The HealthInterlink® Beacon® device is for use by patients to collect and transmit general health information, physiological measurements such as blood pressure, weight, glucose and SpO2 using commercially available FDA cleared wireless medical devices designed for home use, and other data between themselves and a caregiver.

The HealthInterlink® Beacon® makes no diagnosis. Clinical judgment and experience are required to check and interpret the information transmitted. HealthInterlink® Beacon® is not intended as a substitute for medical care.

Device Description

The HealthInterlink Beacon is a software application. Once installed on a commerciallyavailable device, the HealthInterlink Beacon software uses standard communication protocols to exchange information with other medical devices (peripherals). Data collected from the medical devices is transmitted to a server database for review by a caregiver. The HealthInterlink Beacon software has a user interface which allows the patient and caregiver to communicate using methods which include questions, answers, and messages.

HealthInterlink Beacon is not intended for emergency use or real-time monitoring.

AI/ML Overview

The HealthInterlink Beacon is a remote patient monitoring system. Given the provided documentation, there is no specific acceptance criteria or study that proves device performance in the traditional sense of a clinical trial for diagnostic devices.

This device is not a diagnostic tool and does not make diagnoses. Its function is to collect and transmit general health information and physiological measurements from other FDA-cleared wireless medical devices to a caregiver.

Here's a breakdown based on the information provided, with an emphasis on what is not present given the nature of the device and its clearance:

1. Table of Acceptance Criteria and Reported Device Performance

As HealthInterlink Beacon is a data collection and transmission software, its "performance" is assessed more in terms of its functionality and integration rather than clinical metrics like sensitivity or specificity.

Acceptance Criteria (Implied from Submission)	Reported Device Performance (Implied from Submission)
Ability to collect and transmit general health information and physiological measurements from commercially available FDA cleared wireless medical devices.	Ensured by design control verification and validation testing, confirming system works with each type of user accessory medical device (blood pressure monitor, scale, thermometer, glucose, pulse oximeter) including integration to Beacon Clinical Care Access (CCA) backend software application.
Functionality of all executable code.	Confirmed through design control verification and validation testing.
All identified risks adequately addressed by software functionality, user interface, documentation, or user SOP.	Confirmed through design control verification and validation testing.
System works with specified accessory medical devices (blood pressure monitor, scale, thermometer, glucose, pulse oximeter).	Confirmed through verification plan execution.
Output of design control verification analysis documents meet requirements and design specifications.	The output met requirements and design specifications as intended.

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

Test Set Sample Size: Not applicable in the context of clinical performance evaluation. The "test set" for this device's validation refers to its software components, integration points, and compatibility with various medical peripherals. The document mentions "testing of all executable code and functionality" and verification with "each type of user accessory medical device."
Data Provenance: Not applicable as there was no clinical study involving patient data collection for performance evaluation of this device. The device acts as an intermediary for data from other FDA-cleared medical devices.

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

Number of Experts: Not applicable. For a device that collects and transmits data, ground truth is typically established by verifying data integrity, transmission accuracy, and functional performance, rather than through expert medical interpretation of generated data.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Software and system functionality testing does not typically involve an adjudication method in the same way a diagnostic image interpretation study would. Any discrepancies found during verification and validation would be addressed through standard software development and quality assurance processes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done.
Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as this device is a remote patient monitoring system software and not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Yes, the validation performed primarily assessed the standalone functionality of the HealthInterlink Beacon software system (algorithm only, without human interpretation of the device's own output for diagnosis). The device itself performs no diagnosis and is not intended for real-time monitoring; it is a data collection and transmission utility. Its performance is entirely "standalone" in this context of data handling.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device's validation was based on the design specifications and requirements of the software and its integration with existing, FDA-cleared external medical devices. This includes verifying that data is collected accurately, transmitted correctly, and that the software functions as designed. This is a functional and technical ground truth, not a clinical one based on pathology, expert consensus on patient conditions, or outcomes data.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. The HealthInterlink Beacon is not an AI/ML device that requires a "training set" for model development. It is software that performs defined functions of data collection and transmission.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of software device.

Summary

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MAR 1 4 2014

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:_

Submitter's Identification; 1. HealthInterlink, LLC 2323 S. 171 Street, Suite 202, Omaha, NE 68130 Tel: 402-718-8824 Fax: 402-519-2173
Date Summary Prepared: October 1, 2013
1. Name of the Device: HealthInterlink Beacon
1. Common or Usual Name: Remote Patient Monitoring System Regulation No. 21 CFR 870.2910 Product Codes: DRG, DXN, FRI, FLL, NBW, DQA, JQP

4. Predicate Device Information:

K112559	MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
K112858	GENESIS TOUCH SYSTEM
K122285	TABLET COMMANDER
K103276	INTEL HEALTH GUIDE EXPRESS

ട്. Device Description:

.....

The Healthinterlink Beacon is a software application. Once installed on a commerciallyavailable device, the HealthInterlink Beacon software uses standard communication protocols to exchange information with other medical devices (peripherals). Data collected from the medical devices is transmitted to a server database for review by a caregiver. The HealthInterlink Beacon software has a user interface which allows the patient and caregiver to communicate using methods which include questions, answers, and messages.

HealthInterlink Beacon is not intended for emergency use or real-time monitoring.

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6. Intended Use:

The HealthInterlink Beacon device is for use by patients to collect and transmit general health information, physiological measurements such as blood pressure, temperature, weight, glucose and SpO2 using commercially available FDA cleared wireless medical devices designed for home use, and other data between themselves and a caregiver.

The HealthInterlink Beacon makes no diagnosis. Clinical judgment and experience are required to check and interpret the information transmitted. HealthInterlink Beacon is not intended as a substitute for medical care.

7. Comparison to Predicate Devices:

	Honeywell HonsMed Genesis TouchK112858	CardioCom Tablet CommanderK22285	Intel Health Guide Express K103276	MedApps 20 Remote PatientMonitoring System K112559	HealthInterlink Beacon
			Same	Same	Same
Indications for Use	Enables healthcare providers tomonitor and manage conditions ofpatients remotely	Same	Same	Same	Same
Intended Use	Telemedicine System	Same	Same	Same	Same
Intended Users	Home users and healthcare providers	Same	Same	Same	Same
Site of Use	Healthcare related environment orhome	Same	Same	Same	Same
Data Collection Software	LifeStream Management Suite	Cardiocom's OMNIVISOR ManagementSystem	Intel Care Management Suite Software	MedApps Proprietary Software	HealthInterlink Beacon Software
Data Collection Software Functionality	Transmit data from Sensor devices toCentral Database	Same	Same	Same	Same
Communication method of hub withCentral Server	Via public telecommunications network	Via public telecommunications network	Via DSL or Phone Line Connection	Via Embedded Cellular Technology	Via public telecommunications network
Types of sensors which can beinterfaced (wired or wirelessly) toreceiver hub	Medical Devices designed for Homeuse: Scale, Blood Pressure, Pulse Ox,Thermometer	Medical Devices designed for Homeuse: Glucose, Scale, Blood Pressure,Pulse Ox, Peak Flow	Medical Devices designed for Homeuse: Glucose, Scale, Blood Pressure,Pulse Ox, Peak Flow	Medical Devices designed for Homeuse: Glucose, Scale, Blood Pressure,Pulse Ox	Medical Devices designed for Homeuse: Glucose, Scale, Blood Pressure,Pulse Ox, Temperature, Spirometer
Implementation method of collectingdata from sensors	Short range radio system usingBluetooth (Manual entry forThermometer)	Short range radio system using Wireless(Bluetooth) and Wired (tethered)cables	Short range radio system using Wireless(Bluetooth) and Wired (tethered)cables	Currently using Wired (tethered),cables (USB), Smart Cables	Short range radio system usingBluetooth, manual entry.Text/Interactive Voice Response
Sensor Software	Sensor Software unchanged	Same	Same	Same	Same
Connectivity	Short range radio system usingBluetooth	Short range radio system usingBluetooth and Wired (tethered) cables	Short range radio system usingBluetooth and Wired (tethered) cables	Wired (tethered) cables Futurecapability to use Bluetooth dongles	Short range-radio system usingBluetooth
Communication method of hub withdevices	Short range radio system usingBluetooth	Short range radio system using Wireless(Bluetooth) and Wired (tethered)cables	Short range radio system using Wireless(Bluetooth) and Wired (tethered)cables	Currently using Wired (tethered)cables	Short range radio system usingBluetooth
Communications Protocol	Wireless (Bluetooth) V20	Wireless (Bluetooth) V20 & Wired(Tethered)	Wireless (Bluetooth) V20 & Wired(Tethered)	Wired (Tethered)	Wireless (Bluetooth) V20 and Wireless(Bluetooth) V40
Communication Frequency	Bluetooth: 2402 to 2480 GHz	Bluetooth: 2402 to 2480 GHz	Bluetooth: 2402 to 2480 GHz	GDM: 850/900/1800/1950	Bluetooth 2402-2480 GHz
Power Source	Wall power plug (120 VAC/50-60)	Same	Same	Same	Same
Visual Feedback/Display	On devices and hub, monitorsconnected to central server	On devices and hub, monitorsconnected to central server	On devices and hub, monitorsconnected to central server	HealthAIR uses LED light indicators	On devices and hub, monitorsconnected to central server
Communication with Patients	On screen display	On screen display	On screen display	Audio/visual feedback from LED lightindicators & audio tones; InteractiveVoice Response (IVR) system for patient	On screen display, Text/InteractiveVoice Response

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Discussion of Non-Clinical Tests Performed for Determination of Substantial 8. Equivalence are as follows:

The submitted HealthInterlink Beacon system has undergone design control verification and validation testing. HealthInterlink Beacon validation testing includes testing of all executable code and functionality and confirmation that all identified risks have been adequately addressed by software functionality, the user interface, documentation or user SOP. HealthInterlink Beacon system verification and validation activities as part of the design control process include testing of all Design Specifications (Design Control Inputs) based on risk analysis and Verification plans. HealthInterlink Beacon Verification Plan execution ensures the system works with each type of user accessory medical device (blood pressure monitor, scale, thermometer, glucose, and pulse oximeter) as part of the HealthInterlink Beacon system including integration to Beacon Clinical Care Access (CCA) backend software application. The output of these design control verification analysis documents for the HealthInterlink Beacon system shall meet its requirements and design specifications as intended. No new hazards to safety or effectiveness are presented by HealthInterlink Beacon, therefore, no clinical tests were conducted.

9. Discussion of Clinical Tests Performed:

No new hazards to safety or effectiveness are presented by HealthInterlink Beacon, therefore, no clinical tests were conducted.

10. Conclusions:

···· ·

HealthInterlink considers the HealthInterlink Beacon to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 14, 2014

Healthinterlink, LLC % Susan Goldstein-Falk Official Correspondent MDI Consultants. Inc. 55 Northern Blvd. Ste. 200 Great Neck, NY 11021 US

Re: K133252

Trade/Device Name: Healthinterlink beacon Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Reciever Regulatory Class: Class II Product Codes: DRG, DXN, FRI, FLL, NBW, DOA, JQP Dated: January 29, 2014 Received: February 11, 2014

Dear Susan Goldstein-Falk:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 - Susan Goldstein-Falk

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 devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Athelstein

for 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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K133252 Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

Device Name

HealthInterlink® Beacon®

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Date:
2014.03.14
13:46:10 -04'00'
for Bram Zuckerman

FORM FDA 3881 (9/13)

Cor

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).