ALCATEL-LUCENT TELEHEATH MANAGER

{0}------------------------------------------------ --- ・・、 # Alcatel·Lucent ## 510(k) Summary (in accordance with 21 CFR 807.92) 510(k) Number KO92635 #### I. Applicant Information ### Applicant: Alcatel-Lucent Canada Inc 1380 Rodick Road Markham, Ontario Canada L3R 4G5 Contact Person: Alex Giosa President Tel: (905) 943-5768 Fax: (905) 943-5768 e-mail: agiosa@alcatel-lucent.com Application Correspondent: SALVEO 101-2550 Sandra Schmirler Way Regina, SK S4P 3Y2 Canada Contact Person: Ms. Pat Tulloch, Chief Operating Officer Tel: (306) 337-0506 Fax: (306) 337-0512 e-mail: pat.tulloch@salveo.ca Date Prepared: July 3, 2009 #### II. Device Name and Classification Proprietary Name: Classification Name: Common/Usual Name: Regulation Number: Product Codes: Classification: Classification Panel: Alcatel-Lucent TeleHealth Manager Radiofrequency Physiological Signal Transmitter and Receiver Telemedicine System 870.2910 DRG Class II Cardiovascular Devices Alcatel-Lucent TeleHealth Manager {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for Alcatel-Lucent. The text "Alcatel-Lucent" is written in a bold, sans-serif font. To the right of the text is a stylized graphic of a circle with a curved line running through it. The logo is simple and modern. #### Predicate Devices III. The Alcatel-Lucent TeleHealth Manager device is substantially equivalent to the following two FDA cleared predicate devices: | 510(k) Number: | K040966 | |----------------------|-----------------------------------------------------------------------| | Trade Name: | Carematix Wellness System | | Manufacturer: | Carematix, Inc. | | Classification Name: | Radiofrequency Physiological Signal Transmitter<br>and Receiver | | Common/Usual Name: | Telemedicine System | | Regulation Number: | 870.2910 | | Product Codes: | DRG | | Classification: | Class II | | SE with respect to: | Indications for use, performance and technological<br>characteristics | | 510(k) Number: | K072698 | | Trade Name: | Confidant 2.5 | | Manufacturer: | Confidant International, LLC | | Classification Name: | Radiofrequency Physiological Signal Transmitter<br>and Receiver | | Common/Usual Name: | Telemedicine System | | Regulation Number: | 870.2910 | | Product Codes: | DRG | | Classification: | Class II | | SE with respect to: | Communication method with the hosting server | #### IV. Device Description Alcatel-Lucent TeleHealth Manager is a software system that collects patient physiological data such as blood pressure and blood sugar levels, via Bluetooth technology combined with cellular or plain old telephone system (POTS) home access point, for transmission to a secure central storage server which can be accessed by health care professionals for analysis and intervention. This data is also available to the patient for viewing purposes and as an aid in the self management of their specific health condition. As Alcatel-Lucent TeleHealth Manager main function is to relay a reading to the appropriate users without alteration or post processing of the measurement, it is the responsibility of the patient-user to verify that the reading has been correctly executed. Alcatel-Lucent TeleHealth Manager {2}------------------------------------------------ # Alcatel·Lucent With respect to patient data privacy, patient data is encrypted by the Alcatel-Lucent TeleHealth Manager system in such a way that it can be securely accessed only by the authorized users. #### V. Intended Use Alcatel-Lucent TeleHealth Manager is a Remote Patient Monitoring solution intended to provide monitoring services of patient vital signs and other physiological data by remote data transmission from a patient to the practitioner. The system can be used by patients during their daily lives and allows the collection, recording and transmission of physiological information such as blood glucose levels, using a glucometer, and non-invasive blood pressure measurements. The transmission of data to a secure server hosting platform is carried out over existing telecommunications infrastructure via common telephone lines and mobile networks. The data is collected in a secure server hosting platform. which stores the information and allows its remote access by the patient and/or health care professional. Alcatel-Lucent TeleHealth Manager is intended as an aid for the continuous monitoring of physiological processes and is not intended as a replacement of the medical oversight of a trained healthcare professional. #### VI. Summary of the Technical Characteristics The Alcatel-Lucent TeleHealth Manager system is comprised of a software component (downloaded and installed by the user in their mobile phone), a central server component (for secure data storage), a web communication protocol component (for making data available on line), and a SMTP getaway and Interactive Voice Response system components (used for user and/or health care provider notification). Collection, transmission, and storage of physiological and lifestyle data originating from patients is part of this automated telemonitoring system. The system incorporates the necessary communication protocols to enable the patient to use home medical monitoring devices such as a blood pressure monitor or a glucometer. Readings are taken in the same fashion as any patient currently using these devices would do. Data readings remain in the original medical monitoring devices as per manufacturer's specifications. Alcatel-Lucent TeleHealth Manager {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Alcatel-Lucent. The logo consists of the words "Alcatel-Lucent" in a bold, sans-serif font, with a dot between the two words. To the right of the words is a circular graphic with a stylized "A" inside. #### VII. Testing Alcatel-Lucent has conducted extensive validation testing of the Alcatel-Lucent TeleHealth Manager system, as a telemonitoring system that is capable of providing reliable remote patient monitoring functionalities. Testing was carried out to verify the product requirements and functional specifications, to verify that the physiologic data received by the patient measuring devices is stored properly and to verify that the data is transmitted to the healthcare practitioner in a manner that maintains the security and integrity of the information. All of the different components of Alcatel-Lucent TeleHealth Manager have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate safely and effectively. #### VIII. Safety & Effectiveness Conclusions Based on the comparison of intended use and technological characteristics, the Alcatel-Lucent TeleHealth Manager system is substantially equivalent to the Carematix Wellness System manufactured by Carematix, Inc. (K040966), with respect to indications for use, performance and technological characteristics, and to the Confidant 2.5 (K072698) manufactured by Confidant International, LLC, with respect to the communication method with the hosting server. The Alcatel-Lucent TeleHealth Manager device raises no new safety or effectiveness issues. {4}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Alcatel-Lucent Canada, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313 ### Re: K092635 Trade/Device Name: Alcatel-Lucent TeleHealth Manager Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (two) Product Code: DRG, DXG, DXN, NBW Dated: August 26, 2009 Received: August 27, 2009 ### Dear Mr. Job: 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 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. SFP 1 0 2009 {5}------------------------------------------------ Page 2 - Mr. Mark Job 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## 4. Indication for Use Statement 510(k) Number (if known): K092635 Device Name: Alcatel-Lucent TeleHealth Manager Indications for Use: Alcatel-Lucent TeleHealth Manager is a Remote Patient Monitoring solution intended to provide monitoring services of patient vital signs and other physiological data by remote data transmission from a patient to the practitioner. The system can be used by patients during their daily lives and allows the collection, recording and transmission of physiological information such as blood glucose levels, using a glucometer, and non-invasive blood pressure measurements. The transmission of data to a secure server hosting platform is carried out over existing telecommunications infrastructure via common telephone lines and mobile networks. The data is collected in a secure server hosting platform, which stores the information and allows its remote access by the patient and/or health care professional. Alcatel-Lucent TeleHealth Manager is intended as an aid for the continuous monitoring of physiological processes and is not intended as a replacement of the medical oversight of a trained healthcare professional. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) I (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|-----------| | (Division Sign-Off) Division of Cardiovascular Devices | Page 1 of | | 510(k) Number | |