(134 days)
No
The summary describes automated detection algorithms based on established standards (ANSI/AAMI EC57:1998) and does not mention AI or ML.
No.
The device is an insertable cardiac monitor designed for diagnostic purposes (recording ECG and detecting arrhythmias), not for providing therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is indicated for "Patients who experience transient symptoms... that may suggest a cardiac arrhythmia" and the "Device Description" section states it is "designed to automatically record the occurrence of arrhythmias in a patient." These functions involve identifying medical conditions or diseases.
No
The device description explicitly states it is a "small, leadless device that is typically implanted under the skin" and has "Two electrodes on the body of the device". This indicates a physical hardware component, not a software-only device.
Based on the provided text, the Reveal LINQ ICM is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, outside of the body to provide information for diagnosis, monitoring, or screening.
- Reveal LINQ ICM Function: The Reveal LINQ ICM is an insertable device that records subcutaneous ECG within the patient's body. It monitors electrical activity of the heart directly, not through the analysis of bodily fluids or tissues in a lab setting.
Therefore, the Reveal LINQ ICM falls under the category of an implantable medical device for monitoring physiological signals, not an IVD.
N/A
Intended Use / Indications for Use
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 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
- o 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.
Product codes
DSI
Device Description
The Reveal LINQ Model LNQ11 Insertable Cardiac Monitors (ICM) is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial tachyarrhythmia/atrial fibrillation (AT/AF), bradyarrhythmia, pause, or (fast) ventricular tachyarrhythmia. The Reveal LINO ICM provides storage of ECG and Marker Channel during patient-activated and automatically-detected (auto-activated) events. Auto activation may help to detect abnormal heart rhythms in patients who may not activate/trigger the ICM.
The Reveal LINQ ICM Model LNQ11 is a small, leadless device that is typically implanted under the skin, in the chest. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG.
The Reyeal LINO ICM consists of three major subassemblies which include the hermetically enclosed battery, hermetically enclosed electronics module, and molded header assembly. The battery is a custom D-shaped cell based on LiCFx chemistry and supports a 12-month shelf life and 3-year usable capacity. The Electronics Module contains the hybrid comprised of a printed circuit board with surface mount components on one side and an over molded stack on the other side which contains analog, digital and memory IC's along with capacitor arrays. The molded Header Assembly contains a Titanium Nitride coated sensing electrode, an embedded miniature RF antenna, suture hole, and a mounting bracket.
The Reveal LINQ ICM will continue to use the same technology. It is designed to automatically record the occurrence of an arrhythmia in a patient, continuously senses the patient's subcutaneous ECG, and analyzes the timing of ventricular events to detect possible episodes of arrhythmia. The Reveal LINQ ICM has a small form factor, and uses Titanium, Parylene, Urethane, and Titanium Nitride coating on the sensing electrodes as body contacting materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous, in the chest
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 regression testing, design verification, system verification, and system design validation testing were performed to demonstrate that the subject device – the Reveal LINO ICM with modified firmware, met established performance criteria to support equivalency to the referenced predicate device, the existing Reveal LINQ ICM (cleared by FDA under K160809).
- . Firmware regression testing: This testing of unchanged firmware was performed to ensure that no unintended side effects were introduced.
- Firmware design verification: This testing was made up of two parts: verification of the 0 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.
- System level testing: This testing was performed on the subject device the Reveal ● LINQ ICM with modified firmware, 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 validation for the changes to enhance the atrial and ventricular algorithms of the Reveal LINQ ICM firmware was based on the ANSI/AAMI EC57:1998 standard for Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms.
The results of the above testing met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the modifications made to the Reveal LINQ Model LNQ11 Insertable Cardiac Monitor described in this submission result in a device that is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reveal LINQ Insertable Cardiac Monitor (Model LNQ11) K160809
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2017
Medtronic, Inc. Syed Mohiuddin Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K162855
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: January 20, 2017 Received: January 23, 2017
Dear Syed Mohiuddin:
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
1
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 Jellim
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162855
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Page 1 of 1
3
510(k) Summary
| [As required by 21 CFR 807.92] | |
|---|---|
| Date Prepared: | October 11, 2016 |
| Submitter: | Medtronic, Inc. |
| Medtronic Cardiac Rhythm Heart Failure | |
| 8200 Coral Sea Street N.E. | |
| Mounds View, MN 55112 | |
| Establishment Registration Number: 2182208 | |
| Contact Person: | Syed Sumran Mohiuddin |
| Principal Regulatory Affairs Specialist | |
| Medtronic Cardiac Rhythm Heart Failure | |
| Phone: 763.526.2380 | |
| Fax: 651.367.0603 | |
| Email: syed.s.mohiuddin@medtronic.com | |
| Alternate Contact: | Ryan Calabrese |
| 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: | Reveal LINQTM Insertable Cardiac Monitor"*O qf gn'NP S 33+ |
|---|---|
| Common Name: | Insertable Cardiac Monitor |
| Regulation Number: | CFR 870.1025 |
| Product Code: | DSI |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
| Special Controls: | Class II Special Controls Guidance Document: Arrhythmia Detector and |
| Alarm | |
| Predicate Devices: | Reveal LINQ Insertable Cardiac Monitor (Model LNQ11) K160809 |
4
Device Description
The Reveal LINQ Model LNQ11 Insertable Cardiac Monitors (ICM) is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial tachyarrhythmia/atrial fibrillation (AT/AF), bradyarrhythmia, pause, or (fast) ventricular tachyarrhythmia. The Reveal LINO ICM provides storage of ECG and Marker Channel during patient-activated and automatically-detected (auto-activated) events. Auto activation may help to detect abnormal heart rhythms in patients who may not activate/trigger the ICM.
The Reveal LINQ ICM Model LNQ11 is a small, leadless device that is typically implanted under the skin, in the chest. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG.
Indications for Use
There are no changes to the Indications for Use as a result of this submission. The Indications for Use are provided below:
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
- o 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 Reyeal LINO ICM consists of three major subassemblies which include the hermetically enclosed battery, hermetically enclosed electronics module, and molded header assembly. The battery is a custom D-shaped cell based on LiCFx chemistry and supports a 12-month shelf life and 3-year usable capacity. The Electronics Module contains the hybrid comprised of a printed circuit board with surface mount components on one side and an over molded stack on the other side which contains analog, digital and memory IC's along with capacitor arrays. The molded Header Assembly contains a Titanium Nitride coated sensing electrode, an embedded miniature RF antenna, suture hole, and a mounting bracket.
The Reveal LINQ ICM will continue to use the same technology. It is designed to automatically record the occurrence of an arrhythmia in a patient, continuously senses the patient's subcutaneous ECG, and analyzes the timing of ventricular events to detect possible episodes of arrhythmia. The Reveal LINQ ICM has a small form factor, and uses Titanium, Parylene, Urethane, and Titanium Nitride coating on the sensing electrodes as body contacting materials.
When compared to the predicate device, the existing Reveal LINO ICM (cleared by FDA under K160809), the Reveal LINQ ICM with modified firmware (subject of this submission) has the same:
- Intended use/indications for use ●
- . Operating principle
- Design features ●
5
- Device functionality ●
- Biological safety
- Packaging materials
- o Shelf life
When compared to the predicate device, the existing Reveal LINO ICM (cleared by FDA under K160809), the Reveal LINQ ICM with modified firmware (the subject of this submission) differs as follows:
- o The Reveal LINQ ICM with modified firmware includes minor changes to enhance its atrial and ventricular arrhythmia detection algorithms by adding three rules to reduce false positive detections listed below:
- Atrial Algorithms Adaptive P-sense rule O
- Dual Sense Brady rejection rule o
- Dual Sense Asystole rejection rule O
- The Reveal LINQ ICM with modified firmware includes minor cumulative updates that ● are categorized as under:
- Minor diagnostic updates o
- Minor telemetry updates O
- LINQ RRT update integration O
- Minor bug fixes o
Substantial Equivalence
Technological differences between the subject and predicate devices have been evaluated through bench testing to provide evidence of safe and effective use. The Reveal LINO ICM with modified firmware is substantially equivalent to the predicate device, the existing Reveal LINQ ICM (cleared by FDA under K160809) based on comparisons of device functionality, technological characteristics, and indications for use.
Summary of Testing
Firmware regression testing, design verification, system verification, and system design validation testing were performed to demonstrate that the subject device – the Reveal LINO ICM with modified firmware, met established performance criteria to support equivalency to the referenced predicate device, the existing Reveal LINQ ICM (cleared by FDA under K160809).
- . Firmware regression testing: This testing of unchanged firmware was performed to ensure that no unintended side effects were introduced.
- Firmware design verification: This testing was made up of two parts: verification of the 0 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.
- System level testing: This testing was performed on the subject device the Reveal ● LINQ ICM with modified firmware, which included system verification testing and system validation testing. System design verification ensured that the proposed
6
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 validation for the changes to enhance the atrial and ventricular algorithms of the Reveal LINQ ICM firmware was based on the ANSI/AAMI EC57:1998 standard for Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms.
The following standards and guidance documents were used for development and testing of the subject device:
| Standard
Number | Standard
Organization | Standard Title |
|--------------------|--------------------------|------------------------------------------------------------------------------------------------------|
| 14971:2012 | ISO | Medical Devices - Application of Risk Management to Medical
Devices |
| 62304:2006 | IEC EN | Medical device software - Software life-cycle processes |
| EC57:1998 | AANSI/AAMI | Testing and Reporting Performance Results of Cardiac Rhythm
and ST Segment Measurement Algorithms |
| 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 |
Conclusion
The results of the above testing met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the modifications made to the Reveal LINQ Model LNQ11 Insertable Cardiac Monitor described in this submission result in a device that is substantially equivalent to the predicate.