AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)

{0}------------------------------------------------ Inovise Medical, Inc. 510(k) Notification: Modification to AUDICOR System – 2nd Response to Reviewer Questions 15 of 54 OCT 2 4 2011 ## Summary of Safety and Effectiveness | As required by 21 CFR, part 807.92 | | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By: | Inovise Medical, Inc.<br>8770 SW Nimbus Ave, Suite D<br>Beaverton, OR 97008-7196<br>Phone 503-313-0149<br>Fax 503-431-3801 | | Contact: | Earl Anderson<br>Director, Quality and Regulatory | | Date Prepared: | September 30, 2011 | | Proprietary Name: | AUDICOR CPAM (Cardiopulmonary Ambulatory Monitor) | | Common/ Usual Name: | Ambulatory Monitor / Acoustic Cardiograph | | Classification: | 870.2800, MLO, class II, Electrocardiograph, Ambulatory (with analysis program) | | Performance Standards: | ANSI/AAMI EC38 and ANSI/AAMI EC57 | | Intended Use: | The Audicor® System, when used with AUDICOR Sensors on the chest<br>wall and properly attached Holter unit, is intended for use on adults 18<br>years of age and older in acquiring, analyzing and reporting ECG and heart<br>sound data and to provide interpretation of the data in an integrated report<br>for consideration by physicians. The Audicor recording may be obtained at<br>any location specified by a physician including home, hospital or clinic.<br>The measurements provided and interpretations of ECG and heart sound<br>data offered by the device are only significant when used in conjunction<br>with physician over-read as well as consideration of other relevant patient<br>data.<br>The device is intended for use only under the direct supervision of a<br>physician. | | Device Description: | The Audicor System is an ambulatory device that can be used to capture<br>up to 48 hours of continuous data or 10-second snapshots of ECG and<br>heart sounds data. The Audicor System includes software to display,<br>analyze and provide a summary of patient data over time in a trended<br>format. Notable events are detected and displayed for review by the<br>clinician. The analysis package includes heart rate variability and performs<br>ECG beat classification, editing and reporting of arrhythmias.<br>The Audicor System analyzes and reports the following parameters: | 71/3 110569 {1}------------------------------------------------ | | Heart rate distributions of heart sound parameters Heart rate and associated events Atrial fibrillation ECG beat classification and morphology grouping Ventricular and atrial ectopic beat arrhythmias Heart rate variability | | | |------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Test Summary<br>& Conclusion: | The Audicor System has been tested to the applicable requirements of the<br>following standards, and shown to comply. EN 60601-1 Standard for Medical Electrical Equipment: General<br>Requirements for Safety EN 60601-1-2 Standard for Medical Electrical Equipment Part 1-2:<br>General Requirements for Safety - Collateral Standard: Electromagnetic<br>Compatibility - Requirements and Tests ANSI/AAMI EC38:Ambulatory Electrocardiographs ANSI/AAMI EC57: Test and Reporting Performance Results of Cardiac<br>Rhythm and ST-segment Measurement Algorithms Compliance to intermal Inovise Medical software and algorithm<br>performance assessment protocols | | | | Substantial<br>Equivalence: | Product Functionality<br>ECG and Heart<br>Sound Recording and<br>Analysis | The functionality for reporting of ECG and heart sound analysis including<br>heart rate variability and Holter ECG features (beat classification, editing<br>and reporting of arrhythmias) are substantially equivalent to:<br> | Predicate<br>Audicor Hemo Ambulatory Monitor (510(k)<br>K073545);<br>Spacelabs Pathfinder SL (510(k) K110001) | | Technological<br>Characteristics<br>: | The Audicor System and the predicate devices (Spacelabs Pathfinder SL<br>and Audicor [Hemo] AM) are technologically equivalent in that the<br>devices: Are small, wearable, battery-powered devices Acquire ECG data from patients using limited ECG leads, as well<br>as perform beat classification, editing, reporting of arrhythmias and<br>heart rate<br>variability Use non-volatile memory to store patient data for further analysis | | | | | Substantial equivalence has been measured by review of the respective<br>technologies and their effectiveness to provide equivalent performance.<br>The technological characteristics of the AUDICOR system compares to the | | | | predicates as follows: | | | | | Product<br>Functionality | Predicate | Comparison | | | ECG and Heart<br>Sound Recording;<br>Heart Sound<br>Analysis | Audicor Hemo<br>Ambulatory<br>Monitor (510(k)<br>K073545) | Same platform and<br>specification for ECG and<br>heart sound acquisition and<br>analysis as predicate. | | | Heart Rate<br>Variability and ECG<br>Holter analysis and<br>report generation<br>(beat classification,<br>edting and<br>reporting of<br>arrhythmias) | Pathfinder SL,<br>Spacelabs<br>(510(k)<br>K110001) | Both are Windows-based<br>ECG analysis systems,<br>editing and report generation<br>systems that include heart<br>rate variability. | | {2}------------------------------------------------ K110569 p3/3 . · {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 OCT 2 4 2011 Inovise Medical, Inc. c/o Mr. Earl Anderson Director Quality and Regulatory 8770 SW Nimbus Ave., Suite D Beaverton, OR 97008-7196 K110569 Re: Trade/Device Name: Audicor System Regulatory Number: 21 CFR 870.2800 Regulatory Number. 21 CF N 07012000 Regulation Name: Ambulatory Electrocardiograph with Analysis Algorithm Regulatory Class: II (two) Product Code: 74 MLO Dated: September 30, 2011 Received: October 11, 2011 Dear Mr. Anderson: We have reviewed your Section 510(k) premarket notification of intent to market the devices We have reviewed your Section 510(x) premainer nethstantially equivalent (for the indications referenced above and have determined the device is substantially equivaled in in for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure for legally manation profitace device Ameralments, or los commerce prior to May 28, 1976, the chacinom auto of the Federal Food, Drug, devices that have been reclassified in accordance will of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a la previoions of th and Cosment Act (Act) that to not require approvince of controls provisions of the Act. The Act. The Act. The Act. The You may, include, market the device, subject to the gents for annual registration, listing of the pod general Controls provisions of the Fiel Includes and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Sec above) into endor regulations affecting your device can be If may be subject to additional controls. Extraing major regoriogations In addition, FDA may found in the Code of reactive regional registerning your device in the Federal Register. {4}------------------------------------------------ Page 2 - Mr. Earl Anderson 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 D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K110569 Inovise Medical, Inc. 510(k) Notification: Modification to AUDICOR System - 200 Response to Reviewer Questions 13 of 54 ## Indications for Use 510(k) Number K110569 Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Audicor® System, when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated report for consideration by physicians. The Audicor recording may be obtained at any location specified by a physician including home, hospital or clinic. The measurements provided and interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data. The device is intended for use only under the direct supervision of a physician. Prescription Use __ XXX_ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Page 1 of 1 Division of Cardiovascular Devices 510(k) Number K110569