K Number
K240902
Device Name
Dexcom G7 Continuous Glucose Monitoring System
Manufacturer
Date Cleared
2024-04-23

(21 days)

Product Code
Regulation Number
862.1355
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 hypodlycemia, 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 purpose of managing diabetes.
Device Description
The Dexcom G7 Continuous Glucose Monitoring System) is an interoperable continuous glucose monitoring (CGM) system intended to continuously measure the interstitial fluid, calculate the qucose reading and make this available to the user. The G7 System is intended for single patient use at home and requires a prescription. The G7 System comprises the following primary components: a wearable, consisting of a G7 sensor and transmitter worn on the body and a display device, which can be a G7 Mobile App) on an iOS or Android OS smart device, or a G7 Receiver (Receiver). To achieve the intended functions and performance of the G7 System, one sensor and at least one display device (App or Receiver) must be used together. The user must pair the display device(s) with each unique sensor to enable communication and start a sensor session. During an active session, the sensor reports new glucose data to the display device every 5-minutes. The displays glucose data and provides alerts and information signals to the user. The reportable glucose range for the G7 System is 40 mg/dL to 400 mg/dL. Glucose values below this range are reported as 'LOW' and glucose values above this range are reported as 'HIGH'. 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 G7 is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely to and from 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 Mobile App communicates to another app on a single mobile platform · The Mobile App communicates through the cloud to another software device o Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable secure and reliable communication of CGM data to authorized client software intended to receive the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID). Principle of Operation: The principles of operation for the Dexcom G7 System renain the same as prior generations of Dexcom CGM System uses a wire-type sensing mechanism that continuously measures interstitial glucose levels and uses a radio transmitter to wirelessly communicate glucose data to the display device for the user to see and use accordingly.
More Information

Not Found

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the principle of operation does not mention any AI/ML components.

Yes
The device is indicated for the "management of diabetes" and "aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments," which directly relates to managing a disease.

Yes

The device continuously measures interstitial glucose levels to aid in the detection of hyperglycemia and hypoglycemia and inform diabetes treatment decisions, which are diagnostic purposes for managing diabetes.

No

The device description explicitly states that the system comprises a wearable sensor and transmitter worn on the body, in addition to the software components (Mobile App or Receiver). This indicates the presence of hardware components essential for the device's function.

Based on the provided text, the Dexcom G7 Continuous Glucose Monitoring System is an In Vitro Diagnostic (IVD).

Here's why:

  • Measures a biological substance: The device continuously measures glucose levels in interstitial fluid. Glucose is a biological substance.
  • Used for medical purposes: The intended use clearly states it's for the "management of diabetes," "replace fingerstick BG testing for diabetes treatment decisions," and "aids in the detection of episodes of hyperglycemia and hypodlycemia." These are all medical purposes related to diagnosing, monitoring, or treating a disease.
  • Performed outside the body: While the sensor is worn on the body, the measurement of the interstitial fluid and the calculation of the glucose reading are processes that occur outside of the major physiological functions of the body in the same way that a blood glucose meter measures blood glucose outside the body.

Therefore, the Dexcom G7 fits the definition of an In Vitro Diagnostic device.

N/A

Intended Use / 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 hypodlycemia, 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 purpose of managing diabetes.

Product codes (comma separated list FDA assigned to the subject device)

QBJ, KGX

Device Description

The Dexcom G7 Continuous Glucose Monitoring System is an interoperable continuous glucose monitoring (CGM) system intended to continuously measure the interstitial fluid, calculate the glucose reading and make this available to the user. The G7 System is intended for single patient use at home and requires a prescription.

The G7 System comprises the following primary components: a wearable, consisting of a G7 sensor and transmitter worn on the body and a display device, which can be a G7 Mobile App on an iOS or Android OS smart device, or a G7 Receiver.

To achieve the intended functions and performance of the G7 System, one sensor and at least one display device (App or Receiver) must be used together. The user must pair the display device(s) with each unique sensor to enable communication and start a sensor session. During an active session, the sensor reports new glucose data to the display device every 5-minutes. The displays glucose data and provides alerts and information signals to the user. The reportable glucose range for the G7 System is 40 mg/dL to 400 mg/dL. Glucose values below this range are reported as 'LOW' and glucose values above this range are reported as 'HIGH'. 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 G7 is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely to and from 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 Mobile App communicates to another app on a single mobile platform
• The Mobile App communicates through the cloud to another software device
o Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable secure and reliable communication of CGM data to authorized client software intended to receive the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).

Principle of Operation:
The principles of operation for the Dexcom G7 System remain the same as prior generations of Dexcom CGM System uses a wire-type sensing mechanism that continuously measures interstitial glucose levels and uses a radio transmitter to wirelessly communicate glucose data to the display device for the user to see and use accordingly.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

2 years and older.

Intended User / Care Setting

user, at home

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The subject device G7 CGM System is substantially equivalent to the predicate device G7 CGM System. The difference between the subject device and predicate device is the BLE communication and associated labeling updates. No design change was required to support the extended BLE communication. The following performance characteristic was established through nonclinical testing performed on the subject device G7 CGM System:

  • Communication Range testing: This testing demonstrates that the subject device G7 CGM System met the extended BLE communication range specification.
    Nonclinical testing results demonstrate that the proposed G7 Continuous Glucose Monitoring System meets pre-defined acceptance criteria, support that the device is acceptable for its intended use, and is as safe and effective as the predicate device.
    No clinical data was necessary to determine substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K234133

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 862.1355 Integrated continuous glucose monitoring system.

(a)
Identification. An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Robust clinical data demonstrating the accuracy of the device in the intended use population.
(ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order (
e.g., an internationally recognized reference material and/or method).(iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device.
(iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period.
(v) Clinical study results in the adult population must meet the following performance requirements:
(A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent.
(B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent.
(C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent.
(D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent.
(E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent.
(H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL.
(I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL.
(J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements.
(K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements.
(vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate.
(vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use.
(2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data.
(3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section.
(4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications.
(5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period.
(6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy.
(7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites (
e.g., abdomen, arm, buttock):(i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL.
(ii) A description of the accuracy of positive and negative rate of change data.
(iii) A description of the frequency and duration of gaps in sensor data.
(iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable.
(v) A description of the observed duration of iCGM life for the device.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 23, 2024

Dexcom Inc. Bob Shen Sr. Regulatory Affairs Specialist 6340 Sequence Dr San Diego. CA 92121

Re: K240902

Trade/Device Name: Dexcom G7 Continuous Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: QBJ Dated: April 1, 2024 Received: April 2, 2024

Dear Bob Shen:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Joshua Balsam -S

Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

2

Indications for Use

Submission Number (if known)

Device Name

Dexcom G7 Continuous Glucose Monitoring System

Indications for Use (Describe)

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 hypodlycemia, 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 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)

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510(k) #:

510(k) Summary

Prepared on: 2024-04-22

Contact Details

21 CFR 807.92(a)(1)

Applicant NameDexcom Inc.
Applicant Address6340 Sequence Dr San Diego CA 92121 United States
Applicant Contact Telephone1(858) 203-6362
Applicant ContactMrs. Neeta Sharma
Applicant Contact Emailneeta.sharma@dexcom.com
Correspondent NameDexcom Inc.
Correspondent Address6340 Sequence Dr San Diego CA 92121 United States
Correspondent Contact Telephone1(858) 529-4459
Correspondent ContactMr. Bob Shen
Correspondent Contact Emailyucheng.shen@dexcom.com

Device Name
21 CFR 807.92(a)(2)

Device Trade NameDexcom G7 Continuous Glucose Monitoring System
Common NameIntegrated continuous glucose monitoring system
Classification NameIntegrated Continuous Glucose Monitoring System, Factory Calibrated
Regulation Number862.1355
Product Code(s)QBJ, KGX (CLASS 1) - TAPE AND BANDAGE, ADHESIVE

Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)

Predicate #Predicate Trade Name (Primary Predicate is listed first)Product Code
K234133Dexcom G7 Continuous Glucose Monitoring SystemQBJ

Device Description Summary
21 CFR 807.92(a)(4)The Dexcom G7 Continuous Glucose Monitoring System) is an interoperable continuous glucose monitoring (CGM) system intended to continuously measure the interstitial fluid, calculate the qucose reading and make this available to the user. The G7 System is intended for single patient use at home and requires a prescription.

The G7 System comprises the following primary components: a wearable, consisting of a G7 sensor and transmitter worn on the body and a display device, which can be a G7 Mobile App) on an iOS or Android OS smart device, or a G7 Receiver (Receiver).

To achieve the intended functions and performance of the G7 System, one sensor and at least one display device (App or Receiver) must be used together. The user must pair the display device(s) with each unique sensor to enable communication and start a sensor session. During an active session, the sensor reports new glucose data to the display device every 5-minutes. The displays

4

glucose data and provides alerts and information signals to the user. The reportable glucose range for the G7 System is 40 mg/dL to 400 mg/dL. Glucose values below this range are reported as 'LOW' and glucose values above this range are reported as 'HIGH'. 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 G7 is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely to and from 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 Mobile App communicates to another app on a single mobile platform

· The Mobile App communicates through the cloud to another software device

o Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable secure and reliable communication of CGM data to authorized client software intended to receive the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).

Principle of Operation:

The principles of operation for the Dexcom G7 System renain the same as prior generations of Dexcom CGM System uses a wire-type sensing mechanism that continuously measures interstitial glucose levels and uses a radio transmitter to wirelessly communicate glucose data to the display device for the user to see and use accordingly.

Intended Use/Indications for Use

The Dexcom G7 Continuous Glucose Monitoring System 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 clabetes 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, 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 purpose of managing diabetes.

Indications for Use Comparison

The indications for use are the same as the predicate device.

Technological Comparison

The subject device has the same technological characteristics as the predicate device. The difference between the subject device and predicate device is the BLE communication and associated labeling updates. No design change was required to support the extended BLE communication. The specification and labeling differences between the subject device and the predicate device do not constitute a new intended use. The safe and effective as the predicate device and does not raise different questions of safety and effectiveness.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The subject device G7 CGM System is substantially equivalent to the predicate device G7 CGM System. The difference between the subject device and predicate device is the BLE communication and associated labeling updates. No design change was required to support the extended BLE communication. The following performance characteristic was established through nonclinical testing performed on the subject device G7 CGM System:

  • Communication Range testing: This testing demonstrates that the subject device G7 CGM System met the extended BLE communication range specification.

Nonclinical testing results demonstrate that the proposed G7 Continuous Glucose Monitoring System meets pre-defined acceptance criteria, support that the device is acceptable for its intended use, and is as safe and effective as the predicate device.

No clinical data was necessary to determine substantial equivalence.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)