ONETOUCH REVEAL

K132618 · Lifescan, Inc. · MRZ · Dec 16, 2013 · General Hospital

Device Facts

• Record ID: K132618
• Device Name: ONETOUCH REVEAL
• Applicant: Lifescan, Inc.
• Product Code: MRZ · General Hospital
• Decision Date: Dec 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

OneTouch® Reveal™ is a web-based diabetes management system; facilitates data transmission from home monitoring devices (glucose meters, insulin pumps) to a server database. Used by patients and healthcare professionals in homes or clinical facilities. System identifies glycemic patterns; generates reports; enables remote data viewing. Assists in tracking blood glucose levels and insulin doses to support glycemic control. Healthcare providers use output to inform clinical decision-making; patients benefit from improved diabetes management through pattern recognition and data tracking.

Clinical Evidence

Bench testing only. Evidence consists of software verification and validation testing and Human Factors Usability Studies demonstrating the device meets required specifications and performs as intended.

Technological Characteristics

Web-based software application; functions as a data management system for glucose meters and insulin pumps. Connectivity via server database. No hardware transmitter required. Software-based pattern recognition and reporting.

Indications for Use

Indicated for individuals with diabetes or health care professionals managing diabetes; used in home or clinical settings to transmit data from glucose meters and insulin pumps to a server for management.

Regulatory Classification

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.

Predicate Devices

• Aidera Diasend System (K101806)

Submission Summary (Full Text)

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·KV32618

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DEC 1 6 2013

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## 4. 510(k) Summary

| Name of Firm: | LifeScan Inc.<br>A Johnson & Johnson Company<br>965 Chesterbrook Bld.<br>Wayne, PA 19087 |
|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary 510(k) Contact: | Gabrielle Logan<br>Regulatory Affairs Analyst<br>LifeScan Inc.<br>A Johnson & Johnson Diabetes Care Franchise<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Secondary 510(k) Contact: | Amy Smith<br>Director, Regulatory Affairs<br>Advanced Sterilization Products<br>A Johnson & Johnson Company<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | August 19, 2013 |
| Device Trade Name: | OneTouch® Reveal™ |
| Device Generic Name: | Accessories, Pump, Infusion System<br>Test, Blood Glucose, Over The Counter |
| Device Class: | II |
| Review Panel: | General Hospital |
| Product Code: | Classification Product Code: MRZ<br>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<br>system. The application is designed to assist health care<br>professionals and people with diabetes to track blood glucose<br>levels and insulin doses. The application identifies patterns to<br>help patients manage glycemic control. OneTouch® Reveal™<br>includes pattern recognition messages, reports, and the ability to<br>view patient data remotely. |
| Traditional 510(k) | Confidential |
| Intended Use /<br>Indications for Use: | OneTouch® Reveal™ is indicated for use by individuals or<br>health care professionals in the home or health care facilities for<br>transmitting data from home monitoring devices such as<br>glucose meters and insulin pumps to a server database to<br>support diabetes management. The device is indicated for<br>professional use and over-the-counter sales. |
| Comparison of the<br>technological<br>characteristics of the<br>device to the predicate<br>device: | The LifeScan Inc.'s OneTouch® Reveal™ is substantially<br>equivalent to the legally marketed predicate, Aidera Diasend<br>System and incorporates the following similar technology and<br>functionality including:<br>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™<br>does not use a transmitter to transfer data. |
| Performance Data<br>(Nonclinical and/or<br>Clinical): | Performance testing consisted of software verification and<br>validation testing and Human Factors Usability Studies that<br>demonstrated OneTouch® Reveal™ meets its required<br>specifications and performs as intended. |
| Substantial Equivalence to<br>Predicate Device: | Based on the information presented in this submission,<br>OneTouch® Reveal™ does not raise new questions of safety<br>and effectiveness and is substantially equivalent in its intended<br>use, performance, safety, effectiveness and underlying scientific<br>and operating principles compared to the predicate. |

: : : :

LifeScan OneTouch® Reveal™

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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 [phone] FORM FDA 3881 (9/13) EI