For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Catheter may also be used for delivery of externally generated pacing stimuli.

Device Description

The catheter is used in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Multiple Electrode Recording and Pacing Catheter may also be used for delivery of externally generated pacing stimuli.

The FIRMap catheter is delivered to the heart chamber via an intravascular sheath. After the catheter is positioned the sheath is withdrawn enough to allow the basket to expand and the electrodes to contact the heart wall.

AI/ML Overview

The provided text is a 510(k) Summary for the FIRMap Catheter, which outlines the device's technical characteristics and the performance testing conducted to demonstrate its substantial equivalence to a predicate device. This document describes a medical device, not an AI/ML powered device, and therefore the relevant information for an AI/ML acceptance criteria and study cannot be extracted.

Reasoning for inability to extract AI/ML specific information:

The document describes the FIRMap Catheter, an electrode recording catheter used in cardiac electrophysiology procedures. The testing described is focused on the mechanical integrity and functionality of the catheter's basket subassembly, which are hardware-related aspects (e.g., radial force, spline stiffness, introduction/withdrawal cycling, and in-vivo testing in a "Pancake Atrium").

There is no mention of:

An algorithm or AI/ML model.
Data provenance, test sets, or training sets in the context of an AI/ML model.
Expert interpretation of AI/ML outputs or ground truth establishment for AI/ML.
Multi-reader multi-case studies related to AI/ML assistance.
Standalone performance of an algorithm.

The document entirely focuses on the physical device and its mechanical/electrical performance, not on software or AI capabilities.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 7, 2016

Abbott Electrophysiology Dennis Pozzo Sr. Regulatory Affairs Specialist 3368 S. Geyer Road, Suite 365 St. Louis, MO 63127

Re: K153093

Trade/Device Name: FIRMap Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: MTD Dated: March 4, 2016 Received: March 7, 2016

Dear Dennis Pozzo:

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

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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 yours,

Mitchell Stein

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) K153093

Device Name

FIRMap Catheter

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)

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Appendix 1: 510(k) Summary per 21CFR §807.92

Submitter'sinformation	Abbott Electrophysiology3668 S. Geyer Road, Suite 365St. Louis, MO 63127Contact: Dennis Pozzo/Phone 314-300-6580
Device/classificationname	Device Name: FIRMap Catheter Classification/Common name: Electrode recording catheter or electroderecording probe Product Code/Classification No.: MTD/21 CFR 870.1220 The marketed device(s) to which substantial equivalence is claimed:K130827, cleared October. 31, 2013
Devicedescription	The catheter is used in cardiac electrophysiology procedures to assist in thediagnosis of complex arrhythmias that may be difficult to identify usingconventional mapping systems alone (i.e., linear mapping catheters). TheFIRMap Multiple Electrode Recording and Pacing Catheter may also be usedfor delivery of externally generated pacing stimuli.The FIRMap catheter is delivered to the heart chamber via an intravascularsheath. After the catheter is positioned the sheath is withdrawn enough toallow the basket to expand and the electrodes to contact the heart wall.
Indications foruse	For use in cardiac electrophysiology procedures to assist in the diagnosis ofcomplex arrhythmias that may be difficult to identify using conventionalmapping systems alone (i.e., linear mapping catheters). The FIRMap Cathetermay also be used for delivery of externally generated pacing stimuli.
Technologicalcharacteristics	Both the proposed and predicate FIRMap catheters contain a distal basketassembly. Arranged into a three dimensional shape that expands, Contain an array of 64 electrodes mounted onto eight support structurescalled splines. Each spline has 8 electrodes spaced at an equal distance along thelength of the spline. The splines are fixed at an equal distance labeled A through H in aclockwise direction viewed from the catheter/basket's distal tip. The array orientation is displayed by use of radiopaque markers. Continued on next page

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Appendix 1: 510(k) Summary per 21CFR §807.92, Continued

The proposed device incorporates a design change to the distal spline which is Design change intended to improve performance and manufacturability compared with the predicate device.

Device Characteristic(Technological Comparison)	Predicate FIRMapCatheter (K130827)	Proposed FIRMapCatheter
Intended Use	Intracardiacelectrophysiologicalmapping and pacing.	Intracardiacelectrophysiologicalmapping and pacing.
Splines
No. of splines	8 (expanding)	8 (expanding)
Spline Material	Nitinol	Nitinol
Spline Tube Material	Pebax	Pebax
Spline radiopaque material	platinum-iridium alloy	platinum-iridium alloy
Distal spline connecting tip(tip dome and cap)	316 Stainless steel	316 Stainless steel
Distal Catheter Tubing	Polyester Shrink Tubing	Polyester Shrink Tubing
Distal Spline Tubing	Polyester Shrink Tubing	NA
Method for limiting splinemovement	EDM "bowtie" feature	Extend Pebax tubing
Electrodes
No. of electrodes	64	64
Electrode material	Gold plated copper	Gold plated copper
Electrode configuration	Unipolar or bipolar	Unipolar or bipolar
Dimensions
Basket diameter/ Electrodespacing	40mm/ 6.8mm50mm/ 9.0mm60mm/ 11.2mm70mm/13.5mm	40mm/ 6.8mm50mm/ 9.0mm60mm/ 11.2mm70mm/13.5mm
Device Characteristic(Technological Comparison)	Predicate FIRMapCatheter (K130827)	Proposed FIRMapCatheter
Catheter shaft diameter	2.8mm	2.8mm
Working length	128cm +/-1cm	128cm +/-1cm
Recommended guide catheter	ID = 8.5 Fr.	ID = 8.5 Fr.
Electrical Rating
Electrical rating - Typical	+/- 27V, 25mA	+/- 27V, 25mA
Dielectric strength	500V DC	500V DC
Sterilization
Method of sterilization	EO gas	EO gas
Single use	Yes	Yes

Continued on next page

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Appendix 1:510(k) Summary per 21CFR §807.92, Continued

Applicable standards

ISO 14971: 2012, Medical Devices Application of risk management to ● medical devices
ISO 10555-1: 2012 Intravascular catheters Sterile and single-use ● catheters - Part 1: General requirements

Performance Bench Testing data The modification only impacts the basket subassembly of the catheter; the scope of testing was limited to confirming the mechanical integrity of the basket subassembly and its functionality.

Test Description	Acceptance Criteria	Conclusion
Basket Radial force	Variable - 95/95Confidence/Reliability	PASS
Basket Lateral SplineStiffness	Variable - 95/95Confidence/Reliability	PASS
Introduction/ WithdrawalCycling	Attribute - 95/95Confidence/reliabilityper Weibull analysis	PASS
FIRMap Catheter Testing inPancake Atrium	Attribute - 95/95Confidence/reliability	PASS

Continued on next page

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Appendix 1: 510(k) Summary per 21CFR §807.92, Continued

Performance	In-Vivo Testing
data, continued	Evaluated the modification of the basket assembly during simulated use. Noclinically significant differences in use or functionality were noted betweenthe proposed and predicate catheters.

Conclusion

Performance testing has demonstrated that the modified FIRMap Catheter provides reasonable assurance of conformance to predicate device requirements. Therefore, it is substantially equivalent to the predicate device, safe and effective for its intended use.

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).