(349 days)
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.
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.
The OneTouch® Reveal Diabetes Management Application is a software accessory designed to aid in the review, analysis, and evaluation of patient data to support diabetes management. The device works in conjunction with the OneTouch® Verio™ Sync Meter, receiving blood sugar test results via Bluetooth, and allowing users to tag results, receive pattern messages, add data (carbs, activity, medication, notes), and review/share results.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided summary does not explicitly list quantitative acceptance criteria with corresponding performance metrics in a defined table format. Instead, it describes general validation activities and concludes with substantial equivalence. The "Summary of Performance Characteristics" section indicates:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functionality and compliance with FDA Guidance Document | "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)'." This implies the software met all functional, performance, and safety requirements outlined in the validation plan derived from the guidance. |
| User performance and usability | "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." This indicates the device was found usable and effective for its intended user group. |
| Equivalence to predicate device (DiabetesManager® System, K100066) | "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..." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the user performance evaluation study or the human factors usability studies.
The data provenance is not explicitly stated. Given it's a submission for the US FDA, it's likely that at least some of the testing involved participants in a US-equivalent demographic or was overseen by US regulatory standards. However, the sponsor is LifeScan Europe, a Division of Cilag GmbH International (Switzerland), so testing could have occurred internationally. The summary does not indicate whether data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set in the context of blood glucose pattern recognition or other analytical features. The validation focuses on software functionality and user interaction rather than diagnostic accuracy requiring expert consensus on specific cases.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method like 2+1 or 3+1. This type of adjudication is typically used for image-based diagnostics where multiple experts' opinions are combined to form a ground truth, which is not directly applicable to the described functionalities of this diabetes management application (e.g., displaying data, identifying patterns based on predefined algorithms).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study was mentioned in the provided summary. The device's primary function is to process and display blood glucose data, not to perform interpretations that typically require multiple human readers. The summary focuses on comparing the device's functionality to a predicate device and validating its software and usability.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, a form of standalone evaluation was conducted as part of the "Full verification and validation testing of the OneTouch® Reveal™ Diabetes Management Application software." This validation would inherently involve testing the software's algorithms and functionalities (e.g., pattern recognition, data storage, display accuracy) in a standalone manner, separate from human-in-the-loop performance, to ensure they meet design specifications before user performance studies. The "user performance evaluation study" and "Human Factors Formative Usability studies" assessed the human-in-the-loop aspects.
7. The Type of Ground Truth Used
For the software validation, the "ground truth" would be established by the predefined software specifications and functional requirements. For example:
- Data Storage and Transmission: The ground truth would be that the data received, stored, and sent accurately matches the input data from the OneTouch® Verio™ Sync Meter or manual entry.
- Pattern Recognition: The ground truth would be the predefined rules or algorithms for identifying "Low patterns" and "Before-Meal High patterns." The algorithm's output (identification of a pattern) would be compared against the expected output based on these rules.
- Calculations/Display: The ground truth would be accurate mathematical calculations and correct display of data as per design.
No mention of pathology, outcomes data, or expert consensus specific to establishing the "correctness" of interpreted medical findings is made, as the device's main role is data management and simple pattern alerts based on pre-set thresholds.
8. The Sample Size for the Training Set
The document does not specify a sample size for a "training set." This type of application (diabetes management software) typically does not involve machine learning models that require explicit training data in the same way an AI diagnostic algorithm would. Its functionalities are rule-based and deterministic (e.g., displaying data, recognizing patterns based on pre-defined thresholds, calculating averages). Therefore, the concept of a "training set" is not applicable in the context usually addressed by such questions for AI/ML devices.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a traditional machine learning "training set," the concept of establishing ground truth for it is not applicable here. The "ground truth" for the device's functions (e.g., correct data processing, accurate pattern identification) would be established by its design specifications and the underlying mathematical or logical rules programmed into the software.
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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
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| System Description | The OneTouch® Reveal Diabetes ManagementApplication (App) is a diabetes management tool thatcan help you determine what your blood glucose testresults mean. This allows you and your health careprofessional to better monitor and adjust your diabetescare plan. The App is designed to work in conjunctionwith the OneTouch® Verio™ Sync Meter. Using theBluetooth® feature on your meter and Apple® device,blood sugar test results can be sent directly from yourmeter to the App. Once a blood sugar result is sent tothe App you can:Tag the blood sugar result with a meal flag, Receive Low and High Pattern messages, Add carbs, activity, medication data and Notesabout your activities, Manually enter other blood sugar test results, Review results on graphs, Share your blood sugar results with others forreview and follow-up, and Set reminders to prompt you to completecertain tasks. |
|---|---|
| Predicate Device | DiabetesManager® System, WellDoc, Inc. (K100066) |
| Intended Use/Indications for Use | The OneTouch® Reveal Diabetes ManagementApplication is a software accessory to the OneTouch®Verio Sync Blood Glucose Monitoring System, and isintended for use in the home setting by people withdiabetes. It is intended to aid in the review, analysis,and evaluation of patient data to support diabetesmanagement. The OneTouch® Reveal DiabetesManagement 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®RevealDiabetes ManagementThe |
| Applicationincorporates similar technology and | |
| functionality provided by theDiabetesManager | |
| System including; | |
| Capture, storage and transmission of patient data; | |
| Analysis and reporting of blood glucose results toaid in blood glucose management; | |
| Entry of diabetes related information to aid indiabetes 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. |
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| Technological Characteristics | The OneTouch® Reveal™ Application is designed torun under Apple iOS 4+ operating systems on thefollowing 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. |
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| Summary of PerformanceCharacteristics | Full verification and validation testing of theOneTouch® Reveal™ Diabetes ManagementApplication software was performed in accordancewith the FDA Guidance Document 'General Principlesof Software Validation (2002)'. |
|---|---|
| A user performance evaluation study was conducted tovalidate the OneTouch® Reveal DiabetesManagement Application. Human Factors FormativeUsability studies were also conducted to evaluate theusability of the OneTouch Reveal DiabetesManagement Application and to inform final design ofthe 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).
.
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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.
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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
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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
§ 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.