The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures.

EnSite™ X EP System Contact Force Software License:

When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ X EP System Surface Electrode Kit:

The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.

Device Description

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber. The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

AI/ML Overview

The provided document is a 510(k) summary for the EnSite™ X EP System, outlining its substantial equivalence to a predicate device. This type of submission focuses on demonstrating safety and effectiveness compared to an already legally marketed device, not necessarily on novel AI algorithm performance studies as might be found in a De Novo submission.

Therefore, the specific information requested about acceptance criteria and study details often associated with AI/ML device performance (like sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, and training set details) is not directly available in this document.

The document discusses "Design verification activities" and "Performance Testing of updated feature functionality" for the software updates, but these are general engineering and software validation tests rather than clinical performance studies demonstrating diagnostic accuracy with human readers or standalone AI performance.

Here's how to address the requested points based on the available information:

1. A table of acceptance criteria and the reported device performance

The document states that "Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are safe and effective." However, it does not provide a table specifying the explicit acceptance criteria for each software update or the detailed reported performance metrics against those criteria. It lists the types of testing, implying that the outcomes of these tests met their internal acceptance criteria.

2. Sample sized used for the test set and the data provenance

Not explicitly stated for the "performance testing of updated feature functionality." The document mentions "Bench studies to evaluate substantial equivalence" and "Preclinical Validation Testing to confirm the system could meet user requirements." These usually involve in-vitro or simulated data, rather than large clinical test sets with specified patient populations. The provenance of such data (e.g., country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable or not specified. This level of detail for expert ground truth is typically provided for diagnostic accuracy studies involving human interpretation of clinical data, which is not the primary focus of this 510(k) for software updates to an existing electrophysiology system.

4. Adjudication method for the test set

Not applicable or not specified.

5. 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

No MRMC comparative effectiveness study is mentioned. This submission is about software updates to an existing system, not the introduction of an AI algorithm requiring a comparative effectiveness claims with human readers. The new features (e.g., calculated waveforms, activation direction arrows, wave speed maps, deflection direction indicators, real-time map points) are presented as direct display enhancements or functional improvements rather than AI-driven diagnostic assistance to human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to an "EnSite™ X EP System" which is a catheter navigation and mapping system, intended to be used by trained medical professionals. It's an interactive diagnostic tool, not a standalone AI algorithm producing a diagnosis without human interaction. Therefore, a standalone (algorithm only) performance study as typically understood for AI/ML devices is not applicable or described here. Its function is to provide information for a human clinician.

7. The type of ground truth used

For the software updates, the "ground truth" would likely be defined by internal engineering specifications, established scientific principles of electrophysiology, and potentially comparisons against existing validated methods or simulations, rather than clinical 'ground truth' such as pathology or long-term outcomes data, which is more relevant for diagnostic accuracy claims. The validation would ensure the calculated waveforms, map displays, etc., are accurate representations of the underlying electrophysiological data according to accepted standards.

8. The sample size for the training set

Not applicable. The document describes software updates for an electrophysiology system, not a machine learning algorithm that undergoes a training phase with a specific dataset.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a machine learning model with a training set.

Summary

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October 22, 2021

Abbott Medical Jamie Glaser Senior Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, Minnesota 55117

Re: K212061

Trade/Device Name: EnSite™ X EP System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: June 30, 2021 Received: July 1, 2021

Dear Jamie Glaser:

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

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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,

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) K212061

Device Name EnSite™ X EP System

Indications for Use (Describe)

EnSite™ X EP System

The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures.

EnSite™ X EP System Contact Force Software License:

When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ X EP System Surface Electrode Kit:

The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue stylized letter 'a' on the left and the word 'Abbott' in black font on the right. The blue 'a' symbol is a modern, abstract design, and the word 'Abbott' is written in a bold, sans-serif typeface.

5. 510(K) SUMMARY

510(k) Information
510(k) Number	K212061
510(k) Type	Traditional 510(k)
Date Prepared	30 June 2021
Submitter Information
Manufacturer Name &Address	Abbott MedicalOne St. Jude Medical Drive,St. Paul, Minnesota, 55119, USAManufacturer of the EnSite X EP SystemSt. Jude Medical Costa Rica Ltda.Edificio #44 Calle 0, Ave. 2Zona Franca CoyolEl Coyol Alajuela, Costa Rica 1897-4050Manufacturer of the EnSite X EP System Surface Electrode Kit
Contact Person	Jamie GlaserSenior Regulatory Affairs Specialist651-756-5091jamie.glaser@abbott.com
EnSite™ X EP System Device Information
Trade Name	EnSite™ X EP System
Common Name	Programmable Diagnostic Computer
Class	II
Classification Name	870.1425, computer, diagnostic, programmable
Product Code	DQK
Predicate Device	EnSite™ X EP System (K202066)
Device Description	The EnSite™ X EP System is a catheter navigation and mapping system. A catheternavigation and mapping system is capable of displaying the 3-dimensional (3-D)position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, aswell as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.The contoured surfaces of the 3D maps are based on the anatomy of the patient's owncardiac chamber. The system creates a model by collecting and labeling the anatomiclocations within the chamber. A surface is created by moving a selected catheter tolocations within a cardiac structure. As the catheter moves, points are collected at andbetween all electrodes on the catheter. A surface is wrapped around the outermostpoints.
Indications for Use	EnSite™ X EP System
The EnSite™ X EP System is a suggested diagnostic tool in patients for whomelectrophysiology studies have been indicated.
The EnSite™ X EP System provides information about the electrical activity of theheart and displays catheter location during conventional electrophysiological (EP)procedures.
EnSite™ X EP System Contact Force Software License
When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP SystemContact Force Module is intended to provide visualization of force information fromcompatible catheters.
EnSite™ X EP System Surface Electrode Kit
The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EPSystem in accordance with the EnSite™ X EP System indications for use.
Predicate Comparison
Comparison	EnSite™ X v1.1 and the predicate EnSite™ X v1.0.1 have the same intended use andindications for use. They use the same fundamental scientific technology to facilitatecatheter position and orientation, as well as cardiac mapping and model creation.There were no changes to the hardware. The subject device software was revised toinclude the following updates;
	Displays calculated waveforms of the optimal bipole (maximum voltage)independent of catheter orientation
	Displays activation direction arrows on maps
	Displays calculated wave speed maps
	Displays deflection direction indicators to assist in determining deflectiondirection
	Allows for exporting electrograms and electrode locations over ethernetduring a live study to a 3rd party client
	Allows more targeted map editing using the Sandpaper tool
	Expands the use case for the remote support tool EnSite™ Connect(formerly SJM Connect)
	Displays map points in real time using EnSite™ LiveView Dynamic Display
	Displays catheter visualization differently under certain scenarios
	Fixes minor known software issues (bug fixes)
	All risks were mitigated to acceptable levels. No new questions of safety oreffectiveness were raised.
Non-Clinical TestingSummary	Design verification activities were performed and met their respective acceptancecriteria to ensure that the devices in scope of this submission are safe and effective.Testing
	The EnSite™ X EP System v1.1 in scope of this submission was developed and testedin accordance with the following industry guidance documents and standards:
	Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices IEC 62304: 2015-06 Edition 1.1, Medical Device Software - SoftwareLife Cycle Processes EN ISO 14971:2019 Medical Devices – Application of RiskManagement to Medical Devices
	Types of Testing Performed – EnSite X EP System v1.1 Software Verification at unit, software and system level Performance Testing of updated feature functionality Bench studies to evaluate substantial equivalence Preclinical Validation Testing to confirm the system could meet user requirements and its intended use after modifications Human Factors Evaluations to confirm the user interface of the subject device can be used as intended by the defined user groups
Statement ofEquivalence	All subject and predicate devices have the same intended use, and same indicationsfor use. All devices operate using the same fundamental scientific technology tofacilitate catheter position and orientation, as well as cardiac mapping and modelcreation. The testing completed and submitted in this Traditional 510(k) providesobjective evidence the subject device is at least as safe and effective as the predicatedevice and that the subject device is substantially equivalent to the predicate device.

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Image /page/4/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue stylized letter 'A' on the left and the word 'Abbott' in black bold font on the right. The blue 'A' is made up of three horizontal lines, and the word 'Abbott' is in a sans-serif font.

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Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).