(243 days)
Not Found
No
The description focuses on data management, manual entry, and calculations based on pre-programmed parameters provided by a healthcare professional. There is no mention of the device learning or adapting based on data, which is characteristic of AI/ML.
Yes
Explanation: The device is indicated as an aid in the treatment of diabetes and calculates insulin doses, which directly supports the treatment of a disease.
No
The device is described as an aid in the treatment of diabetes, providing tools for managing blood glucose data and calculating insulin doses. It does not perform diagnostic testing itself.
Yes
The device is described as an "App" and its functions are entirely 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, including the ACCU-CHEK Bolus Advisor component, is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The text describes the app as a software application that receives data from a blood glucose meter (which is an IVD itself) and allows for manual data entry. It then processes and displays this data for diabetes management. It does not perform any tests on biological samples.
- The primary function is data management and calculation. The app's core functions are downloading, storing, displaying, and analyzing blood glucose data and other related health indicators. The Bolus Advisor component calculates insulin doses based on user-entered data and pre-programmed parameters, not on the direct analysis of a biological sample.
- The predicate device is a blood glucose meter (K111353 ACCU-CHEK Aviva Combo meter). Blood glucose meters are IVDs because they measure glucose in a blood sample. The fact that the app is compared to a blood glucose meter as a predicate device further supports that the app itself is not an IVD.
In summary, the ACCU-CHEK Connect Diabetes Management App is a software tool that aids in diabetes management by processing and presenting data, including data from an IVD (the blood glucose meter). It does not perform the diagnostic test itself.
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
For Over-the-Counter Use: Diabetes patients (self-managing)
For Prescription Use: Patients under the supervision of a healthcare professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary performance testing was conducted on the ACCU-CHEK Connect Diabetes Management App to support a determination of substantial equivalence. The results of usability testing of representative users of the device, software testing and performance testing of the device demonstrate the device functions as intended. The non-clinical testing included software verification and algorithm validation to demonstrate the functionality of the software application and the performance of the algorithms. The Human Factors clinical study demonstrated the diabetes management app fulfilled all predefined requirements for safety risk-mitigating controls when handled by persons with diabetes mellitus or their caregivers, according to its intended use.
Performance testing on the ACCU-CHEK Connect Diabetes Management App demonstrated that the device meets the performance requirements for its intended use. The data demonstrate that the device is substantially equivalent to the predicate device.
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.
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 a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16. 2015
Roche Diagnostics Corporation Ms. Chunhong Tao Regulatory Affairs Specialist 9115 Hague Road Indianapolis, IN 46250
Re: K141929
Trade/Device Name: ACCU-CHEK Connect Diabetes Management App Regulation Number: 21 CFR 868.1890 Regulation Name: Drug Dosing Calculator Regulatory Class: II Product Code: NDC, LZG, LFR, JQP Dated: February 9, 2015 Received: February 12, 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. Division 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) K141929
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) K141929
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 bold, black letters, centered within a white hexagon. The hexagon is outlined in black. The logo is simple and recognizable.
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 | Primary contact: | Secondary contact: |
| | Mike Flis | Chunhong (Emma) Tao |
| | Roche Diagnostics Corporation | Roche Diagnostics Corporation |
| | 9115 Hague Rd. | 9115 Hague Rd. |
| | Indianapolis, IN 46250 | Indianapolis, IN 46250 |
| | (317) 521-2110 | (317) 521-7227 |
| 2) Device
name | Date Prepared: January 27, 2015 | |
| | Proprietary Name: ACCU-CHEK Connect Diabetes Management App
Common Name: diabetes management software | |
| | Primary
Classification Name: drug dosing calculator
Classification Regulation: 21 C.F.R. § 868.1890; Class II
Product Code: NDC | |
| | Secondary
Classification Name: calculator/data processing module for clinical use
Classification Regulations: 21 C.F.R. § 880.5725, 862.1345, 862.2100; Class II
Product Code: LZG, LFR, JQP | |
5
- Predicate ACCU-CHEK Aviva Combo meter, cleared as a component of the ACCUdevice CHEK Combo System in #K111353.
The ACCU-CHEK Combo System consists of three (3) main components:
- . ACCU-CHEK Aviva Combo blood glucose meter
- . ACCU-CHEK Spirit Combo insulin pump
- ACCU-CHEK 360° Insulin Pump Configuration Software .
The ACCU-CHEK Aviva Combo meter serves as a hub for the ACCU-CHEK Combo System. The monitor has three main functions:
- . Blood glucose monitor
- Remote control of ACCU-CHEK Spirit Combo insulin pump .
- Calculation of insulin bolus י
The ACCU-CHEK Aviva Combo blood glucose meter is intended for the quantitative measurement of blood glucose. The ACCU-CHEK Aviva Combo meter is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. The ACCU-CHEK Aviva Combo meter can be used to interface with and remotely control the ACCU-CHEK Spirit Combo insulin infusion pumps via radio frequency communication. The ACCU-CHEK Aviva Combo meter is also indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data.
Continued on next page
6
| 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 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5) Intended
use | For Over-the-Counter 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 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. |
| 6) Substantial
equivalence | The ACCU-CHEK Connect Diabetes Management App utilizes the
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. These software functions were built within the predicate
device's embedded software and PC-platform software. The App moves
these functions outside the glucose meter. The App is compatible with
glucose meters with BLE transmitter. The insulin bolus calculator algorithm
is unchanged as compared to the predicate device. The App will not interact
with an insulin pump. The insulin bolus calculations provided by the App are
meant for patients undergoing conventional multiple daily injection therapy.
The ACCU-CHEK Connect Diabetes Management App is substantially |
| | equivalent to the drug dosage calculator function of the ACCU-CHEK Aviva
Combo meter.
Continued on next page |
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
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7) Data demonstrating substantial equivalence
All necessary performance testing was conducted on the ACCU-CHEK Connect Diabetes Management App to support a determination of substantial equivalence. The results of usability testing of representative users of the device, software testing and performance testing of the device demonstrate the device functions as intended. The non-clinical testing included software verification and algorithm validation to demonstrate the functionality of the software application and the performance of the algorithms. The Human Factors clinical study demonstrated the diabetes management app fulfilled all predefined requirements for safety risk-mitigating controls when handled by persons with diabetes mellitus or their caregivers, according to its intended use.
Performance testing on the ACCU-CHEK Connect Diabetes Management App demonstrated that the device meets the performance requirements for its intended use. The data demonstrate that the device is substantially equivalent to the predicate device.
Continued on next page
9
| 8) | The following is a listing of the key similarities and differences between the |
|---|---|
| Similarities/ | ACCU-CHEK Connect Diabetes Management App and the predicate device. |
| Differences |
| Feature /Claim | ACCU-CHEK Connect Diabetes
Management App | ACCU-CHEK Combo System
(#K111353) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The ACCU-CHEK Aviva Combo
blood glucose meter is intended for
the quantitative measurement of
blood glucose. The ACCU-CHEK
Aviva Combo meter is intended for
self-testing outside the body (in
vitro diagnostic use) by people with
diabetes at home as an aid to
monitoring the effectiveness of
diabetes control. The ACCU-
CHEK Aviva Combo meter can be
used to interface with and remotely
control the ACCU-CHEK Spirit
Combo insulin infusion pumps via
radio frequency communication.
The ACCU-CHEK Aviva Combo
meter is also indicated for the
management of diabetes by
calculating an insulin dose or
carbohydrate intake based on user-
entered data. |
| Prescription /
over-the-counter
use? | Over-the-counter distribution of
App, with bolus calculator function
disabled until activated by physician | Prescription use due to relationship
with insulin pump |
| User Group | Diabetes patients treated with
multiple daily insulin injection
(MDI) therapy | Diabetes patients treated with
insulin pump therapy or multiple
daily insulin injection (MDI)
therapy |
| Bolus Calculator
Set-up stage | During the ACCU-CHEK Connect
Diabetes Management App's bolus
calculator set-up stage, the
following information must be | No difference, the same information
is inputted into the ACCU-CHEK
Combo meter during the bolus |
| Feature /Claim | ACCU-CHEK Connect Diabetes
Management App | ACCU-CHEK Combo System
(#K111353) |
| entered.
Time Blocks
Target Range
Carb Ratio
Insulin Sensitivity
Health Event Percentages
Meal Rise
Snack Size
Acting Time
Offset Time | calculator set-up stage. | |
| Bolus Calculator
inputs | Once the set-up stage has been
completed, the patient may begin
using the ACCU-CHEK Bolus
Advisor in the 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 | No difference, the same information
is inputted by the patient prior to
each meal to trigger a
recommendation. |
| Communicate
with insulin
pumps? | No | Yes |
| Software Level of
Concern | Major | Major |
| Operating
platform | Mobile based application | Built within the blood glucose meter |
| Connectivity to
Meter | Bluetooth Low Energy (BLE) | N/A |
| Control or affect
the blood glucose
meter's
measurements? | No | No |
| Reports, graphs,
and Electronic
Log Book | Yes | No |
| Carbohydrate
Calculator | Calculate carbohydrate intake based
on user-entered data | Calculate carbohydrate intake based
on user-entered data |
| Feature /Claim | ACCU-CHEK Connect Diabetes
Management App | ACCU-CHEK Combo System
(#K111353) |
| Bolus Calculator | Yes | Yes |
| Bolus Calculator
Security | Bolus calculator function is
controlled as a prescription device;
the bolus calculator must be
activated by licensed healthcare
provider. Access to the bolus
calculator function requires licensed
healthcare provider activation. | The bolus calculator software is
embedded within a prescription
device. |
| Allow manual
entry? | Yes | No |
| Back-calculation
prevents insulin
stacking? | Yes | Yes |
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