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.The EnSite™ X EP System TactiFlex™ Ablation Catheter Sensor Enabled™ Software Module is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.

EnSite™ X EP System, TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade and EnSite™ X EP System, TactiFlexTM Ablation Catheter, Sensor EnabledTM, Software License:

The EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™ Software Module 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 text is a 510(k) summary for the EnSite™ X EP System, which is a catheter navigation and mapping system. The submission describes a software upgrade that enables compatibility with a new ablation catheter (TactiFlex™ Ablation Catheter, Sensor Enabled™). However, it does not provide specific acceptance criteria or a detailed study proving that the device meets those acceptance criteria.

Instead of specific acceptance criteria and detailed study results, the document generally 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." It also lists various types of testing performed and the standards followed.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or explicitly stated based on the provided text:

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

The document does not provide a table of acceptance criteria with corresponding performance metrics. It indicates 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."

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

The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "Preclinical Validation Testing to confirm the system could meet user requirements and its intended use after modifications" but does not give details.

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

Not mentioned in the document.

4. Adjudication method for the test set

Not mentioned in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a "Programmable Diagnostic Computer" for electrophysiology, assisting in catheter navigation and mapping, not an AI for image interpretation or diagnosis that would typically involve human readers.

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

The document states, "Software Verification at a software and system level to test the new software features added for the display of the TactiFlex™ Ablation Catheter, Sensor Enabled™ Force Number Refresh Rate Force Direction Indicator". This indicates software-level testing, which could be considered standalone performance for the specific software features implemented. However, detailed performance metrics are not given.

7. The type of ground truth used

The document does not explicitly state the "ground truth" used for testing, but given the nature of the device (catheter navigation and mapping, force display), it would likely involve:

Engineering validation/simulations: For verifying force number refresh rates and direction indicator accuracy (implied by "Software Verification").
User requirements and intended use: For "Preclinical Validation Testing to confirm the system could meet user requirements and its intended use."
Safety standards: For "Electrical Safety Testing."

8. The sample size for the training set

The document does not mention a training set, as the changes described are software adaptations for a new catheter, rather than the development of a machine learning model that would require a training set.

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

Not applicable, as no training set is mentioned in the context of the described software upgrade.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 27, 2022

Abbott Medical Alyssa Timmers Senior Regulatory Affairs Specialist One St. Jude Medical Device St. Paul, Minnesota 55117

Re: K223094

Trade/Device Name: EnSite™ X EP System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: September 29, 2022 Received: September 30, 2022

Dear Alyssa Timmers:

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) K223094

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:

EnSite™ X EP System, TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade and EnSite™ X EP System, TactiFlexTM Ablation Catheter, Sensor EnabledTM, Software License:

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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510(k) Summary

The 510(k) Summary was drafted in accordance with 21 CFR 807.92 and is included below.

510(k) Information
510(k) Number	K223094
510(k) Type	Traditional 510(k)
Date Prepared	29 September 2022
Submitter Information
Manufacturer Name & Address	Abbott MedicalOne St. Jude Medical Drive,St. Paul, Minnesota, 55117, USAManufacturer of the EnSite™ X EP SystemAbbott 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	Alyssa TimmersSenior Regulatory Affairs Specialist651-756-3706alyssa.timmers@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 (K221213)
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'sown cardiac chamber. The system creates a model by collecting and labeling theanatomic locations within the chamber. A surface is created by moving a selectedcatheter to locations within a cardiac structure. As the catheter moves, points arecollected at and between all electrodes on the catheter. A surface is wrapped aroundthe outermost points.
Indications for Use	EnSite™ X EP SystemThe 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.
	EnSite™ X EP System, TactiFlex™ Ablation Catheter, Sensor Enabled™,Software Upgrade and Software License
	The EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™Software Module is indicated for use with the EnSite™ X EP System in accordancewith the EnSite™ X EP System indications for use.
Predicate Comparison
Comparison	The subject devices are:EnSite™ X EP System TactiFlex™ Ablation Catheter, SensorEnabled™, Software Upgrade, v2.0 andEnSite™ X EP System TactiFlex™ Ablation Catheter, SensorEnabled™, Software License.
	The subject devices are intended to be installed on the EnSite™ X EP System withversion 2.0.1 software. The predicate device is EnSite X EP System v2.0 with theContact Force License, catalog number ENSITE-CF-01 (included in the predicatesubmission).
	The subject device adds a new indication for use specific for the EnSite™ X EPSystem TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade. Thepredicate intended use and indications for use have not changed with this addition.The addition of this intended use is not critical to the intended diagnostic use of thedevice as it refers to use of the subject device in accordance with the indications foruse of the predicate device.
	The subject device adds additional user selectable settings for Force NumberRefresh Rate as compared with the predicate which has a fixed setting for this. Thisfeature is available when either a TactiCath™ Contact Force Ablation Catheter,Sensor Enabled™ or TactiFlex™ Ablation Catheter, Sensor Enabled™ areconnected.
	The predicate device displays force direction by a graphical representation and theForce Cone feature, while the subject device uses those features and adds ForceDirection Indicator arrows displayed at the catheter tip at the 3D location of thecatheter. This feature is only available when a TactiFlex™ Ablation Catheter, SensorEnabled™ is connected.
	The subject and predicate device use the same fundamental scientific technology tofacilitate catheter position and orientation, as well as cardiac mapping and modelcreation. There were no changes to the hardware. The device software was modifiedto enable compatibility with Abbott's ablation catheter, TactiFlex™ Ablation Catheter,Sensor Enabled™. All risks associated with these modifications were mitigated toacceptable levels. No new questions of safety or effectiveness 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 v2.0.1 used with the EnSite™ X EP System TactiFlex™Ablation Catheter, Sensor Enabled™, Software Upgrade and License was developedand tested in accordance with the following industry guidance documents andstandards:
	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 ISO 14971:2019 Medical Devices - Application of Risk Management toMedical Devices ANSI AAMI IEC 62366-1:2015, Medical devices - Part 1: Application ofusability engineering to medical devices IEC 60601-1: 2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 +A1:2012, Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance.
Types of Testing Performed
	Software Verification at a software and system level to test the newsoftware features added for the display of the TactiFlex™ AblationCatheter, Sensor Enabled™ Force Number Refresh Rate Force Direction Indicator Preclinical Validation Testing to confirm the system could meet userrequirements and its intended use after modifications Human Factors Evaluations to confirm the user interface of the subjectdevice can be used as intended by the defined user groups Electrical Safety Testing to ensure the system when used with theTactiFlex™ Ablation Catheter, Sensor Enabled™ continues to complywith safety standards
Statement of Equivalence	The subject and predicate devices have the same intended use, and similarindications for use. The devices operate using the same fundamental scientifictechnology to facilitate catheter position and orientation, as well as cardiac mappingand model creation. The non-clinical and clinical testing completed and submitted inthis Traditional 510(k) provides objective evidence the subject device is as safe, aseffective, and performs as well as or better than the legally marketed devicepredicate.

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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).