K Number

Device Name

Cardio-TriTest v6.5

Manufacturer

Cardio-Phoenix Inc.

Date Cleared

2018-12-14

(74 days)

Product Code

DPS DQC DXR

Regulation Number

870.2340

Intended Use

The intended use of the device is to acquire and record the 3 different types of heart bio-signals (ECG, PCG, and 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 cycle c. an aid to detect S1 & S2 hearts sounds and murmurs. 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 v6.5 (CTT) is three devices in one; combining a 12-Lead Electrocardiograph (ECG), a 4 Lead Phonocardiograph and a 4 lead 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 for general practitioners to visually determine a patient's current heart health. The ECG component is a Standard 12-Lead ECG, conformant with EN IEC 60601-2-25 standards. The CTT v6.5 device uses approved Standard 12-Lead FDA/CE cables. The CTT includes 4 Kombi-Sensors that include combine PCG/MCG functionality. The PCG component consists of 4 electronic stethoscopes into one Phono recording device. PCG sensors are equipped with diaphragms and non-chill rings. The MCG component consists of 4 MCG recording devices integrated into the Kombi-Sensor housing (PCG and MCG in same Sensor Housing). The PCG and MCG signal verification can be found in Annex E - Signal Testing. The PCG and MCG sensors are housed in common sensor housing, Kombi-Sensor, this allows the Kombi-sensor of being positioned/located in one of the 4 standard auscultation points on the thoracic wall. The combined PCG/MCG sensors record their signals when positioned on the four primary auscultation points on the thoracic wall.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K143432

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the acquisition and synchronized presentation of bio-signals, with no mention of AI/ML for analysis or interpretation. The device is described as an "aid to diagnostic interpretation" by a physician, implying the physician performs the interpretation.

Therapeutic

No
The device is intended to acquire and record bio-signals (ECG, PCG, MCG) as an aid to diagnostic interpretation, not for therapeutic intervention.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "an aid to diagnostic interpretation by a Physician in a clinical setting." It further specifies its indication for use as "a Standard 12 Lead Diagnostic ECG."

SaMD (Software as a Medical Device)

The device description explicitly mentions hardware components such as "Standard 12-Lead FDA/CE cables", "4 Kombi-Sensors that include combine PCG/MCG functionality", "PCG sensors are equipped with diaphragms and non-chill rings", and "MCG recording devices integrated into the Kombi-Sensor housing". It also references standards related to hardware like IEC 60601-1 and EN IEC 60601-2-25.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
Device Function: The Cardio-TriTest device acquires and records bio-signals (ECG, PCG, and MCG) directly from the patient's body (thoracic wall) using non-invasive sensors. It does not analyze samples taken from the body.
Intended Use: The intended use is to acquire and present bio-signals as an aid to diagnostic interpretation by a physician. This is a direct measurement of physiological activity, not an analysis of a biological sample.

Therefore, the Cardio-TriTest is a medical device used for physiological monitoring and recording, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The indication for use is as ...
a. a Standard 12 Lead Diagnostic ECG
b. an aid to identify events in the cardiac cycle
c. an aid to detect S1 & S2 hearts sounds and murmurs.

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.

Product codes

DPS, DXR, DQC

Device Description

The ECG component is a Standard 12-Lead ECG, conformant with EN IEC 60601-2-25 standards.

The CTT v6.5 device uses approved Standard 12-Lead FDA/CE cables.

The CTT includes 4 Kombi-Sensors that include combine PCG/MCG functionality.

The PCG component consists of 4 electronic stethoscopes into one Phono recording device.

PCG sensors are equipped with diaphragms and non-chill rings.

The MCG component consists of 4 MCG recording devices integrated into the Kombi-Sensor housing (PCG and MCG in same Sensor Housing).

The PCG and MCG signal verification can be found in Annex E - Signal Testing.

The PCG and MCG sensors are housed in common sensor housing, Kombi-Sensor, this allows the Kombi-sensor of being positioned/located in one of the 4 standard auscultation points on the thoracic wall.

The combined PCG/MCG sensors record their signals when positioned on the four primary auscultation points on the thoracic wall.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Thoracic wall (specifically, four primary auscultation points on the thoracic wall for PCG/MCG sensors)

Indicated Patient Age Range

Males and females greater than or equal to 20 years of age. Not intended for use in pediatrics.

Intended User / Care Setting

Physician in a clinical setting; Certified Medical Practitioner. Not intended for patients in the intensive care units.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:
Standards covered:

IEC 60601-1:2012 ed. 3, Medical electrical equipment - Part 1: General requirements for safety
EN IEC 60601-1-2:2015 ed.4, Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
EN IEC 60601-2-25:2015 ed. 2. Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
IEC 60601-1-6:2010, ed. 3, Medical electrical equipment Part 1-6: General . requirements for basic safety and essential performance - Collateral standard: Usability

The modifications made have not impacted the safety and effectiveness of the device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K143432

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 14, 2018

Cardio-Phoenix Inc. Marc Bisnaire President 44 Rosemead Close Markham, L3R 3Z3 Canada

Re: K182790

Trade/Device Name: Cardio-TriTest v6.5 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DXR, DQC Dated: September 27, 2018 Received: October 1, 2018

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica E. Paulsen -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known)

K182790

Device Name Cardio-TriTest v6.5

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 cycle

c. an aid to detect S1 & S2 hearts sounds and murmurs.

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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Chapter 8 510(k) Summary Cardio-TriTest v6.5

510(k) Summary

The assigned 510(k) number is: _K182790

Submitter of 510(k):	Cardio-Phoenix Inc.
	44 Rosemead Close
	Markham, L3R 3Z3
	Canada
	Phone: 416-595-0795
	Email: marc.bisnaire@uvaresearch.com
Contact person:	Marc Bisnaire
Date of summary:	27th September 2018
Trade/Proprietary name:	Cardio-TriTest™
Classification name:	EPMCG v6.5
Classification:	DPS – Electrocardiograph
	DXR - Ballistocardiograph
	DQC - Phonocardiograph
Product codes:	DPS
	DXR
	DQC

The following device classifications apply to this device:

Name	Class	CFR
Electrocardiograph	II.	870.2340
Ballistocardiograph	II.	870.2320
Phonocardiograph	I.	870.2390

Classification panel:

Cardiovascular

Legally marketed predicate devices:

Cardio-TriTest v5.5 (K143432) ●