← Product Code [DRF](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF) · K160335 # Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D (K160335) _St Jude Medical · DRF · Dec 13, 2016 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K160335 ## Device Facts - **Applicant:** St Jude Medical - **Product Code:** [DRF](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF.md) - **Decision Date:** Dec 13, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1220 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Intended Use The Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is a sensor-enabled steerable electrophysiology catheter 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. The catheter is used with the EnSite Precision™ System to combine and display magnetic processed patient positioning and navigation mapping information. The catheter is used with the MediGuide™ Technology system to enable real-time positioning and navigation. The MediGuide™ Technology system is indicated for use as an adjunct to fluoroscopy. ## Device Story Steerable electrophysiology catheter; features distal magnetic sensor for real-time positioning/navigation. Inputs: intracardiac electrical signals; magnetic field data from EnSite Precision or MediGuide systems. Operation: physician navigates catheter to atrial regions; records signals; provides pacing. Output: electrical signal data; visual navigation/positioning data displayed on external systems. Used in clinical electrophysiology labs. Benefits: improved maneuverability; real-time visualization; facilitates diagnostic mapping of cardiac arrhythmias. ## Clinical Evidence No clinical data. Evidence consists of bench and animal testing. Bench tests included patient leakage, dielectric strength, defibrillation protection, anchorage, flex, handle push, radiopacity, surface corrosion resistance, tensile, loop characteristics, shaft properties, functional simulated use, electrical properties, and visualization/navigation. GLP animal safety study performed. ## Technological Characteristics Steerable circular mapping catheter; distal magnetic sensor; compatible with EnSite Precision and MediGuide systems. Materials: biocompatible components. Sterilization: validated method. Connectivity: wired interface to external navigation/mapping systems. Form factor: circular distal tip with 12-pole electrode configuration. ## Regulatory 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 - Inquiry AFocus II ([K042775](/device/K042775.md)) - MediGuide Enabled Livewire Steerable Electrophysiology Catheter ([K101955](/device/K101955.md)) ## Related Devices - [K200205](/device/K200205.md) — Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled · Stryker Sustainability Solutions · May 13, 2020 - [K201806](/device/K201806.md) — Reprocessed PentaRay Nav eco High-Density Mapping Catheter · Sterilmed Inc. (Johnson and Johnson) · Jun 23, 2021 - [K052083](/device/K052083.md) — NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER · Biosense Webster, Inc. · Sep 29, 2005 - [K181458](/device/K181458.md) — Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter · Innovative Health, LLC · Oct 27, 2018 - [K212776](/device/K212776.md) — Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled · Innovative Health, LLC · Dec 20, 2021 ## Submission Summary (Full Text) {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 resembling a stylized eagle or bird in flight, composed of flowing lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 13, 2016 St. Jude Medical Tamara Stanczak Principal Regulatory Affairs Specialist 5050 Nathan Lane Plymouth, Minnesota 55442 # Re: K160335 Trade/Device Name: Advisor FL Circular Mapping Catheter, Sensor Enabled Advisor FL 15mm 12 Pole 333 Uni D Advisor FL 20mm 12 Pole 555 Uni D Advisor FL 15mm 12 Pole 333 Bi D Advisor FL 20mm 12 Pole 555 Bi D Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: September 26, 2016 Received: September 27, 2016 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. 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 {1}------------------------------------------------ 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 the quality systems (QS) 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 vours. Muda Jellman 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) K160335 Device Name Advisor™ FL, Circular Mapping Catheter, Sensor EnabledTM #### Indications for Use (Describe) The Advisor™ FL Circular Mapping Catheter, Sensor Enabled steerable electrophysiology catheter 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. The catheter is used with the EnSite Precision™ System to combine and display magnetic processed patient positioning and navigation mapping information. The catheter is used with the MediGuide™ Technology system to enable real-time positioning and navigation. The MediGuide™ Technology system is indicated for use as an adjunct to fluoroscopy. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a green square made up of smaller squares, with one square slightly tilted. To the right of the square is the text "ST. JUDE MEDICAL" in a serif font. | 510(k) Summary | | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K160335 | | Submitter Information: | | | Date Prepared: | December 13, 2016 | | Submitter Name & Address: | St. Jude Medical<br>5050 Nathan Lane<br>Plymouth, MN 55442 | | Contact Person: | Tamara L Stanczak<br>Principal Regulatory Affairs Specialist<br>Phone (651) 756-6656<br>Fax (651) 756-3301<br>Tstanczak@sjm.com | | Device Information: | | | Trade Name: | Advisor™ FL, Circular Mapping Catheter, Sensor Enabled™ | | Common Name: | Diagnostic Electrophysiology Catheter | | Class: | II, 870.1220, Product Code DRF | | Models | Advisor FL 15mm 12 Pole 333 Uni D<br>Advisor FL 20mm 12 Pole 555 Uni D<br>Advisor FL 15mm 12 Pole 333 Bi D<br>Advisor FL 20mm 12 Pole 555 Bi D | | Classification Name: | Electrode recording catheter or electrode recording probe | | Primary Predicate Device: | Inquiry AFocus II (K042775) | | Secondary Predicate<br>Device: | MediGuide Enabled Livewire Steerable Electrophysiology Catheter<br>(K101955) | | Device Description: | Advisor FL Circular Mapping Catheter, Sensor Enabled (Advisor<br>FL, SE) is a circular mapping catheter for performing<br>electrophysiology mapping procedures and providing pacing signals<br>to the heart during electrophysiology procedures. The catheter<br>handle and shaft design allows for improved maneuverability. A<br>magnetic sensor in the distal shaft pocket provides compatibility<br>with visualization and navigation systems. The catheter is<br>compatible with SJM's EnSite™ Precision™ Cardiac Mapping<br>system or MediGuide™ System (MG). | | Intended Use:<br>(Indications for Use) | The Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is<br>a sensor-enabled steerable electrophysiology catheter used for<br>recording intracardiac signals and cardiac stimulation during<br>diagnostic electrophysiology studies. The catheter can be used to<br>map the atrial regions of the heart.<br><br>The catheter is used with the EnSite Precision™ System to<br>combine and display magnetic processed patient positioning and<br>navigation mapping information.<br><br>The catheter is used with the MediGuide™ Technology system to<br>enable real-time positioning and navigation. The MediGuide™<br>Technology system is indicated for use as an adjunct to<br>fluoroscopy. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for St. Jude Medical. The logo consists of a green square grid on the left and the text "ST. JUDE MEDICAL" on the right. The grid is made up of nine smaller squares, with one square slightly tilted. | 510(k) Summary | | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K160335 | | Comparison to Predicate<br>Devices | The Advisor FL, SE has the same intended use and fundamental<br>scientific technology as the predicate devices. The technological<br>characteristics of the Advisor FL,SE are substantially equivalent to<br>the predicate device including packaging, biocompatibility,<br>sterilization, and labeling. Bench and animal testing demonstrated<br>that the subject device is substantially equivalent to the predicate<br>device. | | Summary on Non-Clinical<br>Testing | Bench and animal testing was performed to verify the device met<br>the pre-determined acceptance criteria. The following tests were<br>performed:<br>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 | | Statement of Equivalence | The Advisor FL, SE has the same indications for use and<br>technological characteristics as the predicate devices. Based on<br>this and the data provided in this pre-market notification, the subject<br>device and predicate device has been shown to be substantially<br>equivalent. | --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K160335](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K160335) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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