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 or Ethernet connection. 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 pulse rate, blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO2). 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 telephone or Ethernet connection 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 or an Ethernet connection to send patient responses since the previous data transfer and to retrieve the new dialogue.

The screen displays information sent by the patient's healthcare provider and asks questions about vital signs, symptoms and behaviors, 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 the Health Buddy® Appliance, which is a communication product designed to collect and transmit patient data from various medical devices to healthcare professionals.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that "Verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of the Health Buddy Appliance." And concludes that "The Health Buddy Appliance performed as intended."

The core "performance" of this device is its ability to communicate and transmit data correctly. The acceptance criteria, therefore, would be that these functions work as expected.

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Functional Performance	- Ability to correctly connect to medical devices (blood glucose meters, BP cuffs, weight scales, peak flow meters, pulse oximeters)	"The Health Buddy Appliance performed as intended."
	- Ability to retrieve data from connected medical devices	"The Health Buddy Appliance performed as intended."
	- Ability to store retrieved data	"The Health Buddy Appliance performed as intended."
	- Ability to transmit data to healthcare professionals via telephone or Ethernet connection at predetermined times	"The Health Buddy Appliance performed as intended."
	- Ability to display information to the patient and receive responses via buttons	"The Health Buddy Appliance performed as intended."
	- Ability to respond to patient answers with education, reinforcement, and messages	"The Health Buddy Appliance performed as intended."
Reliability	- Consistent operation over time	"Verification and validation testing activities were conducted to establish the... reliability characteristics of the Health Buddy Appliance."
Safety	- Electrical safety compliance	"Testing included electrical safety..."
	- EMC environmental testing compliance	"...EMC environmental testing..."
Integration	- Proper integration with infrared, Ethernet network connectivity, and new LCD technologies	"Integration testing..."
Signal Integrity	- Accurate and unaltered transmission of data from medical devices	"Signal integrity testing..."
System Functionality	- Overall system operation as a complete unit	"System testing..."
Physical Durability	- Ability to withstand shipping and distribution conditions	"Shipping/distribution..."
Risk Mitigation	- Identification and mitigation of hazards through design or labeling	"A hazard risk analysis was also performed and associated risks mitigated through design or labeling."

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

The document does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "Verification and validation testing activities."

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

The document does not mention using experts or establishing ground truth in the context of clinical performance for the test set. This device is an accessory for data transmission, not a diagnostic tool requiring expert interpretation of results. Its performance is evaluated based on its technical functionality (e.g., proper data relay), rather than clinical accuracy adjudicated by experts.

4. Adjudication Method for the Test Set:

Given that the device's function is data transmission and not diagnostic interpretation, an adjudication method for a test set (like 2+1 or 3+1) is not applicable and not mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study is not applicable and not mentioned. The Health Buddy Appliance is not an AI-powered diagnostic tool that assists human readers in interpreting medical images or data. Therefore, there is no "human readers improve with AI vs without AI assistance" effect size to report.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance study focused on the algorithm itself was implicitly done through the "Verification and validation testing activities." The software within the Health Buddy Appliance was tested to ensure it correctly handled data retrieval, storage, and transmission. However, the document doesn't quantify this performance with typical standalone metrics like sensitivity or specificity because the device's primary function is communication, not diagnostic interpretation. Its "standalone" performance is its ability to perform its communication tasks correctly.

7. Type of Ground Truth Used:

For the Health Buddy Appliance, the "ground truth" would be related to the correctness of data transmission and device functionality. This would involve:

Known input data: Inputting specific physiological data from medical devices and verifying that the exact same data is received by the healthcare professional's system.
Functional specifications: Verifying that all programmed features (e.g., displaying questions, receiving button presses, responding with messages, connecting via Ethernet/phone) work according to their design specifications.
Electrical and environmental standards: Compliance with relevant industry standards for electrical safety and electromagnetic compatibility.

This is not "expert consensus," "pathology," or "outcomes data" in the traditional clinical sense, but rather a verification against defined technical and functional requirements.

8. Sample Size for the Training Set:

The Health Buddy Appliance appears to be a rule-based or firmware-driven device for data transmission, not an AI/machine learning product that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable and not mentioned in the document.

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

As there is no mention of a training set for an AI/ML algorithm, the method for establishing its ground truth is not applicable and not mentioned.

Summary

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Section 1.3

510k Summary

K080091

REGULATORY AUTHORITY

FEB - 5 2008

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT

Robin Bush Health Hero Network 2400 Geng Road, Suite 200 Palo Alto, CA 94303 (650) 690-9191 (phone) (650) 798-3770 (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	==============================================================================================================================================================================
Medical Device Product Codes Supported by Health Buddy
862.1345	CGA	Glucose Test System	==============================================================================================================================================================================
870.1130	DXN	Noninvasive BloodPressure MeasurementSystem	==============================================================================================================================================================================
880.2700	FRI	Patient Weight Scale
868.1860	BZH	Meter, Peak Flow,Spirometry	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.2700	DQA	Oximeter	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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PREDICATE DEVICES

Health Buddy® Appliance (#K070543, #K063612, #K060843, #K050567, . #K042273, #K040086, #K993128)
CareMatix Wellness System (#K040966) .
· VMS-01, Medic4All Telemedicine System, (#K061502, #K062127, #K062662)

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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The Health Buddy® Appliance 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 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 physical design and the software in the Health Buddy® Appliance to support the integration of infrared, Ethernet network connectivity, and a new LCD, in addition to the improvements in manufacturability and serviceability. It is therefore substantially equivalent to the cleared Health Buddy Appliance (#K063612, #K060843, #K050567, #K040086 and #K993128). The device is also substantially equivalent to the CareMatix Wellness System (#K040966), and the Medicine System (VMS-01) (#K062662), which uses an internet wireless connection between the monitoring device and receiving station located inside the home.

PERFORMANCE TESTING

Verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of the Health Buddy Appliance. Testing included electrical safety, EMC environmental testing, integration testing, signal integrity testing, system testing, shipping/distribution, and functional testing. A hazard risk analysis was also performed and associated risks mitigated through design or labeling. The Health Buddy Appliance performed as intended.

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 logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

FEB - 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Health Hero Network, Inc. c/o Ms. Robin Bush Regulatory Affairs 2400 Geng Road, Suite 200 Palo Alto, CA 94303

Re: K080091

Health Buddy® Appliance Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiologic Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: January 11, 2008 Received: January 14, 2008

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.

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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 (OS) 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,

Bhimmon 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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Section 1.2

Indications for Use

510(k) Number:

K080091

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 of Cardiovascular Devices
1000 Number
Page 1 c

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).