The Reveal LINQ Insertable Cardiac Monitor is an implantable patient-activated and 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 Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management features in the Reveal LINQ ICM to initiate recording of cardiac event data in the implanted device memory.

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) ventrioular 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 LINO model LNO11 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.

A set of tools are provided with the Reveal LINQ ICM to create the small incision in the skin and to easily form a tight pocket and insert the ICM into the shallow subcutaneous pocket. There are two implant tools: the Incision Tool, used to make a small incision through the patient's skin; and the Insertion Tool, used to insert the device through the incision and into the patient's body at the desired location.

The Reveal Patient Assistant Model 9538 is a hand-held, battery-operated telemetry devices The Patient Assistant activates the data management features in the Reveal LINQ ICM to initiate recording of cardiac event data in the implanted device memory.

AI/ML Overview

Here's a breakdown of the acceptance criteria and supporting study details based on the provided text, focusing on the Reveal LINQ ICM (Model LNQ11) as the primary device mentioned with performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

For the Reveal LINQ ICM, the primary performance criterion explicitly detailed in the document relates to its ability to detect Atrial Fibrillation (AF). The relevant study is the XPECT Trial, which was conducted on a predicate device (Reveal XT), but the results are used to support the new device's capabilities.

Acceptance Criterion (Clinical Performance)	Reported Device Performance (from XPECT Trial on Reveal XT)
Reliable detection of presence or absence of AF	Sensitivity: 96.1%
	Specificity: 85.4%
	Positive Predictive Value: 79.3%
	Negative Predictive Value: 97.4%
	Overall AF detection accuracy: 98.5%

Note: The document states "The sensitivity, specificity, positive predictive value, and negative predictive value for identifying patients with any AF were 96.1%, 85.4%, 79.3%, and 97.4%, respectively. Overall accuracy reported for detecting AF was 98.5% for the Reveal XT ICM." These are presented as the performance metrics that presumably satisfied the acceptance criteria for AF detection.

Other performance tests mentioned are at a high level and don't provide specific numerical acceptance criteria or performance figures in this summary:

Bench Testing: Electromagnetic compatibility (EMC), Electrical safety, Firmware and Hardware verification, Mechanical Verification, Implant Tools Verification, Packaging Design Verification, Sterilization, Biocompatibility, MRI compatibility, Sensing and Detection performance validation, System Validation.
Animal Testing: Reveal LINQ GLP Study.
Human Factors Testing: Formative and Validation Testing.

2. Sample Size Used for the Test Set and Data Provenance

XPECT Trial (AF detection):
- Sample Size: N = 247
- Data Provenance: Not explicitly stated (e.g., country of origin). The study type is "Validation," and it utilized a "specialized Holter to record the accuracy of the AF algorithm." It implies a prospective collection of data to validate the algorithm against a reference standard (Holter).
AIM Study (Insertion Force):
- Sample Size: N = 41
- Data Provenance: Not explicitly stated, described as "Prospective, multicenter, feasibility" study.
MapReveal Study (Signal Amplitude):
- Sample Size: N = 42
- Data Provenance: Not explicitly stated, described as "Prospective, multicenter, feasibility" study, with follow-up from 24 hours to > 1 month.
Subcutaneous Implant Migration (SubQ-IM) Study (Migration Observation/Insertion Force/ECG measurements):
- Sample Size: N = 40 healthy volunteers (implanted with 1 or 2 nonfunctional device prototypes)
- Data Provenance: Not explicitly stated, described as "Prospective, multicenter, randomized feasibility" study.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth for any of the studies mentioned. Specifically for the XPECT trial, it mentions a "specialized Holter to record the accuracy of the AF algorithm," which implies a reference standard, but doesn't detail human expert involvement in its interpretation or adjudication.

4. Adjudication Method for the Test Set

The document does not explicitly mention an adjudication method (e.g., 2+1, 3+1, none) for any of the studies.

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

No MRMC comparative effectiveness study is mentioned in the provided text, nor is there any discussion of an effect size of how much human readers improve with AI vs. without AI assistance. The focus of the clinical performance data (XPECT trial) is on the device's algorithm performance in detecting AF rather than human-in-the-loop performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone algorithm performance study was done for AF detection. The XPECT Trial was designed "To assess whether the AF detection algorithm reliably detected the presence or absence of AF." This directly evaluates the device's algorithm without explicit human intervention in the detection process quantified by the reported sensitivity, specificity, and accuracy.

7. The Type of Ground Truth Used

XPECT Trial (AF detection): The ground truth was established by a "specialized Holter to record the accuracy of the AF algorithm." This suggests a reference standard based on another established physiological measurement device and its interpretation.
AIM Study (Insertion Force): Ground truth was likely direct measurement of insertion force.
MapReveal Study (Signal Amplitude): Ground truth likely involved direct measurement of R-wave amplitude from ECG and subcutaneous ECG data.
SubQ-IM Study (Migration): Ground truth for migration was "Using fluoroscopy imaging."

8. The Sample Size for the Training Set

The document does not provide information about the training set size for any algorithms or models used in the device. The XPECT trial is described as a "Validation" study, implying the algorithm was already developed and this study was for its validation using a test set.

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

The document does not provide information on how the ground truth for any training set was established, as details about a training set are not included.

Summary

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K132649

510(k) Summary

Date Prepared:	15 August 2013
Submitter:	Medtronic, Inc.Cardiac Rhythm Disease Management8200 Coral Sea Street NEMounds View, MN 55112
Contact:	Eric KalmesPrincipal Regulatory Affairs Specialist
Telephone:	(763)526-2809
Fax:	(651)367-0603
E-mail:	eric.b.kalmes@medtronic.com
Proprietary Name:	Reveal LINQTM Insertable Cardiac Monitor,Model LNQ11Reveal Patient Assistant 9538
Common Name:	Arrhythmia detector and alarm
Device Classification	Class II, 21 CFR 870.1025, Arrhythmiadetector and alarm
Product Code:	DSI

Summary of Substantial Equivalence

The intended use, design, materials and performance of the Reveal LINO ICM (Model LNQ) I ) and Reveal Patient Assistant (Model 9538) are substantially equivalent to the following predicate devices:

The Reveal XT (Model 9529) and Reyeal DX (Model 9528) were initially cleared via . separate 510/k) applications, reference numbers K071655 on November 21, 2007. The Reveal XT (Model 9529) and Reveal DX (Model 9528) most recent modifications submission were cleared via K103764 on May 4, 2011.
Instromedix King of Hearts Express AF Recorder K020825, Cleared April 5,2002 .

Device Description

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Indications for Use

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

The Reveal LINO Insertable Cardiac Monitors is an implantable patient-activated and automatically-activated monitoring system that record subcutaneous ECG and are 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.

Technological Characteristics

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

Summary of Testing

Device system verification and validation testing was performed to demonstrate the Reveal LINO Model LNO11 Insertable Cardiac Monitor and its accessories meet established performance criteria to support equivalency to the reference predicate devices.

In addition the following testing was completed Reveal LINQ ICM Model LNQ11 :

Performance Testing - Bench

Electromagnetic compatibility (EMC) .
. Electrical safety
Firmware and Hardware verification .
Mechanical Verification .
. Implant Tools Verification

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Packaging Design Verification .
. Sterilization
Biocompatibility ●
. MRI compatibility
Sensing and Detection performance validation .
System Validation .
Only the labeling changed to support Reveal LINQ ICM for the Reveal Patient Assistant . Model 9538, therefore no performance testing was completed on the 9538 Patient Assistant.

Performance Testing – Animal

Reveal LINQ GLP Study .
Performance Testing - Clinical

The following table summarizes the clinical studies that support the incremental features and labeling of LINQ:

Study Name /Number	Design	Primary Objectives	Results
XPECT Trial	Type: ValidationFollow-up: 46 hoursSample: N = 247Device: Reveal XT	To assess whether the AF detectionalgorithm reliably detected thepresence or absence of AF.The XPECT trial utilized aspecialized Holter to record theaccuracy of the AF algorithm.	The sensitivity, specificity, positivepredictive value, and negativepredictive value for identifyingpatients with any AF were 96.1%,85.4%, 79.3%, and 97.4%,respectively. Overall accuracyreported for detecting AF was 98.5%for the Reveal XT ICM.12
AIM Study	Type: Prospective, multicenter,feasibilityFollow-Up: AcuteSample: N= 41Device: Reveal LINQ ProfileForce Probe	To characterize the insertion forcebased on various disease states andbody types.	The insertion force of a medicaldevice implant is higher in males thanfemales and may exceed the limit of 5pounds of force. This data contributedto development of Insertion Tool.
MapReveal	Type: Prospective, multicenter,feasibilityFollow-up: 24 hours to > 1 monthSample: N = 42Device: Reveal DX/XT	To assess the signal amplitude at therecommended location of V2V3, 45degrees. This study was designed tocollect 24 hour ambulatory surfaceECG mapping data and acutesubcutaneous ECG data withelectrode spacing shorter than that ofthe Reveal DX/XT devices.	The recommended location offeredacceptable R-wave amplitude whenselected without mapping.
SubcutaneousImplantMigration(SubQ-IM)	Type: Prospective, multicenter,randomized feasibilityFollow-up: 12 weeksSample: N= 40 healthyvolunteers (1 or 2 nonfunctionaldevice prototypes)	To observe and quantify prototypemigration, or lack thereof, as well asthe force of device insertion.	Using fluoroscopy imaging, results ofthis study indicated that no significantmigration occurred for a device ofidentical weight and shape of theReveal LINQ device. Additionally,data regarding the force measurementscontributed to the development of theInsertion Tool and Subcutaneous ECGmeasurements contributed to the

Table 1: Study Summaries

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Study Name /Number	Design	Primary Objectives	Results
	Device: Reveal LINQNonfunctional Prototype		recommended "Good" and "Best"Locations.

Performance Testing - Human Factors

Formative and Validation Testing .
The following standards were used for bench testing; Sterilization testing; Software testing; Electromagnetic Compatibility and Electrical Safety testing; and Biocompatibility testing:

	Standard
1	AAMI / ANSI / IEC 62366:2007/2008 Medical devices - Application of usability engineering tomedical devices
2	ISO 10993-1:2010 (Forth Edition) Biological evaluation of medical devices - Part 1: Evaluationand testing within a risk management process
3	ISO 10993-7:2008 (Second Edition) Biological evaluation of medical devices - Part 7: Ethyleneoxide sterilization residuals
4	EN 45502-1:2003 Active implantable medical devices - Part 1: General requirements for safety,marking and information to be provided by the manufacturer
5	ISO 11135-1:2007 (First Edition)Sterilization of health care products - Ethylene oxide - Part 1:Requirements for development, validation and routine control of a sterilization process for medicaldevices
6	EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirementsfor materials, sterile barrier systems and packaging systems
7	ISO 14971: 2007 (Second Edition) Medical devices - Applications of risk management to medicaldevices
8	IEC EN 62304: 2006/AC: 2008 Medical device software - Software life-cycle processes
9	EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to bedesignated "STERILE" - Part 1: Requirements for terminally sterilized medical devices.
10	IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
11	ISO 14708-1:2000 Implants for surgery -- Active implantable medical devices -- Part 1: Generalrequirements for safety, marking and for information to be provided by the manufacturer
12	ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with anactive implantable medical device

The results of the testing indicate that the Reveal LINQ ICM Model LNQ11, implant tools and Reveal Patient Assistant Model 9538 perform as intended and are safe and effective for their intended use.

Reveal Patient Assistant Model 9538 Performance Testing

Only the labeling changed for the Reveal Patient Assistant Model 9538, therefore no performance testing was completed on the 9538 Patient Assistant.

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The results of the testing indicate that the Reveal LINQ Insertable Cardiac Monitor Model LNQ11, implant tools and Reveal Patient Assistant Model 9538 perform as intended and are safe for their intended use.

Conclusion

Medtronic has demonstrated that the Reveal LINQ device described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate device(s).

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

February 14, 2014

Medtronic, Inc. Eric Kalmes Principal Regulatory Affairs Specialist 8200 Coral Sea Street, MVS11 Mounds View, MN 55112

Re: K132649

Trade/Device Name: Reveal LINQ Insertable Cardiac Monitor (ICM) model LNQ11, Reveal Patient Assistant Model 9538, and Implant Tools Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm Regulatory Class: Class II Product Code: DSI Dated: February 10 2014 Received: February 11. 2014

Dear Mr. 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. Ilsting 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Eric Kalmes

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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): K132649

Device Name: Reveal LINQ™ Insertable Cardiac Monitor and Reveal XT Patient Assistant

Indications for Use:

The Reveal LINQ Insertable Cardiac Monitor is an implantable patient-activated and 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.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.