Reveal LINQ Insertable Cardiac Monitor

K212008 · Medtronic, Inc. · MXD · Jul 22, 2021 · Cardiovascular

Device Facts

• Record ID: K212008
• Device Name: Reveal LINQ Insertable Cardiac Monitor
• Applicant: Medtronic, Inc.
• Product Code: MXD · Cardiovascular
• Decision Date: Jul 22, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended 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

Small, leadless, subcutaneous insertable cardiac monitor (ICM); implanted in chest. Two electrodes continuously monitor subcutaneous ECG. Device automatically detects and records arrhythmias (AT/AF, bradyarrhythmia, pause, ventricular tachyarrhythmia) and stores ECG/Marker Channel data during auto-detected or patient-activated events. Used in clinical settings; operated by physicians/clinicians. Output allows healthcare providers to review cardiac rhythm data to inform clinical decision-making regarding arrhythmia management. Benefits include detection of abnormal rhythms in patients who may not trigger manual activation.

Clinical Evidence

Bench testing only. Verification and system validation testing were performed to confirm that the added RAMware correctly mitigates incorrect rejection parameter settings. All activities met acceptance criteria.

Technological Characteristics

Leadless, subcutaneous implantable device. Two-electrode sensing. Monitors subcutaneous ECG. Modified with added RAMware for detection parameter configuration. Substantially equivalent to predicate in materials, design, and operating principle.

Indications for Use

Indicated for patients at increased risk of cardiac arrhythmias or experiencing transient symptoms (dizziness, palpitation, syncope, chest pain) suggestive of 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® LINQTM Insertable Cardiac Monitor (ICM), Model LNQ11 (K162855)

Submission Summary (Full Text)

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July 22, 2021

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

Re: K212008

Trade/Device Name: Reveal LINQ Insertable Cardiac Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MXD Dated: June 24, 2021 Received: June 28, 2021

Dear Andrea Artman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K212008

Device Name Reveal LINQ Insertable Cardiac Monitor (ICM)

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)

| 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: | June 25, 2021 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Medtronic, Inc.<br>Medtronic Cardiovascular Diagnostics & Services<br>8200 Coral Sea Street N.E.<br>Mounds View, MN 55112<br>Establishment Registration Number: 2182208 |
| Contact Person: | Andrea Artman<br>Principal Regulatory Affairs Specialist<br>Medtronic Cardiovascular Diagnostics & Services<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Alternate Contact: | Ryan Calabrese<br>Senior Director Regulatory Affairs<br>Medtronic Cardiovascular Diagnostics & Services<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

### General Information

| Trade Name: | Reveal® LINQTM Insertable Cardiac Monitor (ICM) |
|-----------------------|-------------------------------------------------------------------------------|
| Common Name: | Insertable Cardiac Monitor |
| Regulation Number: | 21 CFR 870.1025 |
| Product Code: | MXD |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
| Special Controls: | Class II Special Controls Guidance Document: Arrhythmia Detector and<br>Alarm |
| Predicate Device: | Reveal® LINQTM Insertable Cardiac Monitor (ICM), Model LNQ11<br>(K162855) |

## 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

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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 ICM 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.

## Indications for Use

There are no changes to the Indications for Use as a result of this submission. 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.

When compared to the predicate device (K162855), the modified Reveal LINQ Insertable Cardiac Monitor 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 ICM device differs from the predicate in that the modified device contains added RAMware to ensure the detection parameters are appropriately configured after a partial electrical reset.

# Substantial Equivalence and Summary of Studies

Technological differences between the subject and predicate devices have been evaluated with device verification and system validation testing. The objective evidence from the verification and validation testing confirm that the change adequately mitigates incorrect rejection parameter settings.

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The modified Reveal LINQ Insertable Cardiac Monitor is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The modifications to the subject device were verified and validated through design verification and validation activities. All design verification and design validation activities were completed successfully and demonstrated there was no adverse impact to the functioning of the modified Reveal LINQ ICM device.

## Conclusion

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