The NUVANT" Cardiac Event Monitor (CEM) System and the NUVANT "Mobile Cardiac Telemetry (MCT) System are intended to continuously measure, record, and periodically transmit physiological data. The Systems are indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. Both NUVANT system models monitor, derive and display:

ECG
Heart rate

The Systems may also monitor, derive and display:

Activity
Posture
Respiration rate (including RR Variability)
Body fluid status
Heart rate variability

Device Description

The NUVANT™ Cardiac Event Monitor System and the NUVANT™ Mobile Cardiac Telemetry System include the following components:

PiiX™ (a patient worn adherent device) with Magnet
zLink
Server

The PiiX is a patient-worn device which is applied to the patient's torso. The Adherent Device monitors the patient's ECG in a looping mode. There are three circumstances under which the ECG data will be recorded: (i) when the device is first applied and activated, a baseline ECG is collected, (ii) when the detection algorithms residing in the Adherent Device trigger the collection, or (iii) when the patient activates the collection using the magnet. When the ECG collection is triggered, a total of 45 seconds of ECG signals will be collected, with 15 seconds of pre-event and 30 seconds post-event. Same as the AVIVO™ Mobile Patient Management System (predicate device), the PiiX has additional sensors which monitor other physiological parameters described in the Indications for Use Statement. The collected ECG signals and the other sensor data will be transmitted to the Server via the zLink.

The zLink receives information from the PiiX and transmits them to the Corventis Server. It also interacts with the Corventis Server to receive configuration updates and other relevant hardware diagnostic information.

The Server of the CEM/MCT receives information from the PiiX via zLink. The secure server performs the following functions:

Derive physiological parameters using the raw data collected by the Adherent Device.
Display the physiological parameters in trend graphs format.
Display ECG waveform when the heart rates are beyond the specified threshold.
Provide visual notifications when healthcare professionals need to be aware of heart rates that are beyond the specified threshold.
Provide the users the ability to select CEM vs. MCT prescription.
Provide the users the ability to acknowledge or dismiss events.

The communication between the PiiX and the zLink is enabled via the BlueTooth™ Technology. The zLink transmits the data to the Server via cellular technology, where healthcare professionals can access with standard browsers.

AI/ML Overview

This document describes the NUVANT™ Cardiac Event Monitor (CEM) System and the NUVANT™ Mobile Cardiac Telemetry (MCT) System, but it is a regulatory filing (510(k) summary) focused on demonstrating substantial equivalence to predicate devices, not on presenting a standalone study with detailed acceptance criteria and performance data.

Therefore, much of the requested information regarding specific acceptance criteria, study details, and performance metrics is not explicitly present in the provided text. The document primarily focuses on comparing the new device's intended use and technological characteristics to established predicate devices to argue for substantial equivalence.

Here's an attempt to answer based on the available information, with specific notes on what is not found:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The filing states that the NUVANT systems "have the same intended use, similar operating principles and technological characteristics as their predicate devices" and that "design verification tests" were conducted, but it does not specify the acceptance criteria for these tests or report their numerical performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document makes no mention of a clinical test set, its sample size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. As no clinical test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Again, no clinical test set is described.

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

This information is not provided. The document describes a device for continuously measuring, recording, and transmitting physiological data for cardiac arrhythmia detection. It does not mention any AI component in the context of improving human reader performance, nor does it detail a comparative effectiveness study involving human readers.

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

The document mentions that the PiiX device has "detection algorithms residing in the Adherent Device" which trigger data collection. While this implies an algorithm operating in a standalone fashion to detect events, the document does not provide any performance metrics for these algorithms in a standalone study. The primary focus is on the device's overall functionality and equivalence to predicate devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. Given the absence of detailed study results, the method for establishing ground truth for any internal validation is not described.

8. The sample size for the training set

This information is not provided. There is no mention of a training set or its size in the document.

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

This information is not provided. No training set is described.

Summary of what's largely missing:

The provided document is a 510(k) summary, which aims to demonstrate that a new device is "substantially equivalent" to legally marketed predicate devices. This typically involves showing similar indications for use, technological characteristics, and safety and effectiveness, often through engineering and performance testing that is compared to the predicate device's known characteristics, rather than extensive, detailed clinical trials with specific acceptance criteria and performance reporting as might be found in a primary clinical study publication.

The "Conclusions" section states: "As supported by the descriptive information and the design verification tests, it is concluded that the NUVANT™ Cardiac Event Monitor (CEM) System and the NUVANT™ Mobile Cardiac Telemetry (MCT) System are as safe and effective as the predicate devices." This implies that the 'design verification tests' served as the basis for proving equivalence, but the specifics of these tests are not publicly detailed in this document.

Summary

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December 6, 2023

Corventis, Inc. Dawn Chang Senior Regulatory Affairs Associate 2226 N. First Street San Jose, California 95131

Re: K090696

Trade/Device Name: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry 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, DSI

Dear Dawn Chang:

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 June 19, 2009. 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 a logo for the U.S. Department of Health and Human Services. The logo features a stylized human figure with three flowing lines extending from it. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the logo. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

19 2009 . IIIN

Corventis, Inc. c/o Ms. Dawn Chang Senior Regulatory Affairs Associate 2226 N. First Street San Jose, CA 95131

Re: K090696

Trade/Device Name: NUVANTTM Cardiac Event Monitor System, and NUVANT™ Mobile Cardiac Telemetry System

Regulation Number: 21 CFR 870:1025

Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm)

Regulatory Class: Class II (Two)

Product Code: DSI

Dated: May 19, 2009

Received: May 20, 2009

Dear Ms. Chang:

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. I i

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Dawn Chang

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240). 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

er R. haines

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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KO90696

Indications for Use

510(k) Number (if known):

Device Names:

NUVANT™ Cardiac Event Monitor System NUVANT™ Mobile Cardiac Telemetry System

Indications for Use:

ECG
Heart rate

The Systems may also monitor, derive and display:

Activity
Posture
Respiration rate (including RR Variability)
Body fluid status
Heart rate variability

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)

Page / of

uriel D. Vorhies

(Division Sign-Off) Division of Cardrovascular Devices

510(k) Number_K090696

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510(k) Summary of Safety & Effectiveness

50000

Submitter Name & Address:	Corventis, Inc.2226 N. First StreetSan Jose, CA 95131	JUN 19
Contact Person:	Madhuri Bhat, VP, Clinical & Regulatory Affairs408-790-9306 (phone)408-790-9350 (fax)
Trade/Proprietary Name:	NUVANT™ Cardiac Event Monitor SystemNUVANT™ Mobile Cardiac Telemetry System
Common/Usual Name:	Cardiac Event MonitorMobile Cardiac Telemetry
Classification Name:	Arrhythmia Detector and Alarm(21 CFR 870.1025, Product Code DSI)Patient Physiological Monitor (with arrhythmiadetection)(21 CFR 870.1025, Product Code MHX)
Class:	Class II, Special Controls
510(k):	Special 510(k): Device Modification

Predicate Devices:

1. AVIVO Mobile Patient Management System, Corventis, Inc., cleared by FDA under 510(k) number K083287; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFR 870.1025, MHX "Patient Physiological Monitor (with arrhythmia detection)"
1. E-Tac EX-1000 electrocardiographic Event Recorder, Datrix, Inc., cleared by FDA under 510(k) number K042022; 21 CFR 870.2920, DXH "Telephone electrocardiographic transmitter and receiver"
1. SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM 2100A Patient Activator, St. Jude Medical, CRMD, cleared by FDA under 510(k) number K081365; 21 CFR 870.2800, MXC "Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)"
1. Cardionet Ambulatory ECG Monitor with Arrhythmia Detections, Model CN1004, Cardionet, Inc., cleared by FDA under 510(k) number K063222: CFR 870.1025, DSI "Arrhythmia Detector and Alarm"

Page 1 of 4

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Indication for Use Statement:

The NUVANT™ Cardiac Event Monitor (CEM) System and the NUVANT™ Mobile Cardiac Telemetry (MCT) System are intended to continuously measure, record and periodically transmit physiological data. The Systems are indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. Both NUVANT system models monitor, derive and display:

. ECG
Heart Rate ●

The Systems may also monitor, derive and display:

Activity ●
. Posture
Respiration rate (including RR variability) .
Body fluid status .
Heart rate variability .

Technological Characteristics and Substantial Equivalence

The NUVANT™ Cardiac Event Monitor System and the NUVANT™ Mobile Cardiac Telemetry System include the following components:

PiiX™ (a patient worn adherent device) with Magnet .
zLink .
Server �

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The Server of the CEM/MCT receives information from the PiiX via zLink. The secure server performs the following functions:

Derive physiological parameters using the raw data collected by the Adherent . Device.
Display the physiological parameters in trend graphs format. .
. Display ECG waveform when the heart rates are beyond the specified threshold.
. Provide visual notifications when healthcare professionals need to be aware of heart rates that are beyond the specified threshold.
. Provide the users the ability to select CEM vs. MCT prescription.
Provide the users the ability to acknowledge or dismiss events. .

Four (4) predicate devices have been identified for the various aspects of the CEM System and MCT System. They are:

l . AVIVO Mobile Patient Management System, Corventis, Inc., cleared by FDA under 510(k) number K083287; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFR 870.1025, MHX "Patient Physiological Monitor (with arrhythmia detection)"
1. E-Tac EX-1000 electrocardiographic Event Recorder, Datrix, Inc., cleared by FDA under 510(k) number K042022: 21 CFR 870.2920. DXH "Telephone electrocardiographic transmitter and receiver"
1. SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM 2100A Patient Activator, St. Jude Medical, CRMD, cleared by FDA under 510(k) number K081365; 21 CFR 870.2800, MXC "Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)"
1. Cardionet Ambulatory ECG Monitor with Arrhythmia Detections, Model CN1004, Cardionet, Inc., cleared by FDA under 510(k) number K063222; CFR 870.1025, DSI "Arrhythmia Detector and Alarm"

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Comparables	Predicate Devices for CEM	Predicate Devices for MCT
Patient TriggerFeature	E-Tac EX-1000 electrocardiographic Event Recorder(K042022)
Mechanism of thePatient TriggerFeature	SJM Confirm Model DM2100 Implantable Cardiac Monitorand Model DM 2100A Patient Activator (K081365)
All Other Features	AVIVO Mobile Patient Management System (K083287)
Overall Product	E-Tac EX-1000electrocardiographic EventRecorder (K042022)	Cardionet Ambulatory ECGMonitor with ArrhythmiaDetections, Model CN1004(K063222)

Conclusions

The NUVANT™ Cardiac Event Monitor (CEM) System and the NUVANT™ Mobile Cardiac Telemetry (MCT) System models have the same intended use, similar operating principles and technological characteristics as their predicate devices. As supported by the descriptive information and the design verification tests, it is concluded that the NUVANT™ Cardiac Event Monitor (CEM) System and the NUVANT™ Mobile Cardiac Telemetry (MCT) System are as safe and 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.