(36 days)
Not Found
Yes
The device description explicitly mentions "autonomous navigation system" and "Auto Drive technology" with capabilities like mapping, obstacle detection, and obstacle avoidance, which are common applications of AI/ML in robotics.
No
The device is described as a clinical communications tool and telecommunications platform for transmitting, receiving, and storing real-time audio, video, and patient data. It is used for "communications for active patient monitoring" and for "review[ing] and interpret[ing] the information transmitted," but it does not directly treat or diagnose any condition.
No
The device is a telecommunications platform for real-time audio, video, and patient data transmission, and explicitly states that clinical judgment is required to interpret the information, meaning it does not perform diagnostic functions itself.
No
The device description explicitly states that the system consists of hardware components including a Control Station (desktop or laptop), the RP-VITA™ end point with cameras, displays, microphones, speakers, and an optional integrated electronic stethoscope. It also describes physical movement and navigation capabilities.
Based on the provided information, the Remote Presence System, Model RP-VITA™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "clinical communications tool" for transmitting, receiving, and storing real-time audio, video, and patient data. It's used for communication, monitoring, and assessments, not for examining specimens derived from the human body.
- Device Description: The description details a telecommunications platform with cameras, displays, microphones, speakers, and an optional electronic stethoscope. These are tools for communication and physical examination, not for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any components, reagents, or processes related to analyzing biological samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
- Focus on Communication and Navigation: The core function is remote presence and communication, with an added feature of autonomous navigation. These are not related to in vitro diagnostics.
Therefore, the Remote Presence System, Model RP-VITA™ falls under the category of a medical device used for communication and remote clinical interaction, not an IVD.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DRG
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.
Like the predicate device, the Remote Presence System, Model RP-VITA™ provides a real-time link between the patient and the healthcare professional. This link occurs over a wireless broadband connection. and includes real-time audio and video to facilitate communication between the patient-side healthcare professionals, and remote healthcare professionals. Also like the Remote Presence System. Model RP-VITA™ provides connections for the transfer of data from 510(k)-cleared devices between the patient and the healthcare professional. Like the predicate device, these 510(k)-cleared devices are not controlled or manipulated through the Remote Presence System, Model RP-VITA™, and consequently, no additional risk is presented.
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. Risk analysis and the necessary verification and validation testing were performed to demonstrate that the design outputs of the RP-VITA™ meet the design input requirements.
Redundant safeguards are designed into the Remote Presence System, Model RP-VITA™ to address risks associated with both autonavigation and hardware and software improvements. The safety and effectiveness of these improvements were demonstrated by the verification testing performed on the Remote Presence System, Model RP-VITA™. One article of the RP-VITA™ verification plan states that if a component critical to the ODOA system fails in autonavigation mode, the device will halt and not move as specified. Another article of the RP-VITA™ verification plan states that the device base has LED light strips that are capable of changing color to indicate various states of the device (e.g., autonavigation mode). An article of the RP-VITA™ validation plan states that when the device is in autonavigation mode, the device will slow down in narrow spaces (e.g. doorways less than three (3) feet) as well as slow down whenever un-mapped obstacles are detected nearby. The RP-VITA™ was tested successfully against these and other verification and validation articles to ensure the design outputs of the RP-VITA™ meet the design input requirements. In addition, the communication channel used by the electronic stethoscope was proven safe and effective by independent tests.
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
Intended users: Healthcare professional, inpatient, outpatient
Site of use: Hospital, clinic
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 performance data discussed in this 510(k) application demonstrate that the Remote Presence System, Model RP-VITA™ is as safe and effective as, and performs as well as or better than, the predicate device.
Risk analysis and the necessary verification and validation testing were performed to demonstrate that the design outputs of the RP-VITA™ meet the design input requirements.
The safety and effectiveness of these improvements were demonstrated by the verification testing performed on the Remote Presence System, Model RP-VITA™.
One article of the RP-VITA™ verification plan states that if a component critical to the ODOA system fails in autonavigation mode, the device will halt and not move as specified. Another article of the RP-VITA™ verification plan states that the device base has LED light strips that are capable of changing color to indicate various states of the device (e.g., autonavigation mode). An article of the RP-VITA™ validation plan states that when the device is in autonavigation mode, the device will slow down in narrow spaces (e.g. doorways less than three (3) feet) as well as slow down whenever un-mapped obstacles are detected nearby. The RP-VITA™ was tested successfully against these and other verification and validation articles to ensure the design outputs of the RP-VITA™ meet the design input requirements. In addition, the communication channel used by the electronic stethoscope was proven safe and effective by independent tests.
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
§ 870.2910 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
Remote Presence System
| Name of 510(k) sponsor: | InTouch Health, Inc. | NOV 20 2012 |
|---|---|---|
| Address: | 6330 Hollister Ave. | |
| Goleta, CA 93117 | ||
| Contact information: | Steve Sidwell | |
| Director of Regulatory Affairs & Quality Assurance | ||
| InTouch Health | ||
| 6330 Hollister Ave. | ||
| Goleta, CA 93117 | ||
| Phone: 805 562 8686 (ext. 254) | ||
| Fax: 805 562 8663 | ||
| Date summary prepared: | October 11, 2012 | |
| Proprietary name of device: | Remote Presence System, Model RP-VITATM | |
| Generic/classification name: | Transmitters and Receivers, Physiological Signal, Radiofrequency | |
| Product code (classification): | 21 C.F.R. § 870.2910, Product Code DRG; Class II |
Legally Marketed Predicate Device: InTouch Remote Presence System, Model RP-7i; K120895; May 24, 2012.
Device Description and Technological Characteristics:
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.
Like the predicate device, the Remote Presence System, Model RP-VITA™ provides a real-time link between the patient and the healthcare professional. This link occurs over a wireless broadband connection. and includes real-time audio and video to facilitate communication between the patient-side healthcare professionals, and remote healthcare professionals. Also like the Remote Presence System. Model RP-VITA™ provides connections for the transfer of data from 510(k)-cleared devices between the patient and the healthcare professional. Like the predicate device, these 510(k)-cleared devices are not controlled or manipulated through the Remote Presence System, Model RP-VITA™, and consequently, no additional risk is presented.
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
1
510(k) Submission Remote Presence System
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. Risk analysis and the necessary verification and validation testing were performed to demonstrate that the design outputs of the RP-VITA™ meet the design input requirements.
Redundant safeguards are designed into the Remote Presence System, Model RP-VITA™ to address risks associated with both autonavigation and hardware and software improvements. The safety and effectiveness of these improvements were demonstrated by the verification testing performed on the Remote Presence System, Model RP-VITA™. One article of the RP-VITA™ verification plan states that if a component critical to the ODOA system fails in autonavigation mode, the device will halt and not move as specified. Another article of the RP-VITA™ verification plan states that the device base has LED light strips that are capable of changing color to indicate various states of the device (e.g., autonavigation mode). An article of the RP-VITA™ validation plan states that when the device is in autonavigation mode, the device will slow down in narrow spaces (e.g. doorways less than three (3) feet) as well as slow down whenever un-mapped obstacles are detected nearby. The RP-VITA™ was tested successfully against these and other verification and validation articles to ensure the design outputs of the RP-VITA™ meet the design input requirements. In addition, the communication channel used by the electronic stethoscope was proven safe and effective by independent tests.
The performance data discussed in this 510(k) application demonstrate that the Remote Presence System, Model RP-VITA™ is as safe and effective as, and performs as well as or better than, the predicate device.
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.
Comparison with Predicate Device
A substantial equivalence table comparing the InTouch Remote Presence System, Model RP-VITA™ to the predicate device is provided below.
2
InTouch Health
K123229 pg. 3 of 5
3
ich Health =
| New Device | Predicate Device | |
|---|---|---|
| 510(k) # | To be assigned | K120895 |
| Company | In Touch Health | InTouch Health |
| Name/Model # | Remote Presence System, Model RP-VITA™ | Remote Presence System, Model RP-7i® |
| Indications for 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, | ||
| 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. | 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-, 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. | ||
| Intended use | Telemedicine system | Telemedicine system |
| Intended users | Healthcare professional, inpatient, outpatient | Healthcare professional, inpatient, outpatient |
| Site of use | Hospital, clinic | Hospital, clinic, patient transport |
| Data collection | ||
| software | Proprietary software | Proprietary software |
| Communication | ||
| method with | ||
| remote care | ||
| management | ||
| system | Broadband internet connection | Broadband Internet connection |
| 510(k) # | New Device | Remote Presence System |
| Predicate Device | ||
| Company | To be assigned | K120895 |
| Name/Model # | InTouch Health | InTouch Health |
| Remote Presence System, Model RP-VITA™ | Remote Presence System, Model RP-7i® | |
| Types of devices that can be interfaced (wired or wirelessly) to receiver hub | Electronic Stethoscope (K102893) and other cleared medical devices that transmit patient data. | Electronic Stethoscope (K034046) and other cleared medical devices that transmit patient data. |
| Implementation method of collecting data from device | External communication device | External communication device |
| Sensor software | Additional object detection and collision avoidance software | Object detection and collision avoidance software |
| Connectivity | Wired, wireless to hub | Wireless to hub |
| Communication method of hub with devices | RS-232, Serial communication, USB | RS-232, Serial communication, USB, Bluetooth® |
| Communications protocol | Proprietary or Session Initiation Protocol | Proprietary or Session Initiation Protocol |
| Wireless frequency | 802.11 A, B, G or N (varies based on the customer) | 802.11 A, B, or G (varies based on the customer) |
| Power source | Batteries with AC-DC battery chargers built in | Batteries with AC-DC battery chargers built in |
| Display | VGA Monitors on computers and end points | VGA Monitor on computers and end points |
| Video conferencing | 2-way video conferencing via a broadband internet or cellular connection | 2-way video conferencing via a broadband internet or cellular connection |
able 5-1: Substantial Equivalence Comparison Table
4
K123229 Pg 5.R5
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
NOV 2 0 2012
InTouch Health, Inc. c/o Mr. Steve Sidwell Director of Regulatory Affairs & Quality Assurance 6330 Hollister Avenue Goleta, CA 93117
K123229 Re:
Trade/Device Name: Remote Presence System, Model RP-VITATM Regulatory Number: 21 CFR 870.2910 Regulation Name: Transmitters and Receivers, Physiological Signal, Radiofrequency Regulatory Class: II (two) Product Code: DRG Dated: October 12, 2012 Received: October 15, 2012
Dear Mr. Sidwell:
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. 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.
6
Page 2 - Mr. Steve Šidwell
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,
C. R. Zalesny, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
InTouch Health
Indications for Use Statement 4.
Applicant: InTouch Health, Inc.
Not assigned. K 123229 510(k) Number:
Remote Presence System, Model RP-VITA™ Device Name:
Indications for 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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cwer Z.
Owen P. Faris -S 2012.11.20 12:16:34 -05'00'