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.

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 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.

AI/ML Overview

This device, the Health Buddy® with Buddylink, is a communication product that connects to a telephone line. It is used by patients to answer questions and furnish information to their healthcare professional(s) between office visits. It can retrieve data from an attached medical device (blood glucose meter, non-invasive blood pressure cuff, or patient weight scale) and stores it for later transmission to a healthcare provider.

Based on the provided information, the submission focuses on a modification to the software in the Health Buddy® with Buddylink, not a new stand-alone study to prove effectiveness against specific acceptance criteria. The device is cleared based on substantial equivalence to predicate devices. Therefore, the traditional acceptance criteria and detailed study results, as one might expect for a de novo device, are not explicitly provided in this document.

Here's an attempt to answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for a modification to software and relies on substantial equivalence, explicit "acceptance criteria" and "reported device performance" in the quantifiable sense of a clinical trial are not presented. The primary "acceptance criterion" met here is demonstrating substantial equivalence to legally marketed predicate devices.

Acceptance Criteria Category	Specific Criteria (Implicitly Met by Substantial Equivalence)	Reported Device Performance
Safety	Device is safe for its intended use.	Implied by substantial equivalence to cleared devices. No new safety concerns identified for software modification.
Effectiveness	Device effectively collects and transmits historical medical information to healthcare professionals and supports effective patient management.	Implied by substantial equivalence to cleared devices (K993128, K984527, K020184). The software modification is deemed to maintain or improve effectiveness in data collection and transmission.
Technical Performance	Communication functionality (connecting via telephone line, sending and retrieving data); data download from medical devices; user interface for patient interaction.	Functions as described for data collection and transmission, similar to predicate devices. Software modification did not degrade these functions.
Indications for Use	Aligns with the stated indications: "collect and transmit historical medical information to healthcare professionals to help support effective management of their patients in non-clinical settings."	The device, with the software modification, continues to meet these indications.

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

No specific test set or sample size for a performance study is described as this is a substantial equivalence submission for a software modification. The comparison is against predicate devices.

Sample Size for Test Set: Not applicable / Not provided.
Data Provenance: Not applicable / Not provided for an independent performance study. The comparison is based on the characteristics and cleared status of the predicate devices.

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

Not applicable. As no independent test set performance data is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable. No discrete test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done or described in this document. The submission is based on substantial equivalence to predicate devices, not improvement over human readers or AI assistance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study is not described. The device is a communication tool, and its function involves human input (data from medical devices, patient responses) and human interaction (healthcare providers receiving data). The evaluation focused on its equivalence as a communication tool.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic or interpretive performance. The "ground truth" for the device's function is its ability to reliably collect and transmit data, which is implicitly accepted through the substantial equivalence argument to already cleared devices.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device (hardware with software), not a machine learning algorithm requiring a training set for model development in the sense of AI performance evaluation. The software modification is likely related to connectivity or user interface enhancements rather than a learning algorithm.

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

Not applicable, as no training set for a machine learning model is mentioned.

Summary

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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 (650) 559.1088 (phone) (650) 559.1050 (facsimile) gclapp@hhn.com

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

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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.

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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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 (301) 594-4646. 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 (301) 443-6597 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:

Prescription Use × (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)

Duna R. Vochner

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(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K0400 & G

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).