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 and peak flow meters). 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. In this submission, software changes are made to support hardware replacement to components no longer available in the Health Buddy. In addition, the operating system has changed. The Health Buddy device has data ports that allow it to download readings from identified attached devices, activated only upon appropriate patient enrollment.

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 from the previous day and to retrieve the current day's dialoque.

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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a modification to the Health Buddy® Appliance. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving safety and efficacy through new, independent studies with acceptance criteria in the traditional sense.

Therefore, many of the requested categories (acceptance criteria, specific study design, sample sizes for test and training sets, ground truth establishment for novel algorithms, MRMC studies, and standalone performance) are not applicable to this type of submission.

Here's an breakdown based on the provided text, explaining why certain information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This 510(k) is for modifications to an already cleared device (Health Buddy® Appliance) and focuses on demonstrating substantial equivalence to its predicates. It does not present new acceptance criteria or new performance metrics with specific thresholds that a study would aim to meet, as would be the case for a novel device or a device with new clinical indications. The "performance" here is primarily about maintaining the functionality and safety of the original device despite hardware and OS changes.

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

Not Applicable. No explicit "test set" in the context of an algorithm's performance on a specific dataset is mentioned. The changes are to hardware components and the operating system of an existing communication device. The "testing" would have focused on ensuring the modified device continues to perform its intended functions (collecting and transmitting data from attached medical devices) as reliably as the original, in line with its cleared indications. This would likely involve engineering verification and validation, not a clinical study on a patient data set.

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

Not Applicable. As there's no explicit "test set" involving diagnostic or interpretative tasks, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not Applicable. No test set requiring expert adjudication is described.

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

Not Applicable. An MRMC study is typically conducted for diagnostic devices where human readers interpret medical images or data. The Health Buddy® Appliance is a data collection and transmission device, not an interpretive diagnostic tool. There is no AI component that would "assist" human readers in the way an MRMC study evaluates.

6. Standalone (Algorithm Only) Performance Study

Not Applicable. The Health Buddy® Appliance acts as a communication tool and an accessory to other medical devices (blood glucose meters, blood pressure cuffs, etc.). It does not contain a standalone "algorithm" for making medical decisions or interpretations, nor does it perform any diagnostic functions independently. Its software updates are related to hardware compatibility and the operating system, not to a novel clinical algorithm.

7. Type of Ground Truth Used

Not Applicable. Given the nature of the device (a data communication system), the concept of "ground truth" as it applies to diagnostic accuracy (e.g., pathology, clinical outcome) is not relevant. The device's function is to accurately transmit data, not to interpret it.

8. Sample Size for the Training Set

Not Applicable. This device does not use machine learning algorithms that require a "training set" of data for learning or model development. The software changes are related to hardware drivers and the operating system.

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

Not Applicable. As no training set is described (see point 8), there is no ground truth establishment for a training set.

Summary of the 510(k) Submission:

The provided document describes a Special 510(k) submission for modifications to the "Health Buddy® Appliance." The key points are:

Device Type: A communication product that connects to a telephone line, used by patients to answer questions and transmit data from specific medical devices (blood glucose meters, blood pressure cuffs, scales, peak flow meters) to healthcare professionals.
Modifications: Software changes to support hardware replacement due to components no longer being available, and an update to the operating system.
Indication 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." It explicitly states it is not intended for automated treatment decisions or as a substitute for professional healthcare judgment.
Predicate Devices: The submission claims substantial equivalence to previously cleared versions of the Health Buddy® (K042273, K040086, K993128) and other similar telehealth monitors/systems (CareMatix Wellness System K040966, Viterion 100 TeleHealth Monitor K030419).
Conclusion: The changes maintain the technological features and indications for use, thus demonstrating substantial equivalence to cleared devices, assuring safety and effectiveness.

This 510(k) is a regulatory filing for a device modification, not a report on a clinical study establishing new performance metrics for a novel algorithm or diagnostic capability. The "study" here is essentially the demonstration that the modified device maintains its previously cleared functionality without raising new questions of safety or effectiveness.

Summary

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1/3 Special 510(k): Device Modifications Health Buddy® Appliance

K050567

Section 1.3

Summary of Safety and Effectiveness

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT

Robin Bush Health Hero Network 2570 W. El Camino Real, Suite 111 Mountain View, CA 94040 (650) 559.1000 (phone) (650) 559.1050 (facsimile)

NAME OF DEVICE

Trade Name:	Health Buddy® Appliance
Common Name:	Data Management System; Accessory to MedicalDevice
Classification Names:	Refer to Table

RegulationNumber	ProductCode	Classification Name	DeviceClass
870.2910	DRG	Physiological SignalTransmitters andReceivers	==============================================================================================================================================================================
862.1345	CGA	Glucose Test System	=
870.1130	DXN	Noninvasive BloodPressureMeasurementSystem	==============================================================================================================================================================================
880.2700	FRI	Patient Weight Scale
868.1860	BZH	Meter, Peak Flow,Spirometry	==============================================================================================================================================================================

Confidential

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Special 510(k): Device Modifications Health Buddy® Appliance

C50567 p2/3

PREDICATE DEVICES

Health Buddy® with Device Connectivity (#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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050567 P 3/3

SUBSTANTIAL EQUIVALENCE COMPARISON

This submission represents a modification to the mechanicals and software in the Health Buddy® Appliance, and is therefore substantially equivalent to the cleared Health Buddy appliance (#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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DEPARTMENT OF HEALTH & HUMAN SERVICES-USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 5 2005

Health Hero Network, Inc. c/o Mr Robin Bush Project Manager, Regulatory Affairs 2570 W. El Camino Real, Ste. 111 Mountain View, CA 94040

Re: K050567

Trade Name: Health Buddy® Appliance Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: II (two) Product Code: DRG Dated: February 28, 2005 Received: March 04, 2005

Dear Mr. Bush:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your section of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the enactment date of the Medical Device Amendments, or to conninered pro- to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicrerore, manel as act include requirements for annual registration, listing of general controls profitering 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 n your device is classified (soc aborto) als. Existing major regulations affecting your device can thay be subject to suen additional of Marts 800 to 898. In addition, FDA may be found in the Councements concerning your device in the Federal Register.

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Page 2 – Mr Robin Bush

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 lisualites complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of any it call the Act's requirements, including, but not limited to: registration and listing (21 comply with an the rice 3 requirements, the submanufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forul in the quality byscents (Sections 531-542 of the Act); 21 CFR 1000-1050. product laciation control provisions (Sections of the as described in your Section 510(k) This letter will anow you to obgen mailteing of substantial equivalence of your device to a legally premarket notheadon. The PDA mailing of basification 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 If you desire specific at not arratiance at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Comphalise in (21 CFR Part 807.97). You may obtain Missuranting of Icrerence to premaintentibilities under the Act from the Division of Small other general information on your respended its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely yours,

Bhimmer 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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K050567

Health Hero Network

510(k) #K050567 Health Buddy® Appliance

Indications for Use

510(k) Number (if known): #K050567

Device Name: ____________ Health Buddy® Appliance

Indications For Use:

Prescription Use XXX (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)

Blummen

(Division Sign-Off) Division of Cardiovascular Devices 05056 510(k) Number_

Page 1 of 1

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).