Advisor VL Circular Mapping Catheter, Sensor Enabled by Abbott Medical

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 Description

Advisor VL Circular Mapping Catheter, Sensor Enabled (Advisor VL) is a variable radius, circular mapping catheter. It has an adjustable 4 French (F) distal loop size with a diameter ranging from 15mm – 25mm with models containing both ten (10) equidistant or twenty (20) paired platinum-iridium electrodes. The catheter has integrated sensors with two impedance-based navigational electrodes and two magnetic sensors located at the distal end of the shaft. The catheter is intended to be used with the EnSiteTM PrecisionTM Cardiac Mapping System.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Advisor™ VL Circular Mapping Catheter, Sensor Enabled™". This device is an electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies, specifically for mapping atrial regions of the heart.

Based on the document, this is not an AI/ML medical device submission. The submission focuses on demonstrating substantial equivalence to a predicate device (Advisor FL, Circular Mapping Catheter, Sensor Enabled K160335) through extensive non-clinical testing (bench and animal testing). There is no mention of an AI algorithm, a test set for AI performance, human expert readings, or any of the typical criteria associated with AI/ML device evaluations.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets those criteria, as this document does not pertain to such a device.

To directly address the specific points of your request:

A table of acceptance criteria and the reported device performance: This document lists various non-clinical tests performed (e.g., Patient Leakage, Dielectric Strength, Biocompatibility, Functional Simulated Use, etc.) and states that the device "met the pre-determined acceptance criteria." It does not provide a detailed table with specific acceptance values and corresponding reported performance values for each test. This type of detailed data is typically found in the full 510(k) submission, not the summary.
Sample sized used for the test set and the data provenance: Not applicable for an AI/ML device. For the non-clinical tests, sample sizes for specific bench or animal tests are not detailed in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no AI model's performance on human expert-labeled data is being evaluated.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML model's ground truth. Ground truth for this device would refer to the true physical/electrical properties measured during bench and animal testing.
The sample size for the training set: Not applicable (no AI training involved).
How the ground truth for the training set was established: Not applicable (no AI training involved).

In summary, the provided document details the regulatory clearance of a physical medical device (a cardiac catheter) based on a comparison to a predicate device and extensive non-clinical testing, not an AI/ML diagnostic or therapeutic device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K192037

Device Name

Advisor™ VL Circular Mapping Catheter, Sensor EnabledTM

Indications for Use (Describe)

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)

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}------------------------------------------------

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: 651-756-6656
	Email: tamara.stanczak@abbott.com
Device Information:
Trade Name:	AdvisorTM VL Circular Mapping Catheter,Sensor EnabledTM
Common Name:	Diagnostic Electrophysiology Catheter
Class:	Class II, 21CFR870.1220
Product Code:	DRF
Classification Name:	Catheter, Electrode Recording, or Probe,Electrode Recording
Predicate Device:	Advisor FL, Circular Mapping Catheter,Sensor Enabled (K160335)
Reference Device:	Reflexion Spiral Variable Radius Catheter(K072012)
Device Description:	Advisor VL Circular Mapping Catheter,Sensor Enabled (Advisor VL) is a variableradius, circular mapping catheter. It has anadjustable 4 French (F) distal loop size with adiameter ranging from 15mm – 25mm withmodels containing both ten (10) equidistant ortwenty (20) paired platinum-iridiumelectrodes. The catheter has integrated sensorswith two impedance-based navigationalelectrodes and two magnetic sensors locatedat the distal end of the shaft. The catheter isintended to be used with the EnSiteTMPrecisionTM Cardiac Mapping System.
Intended Use:(Indications for Use)	Advisor VL catheter is a steerableelectrophysiology catheter with integratedsensors. The catheter is used for recordingintracardiac signals and cardiac stimulationduring diagnostic electrophysiology studies.The catheter can be used to map the atrialregions of the heart.
Comparison to Predicate Devices	The Advisor VL is substantially equivalent tothe predicate devices based on comparisons ofthe 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.

{4}------------------------------------------------

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).