(30 days)
Not Found
Yes
The device description explicitly mentions "AccuRhythm AI ECG Classification System Models ZA400, ZA410, ZA420" as part of the LINQ II ICM system.
No.
The device is a monitoring system that records ECG and detects arrhythmias; it does not provide any treatment or therapy.
Yes
The device monitors, records, and classifies cardiac information to detect and diagnose arrhythmias, which are transient symptoms like dizziness, palpitation, syncope, and chest pain, making it a diagnostic device.
No
The device description explicitly states it is an "Insertable Cardiac Monitor (ICM) Model LNQ22," which is a programmable device that continuously monitors a patient's ECG and other physiological parameters. This indicates a physical, implantable hardware component. While it includes software components like the CareLink SmartSync LINQ II Platform Application and the AccuRhythm AI ECG Classification System, 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 devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- LINQ II ICM Function: The LINQ II ICM is an insertable device that records subcutaneous ECG within the patient's body. It monitors electrical activity of the heart directly.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient.
Therefore, the LINQ II ICM falls under the category of an implantable medical device that performs physiological monitoring, not an IVD.
No
The provided text does not contain any explicit statements indicating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
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, syncope, and chest pain that may suggest a cardiac arrhythmia
Product codes (comma separated list FDA assigned to the subject device)
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: LINQ II Tool Kit Model LNQ22TK, Reveal LINQ™ Mobile Manager Model MSW002, Device Command Library Model 2692, Instrument Command Library Model 2691, and AccuRhythm AI ECG Classification System Models ZA400, ZA410, ZA420 and CareLink SmartSync LINQ II ICM Application Model D00U024. New to the LINQ II ICM system is the CareLink SmartSync LINQ II Platform Application Model D00U027.
The LINO II ICM consists of a hybrid substrate that is made of 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 LINQ 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, Parylene, and Titanium Nitride coating on the sensing electrodes as body contacting materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
AccuRhythm AI ECG Classification System Models ZA400, ZA410, ZA420
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Platform Application met design requirements and established performance criteria to support substantial equivalence to the predicate LINQ II ICM (K233320).
- . 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 Platform Application meets the functionality per the requirements and all test executions resulted in a status of Passed.
- Design Validation: System validation review was completed to ensure the CareLink ● SmartSync LINQ II Platform 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LINQ II™ Insertable Cardiac Monitor (Model LNQ22) K233320
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2023
Medtronic, Inc. Kerry Luyster Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K233562
LINQ II Insertable Cardiac Monitor Trade/Device Name: 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: November 6, 2023 Received: November 6, 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Jessica L.
Batista -S
Digitally signed by
Jessica L. Batista -S
Date: 2023.12.06
15:36:19 -05'00'
Jessica L. Batista -S Date: 2023.12.06 15:36:19 -05'00'
for
Sara Royce Acting Assistant Director Division of Cardiac Electrophysiology, Diagnostics
2
and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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 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, 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
K233562 Page 1 of 4
510(k) Summary
| Date Prepared: | November 6, 2023 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Cardiac Rhythm Management | |
| 8200 Coral Sea Street NE | |
| Mounds View, MN 55112 | |
| Establishment Registration Number: 2182208 | |
| Contact Person: | Kerry C Luyster |
| Senior Regulatory Affairs Specialist | |
| Cardiac Rhythm Management | |
| Phone: (763) 505-2124 | |
| Email: kerry.c.luyster@medtronic.com | |
| Alternate Contact: | Syed Mohiuddin |
| Regulatory Affairs Director | |
| Cardiac Rhythm Management | |
| Phone: (763) 526-2380 | |
| Email: syed.s.mohiuddin@medtronic.com |
General Information
| Trade Name: | LINQ II™ 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 II™ Insertable Cardiac Monitor (Model LNQ22) K233320 |
5
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: LINQ II Tool Kit Model LNQ22TK, Reveal LINQ™ Mobile Manager Model MSW002, Device Command Library Model 2692, Instrument Command Library Model 2691, and AccuRhythm AI ECG Classification System Models ZA400, ZA410, ZA420 and CareLink SmartSync LINQ II ICM Application Model D00U024. New to the LINQ II ICM system is the CareLink SmartSync LINQ II Platform Application Model D00U027.
Indications for Use
The LINQ II ICM Indications for Use remain the same as a result of this submission and are as follows:
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, 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 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 LINQ 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, Parylene, and Titanium Nitride coating on the sensing electrodes as body contacting materials.
6
When compared to the predicate LINQ II ICM (K233320), the LINQ II ICM when used with the CareLink SmartSync LINQ II Platform Application has the same indications for use, operating principle, device technology and functionality, and biological safety.
When compared to the predicate LINQ II ICM (K233320), the LINQ II ICM differs only in its use with the CareLink SmartSync LINQ II Platform 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 Platform Application is substantially equivalent to the predicate LINQ II ICM (K233320) 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 Platform Application met design requirements and established performance criteria to support substantial equivalence to the predicate LINQ II ICM (K233320).
- . 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 Platform Application meets the functionality per the requirements and all test executions resulted in a status of Passed.
- Design Validation: System validation review was completed to ensure the CareLink ● SmartSync LINQ II Platform 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 LINO II ICM.
The following standards were used for development and testing of the CareLink SmartSync LINQ II Platform 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 |
7
| 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 Platform Application Model D00U027 described in this submission results in a device that is substantially equivalent to the predicate LINQ II ICM Model LNQ22 (K233320).