(190 days)
No
The summary describes standard continuous glucose monitoring technology and performance metrics without mentioning AI or ML.
Yes.
The device is indicated for the management of diabetes and is intended to replace blood glucose testing for treatment decisions, facilitating both acute and long-term therapy adjustments for hyperglycemia and hypoglycemia.
Yes
The device is intended for the management of diabetes, including detecting trends, tracking patterns, and aiding in the detection of hyperglycemia and hypoglycemia, which are all diagnostic functions for managing a medical condition. It also states its purpose is to "replace blood glucose testing for diabetes treatment decisions," implying a diagnostic role.
No
The device description explicitly states the system consists of two primary components: a sensor (hardware) and a display device (Reader, also hardware). While software is involved in processing and displaying data, the system relies on physical hardware components for glucose measurement and transmission.
Yes, the FreeStyle Libre 2 Flash Glucose Monitoring System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that it is a "continuous glucose monitoring (CGM) device... indicated for the management of diabetes". It is also intended to "replace blood glucose testing for diabetes treatment decisions". These are diagnostic purposes related to a medical condition (diabetes).
- Measurement: The device measures glucose levels, which is a biological marker used in the diagnosis and management of diabetes.
- Sample Type: While the description doesn't explicitly state the sample type in the "Device Description" section, the context of a continuous glucose monitor and the comparison to blood glucose testing (SMBG) and YSI (which measures glucose in biological fluids) strongly indicates that it is measuring glucose in interstitial fluid, which is a biological sample.
- Clinical Studies: The detailed description of clinical studies evaluating the accuracy of the device by comparing its readings to reference glucose values (YSI and SMBG) further supports its classification as a diagnostic device. These studies are designed to demonstrate the performance of the device in providing clinically relevant diagnostic information.
Therefore, based on its intended use, the type of measurement it performs, and the nature of the clinical studies conducted, the FreeStyle Libre 2 Flash Glucose Monitoring System fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.
Product codes (comma separated list FDA assigned to the subject device)
QLG, NBW
Device Description
The FreeStyle Libre 2 Flash Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 2 System or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. The FreeStyle Libre 2 System consists of two primary components: a sensor that transmits via Bluetooth Low Energy (BLE), and a BLE enabled display device (Reader). User-initiated RFID scanning provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may use the sensor glucose results and information provided by the System in making treatment decisions. The System also provides configurable alerts and alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.
FreeStyle Libre 2 Sensor
- The Sensor is single use and disposable. The Sensor is provided as two secondary components, Sensor Applicator and Sensor Pack (sterile device), which are used to assemble and apply the Sensor to the back of the user's arm. During Sensor application, the sensor tail is inserted about 5.5 millimeters below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion. The Sensor continuously measures glucose concentration in interstitial fluid every minute and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 14 days.
FreeStyle Libre 2 Reader
- The Reader is a small handheld device that uses RFID communication to start new sensors, to scan sensors to display and record data and uses BLE communication to issue alarms that notify the user when glucose values pass high or low thresholds, when enabled. The Reader also includes a built-in strip port with blood glucose functionality as a convenience for users (which is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.
The FreeStyle Libre 2 System is an interoperable connected device that can communicate glucose readings and other information wirelessly and from interoperable electronic interfaces. This system is not compatible with AID systems, including insulin suspend systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Back of the upper arm
Indicated Patient Age Range
4 and older
Intended User / Care Setting
Home use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
To demonstrate the accuracy performance of the FreeStyle Libre 2 Flash Glucose Monitoring System, two prospective clinical studies (Study 1, adult: Study 2, pediatric) were conducted at five and four centers, respectively. All study centers were located in the United States.
Study 1 enrolled 146 adult subjects with diabetes. Of these, 91.1% were diagnosed with Type 1 diabetes, while 8.9% were diagnosed with Type 2 diabetes. All subjects required insulin to manage their diabetes. Subjects wore 2 sensors for up to 14 days. Subjects took part in up to three ten-hour clinical sessions. Clinic sessions for each subject took place during four distinct periods: days 1, 2 and 3; days 9 and 12, and days 13 and 14. During each clinic session, each subject's glucose was manipulated to achieve sustained periods of either hypoglycemia or hyperglycemia, or both.
Study 2 enrolled 139 pediatric subjects with diabetes. Of these, 98.6% were diagnosed with Type 1 diabetes, while 1.4% with Type 2 diabetes. All subjects required insulin to manage their diabetes. Subjects wore 2 sensors for up to 14 days. Subjects age six and older took part in up to two eight-hour clinical sessions. No YSI comparator measurements were obtained for subjects 4-5 years of age, and performance for these subjects was compared against self-monitoring blood glucose (SMBG) tests. Clinic sessions for each subject took place during four distinct periods: days 1, 2 and 3; days 7 and 8; days 9 and 12, and days 13 and 14. During each clinic session, each subject's glucose was manipulated to achieve sustained periods of either hypoglycemia or hyperglycemia, or both.
In Study 1 and Study 2, accuracy of the FreeStyle Libre 2 Flash Glucose Monitoring System was evaluated by comparing iCGM glucose values to reference glucose values. Glucose values were obtained from the system and from the comparator at the same or similar time. In both studies, absolute differences in mg/dL of values compared to the comparator method were calculated for all values below 70 mg/dL. For values of 70 mg/dL and above, percentage differences compared to the comparator method were calculated.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Performance Testing
Analytical Performance
a. Reproducibility/Precision
iCGM performance was evaluated in clinical studies described below in Section 1.7.3. In Study 1, all subjects wore two sensors concurrently, one on the back of each upper arm, to evaluate device precision. A total of 26,791 paired readings from 146 subjects were evaluated. Mean coefficient of variation (Mean %CV) was 5.7%.
In Study 2, all subjects wore two sensors concurrently, one on the back of each upper arm, to evaluate device precision. For pediatric age 4-5, a total of 248 paired readings from 7 subjects were evaluated; mean coefficient of variation (Mean %CV) was 4.8%. For pediatric age 6-17, a total of 10,623 paired readings from 130 subjects were evaluated; mean %CV was 5.8%.
b. Linearity/Assay Reportable Range
The reportable range for the FreeStyle Libre 2 System is 40 to 400 mg/dL.
c. Traceability, Stability, Expected Values (Control, Calibrators, or Methods)
The FreeStyle Libre 2 sensor has a storage life of 9 months. Shelf-life was evaluated at 36° -82° Fahrenheit within the humidity range of 10% - 90%.
d. Detection Limit
If a glucose measurement is less than 40 mg/dL, the result will be displayed by the system as 'LO'. If the glucose measurement exceeds 400 mg/dL, the result will be displayed as 'HI'. Data supporting this claimed measurement range was generated in the clinical study described in Section 1.7.3 below.
e. Analytical Specificity
A clinical study was conducted to evaluate ascorbic acid interference for the FreeStyle Libre 2 System. It is a prospective, multi-center, single-arm study that enrolled 60 subjects at 4 sites. The study was designed to evaluate performance of the System in people with diabetes (age 18 and older) taking ascorbic acid. Each subject wore two sensors, one on the back of each upper arm, for a period of up to 10 days. Accuracy performance of the System was assessed by the mean difference (mg/dL) between GM and YSI readings pre and post- ascorbic acid doses. The results show that the maximum bias was observed at around 3 hours after the intake of each dose of vitamin C, with a maximum average bias of 9.3 mg/dL after the first 1000 mg dose. The maximum average biases were 18.4 mg/dL and 19.7 mg/dL after the second and third doses respectively.
Clinical Studies
Two prospective clinical studies (Study 1, adult: Study 2, pediatric) were conducted.
Study 1 enrolled 146 adult subjects with diabetes. Study 2 enrolled 139 pediatric subjects with diabetes.
Accuracy was evaluated by comparing iCGM glucose values to reference glucose values (YSI measurement or SMBG measurements for children 4-5 years of age).
Key results:
- Percent and Point Accuracy by iCGM Glucose Range (Study 1, Adult):
- 180 mg/dL: 91.5% within 15%, 100.0% within 40%.
- Percent and Point Accuracy by iCGM Glucose Range (Study 2, Pediatric):*
- 180 mg/dL: 87.3% within 15%, 99.7% within 40%.
- Percent of iCGM values within 20% of YSI reference:
- Adult (18 years and up): 90.2%
- Pediatric (6-17 years): 90.3%
- Pediatric (4-5 years): 85.4%
Trend Accuracy (Concurrence Analysis by Glucose Rate of Change):
- Study 1, Adult: Highest concurrence is on the diagonal, indicating good agreement between CGM and YSI glucose rate of change. For example, for CGM rate of change 2 mg/dL/min, 49.0% of YSI values were also >2 mg/dL/min.
- Study 2, Pediatric: Similar to adult study, highest concurrence on the diagonal. For example, for CGM rate of change 2 mg/dL/min, 50.2% of YSI values were also >2 mg/dL/min.
Agreement When iCGM Reads 'LO' or 'HI'
- 'LO' CGM Reading (Study 1: Adult): Of 5 instances where CGM read 'LO', 20.0% of YSI values were 350 mg/dL, and 100.0% were >300 mg/dL and >250 mg/dL.
- 'HI' CGM Reading (Study 2: Pediatric):* Of 45 instances where CGM read 'HI', 88.9% of YSI values were >350 mg/dL, 95.6% were >300 mg/dL, and 100.0% were >250 mg/dL.
Alarm Performance (Low Glucose Alarm):
- Adult: For a 70 mg/dL alarm level, True Alarm Rate was 86.0%, False Alarm Rate was 14.0%. Correct Detection Rate was 89.3%, Missed Detection Rate was 10.7%.
- Pediatric: For a 70 mg/dL alarm level, True Alarm Rate was 80.3%, False Alarm Rate was 19.7%. Correct Detection Rate was 93.5%, Missed Detection Rate was 6.5%.
Alarm Performance (High Glucose Alarm):
- Adult: For a 200 mg/dL alarm level, True Alarm Rate was 99.2%, False Alarm Rate was 0.8%. Correct Detection Rate was 97.1%, Missed Detection Rate was 2.9%.
- Pediatric: For a 200 mg/dL alarm level, True Alarm Rate was 98.0%, False Alarm Rate was 2.0%. Correct Detection Rate was 98.0%, Missed Detection Rate was 2.0%.
Sensor Stability:
The mean of the absolute relative differences (MARD) was evaluated over the 14-day life of the sensor.
- Adult: MARD ranged from 8.5% (Early Middle) to 9.9% (Beginning).
- Pediatric: MARD ranged from 8.0% (Early Middle) to 10.7% (Beginning).
Sensor Life:
- Adult Study: 71.1% of sensors lasted until the final day of use (14 days). 4.1% experienced "early sensor shut-off".
- Pediatric Study: 78.1% of sensors lasted until the final day of use (14 days). 2.2% experienced "early sensor shut-off".
Glucose Reading Availability (Capture Rate):
- Adult Study: Capture rate ranged from 98.1% to 98.6% across the 14 days of wear.
- Pediatric Study: Capture rate ranged from 94.6% to 96.0% across the 14 days of wear.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Reproducibility/Precision: Mean Coefficient of Variation (Mean %CV)
- Adults (18+): 5.7%
- Pediatric 4-5 years: 4.8%
- Pediatric 6-17 years: 5.8%
- Accuracy:
- Percent within 15 mg/dL / 15% and 40 mg/dL / 40% (for glucose ranges 180 mg/dL)
- Percent within 20% compared to YSI reference (Adult: 90.2%, Pediatric 6-17: 90.3%, Pediatric 4-5: 85.4%)
- Mean
- MARD (Mean Absolute Relative Difference)
- Alarm Performance:
- True Alarm Rate (TAR)
- False Alarm Rate (FAR)
- Correct Detection Rate (CDR)
- Missed Detection Rate (MDR)
- Sensor Stability: Mean Absolute Relative Difference (MARD) over wear duration
- Sensor Life: Sensor Survival Rate (%)
- Glucose Reading Availability: Capture Rate (%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1355 Integrated continuous glucose monitoring system.
(a)
Identification. An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Robust clinical data demonstrating the accuracy of the device in the intended use population.
(ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order (
e.g., an internationally recognized reference material and/or method).(iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device.
(iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period.
(v) Clinical study results in the adult population must meet the following performance requirements:
(A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent.
(B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent.
(C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent.
(D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent.
(E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent.
(H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL.
(I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL.
(J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements.
(K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements.
(vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate.
(vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use.
(2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data.
(3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section.
(4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications.
(5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period.
(6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy.
(7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites (
e.g., abdomen, arm, buttock):(i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL.
(ii) A description of the accuracy of positive and negative rate of change data.
(iii) A description of the frequency and duration of gaps in sensor data.
(iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable.
(v) A description of the observed duration of iCGM life for the device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 12, 2020
Abbott Diabetes Care Inc. Naveen Thuramalla DVP, Quality Assurance and Regulatory Affairs 1360 South Loop Road Alameda, CA 94502
Re: K193371
Trade/Device Name: FreeStyle Libre 2 Flash Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: QLG, NBW Dated: May 8, 2020 Received: May 11, 2020
Dear Naveen Thuramalla:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193371
Device Name
FreeStyle Libre 2 Flash Glucose Monitoring System
Indications for Use (Describe)
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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1. 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K193371
1.1 Submitter:
Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502
Contact: Naveen Thuramalla Title: DVP Quality Assurance and Regulatory Affairs Phone: 510-239-2618 Fax: (510) 864-4791 Email: naveen.thuramalla@abbott.com
1.2 Device Names and Classification:
| Name of Device: | FreeStyle Libre 2 Flash Glucose Monitoring System |
|---|---|
| Common Name: | Integrated Continuous Glucose Monitoring System, Factory |
| Calibrated, Not for use with automated insulin delivery systems | |
| Regulatory Section: | 21 CFR 862.1355, 21 CFR 862.1345 |
| Classification: | Class II |
| Product Code(s): | QLG, NBW |
| Review Panel: | Clinical Chemistry |
1.3 Predicate Device
Dexcom G6 Continuous Glucose Monitoring System, DEN170088 Predicate Device:
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Image /page/4/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue "a" 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.
1.4 Indications for Use:
Indications for Use:
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.
Contraindications
- Automated Insulin Delivery: The System must not be used with automated insulin ● dosing (AID) systems, including closed loop and insulin suspend systems.
- MRI/CT/Diathermy: The System must be removed prior to Magnetic Resonance ● Imaging (MRI). Computed Tomography (CT) scan. or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.
1.5 Device Description
The FreeStyle Libre 2 Flash Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 2 System or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. The FreeStyle Libre 2 System consists of two primary components: a sensor that transmits via Bluetooth Low Energy (BLE), and a BLE enabled display device (Reader). User-initiated RFID scanning provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may use the sensor glucose results and information provided by the System in making treatment decisions. The System also provides configurable alerts and alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.
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Image /page/5/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue stylized letter "a" on the left, followed by the text "Abbott" in bold, black font on the top line, and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is clean and professional, conveying a sense of trust and reliability.
FreeStyle Libre 2 Sensor
- The Sensor is single use and disposable. The Sensor is provided as two secondary components, Sensor Applicator and Sensor Pack (sterile device), which are used to assemble and apply the Sensor to the back of the user's arm. During Sensor application, the sensor tail is inserted about 5.5 millimeters below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion. The Sensor continuously measures glucose concentration in interstitial fluid every minute and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 14 days.
FreeStyle Libre 2 Reader
- The Reader is a small handheld device that uses RFID communication to start new ● sensors, to scan sensors to display and record data and uses BLE communication to issue alarms that notify the user when glucose values pass high or low thresholds, when enabled. The Reader also includes a built-in strip port with blood glucose functionality as a convenience for users (which is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.
The FreeStyle Libre 2 System is an interoperable connected device that can communicate glucose readings and other information wirelessly and from interoperable electronic interfaces. This system is not compatible with AID systems, including insulin suspend systems.
Test Principle 1.5.1
The FreeStyle Libre 2 Flash 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 a metal electrode, producing a current. The strength of the current is proportional to the amount of glucose present in the subcutaneous space. The FreeStyle Libre 2 System converts the electrical current signal to a glucose value (in mg/dL) for display to the user on the handheld Reader.
Substantial Equivalence 1.6
A. Predicate Device Name:
Dexcom G6 Continuous Glucose Monitoring System
B. Predicate 510(k) Number(s):
C. Comparison with Predicate:
6
The similarities and differences between the FreeStyle Libre 2 Flash Glucose Monitoring System and the predicate device, Dexcom G6 (DEN170088) are highlighted in the tables below:
| Similarities | ||
|---|---|---|
| Item | FreeStyle Libre 2 Flash | |
| Glucose Monitoring System | Dexcom G6 Continuous | |
| Glucose Monitoring System | ||
| (DEN170088) | ||
| Indications for Use | The FreeStyle Libre 2 Flash | |
| Glucose Monitoring System is a | ||
| continuous glucose monitoring | ||
| (CGM) device with real time | ||
| alarms capability indicated for | ||
| the management of diabetes in | ||
| persons age 4 and older. It is | ||
| intended to replace blood | ||
| glucose testing for diabetes | ||
| treatment decisions, unless | ||
| otherwise indicated. | ||
| The System also detects trends | ||
| and tracks patterns and aids in | ||
| the detection of episodes of | ||
| hyperglycemia and | ||
| hypoglycemia, facilitating both | ||
| acute and long-term therapy | ||
| adjustments. Interpretation of | ||
| the System readings should be | ||
| based on the glucose trends and | ||
| several sequential readings over | ||
| time. | ||
| The System is also intended to | ||
| autonomously communicate with digitally connected | ||
| devices. The System can be | ||
| used alone or in conjunction | ||
| with these digitally connected | ||
| devices where the user manually | ||
| controls actions for therapy | ||
| decisions. | The Dexcom G6 Continuous | |
| Glucose Monitoring System | ||
| (Dexcom G6 System) is a real | ||
| time, continuous glucose | ||
| monitoring device indicated for | ||
| the management of diabetes in | ||
| persons age 2 years and older. | ||
| The Dexcom G6 System is | ||
| intended to replace fingerstick | ||
| blood glucose testing for | ||
| diabetes treatment decisions. | ||
| Interpretation of the Dexcom | ||
| G6 System results should be | ||
| based on the glucose trends and | ||
| several sequential readings over | ||
| time. The Dexcom G6 System | ||
| also aids in the detection of | ||
| episodes of hyperglycemia and | ||
| hypoglycemia, facilitating both | ||
| acute and long-term therapy | ||
| adjustments. | ||
| The Dexcom G6 System is also | ||
| intended to autonomously | ||
| communicate with digitally connected devices, including | ||
| automated insulin dosing (AID) | ||
| systems. The Dexcom G6 | ||
| System can be used alone or in | ||
| conjunction with these digitally | ||
| connected medical devices for | ||
| the purpose of managing | ||
| diabetes. | ||
| 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 | |
| Sample Type | Interstitial fluid | Same |
| Similarities | ||
| Item | FreeStyle Libre 2 Flash | |
| Glucose Monitoring System | Dexcom G6 Continuous | |
| Glucose Monitoring System | ||
| (DEN170088) | ||
| Enzyme | Glucose oxidase | Same |
| Clinical Application | Management of diabetes | |
| mellitus | Same | |
| Clinical Setting/Sites of Use | Home use | Same |
| Data Displayed | Current glucose value, current | |
| glucose trend, graph with recent | ||
| glucose history, user entered | ||
| events | Same | |
| Differences | ||
| Item | FreeStyle Libre 2 Flash | |
| Glucose Monitoring System | Dexcom G6 Continuous Glucose | |
| Monitoring System | ||
| (DEN170088) | ||
| Situations where fingerstick | ||
| test is required to confirm | ||
| sensor reading (adjunctive | ||
| use) | The user's symptoms do | |
| not match the glucose | ||
| values displayed by the | ||
| device.The device does not show |
| The user's symptoms do not
match the glucose values
displayed by the device.The device does not show a
glucose value or a trend
arrow. |
| Compatibility with connected
devices | Compatible with digitally
connected devices where the
user manually controls
actions for therapy decisions | Compatible with digitally
connected devices, including
automated insulin dosing (AID)
systems |
| Sensor Calibration | Factory calibrated | Factory calibrated, with optional
user calibration |
| Glucose reading update
interval | Every 1 minute | Every 5 minutes |
| Wireless communications
protocol | Near Field Communication
(NFC): (13.56 MHz RFID)
Bluetooth Low Energy (BLE)
4.0 | Bluetooth Core Specification v4.0 |
| Communications range | 20 feet unobstructed | 20 feet unobstructed |
| Glucose Trend Arrow | ↑, > +2 mg/dL/min
↗, +1 and +2 mg/dL/min
→, -1 to +1 mg/dL/min
↘, -2 to -1 mg/dL/min
↓, +3mg/dL/min
↑, +2 to +3 mg/dL/min
↗, +1 to +2mg/dL/min
→, -1 to +1 mg/dL/min
↘, -2 to -1 mg/dL/min
↓, -3 to -2 mg/dL/min
↓↓, 180 | 7420 | 141 | | | 91.5 (89.4) | 100.0 (99.9) |
Percent and Point Accuracy by iCGM Glucose Range (Study 1, Adult)
| Percent and Point Accuracy by iCGM Glucose Range (Study 2, Pediatric*) | ||||
|---|---|---|---|---|
| iCGM
Glucose Range
(mg/dL) | No.
Pairs | No.
Subject | Percent
within
15 mg/dL (95%
LCL) | Percent
within
40 mg/dL
(95% LCL) | Percent
within
15%
(95% LCL) | Percent
within
40%
(95% LCL) |
|----------------------------------|--------------|----------------|--------------------------------------------|--------------------------------------------|---------------------------------------|---------------------------------------|
| 180 | 2854 | 124 | | | 87.3 (84.4) | 99.7 (99.5) |
- Results only include children 6-17 years of age with YSI measurement as comparator. SMBG measurements were obtained as comparator for children 4-5 years of age.
Percent and Point Accuracy by YSI Glucose Range (Study 1. Adult)
| YSI
Glucose Range
(mg/dL) | No. Pair | No. Subject | Percent
within
15 mg/dL
(95% LCL) | Percent
within
40 mg/dL
(95% LCL) | Percent
within
15%
(95% LCL) | Percent
within
40%
(95% LCL) |
|---------------------------------|----------|-------------|--------------------------------------------|--------------------------------------------|---------------------------------------|---------------------------------------|
| 180 | 7763 | 141 | | | 88.9 (86.3) | 99.9 (99.8) |
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| Percent and Point Accuracy by YSI Glucose Range (Study 2, Pediatric*) | |
|---|---|
| ----------------------------------------------------------------------- | -- |
| YSI
Glucose Range
(mg/dL) | No.
Pairs | No.
Subject | Percent
within
15 mg/dL
(95% LCL) | Percent
within
40 mg/dL
(95% LCL) | Percent
within
15%
(95% LCL) | Percent
within
40%
(95% LCL) |
|---------------------------------|--------------|----------------|--------------------------------------------|--------------------------------------------|---------------------------------------|---------------------------------------|
| 180 | 2921 | 122 | | | 87.7 (84.9) | 99.1 (97.9) |
- Results only include children 6-17 years of age with YSI measurement as comparator. SMBG measurements were obtained as comparator for children 4-5 years of age.
Percent values within 20% of the comparator method were calculated across the measuring range overall.
| iCGM Glucose
Range (mg/dL) | No. Pairs | No. Subject | Percent
within 20%
(95% LCL) |
|-------------------------------|-----------|-------------|------------------------------------|
| Adult (18 years
and up) | 18735 | 144 | 90.2 (88.7) |
| Pediatric (6-17
years) | 6546 | 129 | 90.3 (88.1) |
| Pediatric (4-5 years
old)* | 341 | 8 | 85.4 (80.3) |
Percent of iCGM values within 20% of YSI reference
*Only SMBG measurements were obtained as comparator for children 4-5 years of age
Percent values within 15%/15 mg/dL, 20%/20 mg/dL stratified by glucose ranges of 250 mg/dL for iCGM and laboratory comparator were also provided.
| CGM
Glucose
Level
(mg/dL) | Number
of CGM-
Reference
Pairs | Percent
Within
±15
mg/dL | Percent
Within
±20
mg/dL | Percent
Within
±40
mg/dL | Percent
Within
±15% | Percent
Within
±20% | Percent
Within
±40% | Mean
bias
(mg/dL) | MARI
(%) |
|------------------------------------|-----------------------------------------|-----------------------------------|-----------------------------------|-----------------------------------|---------------------------|---------------------------|---------------------------|-------------------------|-------------|
| 250 | 4383 | | | | 94.0 | 97.9 | 100.0 | -6.3 | 6.1 |
Accuracy to YSI within CGM Glucose Ranges (Study 1, Adult)
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| Accuracy to YSI within CGM Glucose Ranges (Study 2, Pediatric*) | |||||
|---|---|---|---|---|---|
| CGM
Glucose
Level
(mg/dL) | Number
of CGM-
Reference
Pairs | Percent
Within
±15
mg/dL | Percent
Within
±20
mg/dL | Percent
Within
±40
mg/dL | Percent
Within
±15% | Percent
Within
±20% | Percent
Within
±40% | Mean
bias
(mg/dL) | MARD
(%) |
|------------------------------------|-----------------------------------------|-----------------------------------|-----------------------------------|-----------------------------------|---------------------------|---------------------------|---------------------------|-------------------------|-------------|
| 250 | 1618 | | | | 92.2 | 97.7 | 99.8 | -2.2 | 7.2 |
- Results only include children 6-17 years of age with YSI measurement as comparator. SMBG measurements were obtained as comparator for children 4-5 years of age.
| YSI
Glucose
Level
(mg/dL) | Number
of CGM-
Reference
Pairs | Percent
Within
±15
mg/dL | Percent
Within
±20
mg/dL | Percent
Within
±40
mg/dL | Percent
Within
±15% | Percent
Within
±20% | Percent
Within
±40% | Mean
bias
(mg/dL) | MARD
(%) |
|------------------------------------|-----------------------------------------|-----------------------------------|-----------------------------------|-----------------------------------|---------------------------|---------------------------|---------------------------|-------------------------|-------------|
| 250 | 4826 | | | | 90.9 | 95.9 | 99.7 | -11.8 | 6.9 |
Accuracy to YSI within YSI Glucose Ranges (Study 1, Adult)
Accuracy to YSI within YSI Glucose Ranges (Study 2, Pediatric*)
| YSI
Glucose
Level
(mg/dL) | Number
of CGM-
Reference
Pairs | Percent
Within
±15
mg/dL | Percent
Within
±20
mg/dL | Percent
Within
±40
mg/dL | Percent
Within
±15% | Percent
Within
±20% | Percent
Within
±40% | Mean
bias
(mg/dL) | MARD
(%) |
|------------------------------------|-----------------------------------------|-----------------------------------|-----------------------------------|-----------------------------------|---------------------------|---------------------------|---------------------------|-------------------------|-------------|
| 250 | 1817 | | | | 90.2 | 97.5 | 99.9 | -10.2 | 7.6 |
- Results only include children 6-17 years of age with YSI measurement as comparator. SMBG measurements were obtained as comparator for children 4-5 years of age.
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Image /page/18/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue "a" on the left, followed by the text "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the second line. The logo is clean and professional, conveying a sense of trust and reliability.
Concurrence of iCGM values compared to the comparator method across the entire measuring range was also evaluated. iCGM glucose ranges of 400 mg/dL were evaluated against the comparator glucose ranges and percent of iCGM values within those ranges were reported.
| YSI (mg/dL) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CGM | |||||||||||||
| (mg/dL) | 400 | N | |||||||||||
| 400 | . | . | . | . | . | . | . | . | 2.5 | 62.8 | 34.7 | 121 |
Concurrence Analysis by CGM Glucose Level (Study 1, Adult)
Concurrence Analysis by CGM Glucose Level (Study 2, Pediatric*)
| YSI (mg/dL) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CGM | ||||||||||||
| (mg/dL) | 400 | N | ||||||||||
| 400 | . | . | . | . | . | . | . | 4.4 | 6.7 | 33.3 | 55.6 | 45 |
- Results only include children 6-17 years of age with YSI measurement as comparator. SMBG measurements were obtained as comparator for children 4-5 years of age.
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Image /page/19/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue "a" 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.
| CGM (mg/dL) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| YSI | |||||||||||||
| (mg/dL) | 400 | N | |||||||||||
| 400 | . | . | . | . | . | . | . | 1.9 | 16.7 | 42.6 | 38.9 | 108 |
Concurrence Analysis by YSI Glucose Level (Study 1, Adult)
Concurrence Analysis by YSI Glucose Level (Study 2, Pediatric*)
| CGM (mg/dL) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| YSI | ||||||||||||
| (mg/dL) | 400 | N | ||||||||||
| 400 | . | . | . | . | . | . | . | . | 2.7 | 29.7 | 67.6 | 37 |
- Results only include children 6-17 years of age with YSI measurement as comparator. SMBG measurements were obtained as comparator for children 4-5 years of age.
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Image /page/20/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 words "Abbott" in bold black letters on the top line and "Diabetes Care" in smaller, regular black letters on the second line. The logo is simple and professional, conveying a sense of trust and reliability.
Trend Accuracy
Trend accuracy describes the accuracy of the sensor during times of rapidly changing glucose and is characterized by slopes, such as from > 2mg/dL to 2 | |
| 2 | 0.1 | 0.2 | 3.1 | 14.6 | 32.9 | 49.0 | 881 |
Concurrence Analysis by Glucose Rate of Change (Study 1, Adult)
| CGM
(mg/dL/min) | 2 | N |
|--------------------|------|----------|---------|--------|--------|------|------|
| 2 | . | 0.9 | 4.2 | 15.0 | 29.7 | 50.2 | 448 |
- Results only include children 6-17 years of age with YSI measurement as comparator. SMBG measurements were obtained as comparator for children 4-5 years of age.
Agreement When iCGM Reads 'LO' or 'HI'
The FreeStyle Libre 2 Glucose Monitoring System reports glucose readings between 40 and 400 mg/dL. When the system determines that the glucose reading is below 40 mg/dL, it will display 'LO' whenever the sensor is scanned. When the system determines that the glucose reading is above 400 mg/dL, it will display 'HI' whenever the sensor is scanned. Because the system does not display glucose values below 40 mg/dL or above 400 mg/dL, the comparisons to the actual blood glucose levels (as determined by the comparator) when the iCGM value is classified as 'LO' or 'HI' are evaluated separately. The cumulative percentages of when the comparator values were less than certain glucose values (for 'LO') and when comparator values were more that certain glucose values (for 'HI') are presented in the tables below.
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| Concurrence Analysis with 'LO' CGM Reading (Study 1: Adult) | ||||
|---|---|---|---|---|
| CGM-
Reference
Pairs | 350 | >300 | >250 | ≤250 | |
| n | 118 | 121 | 121 | 0 | 121 |
| Cumulative
% | 97.5 | 100.0 | 100.0 | 0.0 | |
Concurrence Analysis with 'HI' CGM Reading (Study 2: Pediatric*)
| CGM-
Reference
| Pairs | YSI Comparator (mg/dL) | N | |||
|---|---|---|---|---|---|
| >350 | >300 | >250 | ≤250 | ||
| n | 40 | 43 | 45 | 0 | 45 |
| Cumulative | |||||
| % | 88.9 | 95.6 | 100.0 | 0.0 |
- Results only include children 6-17 years of age with YSI measurement as comparator. SMBG measurements were obtained as comparator for children 4-5 years of age.
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Image /page/22/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue square with a white "A" inside, followed by the words "Abbott" in bold black letters and "Diabetes Care" in smaller black letters below it. The logo is simple and modern, and the colors are clean and professional.
Alarm Performance
The tables in this section show the accuracy of the System's Low and High Glucose Alarms. The Alarm Rate tells you how often the alarm is right or wrong. The Detection Rate tells you how often the System recognizes and notifies you about a low or high glucose event.
Low Glucose Alarm Performance
True Alarm Rate
Tells you: When you got a low glucose alarm, were you actually low? Definition: Percentage of time the alarm issued and blood glucose was below the alarm level within 15 minutes before or after the alarm.
False Alarm Rate
Tells you: Did you get a low glucose alarm that you shouldn't have? Definition: Percentage of time the alarm issued and blood glucose was not below the alarm level within 15 minutes before or after the alarm.
Detection Rate
Tells you: When you were low, did you get a low glucose alarm? Definition: Percentage of time blood glucose was below the alarm level and the alarm issued within 15 minutes before or after the glucose event.
Missed Detection Rate
Tells you: When you were low, did you miss a low glucose alarm? Definition: Percentage of time blood glucose was below the alarm level and the alarm didn't issue within 15 minutes before or after the glucose event.
For example, the Adult study found that for a Low Glucose alarm level set to 70 mg/dL: 86.0% of the time a low glucose alarm was received when blood glucose was below the alarm level but 14.0% of the time a low glucose alarm was received when blood glucose was not below the alarm level.
89.3% of the time blood glucose was below the alarm level and a low glucose alarm was appropriately issued but 10.7% of the time the glucose event was missed and no alarm was issued.
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| Alarm Rate | Detection Rate | |||||
|---|---|---|---|---|---|---|
| Low Glucose | ||||||
| Alarm level | ||||||
| (mg/dL) | Number of | |||||
| Events (n) | True | |||||
| Alarm | ||||||
| Rate (%) | False | |||||
| Alarm | ||||||
| Rate (%) | Number of | |||||
| Events (n) | Correct | |||||
| Detection Rate | ||||||
| (%) | Missed | |||||
| Detection Rate | ||||||
| (%) | ||||||
| 60 | 9861 | 72.6 | 27.4 | 1527 | 75.7 | 24.3 |
| 70 | 21504 | 86.0 | 14.0 | 3652 | 89.3 | 10.7 |
| 80 | 32784 | 91.3 | 8.7 | 4753 | 97.3 | 2.7 |
| 90 | 41299 | 93.6 | 6.4 | 5591 | 98.5 | 1.5 |
Low Glucose Alarm Performance (Adult)
Low Glucose Alarm Performance (Pediatric*)
| Low Glucose
Alarm level
(mg/dL) | Number of
Events (n) | True
Alarm
Rate (%) | False
Alarm
Rate (%) | Number of
Events (n) | Correct
Detection Rate
(%) | Missed
Detection Rate
(%) |
|---------------------------------------|-------------------------|---------------------------|----------------------------|-------------------------|----------------------------------|---------------------------------|
| 60 | 2780 | 62.9 | 37.1 | 373 | 87.4 | 12.6 |
| 70 | 6363 | 80.3 | 19.7 | 963 | 93.5 | 6.5 |
| 80 | 9747 | 85.6 | 14.4 | 1318 | 96.4 | 3.6 |
| 90 | 12550 | 92.2 | 7.8 | 1656 | 97.3 | 2.7 |
- Results only include children 6-17 years of age with YSI measurement as comparator. SMBG measurements were obtained as comparator for children 4-5 years of age.
High Glucose Alarm Performance
True Alarm Rate
Tells you: When you got a high glucose alarm, were you actually high? Definition: Percentage of time the alarm issued and blood glucose was above the alarm level within 15 minutes before or after the alarm.
False Alarm Rate
Tells you: Did you get a high glucose alarm that you shouldn't have? Definition: Percentage of time the alarm issued and blood glucose was not above the alarm level within 15 minutes before or after the alarm.
Detection Rate
Tells you: When you were high, did you get a high glucose alarm? Definition: Percentage of time blood glucose was above the alarm level and the alarm issued within 15 minutes before or after the glucose event.
Missed Detection Rate
Tells you: When you were high, did you miss a high glucose alarm?
Definition: Amount of time blood glucose was above the alarm level and the alarm didn't issue within 15 minutes before or after the glucose event.
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For example, the Adult study found that for a High Glucose alarm level set to 200 mg/dL: 99.2% of the time a high glucose alarm was received when blood glucose was above the alarm level but 0.8% of the time a high glucose alarm was received when blood glucose was not above the alarm level.
97.1% of the time blood glucose was above the alarm level and a high glucose alarm was appropriately issued but 2.9% of the time the glucose event was missed and no alarm was issued.
| High Glucose
Alarm level
| (mg/dL) | Alarm Rate | Detection Rate | ||||
|---|---|---|---|---|---|---|
| Number of | ||||||
| Events (n) | True | |||||
| Alarm | ||||||
| Rate (%) | False | |||||
| Alarm | ||||||
| Rate (%) | Number of | |||||
| Events (n) | Correct | |||||
| Detection Rate | ||||||
| (%) | Missed | |||||
| Detection Rate | ||||||
| (%) | ||||||
| 120 | 105544 | 99.1 | 0.9 | 11417 | 98.2 | 1.8 |
| 140 | 93574 | 99.1 | 0.9 | 10152 | 98.1 | 1.9 |
| 180 | 74290 | 99.2 | 0.8 | 8080 | 97.8 | 2.2 |
| 200 | 66039 | 99.2 | 0.8 | 7269 | 97.1 | 2.9 |
| 220 | 57549 | 99.0 | 1.0 | 6390 | 96.9 | 3.1 |
| 240 | 48733 | 98.4 | 1.6 | 5550 | 95.6 | 4.4 |
| 300 | 21512 | 96.3 | 3.7 | 2672 | 90.0 | 10.0 |
High Glucose Alarm Performance (Adult)
| Alarm Rate | Detection Rate | |||||
|---|---|---|---|---|---|---|
| High Glucose | ||||||
| Alarm level | ||||||
| (mg/dL) | Number of | |||||
| Events (n) | True | |||||
| Alarm | ||||||
| Rate (%) | False | |||||
| Alarm | ||||||
| Rate (%) | Number of | |||||
| Events (n) | Correct | |||||
| Detection Rate | ||||||
| (%) | Missed | |||||
| Detection Rate | ||||||
| (%) | ||||||
| 120 | 34176 | 98.8 | 1.2 | 4441 | 98.2 | 1.8 |
| 140 | 30107 | 98.0 | 2.0 | 3945 | 98.4 | 1.6 |
| 180 | 22430 | 98.4 | 1.6 | 3125 | 98.0 | 2.0 |
| 200 | 19425 | 98.0 | 2.0 | 2791 | 98.0 | 2.0 |
| 220 | 16371 | 98.2 | 1.8 | 2492 | 96.9 | 3.1 |
| 240 | 13559 | 98.0 | 2.0 | 2172 | 95.7 | 4.3 |
| 300 | 6064 | 90.8 | 9.2 | 962 | 91.0 | 9.0 |
- Results only include children 6-17 years of age with YSI measurement as comparator. SMBG measurements were obtained as comparator for children 4-5 years of age.
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Image /page/25/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue stylized "a" on the left, followed by the text "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is simple and professional, conveying a sense of trust and reliability.
Sensor Stability
Sensor stability describes the performance of the sensor lifetime. Sensors can be worn for up to 14 days. Performance was estimated by calculating the percentage of FreeStyle Libre 2 readings within 15 mg/dL or 15% (15/15%), 20 mg/dL or 20% (20/20%) and 40 mg/dL or 405 (40/40%) of the comparator values at the beginning Adult: Days 1-3, Pediatric: Day 1-2) Early Middle (Adult: Days 7-8, Pediatric: Day 7-8), Late Middle (Adult: Days 9-12, Pediatric: Day 9-12), and End (Adult: Days 13-14, Pediatric: Day 13-14). The mean of the absolute relative differences was evaluated over 14 day life of the sensor within measuring range.
| Wear Period | Number of
CGM-
reference
pairs | MARD (%) | Within ±15%
/ ±15mg/dL | Within ±20%
/ ±20mg/dL | Within ±40%
/ ±40mg/dL |
|--------------|-----------------------------------------|----------|---------------------------|---------------------------|---------------------------|
| Beginning | 6955 | 9.9 | 83.4 | 90.4 | 99.3 |
| Early Middle | 4522 | 8.5 | 87.7 | 94.5 | 99.8 |
| Late Middle | 3503 | 8.8 | 86.8 | 93.4 | 99.7 |
| End | 3755 | 9.1 | 86.4 | 92.9 | 100.0 |
Sensor Accuracy Relative to YSI Comparator over the wear duration (Study 1: Adult)
| Sensor Accuracy Relative to YSI Comparator over the wear duration (Study 2: Pediatric*) | |||
|---|---|---|---|
| ----------------------------------------------------------------------------------------- | -- | -- | -- |
| Wear Period | Number of
CGM-
reference
pairs | MARD (%) | Within ±15%
/ ±15mg/dL | Within ±20%
/ ±20mg/dL | Within ±40%
/ ±40mg/dL |
|--------------|-----------------------------------------|----------|---------------------------|---------------------------|---------------------------|
| Beginning | 1828 | 10.7 | 79.6 | 88.5 | 98.6 |
| Early Middle | 1642 | 8.0 | 89.5 | 94.2 | 98.5 |
| Late Middle | 1534 | 9.7 | 83.6 | 92.9 | 99.5 |
| End | 1542 | 10.2 | 82.6 | 91.1 | 99.3 |
- Results only include children 6-17 years of age with YSI measurement as comparator. SMBG measurements were obtained as comparator for children 4-5 years of age.
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Image /page/26/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue "a" 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.
Sensor Life
The Sensor can be worn for up to 14 days. 146 Sensors were evaluated in the Adult Study and 139 Sensors were evaluated in the Pediatric Study to determine how many days of readings each Sensor provided. Of the 146 Sensors in the Adult study, 71.1% lasted until the final day of use. 6 Sensors (4.1%) had "early sensor shut-off" where the Sensor algorithm detected that the Sensors did not function as intended and presented the user with a "Replace Sensor'' message. In the Pediatric study, 78.1% of the Sensors lasted until the final day of use. 3 Sensors (2.2%) had "early sensor shut-off" where the Sensor algorithm detected that the Sensors did not function as intended and presented the user with a "Replace Sensor" message.
| Day of Wear | Number of Sensors | Survival Rate (%) |
|---|---|---|
| 1 | 145 | 99.3 |
| 2 | 142 | 97.3 |
| 3 | 140 | 95.9 |
| 4 | 137 | 93.8 |
| 5 | 134 | 93.8 |
| 6 | 133 | 91.1 |
| 7 | 132 | 90.4 |
| 8 | 127 | 87.0 |
| 9 | 123 | 84.9 |
| 10 | 119 | 82.2 |
| 11 | 112 | 77.3 |
| 12 | 111 | 76.6 |
| 13 | 104 | 71.8 |
| 14 | 100 | 71.1 |
Sensor Survival Rate Over Wear Duration (Study 1: Adult)
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Image /page/27/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue stylized "a" on the left, followed by the words "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is simple and clean, with a focus on the company name and its area of expertise.
| Day of Wear | Number of Sensors | Survival Rate (%) |
|---|---|---|
| 1 | 137 | 98.6 |
| 2 | 136 | 97.8 |
| 3 | 134 | 97.1 |
| 4 | 133 | 96.4 |
| 5 | 133 | 96.4 |
| 6 | 133 | 96.4 |
| 7 | 133 | 96.4 |
| 8 | 131 | 94.9 |
| 9 | 126 | 91.3 |
| 10 | 124 | 89.9 |
| 11 | 122 | 88.4 |
| 12 | 120 | 87.0 |
| 13 | 114 | 83.4 |
| 14 | 104 | 78.1 |
Sensor Survival Rate Over Wear Duration (Study 2: Pediatric)
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Image /page/28/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the text "Abbott" in bold, and "Diabetes Care" in a smaller font size below it. The text is black, contrasting with the blue symbol.
Glucose Reading Availability
The System is designed to show a Sensor glucose reading after each scan that is performed throughout the wear period after the start-up time. As such, the capture rate characterizes the reliability of the communication between components of the system.
| Glucose Reading Capture Rate Over Wear Duration (Study 1: Adult) | ||
|---|---|---|
| Day of Wear | Number of Sensors | Capture Rate (%) |
| 1 | 146 | 98.3 |
| 2 | 145 | 98.1 |
| 3 | 143 | 98.3 |
| 4 | 140 | 98.3 |
| 5 | 138 | 98.4 |
| 6 | 135 | 98.3 |
| 7 | 134 | 98.4 |
| 8 | 131 | 98.4 |
| 9 | 128 | 98.4 |
| 10 | 123 | 98.4 |
| 11 | 120 | 98.4 |
| 12 | 113 | 98.5 |
| 13 | 112 | 98.5 |
| 14 | 104 | 98.6 |
Glucose Reading Capture Rate Over Wear Duration (Study 1: Adult)
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Image /page/29/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue "a" on the left, followed by the text "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the second line. The logo is simple and professional, conveying a sense of trust and reliability.
| Day of Wear | Number of Sensors | Survival Rate (%) |
|---|---|---|
| 1 | 139 | 94.6 |
| 2 | 137 | 94.9 |
| 3 | 136 | 95.2 |
| 4 | 133 | 95.3 |
| 5 | 134 | 95.5 |
| 6 | 133 | 95.6 |
| 7 | 133 | 96.0 |
| 8 | 133 | 95.9 |
| 9 | 130 | 95.7 |
| 10 | 125 | 95.6 |
| 11 | 125 | 95.6 |
| 12 | 122 | 95.8 |
| 13 | 119 | 95.9 |
| 14 | 116 | 95.8 |
Glucose Reading Capture Rate Over Wear Duration (Study 2: Pediatric)
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Image /page/30/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue square with a stylized "a" inside, 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.
Human Factors 1.7.4
Human factors and usability testing of the FreeStyle Libre 2 System was conducted to determine whether the user interface design and labeling would impact the performance of the device. Human factors testing was conducted in accordance with:
- FDA Guidance titled Applying Human Factors and Usability Engineering to Medical Devices, dated February 3, 2016
- ANSI/AAMI/IEC 62366: Medical devices Application of Usability Engineering to ● Medical Devices
- IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
1.7.5 Software Verification and Validation
Software verification and validation testing was conducted to confirm that the software used in the FreeStyle Libre 2 System performed in accordance with established specifications, EN 62304 and FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 11, 2005. Evaluation activities included unit, system integration (SIT), and system level testing which verified functionality of the device against established software requirements. Results of the software executed protocols for FreeStyle Libre 2 met the acceptance criteria and therefore supports that the System's embedded software is acceptable for its intended use.
1.7.6 Biocompatibility
Biocompatibility testing in accordance with ISO10993-1and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process," June 16, 2016 was performed on Sensor materials including the outer Sensor, casing, adhesive pad, and sensor tail. Biological evaluation included cytotoxicity, genotoxicity, irritation, sensitization, and system toxicity testing. All biocompatibility testing met the acceptance criteria.
Sterilization 1.7.7
Electron beam sterilization vas performed per ISO11137-1 and ISO 11137-2. Sterilization validation confirmed that the Sterility Assurance Level (SAL) of 10-6 is achieved with the selected target dose of 25kGy. The sterilization dose was established by the VDmax25 method described in ISO 11137-2. All sterilization testing met the acceptance criteria and supports sterility of the patient contact components of the device.
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Image /page/31/Picture/0 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 font, with the text 'Diabetes Care' in a smaller, non-bold black font below it.
Shelf-Life and Stability 1.7.8
Sensor Kit shelf life stability testing provided objective evidence to support a shelf life of 9 months. The testing conducted satisfied specifications. Additional testing was conducted to support sensor kit storage temperature range of 36°F and 82°F. Results demonstrated no impact to sensor stability when stored at these storage temperatures.
1.7.9 Packaging Integrity/Shipping Integrity
Packaging and shipping integrity testing was performed for Sensor Kits and Reader Kits in accordance with EN ISO 11607-1, EN ISO 11607-2, ASTM D4169-14, and ASTM D4332-13 guidelines. All tested units passed the testing requirements of all distribution tests.
1.7.10 Electromagnetic Compatibility
Electromagnetic compatibility (EMC) testing was performed for the FreeStyle Libre 2 System to verify that the system is able to withstand the electromagnetic interference in compliance with IEC 60601-1-2, IEC CISPR 11 and Federal Communication Commission Regulations Part 15.209 and 15.225. EMC coexistence testing was also performed to confirm that the Reader and Patch remain functional and perform within acceptable limits while in the presence of common radiating electronic devices in accordance with FDA guidance Radio Frequency Wireless Technology in Medical Devices. Testing was also performed to demonstrate compliance of the FreeStyle Libre 2 System with Category M of RTCA DO-160:
- The FreeStyle Libre 2 Reader and Patch underwent electromagnetic compatibility (EMC) and electromagnetic immunity (EMI) testing and both demonstrated compliance with IEC 60601-1-2:2014.
- The FreeStyle Libre 2 Reader and Patch were exposed to electrostatic events (i.e., static electricity discharges from operators directly and from personnel to adjacent objects) in accordance with IEC 61000-4-2 Edition. Electrostatic discharge testing was performed at ± 8 kV for contact discharge and at ± 15 kV for air discharge. The FreeStyle Libre 2 System met the performance requirements for the ESD Immunity Test.
- Testing was performed to determine compliance with Federal Communications ● Commission (FCC) standards. The FreeStyle Libre 2 System successfully demonstrated compliance with FCC Part 15 Subpart C §15.247 (2016) and FCC Part 15 Subpart B (2016).
- The FreeStyle Libre 2 System demonstrated compliance with airworthiness . requirements per the Federal Aviation Administration (FAA) Advisory Circular RTCA/DO-160 Edition G section 21, Category M (RF Emission specification).
- The FreeStyle Libre 2 System underwent coexistence testing in the presence of . common RF interfering devices that are likely to be encountered by users in a home environment. A representative set of devices known to operate in the same frequency band (2.4 GHz) was selected. The test results showed that the FreeStyle Libre 2 System could tolerate interference generated by these RF interfering devices and still meet the target performance criteria.
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Image /page/32/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized blue letter "a" on the left, followed by the text "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the second line. The logo is clean and professional, conveying a sense of trust and reliability.
- Conducted emissions and radiated emissions testing for the FreeStyle Libre 2 System ● was performed in accordance with IEC/EN 60601-1-2:2014 and CISPR 11. The FreeStyle Libre 2 System demonstrated that maximum emissions did not exceed the limits established for residential or home use (Class B).
1.7.11 Electrical Safety
The basic safety and essential performance of the FreeStyle Libre 2 System was evaluated to IEC 60601-1:2006/A1:2013. Tested units included the FreeStyle Libre 2 Reader and Patch, and both demonstrated compliance to the requirements of IEC 60601-1:2006/A1:2013.
1.7.12 Environmental Testing
Environmental testing on the FreeStyle Libre 2 System was performed in accordance with IEC 60601-1 to ensure the device specifications for operating temperature, operating humidity, operating pressure, impact resistance, vibration resistance, shock resistance, drop resistance, and storage conditions were met.
1.7.13 Test Strip Claim Support
The FreeStyle Precision Neo Blood Glucose Test Strips cleared under K171941 are compatible for use with the FreeStyle Libre 2 built-in meter for quantitative measurement of glucose from fresh capillary whole blood drawn from fingertips. Studies to support the use of the FreeStyle Libre 2 Reader's built-in meter with the FreeStyle Precision Neo Blood Glucose Test Strips (K171941) demonstrated that all acceptance criteria were met as defined by specification.
1.7.14 Interoperability
The FreeStyle Libre 2 System incorporates an approach for interoperability developed in alignment with FDA guidance, "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices," September 6, 2017, which includes expectations, requirements, and interface specifications to potential interoperable devices. In addition, the ADC approach to interoperability includes working with connected device companies regarding contractual approaches, interfaces for data communication and exchange, and post-market reporting procedures and responsibilities with respect to managing complaints (e.g., who is responsible for investigating and reporting complaints, malfunctions, and adverse events).
1.7.15 Cybersecurity
ADC has provided cybersecurity risk management documentation for the FreeStyle Libre 2 System that includes analysis of confidentiality, integrity, and availability for data, information and software related to the System. 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.
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Image /page/33/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue stylized letter "a" on the left, followed by the text "Abbott" in bold black font on the right. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold black font.
In addition, ADC has controls and processes in place to ensure continued support for keeping the device secure and to ensure that the device firmware, software and components are malware free. Additional controls are also in place in manufacturing through distribution to ensure that the medical device firmware and software are malware free from point of origin to the hands of the end user.
1.8 Proposed Labeling
The FreeStyle Libre 2 Flash Glucose Monitoring System labeling is sufficient and satisfies the requirements of 21 CFR Parts 801 and 809, and the special controls for this type of device.
1.9 Conclusion
The FreeStyle Libre 2 Flash Glucose Monitoring System has the same intended use and clinical application as the predicate device. There are no differences in technological characteristics that raise questions of safety or effectiveness. The FreeStyle Libre 2 System provides significant benefits to users (including glucose readings, trends, real time alerts, a short sensor warm-up period, factory calibration, and the ability to autonomously communicate with digitally connected devices where the user manually controls actions for therapy decisions) that outweigh any potential risks associated with iCGM technology. Clinical studies in adult and pediatric patients have demonstrated that the FreeStyle Libre 2 System provides accurate and reliable glucose readings in accordance with the iCGM special controls relating to accuracy and does not post any clinically significant risks not seen with the predicate device. Accordingly, based on this and the data provided in this pre-market notification, the subject device and predicate device have been shown to be substantially equivalent.