NUVANT MCT SYSTEM

K133701 · Corventis, Inc. · QYX · Feb 6, 2014 · Cardiovascular

Device Facts

• Record ID: K133701
• Device Name: NUVANT MCT SYSTEM
• Applicant: Corventis, Inc.
• Product Code: QYX · Cardiovascular
• Decision Date: Feb 6, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

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 monitors, derives and displays: - ECG - Heart Rate

Device Story

NUVANT MCT System provides ambulatory cardiac monitoring. System components: PiiX (wearable sensor) and zLink (handheld transceiver). PiiX continuously monitors ECG/heart rate; uses proprietary algorithms (rate, rhythm, morphology) to detect abnormalities. Upon detection, PiiX transmits data via Bluetooth to zLink; zLink transmits to secure Corventis server via cellular network. Patients use push button to trigger manual ECG transmission during symptoms. Certified cardiographic technicians at Corventis Monitoring Center review data, document symptoms, and prepare clinical reports for prescribing physicians via web portal. System aids diagnosis/identification of cardiac conditions/trends. Modifications include increased PiiX memory, two-part PiiX construction, and replacement of trigger magnet with push button.

Clinical Evidence

Bench testing only. No clinical data presented. Substantial equivalence supported by verification and validation testing, including biocompatibility (ISO 10993), mechanical, electrical, firmware, and system-level validation. Performance of cardiac rhythm and ST-segment measurement algorithms verified per AAMI/ANSI EC57.

Technological Characteristics

Components: PiiX (wearable, medical-grade hydrogel/polyurethane), zLink (transceiver), Server. PiiX battery: Lithium Manganese Dioxide Thin Cell. Connectivity: Bluetooth (PiiX to zLink), cellular (zLink to Server). Standards: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI/IEC 60601-2-47, AAMI/ANSI/IEC 62304, AAMI/ANSI EC12, AAMI/ANSI EC57, ISO 10993-1/5/10. Software: AAMI/ANSI/IEC 62304 compliant.

Indications for Use

Indicated for patients requiring monitoring for detection of non-lethal cardiac arrhythmias, including supraventricular tachycardias (atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias, and conduction disorders.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• NUVANT Mobile Cardiac Telemetry System (K113372)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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:

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

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 measurement<br>and alarm) |
| Product Code | DSI |
| Classification Regulation | 21 CFR 870.1025 |
| 510(k) Submitter/Owner<br>Name: | Corventis, Inc. |
| Submitter Address: | 1410 Energy Park Drive, Suite 1<br>St. Paul, MN 55108 |
| Contact Person: | Cheryl Swanson<br>Director, Quality and Regulatory Affairs<br>1410 Energy Park Drive, Suite 1<br>St. Paul, MN 55108<br>[phone] (office)<br>[phone] (cell)<br>[phone] (fax) |
| Predicate Device: | NUVANT Mobile Cardiac Telemetry<br>System, cleared by FDA under 510(k)<br>number K113372 on March 7, 2012. |
| Prior Submissions for this<br>Change: | 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.

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.

#### 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.

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

### 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
- 2. Convert the PiiX into two parts consisting of an electrode assembly and an electronics module that can only be disassembled in the factory setting
- 3. 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 | FDA<br>Recognition<br>No. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| IEC 60601-1 | Medical electrical equipment -<br>Part 1: General Requirements for<br>Basic Safety and Essential<br>Performance, 2006/A11:2011 | 5-4 |
| IEC 60601-1-2 | Medical electrical equipment -<br>Part 1-2: General requirements<br>for basic safety and essential<br>performance - Collateral<br>standard: Electromagnetic<br>compatibility - Requirements and<br>tests (Edition 3), 2007 | 5-53 |
| ANSI/AAMI/IEC<br>60601-2-47:2012 | Medical electrical equipment -<br>Part 2-47: Particular<br>requirements for the safety and<br>essential performance of<br>ambulatory electrocardiographic<br>systems | This<br>standard<br>replaces<br>EC38 (FDA<br>recognition<br>number 3-<br>65) |
| AAMI/ANSI/IEC<br>62304:2006 | Medical Device Software -<br>Software life cycle processes | 13-32 |
| AAMI/ANSI EC12 | Disposable ECG electrodes,<br>2000(R) 2010 | 3-52 |
| Standards No. | Standards Title | FDA<br>Recognition<br>No. |
| AAMI/ANSI EC57 | Testing and reporting<br>performance results of cardiac<br>rhythm and ST-segment<br>measurement algorithms,<br>1998/(R) 2008 | 3-73 |
| AAMI/ANSI/ISO<br>10993-1:2009 | Biological evaluation of medical<br>devices - Part 1: Evaluation and<br>testing within a risk management<br>process | 2-156 |
| AAMI/ANSI/ISO<br>10993-5:2009 | Biological evaluation of medical<br>devices - Part 5: Tests for in<br>vitro cytotoxicity | 2-153 |
| AAMI/ANSI/ISO<br>10993-10:2010 | Biological evaluation of medical<br>devices - Part 10: Tests for<br>irritation 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.