The AVIVO™ Mobile Patient Management (MPM) System is intended to continuously measure, record and periodically transmit physiological data. The AVIVOTM MPM System is indicated for patients:

· With fluid management problems
· Taking diuretic medication
· Living with heart failure
· Living with end-stage renal disease
Suffering from recurrent dehydration
Who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial florillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarthythmias and conduction disorders.

The AVIVO™ MPM System monitors, derives and displays:

· ECG
· Heart Rate (including HR variability)
· Activity
Posture
· Respiration Rate (including RR variability)
· Body Fluid Status

The system has not been tested specifically for pediatric use.

Device Description

The AVIVO™ MPM System is a wearable, wireless physiological monitoring and arrhythmia detection system that is used by patients to aid clinicians in the identification, diagnosis and management of various clinical conditions, events and/or trends. It consists primarily of the Wearable Sensor (monitoring device) and the Transmitter (portable data transmission device). In combination with interpretation services provided by Medtronic Monitoring, Inc.'s Monitoring Center, as well as secure online review of data by healthcare providers, the AVIVO™ MPM System enables patient- and physician-friendly physiological monitoring and arrhythmia detection for extended periods of time.

The AVIVO™ MPM System is comprised of the following non-sterile components:

The Wearable Sensor, which adheres to the patient's torso, contains electrodes and ● sensors for recording patient information.
. The Transmitter, which is the patient hand-held transceiver, receives information from the Wearable Sensor and transmits it to the Medtronic Server.
. The secure Server, which receives information from the Wearable Sensor via the Transmitter, and among other things, derives, calculates and displays the patient's physiological parameters using the data collected by the Wearable Sensor.

AI/ML Overview

This 510(k) summary explicitly states that it is a "Special 510(k): Device Modification." This means the submission is for a modification to an already cleared device (the predicate AVIVO™ MPM cleared in K113187). Therefore, the provided document does not contain new, comprehensive clinical study details with acceptance criteria and performance data for the entire device as if it were a de novo submission. Instead, the focus is on demonstrating that the modifications made do not raise new questions of safety or effectiveness and that the device remains substantially equivalent to its predicate.

As such, many of the requested details about specific acceptance criteria and a single, overarching study proving performance are not directly available in this document. The document refers to "testing for this change already provided in K133701" or "N/A – no clinical testing required for this modification," indicating that the performance data for the core functions were established in previous submissions.

However, I can extract information related to the demonstration of substantial equivalence for the modifications described:

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

The document does not present a single table detailing acceptance criteria for specific performance metrics of the device itself (e.g., arrhythmia detection sensitivity/specificity) and corresponding reported performance from a new study. Instead, it summarises the types of testing done or referenced for the modifications and states their successful completion to demonstrate substantial equivalence.

Section Description	Acceptance Criteria Implied (Based on standards/guidances referenced)	Reported Device Performance (Summary statement from document)
Sterilization and Shelf Life	Compliance with relevant standards and validated processes.	"N/A – no changes... related to this modification" for Mod 1 & 3. "Testing for this change already provided in K133701" for Mod 2. Implies existing predicate met criteria.
Biocompatibility	Compliance with ISO 10993 standards (e.g., cytotoxicity, irritation, skin sensitization).	"N/A – no changes... related to this modification" for Mod 1 & 3. "Although there were no changes to the patient-contacting materials related to this modification, biocompatibility testing was repeated" for Mod 2. Implies successful completion of repeated testing for Mod 2, and existing predicate met criteria for Mod 1 & 3.
Software	Compliance with IEC 62304 and FDA guidance for software.	"Testing for this modification already provided in K113372" for Mod 1. "Testing for this modification already provided in K133701 and results provided in K133701" for Mod 2. "Discussed in the Software Section" for Mod 3. Implies previous demonstrations for Mod 1 & 2, and details provided for Mod 3.
EMC Testing	Compliance with IEC 60601-1-2 (Electromagnetic compatibility).	"N/A – no EMC changes..." for Mod 1 & 3. "Testing for this modification already provided in K133701" for Mod 2. Implies existing predicate met criteria.
Performance Testing – Bench, Mechanical, Electrical	Compliance with relevant electrical safety (IEC 60601-1, IEC 60601-1-11), specific device standards (ANSI/AAMI/IEC 60601-2-47, AAMI/ANSI EC 12, AAMI/ANSI EC 57).	"N/A – no mechanical or electrical changes..." for Mod 1 & 3. "Testing for this change already provided in K133701" for Mod 2. Implies existing predicate met criteria.
Performance Testing – Animal	Demonstrating functionality and safety in an animal model (if applicable).	"N/A – no animal testing required for this modification" for all modifications. Implies no new animal testing was deemed necessary for these specific modifications.
Performance Testing – Clinical	Demonstrating safety and effectiveness in human subjects (if applicable).	"N/A – no clinical testing required for this modification" for all modifications. Implies no new clinical testing was deemed necessary for these specific modifications based on substantial equivalence.
Cybersecurity	Compliance with FDA guidance on Medical Device Cybersecurity.	"N/A - no cybersecurity changes..." for Mod 1 & 2. "Discussed in the Cybersecurity Section for details" for Mod 3. Implies existing predicate met criteria for Mod 1 & 2, and details provided for Mod 3.
RF & Wireless Technology	Compliance with relevant RF exposure and wireless communication standards.	"N/A – no RF & Wireless changes..." for Mod 1 & 3. "Note: following this submission, the Transmitter's cellular technology was updated. As such, RF Technology is discussed in the RF & Wireless Technology Section" for Mod 2. Implies existing predicate met criteria for Mod 1 & 3, and specific discussion for Mod 2.
System Validation Testing	Device functions as expected and meets user needs and intended use.	"System validation testing was also successfully completed to demonstrate that the modified AVIVO™ MPM System functions as expected and that the system meets user needs and intended use."

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

The document explicitly states "N/A – no clinical testing required for this modification" for all modifications described. Therefore, no new clinical test set with specific sample sizes or data provenance (country, retrospective/prospective) is detailed in this submission for the modified device. The original clearance (K113187) would contain such details for the predicate device.

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):

As no new clinical testing was reported as required for these modifications, this information is not available in the provided document.

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

As no new clinical testing was reported as required for these modifications, this information is not available in the provided 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:

The AVIVO™ MPM System is described as a "wearable, wireless physiological monitoring and arrhythmia detection system" and focuses on collecting and transmitting data for clinicians to review. It does not appear to be an AI-assisted diagnostic tool that aids human readers in interpreting images or complex signals, as would typically be the subject of a MRMC study. No MRMC study is mentioned.

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

The device's core function is to "continuously measure, record and periodically transmit physiological data" and to "derive, calculate and display the patient's physiological parameters." The "arrhythmia detection" is an algorithmic output. The document references "AAMI/ANSI EC 57: Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms." This standard typically outlines methodologies for validating the performance of such algorithms in a standalone manner. While a specific study report isn't included here, the adherence to this standard for the predicate device implies standalone algorithmic testing was conducted and proven.

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

For arrhythmia detection, the AAMI/ANSI EC 57 standard generally requires comparing algorithmic detections against human expert review (e.g., experienced cardiologists or electrophysiologists) of the ECG traces, often with adjudicated consensus to establish ground truth. For other physiological parameters like heart rate, respiration rate, and activity, ground truth would typically be established by simultaneously recorded gold-standard measurement devices. The document does not provide specifics for this submission as it refers to previous clearances.

8. The sample size for the training set:

The document does not detail any new training sets or their sample sizes for the modifications described, as it focuses on demonstrating substantial equivalence to a previously cleared device. Information on the training set for the original arrhythmia detection algorithms would be in the predicate device's 510(k) submission.

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

Similar to point 8, this information is not provided in this specific 510(k) summary as it pertains to modifications rather than a de novo clearance. For the predicate device's algorithms, ground truth for training data would typically be established by expert annotation of physiological data (e.g., ECGs) for arrhythmias, or concurrent measurements from gold-standard devices for other parameters.

Summary

{0}------------------------------------------------

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

March 30, 2016

Medtronic, Inc. Cheryl Swanson Sr. Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112

Re: K153160

Trade/Device Name: AVIVO™ Mobile Patient Management (MPM) 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: MHX, DSB, DSI Dated: February 29, 2016 Received: March 1, 2016

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, listing 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.

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 (reporting of medical device

{1}------------------------------------------------

related 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K153160

Device Name

AVIVO™ ® Mobile Patient Management (MPM) System

Indications for Use (Describe)

The AVIVO™ Mobile Patient Management (MPM) System is intended to continuously measure, record and periodically transmit physiological data. The AVIVOTM MPM System is indicated for patients:

· With fluid management problems
· Taking diuretic medication
· Living with heart failure
· Living with end-stage renal disease
Suffering from recurrent dehydration

· Who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial florillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarthythmias and conduction disorders.

The AVIVO™ MPM System monitors, derives and displays:

· ECG
· Heart Rate (including HR variability)
· Activity
Posture
· Respiration Rate (including RR variability)
· Body Fluid Status

The system has not been tested specifically for pediatric use.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

The following table provides background information regarding this Special 510(k) submission:

Date Prepared:	October 30, 2015
510(k) Owner / Address:	Medtronic, Inc.Cardiac Rhythm and Heart Failure8200 Coral Sea Street NEMounds View, MN 55112
Contact Person:	Cheryl SwansonSenior Principal Regulatory Affairs Specialistcheryl.swanson@medtronic.comOffice: (763) 514-0088Cell: (651) 242-3506Secondary Contact:Ryan CalabreseRegulatory Affairs Directorryan.s.calabrese@medtronic.comOffice: 763-526-3515
Submission Type:	Special 510(k): Device Modification
Device Trade Name:	AVIVOTM Mobile Patient Management (MPM) System
Device Common Name:	Mobile Patient Management (MPM) System
Product Code andClassification RegulationName:	DSB: Plethysmograph, ImpedenceDSI: Detector and Alarm, ArrhythmiaMHX: Monitor, Physiological, Patient (With ArrhythmiaDetection or Alarms)
Predicate Devices:	PrimaryK113187, cleared January 4, 2012 (AVIVO™ MPM)SecondaryK113372, cleared March 7, 2012 (NUVANT™ MCT)K133701, cleared February 6, 2014 (NUVANT™ MCT) -rebranded as SEEQ™ MCT

{4}------------------------------------------------

Device Description

Significant Physical and Performance Characteristics of the Device

The AVIVO™ MPM System is comprised of the following non-sterile components:

The Wearable Sensor, which adheres to the patient's torso, contains electrodes and ● sensors for recording patient information.
. The Transmitter, which is the patient hand-held transceiver, receives information from the Wearable Sensor and transmits it to the Medtronic Server.
. The secure Server, which receives information from the Wearable Sensor via the Transmitter, and among other things, derives, calculates and displays the patient's physiological parameters using the data collected by the Wearable Sensor.

This remains unchanged from the predicate device.

Indications for Use Statement

The AVIVO™ Mobile Patient Management (MPM) System is intended to continuously measure, record and periodically transmit physiological data. The AVIVO™ MPM System is indicated for patients:

. With fluid management problems
. Taking diuretic medication
Living with heart failure
Living with end-stage renal disease
Suffering from recurrent dehydration
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 AVIVO™ MPM System monitors, derives and displays:

. ECG
Heart Rate (including HR variability) ●
Activity
Posture

{5}------------------------------------------------

. Respiration Rate (including RR variability)
. Body Fluid Status

The system has not been tested specifically for pediatric use.

Intended Use of the Device

The AVIVO™ MPM System is intended for the ambulatory recording and monitoring of physiological parameter(s).

This remains unchanged from the predicate device.

Comparison of Fundamental Scientific Technology with the Predicate Devices

The subject AVIVO™ MPM System operates the same as the predicates, based on the following fundamental scientific technology:

. The collection of physiological parameters by a multi-sensor patient-worn device (Wearable Sensor);
. The transmission of these parameters to a remote Server through a transceiver (Transmitter); and
. The receipt of the parameters by the Server and subsequent derivation into appropriate useful values for display.

This remains unchanged from the predicate device.

Summary of Testing and Performance Data to Demonstrate Substantial Equivalence

The AVIVO™ MPM System is supported by the successful completion of the following tests to demonstrate substantial equivalence.

Section Description	Modification 1	Modification 2	Modification 3
Sterilization andShelf Life	N/A – no changes tosterilization or shelflife related to thismodification	Testing for thischange alreadyprovided in K133701	N/A - no changes tosterilization or shelflife related to thismodification
Biocompatibility	N/A – no changes tobiocompatibilityrelated to thismodification	Although there wereno changes to thepatient-contactingmaterials related tothis modification,biocompatibilitytesting was repeated	N/A - no changes tobiocompatibilityrelated to thismodification
Section Description	Modification 1	Modification 2	Modification 3
Software	Testing for thismodification alreadyprovided in K113372	Testing for thismodification alreadyprovided in K133701and results providedin K133701	Discussed in theSoftware Section
EMC Testing	N/A – no EMCchanges associatedwith this modification	Testing for thismodification alreadyprovided in K133701	N/A – no EMCchanges associatedwith this modification
Performance Testing– BenchMechanicalElectrical	N/A – no mechanicalor electrical changesassociated with thismodification	Testing for thischange alreadyprovided in K133701	N/A- no mechanicalor electrical changesassociated with thismodification
Performance Testing– Animal	N/A – no animaltesting required forthis modification	N/A - no animaltesting required forthis modification	N/A - no animaltesting required forthis modification
Performance Testing- Clinical	N/A – no clinicaltesting required forthis modification	N/A – no clinicaltesting required forthis modification	N/A – no clinicaltesting required forthis modification
Cybersecurity	N/A - nocybersecurity changesassociated with thismodification	N/A – nocybersecurity changesassociated with thismodification	N/A - nocybersecurity changesassociated with thismodification.Note: This section isincluded due to therelease of the finalFDA guidancedocument since thelast submission. Seethe CybersecuritySection for details.
RF & WirelessTechnology	N/A – no RF &Wireless changesassociated with thismodification.	N/A - no RF orWireless changesassociated with thismodification.Note: following thissubmission, theTransmitter's cellulartechnology wasupdated. As such, RF	N/A – no RF &Wireless changesassociated with thismodification.
Section Description	Modification 1	Modification 2	Modification 3
		Technology isdiscussed in the RF& WirelessTechnology Section

Table 4: Summary of Completed Testing to Support this Submission

{6}------------------------------------------------

{7}------------------------------------------------

System validation testing was also successfully completed to demonstrate that the modified A VIVO™ MPM System functions as expected and that the system meets user needs and intended use.

Guidance Used to Demonstrate Substantial Equivalence

Guidance documents used/considered for these device modifications include, but are not limited to, the following:

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
Design Considerations for Devices Intended for Home Use, issued on November 24, . 2014
Radio Frequency Wireless Technology in Medical Devices. issued on August 13, 2013 .
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued on October 2, 2014
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 dated ● October 28, 2003

Standards Used to Demonstrate Substantial Equivalence

Table 5 identifies the standards that were also used, in whole or in part, to demonstrate substantial equivalence:

Standards Organization /Number	Standards Title	Date / Version
IEC 60601-1	Medical electrical equipment – Part 1:General requirements for basic safetyand essential performance	2005 + CORR 1(2006) + CORR 2(2007) / 3rd Edition
Standards Organization /Number	Standards Title	Date / Version
IEC 60601-1-2	Medical electrical equipment - Part 1-2:General requirements for basic safetyand essential performance - Collateralstandard: Electromagneticcompatibility - Requirements and tests	2007 / 3rd Edition
IEC 60601-1-6	Medical electrical equipment - Part 1-6: General Requirements for BasicSafety and Essential Performance -Collateral Standard: Usability	2010-01 / 3rd Edition
IEC 60601-1-11	Medical electrical equipment - Part 1-11: General Requirements for BasicSafety and Essential Performance -Collateral Standard Requirements forMedical Electrical Equipment andMedical Electrical Systems Used in theHome Healthcare Environment	2010-04 / 1st Edition
ANSI/AAMI/IEC 60601-2-47	Medical electrical equipment - Part 2-47: Particular requirements for thesafety and essential performance ofambulatory electrocardiographicsystems	2012 / 2nd Edition
ANSI/AAMI/IEC 62304	Medical Device Software - Softwarelife cycle processes (Edition 1)	2006-005
AAMI/ANSI EC 12	Disposable ECG electrodes	2000 (R) 2010
AAMI/ANSI EC 57	Testing and reporting performanceresults of cardiac rhythm and ST-segment measurement algorithms	2012
AAMI/ANSI/ISO 10993-1	Biological evaluation of medicaldevices - Part 1: Evaluation and testingwithin a risk management process	2009
Standards Organization /Number	Standards Title	Date / Version
AAMI/ANSI/ISO 10993-5	Biological evaluation of medicaldevices – Part 5: Tests for in vitrocytotoxicity	2009
AAMI/ANSI/ISO 10993-10	Biological evaluation of medicaldevices – Part 10: Tests for irritationand skin sensitization	2010
ISO 14971	Medical Devices – Application of RiskManagement to Medical Devices(Edition 2)	2007-03-01; 2012

Table 5: Standards to Demonstrate Substantial Equivalence

{8}------------------------------------------------

{9}------------------------------------------------

Conclusion

Medtronic has demonstrated that the AVIVO™ MPM System, as described in this submission, results in a substantially equivalent device because the fundamental scientific technology, operating principles and intended use are unchanged from the predicate devices. Summary data has been provided to demonstrate reasonable assurance of safety and effectiveness of the A VIVO™ MPM System and to demonstrate substantial equivalence to its predicates. As supported by the descriptive information, verification, validation and standards testing, the modified AVIVO™ MPM System is substantially equivalent to the predicate devices.

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.