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.

AI/ML Overview

This document describes the Intouch Health Remote Presence System, Model RP-VITA™, a telemedicine platform. The information provided heavily emphasizes the safety and effectiveness of the device through verification and validation testing, rather than a traditional comparative clinical study with acceptance criteria for performance metrics like sensitivity or specificity. This is typical for devices where the primary function is communication and remote control, and the "performance" is more about reliable operation and safety rather than diagnostic accuracy.

Here's an breakdown based on your request:

1. Acceptance Criteria and Reported Device Performance

The document describes functional and safety acceptance criteria for the new "autonavigation" feature and general device operation. The "reported device performance" is framed as successful verification and validation against these criteria, demonstrating the design outputs meet input requirements.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Autonavigation Safety	If a critical component to the Obstacle Detection Obstacle Avoidance (ODOA) system fails in autonavigation mode, the device will halt and not move.	Tested successfully; device halts and does not move.
Autonavigation Visual Cue	The device base has LED light strips capable of changing color to indicate various states (e.g., autonavigation mode).	Tested successfully; LED light strips change color.
Autonavigation Behavior	When in autonavigation mode, the device will slow down in narrow spaces (e.g., doorways less than three (3) feet).	Tested successfully; device slows down in narrow spaces.
Autonavigation Behavior	When in autonavigation mode, the device will slow down whenever un-mapped obstacles are detected nearby.	Tested successfully; device slows down for un-mapped obstacles.
General Safety/Effectiveness	Design outputs of the RP-VITA™ meet the design input requirements.	Verified and validated successfully.
Electronic Stethoscope	The communication channel used by the integrated electronic stethoscope is safe and effective.	Proven safe and effective by independent tests.

2. Sample Size and Data Provenance for the Test Set

The document does not explicitly state the sample size of a "test set" in terms of patient data or case numbers. The testing described is primarily engineering verification and validation testing of the device's hardware and software functionalities (e.g., autonavigation, obstacle detection, communication). This type of testing typically involves:

Engineering test scenarios: Creating specific situations to evaluate the device's response (e.g., placing obstacles, simulating component failures).
Controlled environments: Testing the device within a facility or a simulated clinical environment.

Therefore, there isn't data provenance in the traditional sense of "country of origin of the data, retrospective or prospective," as this wasn't a clinical study gathering patient data. The provenance for this type of testing is typically the manufacturer's own internal testing laboratories and facilities.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. For this type of device, ground truth for operational and safety features is established against defined functional requirements and engineering specifications (e.g., "device should halt if component fails"). It does not involve expert consensus on clinical findings or diagnoses.

4. Adjudication Method

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers interpret data, and their disagreements need resolution to establish ground truth. This document describes engineering verification and validation testing against predetermined functional specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is not a clinical study comparing human reader performance with or without AI assistance. The "AI" component is the autonomous navigation system, and the testing focuses on its safe and effective operation, not its impact on human diagnostic accuracy or efficiency.

6. Standalone Performance Study (Algorithm Only)

Yes, a form of "standalone" evaluation was done for the algorithm features, specifically the autonavigation system. The verification and validation testing described focused on the functionality and safety of the RP-VITA™'s autonomous navigation, obstacle detection, and collision avoidance systems operating independently (albeit within the integrated device). For example, tests confirmed the device would slow down in narrow spaces or when un-mapped obstacles were detected. This demonstrates the algorithm's direct operational performance.

7. Type of Ground Truth Used

The ground truth used for this device's testing is primarily functional and safety engineering specifications and requirements. These are established by the device's design inputs, industry standards, and risk analysis. For instance:

"The device should halt if a critical component fails."
"The device should slow down in narrow spaces."
"The communication channel should be safe and effective."

This is based on engineered design expectations rather than expert consensus on clinical interpretations, pathology findings, or patient outcomes data.

8. Sample Size for the Training Set

Not applicable. The document describes a medical device clearance based on engineering verification and validation, not a machine learning model that requires a "training set" of data in the typical sense for classification or prediction tasks. The autonavigation system uses built-in mapping and ODOA technologies, which would have been developed and "trained" (or more accurately, engineered and calibrated) by iRobot (the partner) using their proprietary methods and data. This specific regulatory submission does not detail the internal training of the underlying robotics algorithms.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there's no mention of a traditional machine learning training set within the provided text for this cleared device. If the autonavigation system uses machine learning, the establishment of ground truth for its internal development would have been part of iRobot's engineering process, likely involving:

Mapping real-world environments.
Annotating obstacles.
Simulating various navigation scenarios.
Testing robot responses against ideal or desired behaviors.

However, these details are not part of this 510(k) submission. The submission focuses on the verification and validation of the final integrated product against safety and performance requirements.

Summary

{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 SidwellDirector of Regulatory Affairs & Quality AssuranceInTouch Health6330 Hollister Ave.Goleta, CA 93117Phone: 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:

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.

{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:

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 clinicalcommunications 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 beused in conjunction with 510(k)-cleared devices that transmitpatient biometric data, including vital signs information. TheRemote Presence System, Model RP-VITA™ transmits andreceives information over a high-speed connection betweenpatients and health professionals. The Remote Presence System,RP-VITA™ can be used in communications for active patientmonitoring in high acuity clinical environments where immediateclinical action may be required, e.g., pre-, peri-operative and post-surgical, cardiovascular, neurological, pre-natal, psychological,and critical care assessments and examinations. Clinical judgmentand experience are required to review and interpret the informationtransmitted.	The Remote Presence System is a clinical communications toolthat provides a means of transmitting, receiving, and storing real-time audio and video, and patient data. The Remote PresenceSystem may also be used in conjunction with 510(k)-cleareddevices that transmit patient biometric data, including vital signsinformation. The Remote Presence System transmits and receivesinformation over a high-speed connection between patients, healthprofessionals and critical transport teams. The Remote PresenceSystem can be used in communications for active patientmonitoring in high acuity clinical environments where immediateclinical action may be required, e.g., pre-, peri-operative and post-surgical, cardiovascular, neurological, pre-natal, psychological, andcritical care assessments and examinations. Clinical judgment andexperience are required to review and interpret the informationtransmitted.
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 collectionsoftware	Proprietary software	Proprietary software
Communicationmethod withremote caremanagementsystem	Broadband internet connection	Broadband Internet connection
510(k) #	New Device	Remote Presence SystemPredicate 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'

Regulation Number and Section

§ 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).