CORCAM HEART MONITOR

{0}------------------------------------------------ # Section 5: 510(k) Summary The following information is provided as required by 21 CFR § 807.87 for Corcam's 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based. The safety and effectiveness of the Corcam Heart Monitor is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device(s). | Sponsor: | Corcam Technologica S/A<br>Rua Sampaio Viana, n. 202, conjs. 104 / 105, Paraíso,<br>São Paulo, Brazil | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Jennifer A. Daudelin<br>M Squared Associates<br>575 Eighth Avenue, Suite 1212<br>New York, NY 10018<br>Ph: 703-562-9800 x251<br>Fax: 703-562-9797<br>Email: jdaudelin@msquaredassociates.com | | Date Prepared: | March 3, 2014 | | Proposed Class: | II | | Proprietary Name: | Corcam Heart Monitor | | Common Name: | Arrhythmia Detector and Alarm | | Classification Name: | Arrhythmia Detector and Alarm | | Regulation Number: | 21 CFR 870.1025 | | Product Codes: | DSI | Class Manufacturer Device Name Common Name Procode II CardioNet ECG DSI Arrhythmia Detector and CardioNet, Inc. Alarm Monitor with Arrhythmia Detection Patient Physiological II MHX, Preventice, Inc. Body Guardian Monitor, Arrhythmia DSI Detector and Alarm II DSI, Arrhythmia Detector and Applied Cardiac CORE™ ECG Monitor Systems DSH, Alarm DPS {1}------------------------------------------------ ## Indication for Use 、i The Corcam Heart Monitor is a portable device intended to continuously monitor a patient's cardiac condition for early signs of arrhythmia. - 1. Adult patients who have demonstrated a need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease. - 2. Adult patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: dizziness or lightheadedness; syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and dyspnea (shortness of breath). - 3. Adult patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms. - 4. Adult patients who require outpatient monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation). ## Device Description The Corcam Heart Monitor is a battery operated, non-invasive, portable device intended to continuously monitor a patient's cardiac condition for early signs of arrhythmia. The device allows for autonomous remote monitoring via a Global System for Mobile Communications/General Packet Radio Service (GSM/ GPRS). The device is connected to the patient via four commercially available electrodes (Derivations I. II. III. and ground) and is equipped with an accelerometer to detect patient falls, GPS for geographical and accurate location of the user, and a speaker system to allow communication to or with the Monitoring Center. A vibrating mechanism and lights, when activated, provide physical and visual signals to the user. Indicator lights also show the operating status of the unit. An SOS/ Help button can be pressed by the user to send a help signal to the monitoring center. In addition to the transmission of patient data to the monitoring center, the monitoring center or clinician at any given moment can conditionally request a new exam on demand allowing for actual and accurate tracking of a cardiac event. Once the monitor detects an irregular heartbeat, the device generates an electrocardiogram (ECG) and sends it to the monitoring center. A clinician in the monitoring center carries out an analysis on the received ECG. Depending upon the analysis of the clinician can check the symptoms of the patient, request another ECG transmission, or initiate immediate assistance for the form of an ambulance/ emergency services. {2}------------------------------------------------ ## Performance Data (Non-Clinical) The Corcam Heart Monitor meets the requirements of the following standards: - NBR IEC 60601-1:1994, Electromedical Equipment Part 1 General Safety Prescriptions ● - NBR IEC 60601-1, Amendment 1: 1997 . - ABNT NBR IEC 60601-1-2:2006, Electromedical Equipment Part 1-2: Collateral . Standard: Electromagnetic Compatibility - Requirements and tests. - ABNT NBR IEC 60601-2-27:1997, Medical Electrical Equipment Part 2: Particular . Requirements For the Safety of Electrocardiographic Monitoring Equipment - · NBR IEC 60601-2-27:1997, Part 2: Specific Prescriptions for the Equipment Safety for the Electrocardiogram Software - IEC 62209-01: 2005, Human exposure to radio frequency fields from hand-held and body-mounted . wireless communication devices- Human models, instrumentation, and procedures - Part 1: Procedure to determine the specific absorption rate (SAR) for hand-held devices used in close proximity to the ear (frequency range of 300 MHz to 3 GHz - IEC 62209 02: 2010, Procedure to determine the Specific Absorption Rate (SAR) in the head and . body for 30 MHz to 6 GHz Handheld and Body-Mounted Devices used in close proximity to the Bodv - IEEE Std 1528, IEEE Recommended Practice for Determining the Peak Spatial- Average Specific . Absorption Rate (SAR) in the Human Head from Wireless Communications Devices: Measurement Techniques - ETSI TS 151 010-1 V6.5.0 (2005-11) (3GPP TS 51.010-1 version 6.5.0 Release 6), Digital . cellular telecommunications system (Phase 2+); Mobile Station (MS) conformance specification; Part 1: Conformance specification - AAMI / ANSI EC38: 2007, Medical Electrical Equipment Part 2-47: Particular Requirements for . the safety, including essential performance, of ambulatory electrocardiographic systems. (Cardiovascular) - AAMI/ANSI EC 57 1998/(R ) 2003 Testing and Reporting Performance Results of Cardiac . Rhythm and ST Segment Measurement Algorithms ## Performance Data (Clinical) A cross-sectional observational study was designed to assess the accuracy of this monitor as compared to that of conventional ECG (gold standard) as a screening tool for the detection of arrhythmias and myocardial ischemia. From May to August 2012, 152 consecutive patients were included in the study. Patients were inpatients or outpatients with established clinical diagnoses (as reported in medical records) and ECGs meeting the eligibility criteria of the study. Inclusion criteria were patients over 18 years of age with cardiac arrhythmias or myocardial ischemia and an established diagnosis of attial fibrillation, acute coronary syndromes, or ventricular arrhythmias or bradyarrhythmias. All patients underwent conventional electrocardiography and had an electrocardiogram (ECG) generated by the Corcam device. For the Corcam Heart Monitor ECGs, the device was installed onto the patient and automatically generated and sent an ECG to the Central Monitoring Station without human intervention, either from the patient or the investigator. Both tests were performed within a 10-minute window. There were no adverse {3}------------------------------------------------ events. Results showed that in 92% of the cases evaluated, the Central Monitoring Station received the ECGs automatically generated by the Corcam device within 3 minutes. ECGs that took between 4 and 5 minutes to send were generated at peak times, when there is greater data traffic over the cellular network. The study concluded that the Corcam Heart Monitor has the ability to detect relevant ECG changes and generate an electrocardiogram and transmit it automatically (without human intervention) within minutes to a Central Monitoring Station. # Technological Characteristics and Substantial Equivalence The Corcam Heart Monitor has the same indications for use and similar design features as compared with the predicate arrhythmia detectors. Additionally, both the Corcam device and the predicate CORE™ ECG Monitor use an accelerometer to detect accelerated motion. The bench testing along with the clinical data demonstrate that the performance characteristics of the Corcam Heart Monitor is equivalent to those of other legally marketed arrhythmia detectors, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. {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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing the world. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002 May 23, 2014 Corcam Technologia, SA % Ms. Jennifer Daudelin Consultant for Corcam M Squared Associates, Inc. 575 Eighth Ave, Ste 1212 New York, New York 10018 K140548 Re: Trade/Device Name: Corcam Heart Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm Regulatory Class: Class II Product Code: DSI Dated: March 25, 2014 Received: March 26, 2014 Dear Ms. Jennifer Daudelin: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave feviewed your bection by 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 commerce pror to May 20, 1977 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 I ou may, access, mains of the Act include requirements for annual registration, listing of general controls provisions gractice, 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), II your device is classified (500 actrols. 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. 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 {5}------------------------------------------------ ### Page 2 - Ms. Jennifer Daudelin 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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours. Image /page/5/Picture/8 description: The image shows a logo with the letters FDA. The letters are stylized and have a bold, geometric design. The logo appears to be a black and white image. The logo is likely associated with the Food and Drug Administration. for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use Statement K140548 510(k) Number: Corcam Heart Monitor Device Name: ### Indications for Use: The Corcam Heart Monitor is a portable device intended to continuously monitor a patient's cardiac condition for early signs of arrhythmia. - 1. Adult patients who have demonstrated a need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease. - 2. Adult patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: dizziness or lightheadedness; syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and dyspnea (shortness of breath). - 3. Adult patients with palpitations without known arrhythmias to obtain correlation of rhythm with symptoms. - 4. Adult patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation). AND/OR Prescription Use ___X_ (Part 21 CFR 801 Subpart D) 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) Page 1 of __ 1 __ FDA 2014.05.23 0651-04'00'