(58 days)
Not Applicable
No
The document describes a cardiac mapping system with various modules for data acquisition, processing, and visualization. While it includes features like automatic point collection and lesion marking based on user-defined criteria and external data, there is no mention of AI or ML algorithms being used for tasks like pattern recognition, prediction, or complex data analysis beyond standard signal processing and visualization. The "AutoMap" and "AutoMark" modules appear to be rule-based or threshold-based automation rather than AI/ML driven.
No
The device is described as a "diagnostic tool" for "cardiac mapping" and displaying patient information. It primarily aids in identifying and understanding complex arrhythmias, guiding EP catheters, and visualizing cardiac structures. There is no mention of it treating or altering any medical conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the EnSite Velocity Cardiac Mapping System and EnSite Precision Cardiac Mapping System are "suggested diagnostic tool in patients for whom electrophysiology studies have been indicated." Additionally, the "Device Description" section reiterates that the system is "used as a diagnostic tool in electrophysiology (EP) Studies."
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. It also mentions various hardware components like NavLink, ArrayLink, CathLink, etc., and the EnSite Precision™ Module hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Function: The EnSite™ Velocity™ / EnSite Precision™ Cardiac Mapping System is a catheter navigation and mapping system. It works by displaying the position of catheters within the heart and visualizing the heart's electrical activity. While it is a "diagnostic tool," it does not analyze specimens in vitro. It is used in vivo during electrophysiology studies.
- Intended Use: The intended use clearly states it is for use in patients for whom electrophysiology studies have been indicated, and for displaying the position of catheters in the heart.
- Device Description: The description details hardware and software that interact with catheters and surface electrodes placed on or in the patient, not with patient specimens in a laboratory setting.
Therefore, the EnSite™ Velocity™ / EnSite Precision™ Cardiac Mapping System is a medical device used for in vivo diagnostic procedures, not an In Vitro Diagnostic device.
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 the EnSite™ Array™ Catheter, the EnSite™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
or
When used with an EnSite™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
EnSite Precision™ Cardiac Mapping System v2.6:
The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™M Module to combine and display magnetic processed patient positioning and navigation mapping information.
When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
Or
When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
EnSite™ Verismo™ Segmentation Tool:
The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.
EnSite™ Derexi™ Module:
When used with EnSite™ Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™ System / WorkMate Claris™ System for synchronizing and display of patient information.
EnSite™ Courier™ Module:
When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.
EnSite™ Fusion™ Registration Module:
EnSite Fusion is indicated for registering the EnSite Navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.
EnSite™ Contact Force Module:
When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.
EnSite™ AutoMap Module:
When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user.
AutoMark Module:
When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The EnSite™ Velocity™ Cardiac Mapping System v5.2 / EnSite Precision™ Cardiac Mapping System v2.6 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 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 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 EnSiteTM VelocityTM Cardiac Mapping System base software only collects impedance data. Adding EnSite PrecisionTM software to the base software allows the system to receive both magnetic data from the MediGuideTM Technology System or the EnSite PrecisionTM Module hardware and impedance data when using magnetic sensor enabled tools. The EnSite PrecisionTM Module and EnSite PrecisionTM software (added to the base software) together make up the EnSite PrecisionTM Cardiac Mapping System.
The EnSite PrecisionTM software interfaces to the MediGuideTM Technology System or the EnSite PrecisionTM Module to collect magnetic position and orientation information. The EnSite PrecisionTM 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 EnabledTM (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 PrecisionTM Module consists of hardware to support magnetic navigation. The hardware components consist of the EnSite PrecisionTM Link, EnSite PrecisionTM Field Frame, and EnSite PrecisionTM Patient Reference Sensors.
Expansion Module Device Description:
-
EnSiteTM VerismoTM 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 EnSiteTM VelocityTM Cardiac Mapping System. The EnSiteTM VerismoTM Segmentation Tool accepts DICOM images from CT and MRI scanners and converts the images into a 3D model of cardiac structures.
-
EnSiteTM DerexiTM Module - an optional expansion module that that allows the EnSite Velocity System to interface with the WorkMateTM Recording System to support the exchange of mapping point data and patient setup information between the two systems.
-
EnSiteTM CourierTM Module - The EnSiteTM CourierTM Module is an optional expansion module that allows the EnSiteTM VelocityTM 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.
-
EnSiteTM FusionTM 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 EnSiteTM NavXTM 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
Anatomical Site
Right atrium, cardiac chamber, heart, 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.
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.
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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
June 26, 2020
Abbott Medical Alyssa Timmers Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, Minnesota 55117
Re: K201148
Trade/Device Name: EnSite Precision™ Cardiac Mapping System v2.6 EnSite™ Velocity™ Cardiac Mapping System v5.2 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: April 28, 2020 Received: April 29, 2020
Dear Alyssa Timmers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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) K201148
Device Name
EnSite Precision™ Cardiac Mapping System v2.6 EnSite™ Velocity™ Cardiac Mapping System v5.2
Indications for Use (Describe) EnSite™ Velocity™ Cardiac Mapping System v5.2:
The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
When used with the EnSite™ Array™ Catheter, the EnSite™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
or
When used with an EnSite™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
EnSite Precision™ Cardiac Mapping System v2.6:
The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™M Module to combine and display magnetic processed patient positioning and navigation mapping information.
When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
Or
When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
EnSite™ Verismo™ Segmentation Tool:
The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.
EnSite™ Derexi™ Module:
When used with EnSite™ Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™ System / WorkMate Claris™ System for synchronizing and display of patient information.
EnSite™ Courier™ Module:
When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.
3
EnSite™ Fusion™ Registration Module:
EnSite Fusion is indicated for registering the EnSite Navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.
EnSite™ Contact Force Module:
When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.
EnSite™ AutoMap Module:
When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user.
AutoMark Module:
When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Traditional 510(k)
EnSite Precision™ Cardiac Mapping System
Image /page/4/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue abstract symbol on the left and the word "Abbott" in black bold font on the right. The symbol is made up of three horizontal lines that are connected on the left side.
| 510(k) Information | ||
|---|---|---|
| 510(k) Number | K201148 | |
| 510(k) Type | Traditional 510(k) | |
| Date Prepared | 28 April 2020 | |
| Submitter Information | ||
| Manufacturer Name | ||
| & Address | Abbott Medical | |
| One St. Jude Medical Drive, | ||
| St. Paul, Minnesota, 55119, USA | ||
| Contact Person | Alyssa Timmers | |
| Regulatory Affairs Specialist | ||
| 651-756-3706 | ||
| alyssa.timmers@abbott.com | ||
| Device Information | ||
| Trade Name | EnSite Precision™ Cardiac Mapping System v2.6 | |
| EnSite™ Velocity™ Cardiac Mapping System v5.2 | ||
| Common Name | Programmable Diagnostic Computer | |
| Class | II | |
| Classification Name | 870.1425, computer, diagnostic, programmable | |
| Product Code | DQK | |
| Predicate Device | EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac | |
| Mapping System v2.2 (K183128) | ||
| Reference Device | Not Applicable | |
| Device Description | The EnSite™ Velocity™ Cardiac Mapping System v5.2 / EnSite Precision™ Cardiac | |
| Mapping System v2.6 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 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 | |
| Device Description | signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, | |
| (continued) | converts these signals to a digital format, and sends them to the workstation for processing. | |
| | The NavLink connects surface electrodes and the system reference surface electrode to the
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 EnSiteTM VelocityTM Cardiac Mapping System base software only
collects impedance data. Adding EnSite PrecisionTM software to the base software allows the
system to receive both magnetic data from the MediGuideTM Technology System or the EnSite PrecisionTM Module hardware and impedance data when using magnetic sensor
enabled tools. The EnSite PrecisionTM Module and EnSite PrecisionTM software (added to
the base software) together make up the EnSite PrecisionTM Cardiac Mapping System. | |
| | The EnSite PrecisionTM software interfaces to the MediGuideTM Technology System or the
EnSite PrecisionTM Module to collect magnetic position and orientation information. The
EnSite PrecisionTM 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 EnabledTM (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 PrecisionTM Module consists of hardware to support magnetic navigation. The
hardware components consist of the EnSite PrecisionTM Link, EnSite PrecisionTM Field
Frame, and EnSite PrecisionTM Patient Reference Sensors. | |
| Expansion Module
Device Description | The EnSite PrecisionTM Cardiac Mapping System v2.6 includes the following optional
expansion software modules: | |
| | 1. EnSiteTM VerismoTM 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 EnSiteTM VelocityTM Cardiac Mapping System. The EnSiteTM
VerismoTM Segmentation Tool accepts DICOM images from CT and MRI scanners and
converts the images into a 3D model of cardiac structures. | |
| | 2. EnSiteTM DerexiTM Module - an optional expansion module that that allows the EnSite
Velocity System to interface with the WorkMateTM Recording System to support the
exchange of mapping point data and patient setup information between the two systems. | |
| | 3. EnSiteTM CourierTM Module - The EnSiteTM CourierTM Module is an optional expansion
module that allows the EnSiteTM VelocityTM 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. EnSiteTM FusionTM 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 EnSiteTM NavXTM Navigation and Visualization Technology
Surface Electrode Kit and CT or MR scans segmented into a compatible file format. 3D | |
| Expansion Module
Device Description | models created from digital images from CT and MRI data can be imported onto the
EnSite™ Velocity™ System. | |
| (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 v5.2: | |
| | The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients
for whom electrophysiology studies have been indicated. | |
| | When used with the EnSite™ Array™ Catheter, the EnSite™ 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 systems alone. | |
| | or | |
| | When used with an 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 v2.6: | |
| | The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients
for whom electrophysiology studies have been indicated. | |
| | The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or
the EnSite Precision™ 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. | |
| Indications for Use | EnSite™ Courier™ Module: | |
| (continued) | 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. | |
| 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 EnSite Precision
Cardiac Mapping System v2.6 software release is a minor level software release to enable
implementation of a software feature, EnSite LiveView, which provides the users the ability
to display real-time mapping data without the need to save mapping points, addresses open
software anomalies, and improves the system's ability to limit personally identifiable
information when archiving studies. | |
| | 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 Precision Cardiac Mapping System v2.6 was developed and tested in accordance
with the following industry guidance documents and standards: | |
| | FDA Reviewers and Compliance on Off-the-Shelf Software used in Medical Devices | |
| | 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 62304 Edition 1.1 2015-06 Medical Device Software - Software Life Cycle
Processes |
| | | Types of Testing Performed |
| | - | Software verification testing to ensure the software continues to meet requirements
following the proposed modifications |
| | - | Design validation studies to ensure the installation process for updating the software
meets requirements |
| | - | An acute system level animal study to ensure the modified system had acceptable
performance |
| Non-Clinical Testing
Summary | | |
| (continued) | | Risk Management |
| | | The changes to 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. |
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