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 Description

Advisor FL Circular Mapping Catheter, Sensor Enabled (Advisor FL, SE) is a circular mapping catheter for performing electrophysiology mapping procedures and providing pacing signals to the heart during electrophysiology procedures. The catheter handle and shaft design allows for improved maneuverability. A magnetic sensor in the distal shaft pocket provides compatibility with visualization and navigation systems. The catheter is compatible with SJM's EnSite™ Precision™ Cardiac Mapping system or MediGuide™ System (MG).

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the St. Jude Medical Advisor™ FL Circular Mapping Catheter, Sensor Enabled™. This document describes a medical device, specifically an electrophysiology catheter, and its substantial equivalence to previously marketed devices. It outlines the device's intended use, technological characteristics, and results from non-clinical testing.

However, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device. The provided text details:

Device Type: An electrophysiology catheter, which is a physical medical device, not an AI/ML algorithm.
Study Type: Bench and animal testing, focusing on physical and electrical properties, biocompatibility, and functional aspects of the catheter. There is no mention of an AI/ML model, its performance metrics (accuracy, sensitivity, specificity), or how it assists human readers.
Comparison Method: Substantial equivalence to predicate devices based on shared intended use and technological characteristics, as demonstrated through non-clinical testing. This is different from proving an AI/ML algorithm meets specific performance acceptance criteria against a ground truth.

Therefore, I cannot extract the requested information (table of acceptance criteria with reported performance, sample sizes for test/training sets, expert details for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used for AI) from the provided text, as it describes the regulatory review for a physical medical device.

Summary

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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

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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

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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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 Medical5050 Nathan LanePlymouth, MN 55442
Contact Person:	Tamara L StanczakPrincipal Regulatory Affairs SpecialistPhone (651) 756-6656Fax (651) 756-3301Tstanczak@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 DAdvisor FL 20mm 12 Pole 555 Uni DAdvisor FL 15mm 12 Pole 333 Bi DAdvisor FL 20mm 12 Pole 555 Bi D
Classification Name:	Electrode recording catheter or electrode recording probe
Primary Predicate Device:	Inquiry AFocus II (K042775)
Secondary PredicateDevice:	MediGuide Enabled Livewire Steerable Electrophysiology Catheter(K101955)
Device Description:	Advisor FL Circular Mapping Catheter, Sensor Enabled (AdvisorFL, SE) is a circular mapping catheter for performingelectrophysiology mapping procedures and providing pacing signalsto the heart during electrophysiology procedures. The catheterhandle and shaft design allows for improved maneuverability. Amagnetic sensor in the distal shaft pocket provides compatibilitywith visualization and navigation systems. The catheter iscompatible with SJM's EnSite™ Precision™ Cardiac Mappingsystem or MediGuide™ System (MG).
Intended Use:(Indications for Use)	The Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ isa sensor-enabled steerable electrophysiology catheter used forrecording intracardiac signals and cardiac stimulation duringdiagnostic electrophysiology studies. The catheter can be used tomap the atrial regions of the heart.The catheter is used with the EnSite Precision™ System tocombine and display magnetic processed patient positioning andnavigation mapping information.The catheter is used with the MediGuide™ Technology system toenable real-time positioning and navigation. The MediGuide™Technology system is indicated for use as an adjunct tofluoroscopy.

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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 PredicateDevices	The Advisor FL, SE has the same intended use and fundamentalscientific technology as the predicate devices. The technologicalcharacteristics of the Advisor FL,SE are substantially equivalent tothe predicate device including packaging, biocompatibility,sterilization, and labeling. Bench and animal testing demonstratedthat the subject device is substantially equivalent to the predicatedevice.
Summary on Non-ClinicalTesting	Bench and animal testing was performed to verify the device metthe pre-determined acceptance criteria. The following tests wereperformed: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 andtechnological characteristics as the predicate devices. Based onthis and the data provided in this pre-market notification, the subjectdevice and predicate device has been shown to be substantiallyequivalent.

Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
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.(b)
Classification. Class II (performance standards).