For use in cardiac electrophysiology procedures to assist in the diagnosis of 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 FIRMap Catheter is a sterile, single use device used to detect and record intracardiac electrical potentials and to deliver externally generated pacing stimuli. 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 After the catheter is positioned the sheath is withdrawn enough to allow the basket to expand and the electrodes to contact the heart wall.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 furnished document is a 510(k) summary for the FIRMap Catheter, which is an electrode recording catheter used in cardiac electrophysiology procedures. It states that "No animal or clinical testing was conducted." Therefore, there is no study described that proves the device meets specific acceptance criteria based on performance with human or animal subjects.

However, the document lists several performance data tests and concludes that these tests demonstrate substantial equivalence to the predicate device and assure conformity to appropriate requirements. This represents the "study" that was performed and its findings regarding acceptance.

Here is an attempt to structure the requested information based on the provided text, while noting the absence of clinical performance data in the traditional sense:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific acceptance criteria values were explicitly stated for the listed tests, and the "reported device performance" is a general statement of success rather than quantitative results, I will infer the acceptance criterion as "conforms to requirements" and the performance as "met this standard."

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Radial Strength tests passed	Conforms to requirements
Lateral Strength tests passed	Conforms to requirements
Insertion/Withdrawal cycling tests passed	Conforms to requirements
Torque tests passed	Conforms to requirements
Pancake Atrium tests passed	Conforms to requirements
Substantially equivalent to predicate device	Demonstrated
Safe and effective for intended use	Demonstrated

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for the listed tests (Radial Strength, Lateral Strength, etc.). These appear to be bench or engineering tests where "sample size" might refer to the number of catheters tested, which is not provided.
Data Provenance: The tests are likely retrospective bench/engineering tests conducted in a lab setting by the manufacturer (Abbott Electrophysiology) to demonstrate the physical properties and functional aspects of the device, rather than involving patient data. Country of origin not specified, but likely where Abbott Electrophysiology's R&D is located.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. For bench/engineering tests like Radial Strength or Torque, "ground truth" is typically established by engineering specifications, material properties, and relevant industry standards, not by human expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As these were non-clinical bench tests, adjudication methods like 2+1 or 3+1 (common in image interpretation or clinical trials) are not relevant. Test results would be compared against predefined engineering specifications or performance limits.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No animal or clinical testing was conducted." Therefore, no MRMC study involving human readers or AI assistance was performed or described.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. The FIRMap Catheter is a physical medical device, not a software algorithm or AI. Performance is related to its physical and functional characteristics, not algorithm capability.

7. Type of Ground Truth Used

The ground truth for the performance data (Radial Strength, Lateral Strength, etc.) would be established by engineering specifications and recognized industry standards (e.g., ISO and IEC standards listed in the document), rather than expert consensus, pathology, or outcomes data, as no clinical testing was performed.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing process would involve engineering and material testing, but not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often used as a symbol of medicine. The logo is presented in black and white.

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

February 28, 2017

Abbott Electrophysiology Dennis Pozzo Senior Regulatory Affairs Specialist 3668 S. Geyer Road Suite 365 St. Louis, Missouri 63127

Re: K163709

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: January 17, 2017 Received: January 18, 2017

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 (OS) 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.

Mude Yellman
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)

K163709

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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Section 5: 510(k) Summary per 21CFR §807.92

Submitter'sinformation	Abbott Electrophysiology3668 S. Geyer Road, Suite 365, St. Louis, MO 63127Contact: Dennis PozzoPhone 314-300-6580
Device/classificationname	• Device Trade 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:FIRMap Catheter. K153093, cleared April 7, 2016
Devicedescription	The FIRMap Catheter is a sterile, single use device used to detect and recordintracardiac electrical potentials and to deliver externally generated pacingstimuli. The FIRMap Multiple Electrode Recording and Pacing Catheter mayalso be used for 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 ofarrhythmias that may be difficult to identify using conventional mappingsystems alone (i.e., linear mapping catheters). The FIRMap Catheter may alsobe used for delivery of externally generated pacing stimuli.
Technologicalcharacteristics	The distal, expandable basket assembly is arranged into a three dimensional"basket" shape. The basket assembly contains an array of 64 electrodesmounted onto eight support structures called splines. Each spline has 8electrodes spaced at an equal distance along the length of the spline.The eight splines are fixed at an equal distance labeled A through H in aclockwise direction if viewed from the catheter/basket's distal tip. The arrayorientation is displayed by use of radiopaque markers. To distinguish splinesunder fluoroscopy, Spline A has a larger radiopaque marker next to electrode8, Spline B has a larger marker next to electrode 7, Spline C has an additionalmarker next to electrode 6, and so onwards in progression to Spline G.

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Section 5: 510(k) Summary per 21CFR §807.92, Continued

Device Characteristic	Predicate RhythmViewWorkstation	Proposed RhythmViewWorkstation
Device Characteristic	Predicate FIRMapCatheter (K153093)	Proposed FIRMapCatheter
Intended Use	Intracardiacelectrophysiologicalmapping and pacing.	Intracardiacelectrophysiologicalmapping and pacing.
Splines expand	Yes	Yes
No. of Splines	8	8
No. of electrodes	64	64
Sterile	Yes	Yes
Method of sterilization	EO gas	EO gas
Single use	Yes	Yes
Radiopaque markers	Yes	Yes
Spline radiopaque material	platinum-iridium alloy	platinum-iridium alloy
Basket diameter/ Electrodespacing	50mm/ 9.0mm60mm/ 11.2mm70mm/13.5mm	50mm/ 9.0mm60mm/ 11.2mm70mm/13.5mm
Basket Tip	Two Piece - Tip Domeand Cap	Single Piece
Basket Tip Material	Stainless Steel	Stainless Steel

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

Since there are no electrical updates, the EMC and Electrical Safety reports referenced in K153093 still apply.

IEC 60601-1, 3rd Edition, Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
. IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

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Section 5: 510(k) Summary per 21CFR §807.92, Continued

Performancedata	The following is a list of the tests conducted: Radial Strength, LateralStrength, Insertion/Withdrawal cycling, Torque and Pancake Atrium.P q'animal or clinical testing was conducted.
	The testing has demonstrated that the FIRMap catheter providesreasonable assurance that the proposed device conforms to theappropriate requirements for its intended use. Therefore, it issubstantially equivalent to the predicate device, safe and effective forits 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).