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 HR variability)
Activity
Posture
Body Temperature
Respiration rate (including RR variability)
Body fluid status

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. The NUVANT system model monitors, derives and displays:

ECG
Heart rate

The Systems may also monitor, derive and display:

Activity
Posture
Body temperature
Respiration rate (including RR Variability)
Body fluid status
Heart rate variability

Device Description

The NUVANT is essentially the AVIVO with the addition of a patient trigger magnet. The following are the system components of both models:

PiiX™ (aka Adherent Device)
Patient Trigger Magnet (specific to NUVANT)
zLink™ (aka Gateway)
Server

The PiiX is a patient-worn device which is applied to the patient's torso. It contains the ECG electrodes for recording ECG and heart rate data; the impedance sensor for collecting respiration and body fluid data; the accelerometer for collecting activity and posture. Additionally, resided in the PiiX is a heart rate, timing and morphology based arrthythmia detection algorithm which allows the system to discriminate waveforms based on morphology and also count ectopic beats (such as PVCs and PACs) and calculate atrial fibrillation burden of the patient.

Specfic to the NUVANT is the Magnet, which is part of the Patient Trieger feature. This external piece accompanying the PiiX and is used by the patient to manually trigger the ECG collection when he/she experiences symptoms. Patient triggers the ECG collection by swiping the Magnet across the PiiX. The ECG waveform will then be transmitted to the Server via zLink.

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 receives sensor data from the PiiX via zLink. Data from the accelerometer is derived into activity and posture; data from the impedance sensor is derived into respiration rate, respiration variability and body fluid status. ECG and heart rate are presented without derivation.

Additionally, the secure server performs the following functions:

Display the physiological parameters in trend graphs format.
Display ECG waveform that corresponds to a detected arrhythmia
Provide patient's Afib burden, if applicable
Provide visual notifications for the detected arrhythmia.
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.

AI/ML Overview

This document describes a Special 510(k) submission for modifications to the AVIVO™ Mobile Patient Management System and NUVANT™ Mobile Cardiac Telemetry System. The primary modification involves an enhanced arrhythmia detection algorithm that incorporates morphology and timing of waveforms, in addition to heart rate, to discriminate waveforms, count ectopic beats (PVCs, PACs), and calculate atrial fibrillation (Afib) burden.

Unfortunately, the provided text does not contain a dedicated section detailing acceptance criteria or specific study results that prove the device meets these criteria. It asserts that the devices are "as safe and as effective as the predicate devices" based on "descriptive information and the design verification tests," but does not present the data from these tests.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I provide information regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as this information is not present in the provided text.

Based on the available information, here's what can be inferred:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in the document. The document implies the acceptance criteria were met by demonstrating substantial equivalence to predicate devices, particularly in the modified arrhythmia detection algorithm.
Reported Device Performance:
- The modified algorithm allows the devices to:
  - Discriminate waveforms based on morphology.
  - Count ectopic beats (PVCs and PACs).
  - Calculate atrial fibrillation burden.
- The intent of the subject devices remains the same as the predicate devices: to monitor ECG and other vital parameters.
- No change has been made to the Indication for Use Statements, implying performance is at least equivalent to the predicate performance for those indications.

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

This information is not provided in the document.

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.

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

This information is not provided in the document.

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:

An MRMC study is not mentioned in the document. The submission focuses on the algorithm's performance and equivalence to predicate devices, not on human-AI collaboration.

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

Yes, implicitly. The document describes modifications to an "arrhythmia detection algorithm" (page 3) and refers to demonstrating substantial equivalence based on "descriptive information and the design verification tests" (page 5). While direct performance metrics for the algorithm are not provided, the claim of "discriminating waveforms based on morphology and also count ectopic beats (such as PVCs and PACs) and calculate atrial fibrillation burden" implies internal testing of the algorithm itself.

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

This information is not provided in the document. Given the context of arrhythmia detection, it is highly likely that cardiologist review or a validated ECG database would be used, but this is not explicitly stated.

8. The sample size for the training set:

This information is not provided in the document.

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

This information is not provided in the document.

Summary

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AUG 2 7 2009

		510(k) Summary of Safety & Effectiveness

Date: June 29, 2009

Submitter Name & Address:	Corventis, Inc.2033 Gateway Place Suite 100San Jose, CA 95110
Contact Person:	Madhuri Bhat, VP, Clinical & Regulatory Affairs408-790-9306 (phone)408-790-9350 (fax)
Trade/Proprietary Name:	AVIVO™ Mobile Patient Management SystemNUVANT™ Mobile Cardiac Telemetry System
Common/Usual Name:	Mobile Patient Management SystemMobile Cardiac Telemetry System
Classification Name:	Arrhythmia Detector and Alarm(21 CFR 870.1025, Product Code DSI)Patient Physiological Monitor (with arrhythmiadetection)(21 CFR 870.1025, Product Code MHX)
Class:	Class II, Special Controls
510(k):	Special 510(k): Device Modification

Predicate Devices:

l . AVIVO Mobile Patient Management System, Corventis, Inc., cleared by FDA under 510(k) number K083287; 21 CFR 870.1025. DSI "Arrhythmja Detector and Alarm", and 21 CFR 870.1025, MHX "Patient Physiological Monitor (with arrhythmia detection)"
1. NUVANT Mobile Cardiac Telemetry System, Corventis, Inc. cleared by FDA under 510(k) number K090606; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFR 870.1025, MHX "Patient Physiological Monitor (with arrhythmia detection)"
1. Heartrak Smart AF, Universal Medical Incorporated, cleared by FDA under K071130; 21 CFR 870.0290, DXH "Telephone Electrocardiograph Transmitter and Receiver"
1. CardioNet ECG Monitor with Arrhythmia Detection Model CN1005, CardioNet Inc., cleared by FDA under K072558; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm"

Page 1 of 5

K091971

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510(k) Summary of Safety & Effectiveness

1. BACKGROUND INFORMATION

The following two models are the subject devices of this Special 510(k):

The AVIVO™ Mobile Patient Management System (hereafter referred to as . "subject AVIVO")
The NUVANT™ Mobile Cardiac Telemetry System (hereafter referred to as . "subject NUVANT")

The subject AVIVO is a modification of the AVIVO Mobile Patient Management System cleared by the FDA under K083287 (hereafter referred to as "predicate A VIVO); whereas the NUVANT is a modification of the NUVANT Mobile Cardiac Telemetry System cleared by the FDA under K090696 (hereafter referred to as "predicate NUVANT"). The predicate AVIVO and the predicate NUVANT are intended for the monitoring of ECG and other vital parameters, in which ECG is collected when the heart rate based algorithm embedded in the device detects an abnormal heart rate, i.e. a heart rate that goes beyond a non-user adjustable predetermined threshold.

The modification made to the subject AVIVO and NUVANT permits the devices to collect ECGs based on morphology / timing of the wave form in addition to the rate. This modification enables the subject devices to discriminate waveforms based on morphology and also count ectopic beats (such as PVCs and PACs) and calculate atrial fibrillation burden of the patient.

The intent of the subject devices remains the same as that of the predicate devices, which is to monitor ECG and other vital parameters. No change has been made to the Indication for Use Statements.

2. INDICATION FOR USE STATEMENT

a. AVIVO

ECG .
Heart Rate (including HR variability) .
Activity .
. Posture
Body Temperature .
Respiration rate (including RR variability)

Page 2 of 5

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510(k) Summary of Safety & Effectiveness

. Body fluid status

b. NUVANT

. ECG
Heart rate .

The Systems may also monitor, derive and display:

Activity .
Posture .
. Body temperature
. Respiration rate (including RR Variability)
. Body fluid status
Heart rate variability .

3. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The NUVANT is essentially the AVIVO with the addition of a patient trigger magnet. The following are the system components of both models:

PiiX™ (aka Adherent Device) .
. Patient Trigger Magnet (specific to NUVANT)
zLink™ (aka Gateway) ●
Server ●

a.

Page 3 of 5

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Sensor data and ECG collected by the PiiX are transmitted to the Server via zLink.

b. Patient Trigger Magnet

c. zLink

d. Server

Additionally, the secure server performs the following functions:

Display the physiological parameters in trend graphs format. .
. Display ECG waveform that corresponds to a detected arrhythmia
Provide patient's Afib burden, if applicable .
Provide visual notifications for the detected arrhythmia. .
Provide the users the ability to acknowledge or dismiss events. .

Transmission Technologies e.

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4. PREDICATE DEVICES

Four (4) predicate devices have been identified:

1. 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)"
1. NUVANT Mobile Cardiac Telemetry System, Corventis, Inc. cleared by FDA under 510(k) number K090606; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm", and 21 CFR 870.1025, MIIX "Patient Physiological Monitor (with arrhythmia detection)"
1. Heartrak Smart AF, Universal Medical Incorporated, cleared by FDA under K071130; 21 CFR 870.0290, DXH "Telephone Electrocardiograph Transmitter and Receiver"
1. CardioNet ECG Monitor with Arrhythmia Detection Model CN1005, CardioNet Inc., cleared by FDA under K072558; 21 CFR 870.1025, DSI "Arrhythmia Detector and Alarm"

Table 2 below summarizes the compared features and the corresponding predicate devices.

Features beingcompared	Subject Devices	Predicate Devices
ArrhythmiaDetectionAlgorithm	Modified AVIVO	Heartrak Smart AF (K07113)& Cardionet CN1005(K072558)
	Modified MCT

All other features	Modified AVIVO	Original AVIVO (K083287)
	Modified MCT	Original MCT (090696)

Table 2 Features comparison and corresponding predicate devices

5. CONCLUSION

The modified arrhythmia detection algorithm made to the AVIVO Mobile Patient Management System and NUVANT" Mobile Cardiac Telemetry (NUVANT) System does not change the intended use or the fundamental scientific technology of the devices. As supported by the descriptive information and the design verification tests, it is concluded that the AVIVO Mobile Patient Management System and NUVANT™ Mobile Cardiac Telemetry (NUVANT) Systems are as safe and as effective as the predicate devices.

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Image /page/5/Picture/0 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 abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

AUG 2 7 2009

Corventis, Inc. c/o Madhuri Bhat VP, Clinical and Regulatory Affairs 2033 Gateway Place, Suite 100 San Jose, CA 95110

Re: K091971

Trade/Device Name: AVIVOTM Mobile Patient Management System; and, NUVANT™ Mobile Cardiac Telemetry System

Regulatory 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

Additional Product Code: MHX

Dated: August 18, 2009

Received: August 20, 2009

Dear Mr. Bhat:

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.

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.

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Page 2 - Madhuri Bhat

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 (OS) 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.

una R. Vilmer

A 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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Indications for Use

510(k) Number (if known): N/A> K 0 9 197 |

AVIVO™Mobile Patient Management System Device Names:

Indications for Use:

ECG ●

Heart Rate (including HR variability) .
Activity .
Posture .
Body Temperature
Respiration rate (including RR 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 2

Duna R. hihnes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K091971

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Indications for Use

510(k) Number (if known): N/A> K 09 | 9 7 /

NUVANT™ Mobile Cardiac Telemetry System Device Names:

Indications for Use:

The NUVANT" Mobile Cardiac Telemetry (NUVANT) 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. The NUVANT system model monitors, derives and displays:

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 2 of 2

Nuna R. Vochner

ion if Caronwascalar Devices

510(k) Number_k09197 |

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.