arm. If placed in other areas, the Sensor may not function properly.

Taking more than 1000 mg of Vitamin C per day may falsely raise your Libre Rio Continuous Glucose Monitoring System readings. Vitamin C can be found in supplements including multivitamins and cold remedies such as Airborne® and Emergen-C®. See your health care professional to understand how long Vitamin C is active in your body.

### D Special Instrument Requirements:
Not Applicable.

## IV Device/System Characteristics:

### A Device Description:
The Libre Rio Continuous Glucose Monitoring System (herein referred to as the 'Libre Rio System' or '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

{2}

(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. The Libre Rio System is compatible with the Libre Data 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 of the glucose data.

## B Principle of Operation:

The Libre Rio Continuous Glucose Monitoring System uses an electrochemical sensor to monitor glucose levels in the interstitial fluid (ISF). The sensor is held in place with an adhesive pad and incorporates both the subcutaneously implanted sensor and associated electronics. The sensor uses a 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 ISF. The system converts the electrical current signal to a glucose value (in mg/dL) for display to the user on a display device.

## C Instrument Description Information:

1. Instrument Name:
Libre Rio Continuous Glucose Monitoring System

2. Specimen Identification:
Not applicable

3. Specimen Sampling and Handling:
Not applicable

4. Calibration:
The sensor is factory calibrated and does not require calibration from the user/operator.

5. Quality Control:
Not applicable

This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this application, if the product has functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.

K233861 - Page 3 of 8

{3}

V Substantial Equivalence Information:

A Predicate Device Name(s):
FreeStyle Libre 2 Flash Glucose Monitoring System

B Predicate 510(k) Number(s):
K222447

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K233861 | K222447 |
| --- | --- | --- |
| Device Trade Name | Libre Rio Continuous Glucose Monitoring System | FreeStyle Libre 2 Flash Glucose Monitoring System |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The System is intended to monitor interstitial fluid glucose concentrations and communicate with digitally connected devices. | Same |
| Principle of operation | Amperometric measurement of current proportional to glucose concentration in interstitial fluid via glucose oxidase chemical reaction | Same |
| Measuring range | 40 to 400 mg/dL | Same |
| Site of use | Home | Same |
| Sensor calibration | Factory calibrated | Same |
| Sensor hardware | Sensor hardware established for the predicate device | Same |
| App compatibility | iOS and Android | Same |
| Application Programming Interfaces (APIs) | Enables users to share their glucose data with authorized client software.
Can communicate iCGM data wirelessly and securely to and from digitally | Same |

K233861 - Page 4 of 8

{4}

K233861 - Page 5 of 8
| | connected devices
(client software)
through a cloud-based
communication method,
the Libre Data Sharing
API. | |
| --- | --- | --- |
| **General Device Characteristic Differences** | | |
| **Intended use population** | Persons age 18 and
older not on insulin | Persons with diabetes
age 2 and older |
| **Device use** | Over the counter | Prescription use |
| **Glucose alarms** | No mandatory or
optional alarms for low
glucose, high glucose,
or urgent low glucose | Optional Glucose
Alarms: Low Glucose
Alarm, High Glucose
Alarm

Mandatory Glucose
Alarms: Urgent Low
Glucose Alarm |
| **Interoperable with AID systems** | No | Yes |
| **Method to display current glucose result and trend arrow** | Bluetooth Low Energy
(BLE). Data
automatically transfers
and displays glucose
data without user-
initiated scan
(streaming data).
A user-initiated scan
can also be performed
to display real-time
glucose data and
historical data,
consistent with the
predicate App. | BLE for glucose data
transfer. User-initiated
scan via NFC required
to display glucose data. |
| **Contraindications against MRI/diathermy/CT** | Diathermy | MRI, Diathermy and
CT |

{5}

VI Standards/Guidance Documents Referenced:

- 21 CFR 862.1355 (integrated continuous glucose monitoring system (iCGM)) special controls
- ISO14971-2019-12 “Medical Devices-Application of Risk Management to Medical Devices”
- IEC 62304 -“Medical Device Software-Software Life Cycle Processes”
- IEC 60601-1-“Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance”
- AAMI TIR69-“Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems”
- AAMI TIR57: 2016- “Principles for medical device security – Risk management”
- IEC 60601-1-2-“Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests”
- ISO 15223-1-“Medical Device-Symbols to be used with Medical Device Labels, Labeling and Information to be Supplied-Part 1: General Requirements”

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:
Previously established in K222447.

2. Linearity:
See Assay Reportable Range below.

3. Analytical Specificity/Interference:
Previously established in K222447.

4. Assay Reportable Range:
Previously established in K222447.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The FSL2 sensor storage shelf-life of 9 months at 36 to 82 °F within the humidity range of 10 % - 90 % was previously established in K222447.

6. Detection Limit:
Previously established in K222447.

K233861 - Page 6 of 8

{6}

7. Assay Cut-Off:
Previously established in K222447.

8. Accuracy (Instrument):
See comparison studies below.

9. Carry-Over:
Not applicable.

B Comparison Studies:
1. Method Comparison with Predicate Device:
Previously established in K222447.
2. Matrix Comparison:
Not applicable.

C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Previously established in K222447.

D Clinical Cut-Off:
Not applicable.

E Expected Values/Reference Range:
The glucose measurement range of the device is 40 to 400 mg/dL.

K233861 - Page 7 of 8

{7}

K233861 - Page 8 of 8

F Other Supportive Instrument Performance Characteristics Data:

Software Verification and Validation

Software verification and validation testing was conducted in accordance with established specifications and IEC 62304 and documentation was provided as recommended by FDA Guidance “Content of Premarket Submissions for Device Software Functions,” issued June 14, 2023. Results of executed protocols met the acceptance criteria and therefore support that the sensor’s embedded software and the Libre Rio App software are acceptable for its intended use.

Cybersecurity

The sponsor 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 “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” issued September 27, 2023. For each identified threat and vulnerability risk event scenario, risk assessment of impact to confidentiality integrity, and availability was performed and documented within the cybersecurity risk management documentation. Appropriate risk mitigation controls have been implemented and tested.

Human Factors

The user interface of the Libre Rio Continuous Glucose Monitoring System has been found to support that the device is substantially equivalent to the predicate device for the intended users, uses, and use environments.

Bench Testing – MR, CT, X-Ray Compatibility

In k233537, bench testing was performed to support the removal of the contraindications against MRI and CT scans for the FSL2. As the sensor component of the subject device is identical to the FSL2, the subject device is labeled MR conditional, and the warning and caution against CT scans and X-Rays is removed in the subject device.

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.