(200 days)
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 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
The FreeStyle Libre 2 Flash Glucose Monitoring System (with modified Sensor tail), hereinafter also referred to as 'modified FSL2 System' and FreeStyle Libre 3 Continuous Glucose Monitoring System (with modified Sensor tail), hereinafter also referred to as 'modified FSL3 System' are integrated continuous glucose monitoring (iCGM) systems that provide continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The Systems also provide configurable alarms designed to warn the user of Low Glucose or Signal Loss. The user may make treatment decisions based in part on the Sensor glucose results provided by the Systems require a prescription and are intended for home use.
The FreeStyle Libre 2 System consists of the FreeStyle Libre 2 Sensor and either the FreeStyle Libre 2 Reader or the FreeStyle Libre 2 App downloaded to a compatible smartphone as a primary display device. The FreeStyle Libre 3 System consists of the FreeStyle Libre 3 Sensor and the FreeStyle Libre 3 App downloaded to a compatible smartphone as a primary display device.
Both the FreeStyle Libre 2 and FreeStyle Libre 3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FreeStyle Libre 2 or FreeStyle Libre 3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms.
The Abbott FreeStyle Libre 2 Flash Glucose Monitoring System and FreeStyle Libre 3 Continuous Glucose Monitoring System sought clearance for modified sensor tails to reduce vitamin C interference, extend sensor wear to 15 days, and enable compatibility with automated insulin dosing (AID) systems.
Here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly list a table of "acceptance criteria" with specific numeric targets for device performance. Instead, it states that the devices meet the iCGM special controls for clinical performance set forth in 21 CFR 862.1355. This regulation broadly outlines requirements for accuracy, reliability, and safety of integrated Continuous Glucose Monitoring systems.
However, based on the provided text, we can infer some key performance objectives and the reported outcome:
| Acceptance Criteria (Inferred from Changes & Regulations) | Reported Device Performance |
|---|---|
| Accuracy across measuring range (15-day wear) | The clinical study demonstrated that the subject devices meet the iCGM special controls for clinical performance. Specific accuracy metrics (e.g., MARD) are not provided in this summary but would be part of the full submission. |
| Reduced Vitamin C Interference | An additional clinical study evaluated the effects of high doses of vitamin C, and the results showed the devices met iCGM special controls. Labeling was updated to reflect Vitamin C interference at doses >1000 mg/day (improved from >500 mg/day for the predicate). |
| Extended Sensor Wear Duration (from 14 to 15 days) | The subject devices (modified FreeStyle Libre 2 and 3 Sensors) are designed for a 15-day wear duration, and performance was evaluated throughout this duration in the clinical study. |
| Compatibility with Automated Insulin Dosing (AID) systems | Interoperability testing and an interoperability communication plan were provided to ensure secure and reliable data transfer with digitally connected devices, including AID systems. |
| Software Functionality and Safety | Software regression testing was conducted in accordance with established specifications and IEC 62304. Results met acceptance criteria. |
| Non-clinical Performance | Non-clinical performance testing was conducted as per internal design control process requirements, and results met acceptance criteria. |
| Known Performance of Unaffected Aspects | Sterilization, biocompatibility, shelf life stability, packaging integrity/shipping integrity, mechanical engineering, electrical safety and electromagnetic compatibility, and human factors were established in predicate/reference devices and are not affected. Cybersecurity for FSL3 also relies on existing data. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The clinical study evaluated performance in adult (18 years and older) and pediatric (2 to 17 years) participants with diabetes. Specific numbers of participants within these age groups are not provided in this summary.
- Data Provenance: The document does not specify the country of origin. It indicates the studies were clinical studies, implying a prospective nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document mentions that the clinical study evaluated performance with respect to reference venous plasma sample YSI measurements.
- Ground Truth Providers: YSI measurements are obtained from laboratory instruments, which are considered the gold standard for glucose measurement. The "experts" involved would be trained lab technicians and medical professionals responsible for collecting and processing blood samples and operating the YSI instrumentation.
- Qualifications: Not explicitly stated, but they would be certified laboratory personnel and healthcare providers responsible for patient care and sample collection within a clinical study setting.
4. Adjudication Method for the Test Set:
Not applicable. The ground truth was established by YSI laboratory measurements, not subjective expert review or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Human-in-the-loop or MRMC study is not applicable for this device type (Continuous Glucose Monitoring System). The device provides continuous glucose values, and its performance is assessed against a laboratory reference, not human interpretation of images or other data that would involve multiple readers.
6. Standalone Performance:
Yes, the studies described are primarily focused on the standalone performance of the algorithm (as embedded in the device) in measuring glucose levels against a reference method (YSI venous plasma samples). The "clinical study" directly assesses how well the device's sensor and algorithm perform without direct human intervention in the glucose reading process itself, other than the placement and use of the device by participants.
7. Type of Ground Truth Used:
The ground truth used was venous plasma sample YSI measurements. This is a highly accurate and accepted laboratory reference method for glucose concentration.
8. Sample Size for the Training Set:
The document does not specify the sample size for the training set used for the device's glucose algorithm. It mentions that the "ADC Glucose Algorithm established for the predicate device" is used, implying that the core algorithm was developed and trained previously, and this submission focuses on modifications and re-validation.
9. How the Ground Truth for the Training Set Was Established:
The document does not specify how the ground truth for the training set of the ADC Glucose Algorithm was established. However, given that the clinical performance evaluation uses venous plasma YSI measurements as ground truth, it is highly probable that similar high-accuracy reference methods would have been employed during the development and training of the original algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
March 3, 2023
Abbott Diabetes Care Inc. Catherine Yang Regulatory Affairs Manager 1360 South Loop Road Alameda, California 94502
Re: K222447
Trade/Device Name: FreeStyle Libre 2 Flash Glucose Monitoring System, FreeStyle Libre 3 Continuous Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: QBJ, NBW Dated: August 12, 2022 Received: August 15, 2022
Dear Catherine Yang:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 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 (QS) 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.
Marianela Perez-torres -S
Marianela Perez-Torres, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222477
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 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Indications for Use
510(k) Number (if known) K222447
Device Name
FreeStyle Libre 3 Continuous Glucose Monitoring System
Indications for Use (Describe)
The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the text "Abbott" in bold black font on the top line and "Diabetes Care" in a regular black font on the bottom line. The logo is simple and modern, with a focus on the company's name and area of expertise.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K222447
1.1. Submitter:
Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502
Contact: Catherine Yang Title: Manager, Regulatory Affairs Phone: (510) 206-9452 Fax: (510) 864-4791
Date Prepared: March 1, 2023
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 |
| Regulatory Section(s): | 21 CFR 862.1355, 21 CFR 862.1345 |
| Classification: | Class II |
| Product Code(s): | QBJ, NBW |
| Review Panel: | Clinical Chemistry |
| Name of Device: | FreeStyle Libre 3 Continuous Glucose Monitoring System |
| Common Name: | Integrated Continuous Glucose Monitoring System,Factory Calibrated |
| Regulatory Section(s): | 21 CFR 862.1355 |
| Classification: | Class II |
| Product Code(s): | QBJ |
| Review Panel: | Clinical Chemistry |
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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 words "Abbott" in bold black font and "Diabetes Care" in a smaller, regular black font on the right. The logo is simple and professional, and it is likely used to represent the company and its products.
1.3. Predicate Device
| Predicate Device: | FreeStyle Libre 2 Flash Glucose Monitoring System(K210943, cleared on November 22, 2021) |
|---|---|
| Reference Devices: | 1) FreeStyle Libre 3 Continuous Glucose Monitoring System(K213996 and K212132 cleared May 26, 2022) |
| The reference device is used only to support the substantialequivalence of the FreeStyle Libre 3 subject device to thepredicate device. With the exception of the modified Sensor tail,the FreeStyle Libre 3 subject device is physically identical to thereference device and uses the same cybersecurity design andcontrols. Therefore, testing completed for the reference device inthe areas of sterilization, biocompatibility, shelf-life stability,packaging integrity/shipping integrity, mechanical engineering,electrical safety and electromagnetic compatibility, andcybersecurity applies to the FreeStyle Libre 3 subject device. |
1.4. Indications for Use
1.4.1. FreeStyle Libre 2 Flash Glucose Monitoring System
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 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
Contraindication
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.
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Image /page/6/Picture/0 description: The image contains 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 letters. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.
1.4.2. FreeStyle Libre 3 Continuous Glucose Monitoring System
The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
Contraindication
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 (with modified Sensor tail), hereinafter also referred to as 'modified FSL2 System' and FreeStyle Libre 3 Continuous Glucose Monitoring System (with modified Sensor tail), hereinafter also referred to as 'modified FSL3 System' are integrated continuous glucose monitoring (iCGM) systems that provide continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The Systems also provide configurable alarms designed to warn the user of Low Glucose or Signal Loss. The user may make treatment decisions based in part on the Sensor glucose results provided by the Systems require a prescription and are intended for home use.
The FreeStyle Libre 2 System consists of the FreeStyle Libre 2 Sensor and either the FreeStyle Libre 2 Reader or the FreeStyle Libre 2 App downloaded to a compatible smartphone as a primary display device. The FreeStyle Libre 3 System consists of the FreeStyle Libre 3 Sensor and the FreeStyle Libre 3 App downloaded to a compatible smartphone as a primary display device.
Both the FreeStyle Libre 2 and FreeStyle Libre 3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FreeStyle Libre 2 or FreeStyle Libre 3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms.
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Image /page/7/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 word "Abbott" in bold, black font on the top line. Below "Abbott" is the phrase "Diabetes Care" in a smaller, non-bold, black font. The logo is simple and professional, conveying a sense of trust and reliability.
FreeStyle Libre 2 Flash Glucose Monitoring System 1.5.1.
FreeStyle Libre 2 Sensor
- The Sensor is single use, disposable, and powered by a silver oxide battery. The Sensor is provided as two secondary components, Sensor Applicator and Sensor Pack (electron beam sterilized 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 below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the Sensor remains attached to the skin with a medical grade adhesive. The Sensor continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 15 days.
FreeStyle Libre 2 Reader
- The Reader is a small handheld device that is powered by a lithium-ion rechargeable battery and uses NFC communication to start new Sensors and to scan Sensors to display and record data and uses BLE communication to issue alarms that notify the user to scan his/her sensor when glucose values pass a high or low glucose threshold. The Reader also has a built-in strip port with blood glucose functionality (that 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.
FreeStyle Libre 2 App (iOS and Android)
- The App's design, functionality and user interface is based on the handheld Reader. When ● downloaded to a compatible smartphone, the App uses NFC communication to start new Sensors and to scan Sensors to display and record data and uses BLE communication to issue alarms. As a mobile application, the FreeStyle Libre 2 App allows connectivity with cloud-based applications. The FreeStyle Libre 2 App is an alternative primary display for the System and does not interact with the Reader. The FreeStyle Libre 2 App is distributed using the Apple App Store and Google Play Store, and a list of compatible devices is accessible in the App via the Help feature or product website.
1.5.2. FreeStyle Libre 3 Continuous Glucose Monitoring System
FreeStyle Libre 3 Sensor
- . The Sensor is single use, disposable, and powered by a silver oxide battery. The Sensor is provided through a Sensor Applicator (which includes an electron beam sterilized subcomponent) which is used to apply the Sensor to the back of the user's arm. During Sensor application, the sensor tail is inserted below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the Sensor remains attached to the skin with a medical grade adhesive. The Sensor continuously measures glucose concentration in interstitial fluid and has a 15-day memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 15 days.
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Image /page/8/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 letters. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.
FreeStyle Libre 3 App (iOS or Android)
- When downloaded to a compatible smartphone, the FreeStyle Libre 3 App uses NFC . communication to start new Sensors and BLE communication to display glucose data and issue alarms based on the measurements calculated by the Sensor. As a mobile application, the FreeStyle Libre 3 App allows connectivity with cloud-based applications. The FreeStyle Libre 3 App is distributed using the Apple App Store and Google Play Store and a list of compatible devices is accessible in the App via the Help feature or product website.
1.6. Substantial Equivalence
The similarities and differences between the subject and the predicate devices are highlighted in the tables below.
| Similarities | ||
|---|---|---|
| Item | Subject Device: FreeStyle Libre 2 FlashGlucose Monitoring System (with modifiedSensor tail) (K222447) | Predicate Device: FreeStyle Libre 2Flash Glucose Monitoring System(K210943) |
| Intended Use | The System is intended to monitor interstitialfluid glucose concentrations and communicatewith digitally connected devices for thepurpose of managing a disease or conditionrelated to glycemic control. | Same |
| Device type | Integrated CGM | Same |
| Primary displaydevice(s) | FreeStyle Libre 2 Reader or FreeStyle Libre 2App (iOS or Android) | Same |
| Compatible operatingsystems andhardware platformfor App | App is compatible with iOS and Applesmartphone; Android operating system andAndroid-enabled smartphones | Same |
| Principle ofOperation | Amperometric measurement of currentproportional to glucose concentration ininterstitial fluid via glucose oxidase chemicalreaction | Same |
| Test Range | 40 to 400 mg/dL | Same |
| Clinical Application | Management of diabetes mellitus | Same |
| Clinical Setting/Sitesof Use | Home use | Same |
| Data Displayed | Current glucose value, current glucose trend,graph with recent glucose history, userentered events | Same |
| Method of SensorActivation | Near Field Communication (NFC) | Same |
| Optional Alarms | Glucose Alarms: Low Glucose Alarm, HighGlucose AlarmSystem Alarm: Signal Loss Alarm | Same |
| Similarities | ||
| Item | Subject Device: FreeStyle Libre 2 FlashGlucose Monitoring System (with modifiedSensor tail) (K222447) | Predicate Device: FreeStyle Libre 2Flash Glucose Monitoring System(K210943) |
| For Low and High Glucose alarms, a user-initiated action is required to see glucosereading. | ||
| Mandatory Alarms | Glucose Alarm: Urgent Low GlucoseSystem Alarm: Replace Sensor, SensorEnded, App Stopped (iOS only)These alarms are mandatory (set to 'On') andcannot be turned off or modified by the user.It will always sound regardless of the phonesound and vibe or Do Not Disturb settings. | Same |
| Wirelesscommunicationprotocol | Near Field Communication (NFC): (13.56MHz RFID)Bluetooth Low Energy (BLE) | Same |
| BLE CommunicationRange | 20 feet unobstructed | Same |
| Sensor GlucoseAlgorithm | ADC Glucose Algorithm established for thepredicate device | Same |
| Glucose readingupdate interval | Every 1 minute | Same |
| Trend Graph GlucoseHistory | 8 hours, 24 hour graph and other reports canbe used to view logged data | Same |
| Glucose Trend Arrow | ↑, > +2 mg/dL/min↗, +1 to +2 mg/dL/min→, -1 to +1 mg/dL/min↘, -2 to -1 mg/dL/min↓, < -2 mg/dL/min | Same |
| Method ofcommunication andconnectivity withcloud-basedapplications | Reader can communicate and connect withLibreView through the USB port connectionwith the desktop computer.App only: can communicate wirelessly toLibreView. Through LibreView, cancommunicate to LibreLinkUp App | Same |
| Sensor calibration | Factory calibrated | Same |
| Compatible Sensorwarmup time | 1 hour | Same |
| Blood Glucose Meter | While using the App, user must have access toa blood glucose monitoring system as the Appdoes not provide one. | Same |
| Situations wherefingerstick test isrequired to confirmsensor reading(adjunctive use) | The user's symptoms do not match theglucose values displayed by the device.• The device does not show a glucose value• During the first 12 hours of wear during• which the check blood glucose icon isdisplayed | Same |
| Differences | ||
| Item | Subject Device: FreeStyle Libre 2Flash Glucose Monitoring System(with modified Sensor tail) (K222447) | Predicate Device: FreeStyle Libre 2 FlashGlucose Monitoring System (K210943) |
| Indications for Use | The FreeStyle Libre 2 Flash GlucoseMonitoring System is a continuousglucose monitoring (CGM) device withreal time alarms capability indicated forthe management of diabetes in personsage 2 and older. It is intended to replaceblood glucose testing for diabetestreatment decisions, unless otherwiseindicated.The System also detects trends and trackspatterns and aids in the detection ofepisodes of hyperglycemia andhypoglycemia, facilitating both acute andlong-term therapy adjustments.Interpretation of the System readingsshould be based on the glucose trends andseveral sequential readings over time.The System is also intended toautonomously communicate withdigitally connected devices, includingautomated insulin dosing (AID) systems.The System can be used alone or inconjunction with these digitallyconnected devices for the purpose ofmanaging diabetes. | The FreeStyle Libre 2 Flash GlucoseMonitoring System is a continuous glucosemonitoring (CGM) device with real timealarms capability indicated for themanagement of diabetes in persons age 4and older. It is intended to replace bloodglucose testing for diabetes treatmentdecisions, unless otherwise indicated.The System also detects trends and trackspatterns and aids in the detection of episodesof hyperglycemia and hypoglycemia,facilitating both acute and long-term therapyadjustments. Interpretation of the Systemreadings should be based on the glucosetrends and several sequential readings overtime.The System is also intended toautonomously communicate with digitallyconnected devices. The System can be usedalone or in conjunction with these digitallyconnected devices where the user manuallycontrols actions for therapy decisions. |
| Intended UsePopulation | Persons with diabetes age 2 and older | Persons with diabetes age 4 and older |
| Compatibility withconnected devices | Compatible with digitally connecteddevices, including automated insulindosing systems for therapy decisions | Compatible with digitally connected deviceswhere the user manually controls actions fortherapy decisions |
| Compatible Sensors | FreeStyle Libre 2 Sensor (15 day) | FreeStyle Libre 2 Sensor (14 day) |
| Sensor Component | Modified Sensor tail | Sensor tail |
| Differences | ||
| Item | Subject Device: FreeStyle Libre 2Flash Glucose Monitoring System(with modified Sensor tail) (K222447) | Predicate Device: FreeStyle Libre 2 FlashGlucose Monitoring System (K210943) |
| Contraindications | MRI/CT/Diathermy: The System must beremoved prior to Magnetic ResonanceImaging (MRI), Computed Tomography(CT) scan, or high-frequency electricalheat (diathermy) treatment. The effect ofMRI, CT scans, or diathermy on theperformance of the System has not beenevaluated. The exposure may damage theSensor and may impact proper functionof the device which could cause incorrectreadings. | Automated Insulin Dosing: The Systemmust not be used with automated insulindosing (AID) systems, including closed loopand insulin suspend systems.MRI/CT/Diathermy: The System must beremoved prior to Magnetic ResonanceImaging (MRI), Computed Tomography(CT) scan, or high-frequency electrical heat(diathermy) treatment. The effect of MRI,CT scans, or diathermy on the performanceof the System has not been evaluated. Theexposure may damage the Sensor and mayimpact proper function of the device whichcould cause incorrect readings. |
| InterferingSubstance Labeling | Vitamin C labeled as an interferingsubstance at doses of more than 1000 mgof vitamin C per day. | Vitamin C labeled as an interferingsubstance at doses of more than 500 mg ofvitamin C per day. |
| Interoperability | Allows the same wireless and securecommunications as the predicate deviceand additionally enables users tocommunicate iCGM data wirelessly andsecurely to and from digitally connecteddevices (client software) through a cloud-based communication method, the LibreData Sharing API.An interoperability communication planwill be provided to potentialpartners/developers. Thisinteroperability communication planspecifies expectations, requirementsand interface specifications to ensure thedata is transmitted and received securelyand reliably by the digitally connecteddevices. | Designed to enable communication ofglucose data and other informationwirelessly and securely to and fromdigitally connected devices as describedbelow:Wireless communication from theFreeStyle Libre 2 Sensor directly tointeroperable receiver devices, whichconnect with the Sensor using theNFC and BLE wireless interfacesprovided by the Sensor The FreeStyle Libre 2 Appcommunicates through the cloud toanother software device. |
| Similarities | ||
| Item | Subject Device: FreeStyle Libre 3Continuous Glucose Monitoring System(with modified Sensor tail) (K222447) | Predicate Device: FreeStyle Libre 2Flash Glucose Monitoring System(K210943) |
| Intended Use | The System is intended to monitor interstitialfluid glucose concentrations and communicatewith digitally connected devices for thepurpose of managing a disease or conditionrelated to glycemic control. | Same |
| Device type | Integrated CGM | Same |
| Compatible operatingsystems andhardware platformfor App | App is compatible with iOS and Applesmartphone; Android operating system (OS)and Android-enabled smartphones. | Same |
| Principle ofOperation | Amperometric measurement of currentproportional to glucose concentration ininterstitial fluid via glucose oxidase chemicalreaction | Same |
| Test Range | 40 to 400 mg/dL | Same |
| Clinical Application | Management of diabetes mellitus | Same |
| Clinical Setting/Sitesof Use | Home use | Same |
| Data Displayed | Current glucose value, current glucose trend,graph with recent glucose history, userentered events | Same |
| Method of SensorActivation | Near Field Communication (NFC) | Same |
| Optional Alarms | Glucose Alarms: Low Glucose Alarm, HighGlucose AlarmSystem Alarm: Signal Loss Alarm | Same |
| Mandatory Alarms | Glucose Alarm: Urgent Low GlucoseSystem Alarm: Replace Sensor, SensorEnded, Check Sensor, App Stopped (iOSonly)These alarms are mandatory (set to 'On') andcannot be turned off or modified by the user.It will always sound regardless of the phonesound and vibe or Do Not Disturb settings. | Same |
| Wirelesscommunicationprotocol | Near Field Communication (NFC): (13.56MHz RFID)Bluetooth Low Energy (BLE) | Same |
| Sensor GlucoseAlgorithm | ADC Glucose Algorithm established for thepredicate device | Same |
| Glucose readingupdate interval | Every 1 minute | Same |
| Similarities | ||
| Item | Subject Device: FreeStyle Libre 3Continuous Glucose Monitoring System(with modified Sensor tail) (K222447) | Predicate Device: FreeStyle Libre 2Flash Glucose Monitoring System(K210943) |
| Glucose History | Graph and other reports can be used to viewlogged data | Same |
| Glucose Trend Arrow | ↑, > +2 mg/dL/min↗, +1 to +2 mg/dL/min→, -1 to +1 mg/dL/min↘, -2 to -1 mg/dL/min↓, < -2 mg/dL/min | Same |
| Method ofcommunication andconnectivity withcloud-basedapplications | App can communicate wirelessly toLibreView. Through LibreView, cancommunicate to LibreLinkUp App. | Same |
| Sensor calibration | Factory calibrated | Same |
| Compatible Sensorwarmup time | 1 hour | Same |
| Blood Glucose Meter | While using the App, user must have access toa blood glucose monitoring system as the Appdoes not provide one. | Same |
| Situations wherefingerstick test isrequired to confirmsensor reading(adjunctive use) | The user's symptoms do not match the•glucose values displayed by the device.• The device does not show a glucose value•During the first 12 hours of wear duringwhich the check blood glucose icon isdisplayed | Same |
| Differences | ||
| Item | Subject Device: FreeStyle Libre 3Continuous Glucose MonitoringSystem (with modified Sensor tail)(K222447) | Predicate Device: FreeStyle Libre 2 FlashGlucose Monitoring System (K210943) |
| Indications for Use | The FreeStyle Libre 3 ContinuousGlucose Monitoring System is a real timecontinuous glucose monitoring (CGM)device with alarms capability indicatedfor the management of diabetes inpersons age 2 and older. It is intended toreplace blood glucose testing for diabetestreatment decisions, unless otherwiseindicated.The System also detects trends and trackspatterns and aids in the detection of | The FreeStyle Libre 2 Flash GlucoseMonitoring System is a continuous glucosemonitoring (CGM) device with real timealarms capability indicated for themanagement of diabetes in persons age 4 andolder. It is intended to replace blood glucosetesting for diabetes treatment decisions,unless otherwise indicated.The System also detects trends and trackspatterns and aids in the detection of episodesof hyperglycemia and hypoglycemia, |
| episodes of hyperglycemia andhypoglycemia, facilitating both acute andlong-term therapy adjustments.Interpretation of the System readingsshould be based on the glucose trends andseveral sequential readings over time. | facilitating both acute and long-term therapyadjustments. Interpretation of the Systemreadings should be based on the glucosetrends and several sequential readings overtime.The System is also intended to autonomously | |
| The System is also intended toautonomously communicate withdigitally connected devices, includingautomated insulin dosing (AID) systems.The System can be used alone or inconjunction with these digitallyconnected devices for the purpose ofmanaging diabetes. | communicate with digitally connecteddevices. The System can be used alone or inconjunction with these digitally connecteddevices where the user manually controlsactions for therapy decisions. | |
| Intended UsePopulation | Persons with diabetes age 2 and older | Persons with diabetes age 4 and older |
| Compatibility withconnected devices | Compatible with digitally connecteddevices, including automated insulindosing systems for therapy decisions | Compatible with digitally connected deviceswhere the user manually controls actions fortherapy decisions |
| System Components | On-body Sensor(No Sensor Applicator assembly requiredby user prior to applying the Sensor)FreeStyle Libre 3 App | On-body Sensor(User assembles Sensor Applicator andSensor Container prior to applying theSensor)FreeStyle Libre 2 AppFreeStyle Libre 2 Reader |
| Primary displaydevice(s) | FreeStyle Libre 3 App (iOS or Android) | FreeStyle Libre 2 App (iOS or Android) orFreeStyle Libre 2 Reader |
| Differences | ||
| Item | Subject Device: FreeStyle Libre 3Continuous Glucose MonitoringSystem (with modified Sensor tail)(K222447) | Predicate Device: FreeStyle Libre 2 FlashGlucose Monitoring System (K210943) |
| Compatible Sensors | FreeStyle Libre 3 Sensor (15 day) | FreeStyle Libre 2 Sensor (14 day) |
| Sensor Component | Modified Sensor tail | Sensor tail |
| Sensor Dimension | 2.9 mm height / 21 mm diameter | 5 mm height / 30 mm diameter |
| Location of glucosealgorithm | Sensor | Receiver (Reader or App) |
| Method of DataTransfer from Sensor | Bluetooth Low Energy (BLE). Dataautomatically transfers without user-initiated scan (streaming data). | BLE for glucose data transfer to issue alarms.User-initiated scan via NFC required todisplay glucose data |
| BLE CommunicationRange | 33 feet unobstructed | 20 feet unobstructed |
| Informationprovided withglucose alarm | Alarm type, glucose result and trendarrow | Alarm type |
| Contraindications | MRI/CT/Diathermy: The System must beremoved prior to Magnetic ResonanceImaging (MRI), Computed Tomography(CT) scan, or high-frequency electricalheat (diathermy) treatment. The effect ofMRI, CT scans, or diathermy on theperformance of the System has not beenevaluated. The exposure may damage theSensor and may impact proper functionof the device which could cause incorrectreadings. | Automated Insulin Dosing: The System mustnot be used with automated insulin dosing(AID) systems, including closed loop andinsulin suspend systems.MRI/CT/Diathermy: The System must beremoved prior to Magnetic ResonanceImaging (MRI), Computed Tomography(CT) scan, or high-frequency electrical heat(diathermy) treatment. The effect of MRI, CTscans, or diathermy on the performance of theSystem has not been evaluated. The exposuremay damage the Sensor and may impactproper function of the device which couldcause incorrect readings. |
| InterferingSubstance Labeling | Vitamin C labeled as an interferingsubstance at doses of more than 1000 mgof vitamin C per day. | Vitamin C labeled as an interfering substanceat doses of more than 500 mg of vitamin Cper day. |
| Interoperability | Allows the same wireless and securecommunications as the predicate deviceand additionally enables users tocommunicate iCGM data wirelessly andsecurely to and from digitally connecteddevices (client software) through a cloud-based communication method, the LibreData Sharing API. | Designed to enable communication ofglucose data and other informationwirelessly and securely to and from digitallyconnected devices as described below:• Wireless communication from theFreeStyle Libre 2 Sensor directly tointeroperable receiver devices, whichconnect with the Sensor using the NFCand BLE wireless interfaces providedby the Sensor |
| Differences | ||
| Item | Subject Device: FreeStyle Libre 3Continuous Glucose MonitoringSystem (with modified Sensor tail)(K222447) | Predicate Device: FreeStyle Libre 2 FlashGlucose Monitoring System (K210943) |
| An interoperability communication planwill be provided to potentialpartners/developers. Thisinteroperability communication planspecifies expectations, requirementsand interface specifications to ensure thedata is transmitted and received securelyand reliably by the digitally connecteddevices. | The FreeStyle Libre 2 Appcommunicates through the cloud toanother software device. |
1.6.1. FreeStyle Libre 2 Flash Glucose Monitoring System
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Image /page/9/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol 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.
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Image /page/10/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.
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Image /page/11/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the text "Abbott" in bold black font on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, regular black font.
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Image /page/12/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the text "Abbott" in bold black font on the top line and "Diabetes Care" in a regular black font on the bottom line. The logo is simple and modern, with a focus on the company's name and area of expertise.
1.6.2. FreeStyle Libre 3 Continuous Glucose Monitoring System
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Image /page/13/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol 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.
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Image /page/14/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 on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font.
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Image /page/15/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 on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font.
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Image /page/16/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue, stylized "a" symbol on the left, followed by the text "Abbott" in bold, black letters on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black. The logo is clean and professional, suggesting a focus on healthcare and technology.
1.7. Comparison of Technological Characteristics with the Predicate Device
Amperometric measurement of glucose concentration (via glucose oxidase chemical reaction) in the interstitial fluid is the technological principle for both the subject and predicate devices. The electrochemical 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 subcutaneous space. The compatible receiver converts the electrical current signal to a glucose value (in mg/dL) for display to the user.
At a high-level, the subject and predicate devices are based on the following technological elements:
- Use of NFC interface for starting new Sensors
- Use of BLE interface to issue alarms ●
- Use of software algorithm for conversion of the raw glucose measurements from the Sensor ● to calculate glucose results
- Display of glucose results from FreeStyle Libre 2 Sensors after a user-initiated scan via ● NFC. Automatic display of glucose results from FreeStyle Libre 3 Sensors without a user-initiated scan.
- Inclusion of software interface to wirelessly communicate with cloud-based application ● (App only)
The following technological differences exist between the subject and predicate devices
- Incorporate a modified Sensor tail to reduce vitamin C interference .
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Image /page/17/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract shape on the left, followed by the text "Abbott" in bold black font on the top line. Below "Abbott" is the text "Diabetes Care" in a regular black font. The logo is clean and professional, with a focus on the company's name and area of expertise.
- Update Sensor Software and interoperability specification provided to authorized partners ● to allow compatibility with AID systems and extend the Sensor wear duration from 14 days to 15 days
- . Update the App and Reader configurations to disable display of vitamin C interference statements
- Additional software component, the Libre Data Sharing API, to communicate iCGM data ● with authorized client software for specific and permitted use cases in accordance with the cleared intended use environments
1.8. Summary of Performance Testing
The following summary of performance testing support substantial equivalence to the predicate device:
-
. Software
Software regression testing was conducted in accordance with established specifications and IEC 62304 and documentation was provided as recommended by FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The test results met acceptance criteria and support that the subject devices are acceptable for their intended use. -
. Interoperability
Approach to interoperability with authorized partners provides appropriate inputs to support expectations, requirements, and interface specifications to interoperable devices, including AID systems. -
. Non-clinical Testing
Non-clinical performance testing was conducted as per internal design control process requirements. The test results met acceptance criteria and support that the subject devices are acceptable for their intended use. -
Clinical Performance ●
A clinical study evaluated clinical performance with respect to reference venous plasma sample YSI measurements across the measuring range throughout a 15-day wear duration in adult (18 years and older) and pediatric (2 to 17 years) participants with diabetes. An additional clinical study evaluated the effects of high doses of vitamin C on the performance with respect to reference venous plasma sample YSI measurements. Analysis of the results from the clinical studies show that the subject devices meet the iCGM special controls for clinical performance set forth in 21 CFR 862.1355.
The following supportive performance characteristics were established in the predicate device (K210943) and the reference devices (K213996 and K212132) and are not affected by the introduction of the modified Sensor tail in this 510(k):
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Image /page/18/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the word "Abbott" in bold, black font. Below "Abbott" is the phrase "Diabetes Care" in a smaller, non-bold, black font.
- Sterilization ●
- Biocompatibility
- Shelf Life Stability
- Packaging Integrity/Shipping Integrity ●
- Mechanical Engineering
- Electrical Safety and Electromagnetic Compatibility
- Human Factors
- Cybersecurity ●
1.9. Conclusion
The modified FreeStyle Libre 2 Flash Glucose Monitoring System and the modified FreeStyle Libre 3 Continuous Glucose Monitoring System have the same intended use as the predicate device. There are no differences in technological characteristics that raise different questions of safety and effectiveness. Based on the performance testing and data provided in this pre-market notification, the subject devices and predicate device have been shown to be substantially equivalent.
§ 862.1355 Integrated continuous glucose monitoring system.
(a)
Identification. An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Robust clinical data demonstrating the accuracy of the device in the intended use population.
(ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order (
e.g., an internationally recognized reference material and/or method).(iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device.
(iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period.
(v) Clinical study results in the adult population must meet the following performance requirements:
(A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent.
(B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent.
(C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent.
(D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent.
(E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent.
(H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL.
(I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL.
(J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements.
(K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements.
(vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate.
(vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use.
(2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data.
(3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section.
(4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications.
(5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period.
(6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy.
(7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites (
e.g., abdomen, arm, buttock):(i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL.
(ii) A description of the accuracy of positive and negative rate of change data.
(iii) A description of the frequency and duration of gaps in sensor data.
(iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable.
(v) A description of the observed duration of iCGM life for the device.