(102 days)
K/DEN number: Not Found
No
The description focuses on real-time audio/video transmission and robotic control for telepresence, with no mention of AI or ML for data analysis, interpretation, or decision-making.
No
The device is described as a "communications tool" for transmitting audio, video, and patient data, and it does not directly treat or diagnose any medical condition.
No
The device is described as a "communications tool" and a "telecommunications platform" that transmits and stores real-time audio, video, and patient data. It is intended for remote presence and communication, not for diagnosis. While it can transmit data from other 510(k)-cleared devices (like a stethoscope), the system itself does not perform any diagnostic function; clinical judgment and experience are required to interpret the information.
No
The device description explicitly states it consists of a "mobile, robotic telecommunications platform" including a "RP-7 mobile robot" and a "ControlStation (a desktop or laptop computer)" equipped with hardware like cameras, displays, microphones, speakers, and a joystick. It also mentions an optional integrated electronic stethoscope. This clearly indicates the device is a hardware system with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "communications tool" for transmitting real-time audio, video, and patient data. It facilitates remote presence and communication between patients and healthcare professionals.
- Device Description: The description focuses on the robotic platform, cameras, displays, microphones, speakers, and the ability to control movement. While it can integrate with a separate FDA-cleared electronic stethoscope, the core function is communication and remote presence, not analyzing biological samples or providing diagnostic information based on in vitro tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any process that would fall under the definition of an in vitro diagnostic device.
The device acts as a conduit for information, including potentially biometric data from other devices, but it does not perform the diagnostic analysis itself. The clinical judgment and experience are required to interpret the transmitted information, not for the device to perform a diagnostic test.
N/A
Intended Use / Indications for Use
The Remote Presence Robotic System is a communications tool that provides a means of transmitting, receiving, and storing real-time audio and video, and patient data. The Remote Presence Robotic also can be used in conjunction with 510(k)-cleared devices that transmit patient biometric data including vital signs information. The Remote Presence Robotic System transmits and receives information over 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.
Product codes
DRG, DQD
Device Description
The Remote Presence Robotic System is a mobile, robotic telecommunications platform that enables real-time videoconferencing. The Remote Presence Robotic System consists of a ControlStation (a desktop or laptop computer) and the RP-7 mobile robot, which is most often linked via broadband Internet and an 802.11 wireless network. The Robot and ControlStation are each equipped with cameras, displays, microphones and speakers, allowing two-way audio-video communication. Additionally, the ControlStation is equipped with a joystick that the operator uses to control the movement of the Robot in the remote location. As a result, the user can move through a remote facility and engage in conversations as if physically present while seated at a ControlStation in a remote facility with broadband Internet access.
As an option, the Remote Presence Robotic System includes an integrated electronic stethoscope. The stethoscope is a FDA-cleared device which is used for the same purpose for which it received 510(k) clearance, i.e., to transmit auscultation sounds from a patient at one location to a clinic at a different location. The System provides a channel for the digital data that the stethoscope transmits.
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
hospital or clinic environment
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
The effectiveness of these measures, and the videoconferencing link were demonstrated by the validation testing performed on the system. The communication channel used by the electronic stethoscope was also proven effective by independent tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
073710
P1/2
510(k) Submission
Remote Presence Robotic System
APR 1 1 2008
ATTACHMENT 2 510(k) SUMMARY
InTouch Health® 510(k) Owner: 90 Castilian Drive, Suite 200 Goleta, CA 93117
| Contact: | Bill Stout |
|---|---|
| Phone: 805-862-8686 x112 | |
| Fax: 805-562-8663 |
Date Summary 12/28/07 Prepared:
Device:
Remote Presence Robotic System
Physiological signal transmitter and receiver (21 C.F.R. § 870.2910, Product Code DRG); Class II electronic stethoscope (21 C.F.R. § 870.1875. Product Code DQD)
Classification:
Trade Name:
Class II
Predicate Devices:
BL Healthcare Remote Care Management System BL Healthcare, Inc. K051470
Common/Classification Name:
Telecare D.R. HealthCare Vision, Inc. K033133
CareStation 126S Videophone Motion Media Technology, Inc. K031863
Device Description: The Remote Presence Robotic System is a mobile, robotic telecommunications platform that enables real-time videoconferencing. The Remote Presence Robotic System consists of a ControlStation (a desktop or laptop computer) and the RP-7 mobile robot, which is most often linked via broadband Internet and an 802.11 wireless network. The Robot and ControlStation are each equipped with cameras, displays, microphones and speakers, allowing two-way audio-video communication. Additionally, the ControlStation is equipped with a joystick that the operator uses to control the movement of the Robot in the remote location. As a result, the user can move through a remote facility and engage in conversations as if physically present while seated at a ControlStation in a remote facility with broadband Internet access.
1
As an option, the Remote Presence Robotic System includes an integrated electronic stethoscope. The stethoscope is a FDA-cleared device which is used for the same purpose for which it received 510(k) clearance, i.e., to transmit auscultation sounds from a patient at one location to a clinic at a different location. The System provides a channel for the digital data that the stethoscope transmits.
The Remote Presence Robotic System is a communications tool that provides a Intended Use: means of transmitting, receiving, and storing real-time audio and video, and patient data. The Remote Presence Robotic also can be used in conjunction with 510(k)-cleared devices that transmit patient biometric data including vital signs information. The Remote Presence Robotic System transmits and receives information over 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.
Like the predicate devices, the Remote Presence Robotic System provides a Technological real-time link between the patient and the healthcare professional. This link Characteristics: occurs over broadband Internet and includes real-time audio and video to facilitate communication between the patient, patient-side healthcare professionals, and remote healthcare professionals. Also like the predicate devices, the Remote Presence Robotic System transfers data from 510(k)cleared devices between the patient and the healthcare professional. Like the predicate devices, the devices are not controlled or manipulated through the Remote Presence Robotic System, and consequently, no additional risk is presented.
Unlike the predicate devices, the Remote Presence Robotic System provides mobility to the physician by allowing the physician to control the movement of the mobile robotic platform within the healthcare facility. The real-time audio video link allows the driver to see and hear effectively within the remote environment.
Redundant safeguards are designed into the Remote Presence Robotic System Performance to address risks associated with the mobility of the robotic platform. The Data: effectiveness of these measures, and the videoconferencing link were 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 Conclusions: Remote Presence Robotic System is as safe and effective, and performs as well as or better than the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2008
InTouch Technologies Inc. c/o Mr. Bill Stout Director of Operations 90 Castilian Drive, Suite 200 Goleta, CA 93117
Re: K073710
Trade Name: Remote Presence Robotic System, Model RP-7 Regulation Number: 21 CFR 870.2910 Regulation Name: Transmitters And Receivers, Physiological Signal, Radiofrequency Regulatory Class: Class II (two) Product Codes: DRG Date: February 28, 2008 Received: February 29, 2008
Dear Mr. Stout:
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 such 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.
3
Page 2 -- Mr. Bill Stout
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blymmmmmow for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Submission Remote Presence Robotic System
ATTACHMENT 1 Indications for Use
510(k) Number Not assigned. (if known):
Device Name:
Remote Presence Robotic System
Indications for Use: The Remote Presence Robotic System is a communications tool that provides a means of transmitting, receiving, and storing real-time audio and video, and patient data. The Remote Presence Robotic also can be used in conjunction with 510(k)-cleared devices that transmit patient biometric data including vital signs information. The Remote Presence Robotic System transmits and receives information over 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.
Prescription Use X (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)
B.Bimmerman
(Division Sign-O
Division of Cardiovascular Devices
510(k) Number K0233710