EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System

K201181 · ABBOTT MEDICAL · DQK · Jun 26, 2020 · Cardiovascular

Device Facts

• Record ID: K201181
• Device Name: EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
• 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: 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: 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™M 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 realtime. 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; physician-operated. Inputs: electrical signals from EP catheters via specialized input modules; magnetic data from MediGuide/Precision modules; DICOM images (CT/MR/angiography) for 3D modeling. Operation: processes impedance and/or magnetic data to visualize catheter position, cardiac electrical activity, and 3D isopotential maps. Outputs: real-time 3D cardiac models, waveform traces, and catheter navigation data. Modules provide additional functionality: Verismo (segmentation), Derexi (EP system interface), Courier (PACS archiving), Fusion (anatomic registration), Contact Force (force visualization), AutoMap (automated point collection), and AutoMark (RF lesion cataloging). Output assists physicians in identifying complex arrhythmias and guiding catheter placement; benefits include improved visualization and procedural efficiency.

Clinical Evidence

Bench testing only. Design verification activities included packaging (visual inspection, bubble leak, seal strength), shelf life (gel adhesion, impedance, capacitance, stability, temperature, current dispersion, cable pullout), and electrical safety/nominal design verification. No clinical data presented.

Technological Characteristics

System comprises display workstation (DWS), amplifier subsystem, and specialized catheter input modules. Operates via impedance-only or impedance-plus-magnetic sensing. Connectivity via Ethernet. Software modules include segmentation, PACS communication, and registration. Complies with EN ISO 14971:2012.

Indications for Use

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

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 v5.6 and EnSite Precision™ Cardiac Mapping System (K183128)

Submission Summary (Full Text)

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June 26, 2020

Abbott Medical Charlie Pickrell Regulatory Affairs Specialist II 5050 Nathan Lane North Nathan Lane North, Minnesota 55442

## Re: K201181

Trade/Device Name: EnSite Velocity Cardiac Mapping System, and EnSite Precision Cardiac Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: April 30, 2020 Received: April 30, 2020

Dear Charlie Pickrell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([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

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# Indications for Use

510(k) Number (if known) K201181

#### Device Name

EnSite™ VelocityTM Cardiac Mapping System EnSite Precision™ Cardiac Mapping System

Indications for Use (Describe) EnSite Velocity Cardiac Mapping System:

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:

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™M 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.

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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 realtime.

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)

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| 510(k) Information | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K201181 |
| 510(k) Type | Traditional 510(k) |
| Date Prepared | 30 April 2020 |
| Submitter Information | |
| Manufacturer Name<br>& Address | Abbott Medical<br>One St. Jude Medical Drive,<br>St. Paul, Minnesota, 55119, USA |
| Contact Person | Charlie Pickrell<br>Regulatory Affairs Specialist<br>651-756-3130<br>[e-mail] |
| Device Information: | |
| Trade Name | EnSite Velocity Cardiac Mapping System and EnSite PrecisionTM Cardiac Mapping System |
| Common Name | Programmable Diagnostic Computer |
| Class | II |
| Classification Name | 870.1425, computer, diagnostic, programmable |
| Product Code | DQK |
| Predicate Device | EnSite Velocity Cardiac Mapping System v5.6 and EnSite PrecisionTM Cardiac Mapping<br>System (K183128) |
| Reference Device | Not Applicable |
| Device Description | The EnSiteTM VelocityTM Cardiac Mapping System / EnSite PrecisionTM Cardiac Mapping<br>System is a catheter navigation and mapping system capable of displaying the three-<br>dimensional (3D) position of conventional electrophysiology catheters, as well as displaying<br>cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the<br>cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the<br>anatomy of the patient's own cardiac chamber.<br><br>The EnSiteTM VelocityTM 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 EnSiteTM VelocityTM Cardiac Mapping System through specialized catheter input<br>modules (CIMs). The EnSiteTM VelocityTM Cardiac Mapping System is designed for use in<br>the EP laboratory in conjunction with other equipment.<br><br>The EnSite VelocityTM Cardiac Mapping System consists of hardware and software<br>elements. The EnSite Velocity / EnSite Precision System consists of software, a display<br>workstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS Power<br>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<br>signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, |
| Device Description | converts these signals to a digital format, and sends them to the workstation for processing. |
| (continued) | |
| | 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 EnSite™ Velocity™ Cardiac Mapping System base software only<br>collects impedance data. Adding EnSite Precision™ software to the base software allows the<br>system to receive both magnetic data from the MediGuide™ Technology System or the<br>EnSite Precision™ Module hardware and impedance data when using magnetic sensor<br>enabled tools. The EnSite Precision™ Module and EnSite Precision™ software (added to<br>the base software) together make up the EnSite Precision™ Cardiac Mapping System. |
| | The EnSite Precision™ software interfaces to the MediGuide Technology System or the<br>EnSite Precision™ Module to collect magnetic position and orientation information. The<br>EnSite Precision™ 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 Enabled™ (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 Precision™ Module consists of hardware to support magnetic navigation. The<br>hardware components consist of the EnSite Precision™ Link, EnSite Precision™ Field<br>Frame, and EnSite Precision™ Patient Reference Sensors. |
| Expansion Module | The EnSite Precision Cardiac Mapping System includes the following optional expansion |
| Device Description | software modules:<br>1. EnSite™ Verismo™ 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 EnSite™ Velocity™ Cardiac Mapping System. The EnSite™<br>Verismo™ Segmentation Tool accepts DICOM images from CT and MRI scanners and<br>converts the images into a 3D model of cardiac structures. |
| | 2. EnSite™ Derexi™ Module - an optional expansion module that that allows the EnSite<br>Velocity System to interface with the WorkMate™ Recording System to support the<br>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<br>module that allows the EnSite™ Velocity™ 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. |
| Expansion Module | 4. EnSite™ Fusion™ 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 EnSite™ NavX™ Navigation and Visualization Technology<br>Surface Electrode Kit and CT or MR scans segmented into a compatible file format. 3D<br>models created from digital images from CT and MRI data can be imported onto the<br>EnSite™ Velocity™ System. |
| Device Description<br>(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 |
| | The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool in patients for<br>whom electrophysiology studies have been indicated. When used with EnSite™ Array<br>Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the<br>right atrium of patients with complex arrhythmias that may be difficult to identify using<br>conventional mapping system alone. |
| | or |
| | When used with the EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™<br>Cardiac Mapping System is intended to display the position of conventional<br>electrophysiology (EP) catheters in the heart. |
| | EnSite Precision™ Cardiac Mapping System |
| | The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients<br>for whom electrophysiology studies have been indicated. The EnSite Precision™ System<br>interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module<br>to combine and display magnetic processed patient positioning and navigation mapping<br>information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™<br>Cardiac Mapping System is intended to be used in the right atrium of patients with complex<br>arrhythmias that may be difficult to identify using conventional mapping systems alone. |
| | or…