HEALTHINTERLINK BEACON

K133252 · Healthinterlink, LLC · DRG · Mar 14, 2014 · Cardiovascular

Device Facts

• Record ID: K133252
• Device Name: HEALTHINTERLINK BEACON
• Applicant: Healthinterlink, LLC
• Product Code: DRG · Cardiovascular
• Decision Date: Mar 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

HealthInterlink Beacon is a software application installed on commercially available devices; acts as a hub for remote patient monitoring. Inputs: physiological data (BP, weight, glucose, SpO2, temperature) from FDA-cleared wireless medical devices via Bluetooth or manual entry. Transformation: software collects, aggregates, and transmits data via public telecommunications networks to a central server database. Output: data available for caregiver review; interactive interface allows patient-caregiver communication via questions, answers, and messages. Used in home settings by patients; caregivers access data via backend software (Beacon Clinical Care Access). Does not perform diagnosis; requires clinical interpretation. Benefits: facilitates remote management of patient health information.

Clinical Evidence

Bench testing only. No clinical data conducted. Verification and validation testing confirmed system functionality, integration with peripheral medical devices, and adherence to design specifications.

Technological Characteristics

Software application; operates on commercially available hardware. Connectivity: Bluetooth (V2.0/V4.0) and public telecommunications network. Interfaces with home-use medical devices (BP, scale, thermometer, glucose, pulse oximeter). Power source: wall power (120 VAC).

Indications for Use

Indicated for patients to collect and transmit physiological measurements (BP, weight, glucose, SpO2, temperature) and general health data to caregivers using FDA-cleared home-use wireless medical devices. Not for emergency use or real-time monitoring.

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

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

Submission Summary (Full Text)

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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: [phone] Fax: [phone]
Date Summary Prepared: October 1, 2013

- 2. Name of the Device: HealthInterlink Beacon
- 3. 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 Touch<br>K112858 | CardioCom Tablet Commander<br>K22285 | Intel Health Guide Express K103276 | MedApps 20 Remote Patient<br>Monitoring System K112559 | HealthInterlink Beacon |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| | | | Same | Same | Same |
| Indications for Use | Enables healthcare providers to<br>monitor and manage conditions of<br>patients 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 or<br>home | Same | Same | Same | Same |
| Data Collection Software | LifeStream Management Suite | Cardiocom's OMNIVISOR Management<br>System | Intel Care Management Suite Software | MedApps Proprietary Software | HealthInterlink Beacon Software |
| Data Collection Software Functionality | Transmit data from Sensor devices to<br>Central Database | Same | Same | Same | Same |
| Communication method of hub with<br>Central 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 be<br>interfaced (wired or wirelessly) to<br>receiver hub | Medical Devices designed for Home<br>use: Scale, Blood Pressure, Pulse Ox,<br>Thermometer | Medical Devices designed for Home<br>use: Glucose, Scale, Blood Pressure,<br>Pulse Ox, Peak Flow | Medical Devices designed for Home<br>use: Glucose, Scale, Blood Pressure,<br>Pulse Ox, Peak Flow | Medical Devices designed for Home<br>use: Glucose, Scale, Blood Pressure,<br>Pulse Ox | Medical Devices designed for Home<br>use: Glucose, Scale, Blood Pressure,<br>Pulse Ox, Temperature, Spirometer |
| Implementation method of collecting<br>data from sensors | Short range radio system using<br>Bluetooth (Manual entry for<br>Thermometer) | Short range radio system using Wireless<br>(Bluetooth) and Wired (tethered)<br>cables | Short range radio system using Wireless<br>(Bluetooth) and Wired (tethered)<br>cables | Currently using Wired (tethered),<br>cables (USB), Smart Cables | Short range radio system using<br>Bluetooth, manual entry.<br>Text/Interactive Voice Response |
| Sensor Software | Sensor Software unchanged | Same | Same | Same | Same |
| Connectivity | Short range radio system using<br>Bluetooth | Short range radio system using<br>Bluetooth and Wired (tethered) cables | Short range radio system using<br>Bluetooth and Wired (tethered) cables | Wired (tethered) cables Future<br>capability to use Bluetooth dongles | Short range-radio system using<br>Bluetooth |
| Communication method of hub with<br>devices | Short range radio system using<br>Bluetooth | Short range radio system using Wireless<br>(Bluetooth) and Wired (tethered)<br>cables | Short range radio system using Wireless<br>(Bluetooth) and Wired (tethered)<br>cables | Currently using Wired (tethered)<br>cables | Short range radio system using<br>Bluetooth |
| Communications Protocol | Wireless (Bluetooth) V20 | Wireless (Bluetooth) V20 & Wired<br>(Tethered) | Wireless (Bluetooth) V20 & Wired<br>(Tethered) | Wired (Tethered) | Wireless (Bluetooth) V20 and Wireless<br>(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, monitors<br>connected to central server | On devices and hub, monitors<br>connected to central server | On devices and hub, monitors<br>connected to central server | HealthAIR uses LED light indicators | On devices and hub, monitors<br>connected to central server |
| Communication with Patients | On screen display | On screen display | On screen display | Audio/visual feedback from LED light<br>indicators & audio tones; Interactive<br>Voice Response (IVR) system for patient | On screen display, Text/Interactive<br>Voice 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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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)

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