(99 days)
No
The summary describes automated detection of pre-defined arrhythmia types based on ECG analysis, but does not mention AI or ML algorithms for this detection or any other function. The performance studies focus on traditional verification and validation methods.
No.
The device functions as a monitoring system for cardiac arrhythmias, recording ECG data and identifying arrhythmia episodes. It does not actively treat or provide therapy to resolve the identified conditions.
Yes
The device monitors a patient's ECG and records cardiac information to detect and classify various arrhythmias (tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation), which are used to identify or characterize a disease or condition. This clearly aligns with the definition of a diagnostic device.
No
The device description explicitly states it is an "Insertable Cardiac Monitor (ICM)" and mentions hardware components like the device itself, a tool kit, and a patient assistant. The performance studies also include mechanical, electrical, and sterilization testing, which are associated with hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. The LINQ II ICM is an implantable device that records subcutaneous ECG within the body (in vivo).
- The intended use and device description clearly state it monitors and records cardiac activity directly from the patient's body. There is no mention of analyzing samples outside the body.
Therefore, the LINQ II ICM is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
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 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
MXD, DSI
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. LINQ II ICM and this submission includes the following accessories: LINO Tool Kit Model LNO22TK, Reveal LINQTM Mobile Manager Model MSW002, Device Command Library Model 2692, and Instrument Command Library Model 2691.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The device has not been tested specifically for pediatric use.
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)
Firmware testing, design verification, system verification, and system design validation testing were performed to demonstrate that the subject device, the LINQ II ICM, met established performance criteria to support equivalency to the referenced predicate device, the existing Reveal LINQ ICM (cleared by FDA under K162855).
- Firmware design verification: This testing was made up of two parts: verification of the individual design artifacts (firmware units) associated with the development and release of the firmware; and verification of the finished firmware product (implemented design) to confirm that it meets the associated input requirements.
- Firmware regression testing: This testing of unchanged firmware was performed to ensure that no unintended side effects were introduced.
- Verification testing:
- Mechanical
- Electrical
- Electromagnetic compatibility (EMC) and electrical safety
- Sterilization
- Biocompatibility
- MRI Compatibility
- Sensing and detection performance validation
- Packaging testing
- Human Factors
- Security
- System testing: This testing was performed on the subject device (LINO II) and its . accessories which included system verification testing and system validation testing. System design verification ensured that the proposed modifications did not impact the existing system level design inputs. System design validation confirmed through a combination of test and analysis that the stakeholder needs and intended use continued to be met by the subject device.
The results of the above testing met the specified acceptance criteria and did not raise new safety or performance issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reveal LINQ Insertable Cardiac Monitor (Model LNQ11) K162855, Reveal XT Model (Model 9529) K071641
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
July 3, 2020
Medtronic, Inc. Eric Kalmes Sr. Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K200795
Trade/Device Name: LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit 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, DSI Dated: June 19, 2020 Received: June 22, 2020
Dear Eric Kalmes:
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,
Jennifer Shih Acting 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
2
Indications for Use
510(k) Number (if known) K200795
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 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Date Prepared: | March 13, 2019 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Cardiac Rhythm Heart Failure | |
| 8200 Coral Sea Street N.E. | |
| Mounds View, MN 55112 | |
| Establishment Registration Number: 2182208 | |
| Contact Person: | Eric Kalmes |
| Sr. Principal Regulatory Affairs Specialist | |
| Medtronic Cardiac Rhythm Heart Failure | |
| Phone: 763.526.2809 | |
| Fax: 651.367.0603 | |
| Email: eric.b.kalmes@medtronic.com | |
| Alternate Contact: | Ryan Calabrese |
| Senior Director Regulatory Affairs | |
| Medtronic Cardiac Rhythm Heart Failure | |
| Phone: 763.526.3515 | |
| Fax: 651.367.0603 | |
| Email: ryan.s.calabrese@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: | Primary Predicate Reveal LINQ Insertable Cardiac Monitor (Model LNQ11) K162855 and additional supporting predicate Reveal XT Model (Model 9529) K071641 |
4
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. LINQ II ICM and this submission includes the following accessories: LINO Tool Kit Model LNO22TK, Reveal LINQTM Mobile Manager Model MSW002, Device Command Library Model 2692, and Instrument Command Library Model 2691.
Accessories Subject to this Submission
- 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.
- The Reveal LINQ™ 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.
- The 2691 Instrument Command Library (ICL) software is the logic and data files required for remote programming.
Indications for Use
Aside from the name of the device, there are no changes as compared to the Reveal LINQ ICM Indications for Use as a result of this submission. The Indications for Use are provided below:
The LINO 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
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,
5
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 will be coated with sputtered titanium nitride. The sapphire will be 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 LINQ II ICM has a small form factor, and uses Sapphire, Titanium, Parylene, and Titanium Nitride coating on the sensing electrodes as body contacting materials.
When compared to the predicate device, the existing Reveal LINQ ICM (most recently cleared by FDA under K162855), the LINQ II ICM has the same:
- Indications for use
- · Operating principle
- Device functionality
- · Biological safety
When compared to the predicate device, the existing Reveal LINQ ICM (most recently cleared by FDA under K162855), the LINQ II differs as follows:
- · 4.5-year longevity
- · Bluetooth Low Energy (BLE) technology to enable communication with mobile devices via a mobile application.
- · The LINO II ICM includes minor changes to enhance the arrhythmia detection algorithms and diagnostics which include pause detection and PVC detector.
- · The insertion tool is being updated to accommodate the LINQ II device form factor.
- · CareLink Network enhancements to support the LINQ II device remote follow-up. This includes updates to the Instrument Command Library and Device Command Library.
- · Reveal LINO Mobile Manger updates to support LINO II ICM.
Substantial Equivalence
Technological differences between the subject and predicate devices have been evaluated through bench and animal testing. The LINO II ICM is substantially equivalent to the predicate device, the existing Reveal LINQ ICM (cleared by FDA under K162855) based on comparisons of device functionality, technological characteristics, and indications for use.
Summary of Testing
Firmware testing, design verification, system verification, and system design validation testing were performed to demonstrate that the subject device, the LINQ II ICM, met established
6
performance criteria to support equivalency to the referenced predicate device, the existing Reveal LINQ ICM (cleared by FDA under K162855).
- . Firmware design verification: This testing was made up of two parts: verification of the individual design artifacts (firmware units) associated with the development and release of the firmware; and verification of the finished firmware product (implemented design) to confirm that it meets the associated input requirements.
- Firmware regression testing: This testing of unchanged firmware was performed to ● ensure that no unintended side effects were introduced.
- . Verification testing:
- · Mechanical
- · Electrical
- · Electromagnetic compatibility (EMC) and electrical safety
- · Sterilization
- · Biocompatibility
- · MRI Compatibility
- · Sensing and detection performance validation
- · Packaging testing
- Human Factors
- · Security
- System testing: This testing was performed on the subject device (LINO II) and its . accessories which included system verification testing and system validation testing. System design verification ensured that the proposed modifications did not impact the existing system level design inputs. System design validation confirmed through a combination of test and analysis that the stakeholder needs and intended use continued to be met by the subject device.
7
The following standards and guidance documents were used for development and testing of the LINQ II device:
| Standard
Number | Standard
Organization | Recognition
Number | Standard Title |
|-------------------------------------------------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 14971:2012 | ISO | 5-40 | Medical Devices - Application of Risk Management to
Medical Devices |
| 62304:2006 | IEC EN | 13-32 | Medical device software - Software life-cycle processes |
| EC57:1998 | AANSI/AAMI | 3-118 | Testing and Reporting Performance Results of Cardiac
Rhythm and ST Segment Measurement Algorithms |
| 62366:
2007/(R)2013 | AAMI/ANSI/
IEC | 5-114 | Medical devices - Application of usability engineering to
medical devices |
| 15223-1:2012 | ISO | 5-117 | Medical devices — Symbols to be used with medical
device labels, labeling, and information to be supplied -
Part 1: General requirements |
| 10993-1:
2009/(R)2013 | AAMI/ANSI/
ISO | 2-220 | Biological evaluation of medical devices. Evaluation and
testing |
| 11135-1:2014 | EN ISO | 14-452 | Medical Devices – validation and routine control of
ethylene oxide sterilization |
| 60601-1: 2005
(2nd Edition)
and 2006 (3rd
Edition) | EN | 19-1 | Medical electrical equipment-Part 1: General requirements
for basic safety and essential performance |
| 11607-1:2009 | EN ISO | 14-454 | Packaging for terminally sterilized medical devices - Part
1: Requirements for materials, sterile barrier systems and
packaging systems |
| 14117:2012 | ISO | 3-139 | Active implantable medical devices -- Electromagnetic
compatibility -- EMC test protocols for implantable cardiac
pacemakers, implantable cardioverter defibrillators and
cardiac resynchronization devices. |
| 14708-1:2000 | ISO | 3-156 | Implants for surgery -- Active implantable medical devices
-- Part 1: General requirements for safety, marking and for
information to be provided by the manufacturer |
| Guidance | FDA | | Class II Special Controls Guidance Document: Arrhythmia Detector and
Alarm |
| Guidance | FDA | Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices | |
| Guidance | FDA | Content of Premarket Submissions for Management of Cybersecurity in
Medical Devices, 14 June 2013 and revised edition of the pre-market
guidance document issued on October 18, 2018 | |
8
The following standards were used for development and testing of the Reveal LINQ™ Mobile Manager:
| Standard Number | Standard
Organization | Recognition
Number | Standard Title |
|----------------------|--------------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 14708-1:2014 | ISO | 3-156 | Implants for surgery -- Active implantable
medical devices -- Part 1: General requirements
for safety, marking and for information to be
provided by the manufacturer |
| 14971:2007 | ISO | 5-40 | 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 |
| 62304:2006/AMD1:2015 | IEC | 13-79 | Medical device software – Software life cycle
processes |
| 62366-1 | IEC | 5-114 | Medical devices - Part 1: Application of usability
engineering to medical devices |
The following standards were used for development and testing of the Device Command Library Model 2692:
| Standard Number | Standard Organization | Recognition Number | Standard Title |
|---|---|---|---|
| EN ISO 14971: 2012 | ISO | 5-40 | Medical devices – Application of risk |
| management to medical devices | |||
| EN 60601-1: 2006/ | |||
| A1:2013 | EN | 19-1 | Medical electrical equipment - Part 1: General |
| requirements for basic safety and essential | |||
| performance | |||
| EN 62304:2006/ | |||
| A1:2015 | IEC EN | 13-32 | Medical device software. Software life-cycle |
| processes |
9
The following standards were used for development and testing of the Instrument Command Library, Model 2691:
| Standard Number | Standard Organization | Recognition Number | Standard Title |
|---|---|---|---|
| EN ISO 14971:2012 | ISO | 5-40 | Medical devices - Application of risk management to medical devices |
| EN 60601-1: | |||
| 2006/AC:2010 | EN | 19-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN 62304:2006/A1:2015 | IEC | 13-32 | Medical device software. Software life-cycle processes |
Conclusion
The results of the above testing met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the LINQ II Insertable Cardiac Monitor Model LNQ22 and its accessories, which include: LINQ Tool Kit Model LNQ22TK, Reveal LINQ™M Mobile Manager Model MSW002, Device Command Library Model 2692, and Instrument Command Library Model 2691, described in this submission result in a device that is substantially equivalent to the predicate.