(65 days)
Not Found
No
The description focuses on automatic detection and transmission of rhythm abnormalities based on predefined criteria, not on learning or adaptive algorithms. There is no mention of AI, ML, or related concepts.
No
The device is intended for monitoring and diagnosis of cardiac arrhythmias, not for treatment.
Yes
The device is intended for "monitoring for the detection of non-lethal cardiac arrhythmias" and "to provide data to prescribing physicians for the diagnosis and identification of various clinical conditions, events and/or trends." This directly indicates its use in identifying and understanding medical conditions, which is the definition of a diagnostic device.
No
The device description explicitly states that the system consists of a "PiX monitoring device" and a "zLink data transmission device," both of which are described as hardware components (wearable sensor, data transmission device). The performance studies also include "PiiX Verification and Validation Testing" which covers mechanical, electrical, and firmware testing, indicating hardware components are part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The NUVANT Mobile Cardiac Telemetry (MCT) System is a wearable device that continuously monitors and records physiological data (ECG and Heart Rate) directly from the patient's body (torso). It does not analyze samples taken from the body.
- Intended Use: The intended use is for monitoring and detecting cardiac arrhythmias, which is done by analyzing electrical signals from the heart, not by testing biological samples.
The system is a medical device for physiological monitoring and data transmission, not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes
QYX, DSI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's torso (for the PiiX device)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescribing physicians (for diagnosis), Certified cardiographic technicians at the Corventis Monitoring Center (for data review and symptom documentation)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All of the proposed changes to the subject NUVANT MCT System were fully verified and validated in accordance with design control requirements.
PiiX Verification and Validation Testing:
- 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NUVANT Mobile Cardiac Telemetry System, K113372
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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.
2
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:
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 |
| and alarm) | |
| Product Code | DSI |
| Classification Regulation | 21 CFR 870.1025 |
| 510(k) Submitter/Owner | |
| Name: | Corventis, Inc. |
| Submitter Address: | 1410 Energy Park Drive, Suite 1 |
| St. Paul, MN 55108 | |
| Contact Person: | Cheryl Swanson |
| Director, Quality and Regulatory Affairs | |
| 1410 Energy Park Drive, Suite 1 | |
| St. Paul, MN 55108 | |
| (651) 925-3803 (office) | |
| (651) 762-1824 (cell) | |
| (551) 389-3251 (fax) | |
| Predicate Device: | NUVANT Mobile Cardiac Telemetry |
| System, cleared by FDA under 510(k) | |
| number K113372 on March 7, 2012. | |
| Prior Submissions for this | |
| Change: | None |
5
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
6
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.
7
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:
8
- . 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 :
-
- Increase memory capacity of the PiiX to allow for continuous ECG recording and storage in device memory
-
- Convert the PiiX into two parts consisting of an electrode assembly and an electronics module that can only be disassembled in the factory setting
-
- 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:
10
| Standards No. | Standards Title | FDA
Recognition
No. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| IEC 60601-1 | Medical electrical equipment -
Part 1: General Requirements for
Basic Safety and Essential
Performance, 2006/A11:2011 | 5-4 |
| IEC 60601-1-2 | Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
standard: Electromagnetic
compatibility - Requirements and
tests (Edition 3), 2007 | 5-53 |
| ANSI/AAMI/IEC
60601-2-47:2012 | Medical electrical equipment -
Part 2-47: Particular
requirements for the safety and
essential performance of
ambulatory electrocardiographic
systems | This
standard
replaces
EC38 (FDA
recognition
number 3-
65) |
| AAMI/ANSI/IEC
62304:2006 | Medical Device Software -
Software life cycle processes | 13-32 |
| AAMI/ANSI EC12 | Disposable ECG electrodes,
2000(R) 2010 | 3-52 |
| Standards No. | Standards Title | FDA
Recognition
No. |
| AAMI/ANSI EC57 | Testing and reporting
performance results of cardiac
rhythm and ST-segment
measurement algorithms,
1998/(R) 2008 | 3-73 |
| AAMI/ANSI/ISO
10993-1:2009 | Biological evaluation of medical
devices - Part 1: Evaluation and
testing within a risk management
process | 2-156 |
| AAMI/ANSI/ISO
10993-5:2009 | Biological evaluation of medical
devices - Part 5: Tests for in
vitro cytotoxicity | 2-153 |
| AAMI/ANSI/ISO
10993-10:2010 | Biological evaluation of medical
devices - Part 10: Tests for
irritation and skin sensitization | 2-174 |
11
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.