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.

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.

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.

AI/ML Overview

The provided text describes the Cardio-TriTest device, a 3-in-1 device combining Electrocardiograph (ECG), Phonocardiograph (PCG), and Mechanocardiograph (MCG) functionalities. It aims to acquire and record three types of bio-signals and combine them into a contiguous presentation to aid diagnostic interpretation by a physician.

Here's an analysis of the acceptance criteria and study information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices. For parts of the device where specific standards apply (like the ECG), it states compliance.

Reported Device Performance:

The document primarily focuses on establishing "substantial equivalence" based on technological characteristics and safety. It states:

ECG Component: "The ECG component is a Standard 12-Lead ECG, conformant with IEA60601-2-25 standards." and "In accordance with FDA guidelines, the ECG component is conformant with IEA 60601-2-25 (2014) Diagnostic ElectroCardiographs (ECG)."
MCG Component: "The MCG functionality... is substantially equivalent to the DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300."
PCG Component: "The PCG functionality... is substantially equivalent to the Zargis Acoustic Cardioscan-ZAC."
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." And "The Cardio-TriTest device has passed all the required safety standards and has also been subjected to extensive safety, environmental and performance testing."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a sample size for a test set or the data provenance for performance evaluation. The focus is on demonstrating compliance with standards and substantial equivalence rather than a clinical performance study with a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document refers to "physician over-read" for diagnostic interpretation but does not detail how ground truth for any testing was established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not mentioned in the document. The device is presented as an aid to diagnostic interpretation, but no study comparing human readers with and without the device's assistance is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is explicitly stated as an "aid to diagnostic interpretation by a Physician" and that "Any diagnostic interpretation is only significant when used in conjunction with physician over-read." This indicates it's not intended for standalone (algorithm-only) performance, and no standalone performance study is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not describe the type of ground truth used for any performance evaluation.

8. The sample size for the training set

The document does not mention a training set or its sample size. The description centers on the device's technological characteristics and comparison to predicate devices, not on a machine learning model that would typically require a training set.

9. How the ground truth for the training set was established

Since no training set is mentioned, the method for establishing its ground truth is not provided.

Summary of what's provided related to device performance and criteria:

The document focuses on establishing the Cardio-TriTest's substantial equivalence to existing legally marketed devices based on:

Compliance with recognized standards:
- ECG component: IEA60601-2-25 (2014) Diagnostic ElectroCardiographs (ECG).
- Overall safety: IEA60601-1 and related collateral standards (IEC 60601-1-2, IEC 60601-1-6, EC53, ISO 13485, ISO 14971).
Technological characteristics comparison: Detailed feature-by-feature comparison with predicate devices (DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 and Zargis Acoustic Cardioscan-ZAC), demonstrating that differences "do not raise any significant concern with respect to the safety or on the effectiveness of the operating results."
Signal validation/comparison documents: "The MCG signal validation is in the Annex B of this application." and "The PCG signal comparison document to the Reference device is in Annex A of this application." and "The MCG signal comparison document to the CTT PCG part is in Annex B of this application." (Note: these annexes are referenced but not included in the provided text).

In essence, the "study" proving the device meets acceptance criteria appears to be a demonstration of compliance with relevant safety and performance standards for its individual components (ECG, PCG, MCG) and a detailed comparison of its technological features to predicate devices to establish substantial equivalence, rather than a clinical trial with specific performance metrics against a defined ground truth.

Summary

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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

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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

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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 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."

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510(k) Summary

The assigned 510(k) number is: K143432

Submitter of 510(k):	Cardio-Phoenix Inc.2102-65 Spring Garden AveToronto, M2N 6H9CanadaPhone: 416-595-0795Email: 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 – ElectrocardiographDXR – BallistocardiographDQC – Phonocardiograph

The following device classifications apply to this device:

Name	Class	CFR
Electrocardiograph		870.2340
Ballistocardiograph		870.2320
Phonocardiograph		870.2390

Classification panel:

Cardiovascular

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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 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

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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.

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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

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Technological characteristics comparison table

Features andfunctions	DIGITALBALLISTOCARDIOGRAPH,MODEL DGB 300	Zargis AcousticCardioscan (ZAC)	Cardio-TriTestv5.5
Device Type	BCG1	PCG	ECG/PCG/MCG(BCG)
Software
Test stored asindividual files	YES	YES	YES
Save tests	YES	YES	YES
File retrieval	From Hard Driveor external drive	From Hard drive	From Hard drive
Operating system	Windows XP,Windows Vista	Windows XP SP2or later or Vista32-bit	Windows 7,Windows 8.x(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 intime and frequencydomain	N/A	YES	YES - in timedomain
Recording test
Saving signals just ofacceptable quality	N/A	YES	YES
Reporting errorsduring recording	N/A	YES – voiceprompt	YES – writtenprompt
Indication of thefailure cause andsuggested correctiveaction	N/A	YES	YES
Re-recording ability	N/A	YES	YES
ECG -BCGSynchronized StackedDisplay	Yes (ECG &3 Axis BCG)	N/A	Yes (ECG & PCG &MCG(BCG))
Rhythm Strip	YES	N/A	YES
ECG	No, Single LeadRhythm 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 configurable10, 30, 60 sec	User configurable1 – 20 sec	User configurable30, 60, 120, 180,300 seconds
Pre exercise test	YES	N/A	YES
Post exercise test	YES	N/A	N/A
Data recording	N/A	standard .wav andNative .zac file	24bit binary andzipped
Acoustic sensor	N/A	Electronicstethoscope	Electronicstethoscope
Number of sensors	N/A	1	4
Waveform review
Waveform markers	Yes, User AppliesMarkers for ACCrecognized waves(Mitral Valve Close,J, Mitral ValveOpen, AorticValue Open, AorticValve Close, EarlyDiastole)	N/A	NONot required forIntended 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:Bell mode,Diaphragm modeand Extendedmode	YES4 kind of ECGfilter, 1 PCG, 1BCG/MCG
Heart sound analysis	YES	YES	NO
Lung sound analysis	NO	NO	NO
Number of displaypanels	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.

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Cardio-Phoenix Inc.

QCL2 v1.1 Page

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Identifying presentedspecific heart sounds	N/A	S1, S2	S1, S2
Graphically displaysheart wave intensity,timing and location	N/A	YES	NO
Spectrogram view	N/A	YES	NO
Wavelet view	N/A	YES	NO
Hardware
Portable unit	Portable hand heldunit	N/A	Transportableunit
Battery power	YES	N/A	NO
Tri-axialaccelerometer	YES	N/A	YES
ECG Lead Wires	No (ECGadhesive patchesapplied to sensorand patient)	N/A	YES
Data transmitting	Wireless Bluetoothtransmission fromdBG 300 device todBG Software on aPC	N/A	USB 2.0
PC connection – inputtype	N/A	USB wirelessdongle	USB port
Display requirement	N/A	1024 x 600graphic display orbetter	1024 x 600graphic display orbetter
Connectivity	N/A	USB 1.1 port orbetter	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

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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.

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).