(57 days)
Not Applicable
No
The document describes a cardiac mapping system with various modules for data acquisition, processing, and visualization. While it performs complex tasks like 3D model generation, registration, and automatic point collection, there is no mention of AI or ML algorithms being used for these functions. The "AutoMap" and "AutoMark" modules are described as using user-defined criteria and parameters, not learned patterns or models.
No
Explanation: The device is described as a "diagnostic tool" and a "catheter navigation and mapping system" used in electrophysiology studies to display the position of catheters and cardiac electrical activity. Its purpose is to help identify complex arrhythmias, not to treat them.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state multiple times that the EnSite™ Velocity™ Cardiac Mapping System and EnSite Precision™ Cardiac Mapping System are "suggested diagnostic tool" and "used as a diagnostic tool in electrophysiology (EP) Studies." The system is designed to display cardiac electrical activity and create 3D maps based on the patient's anatomy, which aids in diagnosing arrhythmias.
No
The device description explicitly states that the system consists of both hardware and software elements, including a display workstation subsystem and an amplifier subsystem. While there are software modules, the core system is not software-only.
Based on the provided information, the EnSite™ Velocity™ Cardiac Mapping System and its associated modules are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The EnSite™ Velocity™ Cardiac Mapping System and its modules are used for in vivo procedures. They are used to map the electrical activity and position of catheters within the patient's heart. While they process data derived from the patient, they do not analyze specimens taken from the patient.
- Intended Use: The intended use clearly states that the system is a "suggested diagnostic tool in patients for whom electrophysiology studies have been indicated." Electrophysiology studies are performed directly on the patient.
- Device Description: The device description details the system's function in collecting and displaying electrical signals and catheter positions within the heart.
- Input Data: While the EnSite Verismo Segmentation Tool and EnSite Fusion Registration Module use image data (CT, MR, rotational angiography), this data is used to create anatomical models for navigation and visualization during the in vivo procedure, not for analyzing specimens.
Therefore, the EnSite™ Velocity™ Cardiac Mapping System and its modules fall under the category of medical devices used for in vivo diagnostic and procedural guidance, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The EnSiteTM VelocityTM Cardiac Mapping System / EnSite PrecisionTM Cardiac Mapping System 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 EnSiteTM VelocityTM 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 EnSiteTM VelocityTM Cardiac Mapping System through specialized catheter input modules (CIMs). The EnSiteTM VelocityTM Cardiac Mapping System is designed for use in the EP laboratory in conjunction with other equipment.
The EnSite VelocityTM 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™ 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 Precision Cardiac Mapping System 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, rotational angiography DICOM image data
Anatomical Site
Heart, specifically the right atrium and four individual cardiac chambers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
EP laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification activities were performed with their respective acceptance criteria to ensure that the proposed modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications.
Testing performed:
- Packaging (Visual Inspection, Bubble Leak Test, Pouch Seal Strength)
- Shelf Life (Electrode Gel Adhesion, Electrode Impedance & Capacitance, Impedance Stability, Electrode Temperature & Current Dispersion, Cable Pullout, Electrode Identification)
- Animal Testing
- Nominal Design Verification
- Impedance Tests
- Electrical Safety
- Adhesion Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EnSite Velocity Cardiac Mapping System v5.6 and EnSite PrecisionTM Cardiac Mapping System (K183128)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Applicable
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) 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.
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 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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Image /page/4/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue square with a stylized "a" inside, followed by the word "Abbott" in black, bold font. The logo is simple and modern, and the colors are eye-catching.
| 510(k) Information | |
|---|---|
| 510(k) Number | K201181 |
| 510(k) Type | Traditional 510(k) |
| Date Prepared | 30 April 2020 |
| Submitter Information | |
| Manufacturer Name | |
| & Address | Abbott Medical |
| One St. Jude Medical Drive, | |
| St. Paul, Minnesota, 55119, USA | |
| Contact Person | Charlie Pickrell |
| Regulatory Affairs Specialist | |
| 651-756-3130 | |
| Charlie.pickrell@abbott.com | |
| 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 |
| System (K183128) | |
| Reference Device | Not Applicable |
| Device Description | The EnSiteTM VelocityTM Cardiac Mapping System / EnSite PrecisionTM Cardiac Mapping |
| System 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 EnSiteTM VelocityTM 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 EnSiteTM VelocityTM Cardiac Mapping System through specialized catheter input
modules (CIMs). The EnSiteTM VelocityTM Cardiac Mapping System is designed for use in
the EP laboratory in conjunction with other equipment.
The EnSite VelocityTM 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, |
| 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
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™ 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. |
| Expansion Module | The EnSite Precision Cardiac Mapping System includes the following optional expansion |
| Device Description | 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. |
| | 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. |
| Expansion Module | 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. |
| Device Description
(continued) | 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 user. |
| | 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 | 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 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. |
| | 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 |
| | 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™ 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. |
| Indications for Use
(continued) | EnSite™ Contact Force Module |
| | When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is |
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| 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. | |||||
| Submission History | Pre-sub submission Q191312 was completed with the FDA on August 29th, 2019. | ||||
| Predicate Comparison | |||||
| Comparison | Both the subject and predicate devices have the same intended use, indications for use, and | ||||
| operate using the same fundamental scientific technology to facilitate catheter position and | |||||
| orientation, as well as cardiac mapping and model creation. The proposed EnSite Velocity | |||||
| Surface Electrode Kit and the EnSite Precision Surface Electrode Kit have been tested to | |||||
| equivalent hardware and electrical requirements as the predicate and have been found met | |||||
| all testing requirements. | |||||
| There are no new or increased risks that result from the proposed modifications presented | |||||
| within the submission, and the changes do not raise any new questions of safety and | |||||
| effectiveness in regards to the subject device. | |||||
| Non-Clinical Testing | |||||
| Summary | Design verification activities were performed with their respective acceptance criteria to | ||||
| ensure that the proposed modifications do not affect the safety or effectiveness of the device. | |||||
| All testing performed met the established performance specifications. | |||||
| Testing | |||||
| The EnSite Velocity Cardiac Mapping System and the EnSite Precision Cardiac Mapping | |||||
| System was developed and tested in accordance with the following industry guidance | |||||
| documents and standards: | |||||
| Guidance for the Content of Premarket Submissions for Software Contained in Medical |
Devices | | | | |
| | Content of Premarket Submissions for Management of Cybersecurity in Medical
Devices: Guidance for Industry and Food and Drug Administration Staff | | | | |
| | EN ISO 14971:2012 Medical Devices – Application of Risk Management to Medical
Devices | | | | |
| | Types of Testing Performed | | | | |
| | Packaging
-
| | | | |
| | Visual Inspection
O | | | | |
| | Bubble Leak Test
O | | | | |
| | Pouch Seal Strength
O | | | | |
| | Shelf Life
-
| | | | |
| | Electrode Gel Adhesion
O | | | | |
| | Electrode Impedance & Capacitance
O | | | | |
| Non-Clinical Testing | Impedance Stability
O | | | | |
| Summary | Electrode Temperature & Current Dispersion
O | | | | |
| (continued) | Cable Pullout
O | | | | |
| | Electrode Identification
O | | | | |
| | Animal Testing
-
| | | | |
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Image /page/8/Picture/1 description: The image shows the Abbott logo. The logo consists of a stylized letter "a" in blue, followed by the word "Abbott" in black. The letter "a" is designed with rounded corners and a gap in the upper right, giving it a modern and abstract appearance.
| ○ | Design Validation | |
|---|---|---|
| – | Nominal Design Verification | |
| ○ | Impedance Tests | |
| ○ | Electrical Safety | |
| ○ | Adhesion Testing | |
| Risk Management | ||
| The changes to the EnSite Velocity™ Cardiac Mapping System and the EnSite Precision™ | ||
| Cardiac Mapping System was evaluated through review of risk management to ensure no | ||
| new hazards have been introduced by this change. | ||
| Statement of | ||
| Equivalence | The technological characteristics for the subject device, and the indications for use are the | |
| same as the predicate device. Based on this and the data provided in this pre-market | ||
| notification, the subject device and predicate device have been demonstrated to be | ||
| substantially equivalent. |