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510(k) Data Aggregation
K Number
K123229Device Name
REMOTE PRESENCE SYSTEM, MODEL RP-VITA
Manufacturer
Date Cleared
2012-11-20
(36 days)
Product Code
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
INTOUCH HEALTH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Remote Presence System, Model RP-VITA™ is a clinical communications tool that provides a means of transmitting, receiving, and storing real-time audio and video, and patient data. The Remote Presence System, Model RP-VITA™ may also be used in conjunction with 510(k)-cleared devices that transmit patient biometric data including vital signs information. The Remote Presence System, Model RP-VITA™ transmits and receives information over a high speed connection between patients, and health professionals. The Remote Presence System, Model RP-VITA™ can be used in communications for active patient monitoring in high acuity clinical environments where immediate clinical action may be required, e.g., pre-, peri-operative and post-surgical, cardiovascular, neurological, pre-natal, psychological and critical care assessments and examinations. Clinical judgment and experience are required to review and interpret the information transmitted.
Device Description
The Remote Presence System, Model RP-VITA™ is a telecommunications platform that enables real-time videoconferencing and clinical communications, and provides a means for transmitting, receiving, and storing real-time audio and video, and patient data. The Remote Presence System, Model RP-VITA™ consists of a Control Station ("CS") (i.e., desktop or laptop computer) and the RP-VITA™ end point that is controlled by an input device (e.g., mouse or joystick) that the operator uses to control the movement of the RP-VITA™ from a remote location. The RP-VITA™ and CS are each equipped with various combinations of cameras, displays, microphones, and speakers, depending upon the specific CS used, which facilitate two-way audio-video communication. One accessory is a Class II, integrated electronic stethoscope, which is used for the same purpose for which it received 510(k) clearance. Communication between the CS and the RP-VITA™ end point is established via a wired broadband Internet connection or an 802.11 wireless broadband network connection.
Expanding on the predicate device, the Remote Presence System, Model RP-VITA™ is available with an optional autonomous navigation system ("autonavigation"), providing the ability to autonomously navigate and position the RP-VITA™ end point to a pre-determined location. Developed in partnership with iRobot, the RP-VITA™ contains similar Auto Drive technology that is already being used successfully by the defense and public safety communities (e.q., PackBot bomb disposal robots), as well as by consumers in household environments (e.g., Roomba vacuum cleaners). With a single click or tap, a bedside nurse or a remote clinician will be able to send the RP-VITA™ to the target destination. The RP-VITA™ features mapping and Obstacle Detection Obstacle Avoidance ("ODOA") technologies that support safe, fast, and highly flexible navigation in a clinical environment. As the technology name suggests, the ODOA system allows the RP-VITA™ to steer clear of obstacles in its path and maneuver around them. The RP-VITA's™ mapping technology creates and stores a digital map of a clinical environment that it can access in the future, labeling rooms, controlling device speed in certain areas, and marking areas where the RP-VITA™ should not travel.
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K Number
K120895Device Name
REMOTE PRESENCE SYSTEM
Manufacturer
Date Cleared
2012-05-24
(62 days)
Product Code
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
INTOUCH HEALTH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Remote Presence System is a clinical communications tool that provides a means of transmitting, receiving, and storing real-time audio and video, and patient data. The Remote Presence System may also be used in conjunction with 510(k)-cleared devices that transmit patient biometric data including vital signs information. The Remote Presence System transmits and receives information over a high speed connection between patients, health professionals and critical transport teams. The Remote Presence System can be used in communications for active patient monitoring in . high acuity clinical environments where immediate clinical action may be required, e.g., pre-, perioperative and post-surgical, cardiovascular, neurological, pre-natal, psychological and critical care assessments and examinations. Clinical judgment and experience are required to review and interpret the information transmitted.
Device Description
The Remote Presence System is a telecommunications platform that enables real-time videoconferencing and clinical communications, and provides a means for transmitting, receiving, and storing real-time audio and video, and patient data. The Remote Presence System consists of a Control Station ("CS"), (i.e., desktop or laptop computer) and an end point, which may be controlled by an input device (i.e., mouse or joystick) that the operator uses to control the movement of the end point in the remote location (e.g., RP-70), or manually located by the user (e.g., RP-Lite®, KSEA VisitOR1 Cart, RP-Vantage®, or RP-Xpress™), or used in a restricted clinical environment, such as an operating room, where it is boom mounted (e.g., BoomBot (aka RP-B and KSEA VisitOR1)). The end point and CS are each equipped with various combinations of cameras, displays, microphones and speakers, depending upon the specific device, which facilitate two-wav audio-video communication. Optional accessories include Class II devices, including an integrated electronic stethoscope, which are used for the same purpose for which they received 510(k) clearance. Communication between the CS and the end-point is established wia broadband Internet and an 802.11 wireless network or a broadband cellular connection.
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