(95 days)
No
The description focuses on data collection, storage, display, and transmission, with simple threshold-based alerts. There is no mention of AI/ML terms or capabilities like interpretation, prediction, or learning.
No
The device is described as a communication tool for collecting vital sign measurements and facilitating communication between caregivers and patients. It explicitly states it is "not interpretive, nor is it intended for diagnosis or as a substitute for medical care."
No
The text explicitly states: "The Intel® Health Guide Express is not interpretive, nor is it intended for diagnosis or as a substitute for medical care".
No
The device description explicitly states that the Intel® Health Guide Express is a software application running on a Commercial Off The Shelf (COTS) Personal Computer (PC) and collects measurements from commercially available wireless or tethered medical devices. While the core functionality is software, it relies on and interacts with hardware (the PC and the medical devices) to perform its intended use. Therefore, it is not a software-only medical device.
Based on the provided text, the Intel® Health Guide Express is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Intended Use of Intel® Health Guide Express: The intended use clearly states that the device is for collecting vital sign measurements from physiological measurement devices used in the home. It is a communication tool for caregivers to remotely access this data and interact with patients.
- Lack of Specimen Analysis: There is no mention of the Intel® Health Guide Express analyzing any biological specimens. Its function is to collect, store, display, and transmit data from other medical devices.
Therefore, the Intel® Health Guide Express falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DRG
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.
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.
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
Home use for patients, caregivers, and medical supervision
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K982481, K062347, K062058, K043197, K053529, K043359, K081285, K031024
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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
| 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
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