(194 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on data reception, storage, display, and configuration, without mentioning any analytical or predictive capabilities typically associated with AI/ML.
No
The device is a medical device data system that receives, stores, and displays vital signs parameters and related data. It is explicitly stated that "The Clinical Application is not intended for emergency use or real-time monitoring." and "The Clinical Application displays the data and system alerts for review and interpretation by a healthcare professional." It does not directly provide therapy or therapeutic intervention.
No
The device is described as receiving, displaying, and storing monitored vital signs parameters for review and interpretation by a healthcare professional, and not for emergency or real-time monitoring. While the data can be reviewed and interpreted, the device itself does not perform analysis or provide a diagnosis. Its function is to manage and present data from other monitoring devices.
Yes
The device is described as a "cloud based, web software system" and explicitly states it "accepts data from Watermark Patient Monitors" and "sends configuration information to Watermark home monitoring devices," indicating it is a software component interacting with external hardware, but is itself software only.
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 description clearly states that the Clinical Application "retrospectively receive, display and store monitored vital signs parameters and related data." It also sends configuration information to home monitoring devices.
- No mention of samples: There is no mention of the device analyzing samples taken from the body. It deals with data collected by external monitoring devices.
- Focus on vital signs: The data it handles are vital signs parameters, which are typically collected non-invasively (e.g., heart rate, blood pressure, oxygen saturation).
Therefore, the device functions as a data management and display system for vital signs collected by other devices, not as a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN, FRI, DQA, NBW
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.
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
healthcare professional
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 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.
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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
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.(b)
Classification. Class II (performance standards).
0
K120320
| Submitter: | Watermark Medical | AUG 14 2012 | ||
|---|---|---|---|---|
| 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 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, | |
| Non-Invasive | II | ||
| Medical Device product codes also supported by Clinical Application by | |||
| 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.
1
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.
2
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.
3
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 (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): 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