MODIFICATION TO HEALTH BUDDY APPLIANCE

K063612 · Health Hero Network, Inc. · DRG · Dec 29, 2006 · Cardiovascular

Device Facts

• Record ID: K063612
• Device Name: MODIFICATION TO HEALTH BUDDY APPLIANCE
• Applicant: Health Hero Network, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Dec 29, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended 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. 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.

Device Story

Health Buddy appliance is a home-based communication tool connecting to standard telephone lines. It interfaces with various medical devices—blood glucose meters, blood pressure cuffs, weight scales, peak flow meters, and pulse oximeters—via data port, wireless hub, or infrared. The device retrieves physiological readings and stores them for scheduled transmission to a central Data Center. Patients interact via a screen and four buttons to answer provider-sent questions regarding vital signs, symptoms, and behaviors. The device provides educational messages and reinforcement prompts. Healthcare providers access the transmitted historical data via the Health Hero Online service to monitor patient status between office visits. The system facilitates remote patient management without providing automated clinical diagnoses or treatment decisions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparisons to predicate devices.

Technological Characteristics

Communications appliance connecting to standard telephone lines. Interfaces with medical devices via data port, wireless hub, or infrared. Supports blood glucose meters, blood pressure cuffs, weight scales, peak flow meters, and pulse oximeters. Features a display screen and four-button user interface. Software-based data retrieval and transmission system.

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 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.

Predicate Devices

• Health Buddy® with Device Connectivity (K060843)
• Health Buddy® with Device Connectivity (K050567)
• Health Buddy® with Device Connectivity (K042273)
• Health Buddy® with Device Connectivity (K040086)
• Health Buddy® with Buddylink (K993128)
• CareMatix Wellness System (K040966)

Reference Devices

• Philips TeleMonitoring System (K041674)

Submission Summary (Full Text)

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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 [phone] (phone) [phone] (facsimile)

#### NAME OF DEVICE

| Trade Name: | Health Buddy® Appliance |
|-----------------------|--------------------------------------------------------|
| Common Name: | Data Management System; Accessory to Medical<br>Device |
| Classification Names: | Refer to Table |

| Regulation<br>Number | Product<br>Code | Classification Name | Device<br>Class |
|--------------------------------------------------------|-----------------|-------------------------------------------------------|-----------------|
| 870.2910 | DRG | Physiological Signal<br>Transmitters and<br>Receivers | II |
| Medical Device Product Codes Supported by Health Buddy | | | |
| 862.1345 | CGA | Glucose Test System | II |
| 870.1130 | DXN | Noninvasive Blood<br>Pressure Measurement<br>System | II |
| 880.2700 | FRI | Patient Weight Scale | I |
| 868.1860 | BZH | Meter, Peak Flow,<br>Spirometry | II |
| 870.2700 | DQA | Oximeter | II |

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# 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

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.

#### 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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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.

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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

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#### 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 [phone] or [phone] 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

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## Section 1.2

# Indications for Use

510(k) Number:

K063612

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)

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------|
| (Division Sign-Off) Division of Cardiovascular Devices | |
| 510(k) Number | K063612 |
| | Page 1 of 1 |