(57 days)
Yes
The device description explicitly mentions "AccuRhythm AI ECG Classification System Models ZA400, ZA410, and ZA420" as accessories included with the LINQ II ICM. This indicates the incorporation of AI technology for ECG classification.
No
The device is a monitoring system that records ECG and detects arrhythmias. It does not provide any treatment or therapy.
Yes
Explanation: The device is described as "continuously monitor[ing] a patient's ECG and other physiological parameters," recording "cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings." It also states that the device is "designed to automatically record the occurrence of an episode of arrhythmia in a patient." These functions – monitoring, recording, and identifying arrhythmias – are all diagnostic in nature, aiming to identify a medical condition (cardiac arrhythmias).
No
The device description clearly states it is an "insertable cardiac monitor" and records "subcutaneous ECG," indicating a physical, implantable hardware component. While it includes software components like the MyCareLink Heart App and CareLink SmartSync Application, the core device is hardware.
Based on the provided information, the LINQ II ICM is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- LINQ II ICM Function: The LINQ II ICM is an insertable device that records subcutaneous ECG. It monitors the patient's cardiac activity within the body (in vivo). It does not analyze samples taken from the body.
- Intended Use: The intended use is to monitor for cardiac arrhythmias in patients with certain symptoms or risks. This is a diagnostic process performed by monitoring physiological signals directly from the patient.
Therefore, the LINQ II ICM falls under the category of an in vivo diagnostic or monitoring device, not an in vitro diagnostic device.
No
The input text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" explicitly states "Not Found".
Intended Use / Indications for Use
The LINQ II ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, 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, 0 syncope, and chest pain that may suggest a cardiac arrhythmia
Product codes
MXD
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 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. LINO II ICM includes the following accessories: LINO II Tool Kit Model LNO22TK, Reveal LINO™ Mobile Manager Model MSW002. Device Command Library Model 2692. Instrument Command Library Model 2691, and AccuRhythm AI ECG Classification System Models ZA400, ZA410, and ZA420. New to the LINO II ICM system is the CareLink SmartSync LINO II ICM Application Model D00U024.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
AccuRhythm AI ECG Classification System Models ZA400, ZA410, and ZA420.
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous ECG
Indicated Patient Age Range
adult patients, and in pediatric patients who are at least 2 years old
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and design validation were performed to demonstrate that the LINO II ICM when used with the CareLink SmartSync LINQ II ICM Application met design requirements and established performance criteria to support substantial equivalence to the predicate LINQ II ICM (K211304).
- Design Verification: Software and system design verification were completed to ensure ● the design output meets specifications outlined in the design inputs. The CareLink SmartSync LINQ II ICM Application meets the functionality per the requirements and all test executions resulted in a status of Passed.
- Design Validation: System validation testing and analysis were completed to ensure the ● CareLink SmartSync LINO II ICM Application meets design input requirements under actual or simulated use conditions. All results met the criteria in the Validation Plan.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LINQ IITM Insertable Cardiac Monitor (Model LNQ22) K211304
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 26, 2023
Medtronic, Inc. Kerry Luyster Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K230553
Trade/Device Name: LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application 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: February 27, 2023 Received: February 28, 2023
Dear Kerry Luyster:
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
1
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 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 (QS) 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 medical devices and radiation-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,
Digitally signed Sara M. by Sara M. Royce -5 ROVCe -S Date: 2023.04.26 21:16:35 -04'00' For Hetal Odobasic 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230553
Device Name
LINQ II Insertable Cardiac Monitor (Model LNQ22)
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 adult patients who are at least 2 years old, 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
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: | April 26, 2023 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Cardiovascular Diagnostics and Services | |
| 8200 Coral Sea Street NE | |
| Mounds View, MN 55112 | |
| Establishment Registration Number: 2182208 | |
| Contact Person: | Kerry C Luyster |
| Senior Regulatory Affairs Specialist | |
| Cardiovascular Diagnostics and Services | |
| Phone: (763) 505-2124 | |
| Email: kerry.c.luyster@medtronic.com | |
| Alternate Contact: | Dianna L Johannson |
| Distinguished Regulatory Affairs Advisor | |
| Cardiovascular Diagnostics and Services | |
| Phone: (763) 526-2376 | |
| Email: dianna.johannson@medtronic.com |
General Information
| Trade Name: | LINQ IITM Insertable Cardiac Monitor |
|---|---|
| Common Name: | Insertable Cardiac Monitor |
| Regulation Number: | CFR 870.1025 |
| Product Code: | MXD |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
| Special Controls: | Class II Special Controls Guidance Document: Arrhythmia Detector and |
| Alarm | |
| Predicate Device: | LINQ IITM Insertable Cardiac Monitor (Model LNQ22) K211304 |
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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 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. LINO II ICM includes the following accessories: LINO II Tool Kit Model LNO22TK, Reveal LINO™ Mobile Manager Model MSW002. Device Command Library Model 2692. Instrument Command Library Model 2691, and AccuRhythm AI ECG Classification System Models ZA400, ZA410, and ZA420. New to the LINO II ICM system is the CareLink SmartSync LINO II ICM Application Model D00U024.
Indications for Use
The LINQ II ICM Indications for Use remains the same as a result of this submission and are as follows:
The LINO II ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, 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, 0 syncope, and chest pain that may suggest a cardiac arrhythmia
Technological Characteristics
The LINO II ICM consists of a hybrid substrate that is made of sapphire. The sapphire provides part of the implantable hermetic enclosure, integrates the feedthroughs directly into the substrate, and provides a substrate for component attachment/interconnect. The antenna and sense electrodes are titanium foil laser bonded to the outside of the sapphire substrate and connected directly to the embedded feedthroughs. The sense electrodes are coated with sputtered titanium nitride. The sapphire is laser bonded to the titanium battery cover, which provides the complete hermetic enclosure. The battery is Lithium anode, silver vanadium oxide/carbon monofluoride cathode with a capacity of 167 mAh.
The LINO II ICM will continue to use the same technology. It is designed to automatically record the occurrence of an arrhythmia in a patient, continuously sense the patient's subcutaneous ECG, and analyze the timing of ventricular events to detect possible episodes of arrhythmia. The LINO II ICM has a small form factor, and uses Sapphire, Titanium, Parvlene, and Titanium Nitride coating on the sensing electrodes as body contacting materials.
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When compared to the predicate LINQ II ICM (K211304), the LINQ II ICM when used with the CareLink SmartSync LINQ II ICM Application has the same indications for use, operating principle, device technology and functionality, and biological safety.
When compared to the predicate LINQ II ICM (K211304), the LINQ II ICM differs only in its use with the CareLink SmartSync LINQ II ICM Application.
Substantial Equivalence
Differences between the subject and predicate devices have been evaluated through bench testing to provide evidence of substantial equivalence. The LINQ II ICM when used with the CareLink SmartSync LINO II ICM Application is substantially equivalent to the predicate LINO II ICM (K211304) based on comparisons of indications for use, operating principle, device technology and functionality, and safety.
Summary of Testing
Design verification and design validation were performed to demonstrate that the LINO II ICM when used with the CareLink SmartSync LINQ II ICM Application met design requirements and established performance criteria to support substantial equivalence to the predicate LINQ II ICM (K211304).
- Design Verification: Software and system design verification were completed to ensure ● the design output meets specifications outlined in the design inputs. The CareLink SmartSync LINQ II ICM Application meets the functionality per the requirements and all test executions resulted in a status of Passed.
- Design Validation: System validation testing and analysis were completed to ensure the ● CareLink SmartSync LINO II ICM Application meets design input requirements under actual or simulated use conditions. All results met the criteria in the Validation Plan.
Since there were no changes to the LINQ II ICM itself, there was no development or testing specific to the ICM; therefore, no standards are referenced for the LINQ II ICM.
The following standards were used for development and testing of the CareLink SmartSync LINQ II ICM Application.
| Standard Number | Standard
Organization | Recognition
Number | Standard Title |
|-----------------|--------------------------|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| 14971:2019 | ISO | 5-125 | Medical Devices - Application of
Risk Management to Medical
Devices |
| 15223-1:2016 | ISO | 5-117 | Medical devices - Symbols to be
used with medical device labels,
labelling, and information to be
supplied - Part 1: General
requirements |
| 82304-1:2017 | IEC | 13-97 | Health software - Part 1: General
requirements for product safety |
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| Standard Number | Standard
Organization | Recognition
Number | Standard Title |
|---------------------------|--------------------------|-----------------------|------------------------------------------------------------|
| 62304:2006/ AMD
1:2015 | IEC | 13-79 | Medical device software - Software
life cycle processes |
| 62304:2006/AC:2008 | IEC | 13-79 | Medical device software - Software
life cycle processes |
Conclusion
The results of the testing met the design requirements and specified acceptance criteria and did not raise new safety or performance issues. Therefore, the LINQ II ICM Model LNQ22 when used with the CareLink SmartSync LINQ II ICM Application Model D00U024 described in this submission results in a device that is substantially equivalent to the predicate LINQ II ICM Model LNQ22 (K211304).