← Product Code [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA) · K060843 # MODIFICATION TO HEALTH BUDDY APPLIANCE (K060843) _Health Hero Network, Inc. · DQA · Apr 20, 2006 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K060843 ## Device Facts - **Applicant:** Health Hero Network, Inc. - **Product Code:** [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA.md) - **Decision Date:** Apr 20, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.2700 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## 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. 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 communications hub connecting to standard telephone lines; used by patients to transmit physiological data to healthcare providers via Health Hero Online service. Device interfaces with external medical equipment including blood glucose meters, non-invasive blood pressure cuffs, weight scales, peak flow meters, and pulse oximeters. It retrieves readings from these devices via data port and transmits stored data to a central Data Center at scheduled intervals. Device features a screen and four buttons for patient interaction; displays provider-sent questions regarding vital signs, symptoms, and behaviors; provides educational reinforcement messages. Healthcare providers access transmitted data for retrospective display and evaluation to support clinical decision-making. Device does not provide automated treatment decisions; intended as a communication tool for remote patient monitoring. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Communications appliance connecting to standard telephone lines; includes data port for external medical device integration. Software-based data retrieval and transmission system. Operates as a peripheral accessory to physiological signal transmitters/receivers (glucose, BP, weight, peak flow, oximetry). ## Regulatory Identification An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter. ## Predicate Devices - Health Buddy® with Device Connectivity ([K050567](/device/K050567.md), [K042273](/device/K042273.md), [K040086](/device/K040086.md)) - Health Buddy® with Buddylink ([K993128](/device/K993128.md)) - CareMatix Wellness System ([K040966](/device/K040966.md)) - Viterion 100 TeleHealth Monitor ([K030419](/device/K030419.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K060843 Page. Special 510(k): Device Modifications Health Buddy® Appliance # Section 1.3 Summary of Safety and Effectiveness AFI 20 2006 # 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 (650) 779.9100 (phone) (650) 779.2100 (facsimile) #### NAME OF DEVICE | Trade Name: | Health Buddy® Appliance | | | |-----------------------|----------------------------------------------|--|--| | Common Name: | Data Management System; Accessory to Medical | | | | | Device | | | | Classification Names: | Refer to Table | | | | Regulation
Number | Product
Code | Classification Name | Device
Class | |--------------------------------------------------------|-----------------|-------------------------------------------------------|-----------------| | 870.2910 | DRG | Physiological Signal
Transmitters and
Receivers | II | | Medical Device Product Codes Supported by Health Buddy | | | | | 862.1345 | CGA | Glucose Test System | II | | 870.1130 | DXN | Noninvasive Blood
Pressure Measurement
System | II | | 880.2700 | FRI | Patient Weight Scale | I | | 868.1860 | BZH | Meter, Peak Flow,
Spirometry | II | | 870.2700 | DQA | Oximeter | II | {1}------------------------------------------------ Health Hero Network Kchrt43 Page Special 510(k): Device Modifications Health Buddy® Appliance # PREDICATE DEVICES - Health Buddy® with Device Connectivity (#K050567, #K042273, #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 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, downloads readings from the identified attached device and, at predetermined times, transmits the responses over the phone lines 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. {2}------------------------------------------------ K c60543 Pas Special 510(k): Device Modifications Health Buddy® Appliance 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 (#K050567, #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. {3}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 0 2006 Health Hero Network c/o Ms. Robin Bush Project Manager, Regulatory Affairs 2000 Seaport Blvd. Suite 400 Redwood City, CA 94063 Re: K060843 Trade Name: Health Buddy® Appliance Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: DQA Dated: March 24, 2006 Received: March 28, 2005 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. Iisting 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 vour 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. {4}------------------------------------------------ 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 (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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/indcx.html. Sincerely yours. Bhimuma for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K 060843 Health Hero Network Special 510(k): Device Modifications Health Buddy® Appliance #### Section 1.2 #### Indications for Use 510(k) Number: 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) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) B.A. mmmma VC-33 510iki N Page 1 of 1 Confidential --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K060843](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K060843) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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