(62 days)
No
The description focuses on real-time audio/video transmission and control of a telecommunications platform, with no mention of AI or ML for data analysis, interpretation, or decision support. The document explicitly states "Clinical judgment and experience are required to review and interpret the information transmitted."
No.
The device is a clinical communications tool for transmitting, receiving, and storing audio, video, and patient data, and is used for active patient monitoring and communication, not for administering therapy.
No
The device is described as a "clinical communications tool" and a "telecommunications platform" used for transmitting and receiving audio, video, and patient data. It is for "communications for active patient monitoring" and requires "Clinical judgment and experience...to review and interpret the information transmitted." It explicitly states that it "may also be used in conjunction with 510(k)-cleared devices that transmit patient biometric data," implying it does not generate diagnostic data itself but facilitates the transmission of such data from other devices.
No
The device description explicitly states that the system consists of hardware components such as a Control Station (desktop/laptop), end points with cameras, displays, microphones, and speakers, and optional accessories like an integrated electronic stethoscope. This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a "clinical communications tool" for transmitting and receiving real-time audio, video, and patient data for remote presence and monitoring. This is a communication and data transmission function, not a diagnostic test performed on biological samples.
- Device Description: The device description focuses on the hardware components (computers, cameras, displays, microphones, speakers) and the communication platform (videoconferencing, broadband internet). It describes a system for facilitating remote interaction and data sharing, not for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The data transmitted is described as "patient data" and "biometric data," which are typically physiological measurements or information gathered through other means, not in vitro analysis.
The device's function is to enable remote communication and data sharing for clinical purposes, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for 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-, 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 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.
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, inpatient, outpatient / Hospital, clinic, patient transport
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 is as safe and effective, and performs as well as or better than the predicate device.
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.
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
5. 510(k) Summary
MAY 24 2012
| Name of 510(k) sponsor: | InTouch Health, Inc. |
|---|---|
| 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: | March 22, 2012 |
| Proprietary name of device: | Remote Presence System- RP-7i®, RP-B (a/k/a BoomBot and |
| KSEA VisitOR1); RP-Lite®; KSEA VisitOR1 Cart; RP- | |
| Vantage®; and RP-Xpress™ | |
| 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 Robotic System, Model RP-7; |
| K073710; April 11, 2008 |
Device Description and Technological Characteristics:
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.
Like the predicate device, the Remote Presence System provides a real-time link between the patient and the healthcare professional. This link occurs over a wired or 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 predicate device, the Remote Presence System provides connections for the transfer of data from 510(k)-cleared devices
1
K120895 P2/4
510(k) Submission Remote Presence System
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, and consequently, no additional risk is presented.
Expanding on the predicate device, the Remote Presence System introduces new cart-based and hand-held models, providing improved system flexibility by adapting to additional clinical environments (e.g., operating rooms, emergency departments, intensive care units, patient transport, etc.).
Redundant safeguards are designed into the Remote Presence System to address risks associated with additional models, and hardware and software improvements. The effectiveness of these improvements was demonstrated by the validation testing performed on the system. The communication channel used by the electronic stethoscope was also proven effective by independent tests.
The performance data discussed in this 510(k) application demonstrate that the Remote Presence System is as safe and effective, and performs as well as or better than the predicate device.
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 highspeed 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 postsurgical, 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 to the predicate device is provided below.
2
510(k) Submission
Remote Presence System
| Table
5.1:
Substance | Equivalent
Quantity | Comparison |
|----------------------------|------------------------|------------|
| d-Tartaric | 1 | 1 |
| dl-Tartaric | 2 | 2 |
| L-Tartaric | 1 | 1 |
| Meso-Tartaric | 1 | 3 |
| New Device | Predicate Device | |
|---|---|---|
| 510(k) # | To be assigned | K073710 |
| Company | InTouch Health | InTouch Health |
| Name/Model # | Remote Presence System | Remote Presence Robotic System, Model RP-7 |
| Indications for 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-, 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 RP-7 is a communications tool that provides a means of | |
| transmitting, receiving, and storing real-time audio and video, | ||
| and patient data. The RP-7 also can be used in conjunction | ||
| with 510(k)-cleared devices that transmit patient biometric data, | ||
| including vital signs information. The RP-7 transmits and | ||
| receives information over a high speed connection between | ||
| patients and health professional, and is intended to be used in a | ||
| hospital or clinic environment. 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 |
| Site of use | Hospital, clinic, patient transport | Hospital, clinic |
| Data collection | ||
| software | Proprietary software | Proprietary software |
| Communication | ||
| method with | ||
| remote care | ||
| management | ||
| system | Wired or wireless broadband connection | Wired broadband connection |
| New Device | Predicate Device | |
| 510(k) # | To be assigned | K073710 |
| Company | InTouch Health | InTouch Health |
| Name/Model # | Remote Presence System | Remote Presence Robotic System, Model RP-7 |
| Types of devices that can be interfaced (wired or wirelessly) to receiver hub | Electronic Stethoscope (K034046) and other cleared medical devices that transmit patient data. | Electronic Stethoscope (K034046) |
| Implementation method of collecting data from device | External communication device | External communication device |
| Sensor software | Unchanged | Unchanged |
| Connectivity | Wired, wireless to hub | Wireless to hub |
| Communication method of hub with devices | RS-232, Serial communication, USB, Bluetooth® | RS-232, Serial communication |
| Communications protocol | Proprietary or Session Initiation Protocol | Proprietary |
| Wireless frequency | 802.11 A, B, or G (varies based on the customer) | 802.11 A, B, or G (varies based on the customer) |
| Power source | AC or 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 |
| Video conferencing | 2-way video conferencing via a broadband internet or cellular connection | 2-way video conferencing via a broadband internet connection |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's three main goals: health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 4 2012
InTouch Health, Inc. c/o Mr. Steve Sidwell Director of Regulatory Affairs & Quality Assurance 6330 Hollister Ave. Goleta, CA 93117
K120895 Re:
Trade/Device Name: Remote Presence System RP-7i®, RP-B (a/k/a BoomBot and KSEAVisitOR1 ); RP-Lite®; KSEA VisitOR1 Cart; RPVantage®; and RP-Xpress™
Regulation Number: 21 CFR 870.2910
Regulation Name: Radiofrequency Physiological Signal Transmitters and Receivers, Regulatory Class: Class II (two) Product Codes: DRG Dated: March 22, 2012 Received: March 26, 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.
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.
5
Page 2 – Mr. Steve Sidwell
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 (OS) 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.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Submission Remote Presence System
4. Indications for Use Statement
· Applicant: InTouch Health, Inc. 510(k) Number. Not assigned. Device Name: Remote Presence System
Indications for 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.
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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K120895
CONFIDENTIAL