Who is the manufacturer of INTEL HEALTH GUIDE?

Intel Corporation Digital Health Group filed the 510(k) submission for INTEL HEALTH GUIDE (K103276).

What is the FDA product code for INTEL HEALTH GUIDE?

DRG. It is classified under 21 CFR 870.2910 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for INTEL HEALTH GUIDE?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like INTEL HEALTH GUIDE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

INTEL HEALTH GUIDE

Q: What are the predicate devices for INTEL HEALTH GUIDE?

Intel® Health Guide PHS6000 (K080798, K083115 and K101178).

K103276 · Intel Corporation Digital Health Group · DRG · Feb 8, 2011 · Cardiovascular

Device Facts

Record ID	K103276
Device Name	INTEL HEALTH GUIDE
Applicant	Intel Corporation Digital Health Group
Product Code	DRG · Cardiovascular
Decision Date	Feb 8, 2011
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 870.2910
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The Intel® Health Guide Express is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys. The Intel® Health Care Management Suite allows the caregiver to review patient data and initiate video conferencing with patients, or select and send educational and motivational content to patients. The Intel® Health Guide Express is not interpretive, nor is it 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 Intel® Health Guide Express 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

Remote patient monitoring system; collects vital sign measurements from wireless/tethered home-use medical devices. Software application runs on COTS PC; displays measurements; stores data locally and transmits to host server via telephone/internet. Caregivers access data via Intel® Health Care Management Suite on host server; system allows video conferencing, surveys, and educational content delivery. Caregivers can predefine vital sign limits; system triggers alerts (email/page) if limits exceeded. Device is non-interpretive; not for diagnosis or real-time monitoring. Used by patients at home; managed by caregivers (physicians/nurses) at remote locations. Benefits include improved patient-caregiver communication and remote access to health data.

Clinical Evidence

No clinical data. Bench testing only. Safety and efficacy demonstrated through conformity to recognized consensus standards and risk analysis comparing COTS PC hardware to the predicate device.

Technological Characteristics

Software-based remote monitoring system running on COTS PC (Windows 7, 1.6 GHz CPU, 1GB RAM). Connectivity via 802.3 LAN, USB, and Bluetooth 2.0. Interfaces with external physiological sensors. Data stored locally on SDHC card and transmitted to host server. Safety compliance per UL 60950-1.

Indications for Use

Indicated for patients in a home setting who are willing and capable of managing the device. 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

Intel® Health Guide PHS6000 (K080798, K083115 and K101178)

Reference Devices

A&D UA-767PC (K982481)
A&D UC-321PBT (exempt)
A&D UC-321PL (exempt)
Bayer Diagnostics Ascensia Breeze2 (K062347)
Bayer Diagnostics Ascensia Contour Blood Glucose Monitoring System (K062058)
LifeScan OneTouch Ultra Family of Blood Glucose Monitoring Systems (K043197)
LifeScan OneTouch Ultra 2 of Blood Glucose Monitoring Systems (K053529)
Nonin 4100 Pulse Oximeter (K043359)
Onyx® II 9560 (K081285)
Microlife PF100 (K031024)

Related Devices

K130290 — MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE · Intel-Ge Care Innovations, LLC · Jun 4, 2013
K101178 — MODIFICATION TO INTEL HEALTH GUIDE PHS6000 · Intel Corp. · Jun 29, 2010
K083115 — MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 · Intel Corp. · Nov 26, 2008
K080798 — INTEL HEALTH GUIDE, MODEL: PHS6000 · Intel Corp. · Jun 27, 2008
K130360 — CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION · Constant Care, LLC · Jul 15, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ K103276 FEB - 8 2011 # 510(k) Summary As required by 21 CFR §807.92(c) ### Submitter 5 | 510(k) Owner: | Intel Corporation | |-----------------|---------------------------------------------------| | Address: | 1900 Prairie City Road, FM7-197, Folsom, CA 95630 | | Telephone: | 916 847-7794 | | Contact Person: | Maureen Glynn | | Date Prepared: | 01/06/2011 | ### Device Information | Trade Name: | Intel® Health Guide Express | |----------------------|---------------------------------------------------------------------------------------------------------| | Common Name: | Remote Patient Monitoring System | | Classification Name: | Transmitters and Receivers, Physiological Signal, Radiofrequency (21 CFR 870.2910, Product Code DRG) | Substantial Equivalence is claimed to the following device: 1. Intel's Intel® Health Guide PHS6000 (K080798, K083115 and K101178) ### ' Device Description The Intel® Health Guide Express is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. The Intel® Health Guide Express is a software application running on a Commercial Off The Shelf (COTS) Personal Computer (PC). It collects measurements captured on commercially available wireless or tethered medical devices which are designed for home use and connection to a COTS PC. It displays the collected measurement on the PC, and securely stores the collected information locally on a memory device installed in the PC. The Intel® Health Guide Express also stores the information remotely on a host server, where the caregiver can view the measurement via the host server once synchronization between the host server and Intel® Health Guide Express has been completed. The Intel® Health Guide Express can be used to display educational and motivational content from the caregiver and can facilitate communication between the caregiver and patient via health wellness surveys and optional video conferencing. The Intel® Health Guide Express is not interpretive, nor is it 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. {1}------------------------------------------------ The Intel® Health Guide PHS Express system consists of the: - Intel® Health Guide Express software application: (1) The software application captures, stores, displays and transmits information to a secure database on a host server running the Intel® Health Care Management Suite software via a standard telephone line or internet connection. The Intel® Health Guide Express software runs on a Commercial Off The Shelf (COTS) Personal Computer (PC). Intel® Health Care Management Suite software application: (2) > The software application runs on a host server and allows caregivers to review patient vital signs on the secure website. The Intel® Health Care Management Suite allows for predefining upper and lower limits and, when either limit is exceeded, the system emails and/or pages the caregiver. ### Indications for Use The Intel® Health Guide Express is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys. The Intel® Health Care Management Suite allows the caregiver to review patient data and initiate video conferencing with patients, or select and send educational and motivational content to patients. The Intel® Health Guide Express is not interpretive, nor is it 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 Intel® Health Guide Express 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. #### Technological Characteristics The Intel® Health Guide Express is substantially equivalent to the predicate device Intel® Health Guide PHS 6000 (K080798, K083115 and K101178) 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 {2}------------------------------------------------ . device, implementation method of collecting data from sensors, sensor software, connectivity, communication protocol, power source, and display method. Table 1: Peripherals Comparison between the predicate device and the Intel® Health Guide Express | Physiological Parameter | Intel® Health Guide PHS6000 (K080798, K083115 and K101178) | Intel® Health Guide Express | |----------------------------|---------------------------------------------------------------------------------|-----------------------------| | Blood Pressure | A&D UA-767PC (K982481) | | | Weight | A&D UC-321PBT (exempt) | | | Weight | A&D UC-321PL (exempt) | | | Blood Glucose Level | Bayer Diagnostics Ascensia Breeze2 (K062347) | | | | Bayer Diagnostics Ascensia Contour Blood Glucose Monitoring System (K062058) | | | | LifeScan OneTouch Ultra Family of Blood Glucose Monitoring Systems (K043197) | | | | LifeScan OneTouch Ultra 2 of Blood Glucose Monitoring Systems (K053529) | | | Oxygen Saturation | Nonin 4100 Pulse Oximeter (K043359) | | | | N/A | Onyx® II 9560 (K081285) | | FEV/PEF | Microlife PF100 (K031024) | | {3}------------------------------------------------ K103276 Table 2: Hardware Comparison between the COTS PC meeting minimum specifications and the predicate device 1 | Hardware Parameter | Intel® Health Guide PHS6000 | COTS PC | |-----------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | | (K080798, K083115 and K101178) | | | Operating System | Microsoft Windows XP embedded | Microsoft Windows 7 (32-bit versions) | | CPU Core Frequency | 1.5 GHz | Minimum: 1.6 GHz (Single Core) | | System Memory Size | 512MB | Minimum: 1 Gbyte | | Pointing Device | HID compliant pointing device | HID compliant pointing device | | Available Storage Capacity | 40GB | Minimum: 10 Gbytes | | LAN Connection | Externally accessible RJ45 jack for 802.3 10/100 LAN interface. | Externally accessible RJ45 jack for 802.3 10/100 LAN interface. | | Ports | 4 USB Ports | Minimum: 2 USB Ports | | SD Card Slot | N/A | Minimum: 1 memory card SDHC compliant with the SD Card Association 2.00 card specification, Class 4 or faster. | | Wireless Peripheral Connection | Bluetooth 2.0 Interface | Bluetooth 2.0 Interface | | Display | 600 x 800 18 bit color | Minimum: 1024 x 600 24 bit color | | Speakers | 1 Mono | Minimum: 1 (mono) | | Microphone | 1 Mono | Minimum: 1 (mono) | 1 Differences are to accommodate the Microsoft Windows 7 operating system . {4}------------------------------------------------ K103276 | Parameter | Intel® Health Guide PHS6000 (K080798, K083115 and K101178) | COTS PC | |-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Safety Standard | ES60601-1:2005 Medical electrical equipment – Part 1: General requirements for basic and essential performance | UL 60950-1:2007 Information Technology Equipment – Safety – Part 1: General Requirements | | Patient Leakage Current – From Patient connection to earth1 | 100μA | 3.5mA | Table 3: Main difference between the COTS PC meeting minimum specifications and the predicate device 1 This is not meant to be an exhaustive list of differences between ES60601-1 and UL 60950-1 but highlights the differences covered in the risk analysis for a COTS PC used with the · Intel® Health Guide Express. ### Safety and Efficacy The Intel® Health Guide Express does not rely on an assessment of clinical performance data. The device will conform 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 device. {5}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Intel Corporation c/o Ms. Maureen Glynn 1900 Prairie City Rd. MS FM7-197 Folsom, CA 95630 FEB - 8 201 Re: K103276 Trade Name: Intel Health Guide Express Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: January 10, 2011 Received: January 11, 2011 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. {6}------------------------------------------------ Page 2 - Ms. Maureen Glynn 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 lisuing (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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health #### Enclosure {7}------------------------------------------------ #### 510(k) Notification Submission - Abbreviated Intel Corporation, Inc. Intel® Health Guide Express ## Indications for Use: 510(k) Number: Device Name: Intel® Health Guide Express Indications for Use: The Intel® Health Guide Express is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys. The Intel® Health Care Management Suite allows the caregiver to review patient data and initiate video conferencing with patients, or select and send educational and motivational content to patients. The Intel® Health Guide Express is not interpretive, nor is it 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 Intel® Health Guide Express 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. 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) currence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K103276 Page 1 of 1