Reveal LINQ

K150614 · Medtronic, Inc. · MXD · Aug 6, 2015 · Cardiovascular

Device Facts

• Record ID: K150614
• Device Name: Reveal LINQ
• Applicant: Medtronic, Inc.
• Product Code: MXD · Cardiovascular
• Decision Date: Aug 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Indications for Use

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.

Device Story

Leadless, insertable cardiac monitor (ICM) implanted subcutaneously in chest; continuously monitors subcutaneous ECG via two surface electrodes. Device automatically detects and records arrhythmia events (AT/AF, bradyarrhythmia, pause, ventricular tachyarrhythmia) or records patient-activated events. System includes LINQ Programmer Application (mobile app) and patient connector (telemetry head). Clinician uses mobile app to program diagnostic settings, interrogate device, and extract data. Data transmitted to Medtronic CareLink Network for clinical review. Enables long-term cardiac rhythm monitoring to identify transient symptoms; assists clinicians in diagnosing arrhythmias and managing patient care.

Clinical Evidence

Bench testing only. System verification and validation were performed for the Reveal LINQ ICM, LINQ Programmer Application, and patient connector. Testing included electromagnetic compatibility (EMC), RF compliance, electrical safety, mechanical, packaging, biocompatibility, and performance verification. No clinical data was required or presented.

Technological Characteristics

Leadless implantable device; LiCFx battery; titanium, parylene, urethane, and titanium nitride coated electrodes. Dimensions: 1.2 cc volume, 2.4 g mass. Telemetry: RF (Telemetry B) between implant and patient connector; Bluetooth between connector and mobile device. Standards: AAMI/ANSI/IEC 62366, ISO 10993-1/7, ISO 11607-1, ISO 14971, IEC 62304, IEC 62133, ASTM D4169.

Indications for Use

Indicated for patients with clinical syndromes/situations at increased risk of cardiac arrhythmias or patients experiencing transient symptoms (dizziness, palpitation, syncope, chest pain) suggesting cardiac arrhythmia. Not tested for pediatric use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Reveal LINQ ICM (Model LNQ11) (K132649)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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# 510(k) Summary

| Date Prepared: | 9 March 2015 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------|
| 510(k) Owner / Address: | Medtronic, Inc.<br>Cardiac Rhythm and Heart Failure<br>8200 Coral Sea Street<br>Mounds View, MN 55112 |
| Contact: | Dianna L. Johannson<br>Sr. Pr. Regulatory Affairs Specialist |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Trade / Proprietary Name: | Reveal® LINQTM Insertable Cardiac Monitor,<br>Model LNQ11 |
| Common Name: | Insertable Cardiac Monitor |
| Classification /<br>Classification Name: | Class II<br>Arrhythmia detector and alarm<br>(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

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.

# 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)<br>(with existing programmer<br>software and hardware) | Reveal LINQ (Model LNQ11)<br>(with alternative LINQ<br>Programmer Application and<br>patient connector) |
|------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Longevity | 3 years | Same |
| Electrode Spacing (inside-to-<br>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)<br>(with existing programmer<br>software and hardware) | Reveal LINQ (Model LNQ11)<br>(with alternative LINQ<br>Programmer Application and<br>patient connector) |
|------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Clinician Notification | Nightly Transmission /<br>Notifications | Same |
| Bi-Directional Telemetry | B | Same |
| Detection Algorithms | Full View + P-wave presence<br>filter | Same |
| CareLink | Yes | Same |
| Wireless Telemetry | 1-Way, Transmit Only | Same |
| Patient's CareLink Clinic<br>Name 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.

| Standards<br>Organization /<br>Number | Standards Title | Date /<br>Version |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| AAMI / ANSI /<br>IEC 62366 | Medical devices - Application of usability engineering to medical<br>devices | 2007 |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and<br>testing within a risk management process | 2010 (Forth<br>Edition) |
| ISO 10993-7 | Biological evaluation of medical devices - Part 7: Ethylene oxide<br>sterilization residuals | 2008<br>(Second<br>Edition) |
| ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1:<br>Requirements for materials, sterile barrier systems and packaging<br>systems | 2009 |
| ISO 14971 | Medical devices - Applications of risk management to medical<br>devices | 2007<br>(Second<br>Edition) |
| IEC 62304 | Medical device software - Software life-cycle processes | 2006/ AC:<br>2008 |

#### Standards Referenced for the Reveal LINQ ICM

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| Standard | | |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Standards<br>Organization /<br>Number | Standards Title | Date /<br>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 | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Standards<br>Organization /<br>Number | Standards Title | Date /<br>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-acid<br>electrolytes - Safety requirements for portable sealed secondary cells,<br>and for batteries made from them, for use in portable applications. | 2012 |
| IEC 62366 | Medical devices – Application of usability engineering to medical<br>devices | 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,<br>labeling, and information to be supplied — Part 1: General<br>requirements | 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.