(61 days)
Not Found
No
The summary describes a diabetes management app with a bolus calculator that uses user-entered data and pre-programmed parameters. There is no mention of AI or ML in the intended use, device description, or performance studies. The calculations appear to be based on established algorithms and user-defined settings, not learned patterns.
No.
The device is indicated as an aid in diabetes treatment and a diabetes management app used to calculate insulin dosage based on user-entered data, not a direct therapeutic device.
No
The device is an aid in the treatment and management of diabetes, primarily by helping to collect, display, and analyze blood glucose data and calculate insulin doses. It does not diagnose diabetes or other conditions.
Yes
The device is described as an "App" and its functions are purely software-based (data download, entry, storage, display, transfer, calculation). While it interacts with a blood glucose meter, the device itself is the software application.
Based on the provided text, the ACCU-CHEK Connect Diabetes Management App is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device function: The ACCU-CHEK Connect Diabetes Management App primarily focuses on:
- Data management: Downloading, storing, displaying, and transferring blood glucose data from a meter.
- Manual data entry: Allowing users to input other health indicators.
- Calculations: The Bolus Advisor component calculates insulin doses or carbohydrate intake based on user-entered data and pre-programmed parameters.
- Reporting and visualization: Presenting data in reports and graphs.
- Lack of direct testing: The app itself does not perform any tests on biological samples. It relies on data generated by a separate device (the blood glucose meter) or manually entered by the user.
While the app is an "aid in the treatment of diabetes" and uses data related to a diagnostic measurement (blood glucose), its function is to manage and process this data, not to perform the diagnostic test itself. The blood glucose meter is the device that performs the in vitro diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NDC, LZG, LFR, JQP
Device Description
The ACCU-CHEK Connect Diabetes Management App is designed to facilitate efficient collecting, transmitting, and analyzing of blood glucose results and other diabetes management data. The App helps:
- Wireless transfer of data from ACCU-CHEK Aviva Connect Blood Glucose Meter.
- Assist in general diabetes management through logging of contextual data.
- ACCU-CHEK Bolus Advisor support of mealtime insulin dosing calculations.
- Perform structured testing.
- Wireless transfer of data from mobile devices to ACCU-CHEK Connect Online Diabetes Management System and optionally share this data with healthcare provider (HCP) or caregiver.
The insulin bolus calculations provided by the app are meant for patients undergoing multiple daily injection therapy. Bolus calculators, such as the ACCU-CHEK Bolus Advisor, have been demonstrated to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and under the supervision of healthcare professional 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.
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
Diabetes patients treated with multiple daily insulin injection (MDI) therapy
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)
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:
-
- Changes based on the inherent differences between the iOS and Android operating systems (OS) user interface standards
-
- Enhancements that were made based upon results of the Android version summative and iPhone version formative human factors study
-
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ACCU-CHEK Connect Diabetes Management App (K141929)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a human figure, represented by three overlapping profiles facing to the right. The profiles are stylized and appear to be connected, creating a sense of unity and collaboration.
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.
1
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
2
Indications for Use
510(k) Number (if known)
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.
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."
3
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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."
4
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.
9115 Hague Rd.
Indianapolis, IN 46250
(317) 521-7227
Contact Person: Chunhong (Emma) Tao |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| | Date Prepared: April 2nd, 2015 |
| 2) Device name | Proprietary Name: ACCU-CHEK Connect Diabetes Management App
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. |
|---|---|
| --------------------- | ---------------------------------------------------------------------------------------------- |
Continued on next page
5
| 4) Device
Description | The ACCU-CHEK Connect Diabetes Management App is designed to
facilitate efficient collecting, transmitting, and analyzing of blood glucose
results and other diabetes management data. The App helps:
Wireless transfer of data from ACCU-CHEK Aviva Connect Blood
Glucose Meter. Assist in general diabetes management through logging of contextual
data. ACCU-CHEK Bolus Advisor support of mealtime insulin dosing
calculations. Perform structured testing. Wireless transfer of data from mobile devices to ACCU-CHEK
Connect Online Diabetes Management System and optionally share
this data with healthcare provider (HCP) or caregiver.
The insulin bolus calculations provided by the app are meant for patients
undergoing multiple daily injection therapy. Bolus calculators, such as the
ACCU-CHEK Bolus Advisor, have been demonstrated to facilitate the
optimization of glycemic control in patients who are trained in multiple daily
insulin injection therapy and under the supervision of healthcare professional |
| -------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
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.
Continued on next page
6
- 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).
Continued on next page
7
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:
-
- Changes based on the inherent differences between the iOS and Android operating systems (OS) user interface standards
-
- Enhancements that were made based upon results of the Android version summative and iPhone version formative human factors study
-
- 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)
Similarities/
Differences | The following is a listing of the key similarities and differences between the
modified ACCU-CHEK Connect Diabetes Management App and the
predicate device. | |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Feature /Claim | Modified ACCU-CHEK Connect
Diabetes Management App | ACCU-CHEK Connect Diabetes
Management App (#K141929) |
| Intended 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. | Same |
| Prescription /
over-the-counter
use? | Over-the-counter distribution of
App, with bolus calculator function
disabled until activated by physician | Same |
| User Group | Diabetes patients treated with
multiple daily insulin injection
(MDI) therapy | Same |
| Accessory to
Blood Glucose
Meters? | ACCU-CHEK Aviva Connect blood
glucose meter | Same |
| Feature /Claim | Modified ACCU-CHEK Connect
Diabetes Management App | ACCU-CHEK Connect Diabetes
Management App (#K141929) |
| Bolus Calculator
Set-up stage | During the modified ACCU-CHEK
Connect Diabetes Management
App's bolus calculator set-up stage,
the following information must be
entered.
• Time Blocks
• Target Range
• Carb Ratio
• Insulin Sensitivity
• Health Event Percentages
• Meal Rise
• Snack Size
• Acting Time
• Offset Time | Same |
| Bolus Calculator
inputs | Once the set-up stage has been
completed, the patient may begin
using the ACCU-CHEK Bolus
Advisor in the modified ACCU-
CHEK Connect Diabetes
Management App. Bolus
recommendations can be triggered
by inputting the following
information prior to each meal:
• Measure blood glucose
• Enter carbohydrates
• Enter Health Event | Same |
| Communicate
with insulin
pumps? | No | No |
| Software Level of
Concern | Major | Major |
| Connectivity to
Meter | Bluetooth Low Energy (BLE) | Same |
| Control or affect
the blood glucose
meter's
measurements? | No | No |
| Reports, graphs,
and Electronic
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
Structured Testing data | Same |
| Carbohydrate Calculator | Calculate carbohydrate intake based
on user-entered data | Same |
| Bolus Calculator | Yes | Yes |
| Bolus Calculator Security | The patients will be instructed to
request an activation code from
their healthcare providers; the
healthcare providers will decide
whether any additional multiple
daily injection therapy training
should be provided to the patient
prior to activating the app's bolus
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
screens | Android phones with larger
viewable screens |
| Meter Pairing Code | iOS standard Bluetooth pairing code | Android standard Bluetooth pairing
code |
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