VIGNET TELEHEALTH MANAGER

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "vignet" in lowercase letters, followed by a circle with a checkmark inside. There is a dot above the checkmark. The text and symbol are in black and white. k113446/S002 # 510(k) Summary (in accordance with 21 CFR 807.92) JUL 16 2012 #### 1. Applicant Information Vignet Corporation 1616 Anderson Road McLean, VA 22102 Contact Person: Carlos Gonzalez Tel: 925-209-6605 Fax: 425-940-2417 Email: cgonz1950@gmail.com . Date Prepared: November 9, 2011 ### 2. Device Name and Classification | Trade Name: | Vignet TeleHealth Manager | |----------------------|-----------------------------------------------------------------| | Manufacturer: | Vignet Inc. | | Classification Name: | Radiofrequency Physiological Signal<br>Transmitter and Receiver | | Common/Usual Name: | Telemedicine System | | Regulation Number: | 870.2910 | | Product Codes: | DRG, | | Classification: | Class II | ## 3. Predicate Devices 3.1 The Vignet TeleHealth Manager device is substantially equivalent to the following FDA cleared predicate device: | 510(k) Number: | K092635 | |---------------------------|-----------------------------------------------------------------------| | Proprietary Name: | Alcatel-Lucent TeleHealth Manager | | Classification Name: | Radiofrequency Physiological Signal Transmitter and<br>Receiver | | Common/Usual Name: | Telemedicine System | | Regulation Number: | 870.2910 | | Product Codes: | DRG | | Subsequent Product Codes: | DXN, NBW | | Classification: | Class II | | SE with respect to: | Indications for use, performance and technological<br>characteristics | {1}------------------------------------------------ 3.2 The Vignet TeleHealth Manager is used with in combination with a variety of cleared external bio-metric measuring devices including those identified in the table that follows. Corresponding Predicate devices are identified in the table that follows: | Vital Signs<br>Equipment | Physiological<br>information | Vital Signs Equipment<br>Manufacturers/Models (510k) | Predicate TeleHealth<br>Devices (510k) | |--------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | Blood<br>pressure | Systolic (mmHg),<br>Diastolic<br>(mmHg), Pulse<br>(BPM) | A&D Engineering, Inc. / Model UA-<br>767PBT (K043217)<br>A&D Engineering, Inc. / Model UA-<br>851-PBT<br>Fora Care, Inc. - Taidoc Technology<br>Corporation / Model TD-3250C<br>(K110044) | Alcatel-Lucent<br>TeleHealth Manager<br>(K092635)<br>Avid Care (K011779)<br>Carematix (K040966) | | Weight | Weight (lbs. or<br>Kgs.) | A&D Engineering, Inc. / Model UC-<br>321PBT<br>Omron Weight Scale / Model HBF-<br>206IT | Class 1 device does not<br>require predicate | | Blood<br>glucose | Glucose (mg/dl<br>or mmol/L) | Entra Health Systems, Ltd. / Model<br>MGH-BT1 (K081703)<br>Fora Care, Inc. – Taidoc Technology<br>Corporation / Model TD-3250C<br>(K110044) | Alcatel-Lucent<br>TeleHealth Manager<br>(K092635)<br>Avid Care (K011779)<br>Carematix (K040966) | | Oxygen<br>Saturation | SpO2 (%), Pulse<br>Rate (BPM) | Nonin Medical, Inc. / Model 9560<br>(K081285) | Avid Care (K011779) | | Pedometer | Steps<br>(count),<br>Distance<br>(miles), Time<br>(hours) | Omron Healthcare, Inc. / Model HJ-<br>721IT | Class 1 device does not<br>require predicate | | Temperatu<br>re | Temperature<br>(Fahrenheit or<br>Celsius) | Fora Care, Inc. - Taidoc Technology<br>Corporation / Model IR20b (K090395) | Carematix (K040966) | | Peak flow | Peak flow<br>(FEV1 and PEF) | Vitalograph Ltd. / Model 4000 series<br>ASMA-1 (K073155) | Avid Care (K011779)<br>Carematix (K040966) | #### 4. Device Description: The Vignet TeleHealth Manager is a software system that collects patient physiological data such as blood pressure and blood sugar levels for transmission to a secure central storage server which can be accessed by health care professionals for analysis and intervention using standard digital communication technologies and protocols. This data is also available to the patient for viewing purposes and as an aid in maintaining wellness regimens. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "vignet" in a sans-serif font, followed by a circular logo. The logo contains a checkmark inside the circle, and a small diamond shape is located above the checkmark. The text and logo are both in black and white. #### 5. Intended use: The Vignet TeleHealth Manager is an accessory software application that is intended to be used by patients in non-clincal settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Vignet TeleHealth Manager does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. #### 6. Performance (non-clinical) data The Vignet TeleHealth Manager is a software application, therefore no electrical safety or electromagnetic testing was required. After extensive bench testing to performance requirements and criteria established in accordance with application of EN14971 risk analysis, no new issues of safety, performance, technology or intended use were identified. Therefore the Vignet TeleHealth Manager is concluded to be substantially equivalent to the identified predicates. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JUL 16 2012 Vignet, Inc. c/o Mr. Carlos Gonzalez 7833 Knollbrook Dr. Pleasanton, CA 94588 Re: K113446 Trade Name: Vignet Telehealth Manager Regulation Number: 21.CFR.892.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Codes: DRG, DXG, DXN, NBW Dated: June 26, 2012 Received: June 28, 2012 Dear Mr. Gonzalez: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. {4}------------------------------------------------ #### Page 2 -Mr. Gonzalez 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 (reporting of medical device-related adverse events) (21 CFR 803); 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. 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/CDRH0ffices/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/ReportalProblem/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 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: _Vignet Telehealth Manager Indications for Use: The Vignet TeleHealth Manager is an accessory software application that is intended to be used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Vignet Telehealth Manager is intended to be used in combination with a variety of external vital sign devices. The Vignet TeleHealth Manager does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K 113446 Page*1*of*1*