The Dexcom G7 Continuous Glucose Monitoring (CGM) System is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.

The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on the glucose trends and sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purposes of managing diabetes.

Device Description

The Dexcom G7 Continuous Glucose Monitoring System (G7 System) is an interoperable connected device that measures and displays estimated glucose values for people with diabetes. The G7 System consists of the following components: the Glucose Sensing Subsystem (GSS), the Mobile Application Subsystem (MAS), the Receiver Subsystem (RVS). The GSS is comprised of the sensor applicator and on-body wearable, which includes a Bluetooth Low Energy (BLE) molded transmitter, adhesive patch and sensor. The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The sensor has an expected wear period of up to 10 days with an extended 12-hour grace period after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time.

The molded transmitter is pre-connected to the sensor and is cradled into the applicator needle inside the applicator housing. The applicator external housing consists of a cap and shroud which utilize a threaded cap and seal to create the sterile barrier system. A deployment lock mechanism prevents insertion of the on-body wearable until the applicator is pressed against the insertion site. The insertion is a single button press vertical spring deployed mechanism which introduces the sensor via the needle into the subcutaneous tissue, while also placing the embedded wearable onto the body which adheres to the skin via an adhesive patch.

After deployment, the molded transmitter initiates automatic wakeup and session start. The sensor's small and flexible wire converts glucose to electrical current and the transmitter samples the electrical current produced by the sensor. The transmitter's onboard algorithm converts these measurements into estimated glucose values and calculates the glucose rate of change which are sent every 5 minutes to the MAS and/or the RVS. The MAS and RVS are display devices which present the current qlucose reading and glucose trend to the user. Both display devices alert the user when glucose levels are outside of a target zone and when specific system states occur. The G7 System is designed to communicate to one or both display devices simultaneously.

The G7 System is also designed to communicate estimated glucose values, trend and system information to other compatible electronic interfaces via the following secure wireless connections:

Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol
. The app communicates to another app on a single mobile platform
. The app communicates through the cloud to another software device.
Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable o secure and reliable communication of CGM data to authorized client software intended to receive the data through the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).

AI/ML Overview

The provided document (K213919) is a 510(k) premarket notification for the Dexcom G7 Continuous Glucose Monitoring (CGM) System. While it discusses the device's characteristics and compares them to a predicate device (Dexcom G6), it does not contain the specific acceptance criteria or detailed results of a clinical study that proves the device meets those criteria in the typical format of a clinical trial report.

The document states:
"The Dexcom G7 CGM System was verified and validated according to Dexcom's internal design control processes and in accordance with special controls for integrated continuous glucose monitors. This testing demonstrated that the System performed accordingly to its specifications and that the technological and performance criteria are comparable to the predicate device."

This indicates that internal testing was performed, but the detailed results, sample sizes, ground truth establishment, or expert involvement are not explicitly provided in this summary.

Therefore, I cannot fully provide all the requested information. However, based on the information provided and general knowledge of CGM device regulatory requirements, I can infer and construct some parts of the answer.

Here's an attempt to answer your request based on the available information and reasonable assumptions for a 510(k) submission for a CGM device:

Device: Dexcom G7 Continuous Glucose Monitoring System (K213919)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data. However, for continuous glucose monitoring systems, a key performance metric is accuracy compared to a reference blood glucose measurement. This is typically assessed using metrics like Mean Absolute Relative Difference (MARD) and various error grid analyses (e.g., Consensus Error Grid, Parkes Error Grid).

Inferred Acceptance Criteria (Typical for iCGM) and Assumed Reported Performance (Based on 510(k) Clearance for a similar device):

Performance Metric	Acceptance Criteria (Typical for iCGM)	Reported Device Performance (Inferred from 510(k) clearance, specific data not provided in this document)
Accuracy (MARD)	MARD (Mean Absolute Relative Difference) against YSI reference < 10% (often lower for newer devices, e.g., 9% for iCGM across entire range, or broken down by glycemic range)	The device's performance data, not explicitly detailed here, demonstrated that it "performed accordingly to its specifications and that the technological and performance criteria are comparable to the predicate device." For a predicate iCGM like the G6, MARD values typically fall in the single digits (<10%) across the glycemic range for adults and children, and potentially higher for specific low (hypoglycemic) ranges (e.g., <15% MARD at <70 mg/dL). Given a 510(k) clearance, the G7 would have met or exceeded the accuracy requirements established for its predicate and the iCGM special controls. Specific MARD values are not presented in this summary document.
Consensus Error Grid Analysis	>95% of points in Zones A+B for all glycemic ranges (adults and children); very few, if any, points in Zones C, D, E.	The device would have met the stringent requirements for clinical accuracy as assessed by Consensus Error Grid or similar error grid analyses, demonstrating that a vast majority of CGM readings are clinically accurate (Zone A) or lead to benign or no treatment errors (Zone B). Specific percentages for each zone are not presented in this summary document but are a standard part of CGM submissions.
Rate of Change Accuracy	Performance metrics demonstrating reliable detection of rapid glycemic changes (e.g., >80% accuracy for alerts/alarms for rapid rise/fall).	The system's ability to aid in the detection of hyperglycemia and hypoglycemia and facilitate acute/long-term therapy adjustments implies meeting performance criteria for rate of change and alert accuracy. Specific metrics are not presented.
Sensor Warm-Up Time	Target: Within 30 minutes	Reported: Within 30 minutes (specifically 27 minutes)
Sensor Life	Target: Up to 10 days with a grace period	Reported: Up to 10 days with a 12-hour grace period
Minimum Measuring Range	40-400 mg/dL	Reported: 40-400 mg/dL
Replace Fingerstick BG Testing	Clinical data supporting the ability to replace fingerstick BG testing for diabetes treatment decisions based on accuracy and reliability.	The indication for use explicitly states the system "is intended to replace fingerstick BG testing for diabetes treatment decisions." This implies that the underlying clinical data met the necessary performance thresholds for this claim.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample size for the clinical test set. However, 510(k) submissions for iCGM devices typically involve robust clinical studies with hundreds of participants across various age groups (adults and children/adolescents from 2 years old, as per the indication for use) to evaluate performance under real-world conditions and in controlled clinical settings (e.g., hyperglycemic and hypoglycemic clamps).

The data provenance is not specified. However, for a major medical device company like Dexcom, these studies are typically multi-center, prospective clinical trials conducted in the United States and potentially other geographies, adhering to GCP (Good Clinical Practice) guidelines. The document does not specify whether the data was retrospective or prospective, but clinical validation for a device of this class would almost certainly involve prospective data collection.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

For CGM device validation, ground truth is not established by "experts" in the sense of image readers, but rather through highly accurate laboratory reference methods.

Ground Truth Method: Reference blood glucose measurements obtained from a YSI Glucose Analyzer, which is a gold standard laboratory method.
Personnel Qualifications: Highly trained clinical staff and laboratory technicians who follow strict protocols for blood sample collection and YSI analysis. Not typically "experts" like radiologists, but rather clinical and lab professionals.

4. Adjudication Method for the Test Set:

Not applicable in the context of a CGM device. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers are interpreting images or other subjective data, and a consensus or authoritative reading is needed for ground truth or comparison. For CGM, the "ground truth" is a direct, objective laboratory measurement (YSI).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement:

Not applicable. MRMC studies are used for evaluating the impact of AI on human readers for diagnostic imaging, not for continuous glucose monitors, which provide quantitative measurements. The Dexcom G7 System does not involve human "reading" of data in the same way as, for example, a radiology AI.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, in essence. The primary performance assessment of a CGM device like the Dexcom G7 is its stand-alone accuracy (the algorithm's calculations of glucose values) when compared to a laboratory reference. While the device is intended for human use and interpretation of trends, its fundamental accuracy metrics (e.g., MARD, Error Grid analysis) represent the performance of the device's sensor and algorithm without human intervention in the primary glucose measurement and calculation. The "human-in-the-loop" aspect comes into play with treatment decisions, but the device's numerical output itself is an "algorithm only" performance metric.

7. The Type of Ground Truth Used:

The ground truth used for validating the Dexcom G7's accuracy would be concurrent blood glucose measurements obtained from a YSI Glucose Analyzer (or an equivalent traceable clinical chemistry laboratory method). This is considered the gold standard for glucose measurement in clinical studies.

8. The Sample Size for the Training Set:

The document does not explicitly state the sample size for the training set. For data-driven medical devices like CGMs, the training data (for calibration algorithms, signal processing, etc.) is typically derived from extensive internal research and development studies, often involving hundreds to thousands of sensor wear periods and millions of data points collected over years. This data would encompass a wide range of glucose values, patient populations, and physiological conditions to ensure the algorithm is robust.

9. How the Ground Truth for the Training Set Was Established:

The ground truth for the training set would be established in the same manner as the test set: through concurrent, highly accurate laboratory reference blood glucose measurements (YSI) taken alongside CGM readings. This ensures that the algorithm learns from precise and reliable reference data. These training data sets often include induced hypoglycemia and hyperglycemia to ensure algorithm performance across the full dynamic range of glucose.

Summary

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December 7, 2022

Dexcom. Inc. Holly Drake Director, Regulatory Affairs 6340 Sequence Dr. San Diego, California 92121

Re: K213919

Trade/Device Name: Dexcom G7 Continuous Glucose Monitoring (CGM) System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: QBJ Dated: September 14, 2022 Received: September 15, 2022

Dear Holly Drake:

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 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,

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213919

Device Name

Dexcom G7 Continuous Glucose Monitoring (CGM) System

Indications for Use (Describe)

The Dexcom G7 Continuous Glucose Monitoring (CGM) System is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.

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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5 510(K) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: K213919

5.1 Submitter:

Dexcom, Inc. 6340 Sequence Dr. San Diego, CA 92121

Primary Contact: Holly Drake Position/Title: Director, Regulatory Affairs Phone: 858.875.5326 Fax: 858.332.0204 Email: hdrake@dexcom.com

Alternate Contact: Neeta Sharma Position/Title: VP, Regulatory Affairs Phone: 858.203.6362 Fax: 858.332.0204 Email: neeta.sharma@dexcom.com

Date Prepared: November 29, 2022

5.2 DEVICE NAMES AND CLASSIFICATION:

Proprietary Name	Dexcom G7 Continuous Glucose Monitoring (CGM) System
Common Name	Integrated Continuous Glucose Monitoring System, FactoryCalibrated
Class	II
ClassificationRegulation	21 CFR 862.1355
Product Code	QBJ
Review Panel	Clinical Chemistry

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5.3 PREDICATE DEVICE:

Dexcom G6 Continuous Glucose Monitoring (CGM) System (K201328)

5.4 Device Description:

The G7 System is also designed to communicate estimated glucose values, trend and system information to other compatible electronic interfaces via the following secure wireless connections:

Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol
. The app communicates to another app on a single mobile platform
. The app communicates through the cloud to another software device.

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Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable o secure and reliable communication of CGM data to authorized client software intended to receive the data through the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).
The proposed G7 CGM System is based on the same mode of operation and mechanism of reaction as the predicate G6 CGM System (K201328), which uses a wiretype sensing mechanism that continuously measures interstitial fluid glucose levels and a BLE enabled radio transmitter to wirelessly communicate CGM data to compatible display devices at regular 5-minute intervals. These data are also able to be reliably and securely transmitted to other digitally connected devices, including automated insulin dosing systems, for the purpose of managing diabetes. The Dexcom Partner Web APIs also enable secure and reliable communication of CGM data to authorized client software as another compatible electronic interface.

The G7 CGM System primarily improves upon the user experience of the predicate G6 CGM System by providing a fully enclosed miniaturized wearable with pre-connected sensor that is applied to the body in a single button press. The MAS and RVS include redesigned user interfaces which simplify the use of CGM while including retrospective summary reports for quick access by the user.

5.5 Indications for Use

The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.

The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

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5.6 Comparison of Technological Characteristics with the Predicate Device:

Device and PredicateDevice	Subject Device(K213919)	Predicate Device(K201328)
Device Trade Name	Dexcom G7 Continuous Glucose MonitoringSystem	Dexcom G6 Continuous Glucose Monitoring System
Manufacturer	Dexcom, Inc.	Same
General Device Characteristics
Intended Use	An integrated continuous glucose monitoringsystem (iCGM) is intended to automaticallymeasure glucose in bodily fluids continuously orfrequently for a specified period of time. iCGMsystems are designed to reliably and securelytransmit glucose measurement data to digitallyconnected devices, including automated insulindosing systems, and are intended to be usedalone or in conjunction with these digitallyconnected medical devices for the purpose ofmanaging a disease or condition related toglycemic control.	Same
Indications for Use	The Dexcom G7 Continuous Glucose MonitoringSystem (Dexcom G7 CGM System or G7) is areal time, continuous glucose monitoring deviceindicated for the management of diabetes inpersons 2 years and older.The Dexcom G7 CGM System is intended toreplace fingerstick BG testing for diabetestreatment decisions. Interpretation of the Dexcom	Same except for Trade NameThe Dexcom G6 Continuous Glucose MonitoringSystem (Dexcom G6 System) is a real time,continuous glucosemonitoring device indicated for the management ofdiabetes in persons age 2 years and older.
Device and PredicateDevice	Subject Device(K213919)	Predicate Device(K201328)
	G7 CGM System results should be based on theglucose trends and several sequential sensorreadings over time. The Dexcom G7 CGM Systemalso aids in the detection of episodes ofhyperglycemia and hypoglycemia, facilitating bothacute and long-term therapy adjustments.The Dexcom G7 CGM System is also intended toautonomously communicate with digitallyconnected devices, including automated insulindosing (AID) systems. The Dexcom G7 CGMSystem can be used alone or in conjunction withthese digitally connected medical devices for thepurpose of managing diabetes.	The Dexcom G6 System is intended to replacefingerstick blood glucose testing for diabetestreatment decisions.Interpretation of the Dexcom G6 System resultsshould be based on the glucose trends and severalsequential readingsover time. The Dexcom G6 System also aids in thedetection of episodes of hyperglycemia andhypoglycemia, facilitating both acute and long-termtherapy adjustments.The Dexcom G6 System is also intended toautonomously communicate with digitally connecteddevices, includingautomated insulin dosing (AID) systems. TheDexcom G6 System can be used alone or inconjunction with these digitallyconnected medical devices for the purpose ofmanaging diabetes.
Principle of Operation	Amperometric measurement of currentproportional to glucose concentration in interstitialfluid via glucose oxidase chemical reaction	Same
Sample Type	Interstitial fluid	Same
Enzyme	Glucose Oxidase	Same
Clinical Setting	Home use	Same
Intended Use Population	Persons with diabetes age 2 and above	Same
Measuring Range	40-400 mg/dL	Same
Interferent Substances	Hydroxyurea, Acetaminophen (e.g. > 1 gramevery 6 hours in adults)	Same
Anatomical Wear Locations	Arm (age 2+ years);Upper buttocks (age 2-6 years)	Abdomen (age 2+ years);Upper buttocks (age 2-17 years)
Device and PredicateDevice	Subject Device(K213919)	Predicate Device(K201328)
Data Displayed	Current glucose value, current glucose trend,graph with recent glucose history, user enteredevents	Same
Calibration	Factory calibrated, optional manual calibration	Same
Situations when fingerstick isrequired to confirm sensorreading (adjunctive use)	User's symptoms do not match the glucose value displayed by the device No glucose value or trend is displayed by the device	Same
Primary Display Device	Mobile app installed on compatible smart deviceor Receiver	Same
Compatibility with IntendedEnvironments	iOS and Android	Same
Glucose Alerts	Urgent low, urgent low soon, low glucose, highglucose, falling rate, rising rate	Same
Sensor Warm Up Time	Within 30 minutes (27 minutes)	2 hours
Sensor Life	Up to 10 days with a 12-hour grace period	Up to 10 days
Sterilization	Ethylene Oxide (EO)	Electron Beam radiation
Transmitter Life	Single Use (10.5 days)	Reusable (90 days)
Wireless Communicationprotocol	Bluetooth Core Specification v4.2	Bluetooth Core Specification v4.0
Wireless Communicationrange	20 feet	Same
Glucose reading interval	Autonomously every 5 minutes	Same

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5.7 Summary of Performance Testing

The Dexcom G7 CGM System was verified and validated according to Dexcom's internal design control processes and in accordance with special controls for integrated continuous qlucose monitors. This testing demonstrated that the System performed accordingly to its specifications and that the technological and performance criteria are comparable to the predicate device.

Conclusions 5.8

The Dexcom G7 CGM System is submitted as a proposed Integrated Continuous Glucose Monitoring (iCGM) designed to assist management of diabetes mellitus in persons 2 years and older. Information in this premarket notification demonstrates the Dexcom G7 CGM System conforms to the requirements of 21 CFR 862.1355 (iCGM Special Controls) and all mitigation measures necessary for identified risks to health are successfully implemented.

The submitted information in this premarket notification supports the Dexcom G7 CGM System is substantially equivalent to the Dexcom G6 CGM System as they are identical with regard to intended use and there are no differences in indications, technological characteristics or performance that raise new questions of safety and effectiveness.

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.