(67 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the performance studies focus on standard device testing (biocompatibility, electrical safety, software validation, mechanical testing) rather than algorithmic performance metrics.
No.
The device records subcutaneous ECG and monitors cardiac arrhythmias; it does not provide therapy or treatment.
Yes.
The device records subcutaneous ECG and is indicated for monitoring patients at risk of cardiac arrhythmias or experiencing symptoms that may suggest a cardiac arrhythmia, which are diagnostic purposes.
No
The device description explicitly states it includes an "insertable automatically-activated monitoring system" (Reveal LINQ ICM) and a "patient connector," which are hardware components. While it also includes a mobile application, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Reveal LINQ ICM is an insertable device that records subcutaneous ECG. This is a direct measurement of electrical activity within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use describes monitoring for cardiac arrhythmias based on the recorded ECG data, not analyzing a biological sample.
Therefore, based on the provided information, the Reveal LINQ ICM is a medical device for in-vivo monitoring, not an in-vitro diagnostic device.
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.
Product codes (comma separated list FDA assigned to the subject device)
DSI
Device Description
Not Found
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
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
- 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.
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.
Reveal LINQ ICM (Model LNO11) cleared via K160689 on April 22, 2016.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures in profile, arranged in a cascading manner. The figures are depicted in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
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
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 Yellman
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) 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) Summary
| Date Prepared: | 13 February 2017 |
|---|---|
| 510(k) Owner / Address: | Medtronic, Inc. |
| Cardiac Rhythm and Heart Failure | |
| 8200 Coral Sea Street | |
| Mounds View, MN 55112 | |
| Contact: | Laura L. Danielson |
| Principal 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 II |
| Arrhythmia 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.
4
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 Model
LNQ11 (with existing LINQ
Mobile Manager Application
Models MSW001 or MSW002
and existing patient
connector Model 24965) | Reveal LINQ ICM Model
LNQ11 (with existing LINQ
Mobile Manager Application
Models MSW001 and
MSW002 and additional
patient connector Model
24967) |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Medtronic, Inc. | Medtronic, Inc. |
| 510(k) Number | K160809 | KXXXXXX |
| Model Number | LNQ11 | LNQ11 |
| Intended Use | Same (See Indications for
Use Form 3881) | Same (See Indications for
Use Form 3881) |
| Ambulatory ECG Monitor | Same | Same |
| Continually Record ECG
Information? | 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 Tachycardia
Detection | Same | Same |
| Patient Activated & Auto
Activated | Same | Same |
| Atrial Tachyarrhythmia
Monitoring & Diagnostics | Same | Same |
| Day & Night Heart Rate
Diagnostics | Same | Same |
| Afib Detection | Same | Same |
| Heart Rate Variability
Algorithm & Diagnostics | Same | Same |
| Telemetry | Same | Same |
| Activity Monitoring | Same | Same |
| Longevity | Same | Same |
| Electrode Spacing (inside-
to-inside) | Same | Same |
| | Reveal LINQ ICM Model
LNQ11 (with existing LINQ
Mobile Manager Application
Models MSW001 or MSW002
and existing patient
connector Model 24965) | Reveal LINQ ICM Model
LNQ11 (with existing LINQ
Mobile Manager Application
Models MSW001 and
MSW002 and additional
patient connector Model
24967) |
| 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 Clinic
Name and ID | Yes | Yes |
Predicate Comparisons
5
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 Model
LNQ11 (with existing
LINQ Mobile Manager
Application Models
MSW001 or MSW002 and
existing patient
connector Model 24965) | Reveal LINQ ICM Model
LNQ11 (with existing LINQ
Mobile Manager
Application Models
MSW001 and MSW002 and
additional patient
connector Model 24967) |
|------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Can | Titanium | Yes | Yes |
| Electrodes | Titanium nitride | Yes | Yes |
| Header | Polyurethane,
silicone | Yes | Yes |
| Coating | Parylene | Yes | Yes |
Patient Contacting Material Comparison
6
| Component | Material | Reveal LINQ ICM Model
LNQ11 (with existing
LINQ Mobile Manager
Application Models
MSW001 or MSW002 and
existing patient
connector Model 24965) | Reveal LINQ ICM Model
LNQ11 (with existing LINQ
Mobile Manager
Application Models
MSW001 and MSW002 and
additional patient
connector Model 24967) |
|-------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telemetry
Head | Amorphous
thermal plastics,
thermal plastic
elastomer,
silicone rubber
and polyester film | Polycarbonate Lexan | Silicone rubber Rogers
Bisco HT-6240, clear |
| | | | Polycarbonate Sabic Lexan
EXL9330 with 8T9D168
white colorant (Medtronic
color chip M954239A001) |
| | | | Silicone rubber Wacker
Elastosil LR 3003/60, color
chip SP 50812 (blue) |
| | | | Silicone rubber Momentive
TSE221 per color chip
Pantone Cool Grey 8 button;
polyester Autotex V200 clear
(back screened) with hard
coated top surface and
velvet 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 ●
7
- . 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.