The OPTRELL™ Mapping Catheter with TRUEref™ Technology is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or simulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The cather provides location information only when used with a compatible version of the CARTO™ 3 System.

Device Description

The OPTRELL™ Mapping Catheter with TRUEref™ Technology has been designed to facilitate electrophysiological mapping of the heart with the CARTO™ 3 System. The OPTRELL™ Mapping Catheter with TRUEref™ Technology is deployed in the heart through an 8.5 F guiding sheath. This bi-directional deflectable catheter includes six (6) parallel 2 Fr spines that are joined to form three (3) loops on the deflectable tip. Each spine has six (6) platinum electrodes that are used for stimulating and recording. The electrodes form a 6 by 6 (6x6) grid. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO™ 3 EP Navigation System. Below the spines on the deflectable tip are three (3) electrodes that allow visualization of the tip on the CARTO™ 3 System. The TRUEref™ Electrode, which is embedded in the distal end of the irrigation lumen, can be used as an internal close unipolar reference electrode within the heart chamber. Rotating the catheter's Rocker Lever clockwise or counterclockwise deflects the tip; rotating the Rocker Lever to the neutral position straightens the tip. The catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid. Lastly, the proposed catheter is offered in the same deflectable curve offerings as the predicate.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Important Note: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on proving de novo clinical effectiveness against a set of performance metrics as one might see for a completely novel device or an AI/ML product where clinical performance (e.g., accuracy, sensitivity, specificity) is a key outcome. This 510(k) is for a physical medical device (mapping catheter). Therefore, the "acceptance criteria" and "study" described herein are primarily related to bench and animal testing to show that the modified device performs similarly to its predicate and doesn't raise new safety or effectiveness concerns.

Given the nature of the device and the submission type, there is no mention of AI/ML or human reader studies (MRMC). The "metrics" are mechanical, electrical, and physiological performance in a simulated environment or animal model, not diagnostic accuracy based on human interpretation.

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Reported Device Performance
Mechanical Integrity	Passed all intended criteria
Deflection	Passed all intended criteria
Device Functionality	Passed all intended criteria
Simulated Use	Passed all intended criteria
Electrical Properties	Passed all intended criteria
Visualization	Passed all intended criteria
Shelf Life	Passed all intended criteria
Device Maneuverability	Passed all intended criteria
Signal Quality	Passed all intended criteria
Safety (Animal Testing)	Demonstrated safety equivalent to predicate
Effectiveness (Animal Testing)	Demonstrated effectiveness equivalent to predicate

Study Details (Bench and Animal Testing)

Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated numerically. The document states "Testing included mechanical integrity, deflection, device functionality, simulated use, electrical properties, visualization, shelf life, device maneuverability and signal quality, and animal testing". This implies a series of tests, each likely with its own sample size of devices or animal subjects, sufficient to meet engineering and GLP (Good Laboratory Practice) standards.
- Data Provenance: The studies were conducted by Biosense Webster, Inc. (the manufacturer). The animal testing would be prospective. Location of testing is not specified beyond the manufacturer's address in Irvine, California, and a manufacturing site in Juarez, Mexico.
Number of Experts and Qualifications for Ground Truth:
- This type of submission for a physical device, especially for bench and animal testing, typically relies on objective measurements, engineering specifications, and established biological responses in animal models. There's no indication of human "experts" establishing a subjective "ground truth" for classification or diagnosis as there would be for an AI diagnostic device. The "ground truth" for mechanical and electrical properties is typically defined by the device's design specifications and accepted industry standards, while for animal studies, it would be physiological responses evaluated by qualified veterinarians/scientists.
Adjudication Method for the Test Set:
- Not applicable in the context of bench and animal testing metrics. The results would be objectively measured and compared against defined thresholds or the predicate device's performance.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This device is a mapping catheter, not an AI/ML diagnostic tool that assists human readers in interpretation. The study evaluates the physical and electrical performance of the catheter itself.
Standalone Performance Study (Algorithm Only):
- Not applicable. This device does not contain a standalone algorithm. Its function is to obtain electrograms, which are then used by the CARTO™ 3 System. The "performance" described is of the catheter's ability to achieve its physical and electrical functions, not an algorithm's diagnostic performance.
Type of Ground Truth Used:
- Engineering Specifications/Bench Standards: For mechanical integrity, deflection, electrical properties, etc., the ground truth would be defined by pre-determined engineering specifications, design requirements, and established industry standards.
- Physiological/Biological Outcomes (in Animal Model): For animal testing, the ground truth relates to the physiological responses within the animal model, observed and measured by qualified personnel, demonstrating the device's intended function (obtaining electrograms) and safety (e.g., lack of adverse tissue reactions).
- Predicate Device Performance: A key aspect of this 510(k) is demonstrating that the modified device performs "as well as or better than" the predicate device in these tests, making the predicate's established performance a de facto "ground truth" for comparison.
Sample Size for the Training Set:
- Not applicable. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set" in the computational sense. The design and development of the device would rely on engineering principles, material science, and prior knowledge from the predicate device, not machine learning training data.
How Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for a machine learning model, this question does not apply.

Summary

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March 2, 2023

Biosense Webster, Inc. John Jimenez Senior RA Program Lead 31 Technology Drive, Suite 200 Irvine, California 92618

Re: K230253

Trade/Device Name: OPTRELL™ Mapping Catheter with TRUEref™ Technology Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: MTD Dated: January 27, 2023 Received: January 31, 2023

Dear John Jimenez:

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

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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 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 (QS) 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 medical devices and radiation-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,

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230253

Device Name

OPTRELL™ Mapping Catheter with TRUEref™ Technology

Indications for Use (Describe)

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)
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2. 510(k) Summary

Applicant:	Biosense Webster, Inc.31 Technology Drive, Suite 200Irvine, CA 92618Phone: (949) 923-4774Fax: 949-450-6886
Contact Person:	John JimenezSenior Program Lead, Regulatory Affairs
Date:	January 27, 2023
Trade or Proprietary Name:	OPTRELL™ Mapping Catheter with TRUEref™ Technology
Common or UsualName of Device:	Electrophysiological Mapping Catheter
Classification Name:	Electrode Recording Catheter(21 CFR 870.1220, Product Code MTD)
Predicate Device:	OPTRELL™ Mapping Catheter with TRUEref™ Technology510(k): K211438
Manufacturer:	Biosense Webster, Inc.31 Technology Drive, Suite 200Irvine, CA 92618
Manufacturing Sites:	Biosense Webster, Inc.Circuito Interior Norte #1820Parque Industrial Salvarcar 32599Juarez, Chihuahua, Mexico

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Substantially Equivalent To A.

The OPTRELL™ Mapping Catheter with TRUEref™ Technology is substantially equivalent to the Biosense Webster OPTRELL™ Mapping Catheter with TRUEref™ Technology cleared on March 18, 2022, under 510(k) K211438.

Description of the Device Subject to Premarket Notification B.

The OPTRELL™ Mapping Catheter with TRUEref™ Technology design uses the same technology, has the same intended use, functions, materials, and method of operation as the predicate OPTRELL™ Mapping Catheter with TRUEref™ Technology. Instead of eight (8) platinum electrodes on each spine, the proposed OPTRELL™ Mapping Catheter with TRUEref™ Technology has six (6) electrodes on each spine, forming a 6 by 6 paddle-shaped tip containing thirty-six (36) electrodes arranged across six (6) spines. Like the predicate, the proposed OPTRELL™ also includes a close uni-polar reference electrode located at the confluence of the spines. Otherwise, there are no special technical aspects of the ability of this catheter to detect electrical signals from heart endocardium and transmit this information to the CARTO® 3 EP Navigation System and/or recording equipment for display, analysis, and interpretation in detection of various heart arrhythmias. The difference in paddle size and number of electrodes between the proposed OPTRELL™ Mapping Catheter with TRUEref™ Technology and the predicate OPTRELL™ Mapping Catheter with TRUEref™ Technology have been evaluated through bench and animal testing. Results from the bench and animal data demonstrated that the proposed device is substantially equivalent to the predicate device and did not result in new questions with regards to safety and effectiveness of the device.

Indications for Use ﻥ

The OPTRELL™ Mapping Catheter with TRUEref™ Technology is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the

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K230253

heart. The catheter provides location information only when used with a compatible version of the CARTO™ 3 System.

Performance Data D.

The OPTRELL™ Mapping Catheter with TRUEref™ Technology underwent Bench and Animal Testing. Testing included mechanical integrity, deflection, device functionality, simulated use, electrical properties, visualization, shelf life, device maneuverability and signal quality, and animal testing to assess device effectiveness and safety. The catheter passed all intended criteria in accordance with appropriate test criteria and standards. No new questions of safety or effectiveness were identified. Testing demonstrated that the proposed OPTRELL™ Mapping Catheter with TRUEref™ Technology is as safe, effective, and performs as well as or better, than the predicate device. This testing program supports the determination of substantial equivalence to the predicate device.

Overall Performance Conclusions ட்.

The nonclinical studies demonstrate that the OPTRELL™ Mapping Catheter with TRUEref™ Technology is as safe, effective, and performs as well as or better, than the predicate OPTRELL™ Mapping Catheter with TRUEref™ Technology.

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).