INTEL HEALTH GUIDE, MODEL: PHS6000
Device Facts
| Record ID | K080798 |
|---|---|
| Device Name | INTEL HEALTH GUIDE, MODEL: PHS6000 |
| Applicant | Intel Corp. |
| Product Code | DRG · Cardiovascular |
| Decision Date | Jun 27, 2008 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 870.2910 |
| Device Class | Class 2 |
Intended Use
The Intel® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys. The Intel® Health Guide PHS6000 is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. It is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
Device Story
Intel Health Guide PHS6000 is a remote patient monitoring system; collects vital sign data from external wireless/tethered home medical devices; stores/displays data on LCD screen; transmits data to secure host server via broadband/phone line. Caregivers access data via web-based Care Management Suite; system allows setting of upper/lower vital sign limits; triggers email/page alerts to caregivers if limits exceeded. Device includes touch screen, video camera, microphones, speakers, reminder light. Used in home setting by patients; operated by patients and remote caregivers. Facilitates patient education, surveys, and video conferencing. Does not provide real-time data; intended for non-time-critical care; supports clinical decision-making by providing remote access to patient measurements for caregiver review.
Clinical Evidence
No clinical data. Device relies on conformity to FDA-recognized consensus standards to demonstrate safety and efficacy.
Technological Characteristics
Electronic device in plastic enclosure; touch screen, video camera, microphones, speakers, reminder light. Interfaces with external wireless/tethered medical devices. Connectivity via broadband internet or standard phone line. Software includes patient-side application, Care Management Suite (server-side), and processor interface software.
Indications for Use
Indicated for patients at home willing and capable of managing device use. Contraindicated for patients requiring direct medical supervision or emergency intervention. Not for time-critical care.
Regulatory Classification
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.
Predicate Devices
- Philips Medical Systems' M3810A TeleMonitoring System with M3812B TeleStation (K023749)
- Health Hero Network's Health Buddy Appliance (K063612)
- WHBVMC, LLC's RemoteNurse™ Patient Monitoring system (K041308)
Related Devices
- K101178 — MODIFICATION TO INTEL HEALTH GUIDE PHS6000 · Intel Corp. · Jun 29, 2010
- K103276 — INTEL HEALTH GUIDE · Intel Corporation Digital Health Group · Feb 8, 2011
- K083115 — MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 · Intel Corp. · Nov 26, 2008
- K130290 — MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE · Intel-Ge Care Innovations, LLC · Jun 4, 2013
- K041308 — REMOTENURSE PATIENT MONITORING SYSTEM · Webvmc, LLC · Jun 28, 2004
Submission Summary (Full Text)
{0}------------------------------------------------
# 510(k) Summary As required by 21 CFR §807.92(c)
### Submitter
JUN 2 7 2008
| 510(k) Owner: | Intel Corporation |
|-----------------|---------------------------------------------------|
| Address: | 1900 Prairie City Road, FM7-197, Folsom, CA 95630 |
| Telephone: | (408) 765-2060 |
| Contact Person: | Tac-Woong Koo |
| Date Prepared: | March 19, 2008 |
#### Device Information
| Trade Name: | Intel® Health Guide PHS6000 |
|----------------------|---------------------------------------------------------------------------------------------------------|
| Common Name: | Remote Patient Monitoring System |
| Classification Name: | Transmitters and Receivers, Physiological Signal,<br>Radiofrequency (21 CFR 870.2910, Product Code DRG) |
Substantial Equivalence is claimed to the following devices:
- 1. Philips Medical Systems' M3810A TeleMonitoring System with M3812B TeleStation (K023749)
- 2. Health Hero Network's Health Buddy" Appliance (K063612)
- 3. WHBVMC, LLC's RemoteNurse™ Patient Monitoring system (K041308)
### Device Description
The Intel* Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements remotely access vitar ago available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host scrver. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive Screef. Fattents can review the pregivers. Patients can also optionally engage in cultianonia and morractorers and answer the caregivers` questions by participating in surveys.
The Intel" Health Guide PHS6000 system consists of the:
- Intel* Health Guide PHS6000 hardware: (1)
The physical component of the Intel® Health Guide PHS6000 is an electronic device contained in a plastic enclosure with a touch screen, video camera with privacy screen, microphones, speakers and a reminder light which is mounted into the top of the case. On the back of the device is a power socket, a headphone socket. a
Section 5: 510(k) Summary
Page 1 of 3
{1}------------------------------------------------
#### 510(k) Notification Submission - Abbreviated Intel® Health Guide PHS6000
Broadband (high-speed) internet socket for connection to a broadband network. The device has medical device sockets for connection to specific physiological monitors, and may optionally have a phone socket for modem connection to a standard phone line.
- Intel " Health Guide software application: (2)
The software application captures, stores, and transmits information to a secure website via a standard telephone line or a LAN/WAN connection.
- Intel* Care Management Suite software application: (3)
The application allows caregivers to review patient vital signs on the secure website. The Intel® Care Management Suite allows for predetining upper and lower limits and, when either limit is exceeded, the system emails and/or pages the caregiver.
- Processor software application: (4)
The processor software application manages the interface between the Intel® Health Guide PHS6000 software application and the secure website.
The Intel® Health Guide PHS6000 is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The device is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
## Indications for Use
The Intel* Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.
The Intel * Health Guide PHS6000 is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. It is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable
{2}------------------------------------------------
#### 510/k) Notification Submission - Abbreviated Intel® Health Guide PHS6000
of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
## Technological Characteristics
The Intel® Health Guide PHS6000 is substantially equivalent to the predicate devices in terms of data collection software functionality, operating system for the patient device, communication method of patient device with central server, types of sensors which can be interfaced to the patient device, implementation method of collecting data from sensors, sensor software, connectivity, communication protocol, power source, and display method.
#### Safety and Efficacy
The Intel® Health Guide PHS6000 does not rely on an assessment of clinical performance data. The device conforms to FDA's recognized consensus standards and relies on its conformity to demonstrate the safety and efficacy. The device introduces no new questions concerning the safety or efficacy and is, therefore, substantially equivalent to the predicate devices.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2008
Digital Health Group c/o Ms. Maureen Glynn Director of Regulatory Affairs Intel Corporation 1900 Prairic City Road FM7-197 Folsom, CA 95630
Re: K080798
Trade/Device Name: Intel® Health Guide PHS6000 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitters and Receivers Regulatory Class: Class II Product Code: DRG Dated: June 10, 2008 Received: June 12, 2008
Dear Ms. Glynn:
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.
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
{4}------------------------------------------------
Page 2 - Ms. Maureen Glynn
(21 CFR Part 807); labeling (21 CFR Part 801); 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. 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 the reporting 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Qomall
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
## Indications for Use:
510(k) Number:
KOBO 798
Intel® Ilealth Guide PHS6000 Device Name:
Indications for Use:
The Intel® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive coucational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers` questions by participating in surveys.
The Intel® Health Guide PHS6000 is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. It is contraindicated for patients requiring direct medical mine vision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
Prescription Usc ਮ (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 Sigh-Off) | |
|------------------------------------|--|
| Division of Cardiovascular Devices | |
| 510(k) Number | K080789 |
|---------------|---------|
|---------------|---------|
Pagege I of I
