The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies are indicated.
When used with EnSite Array Catheter, the EnSite Velocity Cardiac Mapping System is intended to be used in the right atrium of patients with complex arthythmias that may be difficult to identify using conventional mapping system alone.
Or
When used with the EnSite Velocity Surface Electrode Kit, the EnSite Velocity Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart

EnSite Precision Cardiac Mapping System v2.2:
The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
or
When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

EnSite™ Verismo™ Segmentation Tool: The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.

EnSite™ Derexi™ Module: When used with EnSite Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™ System / WorkMate Claris™ System for synchronizing and display of patient information.

EnSite™ Courier™ Module: When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.

EnSite™ Fusion™ Registration Module: EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.

EnSite™ Contact Force Module: When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ AutoMap Module: When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user.

EnSite™ AutoMark Module: When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.

Device Description

The EnSite™ Velocity™ Cardiac Mapping System with software version 5.2 / EnSite Precision™ Cardiac Mapping System with software version 2.2 is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber.

The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic tool in electrophysiology (EP) Studies. An EP study involves the introduction of one or more electrode catheters into the heart to record its electrical activity. These catheters connect to the EnSite™ Velocity™ Cardiac Mapping System through specialized catheter input modules (CIMs). The EnSite™ Velocity™ Cardiac Mapping System v5.2 is designed for use in the EP laboratory in conjunction with other equipment.

The EnSite Velocity™ Cardiac Mapping System consists of hardware and software elements. The EnSite Velocity / EnSite Precision System consists of software, a display workstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS Power Kit), and an amplifier subsystem (Amplifier and Amplifier Accessory Kit). The DWS houses the system software and connects all the components together. The amplifier contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software. Its primary function is to collect and transmit via Ethernet the electrical data detected from the patient. The amplifier accepts signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the workstation for processing. The NavLink connects surface electrodes and the system reference surface electrode to the Amplifier. The ArrayLink connects the EnSite Array Multielectrode Diagnostic Catheter to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode. The CathLink connects the diagnostic catheters to the Amplifier. The GenConnect connects the ablation catheter and dispersive surface electrodes to the Amplifier. The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier. The ECG cable connects standard ECG electrodes to the Amplifier. The system operates using impedance only or impedance plus magnetics based upon its configuration. The EnSite™ Velocity™ Cardiac Mapping System base software only collects impedance data. Adding EnSite Precision™ software to the base software allows the system to receive both magnetic data from the MediGuide™ Technology System or the EnSite Precision™ Module hardware and impedance data when using magnetic sensor enabled tools. The EnSite Precision™ Module and EnSite Precision™ software (added to the base software) together make up the EnSite Precision™ Cardiac Mapping System. The EnSite Precision™ software interfaces to the MediGuide Technology System or the EnSite Precision™ M Module to collect magnetic position and orientation information. The EnSite Precision™ software uses the magnetic data for magnetic field scaling (NavX SE), shift detection (EnGuide Stability Monitor), and respiration gating. NavX SE field scaling adjusts the dimensions of the navigation field based on both the positon and orientation of magnetic sensors and the electrodes on Sensor Enabled™ (SE) tools, optimizing the appearance of the model. The system uses EnGuide Stability Monitor to notify the user of a potential shift based on a correlation of magnetic and impedance locations when using any Sensor Enabled catheter. The system uses respiration gating to compensate to the end-point of the respiration cycle using magnetic data to determine respiration phase. The EnSite Precision™ Module consists of hardware to support magnetic navigation. The hardware components consist of the EnSite Precision™ Link, EnSite Precision™ Field Frame, and EnSite Precision™ Patient Reference Sensors.

The EnSite™ Velocity™ Cardiac Mapping System v5.2 includes the following optional expansion software modules:

EnSite™ Verismo™ Segmentation Tool - an optional expansion module used in generating 3D models from CT, MR or rotational angiography DICOM image data and displaying images on the EnSite™ Velocity™ Cardiac Mapping System. The EnSite™ Verismo™ Segmentation Tool accepts DICOM images from CT and MRI scanners and converts the images into a 3D model of cardiac structures.
EnSite™ Derexi™ Module - an optional expansion module that that allows the EnSite Velocity System to interface with the WorkMate™ Recording System to support the exchange of mapping point data and patient setup information between the two systems.
EnSite™ Courier™ Module - The EnSite™ Courier™ Module is an optional expansion module that allows the EnSite™ Velocity™ Cardiac Mapping System to communicate with the hospital PACS (Picture Archiving and Communication System) server for the purposes of storing and retrieving patient data in DICOM format.
EnSite™ Fusion™ Registration Module - an optional expansion module that provides non-fluoroscopic navigation, mapping, and labeling on a Digital Image Fusion (DIF) model. The module is used with the EnSite™ NavX™ Navigation and Visualization Technology Surface Electrode Kit and CT or MR scans segmented into a compatible file format. 3D models created from digital images from CT and MRI data can be imported onto the EnSite™ Velocity™ System.
EnSite™ Contact Force Module - an optional expansion module that provides the display of information from the TactiSys Quartz System. The EnSite Velocity System's EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.
EnSite™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user
AutoMark Module - module allows the user to set parameters and the software automatically displays the lesion marks on the EnSite Velocity model during RF ablation. The user set parameters is based on data from Ensite™ Contact Force Module, the Ampere Generator, and the WorkMate Claris™ System which is displayed on the AutoMark Module as lesion marks on the during RF ablation. The color, size, and ranges of the AutoMark are defined by the user.

AI/ML Overview

This document describes the regulatory submission (K172396) for the EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac Mapping System v2.2. The submission is a Traditional 510(k) and focuses on minor software updates and support for a new catheter. The key takeaway regarding acceptance criteria and study data is that this submission primarily relies on non-clinical software verification and validation, performance testing, and preclinical animal studies, rather than large-scale clinical trials involving human experts for ground truth establishment.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance

The document states that "Design verification activities for functional testing were performed with their respective acceptance criteria to ensure that the software modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." However, specific numerical acceptance criteria and reported device performance values are not explicitly detailed in the provided text. The general statement indicates that all criteria were met.

The device is a "Programmable Diagnostic Computer" for cardiac mapping. The performance is assessed based on:

Catheter compatibility
Catheter impact
Functional testing
EnGuide stability
System accuracy
Effective installation and continued intended use of the software version
Overall clinically acceptable performance (from preclinical animal studies)

Since the document does not provide a table with specific numerical acceptance criteria and performance metrics, it's not possible to create one. The general acceptance criterion is that the software updates and new catheter support do not adversely affect the safety or effectiveness and meet established performance specifications.

Study Details

Given the nature of this submission (minor software update to an existing device, supporting a new catheter), the studies are primarily non-clinical.

A table of acceptance criteria and the reported device performance:
- As mentioned above, specific numerical acceptance criteria and performance data are not provided in this document. The submission states that all testing performed met the established performance specifications.
Sample sized used for the test set and the data provenance:
- Test Set (Non-Clinical): The document refers to "software verification and validation," "performance testing on the bench," and "preclinical animal studies."
  - Software Verification/Validation & Performance Testing: The exact sample sizes (e.g., number of test cases, number of bench tests) are not specified.
  - Preclinical Animal Studies: The sample size (number of animals) is not specified.
- Data Provenance: The studies were conducted as part of the regulatory submission process for St. Jude Medical (now Abbott). The location of the testing is not specified, but it would typically be conducted at the manufacturer's facilities or a contract research organization. The studies are prospective as they were conducted to support this specific regulatory submission for the updated device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For non-clinical software and performance testing, "ground truth" is typically established by comparing the device's output against known, pre-defined correct behaviors or physical measurements using validated reference standards. This does not involve "experts" in the sense of clinicians interpreting patient data.
- For the preclinical animal studies, the "ground truth" would be established by the animal study protocols, surgical procedures, and direct physiological measurements, assessed by veterinary and scientific personnel involved in the study. The number and qualifications of such experts are not specified in the document. This is not a human-in-the-loop clinical study requiring expert readers for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Given that this is primarily non-clinical testing (software verification, bench testing, animal studies), traditional clinical adjudication methods (like 2+1 reader consensus for image interpretation) are not applicable and not mentioned. Results would be evaluated against engineering specifications and veterinary assessments.
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, an MRMC comparative effectiveness study was not done. The document describes updates to a cardiac mapping system, which is a diagnostic tool, but not an AI-assisted diagnostic imaging system in the sense that would typically require an MRMC study to show human reader improvement. The updates are to the system's core mapping and navigation capabilities, and its interoperability, not directly to an AI component for image interpretation requiring human reader evaluation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The software updates and new catheter support were evaluated for their standalone performance (e.g., software verification, bench testing to ensure system accuracy and stability, and animal studies to confirm proper function). The "algorithm only" performance would be part of the "functional testing" and "system accuracy" mentioned. Specific standalone performance metrics or studies are not detailed beyond the general statements that testing met specifications.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For software verification and bench testing: The ground truth is based on engineering specifications, expected software behavior, physical measurements from laboratory equipment, and established hardware/software interface standards.
- For preclinical animal studies: Ground truth is established through direct physiological data collection, procedural observations, and possibly post-mortem analysis in the animal models, as per the study protocol.
- There is no mention of "expert consensus," "pathology," or "outcomes data" from human subjects for establishing ground truth in this particular submission.
The sample size for the training set:
- The document does not mention a training set in the context of machine learning or AI models. This submission is for updates to a pre-existing cardiac mapping system, not the initial development or a significant AI component that would require a distinct "training set." The testing described is verification and validation of software changes and new hardware compatibility.
How the ground truth for the training set was established:
- Since no training set for a machine learning/AI model is mentioned, this question is not applicable to the information provided.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 23, 2018

St. Jude Medical Jack Kromenhoek Associate Director, Regulatory Affairs One St. Jude Medical Drive St. Paul, Minnesota 55117

Re: K172396

Trade/Device Name: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: April 17, 2018 Received: April 18, 2018

Dear Jack Kromenhoek:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Hilleman

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) K172396

Device Name

EnSite™ Velocity™ Cardiac Mapping System v5.2 EnSite Precision Cardiac Mapping System v2.2

Indications for Use (Describe) EnSite™ Velocity™ Cardiac Mapping System v5.2:

The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies are indicated.

When used with EnSite™ Array Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arthythmias that may be difficult to identify using conventional mapping system alone.

When used with the EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart

EnSite Precision Cardiac Mapping System v2.2:

The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K172396

Device Name

EnSite™ Velocity™ Cardiac Mapping System v5.2 EnSite Precision Cardiac Mapping System v2.2

Indications for Use (Describe)

EnSite™ Courier™ Module: When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.

EnSite™ Contact Force Module: When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ AutoMap Module: When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a green square made up of smaller squares on the left. To the right of the square is the text "ST. JUDE MEDICAL" in a serif font.

510(k) Information
510(k) Number	K172396
510k Type	Traditional 510k
Date Prepared	March 15, 2018
Submitter Information
ManufacturerName/Address	St. Jude MedicalOne St. Jude Medical DriveSt. Paul, MN 55117
Contact Person	Jack KromenhoekAssociate Director, Regulatory AffairsJack.kromenhoek@abbott.com
Device Information
Trade Name	EnSite™ Velocity™ Cardiac Mapping System v5.2EnSite Precision™ Cardiac Mapping System v2.2
Common Name	Programmable Diagnostic Computer
Class	II
Classification Name	870.1425, computer, diagnostic, programmable
Product Code	DQK
Predicate Device	EnSite™ Velocity™ Cardiac Mapping System v5.0.1 (K160187)
Secondary Predicates	EnSite™ Precision™ Cardiac Mapping System v2.0.1 (K160210)AutoMark Module (K160218)
Reference Applications	Advisor HD Grid Mapping Catheter (K172393)
Device Description	The EnSite™ Velocity™ Cardiac Mapping System with software version 5.2 /EnSite Precision™ Cardiac Mapping System with software version 2.2 is acatheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as wellas displaying cardiac electrical activity as waveform traces and as dynamic 3-Disopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiacchamber.The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic toolin electrophysiology (EP) Studies. An EP study involves the introduction of oneor more electrode catheters into the heart to record its electrical activity. Thesecatheters connect to the EnSite™ Velocity™ Cardiac Mapping System throughspecialized catheter input modules (CIMs). The EnSite™ Velocity™ CardiacMapping System v5.2 is designed for use in the EP laboratory in conjunctionwith other equipment.

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Image /page/5/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a green square grid with one square tilted. To the right of the grid is the text "ST. JUDE MEDICAL" in a serif font. The text is black and appears to be a trademarked name.

Device Description The EnSite Velocity™ Cardiac Mapping System consists of hardware and software elements. The EnSite Velocity / EnSite Precision System consists of (continued) software, a display workstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS Power Kit), and an amplifier subsystem (Amplifier and Amplifier Accessory Kit). The DWS houses the system software and connects all the components together. The amplifier contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software. Its primary function is to collect and transmit via Ethernet the electrical data detected from the patient. The amplifier accepts signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the workstation for processing. The NavLink connects surface electrodes and the system reference surface electrode to the Amplifier. The ArrayLink connects the EnSite Array Multielectrode Diagnostic Catheter to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode. The CathLink connects the diagnostic catheters to the Amplifier. The GenConnect connects the ablation catheter and dispersive surface electrodes to the Amplifier. The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier. The ECG cable connects standard ECG electrodes to the Amplifier. The system operates using impedance only or impedance plus magnetics based upon its configuration. The EnSite™ Velocity™ Cardiac Mapping System base software only collects impedance data. Adding EnSite Precision™ software to the base software allows the system to receive both magnetic data from the MediGuide™ Technology System or the EnSite Precision™ Module hardware and impedance data when using magnetic sensor enabled tools. The EnSite Precision™ Module and EnSite Precision™ software (added to the base software) together make up the EnSite Precision™ Cardiac Mapping System. The EnSite Precision™ software interfaces to the MediGuide Technology System or the EnSite Precision™ M Module to collect magnetic position and orientation information. The EnSite Precision™ software uses the magnetic data for magnetic field scaling (NavX SE), shift detection (EnGuide Stability Monitor), and respiration gating. NavX SE field scaling adjusts the dimensions of the navigation field based on both the positon and orientation of magnetic sensors and the electrodes on Sensor Enabled™ (SE) tools, optimizing the appearance of the model. The system uses EnGuide Stability Monitor to notify the user of a potential shift based on a correlation of magnetic and impedance locations when using any Sensor Enabled catheter. The system uses respiration gating to compensate to the end-point of the respiration cycle using magnetic data to determine respiration phase. The EnSite Precision™ Module consists of hardware to support magnetic navigation. The hardware components consist of the EnSite Precision™ Link, EnSite Precision™ Field Frame, and EnSite Precision™ Patient Reference Sensors.

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Image /page/6/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a green square grid on the left and the text "St. Jude Medical" on the right. The text is in a serif font and is black.

Expansion ModuleDevice Description	The EnSite™ Velocity™ Cardiac Mapping System v5.2 includes the followingoptional expansion software modules:1. EnSite™ Verismo™ Segmentation Tool - an optional expansion module used in generating 3D models from CT, MR or rotational angiography DICOM image data and displaying images on the EnSite™ Velocity™ Cardiac Mapping System. The EnSite™ Verismo™ Segmentation Tool accepts DICOM images from CT and MRI scanners and converts the images into a 3D model of cardiac structures.2. EnSite™ Derexi™ Module - an optional expansion module that that allows the EnSite Velocity System to interface with the WorkMate™ Recording System to support the exchange of mapping point data and patient setup information between the two systems.3. EnSite™ Courier™ Module - The EnSite™ Courier™ Module is an optional expansion module that allows the EnSite™ Velocity™ Cardiac Mapping System to communicate with the hospital PACS (Picture Archiving and Communication System) server for the purposes of storing and retrieving patient data in DICOM format.4. EnSite™ Fusion™ Registration Module - an optional expansion module that provides non-fluoroscopic navigation, mapping, and labeling on a Digital Image Fusion (DIF) model. The module is used with the EnSite™ NavX™ Navigation and Visualization Technology Surface Electrode Kit and CT or MR scans segmented into a compatible file format. 3D models created from digital images from CT and MRI data can be imported onto the EnSite™ Velocity™ System.5. EnSite™ Contact Force Module - an optional expansion module that provides the display of information from the TactiSys Quartz System. The EnSite Velocity System's EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.6. EnSite™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user7. AutoMark Module - module allows the user to set parameters and the software automatically displays the lesion marks on the EnSite Velocity model during RF ablation. The user set parameters is based on data from Ensite™ Contact Force Module, the Ampere Generator, and the WorkMate Claris™ System which is displayed on the AutoMark Module as lesion marks on the during RF ablation. The color, size, and ranges of the AutoMark are defined by the user.
Indications for Use	EnSite™ Velocity™ Cardiac Mapping System v5.2The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies are indicated.When used with EnSite™ Array Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping system alone.orWhen used with the EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart
	EnSite Precision Cardiac Mapping System v2.2The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information.When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.orWhen used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
	EnSite™ Verismo™ Segmentation ToolThe EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.
	EnSite™ Derexi™ ModuleWhen used with EnSite Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™ System / WorkMate Claris™ System for synchronizing and display of patient information
	EnSite™ Courier™ ModuleWhen used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.
	EnSite™ Fusion™ Registration ModuleEnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers
Indications for Use(continued)	EnSite™ Contact Force ModuleWhen used with the SJM Contact Force Unit, the EnSite™ Contact ForceModule is intended to provide visualization of force information fromcompatible catheters.EnSite™ AutoMap ModuleWhen used with the EnSite AutoMap Module, the EnSite System is intended toautomatically collect mapping points based on criteria set by the userAutoMark ModuleWhen used with compatible hardware, the AutoMark Module is intended toautomatically catalog and display various parameters associated with RFinformation on the 3D model in real-time.
Submission History	No prior submissions have been made to FDA for the device that is the subjectof this submission.
Predicate Comparison
Comparison	Both the subject and predicate devices operate using the same fundamentalscientific technology to facilitate catheter position and orientation, as well ascardiac mapping and model creation. The proposed EnSite Velocity v5.2 /EnSite Precision v2.2 software release is a minor level software release tosupport the new Advisor HD Grid Catheter, Sensor Enabled (SE), disablesupport of the VeriSense software module, address cybersecurity improvements,address open anomalies, and add minor usability improvements.
	There are no new or increased risks that result from the proposed modificationspresented within the submission, and the changes do not raise any newquestions of safety and effectiveness in regards to the subject device.
Non-Clinical TestingSummary	Design verification activities for functional testing were performed with theirrespective acceptance criteria to ensure that the software modifications do notaffect the safety or effectiveness of the device. All testing performed met theestablished performance specifications.
	Testing
	The EnSite™ Velocity™ Cardiac Mapping System v5.2 / EnSite Precision™Cardiac Mapping System v2.2 software was developed and tested in accordancewith the following industry guidance documents and standards:
	- FDA Reviewers and Compliance on Off-the-Shelf Software used inMedical Devices
	- Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices
	- Content of Premarket Submissions for Management of Cybersecurity inMedical Devices: Guidance for Industry and Food and DrugAdministration Staff
	- IEC 62366:2012 Medical Devices - Part 1: Application of Usability
	Engineering to Medical Devices
	- IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012Medical Electrical Equipment-Part 1: General requirements for basic safetyand essential performance
	- IEC 60601-1-2 2007 Medical Electrical Equipment - Part 1-2: Generalrequirements for basic safety and essential performance - Collateralstandard: electromagnetic disturbance – requirements and tests
Non-Clinical TestingSummary(continued)	EN ISO 14971:2012 Medical Devices – Application of Risk Managementto Medical Devices
	Software Documentation for a Major Level of Concern software per FDA'sGuidance Document “Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices” is included as part of this submission.
	The changes to the application software along with addition of software supportfor the new Advisor HD Grid Mapping Catheter were evaluated throughsoftware verification and validation to show that the application software isacceptable for use and meets requirements.
	Types of Testing Performed
	- Software Verification testing to ensure the software continues to meetrequirements following the proposed modifications
	- Performance testing on the bench to cover catheter compatibility, catheterimpact, functional testing, EnGuide stability, and system accuracy
	- Preclinical animal studies to ensure the new version of the software is ableto be effectively installed and continues to meet its intended use followingthe proposed modifications. Additionally, these studies confirm that theoverall performance of the system following the proposed modifications isclinically acceptable.
	Risk Management
	The changes to the application software along with addition of software supportfor the new Advisor HD Grid Mapping Catheter were evaluated through reviewof risk management to ensure no new hazards have been introduced by thischange.
	The Ensite™ Velocity™ Cardiac Mapping System / EnSite Precision™ CardiacMapping System conforms to Cybersecurity requirements through thecybersecurity risk management process comprised of a risk assessment, riskcontrol, and maintenance of cybersecurity activities.
Statement ofEquivalence	The technological characteristics for the devices are the same as the predicatedevices. Based on this and the data provided in this pre-market notification, thesubject devices and predicate devices have been demonstrated to besubstantially equivalent.

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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).