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.

Device Description

The NUVANT MCT System is 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

The provided text describes an Abbreviated 510(k) submission for the NUVANT Mobile Cardiac Telemetry (MCT) System, focusing on adding clarifying language to its indications for use. It asserts that this clarification does not alter the fundamental safety and effectiveness of the device compared to its predicates. However, the document does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria.

The document refers to the device meeting general performance standards, but it does not provide the specific data from a study to demonstrate this.

Therefore, I cannot fulfill all parts of your request with the provided information. I can, however, extract related details:

Missing Information:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set.
Data provenance for the test set (country of origin, retrospective/prospective).
Number of experts used to establish ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI vs. without AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
The sample size for the training set.
How the ground truth for the training set was established.

Information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from regulatory standards)	Reported Device Performance (Inferred from submission statement)
Conformance to IEC 60601-1 (Safety)	Meets requirements of IEC 60601-1
Conformance to IEC 60601-1-2 (EMC)	Meets requirements of IEC 60601-1-2
Conformance to AAMI/ANSI EC38 (Ambulatory ECG Systems)	Meets requirements of AAMI/ANSI EC38
Conformance to AAMI/ANSI EC57 (Cardiac Rhythm/ST-segment)	Meets requirements of AAMI/ANSI EC57
Equivalence to Predicate Devices (Safety & Effectiveness)	"As safe and as effective as the predicate devices"

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: Not specified. The document only mentions "bench tests" for supporting the claim of safety and effectiveness.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document mentions "learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only)" for real-world operation, but this is not tied to establishing ground truth for a test set in the context of the device's validation for this submission.

4. Adjudication method for the test set:

Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not specified. The NUVANT system involves human interpretation (Corventis cardiographic technicians and prescribing physicians), but the document does not describe an MRMC study or quantify human improvement with AI assistance. The system itself is characterized as an "arrhythmia detection system" that, in combination with human interpretation services, enables arrhythmia detection.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document implies the algorithm performs "arrhythmia detection" and transmits data. However, the statement "In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data... NUVANT MCT enables arrhythmia detection" suggests that the full "arrhythmia detection" capability for clinical use involves a human-in-the-loop. A standalone performance study of only the algorithm is not explicitly described with metrics.

7. The type of ground truth used:

Not specified. The document refers to meeting performance standards and "bench tests" without detailing how ground truth data for these tests were derived.

8. The sample size for the training set:

Not specified. The document does not mention an "AI" or machine learning component in a way that suggests a distinct training set. It focuses on the device hardware and its embedded detection capabilities.

9. How the ground truth for the training set was established:

Not specified, as a training set is not explicitly mentioned.

Summary of what the document DOES state regarding "proving" criteria:

The document relies on the following to demonstrate the device's safety and effectiveness:

Substantial Equivalence: The primary assertion is that the "subject NUVANT" is "as safe and as effective as the predicate devices" (NUVANT K091971 and CardioNet CN1005). This is a foundational premise of 510(k) submissions.
Conformance to Industry Standards: The device meets the requirements of:
- IEC 60601-1 (General Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- AAMI/ANSI EC38 (Ambulatory Electrocardiographic Systems)
- AAMI/ANSI EC57 (Cardiac Rhythm and ST-segment Measurement Algorithms)
Bench Tests: The document states that the conclusion of safety and effectiveness is "As supported by the descriptive information and the bench tests". However, no details about these bench tests or their results are provided.
Minor Change: The core argument for this specific 510(k) is that the proposed change (clarifying language in the indications for use) does not alter the fundamental scientific technology, intended use, safety, or effectiveness of the device.

Summary

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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 logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

November 15, 2023

Corventis, Inc. Michele Chin-Purcell Senior Director 1410 Energy Park Drive, Suite 1 St. Paul, Minnesota 55108

Re: K111917

Trade/Device Name: Nuvant, Mobile 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

Dear Michele Chin-Purcell:

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 August 24, 2011. 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

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and the pursuit of well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

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

Corventis, Inc. c/o Michele Chin-Purcell, Ph.D. Senior Director, Quality and Regulatory Affairs 1410 Energy Park Drive, Suite 1 St. Paul, MN 55108

AUG 2 4 2011

ﻟﻠﺒﻨﺎﻧﻴﺔ

ﻷﺷﺘ

Re: K111917

Trade/Device Name: Nuvant Mobile Cardiac Telemetry Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms)
Regulatory Class: II (two) Regulatory Class: II (two) Product Code: 74 MHX Dated: July 5, 2011 Received: July 6, 2011

Dear Dr. Chin-Purcell:

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 marked prodicated in the indicat for use stated in the enclosure) to legally marketed predicate devices marketed in interstated
for use stated in the enclosure) to legally marketed in interstate comments on the enclosin's to tegally marketed predical Devices marketed in interested
comments to May 28, 1976, the enactment date of the Medical Device Amendments, or o devices that have been reclassified in accordance with the provisions of the Federals, or to
and Cosmetic Act (Act) that do not require with the provisions of the Federal Foo and Cosmetic Act (Act) that do not require approval of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market he device, subject to the general controls provisions of PMA),
You may, therefore, market the device, subject to the general controls of the Act. general controls provisions of the Act include requirements for annual registration, fisting of devices, good manufacturing practice, labeling, and prohibitions against misting
adulteration.

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 affective your device controls) or class il! (PMA),
found in the Code of Federal Repulations, Title 21 R 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 - Michele Chin-Purcell, Ph.D.

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.fdaggov/AboutFDA/CentersOffices/CDRH/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.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 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

3
2
1

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િન

111

Indications for Use

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 __ X (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)
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(Division Sign Off)

Page 1 of 1

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K111912

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AUG 2 4 2011

2017 13:30 Presi

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):	Abbreviated 510(k)
Date Prepared:	July 5, 2011

Predicate Devices:

1. NUVANT Mobile Cardiac Telemetry System, Corventis, Inc. cleared by FDA under 510(k) number K091971; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFR 870.1025, MHX "Patient Physiological Monitor (with arrhythmia detection)"
1. CardioNet ECG Monitor with Arrhythmia Detection Model CN1005, CardioNet Inc., cleared by FDA under K072558; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm"

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The following is the subject device of this Abbreviated 510(k):

The NUVANT Mobile Cardiac Telemetry System (hereafter referred to as . "subject NUVANT")
This submission proposes to add clarifying language (e.g., listing the type of non-lethal arrhythmias) to the predicate NUVANT indications for use. This clarifying language is similar to that used in the predicate device from CardioNet. This change is for clarification and 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 intent of the subject devices remains the same as that of the predicate devices, which is to monitor ECG and heart rate.

INDICATION FOR USE:
FOR USE ONLY WITH THE ALIGNER REMOVAL INSTRUMENT

The following are the proposed indications for use in this submission:

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 .

Section 7: Summary of Safety and Effectiveness

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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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Two (2) predicate devices have been identified:

1. NUVANT Mobile Cardiac Telemetry System, Corventis, Inc. cleared by FDA under 510(k) number K091971; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFR 870.1025, MHX "Patient Physiological Monitor (with arrhythmia detection)"
1. CardioNet ECG Monitor with Arrhythmia Detection Model CN1005, CardioNet Inc., cleared by FDA under K072558; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm"

The following table summarizes the compared features and the corresponding predicate devices.

Features beingcompared	Subject Devices	Predicate Devices
All technicalfeatures	Subject NUVANT	Predicate NUVANT (K091971)CardioNet CN1005 (K072558)
Indications for Use	Subject NUVANT	Predicate NUVANT (K091971)CardioNet CN1005 (K072558)

Features comparison and corresponding predicate devices

THE OF BEREORING FOR THE

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

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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

The modifications proposed in the subject NUVANT System make clarifications to 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 NUVANT Mobile Cardiac Telemetry (NUVANT) Systems are as safe and as effective as 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.