Dexcom Pro Q Continuous Glucose Monitoring System

K182405 · Dexcom, Inc. · QDL · Nov 2, 2018 · Clinical Chemistry

Device Facts

• Record ID: K182405
• Device Name: Dexcom Pro Q Continuous Glucose Monitoring System
• Applicant: Dexcom, Inc.
• Product Code: QDL · Clinical Chemistry
• Decision Date: Nov 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1355
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Dexcom Pro Q is a factory-calibrated continuous glucose monitoring (CGM) system for retrospective clinical analysis. Components include a subcutaneous sensor/applicator and a body-worn transmitter. The sensor uses glucose oxidase to convert interstitial glucose into an electrical current; the transmitter samples this current and applies an onboard algorithm to calculate estimated glucose values (EGV) every 5 minutes for up to 10 days. The device is used in home settings, with data extraction and interpretation performed by healthcare professionals in a clinic. The system provides retrospective glucose data to clinicians to identify glycemic variability and glucose excursions, facilitating adjustments to patient care plans. It interfaces with digitally connected devices for data management.

Clinical Evidence

No new clinical data provided. Performance characteristics, including analytical precision, linearity, and clinical study results, were established under the predicate device (DEN170088).

Technological Characteristics

Amperometric sensing principle using glucose oxidase; subcutaneous flexible wire sensor; body-worn transmitter; 5-minute sampling interval; 10-day wear period; factory calibrated; digital connectivity for data extraction.

Indications for Use

Indicated for retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 years and older under the supervision of a healthcare professional for management of glycemic control-related conditions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• G6 Continuous Glucose Monitoring System (DEN170088)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
K182405

B. Purpose for Submission:
New Device

C. Measurand:
Glucose in interstitial fluid

D. Type of Test:
Quantitative, amperometric assay (Glucose Oxidase)

E. Applicant:
Dexcom, Inc.

F. Proprietary and Established Names:
Dexcom Pro Q Continuous Glucose Monitoring System

G. Regulatory Information:
1. Regulation section: 21 CFR 862.1355
2. Classification: Class II
3. Product code: QDL
4. Panel: Chemistry (75)

H. Intended Use:
1. Intended use(s):
See indications for use.

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2. Indication(s) 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 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.

3. Special conditions for use statement(s):

- This device is for prescription use only. Results should be interpreted only by qualified health care professionals.
- The components of the Dexcom Pro Q System (sensor and transmitter) must be removed prior to magnetic resonance imaging (MRI), computed tomography (CT) scan, or high frequency electrical (diathermy) treatment. The Dexcom Pro Q System has not been tested in those situations.
- This device is not intended for pregnant women, people on dialysis, or critically ill patients.
- Although standard dosing of acetaminophen (1000 mg per every 6 hours) does not appear to cause significant bias, higher supra-therapeutic levels of acetaminophen have shown significant positive bias.
- Sensor placement is important to ensure system performance. Users should choose a site:
- At least 3 inches from insulin pump infusion set or injection site or previous CGM insertion site.
- Away from irritated skin, tattoos, near waistband, bones, or scarring.
- Unlikely to be bumped, pushed or laid on while sleeping.
- Store sensors only between 36° F and 86° F. Do not store sensors in the freezer.

4. Special instrument requirements:

Not applicable.

I. Device Description:

The Dexcom Pro Q Continuous Glucose Monitoring (CGM) System is a glucose recording device that measures and logs glucose readings at five-minute intervals for up to ten days. The Pro Q System consists of a sensor and a Bluetooth Low Energy (BLE) transmitter. The sensor is a small, flexible wire inserted into the subcutaneous tissue where it converts glucose into electrical current. The transmitter, which is connected to the sensor and worn on the body, samples the electrical current produced by the sensor and converts these measurements

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into glucose readings using an onboard algorithm. The system does not have a way to display glucose values in real-time and cannot be authorized to do so. A user must use an authorized extraction device after the sensor session has ended to extract and view data collected by the Pro Q Transmitter.

# Pro Q CGM SENSOR

The sensor component is a sterile device that consists of the sensor applicator, plastic base ("transmitter holder"), and sensor probe. The applicator is a single use, disposable unit that contains an introducer needle holding the sensor probe. The applicator deploys the needle and inserts the sensor under the skin. The needle is retracted back into the applicator after insertion. The sensor probe continuously measures glucose concentration in interstitial fluid and can be worn for up to 10 days.

The sensor may be worn in the abdomen for adults, and both the abdomen and buttock for children ages 2-17 years old. The sensor is identical to the predicate G6 sensor.

# Pro Q CGM TRANSMITTER

The Pro Q CGM Transmitter is a miniature radio transmitter that incorporates data processing functionality. The transmitter contains a Bluetooth radio transceiver to enable transmittance of stored data once the sensor session has ended. The transmitter attaches to the sensor and is not reusable. The transmitter hardware is unchanged from the predicate G6 transmitter, with the exception of a firmware (see above). An authorized extraction device must be used to extract and view data collected by the Pro Q Transmitter.

# J. Substantial Equivalence Information:

1. Predicate device name(s): G6 Continuous Glucose Monitoring System
2. Predicate 510(k) number(s): DEN170088
3. Comparison with predicate:

The Dexcom Pro Q System is largely identical to the predicate device with the exception of aspects related to data storage and display; the device stores glucose data for the entire sensor wear period and data are intended for retrospective analysis by a healthcare provider using an authorized extraction device; by contrast, the predicate device includes a display that provides users with glucose information in real-time. The Dexcom Pro Q System includes only a sensor and transmitter, and patients must see their healthcare provider for insertion and removal of the sensor.

| Similarities | | |
| --- | --- | --- |
| Item | Dexcom Pro Q Continuous Glucose Monitoring System (Candidate) | Dexcom G6 Continuous Glucose Monitoring System (Predicate) |
| Intended Use | Intended to automatically measure glucose in bodily | Same |
| Use | use of the G6 system to measure glucose in body | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Dexcom Pro Q Continuous Glucose Monitoring System (Candidate) | Dexcom G6 Continuous Glucose Monitoring System (Predicate) |
| | 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 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. | |
| Principle of Operation | Amperometric measurement of current proportional to glucose concentration in interstitial fluid via glucose oxidase chemical reaction | Same |
| Detection Method | Amperometric electrochemical | Same |
| Sample Type | Interstitial fluid | Same |
| Test Range | 40-400 mg/dL | Same |
| Enzyme | Glucose oxidase | Same |
| Glucose reading update interval | Autonomously every 5 minutes | Same |
| Wireless communications protocol | Bluetooth Core Specification v4.0 | Same |
| | | |
| Anatomical sensor wear locations | Abdomen (age 2+ years) or upper buttocks (age 2-17 years) | Same |
| Sensor dimensions | 45° insertion angle, 8mm depth, 0.2mm diameter | Same |
| Sensor warm up time | 2 hours | Same |
| Sensor life | Up to 10 days (automatic sensor shutoff) | Same |
| Operational conditions | Ambient Temperature: 50°F – 107.6°F
Humidity: 10%-95% RH
Altitude: -1300 feet to 13,800 feet | Same |
| Transmitter power supply | Lithium manganese dioxide battery (not replaceable or rechargeable) | Same |
| Communications range | 20 feet | Same |

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| Differences | | |
| --- | --- | --- |
| Item | Dexcom Pro Q Continuous Glucose Monitoring System (Candidate) | Dexcom G6 Continuous Glucose Monitoring System (Predicate) |
| Application | Retrospective discovery, analysis and interpretation of glucose values | Real-time glucose monitoring |
| System Components | Sensor/Applicator and Transmitter | Sensor/Applicator, Transmitter, Display Device (Mobile App and Receiver) |
| Data Presentation | **Real-Time Data:** no real time data are presented to users.

**Historical Glucose Data:** The glucose data collected throughout the entire wear-period is presented to the user and healthcare professional after the sensor session has ended. | **Real-Time Data:** users are presented with real-time glucose values and glucose rate of change.

**Historical Glucose Data:** Users can view their previous three, six, twelve, or twenty-four hours of glucose data. |
| Glucose Value Transmission Interval | Every 5 minutes (glucose values are collected every 30 seconds and stored for later data extraction and analysis) | Every 5 minutes (glucose values are collected and sent to the display device) |
| Features | Analysis with a healthcare professional: Extraction via authorized tool | Real time data and connect to Dexcom Share app: |
| User Interaction | The system includes an automatic applicator for sensor insertion.

The system does not include a display device or require any user input to start a session or calibrate the system. | The system includes an automatic applicator for sensor insertion.

During system start-up and prior to the start of each sensor session, the system requires the user to input the sensor code into the display device for calibration. User may also choose to calibrate using blood glucose values.

The user can enter an optional calibration at any time, even after the sensor |

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| Differences | | |
| --- | --- | --- |
| Item | Dexcom Pro Q Continuous Glucose Monitoring System (Candidate) | Dexcom G6 Continuous Glucose Monitoring System (Predicate) |
| | | code has been entered. |
| Compatibility with intended environments | Compatible authorized 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 automated insulin delivery devices. |
| Calibration | Factory calibrated (no user calibration code necessary), no user calibration possible | Factory calibrated (user enters calibration code) and optional user calibration |

K. Standard/Guidance Document Referenced (if applicable):

ISO 13485:2003; Medical Devices-Quality management systems-Requirements for regulatory purposes

ISO 14971:2012; Medical devices – Applications of risk management to medical devices

IEC 62304, Ed. 1.1:2015; Medical Device Software – Software Lifecycle Processes (2006+AMD1:2015)

IEC 62366 Ed. 1.1:2014; Medical Devices – Application of usability engineering to medical devices, Edition 1.1 (2014)

IEC 60601-1:2005; Medical Electrical Equipment – Part 1: Requirements for basic safety and essential performance

ISO 15223-1:2012; Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements

Guidance for Industry and FDA Staff, Format for Traditional and Abbreviated 510(k)s, dated August 2005

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Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005

General Principles of Software Validation; Final Guidance for Industry and FDA Staff, dated January 11, 2002

Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, dated September 9, 1999

Guidance for Industry, Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software, dated January 14, 2005

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, dated October 2, 2014

Applying Human Factors and Usability Engineering to Medical Devices – Guidance for Industry and FDA Staff, dated February 3, 2016

Guidance for Industry and FDA Staff Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, dated November 30, 2004

## L. Test Principle:

The Dexcom Pro Q System detects glucose levels from the fluid just beneath the skin (interstitial fluid). The sensor probe continuously measures glucose concentration in the interstitial fluid via an enzymatic electrochemical reaction using glucose oxidase. The enzyme, glucose oxidase, catalyzes the oxidation of glucose and produces hydrogen peroxide. The production of hydrogen peroxide generates an electrical current that is proportionate to the interstitial glucose concentration. The transmitter converts the signal using an algorithm to a glucose value read in $\mathrm{mg/dL}$, which is recorded and stored on the transmitter until the data is extracted by a qualified healthcare professional for interpretation and use.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

a. **Precision/Reproducibility:**

The Pro Q CGM uses the same sensor, transmitter, and algorithm as the predicate device, the Dexcom G6 Continuous Glucose Monitoring System. Therefore, performance was evaluated under DEN170088. Please see the decision summary for the Dexcom G6 Continuous Glucose Monitoring System (DEN170088)

b. **Linearity/assay reportable range:**

The reportable range for the Pro Q CGM is 40 to $400\ \mathrm{mg/dL}$. Data supporting this claimed measurement range was reviewed under DEN170088. Please see the decision summary for DEN170088.

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c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The Pro Q CGM sensor has a storage shelf-life of 12 months and testing is on-going. Shelf life was evaluated at 32°-86° F and 10-90% relative humidity.

The Pro Q Transmitter has sufficient battery life to function for 3 months as intended following its maximum storage time of 8 months. Shelf life was evaluated at 32°-113° F and 10-95% relative humidity.

d. Detection limit:

If a glucose measurement is less than 40 mg/dL, the result is displayed by the system as 'Lo'. If a glucose measurement exceeds 400 mg/dL, result is displayed as 'Hi'. Data supporting this claimed measurement range was generated in the clinical study described in Section L(3) below. Data supporting this was reviewed under DEN170088. Please see the decision summary for DEN170088.

e. Analytical specificity:

Data supporting the analytical specificity was reviewed under DEN170088. Please see the decision summary for DEN170088.

f. Assay cut-off:

Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable.

b. Matrix comparison:

Not applicable. Interstitial fluid is the only indicated matrix.

3. Clinical studies:

Data supporting clinical studies was reviewed under DEN170088. Please see the decision summary for DEN170088.

4. Expected values:

Not applicable.

N. Instrument Name:

Dexcom Pro Q Continuous Glucose Monitoring System

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O. System Descriptions:

1. Modes of Operation:

Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?

Yes ☐ X or No ☐

Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?

Yes ☐ X or No ☐

2. Software:

FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:

Yes ☐ X or No ☐

1. Specimen Identification:

Not applicable

2. Specimen Sampling and Handling:

Not applicable

5. Calibration:

Not applicable (factory calibrated).

6. Quality Control:

Not applicable.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

Biocompatibility:
Data supporting biocompatibility was reviewed under DEN170088. Please see the decision summary for DEN170088.

Sterility:
Data supporting sterility was reviewed under DEN170088. Please see the decision summary for DEN170088.

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# Mechanical Engineering:

The physical dimensions and hardware are identical to the predicate device. Data supporting the mechanical engineering was reviewed under DEN170088. Please see the decision summary for DEN170088.

# Electromagnetic Compatibility:

Data supporting electrocompatibility testing was reviewed under DEN170088. Please see the decision summary for DEN170088.

# Electrical Safety:

Data supporting electrical safety was reviewed under DEN170088. Please see the decision summary for DEN170088.

# Environmental Testing:

Data supporting environmental testing was reviewed under DEN170088. Please see the decision summary for DEN170088.

# Shelf-Life Stability:

Data supporting the shelf life stability was reviewed under DEN170088. Please see the decision summary for DEN170088.

# Packaging Integrity/Shipping Integrity:

Packaging and shipping specifications are the same as the predicate. Data supporting the package and shipping integrity was reviewed under DEN170088. Please see the decision summary for DEN170088.

# Interoperability:

A plan and approach for interoperability were provided according to the FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff" and determined to be adequate to support and clearly specify expectations, requirements, and interface specifications to potential interoperable devices. In addition, their plan covered their approach to working with connected device companies regarding contractual approaches, interfaces for data communication and exchange, and post-market reporting procedures and responsibilities (e.g., who is responsible for investigating and reporting complaints, malfunctions, and adverse events). The device cannot be authorized for real-time data display. In addition, after data extraction, glucose data collected by the Dexcom Pro Q System must pass through Dexcom's cloud-based data infrastructure before being made available for display or analysis. Access to the data is controlled by Dexcom, through user credentials.

# Cyber Security:

The following information was provided for the device:

- Risk Management
- A model describing the assets, threats, vulnerabilities, and controls related to the device system was provided reviewed. Cyber security parameters were identified for each asset and included the transmitter, receiver, and smart device applications. Traceability was provided and adequate. Risk management was acceptable.

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- Planning for Continuing Support
- A plan for continuing to keep the device secure was provided and found to be complete and adequate.
- Plan for Malware-Free Shipping
- A plan to ensure the device is shipped without Malware was provided and found to be complete and adequate.

**Contact Resistance:**

Data supporting the contact resistance was reviewed under DEN170088. Please see the decision summary for DEN170088.

**Q. Proposed Labeling:**

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.

**R. Conclusion:**

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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