(88 days)
Not Found
No
The description focuses on data collection, transmission, derivation of parameters, and display, without mentioning AI or ML algorithms for analysis or interpretation.
No.
The device is intended for monitoring and detection of physiological data and non-lethal cardiac arrhythmias, not for providing therapy or treatment.
Yes
The device is intended for "detection of non-lethal cardiac arrhythmias" and it monitors, derives, and displays various physiological data collected by sensors, providing "visual notifications when healthcare professionals need to be aware of heart rates that are beyond the specified threshold" and "patient summary reports." These functions are consistent with a diagnostic device that detects medical conditions.
No
The device description explicitly lists hardware components: an "Adherent Device" (patient-worn) and a "Gateway," in addition to the "Server" which contains software. The Adherent Device collects physiological data via sensors, indicating it is a physical hardware component.
Based on the provided information, the AVIVO™ Mobile Patient Management System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body). The AVIVO system directly monitors physiological data from the patient's body in vivo (within the body) using sensors applied to the torso.
- The intended use is for monitoring physiological data and detecting cardiac arrhythmias. This is a function of a patient monitoring system, not an IVD.
- The device description details sensors applied to the body and transmission of data. This aligns with a wearable or external monitoring device, not a laboratory-based diagnostic test.
The AVIVO system is a patient monitoring system that collects and transmits physiological data for the detection of cardiac arrhythmias and other parameters.
N/A
Intended Use / Indications for Use
The AVIVO™ Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVO™ Mobile Patient Management System also monitors, derives and displays:
• ECG
• Heart Rate (including Heart Rate Variability)
• Activity
• Posture
• Body Temperature
• Respiration Rate (including Respiratory Rate Variability)
• Body Fluid Status
Product codes
DSI, MHX
Device Description
The AVIVIO Mobile Patient Management System includes the following components:
- Adherent Device .
- Gateway .
- Server .
The Adherent Device is a patient-worn device. It collects, stores and transmits user physiological parameters. The Adherent Device, when applied to the user's torso, will automatically activate and measure the above mentioned physiological parameters. Data collected by the sensors are transmitted to the Server for derivation and display via the Gateway periodically. ECG signals recorded by the Adherent Device will be transmitted on a heart rate trigger basis with predetermined thresholds that are not user adjustable. The ECG signals are also transmitted periodically and will be displayed via the Server.
The Gateway receives information from the Adherent Device 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 receives information from the Adherent Device via the Gateway. 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. t
- Provide visual notifications when healthcare professionals need to be aware of . heart rates that are beyond the specified threshold.
- Provide patient summary reports. .
The communication between the Adherent Device and the Gateway is enabled via the BlueTooth™ Technology. The Gateway 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
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)
Performance testing conducted on the AVIVO Patient Management System demonstrates that the product performs as it is intended to.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary of Safety & Effectiveness
| Submitter Name & Address: | Corventis, Inc.
2226 N. First Street
San Jose, CA 95131 | FEB - 3 2005 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Dawn Chang
408-790-9322 (phone)
408-790-9350 (fax) | |
| Trade/Proprietary Name: | AVIVOTM | |
| Common/Usual Name: | Mobile Patient Management System | |
| 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
Predicate Devices:
-
- CardioNet™ ECG Monitor with Arrhythmia Detection, K072558; DSI, "Arrhythmia Detector and Alarm", 21 CFR 870.1025
-
- LifeShirt™ Real-Time, K043604; DQK, "Programmable Diagnostic Computer", 21 CFR 870.1425
-
- ZOE™ Fluid Status Monitor, K042113; DSB, "Impedance Plethysmograph", 21 CFR 870.2770
-
- SenseWear Armband, 510(k) exempt, IKK, "Isokinetic Testing and Evaluation System", 21 CFR 890.1925
Indication for Use Statement:
The AVIVO Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVO Mobile Patient Management System also monitors, derives and displays:
• ECG
Page 1 of 3
1
510(k) Summary of Safety & Effectiveness
- · Heart Rate (including Heart Rate Variability)
- · Activity
- · Posture
- · Body Temperature
- · Respiration Rate (including Respiratory Rate Variability)
- · Body Fluid Status
Technological Characteristics and Substantial Equivalence
The AVIVIO Mobile Patient Management System includes the following components:
- Adherent Device .
- Gateway .
- Server .
The Adherent Device is a patient-worn device. It collects, stores and transmits user physiological parameters. The Adherent Device, when applied to the user's torso, will automatically activate and measure the above mentioned physiological parameters. Data collected by the sensors are transmitted to the Server for derivation and display via the Gateway periodically. ECG signals recorded by the Adherent Device will be transmitted on a heart rate trigger basis with predetermined thresholds that are not user adjustable. The ECG signals are also transmitted periodically and will be displayed via the Server.
The Gateway receives information from the Adherent Device 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 receives information from the Adherent Device via the Gateway. 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. t
- Provide visual notifications when healthcare professionals need to be aware of . heart rates that are beyond the specified threshold.
- Provide patient summary reports. .
The communication between the Adherent Device and the Gateway is enabled via the BlueTooth™ Technology. The Gateway 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 AVIVO Mobile Patient Management System, and AVIVO has the same uses as these predicates. They are:
Page 2 of 3
2
510(k) Summary of Safety & Effectiveness
Date: Nov 6, 2008
FEB -3 2009
-
- CardioNet ECG Monitor with Arrhythmia Detection, cleared by FDA under 510(k) number K072558; 21 CFR 870.1025 DSI "Arrhythmia Detector and Alarm"
-
- LifeShirt Real-Time, cleared by FDA under 510(k) number K043604: 21 CFR 870.1425 DQK "Programmable Diagnostic Computer"
-
- ZOE 100 Fluid Status Monitor, cleared by FDA under 510(k) number K042113; 21 CFR 870.2770 DSB "Impedance Plethysmograph"
-
- SenseWear Armband, 510(k) exempt, 21 CFR 890.1925 IKK "Isokinetic Testing and Evaluation System"
| AVIVO™ Mobile Patient Management | Predicate Devices for Substantial |
|---|---|
| Features | Equivalence |
| System Configuration, ECG, | Cardionet™ - K072558 |
| Body Fluid Status | Zoe™ - K042113 |
| Respiratory Rate, Heart Rate, Activity & | |
| Posture | LifeShirt™ - K043604 |
| Temperature | SenseWear - 510(k) exempt |
Conclusions
The AVIVO Mobile Patient Management System has the same intended use and similar operating principles and technological characteristics as its predicate devices. The same set of safety and performance standards used by the predicates will be applied to the A VIVO Mobile Management Patient Management System. Performance testing conducted on the AVIVO Patient Management System demonstrates that the product performs as it is intended to. Therefore, it is concluded that the AVIVO Patient Management System is as safe and effective as the predicate devices and, thus, is substantially equivalent to the predicate devices.
Page 3 of 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Public Health Service
FEB - 3 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Corventis, Inc. Dawn Chang Senior Regulatory Affairs Associate 2226 N. First Street San Jose, CA 95131
Re: K083287
Trade/Device Name: AVIVO™ Mobile Patient Management 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: January 23, 2009 Received: January 26, 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 provisions of the Pederal Food, Drug,
You may, therefore, morket the donic concerned in a premarket approval applicat 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 misting and adulteration.
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. 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
4
Page 2 - Ms. Dawn Chang
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 for 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 1egally 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) 633-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/suport/judex.html
Sincerely yours,
er R. Valmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
5
KD83287
Indications for Use
510(k) Number (if known): NA> Ko83287
Device Name: AVIVO™ Mobile Patient Management System
Indications for Use:
The AVIVO™ Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVO™ Mobile Patient Management System also monitors, derives and displays:
• ECG
- · Heart Rate (including Heart Rate Variability)
- · Activity
- Posture
- · Body Temperature
- · Respiration rate (including Respiratory Rate Variability)
- Body fluid status
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 \
Duane R. Wicklund
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number KO83287