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.

Device Description

The Reveal LINQ Model LNQ11 Insertable Cardiac Monitors (ICM) is designed to automatically 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 device that is typically implanted under the skin, in the chest. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Reveal LINQ LNQ11 Insertable Cardiac Monitor. The submission is for a modification to an already cleared device, K150614, and specifically addresses changes to the Recommended Replacement Time (RRT) algorithm and minor updates to power supply management (K-factor) behavior.

Based on the document, here's an analysis of the acceptance criteria and supporting study information:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The submission establishes substantial equivalence to a predicate device (Reveal LINQ LNQ11 Insertable Cardiac Monitor, K150614) based on the assertion that the modified device has the same intended use/indications for use, operating principle, design features, device functionality, biological safety, packaging materials, and shelf life. The key differences are algorithmic changes related to RRT and power supply management. The testing described focuses on demonstrating that these changes do not introduce new safety or performance issues and that the device continues to meet established performance criteria.

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

The document does not provide a direct table of specific quantitative acceptance criteria for arrhythmias or algorithm performance. Instead, it states that "The results of the above testing met the specified acceptance criteria and did not raise new safety or performance issues."

The performance is reported in terms of successful completion of various tests:

Acceptance Criteria Category	Reported Device Performance
Firmware Regression Verification Testing	All 870 regression tests were executed and passed.
Design Verification	No system or product level requirements were modified. Design verification completed by verifying similarity to a previous design, verification of previous designs, verification of no unintended changes, and no unintended RAMware/firmware interactions. All acceptance criteria met.
System Design Validation	Test protocols covered aspects of the system being validated against design input requirements and risk control measures. (No specific outcomes are detailed beyond "met the specified acceptance criteria").

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 does not specify a sample size for any clinical test set, nor does it mention data provenance (country of origin, retrospective/prospective). This is largely because the submission describes bench testing for an algorithmic modification, not a clinical study with patients. The "870 regression tests" likely refer to software test cases, not patient data.

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)

The document does not mention using experts or establishing ground truth by experts in the context of this 510(k) submission. The testing described is primarily focused on software and system verification against established design inputs and previous designs.

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

Given that the document does not describe a clinical test set requiring expert interpretation, there is no mention of an adjudication method.

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

No MRMC comparative effectiveness study was done or reported in this submission. The device is an insertable cardiac monitor that automatically detects arrhythmias, not an AI-assisted diagnostic tool for human readers.

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

Yes, the testing described is effectively a standalone (algorithm and system only) performance evaluation. The Reveal LINQ ICM is an "automatically-activated monitoring system" that records ECG and detects events. The modifications are to internal algorithms (RRT and power management). The firmware regression testing and design verification are evaluations of the algorithm and system's performance in a standalone capacity.

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

For the firmware regression testing and design verification, the "ground truth" would be the expected behavior and outputs defined by the device's design input requirements and the behavior of the predicate device. The aim was to ensure the modified algorithms continued to perform as intended and did not introduce unintended changes or errors compared to the original design. This is a form of design specification-based ground truth rather than clinical outcomes or expert consensus.

8. The sample size for the training set

The document does not mention a training set size. The changes described are to existing algorithms (RRT and power management) for an already cleared device, not the development of a new machine learning algorithm that typically requires a specific training set.

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

Since no training set is mentioned, this information is not applicable.

Summary

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

April 22, 2016

Medtronic, Inc. Eric Kalmes Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112

Re: K160689

Trade/Device Name: Reveal LINQ LNQ11 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: March 24, 2016 Received: March 25, 2016

Dear Eric Kalmes:

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

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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 of medical devicerelated 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

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Indications for Use

510(k) Number (if known) K160689

Device Name Reveal LINQTM 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)

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FOR FDA USE ONLY

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

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510(k) Summary

[As required by 21 CFR 807.92]
Date Prepared:	March 23, 2016
Submitter:	Medtronic, Inc.Medtronic Cardiac Rhythm Heart Failure8200 Coral Sea Street N.E.Mounds View, MN 55112Establishment Registration Number: 2182208
Contact Person:	Eric KalmesPrincipal Regulatory Affairs SpecialistMedtronic Cardiac Rhythm Heart FailurePhone: 763.526.2809Fax: 651.367.0603Email: eric.b.kalmes@medtronic.com
Alternate Contact:	Ryan CalabreseDirector Regulatory AffairsMedtronic Cardiac Rhythm Heart FailurePhone: 763.526.3515Fax: 651.367.0603

General Information

Trade Name:	Reveal LINQ TM LNQ11
Common Name:	Insertable Cardiac Monitor
Regulation Number:	CFR 870.1025
Product Code:	DSI
Classification:	Class II
Classification Panel:	Cardiovascular
Special Controls:	Class II Special Controls Guidance Document: Arrhythmia Detector andAlarm
Predicate Devices:	Reveal LINQ LNQ11 Insertable Cardiac Monitor (K150614)

Email: ryan.s.calabrese@medtronic.com

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Device Description

The Reveal LINQ model LNQ11 is a small, leadless device that is typically implanted under the skin, in the chest. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG.

Indications for Use

There are no changes to the Indications for Use. The Indications for Use are provided below:

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
· 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

Intended use, design, materials, performance and technological characteristics are substantially equivalent to the predicate devices referenced.

Technological Characteristics

When compared to the predicate device (K150614), the modified Reveal LINQ model LNQ11 presented in this submission has the same:

. Intended use/indications for use
Operating principle
Design features
Device functionality
Biological safety ●
Packaging materials ●
. Shelf life

The modified Reveal LINQ model LNQ11 and the predicate device differ in the following:

Modify the Recommended Replacement Time (RRT) algorithm ●

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Minor update to the power supply management (K-factor) behavior to improve the power . supply management efficiency.

Substantial Equivalence and Summary of Studies:

Technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence of safe and effective use. The modified Reveal LINQ Model LNQ11 Insertable Cardiac Monitor is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use.

StandardNumber	StandardOrganization	Standard Title
14971:2012	ISO	Medical Devices - Application of Risk Management to MedicalDevices
62304:2008	IEC EN	Medical device software - Software life-cycle processes
Guidance	FDA	Class II Special Controls Guidance Document: ArrhythmiaDetector and Alarm Document Issued on October 28, 2003
Guidance	FDA	Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices Document issued on: May 11,2005

The following standards and guidance were used for development and testing of this change:

Summary of Testing

Firmware regression testing, design verification and system design validation testing were performed to demonstrate the Reveal LINQ ICM meet established performance criteria to support equivalency to the referenced predicate device.

Performance Testing - Bench

Firmware Regression Verification Testing Verification testing performed for the Reveal . LINQ Firmware with LINQ RRT modification and minor enhancements is complete. All 870 regression tests were executed and passed.
Design Verification No system or product level requirements were modified by this ● submission. Therefore, design verification was completed by verifying similarity to a previous design. The design outputs meet the design inputs based on: system and finished device similarity to the previous design(s), verification of the previous design(s), verification of no unintended changes to the current design(s), and verification of no unintended RAMware/firmware interactions within the finished device. All acceptance criteria have been met. The Reveal LINQ System and Reveal LINQ Insertable Cardiac Monitor are considered verified against their design input requirements.
System Design Validation - System Design Validation Plan, activities fell into two general categories: analyses and test execution. Test protocols were developed to provide coverage of

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the aspects of the system being validated against the design input requirements and risk control measures being validated.

Conclusion

The results of the above testing met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the modifications made to the Reveal LINQ Model LNQ11 Insertable Cardiac Monitor described in this submission result in a device that is substantially equivalent to the predicate.

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.