(22 days)
No
The description focuses on data collection, transmission, and simple rule-based interactions, with no mention of AI/ML terms or capabilities.
No.
The device collects and transmits historical medical information and patient responses to healthcare professionals; it does not provide therapy or treatment.
No
The device collects and transmits historical medical information and physiological parameters from other medical devices to healthcare professionals. It does not perform diagnostic functions itself, but rather supports the management of patients by providing data to healthcare professionals who would then make diagnoses.
No
The device description explicitly states "The Health Buddy Appliance is a communications product that connects to a telephone line or Ethernet connection" and describes physical components like a screen and buttons, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the Health Buddy® Appliance is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Health Buddy's Function: The Health Buddy Appliance collects and transmits historical medical information and physiologic patient parameters from other medical devices (like blood glucose meters, blood pressure cuffs, etc.) and patient responses to questions. It does not perform any testing on specimens taken from the body.
- Data Source: The data it handles comes from external medical devices and patient input, not from analyzing biological samples.
Therefore, the Health Buddy Appliance falls under the category of a device that facilitates the collection and transmission of patient data and communication, rather than performing in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Health Buddy® Appliance is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
Product codes (comma separated list FDA assigned to the subject device)
DRG, CGA, DXN, FRI, BZH, DQA
Device Description
The Health Buddy Appliance is a communications product that connects to a telephone line or Ethernet connection. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy Appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales, peak flow meters and pulse oximeters). The Health Buddy Appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider.
The physiologic patient parameters available for retrospective display and evaluation include pulse rate, blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO2). The Health Buddy receives connections from these medical devices, and through the data port, wireless hub, or infrared device, downloads readings from the identified attached device and transmits the responses over the telephone or Ethernet connection at predetermined times to the patient's health care professional.
The Health Buddy Appliance is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number or an Ethernet connection to send patient responses since the previous data transfer and to retrieve the new dialogue.
The screen displays information sent by the patient's healthcare provider and asks questions about vital signs, symptoms and behaviors, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient responses are sent to the patient's health care provider.
The Health Buddy® Appliance is an accessory device, intended to be a communication tool to enable healthcare providers to receive historical patient information. The product is used in conjunction with Hero Network's Online Service, a communication tool to enable health care providers to educate, motivate, and receive patient information. Health Buddy Appliance is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
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
non-clinical settings, patients, healthcare professional(s)
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)
Verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of the Health Buddy Appliance. Testing included electrical safety, EMC environmental testing, integration testing, signal integrity testing, system testing, shipping/distribution, and functional testing. A hazard risk analysis was also performed and associated risks mitigated through design or labeling. The Health Buddy Appliance performed as intended.
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.
#K070543, #K063612, #K060843, #K050567, #K042273, #K040086, #K993128
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.
#K040966, #K061502, #K062127, #K062662
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
Section 1.3
510k Summary
REGULATORY AUTHORITY
FEB - 5 2008
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT
Robin Bush Health Hero Network 2400 Geng Road, Suite 200 Palo Alto, CA 94303 (650) 690-9191 (phone) (650) 798-3770 (facsimile)
NAME OF DEVICE
| Trade Name: | Health Buddy® Appliance |
|---|---|
| Common Name: | Data Management System; Accessory to Medical |
| Device | |
| Classification Names: | Refer to Table |
| Regulation
Number | Product
Code | Classification Name | Device
Class |
|--------------------------------------------------------|-----------------|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 870.2910 | DRG | Physiological Signal
Transmitters and
Receivers | ============================================================================================================================================================================== |
| Medical Device Product Codes Supported by Health Buddy | | | |
| 862.1345 | CGA | Glucose Test System | ============================================================================================================================================================================== |
| 870.1130 | DXN | Noninvasive Blood
Pressure Measurement
System | ============================================================================================================================================================================== |
| 880.2700 | FRI | Patient Weight Scale | |
| 868.1860 | BZH | Meter, Peak Flow,
Spirometry | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| 870.2700 | DQA | Oximeter | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
.
1
PREDICATE DEVICES
- Health Buddy® Appliance (#K070543, #K063612, #K060843, #K050567, . #K042273, #K040086, #K993128)
- CareMatix Wellness System (#K040966) .
- · VMS-01, Medic4All Telemedicine System, (#K061502, #K062127, #K062662)
DEVICE DESCRIPTION
The Health Buddy Appliance is a communications product that connects to a telephone line or Ethernet connection. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy Appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales, peak flow meters and pulse oximeters). The Health Buddy Appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider.
The physiologic patient parameters available for retrospective display and evaluation include pulse rate, blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO2). The Health Buddy receives connections from these medical devices, and through the data port, wireless hub, or infrared device, downloads readings from the identified attached device and transmits the responses over the telephone or Ethernet connection at predetermined times to the patient's health care professional.
The Health Buddy Appliance is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number or an Ethernet connection to send patient responses since the previous data transfer and to retrieve the new dialogue.
The screen displays information sent by the patient's healthcare provider and asks questions about vital signs, symptoms and behaviors, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient responses are sent to the patient's health care provider.
INDICATION FOR USE STATEMENT
Health Buddy® Appliance is indicated for use in non-clinical settings to collect and transmit historical data to healthcare professionals to help support effective management of their patients.
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The Health Buddy® Appliance is an accessory device, intended to be a communication tool to enable healthcare providers to receive historical patient information. The product is used in conjunction with Hero Network's Online Service, a communication tool to enable health care providers to educate, motivate, and receive patient information. Health Buddy Appliance is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
SUBSTANTIAL EQUIVALENCE COMPARISON
This submission represents a modification to the physical design and the software in the Health Buddy® Appliance to support the integration of infrared, Ethernet network connectivity, and a new LCD, in addition to the improvements in manufacturability and serviceability. It is therefore substantially equivalent to the cleared Health Buddy Appliance (#K063612, #K060843, #K050567, #K040086 and #K993128). The device is also substantially equivalent to the CareMatix Wellness System (#K040966), and the Medicine System (VMS-01) (#K062662), which uses an internet wireless connection between the monitoring device and receiving station located inside the home.
PERFORMANCE TESTING
Verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of the Health Buddy Appliance. Testing included electrical safety, EMC environmental testing, integration testing, signal integrity testing, system testing, shipping/distribution, and functional testing. A hazard risk analysis was also performed and associated risks mitigated through design or labeling. The Health Buddy Appliance performed as intended.
CONCLUSION
The Health Buddy Appliance is substantially equivalent in technology, features, and indications for use to devices cleared under the Federal Food, Drug and Cosmetic Act. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance of this modified device.
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Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
FEB - 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Health Hero Network, Inc. c/o Ms. Robin Bush Regulatory Affairs 2400 Geng Road, Suite 200 Palo Alto, CA 94303
Re: K080091
Health Buddy® Appliance Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiologic Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: January 11, 2008 Received: January 14, 2008
Dear Ms. Bush:
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.
4
Page 2 - Ms. Robin Bush
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); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Bhimmon for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 1.2
Indications for Use
510(k) Number:
Device Name: Health Buddy® Appliance
Indications for Use:
Health Buddy® Appliance is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
Prescription Use XX (Part 21 CFR 801 Subpart D) and/or
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular Devices
1000 Number
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