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

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.

AI/ML Overview

This document is a 510(k) premarket notification for an administrative change to the NUVANT Mobile Cardiac Telemetry (MCT) System (K113372). It details the substantial equivalence to a predicate device (K111917) and mentions performance testing for safety standards but does not present an independent study with acceptance criteria and device performance for the subject device beyond compliance with general safety and performance standards.

The document explicitly states: "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."

Therefore, the device's performance and acceptance criteria are considered to be met by its substantial equivalence to the predicate device and its compliance with recognized safety and performance standards. The submission doesn't include a new, independent study to "prove the device meets acceptance criteria" for arrhythmia detection performance, but rather asserts that the modification does not negatively impact the existing demonstrated safety and effectiveness.

Here’s a breakdown of the requested information based on the provided document, with an emphasis on what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria (e.g., sensitivity, specificity for arrhythmia detection) or direct performance data for arrhythmia detection of the subject NUVANT system are presented in this document. The document states that the subject NUVANT system meets the requirements of listed performance standards (IEC 60601-1, IEC 60601-1-2, AAMI/ANSI EC38, AAMI/ANSI EC57) and is substantially equivalent to its predicate. The predicate device (K111917) would have had such performance data, but it is not included in this document.

Acceptance Criteria	Reported Device Performance (Subject NUVANT System)
Compliance with Standards:
IEC 60601-1 (General Safety)	Meets requirements
IEC 60601-1-2 (EMC)	Meets requirements
AAMI/ANSI EC38 (Ambulatory ECG Systems)	Meets requirements
AAMI/ANSI EC57 (Cardiac Rhythm & ST-Segment Algorithms)	Meets requirements
Arrhythmia Detection Performance (e.g., sensitivity, specificity for SVT, AF, Ventricular Ectopy)	Not explicitly provided in this document as part of the K113372 submission. Performance is inferred from substantial equivalence to K111917.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable as an independent performance study for arrhythmia detection was not conducted or reported in this 510(k) submission for the subject device. The submission focuses on a modification that does not impact the device's fundamental scientific technology or indications for use.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable as an independent performance study for arrhythmia detection was not conducted or reported in this 510(k) submission for the subject device. Compliance with AAMI/ANSI EC57 implies that ground truth would have been established by qualified experts during the development and testing of the predicate device's algorithms, but details are not in this document.

4. Adjudication Method for the Test Set

Not applicable as an independent performance study for arrhythmia detection was not conducted or reported in this 510(k) submission for the subject device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or conducted as part of this 510(k) submission.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Not explicitly presented in this document for the subject device. The document mentions compliance with AAMI/ANSI EC57, which outlines methods for testing cardiac rhythm algorithms, but no specific results from such testing for the subject device are provided here. The NUVANT system description explicitly states that "interpretation services provided by learned intermediaries in the Corventis Monitoring Center" are part of the system, indicating a human-in-the-loop component for the overall clinical use.

7. Type of Ground Truth Used

Not applicable as specific performance data from a new study is not provided. For arrhythmia detection algorithms compliant with AAMI/ANSI EC57, ground truth is typically established by expert cardiologists/electrophysiologists manually reviewing and annotating ECG recordings.

8. Sample Size for the Training Set

Not applicable as this document does not describe the development or training of new algorithms. It concerns a modification to an already cleared device.

9. How the Ground Truth for the Training Set Was Established

Not applicable as this document does not describe the development or training of new algorithms.

Summary

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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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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

Enclosure

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Indications for Use

KII3372

510(k) Number (if known): N/A

Device Name: NUVANT® Mobile Cardiac Telemetry

Indications for Use:

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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MAR - 7 2012

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SECTION 7 - 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter Name & Address:	Corventis, Inc.1410 Energy Park Drive, Suite 1St. 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

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K113372

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

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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

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.

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PREDICATE DEVICES

The predicate device is:

The following table summarizes the compared features and the predicate device.

Features beingcompared	Subject Devices	Predicate Devices
All technicalfeatures	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

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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.

Page 5 of 5

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.