(95 days)
AVIVO™ Mobile Patient Management System
No
The description mentions "detection algorithms residing in the Adherent Device" and the server deriving physiological parameters and displaying ECG waveforms based on thresholds, but it does not explicitly mention or describe the use of AI or ML techniques. The focus is on standard signal processing and threshold-based detection.
No.
This device is designed for monitoring and detecting cardiac arrhythmias, not for treating or providing therapy for a condition.
Yes
The device is intended to monitor patients for the detection of non-lethal cardiac arrhythmias, measure and display ECG and heart rate, and provide visual notifications when heart rates are beyond a specified threshold. These functions are indicative of a diagnostic purpose to identify and characterize cardiac abnormalities.
No
The device description explicitly lists hardware components: "PiiX™ (a patient worn adherent device) with Magnet" and "zLink". These are physical devices that are part of the system, making it more than just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The NUVANT system directly measures and records physiological data (ECG, heart rate, activity, posture, etc.) from the patient's body via a patient-worn device (PiiX). It does not analyze samples taken from the body.
- Intended Use: The intended use is for monitoring patients for the detection of non-lethal cardiac arrhythmias, which is a direct physiological measurement and analysis, not an in vitro test.
The device is a physiological monitoring system.
N/A
Intended Use / Indications for Use
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
Product codes
QYX, DSI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Torso (patient-worn device applied to the patient's torso)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals (implied by "healthcare professionals can access" and prescription use)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K083287, K042022, K081365, K063222
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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and consists of a stylized eagle. The FDA logo is on the right and consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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.
2
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
3
KO90696
Indications for Use
510(k) Number (if known):
Device Names:
NUVANT™ Cardiac Event Monitor System NUVANT™ Mobile Cardiac Telemetry System
Indications for Use:
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
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
4
510(k) Summary of Safety & Effectiveness
50000
| Submitter Name & Address: | Corventis, Inc.
2226 N. First Street
San Jose, CA 95131 | JUN 19 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Contact Person: | Madhuri Bhat, VP, Clinical & Regulatory Affairs
408-790-9306 (phone)
408-790-9350 (fax) | |
| Trade/Proprietary Name: | NUVANT™ Cardiac Event Monitor System
NUVANT™ Mobile Cardiac Telemetry System | |
| Common/Usual Name: | Cardiac Event Monitor
Mobile Cardiac Telemetry | |
| 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): | Special 510(k): Device Modification | |
| | | |
Predicate Devices:
-
- 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)"
-
- 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"
-
- 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)"
-
- 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
5
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 �
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.
6
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.
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)"
-
- 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"
-
- 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)"
-
- 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"
7
| Comparables | Predicate Devices for CEM | Predicate Devices for MCT |
|---|---|---|
| Patient Trigger | ||
| Feature | E-Tac EX-1000 electrocardiographic Event Recorder | |
| (K042022) | ||
| Mechanism of the | ||
| Patient Trigger | ||
| Feature | SJM Confirm Model DM2100 Implantable Cardiac Monitor | |
| and Model DM 2100A Patient Activator (K081365) | ||
| All Other Features | AVIVO Mobile Patient Management System (K083287) | |
| Overall Product | E-Tac EX-1000 | |
| electrocardiographic Event | ||
| Recorder (K042022) | Cardionet Ambulatory ECG | |
| Monitor with Arrhythmia | ||
| Detections, 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.