(143 days)
Not Found
No
The summary describes a software application for collecting and transmitting health data, but there is no mention of AI or ML being used for analysis, interpretation, or any other function. The summary explicitly states that clinical judgment is required to interpret the data.
No.
The device collects and transmits general health information and physiological measurements but explicitly states it "makes no diagnosis" and "is not intended as a substitute for medical care." It facilitates communication between patients and caregivers for review of data but does not provide therapy itself.
No
The "Intended Use / Indications for Use" section explicitly states, "The HealthInterlink® Beacon® makes no diagnosis." The device is intended to collect and transmit health information and physiological measurements, not to interpret them clinically or make diagnostic conclusions.
Yes
The device description explicitly states that HealthInterlink Beacon is a "software application" and that it is "installed on a commercially available device." It focuses on the software's function of collecting and transmitting data from other medical devices and facilitating communication, without mentioning any proprietary hardware components included with the device itself.
Based on the provided information, the HealthInterlink® Beacon® device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- HealthInterlink® Beacon® Function: The description clearly states that the device collects and transmits general health information and physiological measurements from commercially available medical devices. It does not analyze biological specimens.
- Intended Use: The intended use is to collect and transmit data, not to perform diagnostic tests on samples.
- No Mention of Specimen Analysis: The entire description focuses on data collection, transmission, and communication, with no mention of handling or analyzing biological samples.
Therefore, the HealthInterlink® Beacon® falls outside the scope of an In Vitro Diagnostic device. It functions as a data collection and transmission system for remote patient monitoring.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DRG, DXN, FRI, FLL, NBW, DQA, JQP
Device Description
The Healthinterlink Beacon is a software application. Once installed on a commercially-available 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.
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
patients to collect and transmit general health information
Caregiver review
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 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.
No new hazards to safety or effectiveness are presented by HealthInterlink Beacon, therefore, no clinical tests were conducted.
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.
K112559, K112858, K122285, K103276
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.
Not Found
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
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 -
- Name of the Device: HealthInterlink Beacon
-
- 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.
1
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
K112858 | CardioCom Tablet Commander
K22285 | Intel Health Guide Express K103276 | MedApps 20 Remote Patient
Monitoring System K112559 | HealthInterlink Beacon |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| | | | Same | Same | Same |
| Indications for Use | Enables healthcare providers to
monitor and manage conditions of
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
home | Same | Same | Same | Same |
| Data Collection Software | LifeStream Management Suite | Cardiocom's OMNIVISOR Management
System | Intel Care Management Suite Software | MedApps Proprietary Software | HealthInterlink Beacon Software |
| Data Collection Software Functionality | Transmit data from Sensor devices to
Central Database | Same | Same | Same | Same |
| Communication method of hub with
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
interfaced (wired or wirelessly) to
receiver hub | Medical Devices designed for Home
use: Scale, Blood Pressure, Pulse Ox,
Thermometer | Medical Devices designed for Home
use: Glucose, Scale, Blood Pressure,
Pulse Ox, Peak Flow | Medical Devices designed for Home
use: Glucose, Scale, Blood Pressure,
Pulse Ox, Peak Flow | Medical Devices designed for Home
use: Glucose, Scale, Blood Pressure,
Pulse Ox | Medical Devices designed for Home
use: Glucose, Scale, Blood Pressure,
Pulse Ox, Temperature, Spirometer |
| Implementation method of collecting
data from sensors | Short range radio system using
Bluetooth (Manual entry for
Thermometer) | 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 using
Bluetooth, manual entry.
Text/Interactive Voice Response |
| Sensor Software | Sensor Software unchanged | Same | Same | Same | Same |
| Connectivity | Short range radio system using
Bluetooth | Short range radio system using
Bluetooth and Wired (tethered) cables | Short range radio system using
Bluetooth and Wired (tethered) cables | Wired (tethered) cables Future
capability to use Bluetooth dongles | Short range-radio system using
Bluetooth |
| Communication method of hub with
devices | Short range radio system using
Bluetooth | 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 using
Bluetooth |
| 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, monitors
connected to central server | On devices and hub, monitors
connected to central server | On devices and hub, monitors
connected to central server | HealthAIR uses LED light indicators | On devices and hub, monitors
connected to central server |
| Communication with Patients | On screen display | On screen display | On screen display | Audio/visual feedback from LED light
indicators & audio tones; Interactive
Voice Response (IVR) system for patient | On screen display, Text/Interactive
Voice Response |
2
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.
3
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.
4
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
5
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)
Cor