The unidirectional steerable diagnostic catheters acquire electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter(s) percutaneously via either the anterior approach using the internal jugular vein or the subclavian vein or via the femoral vein or for a retrograde approach, via the femoral artery. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface.

The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The EP+XT Catheter has a white rotating handle mechanism which provides curve actuation of the distal tip. The Dynamic Tip and Dynamic XT Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.

The EP•XT, Dynamic Tip, and Dynamic XT Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).

AI/ML Overview

This document describes the FDA's decision to clear Boston Scientific's EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters for marketing based on a determination of substantial equivalence to predicate devices. This clearance is not based on a study proving the device meets specific performance criteria for diagnostic accuracy in the same way an AI/ML diagnostic would be; rather, it relates to the device's physical and functional characteristics and its ability to acquire electrical signals.

Therefore, the requested information (acceptance criteria and study details related to diagnostic performance, human reader improvement with AI, ground truth, expert adjudication, etc.) is not applicable to this 510(k) submission. This is a clearance for a physical medical device (catheter) used to acquire data, not a software-based diagnostic algorithm.

Here's a breakdown based on the provided document, addressing what is relevant and noting what is not:

1. Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are based on the device's physical and functional performance, sterilization, and packaging, demonstrating it is substantially equivalent to a predicate device. There are no diagnostic performance metrics (e.g., sensitivity, specificity, AUC) reported because this is not a diagnostic algorithm.

Acceptance Criteria Category	Reported Device Performance (Summary)
Biocompatibility	Implied by "substantially equivalent ... to predicate device." Specific testing not detailed in summary.
Sterilization	EO (Ethylene Oxide) sterilization validated; packaging maintains sterility.
Mechanical Performance	Demonstrated through "Design Verification Testing" at baseline and 37 months accelerated aging. Ensured adherence to "applicable product specifications." Examples of specific tests would likely include steerability, durability, electrical signal acquisition integrity, etc., but these are not detailed in the summary.
Packaging Integrity	"Packaging Design Verification testing... meet[s] predetermined design input specification and maintain sterility in conformance with ISO 11607-1."

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

N/A. This 510(k) summary does not describe a clinical study for diagnostic performance with a test set of patient data. The "test set" for this device would refer to units of the manufactured catheters themselves undergoing engineering and bench testing. The document states "Design verification testing was performed on the EP.XT, Dynamic Tip, and Dynamic XT Catheters," implying a sample of the manufactured devices were tested, but specific numbers are not provided in this summary.

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

N/A. This is not a diagnostic algorithm requiring expert-established ground truth on patient data. The ground truth for this device's performance relates to engineering specifications and international standards (e.g., ISO 11607-1 for packaging, ISO 11737-1 for bioburden).

4. Adjudication Method for the Test Set

N/A. Not applicable to a physical device's engineering and performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a diagnostic tool that acquires electrical signals, not an AI-powered diagnostic system.

6. If a Standalone Performance Study Was Done

No, not in the context of an algorithm's diagnostic performance. The "performance data" described (Bioburden, Design Verification, Packaging Verification) are standalone tests of the device's physical and functional attributes against engineering specifications and regulatory standards.

7. The Type of Ground Truth Used

The "ground truth" for this device's clearance is based on:

Engineering Specifications: The design inputs and performance requirements set by Boston Scientific for the catheters.
International Standards: E.g., ISO 11737-1 for bioburden, ISO 11607-1 for packaging, and likely other ISO standards for biocompatibility and electrical safety (though not explicitly listed in the summary).
Predicate Device Performance: The primary "ground truth" for 510(k) clearance is that the new device performs "substantially equivalent" to legally marketed predicate devices, meaning it has similar technological characteristics and the same intended use.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device that requires a training set of data.

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

N/A. Not applicable as there is no training set for an AI/ML algorithm.

In summary: The provided document is a 510(k) clearance letter for a medical device (catheter) based on substantial equivalence. It does not contain information about acceptance criteria or studies related to the diagnostic accuracy of an AI/ML algorithm, nor does it describe human-in-the-loop performance studies. The "performance data" refers to the physical and functional characteristics of the catheter itself, not its diagnostic accuracy in interpreting patient data.

Summary

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November 1, 2024

Boston Scientific Corporation Melissa Schneider Senior Regulatory Affairs Specialis 4100 Hamline Ave North St Paul, Minnesota 55112

Re: K240366

Trade/Device Name: EP.XTTM Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XTTM Unidirectional Steerable Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: February 5, 2024 Received: February 6, 2024

Dear Melissa Schneider:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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) K240366

Device Name

EP XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter

Indications for Use (Describe)

EP+XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.

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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510(k) Summary for EP•XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters

1. Submitter

Boston Scientific Corporation Electrophysiology Division 4100 Hamline Ave North St. Paul, MN 55112

Contact:

Melissa Schneider Regulatory Affairs Specialist Phone: 651-582-6935 E-mail: melissa.schneider(@bsci.com

Date Prepared: October 31, 2024

2. Device

Name of Devices: EP.XTTM Unidirectional Steerable Diagnostic Catheter; DYNAMIC TIPTM Unidirectional Steerable Diagnostic Catheter; DYNAMIC XTTM Unidirectional Steerable Diagnostic Catheter

Common Name: Dynamic Unidirectional Steerable Diagnostic Catheter Classification Name: Electrode Recording Catheter or Electrode Recording Probe Product Code: DRF Device Class and Panel: Class II, Cardiovascular Classification Regulation: 21 CFR Part 870.1220

3.Predicate Device

Subject Device	Predicate Device	Predicate 510(k)
EP•XT Steerable Diagnostic Catheter	Bard® Steerable Catheter	K921872
Dynamic Tip Steerable DiagnosticCatheter	Bard® Dynamic Tip Catheter	K912213
Dynamic XT Steerable DiagnosticCatheter	Bard® Steerable Catheter	K921872

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300 Boston Scientific Way Marlborough, MA 01752 www.bostonscientific.com

4. Device Description

5. Intended Use & Indications for Use

Intended Use

EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are intended for temporary intracardiac sensing, recording, stimulation, and temporary pacing during the evaluation or cardiac arrhythmias. The device is intended for use in adult (not pediatric) patients, with the exclusion of pregnant and/or nursing patients.

Indications for Use

EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.

6. Comparison of Technological Characteristics with the Predicate Device

The catheters incorporate substantially equivalent design, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate device.

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7. Performance Data

The following performance data were provided in support of the substantial equivalence determination:

Bioburden Testing

Bioburden testing, per ISO 11737-1, Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products, was performed to confirm bioburden levels of the devices were not adversely affected.

Design Verification Testing

Design verification testing was performed on the EP.XT, Dynamic Tip, and Dynamic XT Catheters to demonstrate that the devices, as manufactured, packaged and 2x EO sterilized, adhere to the requirements set forth in accordance with the applicable product specifications.

Testing was conducted at baseline (T=0) and 37 months (1125 days) accelerated aging to support the labeled shelf life.

Packaging Verification Testing

The Packaging Design Verification testing provides evidence that the catheter packaging configurations meet the predetermined design input specification and maintain sterility in conformance with ISO 11607-1.

8. Conclusion

The subject EP.XT, Dynamic Tip, and Dynamic XT Steerable Diagnostic Catheters are substantially equivalent in indications for use, design, product function, materials, and sterility to the predicate Steerable Diagnostic Catheters. The performance data supports that the subject catheters are substantially equivalent to their respective predicate devices.

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).