The Now Cardio™ System is an ambulatory cardiac monitoring system prescribed by a physician or other qualified healthcare professional for out-patient individuals with known non-lethal arrhythmias such as:

· Atrial Fibrillation
· Bradycardia
Tachycardia
· Pause

It continuously monitors, records, and stores electrocardiographic (ECG) data. If equipped with a transmitter, the Now Cardio™ will also periodically transmit ECG Cardiac Event to a remote computer server. Both recorded and transmitted ECG data are available to HealthCare Providers for analysis and reporting.

Now Cardio™ is intended to be used with adult patients 22 years and older, but not designed for pediatric patients.

Device Description

The NowCardio™ System is a wearable, wireless arrhythmia detection system that provides continuous cardiac monitoring functionality for an extended period of up to 32 days. The NowCardio System is prescribed by healthcare providers to monitor, record, and report on a patient's electrocardiographic (ECG) data. The NowCardio™ system consists of: (1) a wearable electronic component that collects and monitors a patient's ECG data referred to as a NowCardio™ Sensor; (2) a custom cradle, referred to as the NowCardio™ Cradle, that is used to configure/charge the NowCardio™ Sensor in addition to providing ECG data download capability; and (3) a Remote Data Management System (RDMS) which is a remote server with software that will allow qualified healthcare providers to receive, analyze, interpret, and report on the results of the ECG test. The NowCardio™ System can be equipped with an optional Transmitter. The NowCardio™ Transmitter is used to transmit data acquired from the NowCardio™ Sensor to the RDMS as cardiac events are detected or patient triggered.

AI/ML Overview

The provided document, K162956, is a 510(k) premarket notification letter for the NowCardio™ System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a detailed clinical or performance study with a test set. This type of submission relies heavily on non-clinical testing and comparison to legally marketed predicate devices.

Therefore, the document does not contain the specific information required to complete a table of acceptance criteria and reported device performance based on a test set, nor does it detail a study proving the device meets such criteria in terms of algorithm-specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection) as would be derived from a clinical validation study.

The document states:

"Similar performance testing has been conducted on the NowCardio™ System and its predicates. There are no substantial differences in performance testing of the devices. Therefore, the NowCardio™ System is determined to be substantially equivalent to the predicate devices." (Page 5, Section VI)
Under "VII. PERFORMANCE DATA", it lists various nonclinical tests, primarily focusing on general device safety, electrical performance, software validation, and compliance with standards like IEC 60601-1, IEC 60601-2-47, ISO 14971, and IEC 62304. These are engineering and regulatory compliance tests, not performance studies of the arrhythmia detection algorithm.

Given this, I cannot extract the requested information regarding algorithm performance, acceptance criteria for those metrics, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, or training set details from this 510(k) summary.

In summary, the provided document does not contain the information necessary to fulfill the request as it describes a 510(k) submission based on substantial equivalence and non-clinical testing, not a detailed clinical performance study proving specific algorithm-driven acceptance criteria.

Summary

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November 15, 2023

Contex International Technologies (canada), Inc. Ricardo Rodriguez Coo 2798 Thamesgate Drive, Units 5&6 Mississauga, ONTARIO L4T 4E8 Canada

Re: K162956

Trade/Device Name: Nowcardio System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including St-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: QYX, MHX, DSI

Dear Ricardo Rodriguez:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 22, 2017. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Kozen, OHT2: Office of Cardiovascular Devices, 301-796-5813, jennifer.kozen@fda.hhs.gov.

Sincerely,

Jennifer W. Shih -S

Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 22, 2017

Contex International Technologies (Canada), Inc. Ricardo Rodriguez Chief Operating Officer 2798 Thamesgate Drive, Units 5&6 Mississauga, CA L4T 4E8 Ontario

Re: K162956

Trade/Device Name: NowCardio™ System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, DSI Dated: August 14, 2017 Received: August 16, 2017

Dear Ricardo Rodriguez:

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 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

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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 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,

M.A. Hillemann

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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Indications for Use

510(k) Number (if known) K162956

Device Name NowCardio™ System

Indications for Use (Describe)

· Atrial Fibrillation
· Bradycardia
Tachycardia
· Pause

Now Cardio™ is intended to be used with adult patients 22 years and older, but not designed for pediatric patients.

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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I. Submitter:

Company:	Contex International Technologies Inc.
Address	2798 Thamesgate Drive Unit 5&6
	Mississauga, ON L4T 4E8 Canada
Contact:	Ricardo Rodriguez
Phone:	905-677-8324 ext. 202
Fax:	905-676-8324
Email:	ricardo@contexcanada.com
Date Prepared:	August 03, 2017

II. Device:

Trade Name:	NowCardio™ System
Common Name:	NowCardio™
Classification Name:	Arrhythmia Detector and Alarm
Product Code:	DSI, MHX
Regulation:	21 CFR 870.1025Patient Physiological Monitor (with arrhythmia detection)Arrhythmia detector and alarm
Class:	Class II, Special Controls

III. PREDICATE DEVICE(S):

1. NUVANT MCT System, cleared February 6, 2014 (NUVANT™ MCT) K133701 rebranded by Medtronic as SEEQ™ MCT. This is the primary predicate device.
1. BodyGuardian System, manufactured by Preventice, Inc. and cleared under 510(k) number K121197.

IV. DEVICE DESCRIPTION:

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qualified healthcare providers to receive, analyze, interpret, and report on the results of the ECG test. The NowCardio™ System can be equipped with an optional Transmitter. The NowCardio™ Transmitter is used to transmit data acquired from the NowCardio™ Sensor to the RDMS as cardiac events are detected or patient triggered.

INTENTED USE AND INDICATIONS FOR USE V.

The NowCardio™ System is an ambulatory cardiac monitoring system prescribed by a physician or other qualified healthcare professional for out-patient individuals with suspected non-lethal arrhythmias such as:

. Atrial Fibrillation
. Bradycardia
. Tachycardia
. Pause

It continuously monitors, records, and stores electrocardiographic (ECG) data. If equipped with a transmitter, the NowCardio will also periodically transmit ECG Cardiac Event to a remote computer server. Both recorded and transmitted ECG data are available to HealthCare Providers for analysis and reporting.

NowCardio™ is intended to be used with adult patients 22 years and older, but not designed for pediatric patients.

VI. SUBSTANTIAL EQUIVALENCE

Both predicates and the NowCardio™ System are ambulatory cardiac monitors that feature body worn Sensors that monitor and continuously record and periodically transmit ECG patient data. Both predicates and the NowCardio™ System will transmit the ECG data from the Sensor to Transmitter/Phone using Bluetooth, this data is then sent to a remote server with software that will allow HealthCare providers to access, review, and produce reports. There are no substantial differences between technological characteristics of the devices.

The indications for use for both the NowCardio™ System and its predicates state that the devices will provide monitoring of non-lethal cardiac arrhythmias. There are no substantial differences between the Indications for use of the devices.

Similar performance testing has been conducted on the NowCardio™ System and its predicates. There are no substantial differences in performance testing of the devices. Therefore, the NowCardio™ System is determined to be substantially equivalent to the predicate devices.

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The following table compares the NowCardio™ System to the predicate devices with respect to intended use, technological characteristics and principles of operation, etc.

ITEM	Subject Device:NowCardio™SystemK162956	Primary Predicate 1:Medtronic SEEQ™K133701	Predicate 2:BodyGuardianSystemK121197
Regulation Number	21 CFR 870.1025	Same	Same
FDA classification	Class II	Same	Same
Product Code(s)	DSI	DSI	MHX, DSI
ClassificationName:	ArrhythmiaDetector and Alarm	Same	Same
PatientEnvironment:	Ambulatory	Same	Same
Patient Population:	Non-pediatric, non-critical care patients	Same	Same
Transmissioncharacteristics:	Bluetooth andcellular connections	Same	Same
Key SystemComponents:	(1) WearableSensor(2) Transmitter(3) Remote Serverand Software	(1) Wearable Sensor(2) Transmitter(3) Remote Serverand Software	(1) WearableSensor(2) Smart phone/Transmitter(3) Remote Serverand Software
TechnicalOperatingCharacteristics:	ContinuousRecording withperiodictransmission ofECG data.	Same	Same
Non-LethalArrhythmiaDetection:	Yes	Yes	Yes
Event Trigger	Yes	Yes	Yes

Table 1: Substantial Equivalence Summary Table

VII. PERFORMANCE DATA

Nonclinical testing was conducted in full compliance to design control requirements and included the following:

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System Validation testing .
. Mechanical verification testing
Software verification testing .
Firmware verification testing .
Electrical safety and EMC testing .
Biocompatibility testing .
Defibrillation-proof applied parts testing .

The scope of the nonclinical testing summarized in Table 2 demonstrates that the NowCardio™ System is in compliant with FDA-recognized standards and guidance documents.

Standard	Description	Release Date
IEC 60601-1	Medical Electrical Equipment - Generalrequirements for basic safety andessential performance	Ed. 3
IEC 60601-2-47	Particular requirements for the basicsafety and essential performance ofambulatory electrocardiographic systems	2012
IEC 60601-1-2	General requirements for basic safetyand essential performance – Collateralstandard: Electromagnetic compatibility– Requirements and tests	2007
ISO 14971	Application of risk management tomedical devices	2007
IEC 60601-1-6	Medical electrical equipment – Part 1-6:General requirements for safety –Collateral standard: Usability	2010
IEC 60601-1-11	The Collateral Standard for the HomeHealthcare Environment	2010
IEC 62304	Medical device software - Software lifecycle processes	2006
ISO 15223-1	Medical devices - Symbols to be usedwith medical device labels, labeling andinformation to be supplied	2007
ISO 10993-1	Biological evaluation of medical devices– Part 1: Evaluation and testing	2003
IEC 62366	Medical devices – Application ofusability engineering to medical devices	2007
EN 1041	Information supplied by themanufacturer of medical devices	2008

Table 2: Nonclinical Testing Summary

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Guidance forIndustryand FDA Staff	Class II Special Controls GuidanceDocument: Arrhythmia Detectorand Alarm	October 28, 2003
Guidance forIndustryand FDA Staff	Providing Information aboutPediatric Uses of Medical Devices	May 1, 2014
Guidance forIndustryand FDA Staff	Guidance for Industry and FDA onAlternative to Certain PrescriptionDevice Labeling Requirements	1/21/2000
Guidance forIndustryand FDA Staff	Content of Premarket Submissions forManagement of Cybersecurity inMedical Devices	October 2, 2014
Guidance forIndustryand FDA Staff	Design Considerations for DevicesIntended for Home Use	August 8, 2016
Guidance forIndustryand FDA Staff	Class II Special Controls GuidanceDocument: ElectrocardiographElectrodes	July 21, 2011
IEC 60601-1	clauses 8.5.5.1a, 8.5.5.1b, 8.5.5.2 forDEFIBRILLATION-PROOF APPLIEDPARTS testing	2005/A1:2012

VIII. CONCLUSIONS

The NowCardio™ System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.