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 monitors, derives and displays:

ECG
Heart Rate

Device Description

The NUVANT MCT System consists primarily of the PiX monitoring device and the zLink data transmission device. Once activated, the wearable PiX sensor continuously monitors the heart and automatically collects ECGs. When rhythm abnormalities are detected, data are automatically transmitted from the PiiX device to the zLink, which then automatically transmits the data to the Corventis Monitoring Center. Patients can also trigger transmission of ECGs when they experience cardiac symptoms by using the Patient Trigger Button. Certified cardiographic technicians at the Corventis Monitoring Center review received data and document symptoms reported by patients. Clinical reports, prepared by the Corventis Monitoring Center, are delivered and made available at www.corventis.com to provide data to prescribing physicians for the diagnosis and identification of various clinical conditions, events and/or trends.

AI/ML Overview

The provided document is a 510(k) summary for the NUVANT MCT System (K133701). This submission is for a special 510(k) due to device modifications, where the new device is compared to a previously cleared predicate device (NUVANT Mobile Cardiac Telemetry System, K113372). Therefore, the acceptance criteria and study information provided mainly focus on demonstrating that the modified device performs as well as the predicate device.

Here's a breakdown of the requested information based on the document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state a table of "acceptance criteria" with numerical performance metrics for the modified device in comparison to the predicate. Instead, it strongly emphasizes that the modified device operates identically to the predicate device in terms of fundamental scientific technology and intended use. The testing performed aimed to demonstrate that the changes did not negatively impact safety or effectiveness and that the system performs "as well as or better than the predicate device."

Acceptance Criteria (Implied)	Reported Device Performance
PiiX Component Functionality (after memory increase, two-part design, and button change)	All proposed changes were fully verified and validated in accordance with design control requirements. The system performs as well as the predicate device. Risk analysis and testing confirmed no new issues of safety or effectiveness.
Server Functionality (after software verification)	Software Verification Testing and System Validation Testing were performed. The system performs as well as the predicate device. Risk analysis and testing confirmed no new issues of safety or effectiveness.
Overall System Performance (NUVANT MCT System)	System Validation Testing was performed for both PiiX and Server components. The modified NUVANT MCT System is as safe and effective, and performs as well as or better than the predicate device. The fundamental scientific technology (sensors, algorithms, transmission) is identical to the predicate.
Biocompatibility of PiiX electrode assembly	The entire electrode assembly meets requirements of the ISO 10993 biocompatibility standard.
Electrical, Mechanical, and Firmware Performance of PiiX	Mechanical Verification Testing, Electrical Verification Testing, and Firmware Verification Testing were performed. The system performs as well as the predicate device.
Compliance with relevant standards (e.g., IEC 60601-1, ANSI/AAMI/IEC 60601-2-47, AAMI/ANSI EC57 for algorithms)	The listed standards were used, in whole or in part, to demonstrate substantial equivalence. (Implies compliance was achieved where applicable).
No impact on Intended Use or Indications for Use	The Intended Use and Indications for Use for the subject NUVANT MCT System are identical to the predicate device (K113372).

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

The document does not specify the sample size used for clinical test sets or the provenance (country of origin, retrospective/prospective) of any clinical data. The submission focuses on verification and validation testing of the device modifications, not a new clinical study. The changes described (increased memory, two-part PiiX, button instead of magnet) are primarily hardware and software modifications.

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 in the document. Given that this is a 510(k) for device modifications and not a new clinical trial, it's unlikely that external experts were used in this specific context to establish ground truth for a test set of clinical arrhythmias. The "certified cardiographic technicians at the Corventis Monitoring Center" are mentioned as reviewing data from the deployed system, but this relates to the operational use of the device, not the ground truth establishment for the pre-market testing of the modifications themselves.

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

The document does not describe any adjudication method for a test set. This type of detail is typically associated with clinical studies involving human interpretation of data, which is not the primary focus of this submission for device modifications.

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

No MRMC comparative effectiveness study was done or reported. The device is an "Arrhythmia detector and alarm," and its algorithms automatically detect and transmit ECGs. While algorithms are a core part of its function, the document does not mention any "AI assistance" provided to human readers, nor does it quantify any improvement in human reader performance. This submission focuses on validating the hardware and software changes, ensuring the device's automatic detection capabilities remain equivalent to the predicate.

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

Yes, a form of standalone performance assessment was implicitly done. The "proprietary algorithms based on rate, rhythm and morphology to continuously analyze rhythm abnormalities and to initiate automatic ECG transmission to the Server" are central to the device's function. The "Firmware Verification Testing" and "Software Verification Testing" likely assessed these algorithms' performance in a standalone context to ensure they continued to function correctly after the modifications. However, specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection) of these algorithms are not detailed in this summary. The document states that the "subject NUVANT MCT system uses the same sensors, in the same scientific methods (algorithms for detection and transmission methods), as the predicate NUVANT MCT System," suggesting that the algorithmic performance itself was not changed but rather confirmed to remain consistent.

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

The document does not explicitly state the type of ground truth used for algorithm validation. For arrhythmia detectors, ground truth typically involves manually annotated ECGs by cardiologists or other qualified medical professionals. Given that the algorithms are stated to be "identical to the predicate," it's reasonable to infer that the ground truth used for validating the original predicate device's algorithms would have been applied, and confirmed to perform similarly post-modification.

8. The sample size for the training set

The document does not provide any information regarding the sample size for a training set. This is a 510(k) for modifications to an existing device, and details about the original algorithm training would typically be in the initial 510(k) for the predicate device.

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

The document does not provide any information on how the ground truth for a training set was established. Similar to the previous point, such details would pertain to the development of the original algorithms in the predicate device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 6, 2023

Corventis, Inc. Cheryl Swanson Director, Quality And Regulatory Affairs 1410 Energy Park Drive, Suite 1 St. Paul. Minnesota 55108

Re: K133701

Trade/Device Name: Nuvant Mct 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 Cheryl Swanson:

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 February 6, 2014. 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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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an emblem featuring a stylized caduceus, with three human profiles facing to the right, representing health and human services.

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

February 6, 2014

Corventis. Inc Cheryl Swanson Director, Quality and Regulatory Affairs 1410 Energy Park Drive, Suite 1 St. Paul, MN 55108

Re: K133701 Trade/Device Name: NUVANT MCT 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: DSI Dated: January 7, 2014 Received: January 8, 2014

Dear Cheryl Swanson:

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. Iisting 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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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 of medical devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

for

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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SECTION 4 - INDICATIONS FOR USE STATEMENT

Indications for Use

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

Device Name: NUVANT® Mobile Cardiac Telemetry System

Indications for Use:

ECG
· Heart Rate

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Digitally signed by
Owen P. Faris -S
Date: 2014.02.06
15:10:29-05'00'

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SECTION 5 - 510(K) SUMMARY

The following table provides background information regarding this Special 510(k) submission:

Date Prepared:	December 2, 2013
Submission Type:	Special 510(k): Device Modification
Device Trade Name:	NUVANT MCT System
Device Model Number:	MCTX-SY-nnn
Device Common Name:	Mobile Cardiac Telemetry (MCT)
Classification Regulation	Arrhythmia detector and alarm
Name:	(including ST-segment measurementand alarm)
Product Code	DSI
Classification Regulation	21 CFR 870.1025
510(k) Submitter/OwnerName:	Corventis, Inc.
Submitter Address:	1410 Energy Park Drive, Suite 1St. Paul, MN 55108
Contact Person:	Cheryl SwansonDirector, Quality and Regulatory Affairs1410 Energy Park Drive, Suite 1St. Paul, MN 55108(651) 925-3803 (office)(651) 762-1824 (cell)(551) 389-3251 (fax)
Predicate Device:	NUVANT Mobile Cardiac TelemetrySystem, cleared by FDA under 510(k)number K113372 on March 7, 2012.
Prior Submissions for thisChange:	None

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5.1 DEVICE DESCRIPTION

Please note that the only changes in the Device Description relate to replacing the patient trigger magnet with a button.

5.1.1 HOW THE NUVANT MCT SYSTEM FUNCTIONS

Please note this is identical to the predicate NUVANT MCT System.

Once activated, the wearable PiiX sensor continuously monitors the heart and automatically transmits ECGs when rhythm abnormalities are detected.

Communication between the PiiX and zLink is enabled via BlueTooth™ technology, and communication between the zLink and the secure Corventis server is enabled via cellular technology.

5.1.2 SCIENTIFIC CONCEPTS OF THE DEVICE

The subject NUVANT MCT System uses proprietary algorithms based on rate, rhythm and morphology to continuously analyze rhythm abnormalities and to initiate automatic ECG transmission to the Server.

5.1.3 SIGNIFICANT PHYSICAL AND PERFORMANCE CHARACTERISTICS OF THE DEVICE

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The subject NUVANT MCT System is comprised of the following non-sterile components:

. PiiX
zLink .
Server ●

Please note these have always been cleared as a System, most recently under K113372.

PIIX

The PiiX is a patient-worn device applied to the patient's torso. It contains the electrode assembly and electronics module for recording ECG and heart rate data. The primary battery is contained in the electrode assembly and is a non-rechargeable Lithium Manganese Dioxide Thin Cell. The electronics module has a small 3V Manganese Silicon Lithium Rechargeable battery to maintain the Real Time Clock of the electronics module.

The electrode assembly (skin contacting portion) contains the following components that directly contact patient skin:

. Medical Grade Hydrogel Adhesive
Medical Grade Clear Polyurethane Tape .

The PiiX device lasts 7.5 days, and each package can contain up to four PiiX devices for up to 30 days of uninterrupted wear, depending on prescription length.

The entire electrode assembly meets requirements of the ISO 10993 biocompatibility standard.

ZLINK

Please note there are no changes to the zLink in this submission.

The zLink is the patient hand-held transceiver that receives information from the PiiX and transmits it to the Corventis Server. It also interacts with the Corventis Server to receive system configuration data and other relevant hardware diagnostic information.

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The zLink components are surrounded by a plastic housing and the zLink contains a rechargeable Lithium Ion battery.

SERVER

The Server receives information from the PiiX via the zLink. The secure server, among other things, derives, calculates and displays the patient's physiological parameters using the data collected by the PiiX.

5.2 INTENDED USE OF THE DEVICE

Please note that the Intended Use of the Device is identical to the Predicate NUVANT MCT System.

The NUVANT MCT System is intended for the ambulatory recording and monitoring of physiological parameter(s).

5.3 INDICATIONS FOR USE STATEMENT

Please note that the Indications for Use are identical to the predicate NUVANT MCT System.

ECG .
. Heart Rate

5.4 TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT NUVANT МСТ

The subject NUVANT MCT System operates identically to the predicate, based on the following fundamental scientific technology:

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. The collection of physiological parameters by a multi-sensor patientworn device (PiiX);
The transmission of these parameters to a remote Server through a . transceiver (zLink); and
The receipt of the parameters by the Server and subsequent derivation . into appropriate useful values for display.

This fundamental scientific technology is identical to the predicate NUVANT MCT System.

The only differences are non-fundamental to the scientific technology, as explained below :

1. Increase memory capacity of the PiiX to allow for continuous ECG recording and storage in device memory
1. Convert the PiiX into two parts consisting of an electrode assembly and an electronics module that can only be disassembled in the factory setting
1. Replace the patient trigger magnet with a push button on the PiiX

These proposed changes will not impact the fundamental scientific technology of the device. The subject NUVANT MCT system uses the same sensors, in the same scientific methods (algorithms for detection and transmission methods), as the predicate NUVANT MCT System.

5.5 SUMMARY OF TESTING

All of the proposed changes to the subject NUVANT MCT System were fully verified and validated in accordance with design control requirements.

5.5.1 SUMMARY OF TESTS USED TO DEMONSTRATE SUBSTANTIAL EQUIVALENCE

The Subject NUVANT MCT System is supported by the following tests to demonstrate substantial equivalence. Note that the zLink is unchanged in this submission, but was used in system validation tests and is further supported by the same tests as the Predicate NUVANT MCT System.

PiiX Verification and Validation Testing

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K133701 Page 6 of 9

Biocompatibility Testing .
. Mechanical Verification Testing
Electrical Verification Testing .
Firmware Verification Testing .
System Validation Testing .

Server Verification and Validation Tests

Software Verification Testing ●
. System Validation Testing

5.5.2 GUIDANCE DOCUMENTS USED / CONSIDERED IN THESE DEVICE MODIFICATIONS

Guidance documents used/considered for these device modifications include, but are not limited to, the following:

. Draft Guidance Document titled Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued June 14, 2013
Draft Guidance Document titled Use of International Standard ISO . 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, issued on April 23, 2013
Draft Guidance Document titled Design Considerations for Devices . Intended for Home Use, issued December 12, 2012
Radio Frequency Wireless Technology in Medical Devices, issued on . August 14, 2013
Guidance for the Content of Premarket Submissions for Software . Contained in Medical Devices, issued May 11, 2005
Class II Special Controls Guidance Document, Arrhythmia Detector and . Alarm, issued on October 28, 2003.

5.5.3 STANDARDS USED TO DEMONSTRATE SUBSTANTIAL EQUIVALENCE

The following standards were also used, in whole or in part, to demonstrate substantial equivalence:

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Standards No.	Standards Title	FDARecognitionNo.
IEC 60601-1	Medical electrical equipment -Part 1: General Requirements forBasic Safety and EssentialPerformance, 2006/A11:2011	5-4
IEC 60601-1-2	Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirements andtests (Edition 3), 2007	5-53
ANSI/AAMI/IEC60601-2-47:2012	Medical electrical equipment -Part 2-47: Particularrequirements for the safety andessential performance ofambulatory electrocardiographicsystems	ThisstandardreplacesEC38 (FDArecognitionnumber 3-65)
AAMI/ANSI/IEC62304:2006	Medical Device Software -Software life cycle processes	13-32
AAMI/ANSI EC12	Disposable ECG electrodes,2000(R) 2010	3-52
Standards No.	Standards Title	FDARecognitionNo.
AAMI/ANSI EC57	Testing and reportingperformance results of cardiacrhythm and ST-segmentmeasurement algorithms,1998/(R) 2008	3-73
AAMI/ANSI/ISO10993-1:2009	Biological evaluation of medicaldevices - Part 1: Evaluation andtesting within a risk managementprocess	2-156
AAMI/ANSI/ISO10993-5:2009	Biological evaluation of medicaldevices - Part 5: Tests for invitro cytotoxicity	2-153
AAMI/ANSI/ISO10993-10:2010	Biological evaluation of medicaldevices - Part 10: Tests forirritation and skin sensitization	2-174

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The results of the testing indicate that the subject NUVANT MCT System performs as intended. Risk analysis and testing further confirmed that the changes did not introduce any new issues of safety or effectiveness, and the system performs as well as the predicate device.

5.6 CONCLUSION

The Indications for Use for the subject NUVANT MCT System are identical to our previous device (K113372). We have provided summary data to demonstrate reasonable assurance of the safety and effectiveness of the subject NUVANT MCT System and to demonstrate substantial equivalence to its predicate.

As supported by the descriptive information, verification, validation and standards testing, the modified NUVANT MCT System is as safe and effective, and performs as well as or better than the predicate device.

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Therefore, the NUVANT MCT System is substantially equivalent to the legally marketed predicate device.

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.