NOWCARDIO SYSTEM

K162956 · Contex International Technologies (Canada), Inc. · QYX · Sep 22, 2017 · Cardiovascular

Device Facts

• Record ID: K162956
• Device Name: NOWCARDIO SYSTEM
• Applicant: Contex International Technologies (Canada), Inc.
• Product Code: QYX · Cardiovascular
• Decision Date: Sep 22, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

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.

Device Story

NowCardio™ System is a wearable, wireless ambulatory cardiac monitor for continuous ECG recording (up to 32 days). System components: wearable sensor; cradle for configuration/charging/data download; Remote Data Management System (RDMS) server. Optional transmitter sends ECG data to RDMS via Bluetooth/cellular. Healthcare providers access RDMS to analyze, interpret, and report on ECG results. Device aids in detection of non-lethal arrhythmias; supports patient-triggered events. Used in outpatient settings; operated by patients (wearable) and healthcare professionals (analysis).

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including system validation, mechanical verification, software/firmware verification, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-1), and defibrillation-proof testing.

Technological Characteristics

Wearable sensor, cradle, and remote server/software. Connectivity via Bluetooth and cellular. Continuous ECG recording with periodic transmission. Complies with IEC 60601-1 (safety), IEC 60601-2-47 (ambulatory ECG), IEC 62304 (software lifecycle), and ISO 14971 (risk management).

Indications for Use

Indicated for adult patients (22+ years) requiring ambulatory cardiac monitoring for suspected non-lethal arrhythmias, including atrial fibrillation, bradycardia, tachycardia, and pauses. Not for pediatric use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• NUVANT MCT System (K133701)
• BodyGuardian System (K121197)

Submission Summary (Full Text)

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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, [e-mail].

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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: | [e-mail] |
| 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 870.1025<br>Patient Physiological Monitor (with arrhythmia detection)<br>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.
- 2. BodyGuardian System, manufactured by Preventice, Inc. and cleared under 510(k) number K121197.

#### IV. 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

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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:<br>NowCardio™<br>System<br>K162956 | Primary Predicate 1:<br>Medtronic SEEQ™<br>K133701 | Predicate 2:<br>BodyGuardian<br>System<br>K121197 |
|--------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Regulation Number | 21 CFR 870.1025 | Same | Same |
| FDA classification | Class II | Same | Same |
| Product Code(s) | DSI | DSI | MHX, DSI |
| Classification<br>Name: | Arrhythmia<br>Detector and Alarm | Same | Same |
| Patient<br>Environment: | Ambulatory | Same | Same |
| Patient Population: | Non-pediatric, non-<br>critical care patients | Same | Same |
| Transmission<br>characteristics: | Bluetooth and<br>cellular connections | Same | Same |
| Key System<br>Components: | (1) Wearable<br>Sensor<br>(2) Transmitter<br>(3) Remote Server<br>and Software | (1) Wearable Sensor<br>(2) Transmitter<br>(3) Remote Server<br>and Software | (1) Wearable<br>Sensor<br>(2) Smart phone/<br>Transmitter<br>(3) Remote Server<br>and Software |
| Technical<br>Operating<br>Characteristics: | Continuous<br>Recording with<br>periodic<br>transmission of<br>ECG data. | Same | Same |
| Non-Lethal<br>Arrhythmia<br>Detection: | 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 - General<br>requirements for basic safety and<br>essential performance | Ed. 3 |
| IEC 60601-2-47 | Particular requirements for the basic<br>safety and essential performance of<br>ambulatory electrocardiographic systems | 2012 |
| IEC 60601-1-2 | General requirements for basic safety<br>and essential performance – Collateral<br>standard: Electromagnetic compatibility<br>– Requirements and tests | 2007 |
| ISO 14971 | Application of risk management to<br>medical devices | 2007 |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6:<br>General requirements for safety –<br>Collateral standard: Usability | 2010 |
| IEC 60601-1-11 | The Collateral Standard for the Home<br>Healthcare Environment | 2010 |
| IEC 62304 | Medical device software - Software life<br>cycle processes | 2006 |
| ISO 15223-1 | Medical devices - Symbols to be used<br>with medical device labels, labeling and<br>information to be supplied | 2007 |
| ISO 10993-1 | Biological evaluation of medical devices<br>– Part 1: Evaluation and testing | 2003 |
| IEC 62366 | Medical devices – Application of<br>usability engineering to medical devices | 2007 |
| EN 1041 | Information supplied by the<br>manufacturer of medical devices | 2008 |

Table 2: Nonclinical Testing Summary

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| Guidance for<br>Industry<br>and FDA Staff | Class II Special Controls Guidance<br>Document: Arrhythmia Detector<br>and Alarm | October 28, 2003 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------|
| Guidance for<br>Industry<br>and FDA Staff | Providing Information about<br>Pediatric Uses of Medical Devices | May 1, 2014 |
| Guidance for<br>Industry<br>and FDA Staff | Guidance for Industry and FDA on<br>Alternative to Certain Prescription<br>Device Labeling Requirements | 1/21/2000 |
| Guidance for<br>Industry<br>and FDA Staff | Content of Premarket Submissions for<br>Management of Cybersecurity in<br>Medical Devices | October 2, 2014 |
| Guidance for<br>Industry<br>and FDA Staff | Design Considerations for Devices<br>Intended for Home Use | August 8, 2016 |
| Guidance for<br>Industry<br>and FDA Staff | Class II Special Controls Guidance<br>Document: Electrocardiograph<br>Electrodes | July 21, 2011 |
| IEC 60601-1 | clauses 8.5.5.1a, 8.5.5.1b, 8.5.5.2 for<br>DEFIBRILLATION-PROOF APPLIED<br>PARTS testing | 2005/A1:2012 |

# VIII. CONCLUSIONS

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