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.

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, wireless hub, or infrared device, downloads readings from the identified attached device and transmits the responses over the phone lines 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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modification to the Health Buddy® Appliance. However, it does NOT contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The submission focuses on establishing substantial equivalence to previously cleared devices for a modification to the software to support the connection of additional medical devices. This is a regulatory pathway that relies more on demonstrating that the changes do not introduce new questions of safety or effectiveness, rather than providing new performance data for the device as a whole.

Therefore, many of the requested details are not present in the provided document.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) submission for this device modification focuses on establishing substantial equivalence rather than presenting new performance data against specific acceptance criteria. The document explicitly states: "This submission represents a modification to the software in the Health Buddy® Appliance to support the connection of additional medical devices."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. No specific test set or study details with sample sizes are mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. There is no mention of experts or ground truth establishment for a test set.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable/provided. The Health Buddy Appliance is a data management and communication system for physiological parameters, not an AI-assisted diagnostic tool that would typically involve an MRMC study comparing human readers with and without AI. It collects and transmits historical data for healthcare professionals to support patient management.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This information is not provided in the document. The device primarily functions as a data conduit and communication tool, not an autonomous algorithm requiring standalone performance evaluation in the typical sense of a diagnostic or therapeutic algorithm.

7. The Type of Ground Truth Used

This information is not provided in the document. Given the nature of the device as a data transmission system, the "ground truth" would likely relate to the accuracy of data transmission and correlation with the attached medical devices, but specific details are not outlined.

8. The Sample Size for the Training Set

This information is not provided in the document. There is no mention of a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document.

Summary of the Device and its Regulatory Review:

The Health Buddy® Appliance is a communication product that connects to a telephone line. It functions by retrieving data from various medical devices (blood glucose meters, blood pressure cuffs, scales, peak flow meters, pulse oximeters) and transmitting this historical patient information to healthcare professionals. It also allows healthcare providers to send questions and educational messages to patients.

This specific 510(k) submission (K063612) is a modification to the software of an already cleared Health Buddy® Appliance to support the connection of additional medical devices. The regulatory review relies on demonstrating substantial equivalence to previously cleared Health Buddy versions and other similar telemonitoring systems.

The core assertion for clearance is that the modified device is "substantially equivalent in technology, features, and indications for use to devices cleared under the Federal Food, Drug and Cosmetic Act," and therefore its "safety and effectiveness are reasonably assured." This implies that the performance characteristics (e.g., accuracy of data transmission, reliability of communication) of the modified device are considered to be comparable to those of the predicate devices without requiring new, extensive performance studies to define new acceptance criteria and prove them.

Summary

{0}------------------------------------------------

510(k): Device Modifications Health Buddy® Appliance

Section 1.3

510k Summary

K0636/2

DEL 2 y ZUUB

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 MedicalDevice
Classification Names:	Refer to Table

RegulationNumber	ProductCode	Classification Name	DeviceClass
870.2910	DRG	Physiological SignalTransmitters andReceivers	II
Medical Device Product Codes Supported by Health Buddy
862.1345	CGA	Glucose Test System	II
870.1130	DXN	Noninvasive BloodPressure MeasurementSystem	II
880.2700	FRI	Patient Weight Scale	I
868.1860	BZH	Meter, Peak Flow,Spirometry	II
870.2700	DQA	Oximeter	II

{1}------------------------------------------------

PREDICATE DEVICES

Health Buddy® with Device Connectivity (#K060843, #K050567, #K042273, . #K040086)
Health Buddy® with Buddylink (#K993128) .
CareMatix Wellness System (#K040966) .
. Philips TeleMonitoring System, (#K041674)

DEVICE DESCRIPTION

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}------------------------------------------------

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 (#K060843, #K050567, #K042273, #K040086 and #K993128). The device is also substantially equivalent to the CareMatix Wellness System (#K040966), which uses a wireless connection between the monitoring device and receiving station located inside the home.

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}------------------------------------------------

Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its head turned to the left and wings outstretched. The eagle is composed of three thick, curved lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEL & 9 2006

Health Hero Network, Inc. C/O Robin Bush 2000 Seaport Blvd, Suite 400 Redwood City, CA 94063

Re: K063612

Trade/Device Name: Health Buddy Appliance Regulation Number: 21 CFR 870.2910 Regulation Name: Transmitters and Receivers, Physiological Signal, Radiofrequency Regulatory Class: Class II Product Code: DRG Dated: November 30, 2006 Received: December 4, 2006

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.

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

{4}------------------------------------------------

Page 2 - Ms. Robin Bush

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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:

K063612

Device Name:

Health Buddy® Appliance

Indications for Use:

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 Sign-Off) Division of Cardiovascular Devices
510(k) Number	K063612
	Page 1 of 1

Regulation Number and Section

§ 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).