(32 days)
Not Found
No
The description focuses on data collection, transmission, and simple interactive responses based on pre-programmed dialogue, with no mention of AI or ML algorithms for analysis or decision-making.
No.
The device is described as a communications product and an "accessory device, intended to be a communication tool to enable healthcare providers to receive historical patient information." It is explicitly stated that it "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." This indicates it facilitates information transfer rather than directly providing therapy.
No
The device is described as a "communications product" and an "accessory device, intended to be a communication tool to enable healthcare providers to receive historical patient information." It does not make automated treatment decisions or act as a substitute for professional healthcare judgment.
No
The device description explicitly states it is a "communications product that connects to a telephone line" and a "simple, user-friendly device that connects to the patient's standard home telephone line." It also mentions "data ports that allow it to download readings from identified attached devices." These descriptions clearly indicate the presence of hardware components beyond just software.
Based on the provided information, the Health Buddy® Appliance is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Health Buddy's Function: The Health Buddy's primary function is to collect and transmit historical medical information from patients to healthcare professionals. It acts as a communication tool and data aggregator for information gathered from other medical devices (like blood glucose meters, blood pressure cuffs, etc.) or through patient responses to questions.
- No Specimen Examination: The Health Buddy itself does not perform any analysis or examination of biological specimens. It receives data that has already been generated by other devices or provided by the patient.
- Intended Use: The intended use clearly states it's for collecting and transmitting historical medical information to support effective patient management, not for performing diagnostic tests on specimens.
Therefore, the Health Buddy falls under the category of a telehealth or remote patient monitoring device, not an IVD.
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
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 cuffs, patient weight scales and peak flow meters). 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 blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements. In this submission, software changes are made to support hardware replacement to components no longer available in the Health Buddy. In addition, the operating system has changed. The Health Buddy device has data ports that allow it to download readings from identified attached devices, activated only upon appropriate patient enrollment.
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 to send patient responses from the previous day and to retrieve the current day's dialoque.
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
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.
K042273, 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
§ 870.2910 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
1/3 Special 510(k): Device Modifications Health Buddy® Appliance
Section 1.3
Summary of Safety and Effectiveness
REGULATORY AUTHORITY
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT
Robin Bush Health Hero Network 2570 W. El Camino Real, Suite 111 Mountain View, CA 94040 (650) 559.1000 (phone) (650) 559.1050 (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 | ============================================================================================================================================================================== |
| 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 | ============================================================================================================================================================================== |
Confidential
1
Special 510(k): Device Modifications Health Buddy® Appliance
C50567 p2/3
PREDICATE DEVICES
- Health Buddy® with Device Connectivity (#K042273, #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 cuffs, patient weight scales and peak flow meters). 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 blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements. In this submission, software changes are made to support hardware replacement to components no longer available in the Health Buddy. In addition, the operating system has changed. The Health Buddy device has data ports that allow it to download readings from identified attached devices, activated only upon appropriate patient enrollment.
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 to send patient responses from the previous day and to retrieve the current day's dialoque.
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® 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.
2
050567 P 3/3
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 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 mechanicals and software in the Health Buddy® Appliance, and is therefore substantially equivalent to the cleared Health Buddy appliance (#K042273, #K040086 and #K993128). The device is also substantially equivalent to the Viterion 100 TeleHealth Monitor (#K030419), as well as the CareMatix Wellness System (#K040966).
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES-USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 5 2005
Health Hero Network, Inc. c/o Mr Robin Bush Project Manager, Regulatory Affairs 2570 W. El Camino Real, Ste. 111 Mountain View, CA 94040
Re: K050567
Trade Name: Health Buddy® Appliance Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: II (two) Product Code: DRG Dated: February 28, 2005 Received: March 04, 2005
Dear Mr. Bush:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your section of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the enactment date of the Medical Device Amendments, or to conninered pro- to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicrerore, manel as act include requirements for annual registration, listing of general controls profitering 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 n your device is classified (soc aborto) als. Existing major regulations affecting your device can thay be subject to suen additional of Marts 800 to 898. In addition, FDA may be found in the Councements concerning your device in the Federal Register.
4
Page 2 – Mr Robin Bush
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 lisualites complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of any it call the Act's requirements, including, but not limited to: registration and listing (21 comply with an the rice 3 requirements, the submanufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forul in the quality byscents (Sections 531-542 of the Act); 21 CFR 1000-1050. product laciation control provisions (Sections of the as described in your Section 510(k) This letter will anow you to obgen mailteing of substantial equivalence of your device to a legally premarket notheadon. The PDA mailing of basification 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 If you desire specific at not arratiance at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Comphalise in (21 CFR Part 807.97). You may obtain Missuranting of Icrerence to premaintentibilities under the Act from the Division of Small other general information on your respended its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html
Sincerely yours,
Bhimmer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Health Hero Network
510(k) #K050567 Health Buddy® Appliance
Indications for Use
510(k) Number (if known): #K050567
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 XXX (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)
Blummen
(Division Sign-Off) Division of Cardiovascular Devices 05056 510(k) Number_
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