(62 days)
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.
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.
The provided text does not describe the acceptance criteria or the study that proves the device meets the acceptance criteria. Instead, it contains a 510(k) summary for a general-purpose telemedicine system (Remote Presence System- RP-7i® etc.).
Here's what can be extracted from the document, and what cannot:
Information that can be extracted from the provided text:
- Device Description and Intended Use: The Remote Presence System is a telecommunications platform for real-time videoconferencing and clinical communications, transmitting, receiving, and storing real-time audio and video, and patient data. It can also be used in conjunction with 510(k)-cleared devices that transmit patient biometric data. It is intended for use in high acuity clinical environments for active patient monitoring, assessments, and examinations.
- Predicate Device: The legally marketed predicate device is the InTouch Remote Presence Robotic System, Model RP-7 (K073710).
- Comparison to Predicate Device: The new device expands on the predicate by introducing new cart-based and hand-held models, providing improved system flexibility and adapting to additional clinical environments (e.g., operating rooms, emergency departments, intensive care units, patient transport). It also broadens the connectivity options (wired or wireless broadband, USB, Bluetooth®), communication protocols (Session Initiation Protocol), and types of devices that can be interfaced.
- Validation Testing: The document states, "The effectiveness of these improvements was demonstrated by the validation testing performed on the system." and "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."
Information that cannot be extracted from the provided text (and why):
The document is a 510(k) summary for a telemedicine system. It describes the device's function, its predicate, and differences. It does not present clinical study data or acceptance criteria related to a specific AI/ML medical device's performance for diagnosis or prognostication. Therefore, the specific details requested regarding acceptance criteria, study design, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance are not present in this document.
The "validation testing" mentioned is general and typically refers to engineering verification and validation testing for functionality, safety, and effectiveness in a broader sense for a communication system, not clinical performance metrics for an AI-powered diagnostic tool.
To answer your request, if this were an AI/ML device submission, here's what would typically be expected, and why the provided text doesn't contain it:
- A table of acceptance criteria and the reported device performance: This would list specific metrics (e.g., sensitivity, specificity, AUC) and the agreed-upon thresholds (acceptance criteria) along with the actual performance achieved by the device in testing. Not present.
- Sample sized used for the test set and the data provenance: Details on the number of cases/samples in the test set, and whether the data was retrospective/prospective, and its geographical origin. Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Information about the raters/readers who established the truth label for the test data. Not present.
- Adjudication method for the test set: How disagreements among experts were resolved (e.g., 2 majority vote, 3+1 with a tie-breaker). Not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Details of studies comparing human performance with and without AI, including an effect size. Not present.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Metrics for the algorithm's performance without any human intervention. Not present.
- The type of ground truth used: Whether the truth was derived from expert consensus, pathology, long-term outcomes, etc. Not present.
- The sample size for the training set: The number of samples used to train the AI model. Not present.
- How the ground truth for the training set was established: The methodology for creating the reference labels for the training data. Not present.
In summary, the provided document describes a communication device, not an AI/ML diagnostic or predictive device, and therefore does not contain the specific performance study details you are asking for.
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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 SidwellDirector of Regulatory Affairs & Quality AssuranceInTouch Health6330 Hollister Ave.Goleta, CA 93117Phone: 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 andKSEA 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
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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.
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510(k) Submission
Remote Presence System
| Table5.1:Substance | EquivalentQuantity | 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 communicationstool that provides a means of transmitting, receiving, andstoring real-time audio and video, and patient data. TheRemote Presence System may also be used in conjunctionwith 510(k)-cleared devices that transmit patient biometricdata, including vital signs information. The Remote PresenceSystem transmits and receives information over a high-speedconnection between patients, health professionals, andcritical transport teams. The Remote Presence System canbe used in communications for active patient monitoring inhigh acuity clinical environments where immediate clinicalaction may be required, e.g., pre-, peri-operative and post-surgical, cardiovascular, neurological, pre-natal,psychological, and critical care assessments andexaminations. Clinical judgment and experience are requiredto review and interpret the information transmitted. | The RP-7 is a communications tool that provides a means oftransmitting, receiving, and storing real-time audio and video,and patient data. The RP-7 also can be used in conjunctionwith 510(k)-cleared devices that transmit patient biometric data,including vital signs information. The RP-7 transmits andreceives information over a high speed connection betweenpatients and health professional, and is intended to be used in ahospital or clinic environment. Clinical judgment and experienceare 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 collectionsoftware | Proprietary software | Proprietary software |
| Communicationmethod withremote caremanagementsystem | 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.
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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
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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
§ 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).