(112 days)
Not Found
No
The description focuses on hardware components, data transmission, and human interpretation of the data by "learned intermediaries" and "cardiographic technicians." There is no mention of automated analysis or algorithms that learn from data.
No
The device is intended to monitor, record, and transmit physiological data for arrhythmia detection, but it does not provide any therapy or treatment.
Yes
The device is intended to monitor and detect cardiac arrhythmias, which is a diagnostic purpose.
No
The device description explicitly lists multiple hardware components: PiiX (adherent device), Patient Trigger Magnet, and zLink (gateway). These are physical devices, not software.
Based on the provided information, the NUVANT Mobile Cardiac Telemetry (MCT) 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.
- NUVANT System Function: The NUVANT system directly measures and records physiological data (ECG and heart rate) from the patient's body through electrodes applied to the skin. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for monitoring and detecting cardiac arrhythmias in vivo (within the living body), not for analyzing samples in vitro (in a lab setting).
Therefore, the NUVANT MCT System falls under the category of a medical device that performs physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders.
The NUVANT system model monitors, derives and displays:
• ECG
• Heart Rate
Product codes (comma separated list FDA assigned to the subject device)
QYX, MHX, DSI
Device Description
The NUVANT MCT System is a wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias. In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only), NUVANT MCT enables arrhythmia detection for up to 7.5 days for each PiiX application.
The NUVANT system components are:
- PiiX® (aka: Adherent Device) a patient-worn device which is applied to the . patient's torso. It contains the ECG electrodes for recording ECG and heart rate data.
- Patient Trigger Magnet used by the patient to manually trigger the ECG . collection when he/she experiences symptoms.
- . zLink® (aka: Gateway) – hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology.
- Server The Server receives sensor data from the PiiX via zLink. ECG and . heart rate are presented to learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians
The communication between the PiiX and the zLink is enabled via BlueTooth Technology. Sensor data and ECGs collected by the PiiX are transmitted to the Server via zLink.
The system components of the subject NUVANT are identical to the system components of the predicate NUVANT.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's torso
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians, learned intermediaries in the Corventis Monitoring Center, prescribing physicians, Corventis cardiographic technicians
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)
Both the subject and predicate NUVANT MCT meet the requirements of following performance standards in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm.
IEC 60601-1
Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
IEC 60601-1-2
Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004))
AAMI/ANSI EC38
Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems, 2007.
AAMI/ANSI EC57
Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms, 1998/(R) 2008
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a bold, sans-serif font and the full name in a smaller, sans-serif font below it. The seal on the left is a stylized representation of a human figure.
November 15, 2023
Corventis, Inc. Kathleen Lundberg Vice President Of Quality, Regulatory, And Clinica 1410 Energy Park Drive Suite 1 Saint Paul, Minnesota 55108
Re: K113372
Trade/Device Name: Nuvant. Mobilc Cardiac Telemetry 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 Kathleen Lundberg:
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 March 7, 2012. 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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Image /page/1/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized wing segments. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 7 2012
Corventis. Inc c/o Ms. Kathy Lundberg Vice President, QA, RA, Clinicals. 1410 Energy Park Dr. Suite 1 St. Paul. MN 55108
Re: K113372
Trade/Device Name: Nuvant, mobile cardiac telemetry Regulation Number: 21 CFR 878.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and
alarm)
Regulatory Class: Class II Product Code: MHX, DSI Dated: February 7, 2011 Received: February 8, 2011
Dear Ms. Lundberg:
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.
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2
Page 2 - Ms. Kathy Lundberg
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fdaggov/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
KII3372
510(k) Number (if known): N/A
Device Name: NUVANT® Mobile Cardiac Telemetry
Indications for Use:
The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders.
The NUVANT system model monitors, derives and displays:
• ECG
· Heart Rate
Prescription Use _ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
Page 1 of 1
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K113372
Page 1 of 1
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4
MAR - 7 2012
Image /page/4/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K113372". The characters are written in a simple, slightly irregular style, giving it a casual, handwritten appearance.
SECTION 7 - 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter Name & Address: | Corventis, Inc.
1410 Energy Park Drive, Suite 1
St. Paul, MN 55108 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michele Chin-Purcell, Ph.D.
651-925-3803 (phone)
651-389-3251 (fax) |
| Trade/Proprietary Name: | NUVANT ® Mobile Cardiac Telemetry System |
| Common/Usual Name: | Mobile Cardiac Telemetry System |
| Classification Name: | Arrhythmia Detector and Alarm
(21 CFR 870.1025, Product Code DSI)
Patient Physiological Monitor (with arrhythmia detection)
(21 CFR 870.1025, Product Code MHX) |
| Class: | Class II, Special Controls |
| 510(k): | Special 510(k) |
| Date Prepared: | November 15, 2011 |
Predicate Device:
NUVANT Mobile Cardiac Telemetry System, Corventis, Inc. cleared by FDA under 510(k) number K111917; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFR 870.1025, MHX "Patient Physiological Monitor (with arrhythmia detection)"
(Hereafter referred to as the "predicate NUVANT".)
Page 7.1
Page 1 of 5
5
BACKGROUND INFORMATION
The following is the subject device of this Special 510(k):
- The NUVANT Mobile Cardiac Telemetry System (hereafter referred to as . "subject NUVANT")
This Special 510(k) proposes to add a framework that will reserve space for recording ECG strips for each event type; limiting the redundant recording of certain event types.
This change does not change to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and does not affect the safety and effectiveness of the device when used as labeled [807.92(a){5}]. The indications for use of the subject NUVANT are unchanged from the predicate NUVANT. The modification does not impact the fundamental scientific technology of the device.
INDICATION FOR USE STATEMENT
The following are the indications for use for the subject NUVANT. These are unchanged from the predicate NUVANT:
The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of nonlethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders.
The NUVANT system model monitors, derives and displays:
- ECG .
- Heart rate �
Page 7.2
Page 2 of 5
6
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The NUVANT MCT System is a wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias. In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only), NUVANT MCT enables arrhythmia detection for up to 7.5 days for each PiiX application.
The NUVANT system components are:
- PiiX® (aka: Adherent Device) a patient-worn device which is applied to the . patient's torso. It contains the ECG electrodes for recording ECG and heart rate data.
- Patient Trigger Magnet used by the patient to manually trigger the ECG . collection when he/she experiences symptoms.
- . zLink® (aka: Gateway) – hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology.
- Server The Server receives sensor data from the PiiX via zLink. ECG and . heart rate are presented to learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians
The communication between the PiiX and the zLink is enabled via BlueTooth Technology. Sensor data and ECGs collected by the PiiX are transmitted to the Server via zLink.
The system components of the subject NUVANT are identical to the system components of the predicate NUVANT.
7
PREDICATE DEVICES
The predicate device is:
NUVANT Mobile Cardiac Telemetry System, Corventis, Inc. cleared by FDA under 510(k) number K111917; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFR 870.1025, MHX "Patient Physiological Monitor (with arrhythmia detection)"
The following table summarizes the compared features and the predicate device.
| Features being
| compared | Subject Devices | Predicate Devices |
|---|---|---|
| All technical | ||
| features | Subject NUVANT | Predicate NUVANT (K111971) |
| Indications for Use | Subject NUVANT | Predicate NUVANT (K111917) |
Features comparison and corresponding predicate devices
SUMMARY OF PERFORMACE TESTING
Both the subject and predicate NUVANT MCT meet the requirements of following performance standards in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm.
IEC 60601-1
Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
IEC 60601-1-2
Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004))
AAMI/ANSI EC38
Page 4 of 5
8
Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems, 2007.
AAMI/ANSI EC57
Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms, 1998/(R) 2008
CONCLUSION
The modifications proposed in the subject NUVANT System do not change the indications for use and do not change the fundamental scientific technology or use of the devices. As supported by the descriptive information and the bench tests, it is concluded that the subject NUVANT Mobile Cardiac Telemetry (NUVANT) System is as safe and as effective as the predicate device.
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