(29 days)
N/A
No
The document describes automated functions like "AutoMap" and "AutoMark" based on user-defined criteria and data from other systems, but it does not mention any learning or adaptive capabilities characteristic of AI/ML.
No
Explanation: The device is consistently described as a "diagnostic tool" and a "catheter navigation and mapping system" used to display cardiac electrical activity and catheter positions. Its intended uses involve identifying complex arrhythmias and displaying catheter positions, which are diagnostic functions, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that the EnSite™ Velocity™ Cardiac Mapping System and the EnSite Precision™ Cardiac Mapping System are "suggested Diagnostic tool in patients for whom electrophysiology studies have been indicated." The "Device Description" also refers to the EnSite™ Velocity™ Cardiac Mapping System as being "used as a diagnostic tool in electrophysiology (EP) Studies."
No
The device description explicitly states that the EnSite Velocity / EnSite Precision System consists of both hardware and software elements, including a display workstation subsystem and an amplifier subsystem. It also mentions various hardware components like NavLink, ArrayLink, CathLink, GenConnect, RecordConnect, and the EnSite Precision Module hardware.
Based on the provided information, the EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac Mapping System v2.2, along with their various modules, are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The EnSite systems are used in vivo (within the body) during electrophysiology studies. They are used to:
- Display the position of catheters within the heart.
- Display cardiac electrical activity as waveforms and 3D maps.
- Generate 3D models of cardiac structures from imaging data.
- Interface with other systems for data exchange and display.
- Provide visualization of contact force and automatically collect mapping points.
- Intended Use: The intended use clearly states they are "suggested Diagnostic tool in patients for whom electrophysiology studies have been indicated." This refers to a diagnostic procedure performed directly on the patient, not on a specimen.
- Device Description: The description details the hardware and software used to interact with catheters inserted into the heart and collect electrical signals from the patient.
While the system is used for diagnosis, it does so by interacting directly with the patient's body and electrical activity, not by analyzing specimens in vitro. The modules that process imaging data (CT, MR, etc.) are also used to create models for in vivo navigation and mapping, not for analyzing the images themselves as a standalone diagnostic test on a specimen.
N/A
Intended Use / Indications for 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 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™ 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™ 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The EnSite™ Velocity™ Cardiac Mapping System with software version 5.2 / EnSite Precision™ Cardiac Mapping System with software version 2.2 is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber.
The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic tool in electrophysiology (EP) Studies. An EP study involves the introduction of one or more electrode catheters into the heart to record its electrical activity. These catheters connect to the EnSite™ Velocity™ Cardiac Mapping System through specialized catheter input modules (CIMs). The EnSite™ Velocity™ Cardiac Mapping System v5.2 is designed for use in the EP laboratory in conjunction with other equipment.
The EnSite Velocity™ Cardiac Mapping System consists of hardware and software elements. The EnSite Velocity / EnSite Precision System consists of software, a display workstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS Power Kit), and an amplifier subsystem (Amplifier and Amplifier Accessory Kit). The DWS houses the system software and connects all the components together. The amplifier contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software. Its primary function is to collect and transmit via Ethernet the electrical data detected from the patient. The amplifier accepts signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the workstation for processing.
The NavLink connects surface electrodes and the system reference surface electrode to the Amplifier. The ArrayLink connects the EnSite Array Multi-electrode 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 position 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 Device Description
The EnSite™ Velocity™ Cardiac Mapping System v5.2 includes the following optional expansion software modules:
- EnSite™ Verismo™ Segmentation Tool - an optional expansion module used in generating 3D models from CT, MR or rotational angiography DICOM image data and displaying images on the EnSite™ Velocity™ Cardiac Mapping System. The EnSite™ Verismo™ Segmentation Tool accepts DICOM images from CT and MRI scanners and converts the images into a 3D model of cardiac structures.
- EnSite™ Derexi™ Module - an optional expansion module that that allows the EnSite Velocity System to interface with the WorkMate™ Recording System to support the exchange of mapping point data and patient setup information between the two systems.
- EnSite™ Courier™ Module - The EnSite™ Courier™ Module is an optional expansion module that allows the EnSite™ Velocity™ Cardiac Mapping System to communicate with the hospital PACS (Picture Archiving and Communication System) server for the purposes of storing and retrieving patient data in DICOM format.
- EnSite™ Fusion™ Registration Module - an optional expansion module that provides non-fluoroscopic navigation, mapping, and labeling on a Digital Image Fusion (DIF) model. The module is used with the EnSite™ NavX™ Navigation and Visualization Technology Surface Electrode Kit and CT or MR scans segmented into a compatible file format. 3D models created from digital images from CT and MRI data can be imported onto the EnSite™ Velocity™ System.
- EnSite™ Contact Force Module - an optional expansion module that provides the display of information from the TactiSys Quartz System. The EnSite Velocity System's EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.
- EnSite™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user
- AutoMark Module - module allows the user to set parameters and the software automatically displays the lesion marks on the EnSite Velocity model during RF ablation. The user set parameters is based on data from Ensite™ Contact Force Module, the Ampere Generator, and the WorkMate Claris™ System which is displayed on the AutoMark Module as lesion marks on the during RF ablation. The color, size, and ranges of the AutoMark are defined by the user.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, rotational angiography DICOM image data
Anatomical Site
Heart (cardiac chambers, right atrium)
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)
No new non-clinical testing was completed, nor relied upon, in support of this Special 510(k) submission.
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.
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.
N/A
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).
0
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December 12, 2018
Abbott Cody Johnson Regulatory Affairs Specialist II One St. Jude Medical Drive St. Paul, Minnesota 55117
Re: K183128
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: November 9, 2018 Received: November 13, 2018
Dear Cody Johnson:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv
Mude Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183128
Device Name
EnSite™ VelocityTM 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 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™ 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™ 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.
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)
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| 510(k) Information | |
|---|---|
| 510(k) Number | K183128 |
| 510(k) Type | Special 510(k) |
| Date Prepared | November 9, 2018 |
| Submitter Information | |
| Manufacturer | |
| Name/Address | Abbott |
| One St. Jude Medical Drive | |
| St. Paul, MN 55117 | |
| Contact Person | Cody Johnson |
| Regulatory Affairs Specialist II | |
| cody.johnson@abbott.com | |
| Device Information | |
| Trade Name | EnSite™ Velocity™ Cardiac Mapping System v5.2 |
| 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 v5.2 (K182644) |
| Secondary Predicates | EnSite™ Precision™ Cardiac Mapping System v2.2 (K182644) |
| Reference Applications | N/A |
| Device Description | The EnSite™ Velocity™ Cardiac Mapping System with software version 5.2 / |
| EnSite Precision™ Cardiac Mapping System with software version 2.2 is a | |
| catheter navigation and mapping system capable of displaying the three- | |
| dimensional (3D) position of conventional electrophysiology catheters, as well | |
| as displaying cardiac electrical activity as waveform traces and as dynamic 3-D | |
| isopotential maps of the cardiac chamber. The contoured surfaces of these three- | |
| dimensional maps are based on the anatomy of the patient's own cardiac | |
| chamber. |
The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic tool
in electrophysiology (EP) Studies. An EP study involves the introduction of one
or more electrode catheters into the heart to record its electrical activity. These
catheters connect to the EnSite™ Velocity™ Cardiac Mapping System through
specialized catheter input modules (CIMs). The EnSite™ Velocity™ Cardiac
Mapping System v5.2 is designed for use in the EP laboratory in conjunction
with other equipment. |
| Device Description
(continued) | The EnSite Velocity™ Cardiac Mapping System consists of hardware and
software elements. The EnSite Velocity / EnSite Precision System consists of
software, a display workstation (DWS) subsystem (DWS, Monitors, DWS
Accessory Kit, and DWS Power Kit), and an amplifier subsystem (Amplifier
and Amplifier Accessory Kit). The DWS houses the system software and
connects all the components together. The amplifier contains electronic
circuitry and firmware responsible for collecting and transmitting the electrical
signal data of the patient to the DWS software. Its primary function is to collect
and transmit via Ethernet the electrical data detected from the patient. The
amplifier accepts signals from NavLink, ArrayLink, CathLink, ECG Cable,
RecordConnect, and GenConnect, converts these signals to a digital format, and
sends them to the workstation for processing. |
| | The NavLink connects surface electrodes and the system reference surface
electrode to the Amplifier. The ArrayLink connects the EnSite Array Multi-
electrode 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 position 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
Device Description | The EnSite™ Velocity™ Cardiac Mapping System v5.2 includes the following optional expansion software modules: |
| 1. | EnSite™ Verismo™ Segmentation Tool - an optional expansion module used in generating 3D models from CT, MR or rotational angiography DICOM image data and displaying images on the EnSite™ Velocity™ Cardiac Mapping System. The EnSite™ Verismo™ Segmentation Tool accepts DICOM images from CT and MRI scanners and converts the images into a 3D model of cardiac structures. |
| 2. | EnSite™ Derexi™ Module - an optional expansion module that that allows the EnSite Velocity System to interface with the WorkMate™ Recording System to support the exchange of mapping point data and patient setup information between the two systems. |
| 3. | EnSite™ Courier™ Module - The EnSite™ Courier™ Module is an optional expansion module that allows the EnSite™ Velocity™ Cardiac Mapping System to communicate with the hospital PACS (Picture Archiving and Communication System) server for the purposes of storing and retrieving patient data in DICOM format. |
| 4. | EnSite™ Fusion™ Registration Module - an optional expansion module that provides non-fluoroscopic navigation, mapping, and labeling on a Digital Image Fusion (DIF) model. The module is used with the EnSite™ NavX™ Navigation and Visualization Technology Surface Electrode Kit and CT or MR scans segmented into a compatible file format. 3D models created from digital images from CT and MRI data can be imported onto the EnSite™ Velocity™ System. |
| 5. | EnSite™ Contact Force Module - an optional expansion module that provides the display of information from the TactiSys Quartz System. The EnSite Velocity System's EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters. |
| 6. | EnSite™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the 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 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 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 v2.2 |
| | 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 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 | No prior submissions have been made to FDA for the device that is the subject
of this submission. |
| 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 labeling modifications to the subject device
pertain to warnings only. The labeling modifications include removal of the
black box warning from the cover of the Instructions for Use as well as the
addition of a warning in the warnings section of the Instructions for Use.
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 | No new non-clinical testing was completed, nor relied upon, in support of this
Special 510(k) submission. |
| | Risk Management
The changes to the EnSite™ Velocity™ Cardiac Mapping System / EnSite
Precision™ Cardiac Mapping System were 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 devices are the same as the predicate
devices. Based on this and the data provided in this pre-market notification, the
subject devices and predicate devices have been demonstrated to be
substantially equivalent. |
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Image /page/5/Picture/1 description: The image shows the Abbott logo. The logo consists of a stylized blue letter 'a' on the left and the word 'Abbott' in black bold font on the right. The blue 'a' symbol is a modern, abstract design, and the word 'Abbott' is easily readable.
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Image /page/6/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue stylized letter "a" on the left and the word "Abbott" in black bold font on the right. The blue "a" is a rounded square shape with a horizontal line through the middle.
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Image /page/7/Picture/1 description: The image shows the logo for Abbott. The logo consists of a blue, stylized letter "a" on the left and the word "Abbott" in black, bold font on the right. The blue "a" is made up of three horizontal lines connected by a vertical line on the left side.
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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 logo is simple and modern, and it is easily recognizable.