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.

Device Description

The FreeStyle Libre 2 Flash Glucose Monitoring System with the FreeStyle Libre 2 App (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 System requires a prescription and is intended for home use. The System consists of the following components: a sensor which transmits via Bluetooth Low Energy (BLE), a BLE enabled display device (Reader), and an iOS mobile app (FreeStyle Libre 2 App) downloaded to a compatible smartphone. Scanning of the sensor via Reader or App 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 make treatment decisions based in part on the sensor glucose results provided by the System. The System also provides configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.

AI/ML Overview

The provided text describes the FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) and its substantial equivalence to a predicate device. However, the document primarily focuses on explaining the device, its intended use, comparison with a predicate, and the general types of performance testing conducted to support substantial equivalence for the app component.

Crucially, the acceptance criteria and detailed study results proving the device meets those criteria (specific performance metrics, sample sizes for clinical trials, ground truth establishment, expert adjudication, MRMC studies, etc.) are NOT explicitly present in this excerpt. The document states "no additional clinical data beyond that provided in K193371 was used in this 510(k) to support a determination of substantial equivalence" for clinical performance, indicating reliance on prior submissions for the predicate device. Therefore, a comprehensive answer for the requested points regarding the study that proves the device meets the acceptance criteria cannot be fully extracted from this document alone.

However, based on the information provided, I can infer and answer parts of your request.

Here's an attempt to answer your questions based on the provided text, and where information is missing, I will clearly state that:

Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (K193371)

A Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with corresponding performance metrics. It generally states that "Results of executed protocols met the acceptance criteria" for various tests, but does not quantify these criteria or the results.

Acceptance Criteria (Inferred from general statements)	Reported Device Performance (General Statement in document)
Software Verification and Validation: Meets established specifications and IEC 62304 guidance.	"Results of executed protocols for the met the acceptance criteria and therefore supports that the System's embedded software is acceptable for its intended use."
Human Factors: Meets usability requirements.	"Results demonstrated that the System met usability requirements."
Wireless Coexistence: Tolerates interference from various RF interfering devices and meets target performance criteria.	"Test results showed the System could tolerate interference generated by these RF interfering devices and still meet the target performance criteria."
Cybersecurity: Risk mitigation controls are implemented and tested.	"Appropriate risk mitigation controls have been implemented and tested."
Electrical Safety and EMC: Complies with IEC 60601-1:2005(r)2012 and IEC 60601-1-2:2014.	"demonstrated that the System complies with electrical safety and EMC requirements."
Clinical Performance (Accuracy)	"The App utilizes the identical algorithm and implements the same wireless interfaces with the Sensor as used by the Reader. As the App calculates glucose information identically to the Reader, no additional clinical data beyond that provided in K193371 was used in this 510(k) to support a determination of substantial equivalence." (This implies that the clinical performance established for the predicate device is considered applicable and meets criteria, but specific numbers are not here).

1. Sample sized used for the test set and the data provenance:

Sample Size for Test Set: Not specified in this document. The document states that no additional clinical data was used for this 510(k) beyond what was presented in K193371 (the predicate device's submission). The performance testing described (Software V&V, Human Factors, Wireless Coexistence, Cybersecurity, Electrical Safety/EMC) are generally system-level or component-level tests, not direct patient clinical trials with specific "test sets" in the sense of clinical data.
Data Provenance: Not specified for the clinical data that supports the predicate device (K193371). For the testing described in this document (Software, Human Factors, etc.), it's implied to be internal testing by Abbott Diabetes Care Inc. and conducted in laboratory environments. The document does not specify if it's retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not describe specific "ground truth" establishment for a clinical test set in this submission, as it defers to a previous 510(k) (K193371) for clinical performance data. Therefore, the number and qualifications of experts for establishing clinical ground truth are not provided here.
For Human Factors testing, "usability requirements" were met, implying expert evaluation or user testing, but the specifics of who established the "ground truth" or expert qualifications are not detailed.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not specified. Since clinical data specifics are not provided in this submission (deferring to K193371), there's no mention of an adjudication method commonly used in clinical trials for ground truth.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a Continuous Glucose Monitoring (CGM) system, not an AI-assisted diagnostic imaging device that involves human "readers" interpreting cases. Therefore, an MRMC study is not relevant to this device type.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document implies that standalone performance of the algorithm was assessed for the core glucose measurement. It states, "The App utilizes the identical algorithm and implements the same wireless interfaces with the Sensor as used by the Reader. As the App calculates glucose information identically to the Reader..." This suggests that the algorithm's performance in converting raw sensor measurements to glucose values was established and relied upon from the predicate device's data (K193371). No specific standalone performance metrics are provided in this document, but the fact that the algorithm is "identical" means its standalone performance is assumed to be the same as the predicate.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the clinical performance of a CGM, the ground truth typically involves lab-based reference glucose measurements (e.g., YSI analyzer or similar highly accurate methods) from blood samples taken concurrently with sensor readings. However, none of these specifics for ground truth are provided in this document, as it refers back to K193371 for clinical data.

7. The sample size for the training set:

Not specified. The document does not discuss the training of the glucose algorithm. It merely confirms that the app uses the "identical algorithm" as the predicate device.

8. How the ground truth for the training set was established:

Not specified. As the document does not detail the training set, it also does not elaborate on how its ground truth was established.

In summary, this 510(k) summary focuses on demonstrating substantial equivalence for the addition of an app to an already cleared CGM system. It relies heavily on the clinical performance and established ground truth from the predicate device's prior submission (K193371) for the core glucose measurement accuracy. The testing described in this particular document pertains mostly to software validation, human factors, wireless communication, cybersecurity, and electrical safety/EMC, which are specific to the new app component and its interaction with the existing system, rather than new clinical accuracy studies.

Summary

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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

July 30, 2021

Abbott Diabetes Care Inc. Ono Bacani Regulatory Affairs Project Manager 1360 South Loop Road Alameda, CA 94502

Re: K201761

Trade/Device Name: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: QLG, NBW Dated: December 21, 2020 Received: December 23, 2020

Dear Ono Bacani:

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

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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); 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 medical devices and radiation-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, PhD 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) K201761

Device Name

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

Indications for Use (Describe)

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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Image /page/3/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 words "Abbott" in bold black letters on the top line and "Diabetes Care" in smaller black letters 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.

510(k) Number: K201761

1.1 Submitter:

Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502

Contact: Ono Bacani Title: Regulatory Affairs Project Manager Phone: 510-239-2622 Fax: (510) 864-4791

Date Prepared: July 22, 2021

1.2 Device Names and Classification:

Name of Device:	FreeStyle Libre 2 Flash Glucose Monitoring System(with FreeStyle Libre 2 App)
Common Name:	Integrated Continuous Glucose Monitoring System, FactoryCalibrated, Not for use with automated insulin deliverysystems
Regulatory Section:	21 CFR 862.1355, 21 CFR 862.1345
Classification:	Class II
Product Code(s):	QLG, NBW
Review Panel:	Clinical Chemistry

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Image /page/4/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue abstract shape on the left, followed by the text "Abbott" in bold, black letters on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.

1.3 Predicate Device

Predicate Device:	FreeStyle Libre 2 Flash Glucose Monitoring System, K193371
	This predicate device has not been subject to a recall
Reference Device:	Bigfoot Unity Diabetes Management System, K202145
	Subject Device components are a subset of the ReferenceDevice and hence, electromagnetic compatibility testingcompleted for the Reference Device applies to theelectromagnetic compatibility performance of the SubjectDevice compliant to IEC 60601-1-2:2014.

1.4 Indications for Use:

Indications for Use:

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.

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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 "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 clean and professional, conveying a sense of trust and reliability.

Device Description 1.5

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 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, 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 14 days.
FreeStyle Libre 2 Reader
The Reader is a small handheld device that is powered by a lithium-ion rechargeable battery and uses RFID 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)
The App's design, functionality and user interface is based on the handheld Reader. When downloaded to a compatible smartphone, the App uses RFID 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 iOS FreeStyle Libre 2 App is distributed using the Apple App Store, and a list of compatible devices is accessible in the App via the Help feature or product website.

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Image /page/6/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 on the top line, and "Diabetes Care" in a smaller, black font on the bottom line. The logo is simple and modern, and the use of blue and black gives it a professional look.

Substantial Equivalence 1.6

A. Predicate Device Name:

FreeStyle Libre 2 Flash Glucose Monitoring System

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

K193371

C. Comparison with Predicate:

The similarities and differences between the subject and the predicate device are highlighted in the tables below.

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Image /page/7/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" in blue on the left, followed by the words "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, and it is likely used to represent the company's brand.

Similarities
Item	Subject Device: FreeStyle Libre 2 Flash Glucose Monitoring System(with FreeStyle Libre 2 App)	Predicate Device: FreeStyle Libre 2 FlashGlucose Monitoring System (K193371)
Intended Use	The System is intended to monitor interstitial fluid glucoseconcentrations and communicate with digitally connected devices for thepurpose of managing a disease or condition related to glycemic control.	Same
Indications for Use	The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuousglucose monitoring (CGM) device with real time alarms capabilityindicated for the management of diabetes in persons age 4 and older. It isintended to replace blood glucose testing for diabetes treatmentdecisions, unless otherwise indicated.The System also detects trends and tracks patterns and aids in thedetection of episodes of hyperglycemia and hypoglycemia, facilitatingboth acute and long-term therapy adjustments. Interpretation of theSystem readings should be based on the glucose trends and severalsequential readings over time.The System is also intended to autonomously communicate withdigitally connected devices. The System can be used alone or inconjunction with these digitally connected devices where the usermanually controls actions for therapy decisions.	Same
Device type	Integrated CGM	Same
Principle of Operation	Amperometric measurement of current proportional to glucoseconcentration in interstitial fluid via glucose oxidase chemical reaction	Same
Test Range	40 to 400 mg/dL	Same
Clinical Application	Management of diabetes mellitus	Same
Intended Use Population	Persons with diabetes age 4 and older	Same
Clinical Setting/Sites of Use	Home use	Same
Data Displayed	Current glucose value, current glucose trend, graph with recent glucosehistory, user entered events	Same
Compatible Sensor	FreeStyle Libre 2 Sensor	Same
Method of Sensor Activation	RFID communication	Same
Method of Data transfer fromSensor	RFID – upon user-initiated scanBLE - for glucose data to support glucose alarms	Same
Similarities
Item	Subject Device: FreeStyle Libre 2 Flash Glucose Monitoring System(with FreeStyle Libre 2 App)	Predicate Device: FreeStyle Libre 2 FlashGlucose Monitoring System (K193371)
Optional Alarms	Low Glucose Alarm, High Glucose Alarm, Signal Loss Alarm	Same
	For Low and High Glucose alarms, a user-initiated actionis required to see glucose reading
Scan-Based Alerts	Scan Error, Sensor Error, Replace Sensor, Sensor Ended	Same
Wireless communicationprotocol with version number	Near Field Communication (NFC): (13.56 MHz RFID)Bluetooth Low Energy (BLE): 4.0	Same
BLE Communication range	20 feet unobstructed	Same
Sensor Glucose Algorithm	The app uses the same algorithm as the FreeStyle Libre 2 Reader	Same
Glucose reading update interval	Every 1 minute	Same
Trend Graph Glucose History	8 hours, 24-hour graph and other reports can be used to view logged data	Same
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↓, < -2 mg/dL/min	Same
Situations where fingerstick testis required to confirm sensorreading (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 during which the check blood glucose icon is displayed	Same
Compatibility with connecteddevices	Compatible with digitally connected devices where the user manuallycontrols actions for therapy decisions	Same
Sensor calibration	Factory calibrated	Same
Compatible sensor warmup time	1 hour	Same
Compatible sensor life	Up to 14 days (automatic sensor shut off)	Same
Trend graph glucose historycapabilities	8 hours, 24-hour graph and other reports can be used to view logged data	Same
Differences
Item	Subject Device: FreeStyle Libre 2 Flash GlucoseMonitoring System (with FreeStyle Libre 2 App)	Predicate Device: FreeStyle Libre 2 Flash Glucose MonitoringSystem (K193371)
Primary display device(s)	FreeStyle Libre 2 Reader or FreeStyle Libre 2 App	FreeStyle Libre 2 Reader
Mandatory Alarms	The App includes mandatory alarms for Urgent LowGlucose, Replace Sensor, Sensor Ended, App StoppedThese alarms are mandatory (set to 'On') and cannot bemodified by the user. For Urgent Low Glucose alarm, auser-initiated action is required to see glucose reading	Not applicable
Blood Glucose Meter	While using the App, user must have access to a bloodglucose monitoring system as the App does not provideone.	An integrated BGM is provided with the ReaderThe FreeStyle Libre 2 Reader has a built-in blood glucose meterthat is designed to be used only with FreeStyle Precision Neo bloodglucose test strips and MediSense Glucose and Ketone ControlSolution.
Method ofcommunication andconnectivity with cloud-based applications	App only: can communicate wirelessly to LibreView.Through LibreView, can communicate to LibreLinkUpApp	The Reader can communicate and connect with LibreView throughthe USB port connection with the desktop computer.The Reader does not have wireless capabilities to interface withLibreLinkUp App.
Compatible operatingsystems and hardwareplatform	Compatible with Apple iOS	The Reader is microcontroller-based electronic devicemanufactured with various electronics and plastic parts. TheReader does not require iOS operating system function.

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Image /page/8/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, also in black.

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Image /page/9/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 word "Abbott" in bold, black letters. Below "Abbott" is the phrase "Diabetes Care" in a smaller, non-bold font, also in black. The logo is clean and professional, suggesting a focus on healthcare and technology.

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Comparison of Technological Characteristics with the Predicate Device 1.7

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 a metal 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:

Compatibility with FreeStyle Libre 2 Sensor
Use of NFC interface for starting new sensors and scanning sensors to display ● glucose readings
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

The following technological differences exist between the subject and predicate devices:

The Reader is a dedicated medical device whereas the App is installed on a ● compatible iOS smartphone, a multifunctional platform that includes other nonmedical device functions (e.g. smartphone OS settings, phone calls, text messages, and other non-medical device mobile apps). The impact of the interface between the smartphone and the FreeStyle Libre 2 App were evaluated as part of System performance testing, and the App incorporates additional software controls to detect variations in smartphone settings and smartphone operating system configurations that may impact alarm delivery.
The App requires a compatible NFC- and BLE-enabled smartphone for wireless ● communication with the Sensor.
The App provides the added functionality to wirelessly communicate with cloudbased application.
. The App provides the added functionality to share glucose results and screenshots of the glucose reports through the App's share function.

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Image /page/11/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized blue "a" on the left, followed by the words "Abbott" in bold black letters on the top line and "Diabetes Care" in a smaller, non-bold font on the bottom line. The logo is simple and modern, with a focus on the company's name and area of expertise.

Summary of Performance Testing 1.8

The following performance testing was conducted to support substantial equivalence:

Software Verification and Validation - software verification and validation testing was conducted in accordance with established specifications and IEC 62304 and documentation was provided as recommended by FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 11, 2005. Results of executed protocols for the met the acceptance criteria and therefore supports that the System's embedded software is acceptable for its intended use.
Human Factors - human factors testing of the System was conducted in accordance with ANSI/AAMI/IEC 62366, IEC 60601-1-6, and FDA Guidance titled Applying Human Factors and Usability Engineering to Medical Devices," dated February 3, 2016. Results demonstrated that the System met usability requirements.
Wireless Coexistence - the System underwent coexistence testing consistent with AAMI TIR69 and ANSI C63.27 and included test challenges from in-band interference sources defined in ANSI C63.27, as well as other expected wireless interference sources from the intended use environment. Test results showed the System could tolerate interference generated by these RF interfering devices and still meet the target performance criteria.
Cybersecurity - ADC has provided cybersecurity risk management documentation for the System that includes analysis of confidentiality, integrity, and availability for data, information and software related to the System. 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.
. Electrical Safety and Electromagnetic Compatibility (EMC) - the System underwent electrical safety and EMC evaluation. Results of this evaluation in conjunction with EMC testing completed from the reference device (K202145) demonstrated that the System complies with electrical safety and EMC requirements per IEC 60601-1:2005(r)2012 and IEC 60601-1-2:2014, respectively.

The following supportive performance characteristics were established in the predicate device in K193371 and are not affected by the introduction of the iOS FreeStyle Libre 2 App in the current 510(k):

Sterilization
Biocompatibility ●
Mechanical Engineering ●
Environmental Testing
Shelf-Life Stability ●
Packaging Integrity/Shipping Integrity ●
Interoperability ●

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Image /page/12/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.

Clinical Performance the App utilizes the identical algorithm and implements the . same wireless interfaces with the Sensor as used by the Reader. As the App calculates glucose information identically to the Reader, no additional clinical data bevond that provided in K193371 was used in this 510(k) to support a determination of substantial equivalence.

Conclusion 1.9

The FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) has the identical intended use and clinical application as the predicate device. The difference in technological characteristics as a result of introducing the iOS FreeStyle Libre 2 App as an alternate primary display option, have been addressed through risk control measures to provide reasonable assurance of the safety and effectiveness of the modified System. The Reader and the App utilize the identical algorithm and implements the same wireless interfaces with the Sensor. System performance testing (using Sensors and representative smartphone models with the App installed) confirmed that the device met all specified criteria, which supports that the System provides accurate, secure, and reliable glucose readings in accordance with the iCGM special controls. Based on the performance testing and data provided in this pre-market notification, the subject and predicate device have been shown to be substantially equivalent.

Regulation Number and Section

§ 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.