CONNECTED CARE CLINICAL APPLICATION

K120320 · Watermark Medical, Inc. · DXN · Aug 14, 2012 · Cardiovascular

Device Facts

• Record ID: K120320
• Device Name: CONNECTED CARE CLINICAL APPLICATION
• Applicant: Watermark Medical, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Clinical Application's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Additionally, it can send configuration information to Watermark home monitoring devices. Watermark devices include the Connected Care Mobile Application and MiPal. The configuration information may include a patient's vitals collection schedule and parameters to be collected. The Clinical Application displays the data and system alerts for review and interpretation by a healthcare professional. The Clinical Application is not intended for emergency use or real-time monitoring.

Device Story

Cloud-based web software system; receives, stores, and displays vital signs data from Watermark home monitoring devices (Mobile Application, MiPal); sends configuration parameters (collection schedules) to these devices. Accessed via standard PC web browsers. Used by healthcare professionals for retrospective review of patient data and system alerts. Facilitates clinical decision-making by providing historical vital signs trends; does not support real-time monitoring or emergency response.

Clinical Evidence

Bench testing only. Software validation demonstrated compliance with FDA guidelines and functional requirements.

Technological Characteristics

Cloud-based web application; accessed via standard PC hardware/web browser. Functions as a medical device data system (MDDS). Connectivity via network to Watermark home monitoring devices. No specific materials or energy sources as it is software-only.

Indications for Use

Indicated for retrospective review and interpretation of vital signs and related data by healthcare professionals. Not for emergency use or real-time monitoring. Prescription use only.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• Honeywell HomMed Central Station (K072272)

Submission Summary (Full Text)

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# K120320

| Submitter: | Watermark Medical | | AUG 14 2012 | |
|-------------------------------|---------------------------------------------------------------------------------------------------------|---------|---------------------|--------|
| 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 Clinical Application | | | |
| Predicate Device: | Honeywell HomMed Central Station, K072272 | | | |
| Common Name: | Patient Vital Signs Monitor Viewing Station | | | |
| Classification Name: | | | | |
| | Regulation | Product | Classification Name | Device |

#### 510(k) Summary for Watermark Medical Connected Care Clinical Application

| Regulation Number | Product Code | Classification Name | Device Class |
|-------------------------------------------------------------------------------------------------------------|--------------|------------------------------------------------------|--------------|
| 870.1130 | DXN | System, Measurement, Blood-Pressure,<br>Non-Invasive | II |
| Medical Device product codes also supported by Clinical Application by<br>means of separate medical devices | | | |
| 880.2700 | FRI | Patient Weight Scale | I |
| 870.270 | DQA | Oximeter | II |
| 862.1345 | NBW | Glucose Test System | II |

### Device Description:

The Connected Care Clinical Application is a cloud based, web software system. It is accessed from commercially available PC systems with a web browser and minimum performance specifications consistent with typical PC hardware and equipment specifications. The Clinical Application accepts data from Watermark Patient Monitors.

The Connected Care Clinical Application is a medical device data system that receives, stores, and displays data received from Watermark home monitoring devices. Additionally, it can send configuration information to Watermark home monitoring devices. Watermark devices include the Mobile Application and MiPal. The configuration information may include a patient's vitals collection schedule and parameters to be collected.

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### Intended Use:

Clinical Application's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. The Web Application displays the data and system alerts for review and interpretation by a healthcare professional. The Web Application is not intended for emergency use or real-time monitoring.

#### Performance Data:

The software validation results demonstrated that the Clinical Application was in compliance with the guidelines and standards referenced in the FDA reviewer's quides 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 1 4 2012

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

Re: K120320

> Trade/Device Names: Watermark Connected Care Clinical Application Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN, FRI, DQA, NBW Dated: April 27, 2012 Received: July 18, 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, Trug 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.

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Page 2 - Mr. Michael J. Leigh

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.

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 [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): K120320

Watermark Medical Connected Care Clinical Application Device Name:

Indications For Use:

Clinical Application's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Additionally, it can send configuration information to Watermark home monitoring devices. Watermark devices include the Connected Care Mobile Application and MiPal. The configuration information may include a patient's vitals collection schedule and parameters to be collected. The Clinical Application displays the data and system alerts for review and interpretation by a healthcare professional. The Clinical Application is not intended for emergency use or real-time monitoring.

Federal (USA) law restricts this device to sale by or on the order of a physician.

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-C
Division of Cardiovascular Devices