(112 days)
Not Found
Yes
The document explicitly mentions the "Zelda AI ECG Classification System" and states it is "powered by deep-learning neural architectures".
No
The device is a monitoring system that records ECG and detects cardiac arrhythmias. It does not provide treatment or therapy.
Yes
The device is explicitly described as a "monitoring system that records subcutaneous ECG" and is indicated for "patients with clinical syndromes or situations at increased risk of cardiac arrhythmias" and those who "experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia." It also records cardiac information in response to "automatically detected arrhythmias" and uses an "AI ECG Classification System" for AF and Pause detection, all of which point to its role in identifying and classifying medical conditions.
No
The device description clearly states that the LINQ II ICM is an "insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG". This indicates a physical, implantable hardware component. While it includes software components like the MyCareLink Heart App and the Zelda 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).
Here's why:
- IVDs analyze samples taken from the body. IVDs typically involve testing blood, urine, tissue, or other biological samples in a laboratory setting.
- The LINQ II ICM is an insertable device that records subcutaneous ECG within the body. It directly monitors physiological signals from the patient's heart.
- The intended use and device description clearly indicate in-vivo monitoring. The device is inserted under the skin and records ECG data from within the patient.
While the device uses AI to classify ECG data, this processing is applied to signals acquired directly from the patient's body, not from a sample taken from the body. Therefore, it falls outside the definition of an In Vitro Diagnostic.
Yes
The FDA clearance letter explicitly states that "Medtronic will make future algorithm improvements under a Predetermined Change Control Plan (PCCP)" for the Zelda AI ECG Classification System. It further details the scope of planned changes and the methods for their implementation and control under the PCCP.
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 (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. LINQ II ICM includes the following accessories: LINQ Tool Kit Model LNQ22TK, Reveal LINQTM Mobile Manager Model MSW002, Device Command Library Model 2692, and Instrument Command Library Model 2691. New to the LINO II ICM system is the Zelda AI ECG Classification System Models ZA400. ZA410. ZA420. included in this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Yes. The Zelda AI ECG Classification System is powered by deep-learning neural architectures for AF and Pause detection based on the residual convolutional network and ensemble models.
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)
Design verification and design validation were performed to demonstrate that the LINQ II ICM when used with the Zelda AI ECG Classification System met both design requirements and established performance criteria to support substantial equivalence to the predicate LINO II ICM (K200795).
- Design Verification: Software design verification was completed to ensure the design output meets specifications outlined in the design inputs. The Zelda ECG Classification System meets the functionality per the requirements and all test executions resulted in a status of Passed.
- Design Validation: Performance validation testing and analysis were completed to ensure the algorithms were able to reduce false alerts from ICM detected AF and Pause episodes while retaining true alerts. All results met or exceeded 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 (K200795)
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).
The Zelda AI ECG Classification System is powered by deep-learning neural architectures for AF and Pause detection based on the residual convolutional network and ensemble models. Medtronic will make future algorithm improvements under a Predetermined Change Control Plan (PCCP). In the plan, a protocol was provided to specify the methods to achieve and appropriately control the risks of the anticipated types of modifications described in the Software as a Medical Device (SaMD) Pre-specifications (SPS). The planned changes include 1) changing the threshold, 2) re-training the algorithm on data labeled following the original protocol and data labeled following an alternate protocol. 3) pre-training the algorithm. Assessment metrics, acceptance criteria, and statistical methods have been described for the performance testing of the proposed changes. Information on the deployment and post market surveillance of the algorithm are also provided for the proposed changes.
The proposed modifications in the predetermined change control plan (PCCP) of the 510(k) submission outlined anticipated modifications to the Zelda AI ECG Classification System Models ZA400, ZA410, ZA420, and the methods that will be utilized to implement those modifications in a controlled and deliberate manner while maintaining safety and efficacy. In accordance with the PCCP, market release of any modifications will only occur after the modified algorithms are proven to achieve superior performance, increasing sensitivity and/or specificity, while maintaining or improving other performance metrics. The PCCP does not include provisions for implementation of adaptive algorithms that will continuously learn in the field and all algorithm modifications will be locked prior to release to the field.
§ 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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 11, 2021
Medtronic, Inc. Dianna Johannson Distinguished Regulatory Affairs Advisor 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K210484
Trade/Device Name: LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System 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: May 11, 2021 Received: May 12, 2021
Dear Dianna Johannson:
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
1
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 Kozen 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) K210484
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 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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K210484 Page 1 of 4
510(k) Summary
| Date Prepared: | February 16, 2021 | |
|---|---|---|
| Submitter: | Medtronic, Inc. | |
| Cardiovascular Diagnostics and Services | ||
| 8200 Coral Sea Street NE | ||
| Mounds View, MN 55112 | ||
| Establishment Registration Number: 2182208 | ||
| Contact Person: | Dianna L Johannson | |
| Distinguished Regulatory Affairs Advisor | ||
| Cardiovascular Diagnostics and Services | ||
| Phone: (763) 526-2376 | ||
| Fax: (651) 367-0603 | ||
| Email: dianna.johannson@medtronic.com | ||
| Alternate Contact: | Ryan Calabrese | |
| Sr Regulatory Affairs Director | ||
| Cardiovascular Diagnostics and Services | ||
| Phone: (763) 526-3515 | ||
| Fax: (651) 367-0603 | ||
| Email: ryan.s.calabrese@medtronic.com |
General Information
| Trade Name: | LINQ TM II |
|---|---|
| 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 (K200795) |
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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. LINQ II ICM includes the following accessories: LINQ Tool Kit Model LNQ22TK, Reveal LINQTM Mobile Manager Model MSW002, Device Command Library Model 2692, and Instrument Command Library Model 2691. New to the LINO II ICM system is the Zelda AI ECG Classification System Models ZA400. ZA410. ZA420. included in this submission.
Indications for Use
The LINQ II ICM Indications for Use remains 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 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 LINQ 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 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 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.
5
When compared to the predicate LINQ II ICM (K200795), the LINQ II ICM when used with the Zelda AI ECG Classification System has the same Indications for Use, operating principle, device technology and functionality, and biological safety.
When compared to the predicate LINQ II ICM (K200795), the LINQ II ICM differs only in its use with the Zelda AI ECG Classification System.
Substantial Equivalence
Differences between the subject and predicate devices have been evaluated through bench testing to provide evidence of safe and effective use. The LINQ II ICM when used with the Zelda AI ECG Classification System is substantially equivalent to the predicate LINQ II ICM (K200795) 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 LINQ II ICM when used with the Zelda AI ECG Classification System met both design requirements and established performance criteria to support substantial equivalence to the predicate LINO II ICM (K200795).
- . Design Verification: Software design verification was completed to ensure the design output meets specifications outlined in the design inputs. The Zelda ECG Classification System meets the functionality per the requirements and all test executions resulted in a status of Passed.
- Design Validation: Performance validation testing and analysis were completed to ensure the algorithms were able to reduce false alerts from ICM detected AF and Pause episodes while retaining true alerts. All results met or exceeded 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 Zelda AI ECG Classification System.
| 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 |
| 82304-1:2016 | IEC | 13-97 | Health software - Part 1: General
requirements for product safety |
6
| Standard
Number | Standard
Organization | Recognition
Number | Standard Title |
|---------------------------|--------------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| 62304:2006/
AMD 1:2015 | IEC | 13-79 | Medical device software - Software life cycle
processes |
| EC57: 2012 | ANSI/AAMI | 3-118 | Testing and Reporting Performance Results of
Cardiac Rhythm and ST Segment
Measurement Algorithms |
| 60601-1:2005
A1:2012 | AAMI/ANSI | 19-4 | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance (Clause 14)
(IEC 60601-1:2005, mod) |
Predetermined Change Control Plan
The Zelda AI ECG Classification System is powered by deep-learning neural architectures for AF and Pause detection based on the residual convolutional network and ensemble models. Medtronic will make future algorithm improvements under a Predetermined Change Control Plan (PCCP). In the plan, a protocol was provided to specify the methods to achieve and appropriately control the risks of the anticipated types of modifications described in the Software as a Medical Device (SaMD) Pre-specifications (SPS). The planned changes include 1) changing the threshold, 2) re-training the algorithm on data labeled following the original protocol and data labeled following an alternate protocol. 3) pre-training the algorithm. Assessment metrics, acceptance criteria, and statistical methods have been described for the performance testing of the proposed changes. Information on the deployment and post market surveillance of the algorithm are also provided for the proposed changes.
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 Zelda AI ECG Classification System Models ZA400, ZA410, ZA420 described in this submission results in a device that is substantially equivalent to the predicate LINQ II ICM Model LNQ22 (K200795).
The proposed modifications in the predetermined change control plan (PCCP) of the 510(k) submission outlined anticipated modifications to the Zelda AI ECG Classification System Models ZA400, ZA410, ZA420, and the methods that will be utilized to implement those modifications in a controlled and deliberate manner while maintaining safety and efficacy. In accordance with the PCCP, market release of any modifications will only occur after the modified algorithms are proven to achieve superior performance, increasing sensitivity and/or specificity, while maintaining or improving other performance metrics. The PCCP does not include provisions for implementation of adaptive algorithms that will continuously learn in the field and all algorithm modifications will be locked prior to release to the field.