(25 days)
No
The document describes automated functions based on user-defined criteria and data integration, but does not mention AI or ML algorithms.
No.
The device is explicitly described as a "diagnostic tool" used for "electrophysiology studies" to map cardiac electrical activity and display catheter positions, without mention of providing direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that both the EnSite Velocity Cardiac Mapping System and the EnSite Precision Cardiac Mapping System are "suggested Diagnostic tool" and are "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 describes various hardware components like the NavLink, ArrayLink, CathLink, etc., 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 In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The EnSite systems and their modules are used in vivo (inside 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 from imaging data (CT, MR, rotational angiography) for visualization on the system.
- Interface with other systems for data exchange and display.
- Provide visualization of contact force and automatically collect mapping points or display lesion marks.
None of these functions involve the examination of specimens in vitro. The systems are tools used to visualize and analyze electrical and anatomical information directly from the patient's heart during a medical procedure.
Therefore, these devices fall under the category of medical devices used in vivo for diagnostic and procedural guidance purposes, not In Vitro Diagnostics.
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 are 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 arthythmias 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 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
DOK
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 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™ M 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.
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
Anatomical Site
Heart, specifically the 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)
Design verification activities for functional testing 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 v5.2 / EnSite Precision™ Cardiac Mapping System v2.2 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 IEC 62366:2012 Medical Devices – Part 1: Application of Usability Engineering to Medical Devices
IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 Medical Electrical Equipment-Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: electromagnetic disturbance – requirements and tests
EN ISO 14971:2012 Medical Devices – Application of Risk Management to Medical Devices
Types of Testing Performed:
System level verification testing which consisted of electrical safety and electromagnetic compatibility (EMC), basic system function, and system level accuracy.
Hardware verification testing to ensure the EnSite Cardiac Mapping System hardware continues to meet requirements following the proposed modifications
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 applicable software and firmware components meets requirements and that the system remains compatible with common electrophysiology lab equipment.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EnSite™ Velocity™ Cardiac Mapping System v5.2 (K172396)
Reference Device(s)
EnSite™ Precision™ Cardiac Mapping System v2.2 (K172396)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 19, 2018
Abbott Cody Johnson Regulatory Affairs Specialist II One St. Jude Medical Drive St. Paul, Minnesota 55177
Re: K182644
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: DOK Dated: September 20, 2018 Received: September 24, 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.
1
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 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 medical devices and radiation-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).
Sincerely,
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) K182644
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 are 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 arthythmias 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.
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
| 510(k) Information | |
|---|---|
| 510(k) Number | K182644 |
| 510(k) Type | Special 510(k) |
| Date Prepared | September 20, 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 (K172396) |
| Secondary Predicates | EnSite™ Precision™ Cardiac Mapping System v2.2 (K172396) |
| 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. |
5
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 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™ M 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.
6
| 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. |
7
| 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 are 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 | Both the subject and predicate devices 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 12-Coil
Field Frame is a hardware design change. The resulting firmware update is
required to support functionality of the new 12-Coil Field Frame.
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 for functional testing 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 v5.2 / EnSite Precision™
Cardiac Mapping System v2.2 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 IEC 62366:2012 Medical Devices – Part 1: Application of Usability Engineering to Medical Devices |
| | IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012
Medical Electrical Equipment-Part 1: General requirements for basic safety
and essential performance |
| | IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General
requirements for basic safety and essential performance – Collateral
standard: electromagnetic disturbance – requirements and tests |
| | EN ISO 14971:2012 Medical Devices – Application of Risk Management
to Medical Devices |
| | Types of Testing Performed |
| | System level verification testing which consisted of electrical safety and
electromagnetic compatibility (EMC), basic system function, and system
level accuracy. |
| | Hardware verification testing to ensure the EnSite Cardiac Mapping
System hardware continues to meet requirements following the proposed
modifications |
| | 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
applicable software and firmware components meets requirements and that
the system remains compatible with common electrophysiology lab
equipment. |
| | 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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