Cardio-TriTest

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 3, 2015 Cardio-Phoenix Inc. Marc Bisnaire, President 2102-65 Spring Garden Ave Toronto, Ontario M2N 6H9 Canada Re: K143432 Trade/Device Name: Cardio-TriTest Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DXR, DQC Dated: April 22, 2015 Received: April 30, 2015 Dear Marc Bisnaire: 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. 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 {1}------------------------------------------------ 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 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 Industry and Consumer Education at its toll-free 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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. Mitchell Stein for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K143432 Device Name Cardio-TriTest Indications for Use (Describe) The intended use of this device is to acquire and record 3 different types of heart bio-signals (ECG, PCG, MCG) and combine the results into a contiguous presentation as an aid to diagnostic interpretation by a Physician in a clinical setting. The indication for use is as ... a. a Standard 12 Lead Diagnostic ECG b. an aid to identify events in the cardiac cvcle c. an aid to detect S1 & S2 hearts sounds and murmurs. Not intended for use in pediatrics. Not intended for patients in the intensive care units. Intended population: Males and females greater than or equal to 20 years of age. Any diagnostic interpretation is only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data. The Cardio-TriTest is on a prescription basis by a Certified Medical Practitioner. Type of Use (Select one or both, as applicable) 즈 Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary ### The assigned 510(k) number is: K143432 | Submitter of 510(k): | Cardio-Phoenix Inc.<br>2102-65 Spring Garden Ave<br>Toronto, M2N 6H9<br>Canada<br>Phone: 416-595-0795<br>Email: marc.bisnaire@cardiophoenix.com | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Marc Bisnaire | | Date of summary: | November 5th, 2014 | | Trade/Proprietary name: | Cardio-TriTest™ | | | | | Classification name: | EPMCG v5.5 | | Classification: | DPS – Electrocardiograph<br>DXR – Ballistocardiograph<br>DQC – Phonocardiograph | ### The following device classifications apply to this device: | Name | Class | CFR | |---------------------|-------|----------| | Electrocardiograph | | 870.2340 | | Ballistocardiograph | | 870.2320 | | Phonocardiograph | | 870.2390 | ### Classification panel: Cardiovascular {4}------------------------------------------------ ### Legally marketed predicate devices: - DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 (K081603) - Zargis Acoustic Cardioscan-ZAC (K031517) ● #### Reference device: - 3M Littmann Electronic Stethoscope, Model 4000 (K003723) ### Device Description The Cardio-TriTest is three devices in one, combining a 12-Lead Electrocardiograph (ECG), a Phonocardiograph and a Mechanocardiograph. The device will acquire all three types of bio-signals during the same non-invasive test procedure. The three types of signals are synchronized and outputted on the same timeline making it easier and more visual for general practitioners to visually determine a patient's current heart symptoms. The ECG component is a Standard 12-Lead ECG, conformant with IEA60601-2-25 standards. ### The Cardio-TriTest device for catching ECG signals uses Standard 12-Lead FDA/CE approved ECG cables by Sino-Hero Company. The PCG component consists of 4 electronic stethoscopes combined into one Phono recording device. ### PCG/MCG sensors are with FDA/CE approved diaphragms and soft non chill rings manufactured by the Riester Company from Germany. More details: ### http://www.riester.de/cardiophon.431.0.html?&L=79195 The MCG component consists of 4 MCG recording devices. #### The MCG signal validation is in the Annex B of this application. The PCG and MCG sensors are housed in common sensor housing for the purpose of being positioned/located on the thoracic wall in the same four (4) primary and standard auscultation points. The combined PCG/MCG sensors are correctly positioned on the four primary auscultation points on the thoracic wall via a purpose designed harness. Cardio-Phoenix Inc. QCL2 v1.1 Page {5}------------------------------------------------ #### Intended use: The intended use of this device is to acquire and record 3 different types of heart biosignals (ECG, PCG, MCG) and combine the results into a contiguous presentation as an aid to diagnostic interpretation by a Physician in a clinical setting. #### Indication for use The indication for use is as ... - a Standard 12 Lead Diagnostic ECG a. - b. an aid to identify events in the cardiac cycle - an aid to detect S1 & S2 hearts sounds and murmurs. C. Not intended for use in pediatrics. Not intended for patients in the intensive care units. Intended population: Any diagnostic interpretation is only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data. The Cardio-TriTest is on a prescription basis by a Certified Medical Practitioner. #### Technological characteristics and substantial equivalence: The Cardio-TriTest (CTT) is a 3-in-1 device. It combines the functionality of an Electrocardiograph (ECG), a Phonocardiograph (PCG) and Mechanocardiograph (MCG) device into 1 device. Cardio-Phoenix Inc. {6}------------------------------------------------ The value of the CTT is that it synchronizes the 3 different types of bio-signals recorded by each functional aspect of the device and visually correlates them for combined diagnostic purposes. The technical characteristics of each functional device are either conformant to FDA approved standards in the case of the ECG functionality or substantially equivalent to their corresponding FDA approved predicate devices for the PCG and MCG functionality. SAFETY: Being a 3-in-1 device, the safety of the device meets the Standard as per IEA60601-1, in accordance with the standards set in 60601-2-25 for Diagnostic ECG and applies equally to the two other functional aspects of the device. In accordance with FDA guidelines, the ECG component is conformant with IEA 60601-2-25 (2014) Diagnostic ElectroCardiographs (ECG), (as such no comparison chart is produced with the other predicate devices as they do not include any ECG functionality). The MCG functionality, acquires and records the mechanical vibrational waveforms produced by the hearts constructions and transmitted to the chest wall is substantially equivalent to the DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300. The PCG functionality, acquires and records the acoustic waveforms produced by the heart and is substantially equivalent to the Zargis Acoustic Cardioscan-ZAC. ### The PCG signal comparison document to the Reference device is in Annex A of this application. ## The MCG signal comparison document to the CTT PCG part is in Annex B of this application. The Cardio-TriTest (CTT) device and the predicate devices listed above are indicated for use in the clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. They are not intended as a sole means of diagnosis. The interpretations of heart signals offered by CTT are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data. Cardio-Phoenix Inc. QCL2 v1.1 Page {7}------------------------------------------------ ### Technological characteristics comparison table | Features and<br>functions | DIGITAL<br>BALLISTO<br>CARDIOGRAPH,<br>MODEL DGB 300 | Zargis Acoustic<br>Cardioscan (ZAC) | Cardio-TriTest<br>v5.5 | |--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------| | Device Type | BCG1 | PCG | ECG/PCG/<br>MCG(BCG) | | Software | | | | | Test stored as<br>individual files | YES | YES | YES | | Save tests | YES | YES | YES | | File retrieval | From Hard Drive<br>or external drive | From Hard drive | From Hard drive | | Operating system | Windows XP,<br>Windows Vista | Windows XP SP2<br>or later or Vista<br>32-bit | Windows 7,<br>Windows 8.x<br>(32 or 64bit) | | PC-based software | YES | YES | YES | | Printing | YES | YES | YES | | Networked | NO | N/A | NO | | Modem data transfer | NO | N/A | NO | | Display sounds in<br>time and frequency<br>domain | N/A | YES | YES - in time<br>domain | | Recording test | | | | | Saving signals just of<br>acceptable quality | N/A | YES | YES | | Reporting errors<br>during recording | N/A | YES – voice<br>prompt | YES – written<br>prompt | | Indication of the<br>failure cause and<br>suggested corrective<br>action | N/A | YES | YES | | Re-recording ability | N/A | YES | YES | | ECG -BCG<br>Synchronized Stacked<br>Display | Yes (ECG &<br>3 Axis BCG) | N/A | Yes (ECG & PCG &<br>MCG(BCG)) | | Rhythm Strip | YES | N/A | YES | | ECG | No, Single Lead<br>Rhythm Strip | N/A | YES, 12-lead ECG | | X axis BCG | YES | N/A | YES | | Y axis BCG | YES | N/A | YES | | Z axis BCG | YES | N/A | YES | | XYZ combined | NO | N/A | YES | | Preset recording time | User configurable<br>10, 30, 60 sec | User configurable<br>1 – 20 sec | User configurable<br>30, 60, 120, 180,<br>300 seconds | | Pre exercise test | YES | N/A | YES | | Post exercise test | YES | N/A | N/A | | Data recording | N/A | standard .wav and<br>Native .zac file | 24bit binary and<br>zipped | | Acoustic sensor | N/A | Electronic<br>stethoscope | Electronic<br>stethoscope | | Number of sensors | N/A | 1 | 4 | | Waveform review | | | | | Waveform markers | Yes, User Applies<br>Markers for ACC<br>recognized waves<br>(Mitral Valve Close,<br>J, Mitral Valve<br>Open, Aortic<br>Value Open, Aortic<br>Valve Close, Early<br>Diastole) | N/A | NO<br>Not required for<br>Intended Use | | Scroll BCG | YES | N/A | YES | | Zoom BCG | YES | N/A | YES | | Measurement | YES | N/A | YES | | Signal averaging | YES | N/A | NO | | Zoom option | YES | YES | YES | | Scroll option | YES | YES | YES | | Digital filtering | N/A | YES – 3 modes:<br>Bell mode,<br>Diaphragm mode<br>and Extended<br>mode | YES<br>4 kind of ECG<br>filter, 1 PCG, 1<br>BCG/MCG | | Heart sound analysis | YES | YES | NO | | Lung sound analysis | NO | NO | NO | | Number of display<br>panels | N/A | 4 | 3 | ¹ References to BCG and MCG refer to the same accelerometer generated signal but a different naming convention is used, Other names include Vibrocardiograph (VCG), Seismocardiograh (SCG) and all are substantially equivalent to MCG. The literature is confusing as they are often used interchangeably. Cardio-Phoenix Inc. {8}------------------------------------------------ Cardio-Phoenix Inc. QCL2 v1.1 Page {9}------------------------------------------------ | Identifying presented<br>specific heart sounds | N/A | S1, S2 | S1, S2 | |----------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------|--------------------------------------------| | Graphically displays<br>heart wave intensity,<br>timing and location | N/A | YES | NO | | Spectrogram view | N/A | YES | NO | | Wavelet view | N/A | YES | NO | | Hardware | | | | | Portable unit | Portable hand held<br>unit | N/A | Transportable<br>unit | | Battery power | YES | N/A | NO | | Tri-axial<br>accelerometer | YES | N/A | YES | | ECG Lead Wires | No (ECG<br>adhesive patches<br>applied to sensor<br>and patient) | N/A | YES | | Data transmitting | Wireless Bluetooth<br>transmission from<br>dBG 300 device to<br>dBG Software on a<br>PC | N/A | USB 2.0 | | PC connection – input<br>type | N/A | USB wireless<br>dongle | USB port | | Display requirement | N/A | 1024 x 600<br>graphic display or<br>better | 1024 x 600<br>graphic display or<br>better | | Connectivity | N/A | USB 1.1 port or<br>better | USB 2.0 + | | Bluetooth | N/A | YES | N/A | Any differences in technical characteristics, such as differences in Windows OS systems, type and number of sensors, preset recording time, data transmission type, power supply type, recording format, number of display panels, PC connection type do not raise any significant concern with respect to the safety or on the effectiveness of the operating results. ### Safety and performance The Cardio-TriTest is a 3-in-1 device. The criteria for safety is governed best by the ECG functionality which is subject to FDA approved safety standard set out in {10}------------------------------------------------ IEA60601-1. The Cardio-TriTest device has passed all the required safety standards and has also been subjected to extensive safety, environmental and performance testing. Final testing for the device included various performance tests, including software validation corresponding to each functional aspect of the device, to ensure that all safety and performance specifications were met. The Cardio-TriTest device has also been tested to assure compliance to the requirement of various published standards including the following: - IEC 60601-1 - IEC 60601-1-2 ● - IEC 60601-2-25 ● - IEC 60601-1-6 ● - EC53 ● - ISO 13485 - ISO 14971 ### Conclusion: Based upon the each predicates corresponding indications for use, their technological characteristics and their safety and performance testing, the Cardio-TriTest has been shown to be substantially equivalent to the corresponding above listed legally marketed predicate devices under the Federal Food, Drug, and Cosmetic Act.