(23 days)
Not Found
No
The description focuses on data collection, storage, and transmission, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device is described as a communications product that collects and transmits historical medical information. It does not exert any direct therapeutic action on the patient.
No
Explanation: The device collects and transmits historical medical information and physiologic parameters, but it does not independently analyze or interpret this data to make a diagnosis. Its function is to support healthcare professionals in managing their patients by providing data to them.
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 a "screen" and "four large buttons," all of which are hardware components. While it contains software, it is not solely software.
Based on the provided information, the Health Buddy® Appliance is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Health Buddy's Function: The Health Buddy appliance collects and transmits historical medical information and physiologic patient parameters (blood pressure, blood glucose, weight, PEF, FEV1, SpO₂, pulse rate) from connected medical devices. It also facilitates communication of patient responses to questions about vital signs, symptoms, and behaviors.
- No Specimen Analysis: The device itself does not analyze any biological specimens. It acts as a data collection and transmission hub for information gathered by other medical devices or provided by the patient.
Therefore, the Health Buddy® Appliance 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, DQA
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, 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 blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO₂) and pulse rate using a digital pulse oximeter. The Health Buddy receives connections from these medical devices, and through the data port, downloads readings from the identified attached device and, at predetermined times, transmits the responses over the phone lines 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 to send patient responses since the previous data transfer and to retrieve the new dialoque.
The screen displays information and asks 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 responses are 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.
K050567, K042273, K040086, K993128, K030419, K040966
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
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
K060843 Page.
Special 510(k): Device Modifications Health Buddy® Appliance
Section 1.3
Summary of Safety and Effectiveness AFI 20 2006
REGULATORY AUTHORITY
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT
Robin Bush Health Hero Network 2000 Seaport Blvd. Suite 400 Redwood City, CA 94063 (650) 779.9100 (phone) (650) 779.2100 (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 | II |
| Medical Device Product Codes Supported by Health Buddy | | | |
| 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 |
| 870.2700 | DQA | Oximeter | II |
1
Health Hero Network
Kchrt43 Page
Special 510(k): Device Modifications Health Buddy® Appliance
PREDICATE DEVICES
- Health Buddy® with Device Connectivity (#K050567, #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, 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 blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO₂) and pulse rate using a digital pulse oximeter. The Health Buddy receives connections from these medical devices, and through the data port, downloads readings from the identified attached device and, at predetermined times, transmits the responses over the phone lines 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 to send patient responses since the previous data transfer and to retrieve the new dialoque.
The screen displays information and asks 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 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.
2
K c60543 Pas
Special 510(k): Device Modifications Health Buddy® Appliance
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 software in the Health Buddy® Appliance to support the connection of additional medical devices. It is therefore substantially equivalent to the cleared Health Buddy appliance (#K050567, #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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2006
Health Hero Network c/o Ms. Robin Bush Project Manager, Regulatory Affairs 2000 Seaport Blvd. Suite 400 Redwood City, CA 94063
Re: K060843
Trade Name: Health Buddy® Appliance Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: DQA Dated: March 24, 2006 Received: March 28, 2005
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. Iisting 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 vour 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 (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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/indcx.html.
Sincerely yours.
Bhimuma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K 060843
Health Hero Network
Special 510(k): Device Modifications Health Buddy® Appliance
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)
B.A. mmmma
VC-33 510iki N
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Confidential