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510(k) Data Aggregation
K Number
K122333Device Name
MOBILECARE MONITOR
Manufacturer
AFRAME DIGITAL, INC.
Date Cleared
2012-11-19
(109 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
AFRAME DIGITAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MobileCare Monitor remote monitoring system is intended as a support in the care of patients and the elderly in institutional, home, and community care settings. Intended users include the monitored individuals and their caregivers.
MobileCare Monitor includes a MyPHD personal help device that is intended to monitor patients and the elderly as they go about their daily activities. MyPHD can be affixed to the wrist, clipped to the waist or used in a bandage for attachment at other locations on the monitored individual, as determined by the patient or caregiver. MobileCare monitor provides the MyPHD location information, battery life and indication that it is being worn. MyPHD also includes a help button and a tri-axial accelerometer used to convey the degree of motion created by a wearer's movements to support an assessment of impacts.
MobileCare Monitor may also relay physiological data from legally marketed Class I and Class II wireless medical devices (e.g. blood pressure cuff, weight scale, blood glucometer, etc.) to AFrame Digital secure remote servers by means of industry standard networks and public carriers. Physiological data transmitted from these devices are stored and may be retrieved with a secure web browser after the user presents satisfactory security credentials. Users may also request the data to be presented in graphical format.
Alerts can be sent when a patient presses a help button on the myPHD or when any data value from MyPHD or relayed device exceeds an upper or lower limit threshold established by a user. These data include impact sensitivity settings and/or physiological measurements from relayed Class I and Class II devices. Rules may be created for reminders to be scheduled for periodic physiological measurements. Alerts are sent to the browser or to a computer or mobile device address that the user designates.
MobileCare Monitor is not interpretive or predictive, nor is it intended to provide an automated treatment decision or act as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the direct supervision and oversight of an appropriate healthcare professional.
Device Description
AFrame Digital's MobileCare Monitor is a communications platform consisting of a local wireless gateway, a remote computer server and software.
Local Wireless Gateway. A Powered Automated Network Data Aggregator (PANDA) is the wireless gateway to the remote server, similar to wireless routers used in homes and offices to provide wireless internet access. Three or more PANDAs are placed in a residential or patient environment to support internet- or cellular-based communications between the AFrame Digital MyPHD (personal health device) and a remote computer server. In some configurations the server will be in the same facility. All wireless messages are securely encrypted with 256-bit AES. The PANDA access points form a reliable, low-power wireless network 'mesh' in the facility for complete wireless coverage of all residents with MyPHD watches.
Remote Computer and Software. The remote computer server communicates with the PANDA devices. It analyzes the messages received against alert thresholds established by designated staff or caregivers. Staff may make inquiries of the status of wearable monitors. The location of a wearable monitor may be determined from its position relative to nearby fixed-position PANDAs. The server will store messages and status information concerning the residents. Staff will be able to annotate records with support information related to individual residents and patients. To enhance caregiver productivity and mobility, alerts, resident location and other important person-specific information is available using a secure web browser application from a portable electronic device (PED), laptop or fixedstation PC.
The remote computer server also communicates with COTS local wireless gateways that incorporate standardized wireless communications protocols such as Bluetooth to receive health-related data from commercially available, wireless measurement devices (e.q. blood pressure cuffs, pulse-oximeters, weight scales, blood alucose meters, etc.). AFrame Digital's configuration protocols and web-based software tools specify whether a measurement device may be used by a single user or multiple users. They also integrate data from these devices with other personspecific information without the transmission of personal health information. The server's software displays the data remotely to access-enabled users or caregivers over a secure browser, and provides tools for them to select patient-specific alert thresholds.
MyPHD™ Wearable Monitor. This is a small plastic housing and wrist strap with an external "panic" button. Some variations will have additional buttons that may be assigned a messaging or privacy function by the product software (softsettable). Internally, there is an impact sensor that may indicate a fall and a skin temperature sensor to indicate if the monitor has been removed from the wrist. A microprocessor with an industry standard very low power wireless transceiver sends messages to a nearby PANDA.
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K Number
K090138Device Name
MOBILECARE MONITOR, MODEL 2100
Manufacturer
AFRAME DIGITAL, INC.
Date Cleared
2009-04-24
(93 days)
Product Code
KMI
Regulation Number
880.2400Why did this record match?
Applicant Name (Manufacturer) :
AFRAME DIGITAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MobileCare™ Monitor 2100 system includes a MyPHD™ personal help device that is intended to monitor residents in home and long-term care facilities including independent living, assisted living and rehabilitation settings. The monitor can be placed on the wrist using the Velcro strap and used like a watch by the resident. The other form of MyPHD offered has no wrist straps so it can be clipped to the waist or used in a bandage for attachment at other locations on the person as may be appropriate or preferred by the user or healthcare provider. The system provides an alert to designated caregivers or professional staff automatically at pre-set thresholds to indicate an impact has occurred. The system also includes an emergency (panic) button that can be pressed by the monitored individual to alert caregivers as needed. The users of the system include staff and residents. The product is intended to be used on a 24-hour basis. The system is not intended to provide automated treatment decisions, nor is it to be used as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate healthcare professional.
Device Description
The MobileCare™ Monitor 2100 system includes a MyPHD™ personal help device that is intended to monitor residents in home and long-term care facilities including independent living, assisted living and rehabilitation settings. The monitor can be placed on the wrist using the Velcro strap and used like a watch by the resident. The other form of MyPHD offered has no wrist straps so it can be clipped to the waist or used in a bandage for attachment at other locations on the person as may be appropriate or preferred by the user or healthcare provider. The system provides an alert to designated caregivers or professional staff automatically at pre-set thresholds to indicate an impact has occurred. The system also includes an emergency (panic) button that can be pressed by the monitored individual to alert caregivers as needed. The users of the system include staff and residents. The product is intended to be used on a 24-hour basis. The system is not intended to provide automated treatment decisions, nor is it to be used as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate healthcare professional.
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