(117 days)
Not Found
Unknown
The description mentions "pattern recognition messages" and "identifies patterns," which could potentially involve AI/ML, but the summary does not explicitly state the use of these technologies or provide details about training/test sets, making it impossible to confirm.
No.
The device is a data management system for transmitting data from home monitoring devices to a server database to support diabetes management, not directly treating a disease or condition.
No
Explanation: The OneTouch® Reveal™ system is described as a "Web-based Diabetes management system" that helps track blood glucose levels and insulin doses, identifies patterns, and provides reports to support diabetes management. It is not generating a diagnosis itself, but rather helping manage data collected from other monitoring devices. The "Indications for Use" state it is for "transmitting data from home monitoring devices... to a server database to support diabetes management," which points to a data management and support role, not a diagnostic one.
Yes
The device description explicitly states it is a "Web-based Diabetes management system" and an "application," focusing on data transmission, tracking, pattern recognition, and reporting. While it interacts with hardware (glucose meters, insulin pumps), the device itself, as described, is the software system that processes and presents this data. The performance studies mentioned are software verification and validation, further supporting its software-only nature.
Based on the provided information, the OneTouch® Reveal™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for transmitting data from home monitoring devices (like glucose meters) to a server database to support diabetes management. It's a data management and analysis tool, not a device that performs a diagnostic test on a biological sample.
- Device Description: The description reinforces this by stating it's a "Web-based Diabetes management system" designed to "track blood glucose levels and insulin doses" and "identifies patterns." It processes data already generated by other devices.
- Lack of IVD Characteristics: There is no mention of the device performing any test on a biological sample (like blood, urine, etc.) or providing a diagnostic result based on such a test.
IVD devices are specifically designed to perform tests on biological samples to provide information for diagnosis, monitoring, or screening. The OneTouch® Reveal™'s function is to manage and analyze data from devices that do perform those tests (like the glucose meter).
N/A
Intended Use / Indications for Use
OneTouch® Reveal™ is indicated for use by individuals or health care professionals in the home or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database to support diabetes management. The device is indicated for professional use and over-the-counter sales.
Product codes (comma separated list FDA assigned to the subject device)
MRZ, NBW
Device Description
OneTouch® Reveal™ is a Web-based Diabetes management system. The application is designed to assist health care professionals and people with diabetes to track blood glucose levels and insulin doses. The application identifies patterns to help patients manage glycemic control. OneTouch® Reveal™ includes pattern recognition messages, reports, and the ability to view patient data remotely.
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
individuals or health care professionals in the home or health care facilities
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)
Performance testing consisted of software verification and validation testing and Human Factors Usability Studies that demonstrated OneTouch® Reveal™ meets its required specifications and performs as intended.
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
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
·KV32618
Image /page/0/Picture/1 description: The image shows the LifeScan logo. The logo features the word "LIFESCAN" in bold, sans-serif font. Below the word is a tagline in a smaller font. Above the word is a curved line that goes over the word. On the left side of the word is a circular design.
DEC 1 6 2013
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4. 510(k) Summary
| Name of Firm: | LifeScan Inc.
A Johnson & Johnson Company
965 Chesterbrook Bld.
Wayne, PA 19087 |
|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary 510(k) Contact: | Gabrielle Logan
Regulatory Affairs Analyst
LifeScan Inc.
A Johnson & Johnson Diabetes Care Franchise
Phone: 484-328-6159
Fax: 610-651-7271
Email: GLogan2@its.jnj.com |
| Secondary 510(k) Contact: | Amy Smith
Director, Regulatory Affairs
Advanced Sterilization Products
A Johnson & Johnson Company
Phone: 949-789-3803
Email: ASmith21@its.jnj.com |
| Date Prepared: | August 19, 2013 |
| Device Trade Name: | OneTouch® Reveal™ |
| Device Generic Name: | Accessories, Pump, Infusion System
Test, Blood Glucose, Over The Counter |
| Device Class: | II |
| Review Panel: | General Hospital |
| Product Code: | Classification Product Code: MRZ
Subsequent Product Code: NBW |
| Regulation Number: | Infusion Pump 21 CFR § 880.5725 |
| Predicate Device: | K101806 -- Aidera Diasend System (Aidera AB) |
| Device Description: | OneTouch® Reveal™ is a Web-based Diabetes management
system. The application is designed to assist health care
professionals and people with diabetes to track blood glucose
levels and insulin doses. The application identifies patterns to
help patients manage glycemic control. OneTouch® Reveal™
includes pattern recognition messages, reports, and the ability to
view patient data remotely. |
| Traditional 510(k) | Confidential |
| Intended Use /
Indications for Use: | OneTouch® Reveal™ is indicated for use by individuals or
health care professionals in the home or health care facilities for
transmitting data from home monitoring devices such as
glucose meters and insulin pumps to a server database to
support diabetes management. The device is indicated for
professional use and over-the-counter sales. |
| Comparison of the
technological
characteristics of the
device to the predicate
device: | The LifeScan Inc.'s OneTouch® Reveal™ is substantially
equivalent to the legally marketed predicate, Aidera Diasend
System and incorporates the following similar technology and
functionality including:
OTC and Rx Web-based software application Manage patient accounts, filter/sort/search patients, print reports Unlike the predicate, the LifeScan Inc.'s OneTouch® Reveal™
does not use a transmitter to transfer data. |
| Performance Data
(Nonclinical and/or
Clinical): | Performance testing consisted of software verification and
validation testing and Human Factors Usability Studies that
demonstrated OneTouch® Reveal™ meets its required
specifications and performs as intended. |
| Substantial Equivalence to
Predicate Device: | Based on the information presented in this submission,
OneTouch® Reveal™ does not raise new questions of safety
and effectiveness and is substantially equivalent in its intended
use, performance, safety, effectiveness and underlying scientific
and operating principles compared to the predicate. |
: : : :
LifeScan OneTouch® Reveal™
1
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Traditional 510(k) LifeScan OneTouch® Reveal™ Confidential
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002
December 16, 2013
LifeScan Incorporated A Johnson & Johnson Company Ms. Gabrielle Logan Regulatory Affairs Analyst 965 Chesterbrook Bld Wayne, PA 19087
Re: K132618
Trade/Device Name: OneTouch® Reveal™ Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ, NBW Dated: November 13, 2013 Received: November 14, 2013
Dear Ms. Logan:
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.
ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Logan
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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.
- S
Sincerely yours,
Kwame O. Ulmer
for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132618
Device Name
OneTouch® Reveal™
Indications for Use (Describe)
OneTouch® Reveal™ is indicated for use by individuals or health care professionals in the home or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server databes management. The device is indicated for professional use and over-the-counter sales.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
.. FOR FDA USE ONLY . . . . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Digitally signed by Richard C. Chapman Date: 2013.12.16 12:15:19 -05'00' PSC Publishing Services (301) 443-6740 FORM FDA 3881 (9/13) EI