Advisor VL Circular Mapping Catheter, Sensor Enabled

K192037 · ABBOTT MEDICAL · DRF · Sep 17, 2019 · Cardiovascular

Device Facts

• Record ID: K192037
• Device Name: Advisor VL Circular Mapping Catheter, Sensor Enabled
• Applicant: ABBOTT MEDICAL
• Product Code: DRF · Cardiovascular
• Decision Date: Sep 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Advisor VL Circular Mapping Catheter, Sensor Enabled is a steerable electrophysiology catheter with integrated sensors. The catheter is used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.

Device Story

Advisor VL Circular Mapping Catheter, Sensor Enabled is a steerable, variable-radius circular mapping catheter used in diagnostic electrophysiology studies. It features an adjustable 4F distal loop (15mm–25mm diameter) with 10 equidistant or 20 paired platinum-iridium electrodes. Integrated sensors include two impedance-based navigational electrodes and two magnetic sensors at the distal shaft. The device is used in clinical settings by electrophysiologists in conjunction with the EnSite Precision Cardiac Mapping System. It records intracardiac signals and provides cardiac stimulation; navigational sensors allow for real-time visualization and mapping of atrial regions. Output is displayed on the EnSite system, assisting clinicians in identifying cardiac electrical activity to guide diagnostic decision-making and improve procedural accuracy.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (patient leakage, dielectric strength, defibrillation protection, anchorage flex, handle push, radiopacity, corrosion resistance, tensile, loop/shaft properties, electrical properties, visualization/navigation, sterilization, packaging, shelf life, human factors) and GLP-compliant animal safety testing. All tests met pre-determined acceptance criteria.

Technological Characteristics

Steerable electrophysiology catheter; 4F distal loop (15mm-25mm); 10 or 20 platinum-iridium electrodes; integrated impedance-based navigational electrodes and magnetic sensors. Compatible with EnSite Precision Cardiac Mapping System. Materials include platinum-iridium electrodes. Sterilization and biocompatibility verified per standards.

Indications for Use

Indicated for patients undergoing diagnostic electrophysiology studies requiring intracardiac signal recording, cardiac stimulation, and mapping of atrial heart regions.

Regulatory Classification

Identification

An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

Predicate Devices

• Advisor FL, Circular Mapping Catheter, Sensor Enabled (K160335)

Reference Devices

• Reflexion Spiral Variable Radius Catheter (K072012)

Submission Summary (Full Text)

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September 17, 2019

Abbott Medical Tamara Stanczak Regulatory Affairs Project Manager 5050 Nathan Lane North Plymouth, Minnesota 55442

Re: K192037

Trade/Device Name: Advisor VL Circular Mapping Catheter, Sensor Enabled Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: July 29, 2019 Received: July 30, 2019

Dear Tamara Stanczak:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: 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)

K192037

Device Name

Advisor™ VL Circular Mapping Catheter, Sensor EnabledTM

Indications for Use (Describe)

The Advisor VL Circular Mapping Catheter, Sensor Enabled is a steerable electrophysiology catheter with integrated sensors. The catheter is used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;"></span> <span style="text-decoration: overline;"></span> <span style="text-decoration: line-through;"></span> <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;">☑</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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| 510(k) Summary | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K192037 |
| | Submitter Information: |
| Date Prepared: | July 29, 2019 |
| Submitter Name & Address | Abbott Medical |
| | 5050 Nathan Lane North |
| | Plymouth, MN 55442 |
| Contact Person | Tamara L Stanczak |
| | Regulatory Affairs Project Manager |
| | Phone: [phone] |
| | Email: [e-mail] |
| Device Information: | |
| Trade Name: | AdvisorTM VL Circular Mapping Catheter,<br>Sensor EnabledTM |
| Common Name: | Diagnostic Electrophysiology Catheter |
| Class: | Class II, 21CFR870.1220 |
| Product Code: | DRF |
| Classification Name: | Catheter, Electrode Recording, or Probe,<br>Electrode Recording |
| Predicate Device: | Advisor FL, Circular Mapping Catheter,<br>Sensor Enabled (K160335) |
| Reference Device: | Reflexion Spiral Variable Radius Catheter<br>(K072012) |
| Device Description: | Advisor VL Circular Mapping Catheter,<br>Sensor Enabled (Advisor VL) is a variable<br>radius, circular mapping catheter. It has an<br>adjustable 4 French (F) distal loop size with a<br>diameter ranging from 15mm – 25mm with<br>models containing both ten (10) equidistant or<br>twenty (20) paired platinum-iridium<br>electrodes. The catheter has integrated sensors<br>with two impedance-based navigational<br>electrodes and two magnetic sensors located<br>at the distal end of the shaft. The catheter is<br>intended to be used with the EnSiteTM<br>PrecisionTM Cardiac Mapping System. |
| Intended Use:<br>(Indications for Use) | Advisor VL catheter is a steerable<br>electrophysiology catheter with integrated<br>sensors. The catheter is used for recording<br>intracardiac signals and cardiac stimulation<br>during diagnostic electrophysiology studies.<br>The catheter can be used to map the atrial<br>regions of the heart. |
| Comparison to Predicate Devices | The Advisor VL is substantially equivalent to<br>the predicate devices based on comparisons of<br>the device functionality, technological |
| 510(k) Summary | |
| 510(k) Number | K192037 |
| | characteristics, and intended use. The |
| | differences in loop diameter and number of |
| | electrodes between Advisor VL and Advisor |
| | FL have been evaluated through bench, in |
| | vivo, and biocompatibility testing. Bench and |
| | animal testing demonstrated that the subject |
| | device is substantially equivalent to the |
| | predicate device. Results from bench, in vivo, |
| | and biocompatibility testing did not result in |
| | new questions with regard to safety and |
| | effectiveness of the device. |
| Summary on Non-Clinical Tests | Bench and animal testing was performed to |
| | verify the device met the pre-determined |
| | acceptance criteria. The following tests were |
| | performed: |
| | |
| | • Patient Leakage |
| | • Dielectric Strength |
| | • Defibrillation Protection |
| | • Anchorage Flex |
| | • Handle Push |
| | • Radiopacity |
| | • Biocompatibility |
| | • Surface |
| | • Corrosion Resistance |
| | • Tensile |
| | • Loop Characteristics |
| | • Shaft Properties |
| | • Functional |
| | • Functional Simulated Use |
| | • Electrical Properties |
| | • Visualization and Navigation |
| | • Sterilization/ Microbiology |
| | • Packaging |
| | • Shelf Life |
| | • GLP Animal Safety |
| | • Human Factors |
| Statement of Equivalence | The Advisor VL has the same indications for |
| | use and technological characteristics as the |
| | predicate device. Based on this and the data |
| | provided in this pre-market notification, the |
| | subject device and predicate device has been |
| | shown to be substantially equivalent. |

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