(67 days)
The Reveal LINQ ICM is an insertable automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
· patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
· patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia
The device has not been tested specifically for pediatric use.
The Reveal LINQ ICM (Model LNQ11) in association with the LINQ Mobile Manager Application (Model MSW001 or MSW002) and patient connector (Model 24965 and 24967) (referred to as the LINQ Mobile Manager system) are substantially equivalent to the following predicate device: Reveal LINQ ICM (Model LNO11) cleared via K160689 on April 22, 2016.
This document, K163460, is a 510(k) Premarket Notification for the Medtronic Reveal LINQ Insertable Cardiac Monitor, Model LNQ11. It's a submission to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets new acceptance criteria for novel functionality with detailed performance data typically associated with AI/ML devices.
Therefore, many of the requested points regarding acceptance criteria, training/test sets, expert adjudication, MRMC studies, and standalone performance data for AI are not present in this document, as this device primarily relies on proving equivalence to an existing, already approved medical device, and the changes appear to be in a patient connector component, rather than core AI algorithms.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of new acceptance criteria and their corresponding performance metrics because the submission is for showing substantial equivalence to a predicate device, not for a novel device with new performance claims. The performance data provided are generally related to safety and functionality to ensure the new component (patient connector Model 24967) does not negatively impact the existing device's performance.
The "acceptance criteria" here are implicitly that the new device component performs the same as the predicate device component and meets relevant safety standards.
-
Implicit Acceptance Criteria (for the new CareLink SmartSync Device Manager, patient connector, Model 24967):
- Biocompatibility: Must pass cytotoxicity, sensitization, and irritation tests.
- Electrical Safety and EMC: Must comply with IEC 60601-1 and IEC 60601-1-2 standards.
- Software: Verification and validation testing must be passed, with the software considered a "major" level of concern.
- Mechanical: Must pass inspections for design features, function, workmanship, labeling, control activation forces, chemical resistance, environmental/drop testing, and button/contact reliability.
- No negative impact on existing Reveal LINQ ICM functionalities (e.g., R-wave sensing, sampling rate, detection algorithms).
-
Reported Device Performance (from the document):
- Biocompatibility: "The battery of testing for materials used in the Model 24967 included the following tests: Cytotoxicity, Sensitization, Irritation." (Implies successful completion for acceptance).
- Electrical safety and electromagnetic compatibility (EMC): "The system complies with the IEC 60601-1, standards for safety and the IEC 60601-1-2 third and fourth edition versions of the standard for EMC." (Implies successful completion for acceptance).
- Software Verification and Validation Testing: "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..." (Implies successful completion for acceptance).
- Mechanical Testing: "The following is a list of testing performed: Inspection of the required mechanical design features and function...Workmanship inspection...Product labeling inspection...Forces required to activate controls...Chemical resistance testing...Environmental and drop testing...Reliability testing of buttons, electrical contacts, user connector insertions, and replaceable or moving mechanical components." (Implies successful completion for acceptance).
- Functional Equivalence: The comparison table (page 4) explicitly states "Same" for virtually all functional characteristics between the new configuration and the predicate device (e.g., R Wave Sensing, Sampling Rate, Storage Time, Noise Reversion, Brady Detection, Asystole Detection, Ventricular Tachycardia Detection, Afib Detection, Detection Algorithms, etc.). This implies performance is identical to the predicate which would have already met its own performance criteria.
2. Sample sizes used for the test set and the data provenance
The document describes non-clinical performance testing (biocompatibility, electrical safety, mechanical, software V&V) of a new component (patient connector) that connects to an existing, approved device. These tests typically involve lab-based testing of the specific component or system, not "test sets" in the sense of patient data for evaluating an algorithm's performance on clinical outcomes.
- Sample sizes: Not specified in terms of patient data. The tests performed are engineering and lab-based (e.g., number of test units for mechanical testing, number of samples for biocompatibility tests).
- Data provenance: Not applicable in the context of clinical data for AI/ML validation. These are engineering test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for biocompatibility is established by standard ISO tests. For electrical and mechanical safety, it's defined by engineering standards (e.g., IEC 60601 series). For software, it's based on verification and validation against requirements. There's no indication of clinical expert review for "ground truth" establishment in this type of submission for a system where the core algorithmic functionality is unchanged and equivalence is being sought for a specific component.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as noted above, this is about engineering and safety testing, not clinical data adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was performed or is mentioned. This submission is about a device (Insertable Cardiac Monitor) that records ECG and performs automated detection. It does not describe an AI that assists human readers in interpreting images or complex signals that would warrant an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself includes detection algorithms (e.g., Brady, Asystole, VT, Afib). The document states these are "Same" as the predicate device. For the predicate device, or this device in itself, the performance of these automated detection algorithms would be considered a form of standalone performance. However, this submission specifically highlights that the algorithms themselves are unchanged from the predicate device (K160689). The focus of this submission is on the safety and performance of a new patient connector model that interfaces with the existing device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the device's core functionality (i.e., its ability to detect arrhythmias), the ground truth in its initial approval would have likely been established through clinical trials comparing its detections against adjudicated ECGs, perhaps from expert cardiologists or verified clinical events. However, this information pertains to the predicate device's original approval and is not detailed in this 510(k) summary, as the algorithms are stated to be "Same."
For the new component (patient connector Model 24967) being approved in this submission, the "ground truth" for its acceptance criteria are established by:
- Biocompatibility standards: ISO 10993 series.
- Electrical safety standards: IEC 60601-1, IEC 60601-1-2.
- Software V&V best practices: FDA guidance for software in medical devices.
- Mechanical engineering standards: Internal Medtronic standards and potentially relevant industry standards for durability, force, etc.
8. The sample size for the training set
Not applicable. This document is not describing the development or validation of a new AI algorithm where a training set would be used. It's about demonstrating substantial equivalence for a hardware component.
9. How the ground truth for the training set was established
Not applicable, as there is no training set discussed for a new AI algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2017
Medtronic Inc. Laura Danielson Principal Regulatory Affairs Specialist 8200 Coral Sea St NE Mounds View, Minnesota 55112
Re: K163460 Trade/Device Name: Reveal LINO Insertable Cardiac Monitor, Model LNO11 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: DSI Dated: December 8. 2016 Received: December 9, 2016
Dear Laura Danielson:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely
Mude Yellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163460
Device Name
Reveal LINQ Insertable Cardiac Monitor (Model LNQ11)
Indications for Use (Describe)
The Reveal LINQ ICM is an insertable automatically-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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Date Prepared: | 13 February 2017 |
|---|---|
| 510(k) Owner / Address: | Medtronic, Inc.Cardiac Rhythm and Heart Failure8200 Coral Sea StreetMounds View, MN 55112 |
| Contact: | Laura L. DanielsonPrincipal Regulatory Affairs Specialist |
| Telephone: | (763) 526-2385 |
| Fax: | (651) 367-0603 |
| E-mail: | laura.l.danielson@medtronic.com |
| Trade / Proprietary Name: | Reveal® LINQTM Insertable Cardiac Monitor,Model LNQ11 |
| Common Name: | Insertable Cardiac Monitor |
| Classification /Classification Name: | Class IIArrhythmia detector and alarm(21 CFR 870.1025) |
| Product Code: | DSI |
Summary of Substantial Equivalence
The intended use, design, materials and performance of the Reveal LINQ ICM (Model LNQ11) in association with the LINQ Mobile Manager Application (Model MSW001 or MSW002) and patient connector (Model 24965 and 24967) (referred to as the LINQ Mobile Manager system) are substantially equivalent to the following predicate device:
- Reveal LINO ICM (Model LNO11) cleared via K160689 on April 22, 2016. ●
Indications for Use Comparison to the Predicate
The indications for use remains unchanged from the predicate and are as follows:
The Reveal LINQ 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.
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Comparison of Technological Characteristics with Predicate Device
The following table contains a comparison of the CareLink SmartSync Device Manager patient connector, Model 24967 to the predicate device (Model 24965) with no differences.
| Reveal LINQ ICM ModelLNQ11 (with existing LINQMobile Manager ApplicationModels MSW001 or MSW002and existing patientconnector Model 24965) | Reveal LINQ ICM ModelLNQ11 (with existing LINQMobile Manager ApplicationModels MSW001 andMSW002 and additionalpatient connector Model24967) | |
|---|---|---|
| Manufacturer | Medtronic, Inc. | Medtronic, Inc. |
| 510(k) Number | K160809 | KXXXXXX |
| Model Number | LNQ11 | LNQ11 |
| Intended Use | Same (See Indications forUse Form 3881) | Same (See Indications forUse Form 3881) |
| Ambulatory ECG Monitor | Same | Same |
| Continually Record ECGInformation? | Same | Same |
| Record Pre- & post-event | Same | Same |
| R Wave Sensing | Same | Same |
| Sampling Rate | Same | Same |
| Storage Time | Same | Same |
| Noise Reversion | Same | Same |
| Brady Detection | Same | Same |
| Asystole Detection | Same | Same |
| Ventricular TachycardiaDetection | Same | Same |
| Patient Activated & AutoActivated | Same | Same |
| Atrial TachyarrhythmiaMonitoring & Diagnostics | Same | Same |
| Day & Night Heart RateDiagnostics | Same | Same |
| Afib Detection | Same | Same |
| Heart Rate VariabilityAlgorithm & Diagnostics | Same | Same |
| Telemetry | Same | Same |
| Activity Monitoring | Same | Same |
| Longevity | Same | Same |
| Electrode Spacing (inside-to-inside) | Same | Same |
| Reveal LINQ ICM ModelLNQ11 (with existing LINQMobile Manager ApplicationModels MSW001 or MSW002and existing patientconnector Model 24965) | Reveal LINQ ICM ModelLNQ11 (with existing LINQMobile Manager ApplicationModels MSW001 andMSW002 and additionalpatient connector Model24967) | |
| Volume | Same | Same |
| Mass | Same | Same |
| Episode Storage | Same | Same |
| Patient Symptom Mark | Same | Same |
| Cardiac Compass | Same | Same |
| MRI Compatibility | Same | Same |
| Clinician Notification | Same | Same |
| Bi-Directional Telemetry | Same | Same |
| Detection Algorithms | Same | Same |
| CareLink | Same | Same |
| Wireless Telemetry | Same | Same |
| Patient's CareLink ClinicName and ID | Yes | Yes |
Predicate Comparisons
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The following patient contacting material comparison demonstrates substantial equivalence between patient contacting materials. Information on differences can be found in the paragraph following the table.
| Component | Material | Reveal LINQ ICM ModelLNQ11 (with existingLINQ Mobile ManagerApplication ModelsMSW001 or MSW002 andexisting patientconnector Model 24965) | Reveal LINQ ICM ModelLNQ11 (with existing LINQMobile ManagerApplication ModelsMSW001 and MSW002 andadditional patientconnector Model 24967) |
|---|---|---|---|
| Can | Titanium | Yes | Yes |
| Electrodes | Titanium nitride | Yes | Yes |
| Header | Polyurethane,silicone | Yes | Yes |
| Coating | Parylene | Yes | Yes |
Patient Contacting Material Comparison
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| Component | Material | Reveal LINQ ICM ModelLNQ11 (with existingLINQ Mobile ManagerApplication ModelsMSW001 or MSW002 andexisting patientconnector Model 24965) | Reveal LINQ ICM ModelLNQ11 (with existing LINQMobile ManagerApplication ModelsMSW001 and MSW002 andadditional patientconnector Model 24967) |
|---|---|---|---|
| TelemetryHead | Amorphousthermal plastics,thermal plasticelastomer,silicone rubberand polyester film | Polycarbonate Lexan | Silicone rubber RogersBisco HT-6240, clear |
| Polycarbonate Sabic LexanEXL9330 with 8T9D168white colorant (Medtroniccolor chip M954239A001) | |||
| Silicone rubber WackerElastosil LR 3003/60, colorchip SP 50812 (blue) | |||
| Silicone rubber MomentiveTSE221 per color chipPantone Cool Grey 8 button;polyester Autotex V200 clear(back screened) with hardcoated top surface andvelvet finish graphics |
Telemetry Head Material
The housing material of the CareLink SmartSync Device Manager patient connector is polycarbonate. The use of polycarbonate boosts chemical resistance concerning exposure to repeat cleaning and disinfection.
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the CareLink SmartSync Device Manager, patient connector, Model 24967 was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing for materials used in the Model 24967 included the following tests:
- Cytotoxicity ●
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- . Sensitization
- . Irritation
The Model 24967 has acute duration of skin contact with the patient, and is not implanted.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the CareLink SmartSync Device Manager, patient connector, Model 24967, associated applications and non-medical mobile platform (i.e. Tablet) with associated cables as necessary for test. The system complies with the IEC 60601-1, standards for safety and the IEC 60601-1-2 third and fourth edition versions of the standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Mechanical Testing
The following is a list of testing performed:
- Inspection of the required mechanical design features and function ●
- . Workmanship inspection concerning all external surfaces that can cause injury such as sharp edges or pinch points
- Product labeling inspection
- Forces required to activate controls
- Chemical resistance testing for effects of repeat cleaning cycles ●
- Environmental and drop testing ●
- . Reliability testing of buttons, electrical contacts, user connector insertions, and replaceable or moving mechanical components
Animal Study
There were no formalized animal studies performed for this 510(k) submission.
Clinical Studies
There were no formalized clinical studies performed for this 510(k) submission.
Conclusions
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the CareLink SmartSvnc Device Manager, patient connector. Model 24967 should perform as intended in the specified use conditions.
§ 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.