ACCU-CHEK Connect Diabetes Management App
Device Facts
| Record ID | K150910 |
|---|---|
| Device Name | ACCU-CHEK Connect Diabetes Management App |
| Applicant | Roche Diabetes Care, Inc. |
| Product Code | NDC · Anesthesiology |
| Decision Date | Jun 3, 2015 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 868.1890 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Therapeutic |
Indications for Use
The ACCU-CHEK Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.
Device Story
Mobile application for diabetes management; collects, stores, and displays blood glucose data; receives data via Bluetooth Low Energy (BLE) from ACCU-CHEK Aviva Connect meter; allows manual data entry. Features Bolus Advisor for insulin dosing calculations; requires physician activation and parameter entry (target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity). Used by patients with MDI therapy to optimize glycemic control; reduces fear of hypoglycemia; improves confidence. Data can be shared with healthcare providers or caregivers via online management system. App provides reports and graphs for clinical decision-making.
Clinical Evidence
No clinical data. Substantial equivalence supported by design verification bench testing and human factors expert evaluation comparing iOS and Android versions. Risk management performed per ISO 14971 using FMEA.
Technological Characteristics
Mobile software application (iOS platform). Connectivity via Bluetooth Low Energy (BLE) to blood glucose meters. Bolus calculator algorithm is rule-based, requiring physician-programmed parameters. Software level of concern: Major.
Indications for Use
Indicated for diabetes patients treated with multiple daily insulin injection (MDI) therapy. Bolus calculator requires physician activation and programming of patient-specific parameters (target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity).
Regulatory Classification
Identification
A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.
Predicate Devices
- ACCU-CHEK Connect Diabetes Management App (K141929)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2015
Roche Diabetes Care Inc. Ms. Chunhong Tao Regulatory Affairs Specialist 9115 Hague Road Indianapolis, IN 46250
Re: K150910
Trade/Device Name: ACCU-CHEK Connect Diabetes Management App Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: II Product Code: NDC, LZG, LFR, JQP Dated: May 6, 2015 Received: May 7, 2015
Dear Ms. Tao:
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. 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known)
K150910
Device Name
ACCU-CHEK Connect Diabetes Management App
Indications for Use (Describe)
The ACCU-CHEK Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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### Indications for Use
510(k) Number (if known)
#### Device Name
ACCU-CHEK Connect Diabetes Management App
#### Indications for Use (Describe)
The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose. insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.
Type of Use (Select one or both, as applicable)
| <span style="font-size: large;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: large;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image shows the Roche logo. The logo consists of the word "Roche" in black, centered within a black hexagon. The hexagon is outlined in black and has a simple, clean design.
# 510(k) Summary
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1) Submitter name, address, contact | Roche Diabetes Care Inc.<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>(317) 521-7227<br>Contact Person: Chunhong (Emma) Tao |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| | Date Prepared: April 2nd, 2015 |
| 2) Device name | Proprietary Name: ACCU-CHEK Connect Diabetes Management App<br>Common Name: diabetes management software |
|----------------|----------------------------------------------------------------------------------------------------------|
|----------------|----------------------------------------------------------------------------------------------------------|
Primary
Classification Name: predictive pulmonary-function value calculator
Classification Regulation: 21 C.F.R. § 868.1890; Class II
Product Code: NDC
Secondary
Classification Regulations: 21 C.F.R. § 880.5725, 862.1345, 862.2100; Class II
Product Code: LZG, LFR, JQP
| 3) Predicate device | ACCU-CHEK Connect Diabetes Management App (K141929), concurrence received on March 16, 2015. |
|---------------------|----------------------------------------------------------------------------------------------|
|---------------------|----------------------------------------------------------------------------------------------|
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| 4) Device<br>Description | The ACCU-CHEK Connect Diabetes Management App is designed to<br>facilitate efficient collecting, transmitting, and analyzing of blood glucose<br>results and other diabetes management data. The App helps:<br><br>Wireless transfer of data from ACCU-CHEK Aviva Connect Blood<br>Glucose Meter. Assist in general diabetes management through logging of contextual<br>data. ACCU-CHEK Bolus Advisor support of mealtime insulin dosing<br>calculations. Perform structured testing. Wireless transfer of data from mobile devices to ACCU-CHEK<br>Connect Online Diabetes Management System and optionally share<br>this data with healthcare provider (HCP) or caregiver.<br>The insulin bolus calculations provided by the app are meant for patients<br>undergoing multiple daily injection therapy. Bolus calculators, such as the<br>ACCU-CHEK Bolus Advisor, have been demonstrated to facilitate the<br>optimization of glycemic control in patients who are trained in multiple daily<br>insulin injection therapy and under the supervision of healthcare professional |
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experienced in managing insulin-treated patients. Such calculators have also been shown to reduce patient fear of hypoglycemia and improve patient confidence in diabetes management.
The ACCU-CHEK Connect Diabetes Management App is not intended to serve as an accessory to an insulin pump.
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5) Intended For Over-the-Counter Use: use The ACCU-CHEK Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. For Prescription Use: The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on userentered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software. 6) Substantial The ACCU-CHEK Connect Diabetes Management App utilizes the equivalence processing power of a mobile phone operating system platform to transfer data from a blood glucose meter, transfer data to an online diabetes management system, facilitate structured testing data collection, assist in general diabetes management through logging of contextual data, and calculate insulin bolus in response to blood glucose, health events, and carbohydrate input. The App is compatible with glucose meters with BLE transmitter. The insulin bolus calculator algorithm is unchanged as compared to the predicate device. The modification of the ACCU-CHEK Connect Diabetes Management App to work on iOS platform does not change the App's intended use or the interface to the ACCU-CHEK Aviva Connect meter or the ACCU-CHEK Connect Online diabetes management system. The modification of ACCU-CHEK Connect Diabetes Management App is substantially equivalent to ACCU-CHEK Connect Diabetes Management App (K141929).
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Modifying the ACCU-CHEK Connect Diabetes Management App to work on 7) Data demonstrating iOS platform does not change the App's intended use or its place within the substantial ACCU-CHEK Connect Diabetes Management System. The modification to equivalence the ACCU-CHEK Connect Diabetes Management App does not change the data collection, tracking, trending, or transmission functions, the bolus calculator algorithm, the bolus calculator activation prescription control process, the bolus calculator activation and patient training materials, or the bolus calculator user interface screens.
> The risk assessment for the iPhone version relied heavily on the risk assessment performed for the Android OS version of the App. The project management staff assessed potential faulty conditions and monitored ACCU-CHEK Connect Diabetes Management App post launch (Android OS version) to identify any possible faulty conditions that might lead to possible hazards for the patient. A risk analysis according to the "Risk Reduction Principle" laid down in the harmonized ISO standard "14971 Medical Devices -Application of risk management to medical devices" was carried out for the ACCU-CHEK Connect App. Possible hazards and consequences were systematically identified and evaluated by using the "Failure Mode Effect and Criticality Analysis" technique. Where appropriate, adequate protection measures relating to the risk that cannot be eliminated have been implemented, as well as safety information described in the instructions for use.
Design verification bench testing on the modification of ACCU-CHEK Connect Diabetes Management App demonstrated that the device meets the performance requirements for its intended use. The data demonstrate that the new device is substantially equivalent to the predicate device.
A Human Factors expert evaluation was performed to show that the predicate design validation can be used to support iPhone version's design validation. Three types of changes were reviewed using side-by-side comparison of screenshots from the Android version and the iPhone version:
- 1. Changes based on the inherent differences between the iOS and Android operating systems (OS) user interface standards
- 2. Enhancements that were made based upon results of the Android version summative and iPhone version formative human factors study
- 3. Changes to Validation study tasks
All of the changes are attributed to user interface standard differences between iOS and Android operating systems or to enhancements to the user experience. No new use-related hazard was identified during the expert evaluation. This expert evaluation supports design validation of the product.
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| 8)<br>Similarities/<br>Differences | The following is a listing of the key similarities and differences between the<br>modified ACCU-CHEK Connect Diabetes Management App and the<br>predicate device. | |
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| Feature /Claim | Modified ACCU-CHEK Connect<br>Diabetes Management App | ACCU-CHEK Connect Diabetes<br>Management App (#k141929) |
| Intended Use | The ACCU-CHEK Connect<br>Diabetes Management App is<br>indicated as an aid in the treatment<br>of diabetes. The software provides<br>for electronic download of blood<br>glucose meters, manual data entry,<br>storage, display, transfer, and self-<br>managing of blood glucose and<br>other related health indicators which<br>can be shown in report and<br>graphical format.<br><br>The ACCU-CHEK Bolus Advisor,<br>as a component of the ACCU-<br>CHEK Connect Diabetes<br>Management App, is indicated for<br>the management of diabetes by<br>calculating an insulin dose or<br>carbohydrate intake based on user-<br>entered data. Before its use, a<br>physician or healthcare professional<br>must activate the bolus calculator<br>and provide the patient-specific<br>target blood glucose, insulin-to-<br>carbohydrate ratio, and insulin<br>sensitivity parameters to be<br>programmed into the software. | Same |
| Prescription /<br>over-the-counter<br>use? | Over-the-counter distribution of<br>App, with bolus calculator function<br>disabled until activated by physician | Same |
| User Group | Diabetes patients treated with<br>multiple daily insulin injection<br>(MDI) therapy | Same |
| Accessory to<br>Blood Glucose<br>Meters? | ACCU-CHEK Aviva Connect blood<br>glucose meter | Same |
| Feature /Claim | Modified ACCU-CHEK Connect<br>Diabetes Management App | ACCU-CHEK Connect Diabetes<br>Management App (#k141929) |
| Bolus Calculator<br>Set-up stage | During the modified ACCU-CHEK<br>Connect Diabetes Management<br>App's bolus calculator set-up stage,<br>the following information must be<br>entered.<br>• Time Blocks<br>• Target Range<br>• Carb Ratio<br>• Insulin Sensitivity<br>• Health Event Percentages<br>• Meal Rise<br>• Snack Size<br>• Acting Time<br>• Offset Time | Same |
| Bolus Calculator<br>inputs | Once the set-up stage has been<br>completed, the patient may begin<br>using the ACCU-CHEK Bolus<br>Advisor in the modified ACCU-<br>CHEK Connect Diabetes<br>Management App. Bolus<br>recommendations can be triggered<br>by inputting the following<br>information prior to each meal:<br>• Measure blood glucose<br>• Enter carbohydrates<br>• Enter Health Event | Same |
| Communicate<br>with insulin<br>pumps? | No | No |
| Software Level of<br>Concern | Major | Major |
| Connectivity to<br>Meter | Bluetooth Low Energy (BLE) | Same |
| Control or affect<br>the blood glucose<br>meter's<br>measurements? | No | No |
| Reports, graphs,<br>and Electronic<br>Log Book | Yes | Yes |
| Feature /Claim | Modified ACCU-CHEK Connect Diabetes Management App | ACCU-CHEK Connect Diabetes Management App (#k141929) |
| Structured Testing | Facilitate the collection of<br>Structured Testing data | Same |
| Carbohydrate Calculator | Calculate carbohydrate intake based<br>on user-entered data | Same |
| Bolus Calculator | Yes | Yes |
| Bolus Calculator Security | The patients will be instructed to<br>request an activation code from<br>their healthcare providers; the<br>healthcare providers will decide<br>whether any additional multiple<br>daily injection therapy training<br>should be provided to the patient<br>prior to activating the app's bolus<br>calculator function. | Same |
| Allow manual entry? | Yes | Yes |
| Back-calculation prevents insulin stacking? | Yes | Yes |
| Operating platform | iOS platform | Android platform |
| UI Standards | iOS standards | Android standards |
| Size and Spacing | iOS phones with smaller viewable<br>screens | Android phones with larger<br>viewable screens |
| Meter Pairing Code | iOS standard Bluetooth pairing code | Android standard Bluetooth pairing<br>code |
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