(59 days)
No
The description mentions an "onboard algorithm" for converting electrical current to glucose readings, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on retrospective analysis of glycemic variability, which is a data processing task, not necessarily an AI/ML application.
No.
The device is indicated for monitoring and informing care plan adjustments related to glycemic control, but it does not directly treat or provide therapy to a patient.
Yes
The device aids in the "retrospective discovery, analysis, and interpretation of glycemic variability" and helps in "detecting glucose excursions facilitating care plan adjustments," which are diagnostic activities related to disease management.
No
The device description explicitly states that the system consists of a sensor/applicator delivery system and a transmitter, which are hardware components worn on the body and inserted into subcutaneous tissue.
Based on the provided text, the Dexcom Pro Q Continuous Glucose Monitoring System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "retrospective discovery, analysis, and interpretation of glycemic variability" and "collects and processes data for aiding in the management of a disease or condition related to glycemic control." This involves analyzing a biological sample (glucose in subcutaneous tissue) to provide information about a patient's health status.
- Mechanism: The device works by converting glucose in subcutaneous tissue into an electrical current, which is then processed into glucose readings. This is a direct measurement of a biological analyte.
- Comparison to Predicate: The predicate device, the Dexcom G6 CGM System (DEN170088), is also an IVD. The Dexcom Pro Q System is described as having an "altered feature set versus the predicate," implying a similar fundamental function as an IVD.
While the device is worn on the body and involves a sensor inserted into subcutaneous tissue, the core function is the in vitro analysis of glucose levels within that tissue fluid. The data is then used for diagnostic purposes (understanding glycemic variability and aiding in disease management).
N/A
Intended Use / Indications for Use
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.
Product codes
QDL
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
age 2 years and older
Intended User / Care Setting
healthcare professional / Home use (sensor insertion and interpretation of retrospective glucose data occurs in clinic with a healthcare professional)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
1
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
2
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.
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 interface with digitally connected devices.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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.
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).
5.5 Indications For Use:
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.
5
| Device | Dexcom Pro Q System (K182405) | Dexcom G6 CGM System (DEN170088) |
|---|---|---|
| Trade Name | Dexcom Pro Q Continuous Glucose | |
| Monitoring System | Dexcom G6 Continuous Glucose | |
| Monitoring System | ||
| Manufacturer | Dexcom, Inc. | Dexcom, Inc. |
| Intended Use | 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. | 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. | ||
| Indications for Use | 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 | The Dexcom G6 Continuous Glucose | |
| Monitoring System (Dexcom G6 CGM | ||
| System) is a real time, continuous | ||
| glucose monitoring device indicated for | ||
| the management of diabetes in persons | ||
| age 2 years and older. | ||
| The Dexcom G6 System is intended to | ||
| replace fingerstick blood glucose | ||
| testing for diabetes treatment | ||
| decisions. Interpretation of the Dexcom | ||
| G6 System results should be based on | ||
| the glucose trends and several | ||
| sequential readings over time. The | ||
| Dexcom G6 System also aids in the | ||
| detection of episodes of hyperglycemia | ||
| and hypoglycemia, facilitating both | ||
| acute and long-term therapy | ||
| adjustments. | ||
| The Dexcom G6 System is also intended | ||
| to autonomously communicate with | ||
| digitally connected devices, including | ||
| Device | Dexcom Pro Q System (K182405) | Dexcom G6 CGM System (DEN170088) |
| System is also intended to interface | ||
| with digitally connected devices. | automated insulin dosing (AID) | |
| systems. The Dexcom G6 System can be | ||
| used alone or in conjunction with these | ||
| digitally connected medical devices for | ||
| the purpose of managing diabetes. | ||
| Clinical application | Management of a disease or condition | |
| related to glycemic control | Management of a disease or condition | |
| related to glycemic control | ||
| Clinical setting/sites | ||
| of use | Home use (sensor insertion and | |
| interpretation of retrospective glucose | ||
| data occurs in clinic with a healthcare | ||
| professional) | Home use | |
| Principle of | ||
| Operation | Amperometric measurement of current | |
| proportional to glucose concentration | ||
| in interstitial fluid via glucose oxidase | ||
| chemical reaction. | Amperometric measurement of current | |
| proportional to glucose concentration | ||
| in interstitial fluid via glucose oxidase | ||
| chemical reaction | ||
| Data Presented | Estimated Glucose Value (EGV): The | |
| EGV is the nominal glucose value | ||
| presented to the user and healthcare | ||
| professional after the sensor session. | ||
| Historical Glucose Data: The glucose | ||
| data collected throughout the entire | ||
| wear-period is presented to the user | ||
| and healthcare professional after the | ||
| sensor session. | Estimated Glucose Value (EGV): The | |
| EGV is the nominal glucose value | ||
| presented to the user in real-time. | ||
| Based off the glucose rate of change, | ||
| users are shown their real-time glucose | ||
| trend with a corresponding arrow. | ||
| Historical Glucose Data: Users can view | ||
| their previous three, six, twelve, or | ||
| twenty-four hours of glucose data. | ||
| Features | Analysis with a healthcare | |
| professional: Healthcare professionals | ||
| can view the user's glucose data | ||
| collected across the entire sensor | ||
| session to aid in the management of a | ||
| disease or condition related to glycemic | ||
| control. | Connect to Dexcom Share: Users can | |
| share their glucose data to the cloud, | ||
| which communicates with Clarity, and | ||
| allows both users and healthcare | ||
| professionals to view glucose data. | ||
| Compatibility with | ||
| intended | ||
| environments | Compatible authorized data extraction | |
| device. | Compatible with iPhone 5S through | |
| iPhone X, Samsung Note 5, Note 8, | ||
| Galaxy S6-S9, J3, Google Pixel, LG G5- | ||
| G6 | ||
| Compatible with Android OS version 7.0 | ||
| and above, and iOS version 10.3.2 and | ||
| above. | ||
| Compatible with authorized | ||
| interoperable devices, including |
5.6 Comparison with the Predicate Device:
6
7
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.