(29 days)
The LINQ II 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.
The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. In order to manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event.
The provided text is a 510(k) Summary for the Medtronic LINQ II Insertable Cardiac Monitor. This document focuses on demonstrating substantial equivalence to a predicate device after a software update (RAMware). It does not contain a comprehensive study detailing the initial performance of the device against specific acceptance criteria for arrhythmia detection, but rather confirms that the software update did not negatively impact the previously established performance.
Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets these criteria for the core functionality of arrhythmia detection is not present in this specific document. The document only states that "The results of the above verification and validation testing met the specified acceptance criteria and did not raise new safety or performance issues." after a RAMware update.
However, I can extract what is implied and what minimal information is available about the impact of the RAMware update:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria and performance reported relate specifically to the RAMware update and its impact on battery reporting and rejection parameters, not the overall arrhythmia detection performance of the LINQ II ICM.
| Acceptance Criteria (Implied for RAMware update) | Reported Device Performance (for RAMware update) |
|---|---|
| Adequate mitigation of incorrect battery reporting parameter settings | Met via design verification and validation testing, confirming no adverse impact. |
| Adequate mitigation of incorrect rejection parameter settings | Met via design verification and validation testing, confirming no adverse impact. |
| No adverse impact to the functioning of the modified LINQ II ICM device | Confirmed through successful design verification and validation activities. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "device verification and system validation testing" but does not specify sample sizes or data provenance.
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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
An MRMC study is not mentioned in this document. This document is focused on a software update for an existing device, not an AI-assisted interpretation system. The LINQ II is an "automatically-activated and patient-activated monitoring system that records subcutaneous ECG" and is an "arrhythmia detector and alarm," implying automated detection rather than human reader improvement with AI.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
The LINQ II ICM is inherently a standalone device in its primary detection function ("automatically-activated"). The document does not describe a separate standalone performance study in the context of this software update, but rather confirms the continued proper functioning of the device as a standalone detector after the update.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. For an arrhythmia detector, ground truth would typically involve expert-reviewed ECGs or confirmed clinical diagnoses. However, for this submission, the "ground truth" for the RAMware update likely refers to engineering specifications and expected behavior for battery reporting and rejection parameters.
8. The sample size for the training set
This information is not applicable/provided. The document describes a "RAMware update" to existing firmware, implying a software modification rather than a new machine learning model requiring a dedicated training set.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
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May 28, 2021
Medtronic, Inc. Andrea Artman Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K211304
Trade/Device Name: LINQ II 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: April 28, 2021 Received: April 29, 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K211034
Device Name LINQ II Insertable Cardiac Monitor
Indications for Use (Describe)
The LINQ II 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 transent 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (6/20)
LINQ II POR RAMware Update Medtronic Confidential
PSC Publishing Services (301) 443-6740 EF
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510(k) Summary
| Date Prepared: | April 28, 2021 |
|---|---|
| Submitter: | Medtronic, Inc.Medtronic Cardiovascular Diagnostics & Services8200 Coral Sea Street N.E.Mounds View, MN 55112Establishment Registration Number: 2182208 |
| Contact Person: | Andrea ArtmanPrincipal Regulatory Affairs SpecialistMedtronic Cardiovascular Diagnostics & ServicesPhone: 419.708.4172Fax: 651.367.0603Email: andrea.p.artman@medtronic.com |
| Alternate Contact: | Ryan CalabreseSenior Director Regulatory AffairsMedtronic Cardiovascular Diagnostics & ServicesPhone: 763.234.3574Fax: 651.367.0603Email: ryan.s.calabrese@medtronic.com |
General Information
| Trade Name: | LINQ™ II Insertable Cardiac Monitor |
|---|---|
| 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 andAlarm |
| Predicate Device: | LINQ™ II Insertable Cardiac Monitor (Model LNQ22) K200795 |
Device Description
The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually
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record symptoms. In order to manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event.
Accessories
- The LINQ Tool Kit Model LNQ22TK includes two implant tools: The Incision Tool is . used to make a small incision through the patient's skin: and the Insertion Tool is used to insert the device through the incision and into the patient's body at the desired location.
- o The Reveal LINO™ Mobile Manager (LMM) Model MSW002 is the programmer designed as a mobile app that communicates with the Reveal LINQ and LINQ II ICM devices via the existing model 24967 telemetry head.
- The 2692 Device Command Library (DCL) software is a component of the Data Transformation Services subsystem of the CareLink Network. This software is responsible for understanding command status, implant device state within CareLink, and the initiation of commands for the implanted device.
- o The 2691 Instrument Command Library (ICL) software is the logic and data files required for remote programming.
Indications for Use
There are no changes to the LINQ II ICM Indications for Use as a result of this submission. The Indications for Use are provided below:
The LINQ II 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 (K200795), the modified LINQTM II Insertable Cardiac Monitor presented in this submission has the same:
- Intended use/indications for use
- Operating principle ●
- o Design features
- Device functionality
- Biological safety
- . Packaging materials
- Shelf life
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The modified Model LNQ22 ICM differs from the predicate in that the modified device contains RAMware that has been added to augment the firmware ensuring appropriate functionality of the device with respect to battery reporting and rejection parameter settings.
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 battery reporting and rejection parameter settings.
The modified LINQ II 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 LINQ II 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 LINQ II Insertable Cardiac Monitor described in this submission result in a device that is substantially equivalent to the predicate.
§ 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.