(54 days)
No
The description focuses on data collection, transmission, and simple interactive dialogues based on pre-programmed questions and responses, with no mention of adaptive learning, pattern recognition, or other AI/ML characteristics.
No
The device is described as a communications product that collects and transmits historical medical information to healthcare professionals to help support effective management of their patients. It retrieves data from other medical devices but does not itself provide therapy.
No
The device collects and transmits historical medical information and data from other medical devices, but it does not perform any diagnostic function itself. Its purpose is to facilitate communication and data transfer, not to diagnose conditions.
No
The device description explicitly states it is an "appliance" that "connects to a telephone line" and has a "data port," indicating it is a physical hardware device, not solely software.
Based on the provided information, the Health Buddy® with Buddylink 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 (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Health Buddy Function: The Health Buddy with Buddylink collects and transmits historical medical information and data from other medical devices (blood glucose meters, blood pressure cuffs, scales). It does not perform any testing on specimens taken from the body. Its primary function is communication and data transfer.
The device acts as a communication hub and data aggregator, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
Health Buddy® with Buddylink 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
CGA, DXN
Device Description
The Health Buddy appliance is a communications product that connects to a telephone line. 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 (such as blood glucose meter, non-invasive blood pressure cuff and patient weight scale). The Health Buddy with Buddylink retrieves data from a medical device (blood glucose meter, non-invasive blood pressure cuff, or patient weight scale) and stores it for later transmission to a healthcare provider. The device has a data port that allows it to download readings from the attached device, only activated upon appropriate patient enrollment.
The Health Buddy with Buddylink is a simple; user-friendly device that connects to the patient's standard home telephone line. The device connects to the Data Center via a toll-free number to send responses from the previous day and to retrieve the current day's dialogue.
The screen displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, 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 information is sent to the patient's health care provider.
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, healthcare professionals
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Section 1.3
Summary of Safety and Effectiveness
REGULATORY AUTHORITY
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT
Geoffrey J. Clapp Health Hero Network 2570 W. El Camino Real, Suite 111 Mountain View, CA 94040 (650) 559.1088 (phone) (650) 559.1050 (facsimile) gclapp@hhn.com
NAME OF DEVICE
Health Buddy® with Buddylink Trade Name: Accessory to Glucose Test System Common Name: Device Product Code: CGA Glucose Test System (21 CFR 862.1245) Classification Name: 75. Clinical Chemistry Device Panel: Class II Device Classification:
PREDICATE DEVICES
- · Health Buddy® with Buddylink (K993128)
- · In Touch Diabetes Management Software (K984527)
- · HomMed Central Station (K020184)
DEVICE DESCRIPTION
The Health Buddy appliance is a communications product that connects to a telephone line. 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 (such as blood glucose meter, non-invasive blood pressure cuff and patient weight scale). The Health Buddy with Buddylink retrieves data from a medical device (blood glucose meter, non-invasive blood
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pressure cuff, or patient weight scale) and stores it for later transmission to a healthcare provider. The device has a data port that allows it to download readings from the attached device, only activated upon appropriate patient enrollment.
The Health Buddy with Buddylink is a simple; user-friendly device that connects to the patient's standard home telephone line. The device connects to the Data Center via a toll-free number to send responses from the previous day and to retrieve the current day's dialogue.
The screen displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, 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 information is sent to the patient's health care provider.
INDICATION FOR USE STATEMENT
Health Buddy® with Buddylink 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.
The Health Buddy® 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 Health Hero Network's Online Service, a communication tool to enable health care providers to educate, motivate, and receive patient information. Health Buddy with Buddylink is not intended to provide automated treatment decisions, nor 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 software in the Health Buddy® with Buddylink, and is therefore substantially equivalent to the cleared Health Buddy device (#K993128). The device is substantially equivalent to LifeScan ONE TOUCH Profile Diabetes Tracking System (#K950727) and the LifeScan IN TOUCH Diabetes Management Software (#K984527), and HomMed Central Station (#K020184).
CONCLUSION
The Health Buddy with Buddylink is substantially equivalent 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2004
Health Hero Network, Inc. c/o Mr. Geoffrey J. Clapp Chief Technical Officer and Chief Operating Officer 2570 W. El Camino Real, Suite 111 Mountain View, CA 94040
Re: K040086
Trade Name: Health Buddy® with Buddylink Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: January 14, 2004 Received: January 16, 2004
Dear Mr. Clapp:
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 - Mr. Geoffrey J. Clapp
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 (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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Dunn R. Vainonen
A Bram D. Zuckerman, M.D. Director Divison of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): # K040086
Device Name: Health Buddy® with Buddylink
Indications For Use:
Health Buddy® with Buddylink 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 × (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)
Duna R. Vochner
Page 1 of __ 1
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K0400 & G