(349 days)
No
The summary describes a software application for diabetes management that receives, stores, and displays data, and provides basic pattern messages. There is no mention of AI, ML, or any advanced analytical techniques that would typically fall under those categories. The focus is on data management and basic pattern recognition.
No.
The device is a software accessory intended to aid in the review, analysis, and evaluation of patient data to support diabetes management, not to treat or prevent a disease.
No.
The device is described as a software accessory that aids in the review, analysis, and evaluation of patient data to support diabetes management. It does not perform a direct diagnostic function but rather helps in managing information gathered from another diagnostic device (the blood glucose monitoring system).
Yes
The device is described as a "software accessory" and an "Application (App)" that runs on commercially-available mobile devices. While it interacts with a hardware blood glucose meter (OneTouch® Verio™ Sync Meter) for data transfer, the device itself is the software application for data management and analysis, not the meter or any other hardware component. The description focuses entirely on the software's functionalities.
Based on the provided information, the OneTouch® Reveal Diabetes Management Application is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- OneTouch® Reveal's Function: The OneTouch® Reveal application's primary function is to receive, store, display, and analyze data that has already been generated by a blood glucose monitoring system (the OneTouch® Verio Sync Blood Glucose Monitoring System). It does not perform any in vitro testing on a specimen itself.
- Intended Use: The intended use clearly states it is "intended to aid in the review, analysis, and evaluation of patient data to support diabetes management." This is a data management and analysis tool, not a diagnostic test.
- Device Description: The description reinforces this by stating it's a "diabetes management tool" that helps users "determine what your blood glucose test results mean." It processes existing results, it doesn't generate them.
- Predicate Device: The predicate device, K100066 DiabetesManager® System, is also a software system for diabetes management, not an IVD.
In summary, the OneTouch® Reveal Diabetes Management Application is a software accessory that helps users manage their diabetes by organizing and analyzing data from a separate IVD (the blood glucose meter). It does not perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
The OneTouch® Reveal Diabetes Management Application is a software accessory to the OneTouch® Verio Sync Blood Glucose Monitoring System, and is intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The OneTouch® Reveal Diabetes Management Application receives (from both manual entry and wireless transmission), stores, and sends patient data for display and reporting. The OneTouch® Reveal Diabetes Management Application also communicates with web-based applications. The OneTouch® Reveal Diabetes Management Application is available for use on commercially-available mobile devices and uses generally-available networks and communication protocols.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JQP
Device Description
The OneTouch® Reveal Diabetes Management Application (App) is a diabetes management tool that can help you determine what your blood glucose test results mean. This allows you and your health care professional to better monitor and adjust your diabetes care plan. The App is designed to work in conjunction with the OneTouch® Verio™ Sync Meter. Using the Bluetooth® feature on your meter and Apple® device, blood sugar test results can be sent directly from your meter to the App. Once a blood sugar result is sent to the App you can: Tag the blood sugar result with a meal flag, Receive Low and High Pattern messages, Add carbs, activity, medication data and Notes about your activities, Manually enter other blood sugar test results, Review results on graphs, Share your blood sugar results with others for review and follow-up, and Set reminders to prompt you to complete certain tasks.
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
home setting by people with diabetes
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 user performance evaluation study was conducted to validate the OneTouch® Reveal Diabetes Management Application. Human Factors Formative Usability studies were also conducted to evaluate the usability of the OneTouch Reveal Diabetes Management Application and to inform final design of the product.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Full verification and validation testing of the OneTouch® Reveal™ Diabetes Management Application software was performed in accordance with the FDA Guidance Document 'General Principles of Software Validation (2002)'. A user performance evaluation study was conducted to validate the OneTouch® Reveal Diabetes Management Application. Human Factors Formative Usability studies were also conducted to evaluate the usability of the OneTouch Reveal Diabetes Management Application and to inform final design 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.
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.
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510 k Summary
120558 Traditional 510(k)
| OneTouch® Reveal Diabetes Management Application |
|---|
| Confidential and Proprietary Information |
7 2013 .FEB
| Sponsor | LifeScan Europe, a Division of Cilag GmbH |
|---|---|
| International | |
| Landis and Gyr Strasse 1 | |
| Zug, Switzerland 6300 | |
| Correspondent | Andrea M. Tasker |
| Director, Regulatory Affairs | |
| Lifescan Inc. | |
| 200 Lawrence Drive | |
| West Chester, PA 19380 | |
| Phone: 610-651-7282 | |
| Fax: | |
| 610-651-7271 | |
| atasker@its.jnj.com | |
| Alternate 510(k) Contact: | |
| Amy Smith, WW Director Regulatory Affairs | |
| 200 Lawrence Drive | |
| West Chester, PA 19380 | |
| Phone: 484-568-1257 | |
| Email: asmith21@its.jnj.com | |
| Device Trade Name | OneTouch Reveal Diabetes Management Application |
| Common Name | Diabetes Management Software |
| Classification | NBW - system, test, blood glucose, over the counter |
| 862.1345 Glucose test system. Class II | |
| JQP - Calculator/data processing module for clinical | |
| use | |
| 862.2100 Calculator/data processing module for | |
| clinical use. Class I subject to limiations 862.9 (c)(5) | |
| For use in diabetes management | |
LifeScan Europe, a Div. of Cilag GmbH International
1
| System Description | The OneTouch® Reveal Diabetes Management
Application (App) is a diabetes management tool that
can help you determine what your blood glucose test
results mean. This allows you and your health care
professional to better monitor and adjust your diabetes
care plan. The App is designed to work in conjunction
with the OneTouch® Verio™ Sync Meter. Using the
Bluetooth® feature on your meter and Apple® device,
blood sugar test results can be sent directly from your
meter to the App. Once a blood sugar result is sent to
the App you can:
Tag the blood sugar result with a meal flag, Receive Low and High Pattern messages, Add carbs, activity, medication data and Notes
about your activities, Manually enter other blood sugar test results, Review results on graphs, Share your blood sugar results with others for
review and follow-up, and Set reminders to prompt you to complete
certain tasks. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device | DiabetesManager® System, WellDoc, Inc. (K100066) |
| Intended Use/Indications for Use | The OneTouch® Reveal Diabetes Management
Application is a software accessory to the OneTouch®
Verio Sync Blood Glucose Monitoring System, and is
intended for use in the home setting by people with
diabetes. It is intended to aid in the review, analysis,
and evaluation of patient data to support diabetes
management. The OneTouch® Reveal Diabetes
Management Application receives (from both manual |
| | entry and wireless transmission), stores, and sends |
| | patient data for display and reporting. The |
| | OneTouch® Reveal Diabetes Management Application |
| | also communicates with web-based applications. The |
| | OneTouch® Reveal Diabetes Management Application |
| | is available for use on commercially-available mobile |
| | devices and uses generally-available networks and |
| | communication protocols. |
| Comparison to Predicate Device | OneTouch®
Reveal
Diabetes Management
The |
| | Application
incorporates similar technology and |
| | functionality provided by the
DiabetesManager |
| | System including; |
| | Capture, storage and transmission of patient data; |
| | Analysis and reporting of blood glucose results to
aid in blood glucose management; |
| | Entry of diabetes related information to aid in
diabetes self-management; |
| | Unlike the predicate, the OneTouch® Reveal Diabetes |
| | Management Application has a software feature that |
| | alerts users to low and high blood glucose patterns. |
| | This software feature has also been implemented on |
| | another cleared LifeScan blood glucose meter, the |
| | OneTouch Verio IQ Blood Glucose Meter, K110637. |
2
.
3
| Technological Characteristics | The OneTouch® Reveal™ Application is designed to
run under Apple iOS 4+ operating systems on the
following devices: iPhone 4 and iPhone 3GS iPod Touch 3rd and 4th Gen iPad 1st and 2nd Gen The App stores blood glucose test results, events and user settings. The App's memory capacity is 2500 blood glucose results and events; and is limited to a maximum of 1 year of results and events.
In addition to receiving blood glucose measurement readings from the OneTouch Verio Sync Meter via Bluetooth, storing and displaying them, the App provides the following features and tools for the user: Time Synchronization: Synchronizing the time between the App and the OneTouch Verio Sync Meter. Tagging of Results: Allows quick settings of meal tags and notes to results just downloaded from the meter. Pattern Messages: Alerts the user that one or more patterns were found in the results that were downloaded. Events: Allows the user to manually enter data, such as: manual blood glucose results, carbohydrates consumed, activity performed and medications taken. Sharing: Allows the user to share blood glucose results via SMS text or eMail. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • | Summary: Allows the user to view results in summary in the following ways: 14-day Glucose Report, last meter “Sync” results and patterns, “Today” results & events. |
| • | Logbook: Allows the user to view results by date and time-slot, 14-day graph, time-of-day graph. |
| • | Pattern Recognition: Alerts the user of Low patterns and Before-Meal High patterns detected in the last 14-days and allows review of those patterns and their details. |
| • | More: Allows the user to personalize/customize the App through the following: “About Me” personal settings, “General” application options, “Reminders”, “Help”, and “Contact OneTouch” information. |
Page 5 of 7
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Page 6 of 7
5
| Summary of Performance
Characteristics | Full verification and validation testing of the
OneTouch® Reveal™ Diabetes Management
Application software was performed in accordance
with the FDA Guidance Document 'General Principles
of Software Validation (2002)'. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | A user performance evaluation study was conducted to
validate the OneTouch® Reveal Diabetes
Management Application. Human Factors Formative
Usability studies were also conducted to evaluate the
usability of the OneTouch Reveal Diabetes
Management Application and to inform final design of
the product |
Conclusions
The OneTouch Reveal Diabetes Management Application is substantially equivalent in its intended use, performance, safety, effectiveness and underlying scientific and operating principles used to the predicate, the DiabetesManager® System, WellDoc, Inc. (K100066).
.
·
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 7, 2013
Lifescan, Inc. c/o Andrea M. Tasker Director, Regulatory Affairs 200 Lawrence Drive Mailstop C-5-1 West Chester, PA 19380
Re: K120558
Trade/Device Name: OneTouch@ Reveal Diabetes Management Application Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JQP Dated: January 22, 2013 Received: January 24, 2013
Dear Ms. Tasker:
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.
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.
7
Page 2-Ms. Tasker
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Carol C. Benson for
Courtney H. Lias, Ph.D. Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K120558
Device Name: OneTouch® Reveal Diabetes Management Application
Indications for Use:
The OneTouch® Reveal Diabetes Management Application is a software accessory to the OneTouch® Verio Sync Blood Glucose Monitoring System, and is intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The OneTouch® Reveal Diabetes Management Application receives (from both manual entry and wireless transmission), stores, and sends patient data for display and reporting. The OneTouch® Reveal Diabetes Management Application also communicates with web-based applications. The OneTouch® Reveal Diabetes Management Application is available for use on commercially-available mobile devices and uses generally-available networks and communication protocols
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Katherine Serrano
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K120558