(333 days)
Not Found
No
The document does not mention AI, ML, or any related terms in the device description, intended use, or performance studies. The analysis and reporting are described as being performed by qualified healthcare providers using the Remote Data Management System software.
No.
The device is for monitoring, recording, and storing ECG data for analysis, not for providing therapy or treatment.
Yes
The device is described as an "ambulatory cardiac monitoring system" intended to "continuously monitor, record, and store electrocardiographic (ECG) data" and the data is available to "HealthCare Providers for analysis and reporting." Furthermore, the "Remote Data Management System (RDMS)" component allows healthcare providers to "receive, analyze, interpret, and report on the results of the ECG test." These functions are diagnostic in nature as they involve the collection and analysis of physiological data to identify medical conditions (arrhythmias).
No
The device description explicitly states the system consists of a wearable electronic component (NowCardio™ Sensor) and a custom cradle (NowCardio™ Cradle), which are hardware components. The performance studies also include mechanical verification testing, electrical safety and EMC testing, and biocompatibility testing, all related to hardware.
Based on the provided information, the Now Cardio™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Now Cardio™ Function: The Now Cardio™ System directly monitors and records electrical activity of the heart (ECG data) from the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for continuous cardiac monitoring and recording of ECG data in out-patient individuals with known non-lethal arrhythmias. This is a direct physiological measurement, not an analysis of a biological sample.
Therefore, the Now Cardio™ System falls under the category of a medical device that performs physiological monitoring, specifically electrocardiography.
N/A
Intended Use / Indications for Use
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.
Product codes
QYX, MHX, DSI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
electrocardiographic (ECG) data
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients 22 years and older
Intended User / Care Setting
physician or other qualified healthcare professional / out-patient
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)
Nonclinical testing was conducted in full compliance to design control requirements and included the following:
- System Validation testing.
- Mechanical verification testing
- Software verification testing.
- Firmware verification testing.
- Electrical safety and EMC testing.
- Biocompatibility testing.
- Defibrillation-proof applied parts testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure.
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
2
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
3
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) | |
|---|---|
| ☑ 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 870.1025 |
| Patient Physiological Monitor (with arrhythmia detection) | |
| Arrhythmia detector and alarm | |
| Class: | Class II, Special Controls |
III. PREDICATE DEVICE(S):
-
- NUVANT MCT System, cleared February 6, 2014 (NUVANT™ MCT) K133701 rebranded by Medtronic as SEEQ™ MCT. This is the primary predicate device.
-
- 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
5
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™
System
K162956 | Primary Predicate 1:
Medtronic SEEQ™
K133701 | Predicate 2:
BodyGuardian
System
K121197 |
|--------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Regulation Number | 21 CFR 870.1025 | Same | Same |
| FDA classification | Class II | Same | Same |
| Product Code(s) | DSI | DSI | MHX, DSI |
| Classification
Name: | Arrhythmia
Detector and Alarm | Same | Same |
| Patient
Environment: | Ambulatory | Same | Same |
| Patient Population: | Non-pediatric, non-
critical care patients | Same | Same |
| Transmission
characteristics: | Bluetooth and
cellular connections | Same | Same |
| Key System
Components: | (1) Wearable
Sensor
(2) Transmitter
(3) Remote Server
and Software | (1) Wearable Sensor
(2) Transmitter
(3) Remote Server
and Software | (1) Wearable
Sensor
(2) Smart phone/
Transmitter
(3) Remote Server
and Software |
| Technical
Operating
Characteristics: | Continuous
Recording with
periodic
transmission of
ECG data. | Same | Same |
| Non-Lethal
Arrhythmia
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:
7
- 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 | |
| requirements for basic safety and | ||
| essential performance | Ed. 3 | |
| IEC 60601-2-47 | Particular requirements for the basic | |
| safety and essential performance of | ||
| ambulatory electrocardiographic systems | 2012 | |
| IEC 60601-1-2 | General requirements for basic safety | |
| and essential performance – Collateral | ||
| standard: Electromagnetic compatibility | ||
| – Requirements and tests | 2007 | |
| ISO 14971 | Application of risk management to | |
| medical 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 Home | |
| Healthcare Environment | 2010 | |
| IEC 62304 | Medical device software - Software life | |
| cycle processes | 2006 | |
| ISO 15223-1 | Medical devices - Symbols to be used | |
| with medical device labels, labeling and | ||
| information to be supplied | 2007 | |
| ISO 10993-1 | Biological evaluation of medical devices | |
| – Part 1: Evaluation and testing | 2003 | |
| IEC 62366 | Medical devices – Application of | |
| usability engineering to medical devices | 2007 | |
| EN 1041 | Information supplied by the | |
| manufacturer of medical devices | 2008 |
Table 2: Nonclinical Testing Summary
8
| Guidance for
Industry
and FDA Staff | Class II Special Controls Guidance
Document: Arrhythmia Detector
and Alarm | October 28, 2003 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------|
| Guidance for
Industry
and FDA Staff | Providing Information about
Pediatric Uses of Medical Devices | May 1, 2014 |
| Guidance for
Industry
and FDA Staff | Guidance for Industry and FDA on
Alternative to Certain Prescription
Device Labeling Requirements | 1/21/2000 |
| Guidance for
Industry
and FDA Staff | Content of Premarket Submissions for
Management of Cybersecurity in
Medical Devices | October 2, 2014 |
| Guidance for
Industry
and FDA Staff | Design Considerations for Devices
Intended for Home Use | August 8, 2016 |
| Guidance for
Industry
and FDA Staff | Class II Special Controls Guidance
Document: Electrocardiograph
Electrodes | July 21, 2011 |
| IEC 60601-1 | clauses 8.5.5.1a, 8.5.5.1b, 8.5.5.2 for
DEFIBRILLATION-PROOF APPLIED
PARTS testing | 2005/A1:2012 |
VIII. CONCLUSIONS
The NowCardio™ System is substantially equivalent to the predicate devices.