EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License

K201148 · ABBOTT MEDICAL · DQK · Jun 26, 2020 · Cardiovascular

Device Facts

• Record ID: K201148
• Device Name: EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License
• Applicant: ABBOTT MEDICAL
• Product Code: DQK · Cardiovascular
• Decision Date: Jun 26, 2020
• 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 have been indicated. When used with the EnSite™ Array™ Catheter, the EnSite™ 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™ 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 v2.6: The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™M 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 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. 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 Story

System functions as diagnostic tool in EP labs; processes electrical signals from catheters via input modules (CIMs) to display 3D cardiac maps and waveform traces. Operates via impedance or combined impedance/magnetic tracking (Precision configuration). Includes modules for: 3D segmentation (Verismo), data synchronization (Derexi), PACS archiving (Courier), image fusion (Fusion), contact force visualization, and automated point collection/lesion marking (AutoMap/AutoMark). Physician uses system to navigate catheters, identify complex arrhythmias, and guide ablation procedures. Real-time visualization aids clinical decision-making during cardiac interventions.

Clinical Evidence

Bench testing included software verification and design validation studies. An acute system-level animal study was performed to ensure performance of the modified system. No human clinical data presented.

Technological Characteristics

System comprises display workstation (DWS), monitors, and amplifier subsystem. Connectivity via Ethernet. Operates using impedance-based or combined impedance/magnetic navigation. Software modules include segmentation, registration, and automated mapping/marking. Complies with EN ISO 62304 for software lifecycle processes.

Indications for Use

Indicated for patients undergoing electrophysiology studies. Used for 3D visualization/mapping of cardiac electrical activity and catheter positioning. Specific modules support complex arrhythmia identification in the right atrium, 3D model generation from medical imaging, data synchronization with recording systems, PACS archiving, and visualization of contact force/RF ablation parameters.

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 v5.2 and EnSite Precision™ Cardiac Mapping System v2.2 (K183128)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for 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 FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

June 26, 2020

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

Re: K201148

Trade/Device Name: EnSite Precision™ Cardiac Mapping System v2.6 EnSite™ Velocity™ Cardiac Mapping System v5.2 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: April 28, 2020 Received: April 29, 2020

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 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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mark Fellman 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K201148

#### Device Name

EnSite Precision™ Cardiac Mapping System v2.6 EnSite™ Velocity™ Cardiac Mapping System v5.2

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 have been indicated.

When used with the EnSite™ Array™ Catheter, the EnSite™ 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™ 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 v2.6:

The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™M 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.

{3}------------------------------------------------

EnSite™ Fusion™ Registration Module:

EnSite Fusion is indicated for registering the EnSite 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.

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)

X 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.*

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 [e-mail]

"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."

{4}------------------------------------------------

# Traditional 510(k)
EnSite Precision™ Cardiac Mapping System

Image /page/4/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue abstract symbol on the left and the word "Abbott" in black bold font on the right. The symbol is made up of three horizontal lines that are connected on the left side.

| 510(k) Information | | |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K201148 | |
| 510(k) Type | Traditional 510(k) | |
| Date Prepared | 28 April 2020 | |
| Submitter Information | | |
| Manufacturer Name<br>& Address | Abbott Medical<br>One St. Jude Medical Drive,<br>St. Paul, Minnesota, 55119, USA | |
| Contact Person | Alyssa Timmers<br>Regulatory Affairs Specialist<br>651-756-3706<br>[e-mail] | |
| Device Information | | |
| Trade Name | EnSite Precision™ Cardiac Mapping System v2.6<br>EnSite™ Velocity™ Cardiac Mapping System v5.2 | |
| Common Name | Programmable Diagnostic Computer | |
| Class | II | |
| Classification Name | 870.1425, computer, diagnostic, programmable | |
| Product Code | DQK | |
| Predicate Device | EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac<br>Mapping System v2.2 (K183128) | |
| Reference Device | Not Applicable | |
| Device Description | The EnSite™ Velocity™ Cardiac Mapping System v5.2 / EnSite Precision™ Cardiac<br>Mapping System v2.6 is a catheter navigation and mapping system capable of displaying the<br>three-dimensional (3D) position of conventional electrophysiology catheters, as well as<br>displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential<br>maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are<br>based on the anatomy of the patient's own cardiac chamber.<br><br>The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic tool in<br>electrophysiology (EP) Studies. An EP study involves the introduction of one or more<br>electrode catheters into the heart to record its electrical activity. These catheters connect to<br>the EnSite™ Velocity™ Cardiac Mapping System through specialized catheter input<br>modules (CIMs). The EnSite™ Velocity™ Cardiac Mapping System is designed for use in<br>the EP laboratory in conjunction with other equipment.<br><br>The EnSite™ Velocity™ Cardiac Mapping System consists of hardware and software<br>elements. The EnSite™ Velocity™ / EnSite Precision™ System consists of software, a<br>display workstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS<br>Power Kit), and an amplifier subsystem (Amplifier and Amplifier Accessory Kit). The DWS<br>houses the system software and connects all the components together. The amplifier<br>contains electronic circuitry and firmware responsible for collecting and transmitting the<br>electrical signal data of the patient to the DWS software. Its primary function is to collect<br>and transmit via Ethernet the electrical data detected from the patient. The amplifier accepts | |
| Device Description | signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, | |
| (continued) | 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<br>Amplifier. The ArrayLink connects the EnSite Array Multielectrode Diagnostic Catheter to<br>the Amplifier. It also has a connection for an auxiliary unipolar reference electrode. The<br>CathLink connects the diagnostic catheters to the Amplifier. The GenConnect connects the<br>ablation catheter and dispersive surface electrodes to the Amplifier. The RecordConnect<br>allows simultaneous connection for catheters and surface ECG to a recording system and to<br>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<br>configuration. The EnSiteTM VelocityTM Cardiac Mapping System base software only<br>collects impedance data. Adding EnSite PrecisionTM software to the base software allows the<br>system to receive both magnetic data from the MediGuideTM Technology System or the EnSite PrecisionTM Module hardware and impedance data when using magnetic sensor<br>enabled tools. The EnSite PrecisionTM Module and EnSite PrecisionTM software (added to<br>the base software) together make up the EnSite PrecisionTM Cardiac Mapping System. | |
| | The EnSite PrecisionTM software interfaces to the MediGuideTM Technology System or the<br>EnSite PrecisionTM Module to collect magnetic position and orientation information. The<br>EnSite PrecisionTM software uses the magnetic data for magnetic field scaling (NavX SE),<br>shift detection (EnGuide Stability Monitor), and respiration gating. NavX SE field scaling<br>adjusts the dimensions of the navigation field based on both the positon and orientation of<br>magnetic sensors and the electrodes on Sensor EnabledTM (SE) tools, optimizing the<br>appearance of the model. The system uses EnGuide Stability Monitor to notify the user of a<br>potential shift based on a correlation of magnetic and impedance locations when using any<br>Sensor Enabled catheter. The system uses respiration gating to compensate to the end-point<br>of the respiration cycle using magnetic data to determine respiration phase. | |
| | The EnSite PrecisionTM Module consists of hardware to support magnetic navigation. The<br>hardware components consist of the EnSite PrecisionTM Link, EnSite PrecisionTM Field<br>Frame, and EnSite PrecisionTM Patient Reference Sensors. | |
| Expansion Module<br>Device Description | The EnSite PrecisionTM Cardiac Mapping System v2.6 includes the following optional<br>expansion software modules: | |
| | 1. EnSiteTM VerismoTM Segmentation Tool - an optional expansion module used in<br>generating 3D models from CT, MR or rotational angiography DICOM image data and<br>displaying images on the EnSiteTM VelocityTM Cardiac Mapping System. The EnSiteTM<br>VerismoTM Segmentation Tool accepts DICOM images from CT and MRI scanners and<br>converts the images into a 3D model of cardiac structures. | |
| | 2. EnSiteTM DerexiTM Module - an optional expansion module that that allows the EnSite<br>Velocity System to interface with the WorkMateTM Recording System to support the<br>exchange of mapping point data and patient setup information between the two systems. | |
| | 3. EnSiteTM CourierTM Module - The EnSiteTM CourierTM Module is an optional expansion<br>module that allows the EnSiteTM VelocityTM Cardiac Mapping System to communicate with<br>the hospital PACS (Picture Archiving and Communication System) server for the purposes<br>of storing and retrieving patient data in DICOM format. | |
| | 4. EnSiteTM FusionTM Registration Module - an optional expansion module that provides<br>non-fluoroscopic navigation, mapping, and labeling on a Digital Image Fusion (DIF) model.<br>The module is used with the EnSiteTM NavXTM Navigation and Visualization Technology<br>Surface Electrode Kit and CT or MR scans segmented into a compatible file format. 3D | |
| Expansion Module<br>Device Description | models created from digital images from CT and MRI data can be imported onto the<br>EnSite™ Velocity™ System. | |
| (continued) | 5. EnSite™ Contact Force Module - an optional expansion module that provides the<br>display of information from the TactiSys Quartz System. The EnSite Velocity System's<br>EnSite Contact Force Module is intended to provide visualization of force information from<br>compatible catheters. | |
| | 6. EnSite™ AutoMap Module - an optional module that automatically collects mapping<br>points based on criteria set by the user. | |
| | 7. AutoMark Module - module allows the user to set parameters and the software<br>automatically displays the lesion marks on the EnSite Velocity model during RF ablation.<br>The user set parameters is based on data from Ensite™ Contact Force Module, the Ampere<br>Generator, and the WorkMate Claris™ System which is displayed on the AutoMark Module<br>as lesion marks on the during RF ablation. The color, size, and ranges of the AutoMark are<br>defined by the user. | |
| Indications for Use | EnSite™ Velocity™ Cardiac Mapping System v5.2: | |
| | The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients<br>for whom electrophysiology studies have been indicated. |…