EnSite Velocity Cardiac Mapping System v5.2

K172396 · St Jude Medical · DQK · Apr 23, 2018 · Cardiovascular

Device Facts

• Record ID: K172396
• Device Name: EnSite Velocity Cardiac Mapping System v5.2
• Applicant: St Jude Medical
• Product Code: DQK · Cardiovascular
• Decision Date: Apr 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

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. 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.

Device Story

System uses impedance and/or magnetic sensing to track 3D position of EP catheters; displays cardiac electrical activity as waveform traces and dynamic 3D isopotential maps. Used in EP labs by physicians. Input modules (CIMs) collect signals from catheters/electrodes; convert to digital; transmit via Ethernet to display workstation (DWS). DWS processes data to generate anatomical models and maps. EnSite Precision adds magnetic tracking for field scaling, shift detection (EnGuide Stability Monitor), and respiration gating. Optional modules provide 3D segmentation (Verismo), PACS archiving (Courier), registration to CT/MR (Fusion), and contact force visualization. Output assists physicians in identifying complex arrhythmias and guiding catheter placement, potentially improving procedural accuracy and patient outcomes.

Clinical Evidence

Bench testing (functional, catheter compatibility, system accuracy, EnGuide stability) and preclinical animal studies confirmed software performance and clinical acceptability. No clinical human data reported.

Technological Characteristics

System comprises display workstation, amplifier, and accessory kits. Operates via impedance-based or hybrid impedance/magnetic sensing. Connectivity via Ethernet. Software modules include segmentation, registration, and automated mapping/marking. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 62366.

Indications for Use

Indicated for patients undergoing electrophysiology studies. Used in the right atrium for complex arrhythmias or to display position of conventional EP catheters.

Regulatory Classification

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.

Predicate Devices

• EnSite™ Velocity™ Cardiac Mapping System v5.0.1 (K160187)
• EnSite™ Precision™ Cardiac Mapping System v2.0.1 (K160210)
• AutoMark Module (K160218)

Reference Devices

• Advisor HD Grid Mapping Catheter (K172393)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.

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.

| Type of Use (Select one or both, as applicable) | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|----------------------------------------------|--|---------------------------------------------|
| <table><tr><td></td><td>Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td></td><td>Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | | 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) | | | |

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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™ 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.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> |
|----------------------------------------------|-------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <input type="checkbox"/> |

## 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.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> 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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| 510(k) Information | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K172396 |
| 510k Type | Traditional 510k |
| Date Prepared | March 15, 2018 |
| Submitter Information | |
| Manufacturer<br>Name/Address | St. Jude Medical<br>One St. Jude Medical Drive<br>St. Paul, MN 55117 |
| Contact Person | Jack Kromenhoek<br>Associate Director, Regulatory Affairs<br>[e-mail] |
| Device Information | |
| Trade Name | EnSite™ Velocity™ Cardiac Mapping System v5.2<br>EnSite 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)<br>AutoMark Module (K160218) |
| Reference Applications | Advisor HD Grid Mapping Catheter (K172393) |
| Device Description | The EnSite™ Velocity™ Cardiac Mapping System with software version 5.2 /<br>EnSite Precision™ Cardiac Mapping System with software version 2.2 is a<br>catheter navigation and mapping system capable of displaying the three-<br>dimensional (3D) position of conventional electrophysiology catheters, as well<br>as displaying cardiac electrical activity as waveform traces and as dynamic 3-D<br>isopotential maps of the cardiac chamber. The contoured surfaces of these three-<br>dimensional maps are based on the anatomy of the patient's own cardiac<br>chamber.<br><br>The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic tool<br>in electrophysiology (EP) Studies. An EP study involves the introduction of one<br>or more electrode catheters into the heart to record its electrical activity. These<br>catheters connect to the EnSite™ Velocity™ Cardiac Mapping System through<br>specialized catheter input modules (CIMs). The EnSite™ Velocity™ Cardiac<br>Mapping System v5.2 is designed for use in the EP laboratory in conjunction<br>with other equipment. |

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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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| Expansion Module<br>Device Description | The EnSite™ Velocity™ Cardiac Mapping System v5.2 includes the following<br>optional expansion software modules:<br><br>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.<br><br>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.<br><br>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.<br><br>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.<br><br>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.<br><br>6. EnSite™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user<br><br>7. 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 | <b>EnSite™ Velocity™ Cardiac Mapping System v5.2</b><br>The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies are indicated.<br>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.<br>or<br>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 |
| | <b>EnSite Precision Cardiac Mapping System v2.2</b><br>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.<br>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.<br>or<br>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. |
| | <b>EnSite™ Verismo™ Segmentation Tool</b><br>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. |
| | <b>EnSite™ Derexi™ Module</b><br>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 |
| | <b>EnSite™ Courier™ Module</b><br>When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server. |
| | <b>EnSite™ Fusion™ Registration Module</b><br>EnSite 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<br>(continued) | <b>EnSite™ Contact Force Module</b><br>When used with the SJM Contact Force Unit, the EnSite™ Contact Force<br>Module is intended to provide visualization of force information from<br>compatible catheters.<br><br><b>EnSite™ AutoMap Module</b><br>When used with the EnSite AutoMap Module, the EnSite System is intended to<br>automatically collect mapping points based on criteria set by the user<br><br><b>AutoMark Module</b><br>When used with compatible hardware, the AutoMark Module is intended to<br>automatically catalog and display various parameters associated with RF<br>information on the 3D model in real-time. |
| Submission History | No prior submissions have been made to FDA for the device that is the subject<br>of this submission. |
| Predicate Comparison | |
| Comparison | Both the subject and predicate devices operate using the same fundamental<br>scientific technology to facilitate catheter position and orientation, as well as<br>cardiac mapping and model creation. The proposed EnSite Velocity v5.2 /<br>EnSite Precision v2.2 software release is a minor level software release to<br>support the new Advisor HD Grid Catheter, Sensor Enabled (SE), disable<br>support of the VeriSense software module, address cybersecurity improvements,<br>address open anomalies, and add minor usability improvements. |
| | There are no new or increased risks that result from the proposed modifications<br>presented within the submission, and the changes do not raise any new<br>questions of safety and effectiveness in regards to the subject device. |
| Non-Clinical Testing<br>Summary | Design verification activities for functional testing were performed with their<br>respective acceptance criteria to ensure that the software modifications do not<br>affect the safety or effectiveness of the device. All testing performed met the<br>established performance specifications. |
| | <b>Testing</b> |
| | The EnSite™ Velocity™ Cardiac Mapping System v5.2 / EnSite Precision™<br>Cardiac Mapping System v2.2 software was developed and tested in accordance<br>with the following industry guidance documents and standards: |
| | - FDA Reviewers and Compliance on Off-the-Shelf Software used in<br>Medical Devices…