The Reveal® LINQ™ Insertable Cardiac Monitor (ICM) Model LNQ11 is designed to record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial tachyarrhythmia/atrial fibrillation (AT/AF), bradyarrhythmia, pause, or (fast) ventricular tachyarrhythmia. The Reveal LINQ ICM provides storage of ECG and Marker Channel during patient-activated and automatically-detected (auto-activated) events. Auto-activation may help to detect abnormal heart rhythms in patients who may not activate/trigger the ICM. The Reveal LINQ Model LNQ11 is a small, leadless implantable device that is typically implanted under the skin, in the chest. Two electrodes on the body of the implantable device continuously monitor the patient's subcutaneous ECG.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Medtronic Reveal LINQ Insertable Cardiac Monitor (Model LNQ11) when used with an alternative LINQ Programmer Application (Model MSW001) and patient connector (Model 24965). The submission aims to demonstrate substantial equivalence to the previously cleared Reveal LINQ ICM (Model LNQ11) with existing programmer software and hardware.

The document discusses various tests performed to establish this equivalence, but it does not contain specific acceptance criteria or detailed study results for device performance related to diagnostic accuracy (e.g., sensitivity, specificity for arrhythmia detection). Instead, the focus is on showing that the new programmer system does not alter the performance or safety of the previously cleared implantable device. The "Summary of Testing" section primarily lists types of verification and validation activities conducted, rather than specific performance metrics against an acceptance threshold.

Therefore, many of the requested details, especially those pertaining to diagnostic performance, ground truth, expert adjudication, and comparative effectiveness studies, cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not list specific acceptance criteria or reported device performance metrics such as sensitivity, specificity, or accuracy for arrhythmia detection. The testing described focuses on demonstrating that the new programming system does not negatively impact the existing device's performance, rather than establishing new performance benchmarks.

The table in the "Device Description" section lists technical parameters of the Reveal LINQ ICM (e.g., Longevity, Electrode Spacing, Volume, Mass, Episode Storage, MRI Compatibility, Detection Algorithms). For all these parameters, the "Reported Device Performance" is simply "Same" when comparing the device with the existing programmer vs. the alternative LINQ Programmer Application and patient connector. This indicates that the new component introduces no change to these specifications.

2. Sample Size for Test Set and Data Provenance

The document does not provide a sample size for a test set in the context of diagnostic performance. The "Summary of Testing" mentions "System verification and system validation" for the Reveal LINQ ICM and the LINQ Programmer Application, and various tests (EMC, RF compliance, electrical safety, mechanical, packaging, biocompatibility, performance verification, firmware verification, system verification, system validation) for the patient connector. However, these refer to engineering and regulatory compliance testing rather than clinical diagnostic performance studies involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not available in the provided text. The document does not describe a study involving human experts establishing ground truth for a diagnostic performance test set.

4. Adjudication Method for the Test Set

This information is not available in the provided text, as no diagnostic performance test set involving adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not described in this document. The submission focuses on demonstrating substantial equivalence of a new programming interface to an existing one, not on the improvement of human reader performance with AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study focused on algorithmic diagnostic accuracy and reported as such is not explicitly described. The device (Reveal LINQ ICM) itself has "Detection Algorithms" listed (Full View + P-wave presence filter), which implies automated detection. However, the document does not provide details on the performance metrics of these algorithms alone. The testing described is verification and validation of the system and its components.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for diagnostic performance evaluation, as detailed diagnostic performance studies are not the primary focus of this 510(k) submission for the new programmer. Given the nature of a cardiac monitor, ground truth for arrhythmia detection would typically come from expert cardiologists reviewing raw ECG data, possibly correlated with clinical outcomes. However, this is speculative outside the provided text.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size or the development of the detection algorithms. The submission is about a component change for an already cleared device, not the initial development of the detection algorithms themselves.

9. How the Ground Truth for the Training Set Was Established

This information is not available in the provided text.

Summary

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

August 6, 2015

Medtronic Inc. Dianna Johannson Sr. Principal Regulatory Affairs Specialist 8200 Coral Sea St NE Mounds View, Minnesota 55112

Re: K150614

Trade/Device Name: Reveal LINO Insertable Cardiac Monitor (Model LNO11) 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: July 30, 2015 Received: July 31, 2015

Dear Dianna Johannson:

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

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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,

Bram D. Zuckerman -S

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) K150614

Device Name

Reveal LINQ Insertable Cardiac Monitor (Model LNQ11)

Indications for Use (Describe)

The Reveal LINQ ICM is an insertable automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

· patients with clinical syndromes or situations at increased risk of cardiac arrhythmias

· patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

The device has not been tested specifically for pediatric use.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the Medtronic logo. On the left side of the logo is a blue circular graphic with three figures in motion. To the right of the graphic is the company name, "Medtronic", in a bold, blue font.

510(k) Summary

Date Prepared:	9 March 2015
510(k) Owner / Address:	Medtronic, Inc.Cardiac Rhythm and Heart Failure8200 Coral Sea StreetMounds View, MN 55112
Contact:	Dianna L. JohannsonSr. Pr. Regulatory Affairs Specialist
Telephone:	(763) 526-2376
Fax:	(651) 367-0603
E-mail:	dianna.johannson@medtronic.com
Trade / Proprietary Name:	Reveal® LINQTM Insertable Cardiac Monitor,Model LNQ11
Common Name:	Insertable Cardiac Monitor
Classification /Classification Name:	Class IIArrhythmia detector and alarm(21 CFR 870.1025)
Product Code:	DSI

Summary of Substantial Equivalence

The intended use, design, materials and performance of the Reveal LINQ ICM (Model LNQ11) in association with the LINQ Programmer Application (Model MSW001) and patient connector (Model 24965) (referred to as the LINQ Programmer system) are substantially equivalent to the following predicate device:

Reveal LINQ ICM (Model LNQ11) cleared via K132649 on February 14, 2014. ●

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Device Description

Medtronic Reveal LINQ (Model LNQ11) ICM

The Reveal LINO ICM is a small, leadless implantable device that is implanted under the skin, in the chest. The implantable device uses two electrodes on its surface to monitor the patient's subcutaneous ECG continuously. The implantable device memory can store up to 27 min of ECG recordings from automatically detected arrhythmias and up to 30 min of ECG recordings from patient-activated episodes. The system provides 3 options for segmenting the patientactivated episode storage: up to four 7.5 min recordings, up to three 10 min recordings, or up to two 15 min recordings. Arrhythmia detection parameters are set to pending automatically, based on patient information entered on the programmer during pre-insertion implantable device setup: the patient's Date of Birth and the clinician's Reason for Monitoring the patient. Arrhythmia detection parameters can also be programmed manually by the clinician. The following table describes the Reveal LINO ICM Model LNO11 when used with the alternative LINO Programmer Application and patient connector as compared to the Reveal LINQ ICM Model LNQ11 when used with the existing programmer software and hardware.

Parameter	Reveal LINQ (Model LNQ11)(with existing programmersoftware and hardware)	Reveal LINQ (Model LNQ11)(with alternative LINQProgrammer Application andpatient connector)
Longevity	3 years	Same
Electrode Spacing (inside-to-inside)	37.7 mm	Same
Volume	1.2 cc	Same
Mass	2.4 g	Same
Episode Storage	57 min	Same
Patient Symptom Mark	Patient Assistant	Same
Cardiac Compass	Yes	Same
MRI Compatibility	MR Conditional	Same

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Parameter	Reveal LINQ (Model LNQ11)(with existing programmersoftware and hardware)	Reveal LINQ (Model LNQ11)(with alternative LINQProgrammer Application andpatient connector)
Clinician Notification	Nightly Transmission /Notifications	Same
Bi-Directional Telemetry	B	Same
Detection Algorithms	Full View + P-wave presencefilter	Same
CareLink	Yes	Same
Wireless Telemetry	1-Way, Transmit Only	Same
Patient's CareLink ClinicName and ID	No	Yes

The Reveal LINO ICM Model LNO11 was initially cleared via a 510(k) application K132649 on February 14, 2014. This submission introduces an alternative programming option (referred to as the LINQ Programmer system) for the Reveal LINQ ICM. The LINQ Programmer system is comprised of LINO Programmer Application Model MSW001 installed on a clinician's off-theshelf non-medical mobile device and patient connector Model 24965 (also referred to as a telemetry head) used in conjunction with the CareLink Network. The Reveal LINO ICM continues to have the same intended use when used with the LINQ Programmer system. The LINQ Programmer system provides the essential capabilities for programming, interrogating and managing the Reveal LINQ ICM in a clinical or hospital environment.

The LINQ Programmer system has no impact on the physical characteristics, materials, mechanical, electrical, hardware, components, firmware, operation, performance, and telemetry protocol of the Reveal LINQ ICM. There are no differences in the performance, features, materials, hardware, firmware, intended use or programmer-to- implantable device interface between the Reveal LINO ICM used with the LINO Programmer system versus the existing programmer software and hardware. The LINQ Programmer system is capable of interrogating and programming the Reveal LINO ICM like the existing programmer software and hardware.

Indications for Use

There are no changes to the cleared indications for use for the Reveal LINQ ICM Model LNQ11 when used with the LINQ Programmer Application and patient connector as compared to the Reveal LINQ ICM Model LNQ11 indications when used with existing programmer software and hardware.

The indication statement is as follows:

The Reveal LINQ ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

patients with clinical syndromes or situations at increased risk of cardiac arrhythmias o

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patients who experience transient symptoms such as dizziness, palpitation, syncope, . and chest pain that may suggest a cardiac arrhythmia
The device has not been tested specifically for pediatric use.

Technological Characteristics

The Reveal LINQ ICM consists of three major subassemblies which include the hermetically enclosed battery, hermetically enclosed electronics module, and molded header assembly. The battery is a custom D-shaped cell based on LiCFx chemistry and supports a 12-month shelf life and 3-year usable capacity. The Electronics Module contains the hybrid comprised of a printed circuit board with surface mount components on one side and an over molded stack on the other side which contains analog, digital and memory IC's along with capacitor arrays. The molded Header Assembly contains a Titanium Nitride coated sensing electrode, an embedded miniature RF antenna, suture hole, and a mounting bracket.

The Reveal LINO ICM will continue to use the same technology. It is designed to automatically record the occurrence of an arrhythmia in a patient, continuously senses the patient's subcutaneous ECG, and analyzes the timing of ventricular events to detect possible episodes of arrhythmia. The Reveal LINQ ICM has a small form factor, and uses Titanium, Parylene, Urethane, and Titanium Nitride coating on the sensing electrodes as body contacting materials.

The use of the LINO Programmer system to support the Reveal LINO ICM does not alter the existing technology of the Reveal LINQ ICM. Additionally, from the system perspective, the LINQ Programmer Application still communicates via an RF head (the patient connector) which in turn communicates with the Reveal LINQ ICM to program diagnostic settings and to extract data from the implantable device for viewing on either the LINO Programmer Application or the Medtronic CareLink Network. The patient connector utilizes the same telemetry protocol (Telemetry B) to communicate with the Reveal LINQ ICM; however, it utilizes Bluetooth technology to communicate with the mobile device, and has rechargeable battery-powered operation. The LINO Programmer Application utilizes existing infrastructure of the clinician's mobile device to run the programming application facilitating, portability and mobility, direct connectivity with CareLink via cellular and Wi-Fi, Bluetooth connectivity to communicate with the patient connector, software updates via publicly accessible channels (i.e. Google Play Store), and a user interface with workflows, streaming ECG waveform and marker display.

Summary of Testing

Testing was performed to demonstrate equivalency of the Reveal LINQ Model LNQ11 Insertable Cardiac Monitor with LINQ Programmer Application and patient connector to the Reveal LINQ ICM with existing programmer software and hardware. The Reveal LINQ ICM with LINQ Programmer Application and patient connector were subjected to the same use scenarios during testing as the Reveal LINO ICM with existing programmer software and hardware, thus supporting substantial equivalency. Testing included:

Reveal LINO (Model LNO11) Testing

System verification and system validation were completed with the Reveal LINQ Model LNQ11 Insertable Cardiac Monitor.

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LINO Programmer Application (Model MSW001) Testing

Performance verification as well as software verification, system verification and system validation were completed for the LINQ Programmer Application.

Patient Connector (Model 24965) Testing

Electromagnetic compatibility (EMC), RF compliance, electrical safety, mechanical, packaging, biocompatibility and performance verification testing were completed for the patient connector. Additionally, firmware verification, system verification and system validation were completed with the patient connector. The patient connector is provided non-sterile.

The results of the testing indicate that the Reveal LINQ Insertable Cardiac Monitor Model LNQ11 with the LINQ Programmer Application (Model MSW001) and patient connector (Model 24965) perform as intended, and are safe for their intended use.

The FDA recognized standards that the Reveal LINQ Insertable Cardiac Monitor Model LNQ11, LINQ Programmer Application (Model MSW001), and patient connector (Model 24965) complies are identified in the following tables.

StandardsOrganization /Number	Standards Title	Date /Version
AAMI / ANSI /IEC 62366	Medical devices - Application of usability engineering to medicaldevices	2007
ISO 10993-1	Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process	2010 (ForthEdition)
ISO 10993-7	Biological evaluation of medical devices - Part 7: Ethylene oxidesterilization residuals	2008(SecondEdition)
ISO 11607-1	Packaging for terminally sterilized medical devices - Part 1:Requirements for materials, sterile barrier systems and packagingsystems	2009
ISO 14971	Medical devices - Applications of risk management to medicaldevices	2007(SecondEdition)
IEC 62304	Medical device software - Software life-cycle processes	2006/ AC:2008

Standards Referenced for the Reveal LINQ ICM

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Standard
StandardsOrganization /Number	Standards Title	Date /Version
IEC 62304	Medical device software — Software life cycle processes	2006
IEC 62366	Medical devices — Application of usability engineering to medical devices	2007
ISO 14971	Medical devices — Application of risk management to medical devices	2007
ISO 15223-1	Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements	2012

Standards Referenced for the LINQ Programmer Application

Standards Referenced for the Patient Connector

Standard
StandardsOrganization /Number	Standards Title	Date /Version
ASTM D4169	Distribution Cycle 13 Quality Assurance Level 1	2008
ISO 10993-1	Biological evaluation of medical devices. Evaluation and testing	2009
IEC 62133	Secondary cells and batteries containing alkaline or other non-acidelectrolytes - Safety requirements for portable sealed secondary cells,and for batteries made from them, for use in portable applications.	2012
IEC 62366	Medical devices – Application of usability engineering to medicaldevices	2007
ISO 14971	Medical devices – Application of risk management to medical devices	2007 / 2012
ISO 15223-1	Medical devices - Symbols to be used with medical device labels,labeling, and information to be supplied — Part 1: Generalrequirements	2012

Conclusion

Medtronic has demonstrated that the Reveal LINQ ICM (Model LNQ11) with the LINQ Programmer Application (Model MSW001) and patient connector (Model 24965) described in this submission result in a substantially equivalent device the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate Reveal LINQ ICM with existing programmer software and hardware, and it continues to be safe, effective, and performs as intended.

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.