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, 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.

AI/ML Overview

The provided text describes a 510(k) submission for modifications to the Health Buddy® Appliance. However, it does not contain any information about acceptance criteria or a study designed to prove the device meets those criteria.

The document focuses on:

Regulatory Authority and Company Information
Device Name and Classification
Predicate Devices: Identifying previously cleared devices that the modified device is substantially equivalent to.
Device Description: Explaining what the Health Buddy appliance is and how it functions as a communication tool for collecting and transmitting physiological data from various medical devices.
Indication for Use Statement: Defining the intended purpose of the device.
Substantial Equivalence Comparison: Arguing that the modified device is substantially equivalent to existing cleared devices.
Conclusion: Stating that safety and effectiveness are reasonably assured due to substantial equivalence.
FDA Correspondence: The FDA's letter granting 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested information about acceptance criteria or a study that proves the device meets them because this information is not present in the provided text.

In a real-world scenario for a medical device requiring performance testing, the requested information would typically be found in a separate section detailing verification and validation activities, including test protocols, acceptance criteria, and specific study results. This document bypasses such a detailed study by asserting substantial equivalence to previously cleared devices for modifications that are primarily software-related to support additional medical device connections.

Summary

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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

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

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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

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.

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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.

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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.

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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

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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:

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

Page 1 of 1

Confidential

Regulation Number and Section

§ 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).