HEALTH BUDDY WITH BUDDYLINK

K040086 · Health Hero Network, Inc. · DXN · Mar 10, 2004 · Cardiovascular

Device Facts

• Record ID: K040086
• Device Name: HEALTH BUDDY WITH BUDDYLINK
• Applicant: Health Hero Network, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Health Buddy® with Buddylink 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. 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 Buddylink is not intended to provide automated treatment decisions, nor 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.

Device Story

Health Buddy appliance is a home-based communication tool connecting to standard telephone lines; interfaces with medical devices (blood glucose meter, blood pressure cuff, weight scale) via data port. Device retrieves readings from attached medical equipment and stores data for transmission to a central Data Center. Patient interacts via screen and four buttons to answer provider-sent questions regarding vital signs, symptoms, and behaviors. Device provides educational messages and reinforcement prompts. Healthcare providers access transmitted historical data via Health Hero Online service to monitor patients between office visits. System facilitates remote patient management; does not provide automated diagnosis or treatment decisions.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Communication appliance connecting to standard home telephone lines. Features data port for peripheral device connectivity (glucose meter, BP cuff, scale). Includes display screen and four-button user interface. Software-based data retrieval and transmission to remote Data Center. Operates as an accessory to medical devices.

Indications for Use

Indicated for use in non-clinical settings to collect and transmit historical medical data to healthcare professionals to support patient management. Not for automated treatment decisions or as a substitute for professional judgment.

Regulatory Classification

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.

Predicate Devices

• Health Buddy® with Buddylink (K993128)
• In Touch Diabetes Management Software (K984527)
• HomMed Central Station (K020184)

Reference Devices

• LifeScan ONE TOUCH Profile Diabetes Tracking System (K950727)

Submission Summary (Full Text)

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## 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 [phone] (phone) [phone] (facsimile) [e-mail]

#### NAME OF DEVICE

Health Buddy® with Buddylink Trade Name: Accessory to Glucose Test System Common Name: Device Product Code: CGA Glucose Test System (21 CFR 862.1245) Classification Name: 75. Clinical Chemistry Device Panel: Class II Device Classification:

#### PREDICATE DEVICES

- · Health Buddy® with Buddylink (K993128)
- · In Touch Diabetes Management Software (K984527)
- · HomMed Central Station (K020184)

## 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 (such as blood glucose meter, non-invasive blood pressure cuff and patient weight scale). The Health Buddy with Buddylink retrieves data from a medical device (blood glucose meter, non-invasive blood

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pressure cuff, or patient weight scale) and stores it for later transmission to a healthcare provider. The device has a data port that allows it to download readings from the attached device, only activated upon appropriate patient enrollment.

The Health Buddy with Buddylink 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 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 Buddylink 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.

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 Buddylink is not intended to provide automated treatment decisions, nor 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 Buddylink, and is therefore substantially equivalent to the cleared Health Buddy device (#K993128). The device is substantially equivalent to LifeScan ONE TOUCH Profile Diabetes Tracking System (#K950727) and the LifeScan IN TOUCH Diabetes Management Software (#K984527), and HomMed Central Station (#K020184).

#### CONCLUSION

The Health Buddy with Buddylink 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2004

Health Hero Network, Inc. c/o Mr. Geoffrey J. Clapp Chief Technical Officer and Chief Operating Officer 2570 W. El Camino Real, Suite 111 Mountain View, CA 94040

Re: K040086

Trade Name: Health Buddy® with Buddylink Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: January 14, 2004 Received: January 16, 2004

Dear Mr. Clapp:

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.

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Page 2 - Mr. Geoffrey J. Clapp

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Dunn R. Vainonen

A Bram D. Zuckerman, M.D. Director Divison of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): # K040086

Device Name: Health Buddy® with Buddylink

Indications For Use:

Health Buddy® with Buddylink 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 × (Part 21 CFR 801 Subpart D)

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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)

Duna R. Vochner

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(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K0400 & G