AVIVO MOBILE PATIENT MANAGEMENT

{0}------------------------------------------------ #### JAN - 4 2012 ## ECTION 7 - 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | Submitter Name & Address: | Corventis, Inc.<br>1410 Energy Park Drive, Suite 1<br>St. Paul, MN 55108 | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Michele Chin-Purcell, Ph.D.<br>651-925-3803 (phone)<br>651-389-3251 (fax) | | Trade/Proprietary Name: | AVIVO® Mobile Patient Management System | | Common/Usual Name: | Mobile Patient Management System | | Classification Name: | Arrhythmia Detector and Alarm<br>(21 CFR 870.1025, Product Code DSI)<br>Patient Physiological Monitor (with arrhythmia<br>detection)<br>(21 CFR 870.1025, Product Code MHX) | | Class: | Class II, Special Controls | | 510(k): | Abbreviated 510(k) | | Date Prepared: | October 28, 2011 | #### Predicate Devices: - 1. AVIVO Mobile Patient Management System, Corventis, Inc. cleared by FDA under 510(k) numbers K083287, K090696, and K091971; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFR 870.1025, MHX "Patient Physiological Monitor (with arrhythmia detection)" - 2. NUVANT® Mobile Cardiac Telemetry System, Corventis, Inc. cleared by FDA under 510(k) number K090696, K091971, and K111917; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFR 870.1025, MHX "Patient Physiological Monitor (with arrhythmia detection)" - 3. ZOE Fluid Status Monitor, Noninvasive Medical Technologies, LLC, cleared by FDA under K042113; 21 CFR 870.2770, DSB "Impedance Plethysmograph" {1}------------------------------------------------ # BACKGROUND INFORMATION The following is the subject device of this Abbreviated 510(k): - . The AVIVO Mobile Patient Management System (hereafter referred to as "subject AVIVO") This submission proposes to add clarifying language (e.g., listing the type of non-lethal arrhythmias) to the predicate AVIVO indications for use. This clarifying language is similar to that used in the predicate NUVANT device. Additional language is being proposed (e.g.: when fluid status measurements may be useful) to align with the predicate ZOE indications for use. These changes are for clarification and do not change to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and do not affect the safety and effectiveness of the device when used as labeled [807.92(a)(5)]. The intent of the subject devices remains the same as that of the predicate devices, which is to monitor ECG, heart rate and other physiological parameters such as body fluid status. # INDICATION FOR USE STATEMENT The following are the proposed indications for use in this submission: The AVIVO Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for patients: - with fluid management problems . - . taking diuretic medication - living with heart failure . - . living with end-stage renal disease - . suffering from recurrent dehydration - who require monitoring for the detection of non-lethal cardiac arrhythmias such . as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial {2}------------------------------------------------ flutter, paroxysmal SVTs), ventricular ectopy, bradvarrhythmias and conduction disorders. The AVIVO Mobile Patient Management System also monitors, derives and displays: - . ECG - Heart Rate (including HR variability) . - Activity . - . Posture - . Respiration rate (including RR variability) - Body fluid status . # TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE The AVIVO System is wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias and monitor physiologic signals. In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only), AVIVO enables arrhythmia detection and other physiological data monitoring for up to 7 days for each PiiX application. The AVIVO system components are: - . PiiX® (aka: Adherent Device) - a patient-worn device which is applied to the patient's torso. It contains the ECG electrodes for recording ECG, heart rate and other physiological data. - . zLink® (aka: Gateway) – hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology. - Server The Server receives sensor data from the PiiX via zLink. ECG, heart . rate and other physiological parameters are presented to learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians The communication between the PiiX and the zLink is enabled via BlueTooth Technology. Sensor data and ECGs collected by the PiiX are transmitted to the Server via zLink. The AVIVO and NUVANT system components are identical expect for the use of a Patient Trigger Magnet, which is available for the patient to manually trigger the ECG {3}------------------------------------------------ collection when he/she experiences symptoms when using the NUVANT system. The system components of the subject AVIVO are identical to the system components of the predicate AVIVO and predicate NUVANT. ## PREDICATE DEVICES Three (3) predicate devices have been identified: - 1. AVIVO Mobile Patient Management System, Corventis, Inc. cleared by FDA under 510(k) numbers K083287, K090696, and K091971; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFR 870.1025, MHX "Patient Physiological Monitor (with arrhythmia detection)" - 2. NUVANT® Mobile Cardiac Telemetry System, Corventis, Inc. cleared by FDA under 510(k) number K090696, K091971, and K111917; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFR 870.1025, MHX "Patient Physiological Monitor (with arrhythmia detection)" - 3. ZOE Fluid Status Monitor, Noninvasive Medical Technologies, LLC, cleared by FDA under K042113; 21 CFR 870.2770, DSB "Impedance Plethysmograph" The following table summarizes the compared features and the corresponding predicate devices. | Features being compared | Predicate Devices | |-------------------------|----------------------------------------------| | All technical features | Predicate AVIVO (K083287, K090696, K091971) | | All technical features | Predicate NUVANT (K090696, K091971, K111917) | | Body Fluid Status | Predicate Zoe (K042113) | | Indications for Use | Predicate NUVANT (K111917) | | Indications for Use | Predicate ZOE (K042113) | ## Features comparison and corresponding predicate devices ## SUMMARY OF PERFORMACE TESTING The subject and predicate AVIVO and predicate NUVANT meet the requirements of following performance standards in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm. {4}------------------------------------------------ #### IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995 ## IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)) ## AAMI/ANSI EC38 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems, 2007. ## AAMI/ANSI EC57 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms, 1998/(R) 2008 # CONCLUSION The modifications proposed in the subject AVIVO System make clarifications to the indications for use and do not change the fundamental scientific technology or use of the devices. As supported by the descriptive information and the bench tests, it is concluded that the AVIVO Systems are as safe and as effective as the predicate devices. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JAN - 4 2012 Corventis, Inc. c/o Kathleen Lundberg VP of Ouality, Regulatory, and Clinical Affairs 1410 Energy Park Drive, Suite #1 St. Paul, MN 55108 Re: K113187 Trade/Device Name: AVIVO Mobile Patient Management System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: MHX, DSB, DSI Dated: October 28, 2011 Received: October 31, 2011 Dear Ms. Lundberg: 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. {6}------------------------------------------------ Page 2 -- Ms. Kathleen Lundberg 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 (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 Zuckerman, MD Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation -Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ #### Indications for Use 510(k) Number (if known): NA K || 3 | 8 7 Device Name: AVIVO® Mobile Patient Management Indications for Use: The AVIVO Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for patients: - with fluid management problems . - taking diuretic medication . - living with heart failure . - living with end-stage renal disease . - suffering from recurrent dehydration . - who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but . not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The AVIVO Mobile Patient Management System also monitors, derives and displays: - ECG . - Heart Rate (including HR variability) . - . Activity - . Posture - Respiration rate (including RR variability) � - Body fluid status � 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) Page 1 of 1 Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |------------------------------------|---------| | Division of Cardiovascular Devices | | | 510(k) Number | K113187 |