The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a factory calibrated continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 years and older under the supervision of a healthcare professional. The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control.

Interpretation of the data recorded by the Dexcom Pro Q System results should be made only by a qualified healthcare professional based on glucose trends and several sequential readings over time. The Dexcom Pro Q System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom Pro Q System is also intended to interface with digitally connected devices.

Device Description

The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a continuous glucose monitor that offers an altered feature set versus the predicate Dexcom G6 CGM System.

The Dexcom Pro Q System consists of two main components: sensor/applicator delivery system, and a transmitter. The sensor is a small and flexible wire inserted into subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The transmitter logs estimated glucose values every 5 minutes during the sensor wear period (up to 10 days).

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The provided document is a 510(k) summary for the Dexcom Pro Q Continuous Glucose Monitoring System, comparing it to the Dexcom G6 CGM System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting extensive new clinical studies for efficacy. Therefore, a traditional "study that proves the device meets the acceptance criteria" in the sense of a novel clinical trial with specific performance endpoints outlined in detail isn't fully present in this document. Instead, it relies on the predicate's established performance and verifies that the new device performs similarly.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative "acceptance criteria" in a typical table format for a clinical study. Instead, it claims substantial equivalence to the predicate device (Dexcom G6), which implies that its performance should be comparable. The relevant performance claims are related to its function as a continuous glucose recording device for retrospective analysis.

Criteria (Implied by Substantial Equivalence and Device Description)	Reported Device Performance (Dexcom Pro Q System)
Intended Use Equivalence: Retrospective discovery, analysis, and interpretation of glycemic variability in persons aged 2+ under healthcare professional supervision.	Matches the Indications for Use for the Dexcom Pro Q System. The document explicitly states the "Dexcom Pro Q System is substantially equivalent to the Dexcom G6 CGM System as they are identical with regard to intended use" (Page 8, Section 5.8).
Data Collection & Processing: Collects and processes data for aiding in glycemic control management.	"The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control." (Page 4, Section 5.5)
Glucose Measurement Mechanism: Amperometric measurement of current proportional to glucose concentration via glucose oxidase chemical reaction.	Matches the predicate device's principle of operation. (Page 6, Table under "Principle of Operation")
Duration of Sensor Wear: Up to 10 days.	Functions for "up to 10 days" (Page 4, Section 5.4).
Logging Frequency: Logs estimated glucose values every 5 minutes.	"The transmitter logs estimated glucose values every 5 minutes" (Page 4, Section 5.4).
Factory Calibration: The device is factory calibrated.	Explicitly stated as "factory calibrated" (Page 4, Section 5.5).
Accuracy/Performance Comparability to Predicate: Performs according to specifications and is comparable to the predicate device.	"This testing demonstrated that the system performed according to its specifications and that the technological and performance criteria are comparable to the predicate device." (Page 8, Section 5.7)

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

The document does not provide details on the sample size for a test set for the Dexcom Pro Q, nor does it specify data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) submission not requiring new clinical trials, as it relies on the predicate's established performance and the new device's verification against its own specifications. The "performance testing" mentioned is likely internal validation and verification processes rather than a new clinical study with a distinct test set.

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

This information is not provided. Given the nature of a 510(k) submission based on substantial equivalence and typical device verification/validation, a panel of experts for ground truth establishment in a clinical context isn't a stated component of the testing summarized here. Ground truth would be based on reference glucose measurements if any clinical data was collected, but details are absent.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study is more common for diagnostic imaging devices where human interpretation is a critical factor. For a CGM device, the primary "output" is a glucose value, not an interpretation by a reader.

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

The document heavily implies standalone algorithm performance as a core component of its functioning. The "transmitter samples the electrical current... and converts these measurements into glucose readings using an onboard algorithm" (Page 4). The "performance testing" mentioned in Section 5.7 would have verified the accuracy of this algorithm against specified targets, although the specifics of the test protocol are not provided in this summary.

7. The Type of Ground Truth Used

The type of ground truth is not explicitly stated in this summary. For CGM devices, the ground truth for glucose values would typically be obtained from a highly accurate laboratory reference method (e.g., YSI glucose analyzer) applied to blood samples taken simultaneously with CGM readings. This would be part of the predicate device's original clinical validation. For the Dexcom Pro Q, if any new clinical data were collected, similar reference methods would be used.

8. The Sample Size for the Training Set

The document does not provide information about the training set size for the algorithm. It states the Dexcom Pro Q System uses an "onboard algorithm" but doesn't detail its development or training.

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

This information is not provided. Similar to point 8, the document is a 510(k) summary focused on substantial equivalence rather than a detailed algorithm development document.

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). 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.

November 2, 2018

Dexcom, Inc. Luke Olson Senior Specialist, Regulatory Affairs 6340 Sequence Dr. San Diego, CA 92121

Re: K182405

Trade/Device Name: Dexcom Pro Q Continuous Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: QDL Dated: August 30, 2018 Received: September 4, 2018

Dear Luke Olson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K182405

Device Name

Dexcom Pro Q Continuous Glucose Monitoring System

Indications for Use (Describe)

The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a factory calibrated continuous glucose recording device indicated for the retrospective discovery, and interpretation of glycemic variability in persons age 2 years and older under the supervision of a healthcare professional. The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control.

X 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 SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: __ K182405

5.1 Submitter:

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

Contact: Luke Olson

Senior Regulatory Affairs Specialist

Phone: 858.875.5307

Fax: 858.332.0204

Email:

Date Prepared:

5.2 Device Names and Classification:

Proprietary Name	Dexcom Pro Q Continuous Glucose Monitoring System
Common Name	Integrated Continuous Glucose Monitoring System,Factory Calibrated
Class	II
Classification Regulation	21 CFR 862.1355
Product Code	QDL
Review Panel	Clinical Chemistry

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5.3 Predicate Device:

Dexcom G6 Continuous Glucose Monitoring (CGM) System

5.4 Device Description:

The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a continuous glucose monitor that offers an altered feature set versus the predicate Dexcom G6 CGM System.

5.5 Indications For Use:

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Device	Dexcom Pro Q System (K182405)	Dexcom G6 CGM System (DEN170088)
Trade Name	Dexcom Pro Q Continuous GlucoseMonitoring System	Dexcom G6 Continuous GlucoseMonitoring System
Manufacturer	Dexcom, Inc.	Dexcom, Inc.
Intended Use	An integrated continuous glucosemonitoring system (iCGM) is intendedto automatically measure glucose inbodily fluids continuously or frequentlyfor a specified period of time. iCGMsystems are designed to reliably andsecurely transmit glucosemeasurement data to digitallyconnected devices, includingautomated insulin dosing systems, andare intended to be used alone or inconjunction with these digitallyconnected medical devices for thepurpose of managing a disease orcondition related to glycemic control.	An integrated continuous glucosemonitoring system (iCGM) is intendedto automatically measure glucose inbodily fluids continuously or frequentlyfor a specified period of time. iCGMsystems are designed to reliably andsecurely transmit glucosemeasurement data to digitallyconnected devices, includingautomated insulin dosing systems, andare intended to be used alone or inconjunction with these digitallyconnected medical devices for thepurpose of managing a disease orcondition related to glycemic control.
Indications for Use	The Dexcom Pro Q ContinuousGlucose Monitoring System (DexcomPro Q System) is a factory calibratedcontinuous glucose recording deviceindicated for the retrospectivediscovery, analysis, and interpretationof glycemic variability in persons age 2years and older under the supervisionof a healthcare professional. TheDexcom Pro Q System collects andprocesses data for aiding in themanagement of a disease or conditionrelated to glycemic control.Interpretation of the data recorded bythe Dexcom Pro Q System resultsshould be made only by a qualifiedhealthcare professional based onglucose trends and several sequentialreadings over time. The Dexcom Pro QSystem aids in detecting glucoseexcursions facilitating care planadjustments. The Dexcom Pro Q	The Dexcom G6 Continuous GlucoseMonitoring System (Dexcom G6 CGMSystem) is a real time, continuousglucose monitoring device indicated forthe management of diabetes in personsage 2 years and older.The Dexcom G6 System is intended toreplace fingerstick blood glucosetesting for diabetes treatmentdecisions. Interpretation of the DexcomG6 System results should be based onthe glucose trends and severalsequential readings over time. TheDexcom G6 System also aids in thedetection of episodes of hyperglycemiaand hypoglycemia, facilitating bothacute and long-term therapyadjustments.The Dexcom G6 System is also intendedto autonomously communicate withdigitally connected devices, including
Device	Dexcom Pro Q System (K182405)	Dexcom G6 CGM System (DEN170088)
	System is also intended to interfacewith digitally connected devices.	automated insulin dosing (AID)systems. The Dexcom G6 System can beused alone or in conjunction with thesedigitally connected medical devices forthe purpose of managing diabetes.
Clinical application	Management of a disease or conditionrelated to glycemic control	Management of a disease or conditionrelated to glycemic control
Clinical setting/sitesof use	Home use (sensor insertion andinterpretation of retrospective glucosedata occurs in clinic with a healthcareprofessional)	Home use
Principle ofOperation	Amperometric measurement of currentproportional to glucose concentrationin interstitial fluid via glucose oxidasechemical reaction.	Amperometric measurement of currentproportional to glucose concentrationin interstitial fluid via glucose oxidasechemical reaction
Data Presented	Estimated Glucose Value (EGV): TheEGV is the nominal glucose valuepresented to the user and healthcareprofessional after the sensor session.Historical Glucose Data: The glucosedata collected throughout the entirewear-period is presented to the userand healthcare professional after thesensor session.	Estimated Glucose Value (EGV): TheEGV is the nominal glucose valuepresented to the user in real-time.Based off the glucose rate of change,users are shown their real-time glucosetrend with a corresponding arrow.Historical Glucose Data: Users can viewtheir previous three, six, twelve, ortwenty-four hours of glucose data.
Features	Analysis with a healthcareprofessional: Healthcare professionalscan view the user's glucose datacollected across the entire sensorsession to aid in the management of adisease or condition related to glycemiccontrol.	Connect to Dexcom Share: Users canshare their glucose data to the cloud,which communicates with Clarity, andallows both users and healthcareprofessionals to view glucose data.
Compatibility withintendedenvironments	Compatible authorized data extractiondevice.	Compatible with iPhone 5S throughiPhone X, Samsung Note 5, Note 8,Galaxy S6-S9, J3, Google Pixel, LG G5-G6Compatible with Android OS version 7.0and above, and iOS version 10.3.2 andabove.Compatible with authorizedinteroperable devices, including

5.6 Comparison with the Predicate Device:

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5.7 Summary of Performance Testing

The Dexcom Pro Q System was verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors. This testing demonstrated that the system performed according to its specifications and that the technological and performance criteria are comparable to the predicate device.

5.8 Conclusions Drawn from Performance Testing

The Dexcom Pro Q 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 technological characteristics that raise different questions of safety and effectiveness. The Dexcom Pro Q System provides healthcare professionals with retrospective glucose data to assist in the development of individualized care plans.

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.