STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE

• K Number: DEN140016
• Device Name: STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
• Manufacturer: DEXCOM, INC.
• Date Cleared: 2014-08-19 ( 119 days)
• Product Code: PHV
• Regulation Number: 862.2120

Intended Use

The STUDIO on the Cloud Data Manager Software is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to CGM devices with data interface capabilities.

Device Description

The STUDIO on the Cloud Data Management ("STUDIO") Software is comprised of a data analysis and storage platform, report generation software, and an information delivery service. Specifically, the proposed STUDIO Software performs the following functions: - Data Upload: the SweetSpot Fetch Utility application will be used to access data from ● a Receiver, using either Mac or PC operating systems; - Data Analysis: certain SweetSpot Platform functions will be used to validate. ● aggregate, and analyze (e.g., correlate) CGM data, and to create charts and reports that mimic the current STUDIO Pattern and Glucose Strips charts and reports; - . Reports: The current STUDIO Pattern charts will be displayed on the user's computer screen, and both the Pattern and Glucose Strip charts can be saved to the user's computer in PDF format. Both reports may be printed by the user as a PDF document. The STUDIO Software uses only retrospective data stored on the G4 PLATINUM device to create statistical reports, and does not make treatment recommendations.

Predicate Devices

Unable to find the Predicate Device(s) K/DEN number in the text provided.

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on data management, analysis, and report generation using retrospective data, with no mention of AI or ML techniques.

Therapeutic

No
The device is a data management software that analyzes historical CGM data and creates reports; it does not make treatment recommendations or directly intervene in a patient's health condition. It is intended to assist in the review, analysis, and evaluation of historical data, making it an accessory rather than a therapeutic device.

Diagnostic

No

The device is described as software that assists in the review, analysis, and evaluation of historical CGM data, and it explicitly states that it "does not make treatment recommendations." This indicates it is a data management and reporting tool rather than a diagnostic device that interprets data to identify a disease or condition or guide diagnosis.

SaMD (Software as a Medical Device)

Yes

The device is described as "Software" and its functions are solely related to data management, analysis, and reporting of historical CGM data. It does not include any hardware components or interact with the patient's body directly.

IVD (In Vitro Diagnostic)

Based on the provided information, the STUDIO on the Cloud Data Manager Software is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
• STUDIO Software Function: The STUDIO software's intended use is to review, analyze, and evaluate historical CGM data. This data is generated by a Continuous Glucose Monitor (CGM) device, which measures glucose levels in the interstitial fluid (a fluid found between cells).
• Data Source: The software uses retrospective data stored on the CGM device. It does not perform any tests on biological samples taken directly from the patient.
• Purpose: The purpose is to support effective diabetes management by providing insights into glucose trends and patterns based on previously collected data. It explicitly states it does not make treatment recommendations.

While the software is an accessory to a medical device (the CGM), its function is data management and analysis, not performing a diagnostic test on a biological sample. Therefore, it falls outside the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The STUDIO on the Cloud Data Manager Software is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to CGM devices with data interface capabilities.

Indication(s) for use: Same as intended use

Product codes

PHV

Device Description

The STUDIO on the Cloud Data Management ("STUDIO") Software is comprised of a data analysis and storage platform, report generation software, and an information delivery service.

Specifically, the proposed STUDIO Software performs the following functions:

• Data Upload: the SweetSpot Fetch Utility application will be used to access data from ● a Receiver, using either Mac or PC operating systems;
• Data Analysis: certain SweetSpot Platform functions will be used to validate. ● aggregate, and analyze (e.g., correlate) CGM data, and to create charts and reports that mimic the current STUDIO Pattern and Glucose Strips charts and reports;
• . Reports: The current STUDIO Pattern charts will be displayed on the user's computer screen, and both the Pattern and Glucose Strip charts can be saved to the user's computer in PDF format. Both reports may be printed by the user as a PDF document.

The STUDIO Software uses only retrospective data stored on the G4 PLATINUM device to create statistical reports, and does not make treatment recommendations.

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

Not Found

Intended User / Care Setting

patients and healthcare professionals; For prescription home use.

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

A usability study was performed with Forty Four (44) lay and professional users with varying demographic characteristics (age, sex, and education level). The intent of the study was to verify software ease of use and label comprehension. The study determined that 96% of assigned tasks were able to be completed by users without assistance.

Bench Testing was perfomed using data from forty (40) G4 PLATINUM receivers. CGM data were uploaded from the receivers using the STUDIO on the Cloud Data Management Software and were compared to the same data downloaded to a PC. All data fields were reported to be 100% accurate.

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

A usability study was performed with Forty Four (44) lay and professional users with varying demographic characteristics (age, sex, and education level). The intent of the study was to verify software ease of use and label comprehension. The study determined that 96% of assigned tasks were able to be completed by users without assistance.

Bench Testing was perfomed using data from forty (40) G4 PLATINUM receivers. CGM data were uploaded from the receivers using the STUDIO on the Cloud Data Management Software and were compared to the same data downloaded to a PC. All data fields were reported to be 100% accurate.

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

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.2120 Continuous glucose monitor data management system.

(a)
Identification. A continuous glucose monitor data management system is an electronic device intended to acquire, process, and correlate retrospective data from a continuous glucose monitoring device. This device is intended to be used by patients or their healthcare providers when determining therapeutic strategies. A continuous glucose monitor data management system is not a drug dose calculator and does not provide treatment recommendations.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 862.9.

Summary

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EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR STUDIO on the Cloud Data Management Software

DECISION SUMMARY

A. DEN Number:

DEN140016

B. Purpose for Submission:

De novo request for adjunct data management software

C. Measurand:

Not applicable. The submission is for a continuous glucose monitor data management software device.

D. Type of Test:

Diabetes data management system

E. Applicant:

Dexcom, Inc.

F. Proprietary and Established Names:

STUDIO on the Cloud Data Management Software

G. Regulatory Information:

• 1. Regulation: 21 CFR 862.2120, Continuous glucose monitor data management system.
• 2. Classification: Class I, exempt
• PHV 3. Product code:
• 4. Panel: Chemistry (75)

H. Intended Use:

• 1. Intended use(s):

1

The STUDIO on the Cloud Data Manager Software is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to CGM devices with data interface capabilities.

• 2. Indication(s) for use:
     Same as intended use
• 3. Special conditions for use statement(s):
     For prescription home use.

This device is intended for display of retrospective glucose data and not for real-time display of glucose results.

This device is not intended for making treatment decisions.

This device is not intended for calculating insulin or other drug doses.

This device is not intended for controlling insulin pumps or other drug delivery systems.

• 4. Special instrument requirements:
     Dexcom G4 PLATINUM Continuous Glucose Monitoring System

I. Device Description:

The STUDIO on the Cloud Data Management ("STUDIO") Software is comprised of a data analysis and storage platform, report generation software, and an information delivery service.

Specifically, the proposed STUDIO Software performs the following functions:

• Data Upload: the SweetSpot Fetch Utility application will be used to access data from ● a Receiver, using either Mac or PC operating systems;
• Data Analysis: certain SweetSpot Platform functions will be used to validate. ● aggregate, and analyze (e.g., correlate) CGM data, and to create charts and reports that mimic the current STUDIO Pattern and Glucose Strips charts and reports;
• . Reports: The current STUDIO Pattern charts will be displayed on the user's computer screen, and both the Pattern and Glucose Strip charts can be saved to the user's computer in PDF format. Both reports may be printed by the user as a PDF document.

The STUDIO Software uses only retrospective data stored on the G4 PLATINUM device to create statistical reports, and does not make treatment recommendations.

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J. Standard/Guidance Documents Referenced:

• 1. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices, September 9, 1999
• 2. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
• 3. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Draft Guidance for Industry & FDA Staff, June 13, 2013
• 4. Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, January 14, 2005
• 5. General Principles of Software Validation, Final Guidance for Industry and FDA Staff, January 11, 2002
• 6. Guidance for Industry and Food and Drug Administration Staff, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, March 28, 2012
• 7. ISO 14971:2012 Medical devices Application of risk management to medical devices
• 8. IEC/TR 80002-1:2009 Medical device software Part 1: Guidance on the application of ISO 14971 to medical device software
• 9. ANSI/AAMI/IEC 62304:2006 Medical device software Software life cycle processes
• 10. ISO 13485: Quality Systems Medical Devices System Requirements for Regulatory Purposes
• 11. U.S. Food and Drug Administration, 21 CFR Part 820: Quality System Regulation
• 12. NIST SP 800-53 rev3: Recommended Security Controls for Federal Information Systems and Organizations
• 13. HIPAA: Health Insurance Portability and Accountability Act

K. Test Principle:

Not applicable.

L. Performance Characteristics (if/when applicable):

• 1. Analytical performance:
  • a. Reproducibility/Precision

Not applicable.

• b. Linearity/assay reportable range:

3

Not applicable.

• c. Traceability, Stability, Expected values (controls, calibrators, or methods): Not applicable.
• d. Detection limit

Not applicable.

• e. Analytical specificity:
  Not applicable.

• 2. Comparison studies:
  • a. Method comparison with predicate device:

Not applicable.

• b. Matrix comparison:
  Not applicable.

• 3. Clinical studies:
     A usability study was performed with Forty Four (44) lay and professional users with varying demographic characteristics (age, sex, and education level). The intent of the study was to verify software ease of use and label comprehension. The study determined that 96% of assigned tasks were able to be completed by users without assistance.
• 4. Expected Values
     Not applicable.

M. Instrument Names:

STUDIO on the Cloud Data Management Software

N. System Description:

• 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 _

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Does the applicant's device transmit data to a computer, webserver, or mobile device using wireless transmission: Yes or No X > > .

• 2. Software:
     FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:

Yes X_ or No _________________________________________________________________________________________________________________________________________________________

• 2. Specimen Identification:
     Not Applicable
• 3. Specimen Sampling and Handling:
     Not Applicable
• 4. Calibration:
     Not Applicable
• 5. Quality Control:
     Not Applicable

O. Other Supportive Instrument Performance Characteristics Data Not Covered In the "Performance Characteristics" Section above:

• 1. The following documentation related to the STUDIO on the Cloud Data Management Software was reviewed and found to be acceptable: level of concern, software description, device hazard analysis, software requirements specifications, architecture design chart, software design specification, traceability analysis, software development environment description, verification and validation testing, and revision level history.
• 2. Bench Testing was perfomed using data from forty (40) G4 PLATINUM receivers. CGM data were uploaded from the receivers using the STUDIO on the Cloud Data Management Software and were compared to the same data downloaded to a PC. All data fields were reported to be 100% accurate.

P. Proposed Labeling:

The labeling is sufficient and satisfies the requirements of 21 CFR Part 801, 21 CFR Part 809, and 801.109.

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Q. Identified Potential Risks and Required Mitigations

Identified Risk	Required Mitigation
Device malfunction (e.g., incorrect data
analysis, etc.)	General controls, including design controls

Identified Risks and Required Mitigations Table

Device malfunction (e.g., incorrect data analysis, etc.) may lead to diabetes mismanagement and poor glycemic control. This risk can be adequately mitigated by general controls, including design controls and restriction as a prescription device that must comply with 21 CFR 801.109.

R. Benefit/Risk Analysis

Summary
Summary of
the Benefit(s)	The STUDIO on the Cloud Data Management Software is convenient to use since it
analyzes and correlates several sources of diabetes management-relevant information
(e.g. user glucose levels, meals, insulin delivery, and exercise data) into one software
program. The data sorting and presentation functions of the STUDIO on the Cloud
Data Management Software provide patients and their doctors access to a more
complete clinical picture of a patient's current disease, as well as of the impact of past
diabetes management decisions on a patient's glucose levels. The convenience of
using the device should translate into better record-keeping compliance by the patient,
and the greater access provided to data should assist the patient and their physician
with the identification of the patient's unique glucose excursion triggers; together,
these benefits should allow patients and their doctors to make rational modifications to
the patient's diabetes management plan, with the goal of achieving better glycemic
control.
Summary of
the Risk(s)	Device malfunction may lead to diabetes mismanagement and poor glycemic control.
Decisions made based on incorrect data or faulty analyses may put the patient at risk of more frequent acute episodes of hypoglycemic and/or hyperglycemic excursions.
These episodes increase the likelihood of hospitalization and/or death. Chronic poor glycemic control could lead to irreversible diabetes-related sequelae (e.g. retinopathy, neuropathy, nephropathy and arteriosclerosis). These risks can be adequately mitigated by the sponsor's verification and validation and design control activities which ensure that the risk of malfunction is very low.

Continuous glucose meters are only approved for tracking and trending; therefore another risk is that users could modify their current insulin dosage based directly on current CGM glucose values provided by the STUDIO on the Cloud Data Management Software. This risk is mitigated by product labeling which states that users should not make changes in their treatment program without talking to their healthcare providers. In addition, only retrospective CGM glucose values are provided by the software, so real-time CGM glucose values are not readily available to users. Risks are mitigated by general controls, including requiring design controls and restriction as a prescription device that must comply with 21 CFR 801.109. |
| Summary of
Other Factors | Patients are willing to tolerate the low risk associated with use of the STUDIO on the Cloud Data Management Software because they benefit from a substantial improvement in the analysis and correlation of retrospective continuous glucose monitoring information (e.g. glucose values over time, paired with meal, exercise, and insulin bolus information), which can be used by the patients and their doctors to assist in making adjustments to their diabetes management program, with the goal of reducing glucose excursions and maintaining proper glycemic control. |
| Conclusions
Do the
probable
benefits
outweigh the
probable risks? | Yes. The device is likely to provide benefits in improved diabetes management with a low associated risk. |

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S. Conclusion:

The information provided in this de novo submission is sufficient to classify this device into class I, exempt from premarket notification requirements subject to the limitations in 21 CFR 862.9, under regulation 21 CFR 862.2120. As a software containing device, this device type is also subject to design controls. FDA believes that applicable general controls, including design controls, provide reasonable assurance of the safety and effectiveness of the device type. The device is classified under the following:

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Product Code:	PHV
Device Type:	Continuous glucose monitor data management system
Class:	I (general controls)
Regulation:	21 CFR 862.2120

(a) Identification. A continuous glucose monitor data management system is an electronic device intended to acquire, process, and correlate retrospective data from a continuous glucose monitoring device. This device is intended to be used by patients or their healthcare providers when determining therapeutic strategies. A continuous glucose monitor data management system is not a drug dose calculator and does not provide treatment recommendations.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.