CONNECTED CARE MOBILE APPLICATION

K120325 · Watermark Medical · DRG · Jul 18, 2012 · Cardiovascular

Device Facts

• Record ID: K120325
• Device Name: CONNECTED CARE MOBILE APPLICATION
• Applicant: Watermark Medical
• Product Code: DRG · Cardiovascular
• Decision Date: Jul 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The Watermark Medical Mobile Application is intended for personal use. The Mobile Application collects vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices) then can transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions. The Mobile Application is intended for use with adult and pediatric patients over twelve years of age.

Device Story

Connected Care Mobile Application operates on tablets/smartphones; collects vital signs data (BP, pulse, weight, glucose) via Bluetooth from external medical peripherals; transmits data to central database for retrospective review. Not for real-time monitoring or emergency use. Used by patients for data acquisition; healthcare professionals review data retrospectively. Facilitates remote patient data management; enables provider review of physiological trends; supports patient self-management of health data.

Clinical Evidence

Bench testing only. Software validation demonstrated compliance with FDA guidelines and standards, confirming the application performed within specifications and functional requirements.

Technological Characteristics

Mobile software application operating on tablets and smartphones. Connectivity via Bluetooth for peripheral data acquisition and network communication for data transmission. Supports noninvasive blood pressure, pulse, weight, and glucose monitoring peripherals. Software-based data management.

Indications for Use

Indicated for adult and pediatric patients over twelve years of age for the collection and transmission of vital signs data (noninvasive blood pressure, pulse rate, weight, and other data from optional add-on devices) for retrospective review by qualified healthcare professionals.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• Honeywell HomMed Genesis DM (K101242)

Submission Summary (Full Text)

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K120325 Pi/2

JUL 1882012

| Submitter: | Watermark Medical |
|-------------------------------|---------------------------------------------------------------------------------------------------------|
| Address: | 1750 Clint Moore Road, Suite 101<br>Boca Raton, FL 33487 |
| Corporate Contact: | Frank Katarow, Chief Operating Officer<br>WaterMark Medical |
| Telephone: | 877-710-6999 |
| Establishment Registration #: | 3008208119 |
| Submission Contact: | Michael J. Leigh, consultant<br>12715 Falcon Drive<br>Brookfield, Wisconsin 53005<br>Ph: [phone] |
| Trade Name: | Connected Care Mobile Application |
| Predicate Device: | Honeywell HomMed Genesis DM, K101242 |
| Common Name: | Patient Vital Signs Monitor |
| Classification Name: | |

510(k) Summary for Watermark Medical Mobile Application

| Regulation<br>Number | Product<br>Code | Classification Name | Device<br>Class |
|-----------------------------------------------------------------------------------------------------------|-----------------|---------------------------------------------------------------------|-----------------|
| 870.2910 | DRG | Transmitters And Receivers, Physiological<br>Signal, Radiofrequency | II |
| Medical device product codes also supported by Mobile Application by means of<br>separate medical devices | | | |
| 870.1130 | DXN | Noninvasive Blood Pressure Measurement<br>System | II |
| 880.2700 | FRI | Patient Weight Scale | I |
| 870.2700 | DQA | Oximeter | II |
| 862.1345 | NBW | Glucose Test System | II |

### Device Description:

The Connected Care Mobile Application is intended to receive, display and transmit patient information on a retrospective basis. The device is not intended for real-time monitoring or emergency use by patients or caregivers.

The mobile application is designed to operate on various platforms including tablet computers and smart phones, guiding a user through the vitals acquisition process via Bluetooth medical peripherals. Peripherals will include:

- . Scale
- Glucose meter
- NiBP .
- . SPO2

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Intended Use:

The Watermark Medical Mobile Application is intended for personal use. The Mobile Application collects vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices) then can transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions. The Mobile Application is intended for use with adult and pediatric patients over twelve years of age.

#### Performance Data:

The software validation results demonstrated that the Mobile Application was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements for software.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of FDA regarding medical device software.

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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 Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 1 8 2012

Watermark Medical, Inc. c/o Mr. Michael J. Leigh Consultant 12715 Falcon Drive Brookfield, WI 53005

Re: K120325

Trade/Device Name: · Connected Care Mobile Application Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitters and Receivers Regulatory Class: Class II (two) Product Codes: DRG, DXN, FRI, DQA, NBW Dated: April 30, 2012 Received: June 27, 2012

Dear Mr. Leigh:

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.

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

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Page 2 - Watermark Medical, Inc., c/o Mr. Michael J. Leigh

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): Kxxxx K I2 6325

Watermark Medical Connected Care Mobile Application Device Name:

Indications For Use:

Mobile Application allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions by qualified health care professionals. The Mobile Application is intended for use with adult and pediatric patients over twelve years of age.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number

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