(258 days)
No
The document describes automated functions and data processing but does not mention AI or ML.
No.
The device is described as a diagnostic tool used for mapping cardiac electrical activity and displaying the position of catheters, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies are indicated." The "Device Description" also says, "The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic tool in electrophysiology (EP) Studies."
No
The device description explicitly states that the system "consists of hardware and software elements" and lists several hardware components like the display workstation, amplifier subsystem, and various connection modules.
Based on the provided information, the EnSite™ Velocity™ Cardiac Mapping System and its associated 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) to provide information for diagnosis, monitoring, or screening.
- Device Function: The EnSite™ Velocity™ Cardiac Mapping System and its modules are used in vivo (within the living body) to:
- Display the position of catheters within the heart.
- Display cardiac electrical activity.
- Generate and display 3D models of cardiac structures from imaging data.
- Interface with other systems for data exchange and display.
- Provide visualization of contact force and automate mapping point collection and lesion marking.
- Intended Use: The intended use clearly states that the system is a "Diagnostic tool in patients for whom electrophysiology studies are indicated" and is used "in the right atrium of patients" or to "display the position of conventional electrophysiology (EP) catheters in the heart." This describes a procedure performed directly on the patient, not on a specimen outside the body.
Therefore, the EnSite™ Velocity™ Cardiac Mapping System and its modules fall under the category of in vivo diagnostic or therapeutic devices, 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™ 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.
EnSite™ 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, rotational angiography DICOM image data (for segmentation tool only)
Anatomical Site
Heart (cardiac chambers, 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 software 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)
Reference Device(s)
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of 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.
April 23, 2018
St. Jude Medical Jack Kromenhoek Associate Director, Regulatory Affairs One St. Jude Medical Drive St. Paul, Minnesota 55117
Re: K172396
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: April 17, 2018 Received: April 18, 2018
Dear Jack Kromenhoek:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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).
Sincerely,
M.A. Hilleman
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) K172396
Device Name
EnSite™ Velocity™ 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™ 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.
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| Prescription Use (Part 21 CFR 801 Subpart D) | ||||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K172396
Device Name
EnSite™ Velocity™ Cardiac Mapping System v5.2 EnSite Precision Cardiac Mapping System v2.2
Indications for Use (Describe)
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.
EnSite™ 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a green square made up of smaller squares on the left. To the right of the square is the text "ST. JUDE MEDICAL" in a serif font.
| 510(k) Information | |
|---|---|
| 510(k) Number | K172396 |
| 510k Type | Traditional 510k |
| Date Prepared | March 15, 2018 |
| Submitter Information | |
| Manufacturer | |
| Name/Address | St. Jude Medical |
| One St. Jude Medical Drive | |
| St. Paul, MN 55117 | |
| Contact Person | Jack Kromenhoek |
| Associate Director, Regulatory Affairs | |
| Jack.kromenhoek@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 v5.0.1 (K160187) |
| Secondary Predicates | EnSite™ Precision™ Cardiac Mapping System v2.0.1 (K160210) |
| AutoMark Module (K160218) | |
| Reference Applications | Advisor HD Grid Mapping Catheter (K172393) |
| 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
Image /page/5/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a green square grid with one square tilted. To the right of the grid is the text "ST. JUDE MEDICAL" in a serif font. The text is black and appears to be a trademarked name.
Device Description The EnSite Velocity™ Cardiac Mapping System consists of hardware and software elements. The EnSite Velocity / EnSite Precision System consists of (continued) 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
Image /page/6/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a green square grid on the left and the text "St. Jude Medical" on the right. The text is in a serif font and is black.
| 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. |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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™ 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 operate using the same fundamental
scientific technology to facilitate catheter position and orientation, as well as
cardiac mapping and model creation. The proposed EnSite Velocity v5.2 /
EnSite Precision v2.2 software release is a minor level software release to
support the new Advisor HD Grid Catheter, Sensor Enabled (SE), disable
support of the VeriSense software module, address cybersecurity improvements,
address open anomalies, and add minor usability improvements. |
| | 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 software 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 software 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 2007 Medical Electrical Equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral
standard: electromagnetic disturbance – requirements and tests |
| Non-Clinical Testing
Summary
(continued) | EN ISO 14971:2012 Medical Devices – Application of Risk Management
to Medical Devices |
| | Software Documentation for a Major Level of Concern software per FDA's
Guidance Document “Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices” is included as part of this submission. |
| | The changes to the application software along with addition of software support
for the new Advisor HD Grid Mapping Catheter were evaluated through
software verification and validation to show that the application software is
acceptable for use and meets requirements. |
| | Types of Testing Performed |
| | - Software Verification testing to ensure the software continues to meet
requirements following the proposed modifications |
| | - Performance testing on the bench to cover catheter compatibility, catheter
impact, functional testing, EnGuide stability, and system accuracy |
| | - Preclinical animal studies to ensure the new version of the software is able
to be effectively installed and continues to meet its intended use following
the proposed modifications. Additionally, these studies confirm that the
overall performance of the system following the proposed modifications is
clinically acceptable. |
| | Risk Management |
| | The changes to the application software along with addition of software support
for the new Advisor HD Grid Mapping Catheter were evaluated through review
of risk management to ensure no new hazards have been introduced by this
change. |
| | The Ensite™ Velocity™ Cardiac Mapping System / EnSite Precision™ Cardiac
Mapping System conforms to Cybersecurity requirements through the
cybersecurity risk management process comprised of a risk assessment, risk
control, and maintenance of cybersecurity activities. |
| 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/7/Picture/1 description: The image shows the St. Jude Medical logo. The logo consists of a green square grid with a rotated square in the middle. To the right of the grid is the text "ST. JUDE MEDICAL" in a serif font.
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Image /page/8/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a green square grid on the left side. To the right of the grid is the text "ST. Jude Medical" in a serif font.
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Image /page/9/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a green square grid on the left and the text "ST. JUDE MEDICAL" on the right. The grid is made up of smaller squares, with one square slightly rotated. The text is in a serif font and is all capitalized.