(167 days)
Not Found
No
The summary describes a mobile application for collecting, displaying, and transmitting vital signs data. There is no mention of AI, ML, or any algorithms that would process or interpret the data using these technologies. The focus is on data acquisition and transmission for retrospective review.
No
The device is described as collecting, displaying, and transmitting patient information for retrospective review, primarily for data management, rather than directly treating or diagnosing a disease or condition.
Yes
The device collects vital signs data and allows for retrospective review of physiological functions by qualified healthcare professionals, which is consistent with diagnostic purposes.
No
The device description explicitly states that the mobile application guides the user through the vitals acquisition process via Bluetooth medical peripherals, which are hardware devices (Scale, Glucose meter, NiBP, SPO2). While the application itself is software, its intended use and functionality are directly tied to and dependent on these external hardware components for data acquisition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device collects vital signs data (blood pressure, pulse rate, weight, etc.) from the patient using external peripherals. It then transmits this data for retrospective review.
- Lack of Sample Analysis: The device does not perform any analysis on biological samples taken from the patient. It is focused on collecting and transmitting physiological measurements.
The device is a mobile application that facilitates the collection and transmission of vital signs data, which falls under the category of a medical device, but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DRG, DXN, FRI, DQA, NBW
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
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
adult and pediatric patients over twelve years of age.
Intended User / Care Setting
personal use / Not Found
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)
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.
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.
Honeywell HomMed Genesis DM, K101242
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
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).
0
K120325 Pi/2
JUL 1882012
| Submitter: | Watermark Medical |
|---|---|
| Address: | 1750 Clint Moore Road, Suite 101 |
| Boca Raton, FL 33487 | |
| Corporate Contact: | Frank Katarow, Chief Operating Officer |
| WaterMark Medical | |
| Telephone: | 877-710-6999 |
| Establishment Registration #: | 3008208119 |
| Submission Contact: | Michael J. Leigh, consultant |
| 12715 Falcon Drive | |
| Brookfield, Wisconsin 53005 | |
| Ph: (262) 957-6797 | |
| 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
Number | Product
Code | Classification Name | Device
Class |
|-----------------------------------------------------------------------------------------------------------|-----------------|---------------------------------------------------------------------|-----------------|
| 870.2910 | DRG | Transmitters And Receivers, Physiological
Signal, Radiofrequency | II |
| Medical device product codes also supported by Mobile Application by means of
separate medical devices | | | |
| 870.1130 | DXN | Noninvasive Blood Pressure Measurement
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
1
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
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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