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 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 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.

AI/ML Overview

The Intel® Health Guide Express is a remote patient monitoring system. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting them in the way clinical studies for diagnostic accuracy often do.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy or a specific performance study. Instead, it demonstrates substantial equivalence to a predicate device (Intel® Health Guide PHS6000) based on technological characteristics and functional similarities. The key performance aspect is the ability to collect, store, display, and transmit vital sign measurements, and this is compared to the predicate device's capabilities and compatibility with various peripherals.

Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance (as presented in K103276)
Software Functionality: Capture, store, display, and transmit information to a secure database.	The Intel® Health Guide Express software application captures, stores, displays, and transmits information to a secure database on a host server.
Operating System: Compatible with standard PC operating system.	Compatible with Microsoft Windows 7 (32-bit versions). Predicate used Microsoft Windows XP embedded.
Communication Method: Standard telephone line or internet connection.	Uses standard telephone line or internet connection for transmission.
Sensor Interface: Ability to interface with commercially available wireless or tethered medical devices.	Interfaces with listed medical devices for Blood Pressure, Weight, Blood Glucose Level, Oxygen Saturation, and FEV/PEF.
Data Collection Implementation: Similar method to predicate device.	Claimed substantially equivalent to predicate in implementation method of collecting data from sensors.
Connectivity/Communication Protocol/Power Source/Display Method: Similar to predicate device.	Claimed substantially equivalent to predicate in these aspects.
Hardware Compatibility (COTS PC): Meets minimum specified hardware requirements.	Requires a COTS PC with minimum specifications for OS, CPU, Memory, Storage, Ports, Display, etc. (Table 2).
Safety Standard Compliance: Complies with relevant safety standards.	The device relies on conformity to FDA's recognized consensus standards to demonstrate safety and efficacy. COTS PC safety standard: UL 60950-1:2007. Predicate safety standard: ES60601-1:2005. Differences analyzed in risk analysis.
Patient Leakage Current: Within acceptable limits for a COTS PC.	For COTS PC, patient leakage current (from patient connection to earth) is 3.5mA (compared to 100μA for predicate, with differences covered in risk analysis).

Essentially, the "acceptance criteria" here are that the new device performs its intended functions (collecting and transmitting data) and is at least as safe and effective as the predicate device, given its specific use case as a communication tool and not a diagnostic device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific "test set" or a study involving patient data for performance evaluation in the context of diagnostic accuracy or a similar clinical measurement. The device is a "Remote Patient Monitoring System" that collects data from other commercially available medical devices.

The assessment is primarily a technical comparison and declaration of substantial equivalence to a predicate, not a clinical trial evaluating the performance on a patient cohort or a specific dataset. There is no mention of data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as there is no mention of a "test set" requiring ground truth established by experts for performance evaluation. The device's function is data capture and transmission, not interpretation or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. No test set requiring expert adjudication for ground truth establishing is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study was not done. The device is a data collection and communication tool, and its primary purpose is not to assist human readers in interpretation or diagnosis. Therefore, a study of improved human reader performance with AI assistance is not relevant to this type of device.

6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone study in the context of algorithmic performance for diagnosis/interpretation was not described. The device is a software application running on a COTS PC that interacts with other medical devices. Its performance is assessed in terms of its ability to correctly capture, store, transmit data, and its compatibility with hardware, rather than standalone diagnostic accuracy. The safety and efficacy claims "do not rely on an assessment of clinical performance data" but on conformity to recognized consensus standards.

7. The Type of Ground Truth Used

Not applicable. As stated earlier, the submission focuses on substantial equivalence based on technological characteristics and safety standards, not on evaluating diagnostic accuracy against a ground truth. The device itself is "not interpretive, nor is it intended for diagnosis."

8. The Sample Size for the Training Set

Not applicable. This device is a remote patient monitoring software system. There is no mention of a "training set" for an AI algorithm in the context of diagnosis or prediction.

9. How the Ground Truth for the Training Set was Established

Not applicable. For the same reasons as point 8, there is no mention of a training set or ground truth establishment relevant to an AI model's training.

Summary

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K103276

FEB - 8 2011

510(k) Summary As required by 21 CFR §807.92(c)

Submitter

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

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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

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

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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

PhysiologicalParameter	Intel® Health Guide PHS6000(K080798, K083115 and K101178)	Intel® Health Guide Express
BloodPressure	A&D UA-767PC (K982481)
Weight	A&D UC-321PBT (exempt)
Weight	A&D UC-321PL (exempt)
BloodGlucoseLevel	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)
OxygenSaturation	Nonin 4100 Pulse Oximeter (K043359)
	N/A	Onyx® II 9560 (K081285)
FEV/PEF	Microlife PF100 (K031024)

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K103276

Table 2: Hardware Comparison between the COTS PC meeting minimum specifications and the predicate device 1

Hardware Parameter	Intel® Health GuidePHS6000	COTS PC
	(K080798, K083115 andK101178)
Operating System	Microsoft Windows XPembedded	Microsoft Windows 7 (32-bitversions)
CPU Core Frequency	1.5 GHz	Minimum: 1.6 GHz (SingleCore)
System Memory Size	512MB	Minimum: 1 Gbyte
Pointing Device	HID compliant pointingdevice	HID compliant pointingdevice
Available Storage Capacity	40GB	Minimum: 10 Gbytes
LAN Connection	Externally accessible RJ45jack for 802.3 10/100 LANinterface.	Externally accessible RJ45jack for 802.3 10/100 LANinterface.
Ports	4 USB Ports	Minimum: 2 USB Ports
SD Card Slot	N/A	Minimum: 1 memory cardSDHC compliant with theSD Card Association 2.00card specification, Class 4 orfaster.
Wireless PeripheralConnection	Bluetooth 2.0 Interface	Bluetooth 2.0 Interface
Display	600 x 800 18 bit color	Minimum: 1024 x 600 24 bitcolor
Speakers	1 Mono	Minimum: 1 (mono)
Microphone	1 Mono	Minimum: 1 (mono)

1 Differences are to accommodate the Microsoft Windows 7 operating system

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K103276

Parameter	Intel® Health GuidePHS6000(K080798, K083115 andK101178)	COTS PC
Safety Standard	ES60601-1:2005Medical electrical equipment– Part 1: Generalrequirements for basic andessential performance	UL 60950-1:2007Information TechnologyEquipment – Safety – Part 1:General Requirements
Patient Leakage Current –From Patient connection toearth1	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.

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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.

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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

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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:

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

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).