Search Results
Found 3 results
510(k) Data Aggregation
K Number
K131585Device Name
INTEL-GE CARE INNOVATIONS QUIETCARE
Manufacturer
INTEL-GE CARE INNOVATIONS LLC
Date Cleared
2013-10-08
(130 days)
Product Code
KMI
Regulation Number
880.2400Why did this record match?
Applicant Name (Manufacturer) :
INTEL-GE CARE INNOVATIONS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QuietCare-Networked is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. QuietCare-Networked recognizes and monitors certain patterns of activity including but not limited to bathroom and bedroom activity, residence entry/exit, and interaction with food and medication storage.
Caregivers are provided with information and notification about the occurrence of, and changes in, these monitored activity patterns and environmental conditions. Noteworthy occurrences and changes are communicated to caregivers through direct notification (pager, voice alert, email) as well as a secure Internet website.
Data from QuietCare-Networked should not be relied on as medical advice or clinical diagnosis. Caregivers should always rely on licensed medical professionals in making all health decisions and should use the information provided by QuietCare as a resource in that process.
Caregivers should not rely solely on the use of QuietCare-Networked for care management of clients/residents. Caregivers should use standard care practices established within their care organization to ensure the safety and wellness of senior clients/residents.
Device Description
Care Innovations QuietCare-Networked uses advanced motion sensors to monitor Activities of Daily Living for senior residents who require care assistance. It provides alerts and reporting information to care givers when conditions or trends are detected that indicate the senior resident may need care intervention.
Ask a Question
K Number
K130821Device Name
INTEL-GE CARE INNOVATIONS CONNECT RCM
Manufacturer
INTEL-GE CARE INNOVATIONS LLC
Date Cleared
2013-08-09
(137 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
INTEL-GE CARE INNOVATIONS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intel-GE Care Innovations Connect RCM is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in videoconferences with caregivers and answer the caregivers' questions by participating in surveys.
Care Innovations Connect RCM is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.
Care Innovations Connect RCM is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
Care Innovations Connect RCM will be available for over the counter use.
Device Description
Care Innovations™ Connect RCM is a software application for use with measurement devices commercially available for home use. The software executes on a web server and is accessed via a browser from the patient's COTS personal computing device. A small validated software application known as Device Connector runs on patients' home COTS platforms. Off the Shelf (OTS) software is also used with the internally developed software to provide functionality such as: setting & receiving email and text-based notifications, creating & editing calendar entries, playing Learn More videos, and holding a video conference with a clinician.
Care Innovations™ Connect RCM is a software application for use with measurement devices commercially available for home use. Connect RCM provides the same client capabilities of collecting and transmitting patient data to the clinician database system as the predicate devices, and uses the existing clinician database system in the Intel-GE Care Innovations 10 Guide (K130290). No changes were required to the existing clinician database system to support the new client software.
Patients can also enter measurement data manually entered data is stored in the backend clinician database as well as the Personal Health Data Record. It is flagged as manually entered data.
Ask a Question
K Number
K130290Device Name
MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE
Manufacturer
INTEL-GE CARE INNOVATIONS LLC
Date Cleared
2013-06-04
(118 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
INTEL-GE CARE INNOVATIONS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intel-GE Care Innovations Guide is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.
The Intel-GE Care Innovations Health Care Management Suite allows the caregiver to review patient data and initiate video conferencing with patients, or select and send educational content to patients.
The Intel-GE Care Innovations Guide is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.
The Intel-GE Care Innovations Guide is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
Device Description
The Intel-GE Care Innovations Guide is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. The Intel-GE Care Innovations Guide is a software application running on a Commercial Off The Shelf (COTS) Personal Computer (PC). It collects measurements captured on commercially available wireless or tethered medical devices which are designed for home use and connection to a COTS PC. It displays the collected measurement on the PC, and securely stores the collected information locally on a memory device installed in the PC. Intel-GE Care Innovations Guide also stores the information remotely on a host server, where the caregiver can view the measurement via the host server once synchronization between the host server and Intel® Health Guide Express has been completed. Intel-GE Care Innovations Guide can be used to display educational and motivational content from the caregiver and can facilitate communication between the caregiver and patient via health wellness surveys and optional video conferencing.
The Intel-GE Care Innovations Guide is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. It is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered. The Intel-GE Care Innovations Guide system consists of the:
Intel-GE Care Innovations Guide software application: (1)
The software application captures, stores, displays and transmits information to a secure database on a host server running the Intel-GE Care Innovations Health Care Management Suite software via a standard telephone line or internet connection. The Intel-GE Care Innovations Guide software runs on a Commercial Off The Shelf (COTS) Personal Computer (PC).
Intel-GE Care Innovations Health Care Management Suite software application: (2)
The software application runs on a host server and allows caregivers to review patient vital signs on the secure website. The Intel-GE Care Innovations Health Care Management Suite allows for predefining upper and lower limits and, when either limit is exceeded, the system emails and/or pages the caregiver.
Ask a Question
Page 1 of 1