MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY

K042273 · Health Hero Network, Inc. · DXN · Aug 31, 2004 · Cardiovascular

Device Facts

• Record ID: K042273
• Device Name: MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
• Applicant: Health Hero Network, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 31, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Health Buddy® with Device Connectivity 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 Story

Health Buddy is a home-based communication appliance connecting to standard telephone lines. It interfaces with medical devices (blood glucose meters, blood pressure cuffs, weight scales, peak flow meters) to retrieve physiologic data. Patients interact via a screen and four buttons to answer health-related questions and view prompts. Data is transmitted to the Health Hero Online service for retrospective review by healthcare professionals. The device provides education and reinforcement messages to patients. It does not provide automated treatment decisions or replace professional judgment; it serves as a communication tool for remote patient monitoring to facilitate management between office visits.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing of the software modifications and device connectivity features.

Technological Characteristics

Communication appliance connecting to standard telephone lines; includes data port for medical device integration. Software-based data retrieval and transmission. Operates as a peripheral interface for glucose meters, BP cuffs, scales, and peak flow meters. ROM-based software architecture. No specific materials or energy standards cited.

Indications for Use

Indicated for use in non-clinical settings to collect and transmit historical medical data to healthcare professionals for patient management support. No specific age or gender restrictions; intended for patients requiring remote monitoring of vital signs and symptoms.

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 Device Connectivity (K040086)
• Health Buddy® with Buddylink (K993128)
• CareMatix Wellness System (K040966)
• Viterion 100 TeleHealth Monitor (K030419)

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

| Trade Name: | Health Buddy® with Device Connectivity |
|-----------------------|----------------------------------------------|
| Common Name: | Data Management System; Accessory to Medical |
| | Device |
| Classification Names: | Refer to Table |

| Regulation<br>Number | Product<br>Code | Classification Name | Device<br>Class |
|----------------------|-----------------|--------------------------------------------------------|-----------------|
| 862.1345 | CGA | Glucose Test System | II |
| 870.1130 | DXN | Noninvasive Blood<br>Pressure<br>Measurement<br>System | II |
| 880.2700 | FRI | Patient Weight Scale | I |
| 868.1860 | BZH | Meter, Peak Flow,<br>Spirometry | II |
| 870.2910 | DRG | Physiological Signal<br>Transmitters and<br>Receivers | II |

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#### PREDICATE DEVICES

- Health Buddy® with Device Connectivity (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 cuff, patient weight scale and peak flow meter). The Health Buddy with Device Connectivity retrieves data from a specific medical device and stores it for later transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, and weight. In this submission, minor software changes are made in the Health Buddy ROM to allow it to connect to a Peak Flow Meter and monitor Peak Expiratory Flow (PEF) and FEV1 measurements. The Health Buddy has the ability to receive connections from optional, compatible devices, including those identified above, and others, such as digital thermometers, pulse oximeters and prothrombin/INR meters. The Health Buddy device has a data port that allows it to download readings from an identified attached device, activated only upon appropriate patient enrollment.

The Health Buddy with Device Connectivity 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 patient 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 Device Connectivity 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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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 Device Connectivity 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® with Device Connectivity, and is therefore substantially equivalent to the cleared Health Buddy device (#K040086 and #K993128). The device is substantially equivalent to the Viterion 100 TeleHealth Monitor (#K030419), as well as the CareMatix Wellness System (#K040966).

#### CONCLUSION

The Health Buddy with Device Connectivity 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.

005

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Public Health Service

Image /page/3/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized caduceus-like symbol with three wavy lines representing the human services aspect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle, following its curvature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 3 1 2004

Health Hero Network, Inc. c/o Mr. Geoffrey Clapp Chief Technical Officer & Chief Operating Officer 2570 W. El Camino Real, Suite 111 Mountain View, CA 96040

Re: K042273

K042273
Trade Name: Health Buddy® with Device Connectivity Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: August 20, 2004 Received: August 23, 2004

Dear Mr. Clapp:

We have reviewed your Section 510(k) premarket notification of intent to market the device in We have reviewed your Section 310(x) premained is substantially equivalent (for the indications referenced and nave decemblied the devices marketed predicate devices marketed in interstate for use stated in the encrosule, to regally manetice province Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 26, 1976, the enactified in accordance with the provisions of the Federal Food. Drug. devices that have been reclassified in accordance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act and Cosmetic Act (Act) that to not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, merelore, market the devreet, seeject or use gentrements for annual registration, listing of the general controls provisions of the rise 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 If your device is classified (SCC above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Lines and to 898. In addition, FDA may be found in the Code of Peachar Regarning your device in the Federal Register.

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Page 2 – Mr. Geoffrey Clapp

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a succession complies with other requirements of the Act
that FDA has made a determination that your device complies with over marke that FDA has made a decionmation administered by other Federal agencies. You must of any Federal statutes and regulations daminities on thot limited to: registration and listing (21 comply with an the Act 3 requirements, news 801); good manufacturing practice requirements as set any CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declients on a described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your section I ms letter will anow you to oogin maneting of substantial equivalence of your device to a legally premarket notification. The PDA midning of backership 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 (1 CFR Part 801), please If you desire specific advice for your do 100 car. Also, please note the regulation entitled, contact the Office of Comphalled at (50 mg tification" (21CFR Part 807.97). You may obtain Misolallung by reference to premail.com the Act from the Division of Small other general information on your responsibilities and its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nil R&, Ogden

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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K04227=

Health Hero Network

Special 510(k): Device Modifications Health Buddy® with Device Connectivity

#### Section 1.2

#### Indications for Use Statement

| 510(k) Number: | K042273 |
|----------------|---------|
|----------------|---------|

Device Name:

Health Buddy® with Device Connectivity

Indications for Use:

Health Buddy® with Device Connectivity 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 (Per 21 CFR 801.109)

.

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evalua

or

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K042273