(8 days)
Not Found
No
The description focuses on data collection, transmission, and simple interactive dialogues based on pre-programmed questions and responses, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is described as a communications product that collects and transmits historical medical information and physiologic parameters; it does not directly treat or diagnose a disease or condition.
No
The device is indicated for collecting and transmitting historical medical information, not for diagnostic purposes. It functions as a communication product to send patient data to healthcare professionals, not to diagnose conditions itself.
No
The device description explicitly states "The Health Buddy appliance is a communications product that connects to a telephone line" and "The Health Buddy device has a data port". This indicates the device includes hardware components beyond just software.
Based on the provided information, the Health Buddy® with Device Connectivity is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "collect and transmit historical medical information to healthcare professionals to help support effective management of their patients." This focuses on data collection and communication, not on performing diagnostic tests on biological samples.
- Device Description: The device description clearly states it's a "communications product" that connects to a telephone line. It retrieves data from other medical devices (like blood glucose meters, blood pressure cuffs, etc.) and transmits it. It does not perform any analysis or testing on biological samples itself.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information based on laboratory testing
The Health Buddy acts as a data aggregator and communication tool for information gathered by other medical devices. The diagnostic function, if any, resides in the connected devices (like the blood glucose meter) and the interpretation of the data by the healthcare professional.
N/A
Intended Use / Indications for Use
Health Buddy® with Device Connectivity 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.
Product codes (comma separated list FDA assigned to the subject device)
CGA, DXN, FRI, BZH, DRG
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 (including blood glucose meters, non-invasive blood pressure cuff, patient weight scale and peak flow meter). The Health Buddy with Device Connectivity retrieves data from a specific medical device and stores it for later transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, and weight. In this submission, minor software changes are made in the Health Buddy ROM to allow it to connect to a Peak Flow Meter and monitor Peak Expiratory Flow (PEF) and FEV1 measurements. The Health Buddy has the ability to receive connections from optional, compatible devices, including those identified above, and others, such as digital thermometers, pulse oximeters and prothrombin/INR meters. The Health Buddy device has a data port that allows it to download readings from an identified attached device, activated only upon appropriate patient enrollment.
The Health Buddy with Device Connectivity 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 patient 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.
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 Device Connectivity 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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
K040086, K993128, #K040966, #K030419
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
§ 870.1130 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) 559.1188 (phone) (650) 559.1050 (facsimile) clapp@healthhero.com
NAME OF DEVICE
| Trade Name: | Health Buddy® with Device Connectivity |
|---|---|
| Common Name: | Data Management System; Accessory to Medical |
| Device | |
| Classification Names: | Refer to Table |
| Regulation
Number | Product
Code | Classification Name | Device
Class |
|----------------------|-----------------|--------------------------------------------------------|-----------------|
| 862.1345 | CGA | Glucose Test System | II |
| 870.1130 | DXN | Noninvasive Blood
Pressure
Measurement
System | II |
| 880.2700 | FRI | Patient Weight Scale | I |
| 868.1860 | BZH | Meter, Peak Flow,
Spirometry | II |
| 870.2910 | DRG | Physiological Signal
Transmitters and
Receivers | II |
1
PREDICATE DEVICES
- Health Buddy® with Device Connectivity (K040086) .
- Health Buddy® with Buddylink (K993128) ●
- CareMatix Wellness System (#K040966) .
- Viterion 100 TeleHealth Monitor (#K030419) .
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 (including blood glucose meters, non-invasive blood pressure cuff, patient weight scale and peak flow meter). The Health Buddy with Device Connectivity retrieves data from a specific medical device and stores it for later transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, and weight. In this submission, minor software changes are made in the Health Buddy ROM to allow it to connect to a Peak Flow Meter and monitor Peak Expiratory Flow (PEF) and FEV1 measurements. The Health Buddy has the ability to receive connections from optional, compatible devices, including those identified above, and others, such as digital thermometers, pulse oximeters and prothrombin/INR meters. The Health Buddy device has a data port that allows it to download readings from an identified attached device, activated only upon appropriate patient enrollment.
The Health Buddy with Device Connectivity 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 patient 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 Device Connectivity 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.
2
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 Device Connectivity 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 software in the Health Buddy® with Device Connectivity, and is therefore substantially equivalent to the cleared Health Buddy device (#K040086 and #K993128). The device is substantially equivalent to the Viterion 100 TeleHealth Monitor (#K030419), as well as the CareMatix Wellness System (#K040966).
CONCLUSION
The Health Buddy with Device Connectivity 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.
005
3
Public Health Service
Image /page/3/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized caduceus-like symbol with three wavy lines representing the human services aspect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle, following its curvature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2004
Health Hero Network, Inc. c/o Mr. Geoffrey Clapp Chief Technical Officer & Chief Operating Officer 2570 W. El Camino Real, Suite 111 Mountain View, CA 96040
Re: K042273
K042273
Trade Name: Health Buddy® with Device Connectivity Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: August 20, 2004 Received: August 23, 2004
Dear Mr. Clapp:
We have reviewed your Section 510(k) premarket notification of intent to market the device in We have reviewed your Section 310(x) premained is substantially equivalent (for the indications referenced and nave decemblied the devices marketed predicate devices marketed in interstate for use stated in the encrosule, to regally manetice province Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 26, 1976, the enactified in accordance with the provisions of the Federal Food. Drug. devices that have been reclassified in accordance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act and Cosmetic Act (Act) that to not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, merelore, market the devreet, seeject or use gentrements for annual registration, listing of the general controls provisions of the rise 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 If your device is classified (SCC above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Lines and to 898. In addition, FDA may be found in the Code of Peachar Regarning your device in the Federal Register.
4
Page 2 – Mr. Geoffrey Clapp
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a succession complies with other requirements of the Act
that FDA has made a determination that your device complies with over marke that FDA has made a decionmation administered by other Federal agencies. You must of any Federal statutes and regulations daminities on thot limited to: registration and listing (21 comply with an the Act 3 requirements, news 801); good manufacturing practice requirements as set any CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declients on a described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your section I ms letter will anow you to oogin maneting of substantial equivalence of your device to a legally premarket notification. The PDA midning of backership 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 (1 CFR Part 801), please If you desire specific advice for your do 100 car. Also, please note the regulation entitled, contact the Office of Comphalled at (50 mg tification" (21CFR Part 807.97). You may obtain Misolallung by reference to premail.com the Act from the Division of Small other general information on your responsibilities and 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,
Nil R&, Ogden
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K04227=
Health Hero Network
Special 510(k): Device Modifications Health Buddy® with Device Connectivity
Section 1.2
Indications for Use Statement
| 510(k) Number: | K042273 |
|---|---|
| ---------------- | --------- |
Device Name:
Health Buddy® with Device Connectivity
Indications for Use:
Health Buddy® with Device Connectivity 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 (Per 21 CFR 801.109)
.
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evalua
or
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K042273