(57 days)
EnSite™ Velocity™ Cardiac Mapping System: The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. When used with the EnSite™ Array™ Catheter, the EnSite™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR When used with an EnSite™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
EnSite Precision Cardiac Mapping System: The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™M Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
EnSite Verismo Segmentation Tool: The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.
EnSite Derexi Module: When used with EnSite Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™M System / WorkMate Claris™ System for synchronizing and display of patient information.
EnSite Courier Module: When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.
EnSite Fusion Registration Module: EnSite Fusion is indicated for registering the EnSite Navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.
EnSite Contact Force Module: When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.
EnSite AutoMap Module: When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user AutoMark Module When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in realtime.
AutoMark Module: When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.
The EnSiteTM VelocityTM Cardiac Mapping System / EnSite PrecisionTM Cardiac Mapping System is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber. The EnSiteTM VelocityTM Cardiac Mapping System is used as a diagnostic tool in electrophysiology (EP) Studies. An EP study involves the introduction of one or more electrode catheters into the heart to record its electrical activity. These catheters connect to the EnSiteTM VelocityTM Cardiac Mapping System through specialized catheter input modules (CIMs). The EnSiteTM VelocityTM Cardiac Mapping System is designed for use in the EP laboratory in conjunction with other equipment. The EnSite VelocityTM Cardiac Mapping System consists of hardware and software elements. The EnSite Velocity / EnSite Precision System consists of software, a display workstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS Power Kit), and an amplifier subsystem (Amplifier and Amplifier Accessory Kit). The DWS houses the system software and connects all the components together. The amplifier contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software. Its primary function is to collect and transmit via Ethernet the electrical data detected from the patient. The amplifier accepts signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the workstation for processing. The NavLink connects surface electrodes and the system reference surface electrode to the Amplifier. The ArrayLink connects the EnSite Array Multielectrode Diagnostic Catheter to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode. The CathLink connects the diagnostic catheters to the Amplifier. The GenConnect connects the ablation catheter and dispersive surface electrodes to the Amplifier. The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier. The ECG cable connects standard ECG electrodes to the Amplifier. The system operates using impedance only or impedance plus magnetics based upon its configuration. The EnSite™ Velocity™ Cardiac Mapping System base software only collects impedance data. Adding EnSite Precision™ software to the base software allows the system to receive both magnetic data from the MediGuide™ Technology System or the EnSite Precision™ Module hardware and impedance data when using magnetic sensor enabled tools. The EnSite Precision™ Module and EnSite Precision™ software (added to the base software) together make up the EnSite Precision™ Cardiac Mapping System. The EnSite Precision™ software interfaces to the MediGuide Technology System or the EnSite Precision™ Module to collect magnetic position and orientation information. The EnSite Precision™ software uses the magnetic data for magnetic field scaling (NavX SE), shift detection (EnGuide Stability Monitor), and respiration gating. NavX SE field scaling adjusts the dimensions of the navigation field based on both the positon and orientation of magnetic sensors and the electrodes on Sensor Enabled™ (SE) tools, optimizing the appearance of the model. The system uses EnGuide Stability Monitor to notify the user of a potential shift based on a correlation of magnetic and impedance locations when using any Sensor Enabled catheter. The system uses respiration gating to compensate to the end-point of the respiration cycle using magnetic data to determine respiration phase. The EnSite Precision™ Module consists of hardware to support magnetic navigation. The hardware components consist of the EnSite Precision™ Link, EnSite Precision™ Field Frame, and EnSite Precision™ Patient Reference Sensors.
The provided document does not contain information regarding the acceptance criteria or a study proving the device meets those criteria for an AI/ML-driven medical device.
The document is a 510(k) premarket notification for the Abbott EnSite Velocity Cardiac Mapping System and EnSite Precision Cardiac Mapping System. This device is described as a cardiac mapping and navigation system, used to display the 3D position of electrophysiology catheters and cardiac electrical activity.
The "Non-Clinical Testing Summary" section (pages 7-8) details various types of performance and safety tests conducted, such as:
- Packaging tests (Visual Inspection, Bubble Leak Test, Pouch Seal Strength)
- Shelf Life tests (Electrode Gel Adhesion, Electrode Impedance & Capacitance, Impedance Stability, Electrode Temperature & Current Dispersion)
- Cable Pullout
- Electrode Identification
- Design Validation (Nominal Design Verification, Impedance Tests, Electrical Safety, Adhesion Testing)
- Risk Management
However, these are standard engineering and product validation tests for medical devices, focusing on the physical and electrical performance of the system and its components. There is no mention of:
- Any AI/ML components within the device for which acceptance criteria would typically involve performance metrics like sensitivity, specificity, accuracy, or other clinically relevant measures derived from a test set.
- A "study that proves the device meets the acceptance criteria" in the context of an AI/ML product's clinical performance against ground truth.
- Specific quantitative acceptance criteria for algorithm-driven performance.
- Details about a test set, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
- Information on training sets or how ground truth for a training set was established.
The "EnSite Verismo Segmentation Tool," "EnSite AutoMap Module," and "AutoMark Module" are mentioned as optional expansion modules, with "EnSite Verismo" generating 3D models from DICOM images and "AutoMap" automatically collecting mapping points based on user criteria, and "AutoMark" displaying lesion marks based on user parameters and other system data. While these modules involve some level of automation or processing, the document does not treat them as AI/ML systems requiring a specific clinical validation study against diagnostic ground truth. The testing mentioned appears to be functional and safety testing, not statistical performance validation of an AI model's output.
Therefore, I cannot populate the table or answer the specific questions related to AI/ML acceptance criteria and studies based on the provided document. The device in this submission does not appear to be an AI/ML device in the context of the detailed AI/ML performance validation questions.
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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 & Human Services logo. To the right of that is the FDA logo, which 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.
June 26, 2020
Abbott Medical Charlie Pickrell Regulatory Affairs Specialist II 5050 Nathan Lane North Nathan Lane North, Minnesota 55442
Re: K201181
Trade/Device Name: EnSite Velocity Cardiac Mapping System, and EnSite Precision Cardiac Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: April 30, 2020 Received: April 30, 2020
Dear Charlie Pickrell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Fellman Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201181
Device Name
EnSite™ VelocityTM Cardiac Mapping System EnSite Precision™ Cardiac Mapping System
Indications for Use (Describe) EnSite Velocity Cardiac Mapping System:
The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
When used with the EnSite™ Array™ Catheter, the EnSite™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
OR
When used with an EnSite™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
EnSite Precision Cardiac Mapping System:
The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™M Module to combine and display magnetic processed patient positioning and navigation mapping information.
When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
OR
When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
EnSite Verismo Segmentation Tool:
The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.
EnSite Derexi Module:
When used with EnSite Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™M System / WorkMate Claris™ System for synchronizing and display of patient information.
EnSite Courier Module:
When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.
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EnSite Fusion Registration Module:
EnSite Fusion is indicated for registering the EnSite Navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.
EnSite Contact Force Module:
When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.
EnSite AutoMap Module:
When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user AutoMark Module When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in realtime.
AutoMark Module:
When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue square with a stylized "a" inside, followed by the word "Abbott" in black, bold font. The logo is simple and modern, and the colors are eye-catching.
| 510(k) Information | |
|---|---|
| 510(k) Number | K201181 |
| 510(k) Type | Traditional 510(k) |
| Date Prepared | 30 April 2020 |
| Submitter Information | |
| Manufacturer Name& Address | Abbott MedicalOne St. Jude Medical Drive,St. Paul, Minnesota, 55119, USA |
| Contact Person | Charlie PickrellRegulatory Affairs Specialist651-756-3130Charlie.pickrell@abbott.com |
| Device Information: | |
| Trade Name | EnSite Velocity Cardiac Mapping System and EnSite PrecisionTM Cardiac Mapping System |
| Common Name | Programmable Diagnostic Computer |
| Class | II |
| Classification Name | 870.1425, computer, diagnostic, programmable |
| Product Code | DQK |
| Predicate Device | EnSite Velocity Cardiac Mapping System v5.6 and EnSite PrecisionTM Cardiac MappingSystem (K183128) |
| Reference Device | Not Applicable |
| Device Description | The EnSiteTM VelocityTM Cardiac Mapping System / EnSite PrecisionTM Cardiac MappingSystem is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displayingcardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of thecardiac chamber. The contoured surfaces of these three-dimensional maps are based on theanatomy of the patient's own cardiac chamber.The EnSiteTM VelocityTM Cardiac Mapping System is used as a diagnostic tool inelectrophysiology (EP) Studies. An EP study involves the introduction of one or moreelectrode catheters into the heart to record its electrical activity. These catheters connect tothe EnSiteTM VelocityTM Cardiac Mapping System through specialized catheter inputmodules (CIMs). The EnSiteTM VelocityTM Cardiac Mapping System is designed for use inthe EP laboratory in conjunction with other equipment.The EnSite VelocityTM Cardiac Mapping System consists of hardware and softwareelements. The EnSite Velocity / EnSite Precision System consists of software, a displayworkstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS PowerKit), and an amplifier subsystem (Amplifier and Amplifier Accessory Kit). The DWShouses the system software and connects all the components together. The amplifiercontains electronic circuitry and firmware responsible for collecting and transmitting theelectrical signal data of the patient to the DWS software. Its primary function is to collectand transmit via Ethernet the electrical data detected from the patient. The amplifier acceptssignals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, |
| Device Description | converts these signals to a digital format, and sends them to the workstation for processing. |
| (continued) | |
| The NavLink connects surface electrodes and the system reference surface electrode to theAmplifier. The ArrayLink connects the EnSite Array Multielectrode Diagnostic Catheter tothe Amplifier. It also has a connection for an auxiliary unipolar reference electrode. TheCathLink connects the diagnostic catheters to the Amplifier. The GenConnect connects theablation catheter and dispersive surface electrodes to the Amplifier. The RecordConnectallows simultaneous connection for catheters and surface ECG to a recording system and tothe Amplifier. The ECG cable connects standard ECG electrodes to the Amplifier. | |
| The system operates using impedance only or impedance plus magnetics based upon itsconfiguration. The EnSite™ Velocity™ Cardiac Mapping System base software onlycollects impedance data. Adding EnSite Precision™ software to the base software allows thesystem to receive both magnetic data from the MediGuide™ Technology System or theEnSite Precision™ Module hardware and impedance data when using magnetic sensorenabled tools. The EnSite Precision™ Module and EnSite Precision™ software (added tothe base software) together make up the EnSite Precision™ Cardiac Mapping System. | |
| The EnSite Precision™ software interfaces to the MediGuide Technology System or theEnSite Precision™ Module to collect magnetic position and orientation information. TheEnSite Precision™ software uses the magnetic data for magnetic field scaling (NavX SE),shift detection (EnGuide Stability Monitor), and respiration gating. NavX SE field scalingadjusts the dimensions of the navigation field based on both the positon and orientation ofmagnetic sensors and the electrodes on Sensor Enabled™ (SE) tools, optimizing theappearance of the model. The system uses EnGuide Stability Monitor to notify the user of apotential shift based on a correlation of magnetic and impedance locations when using anySensor Enabled catheter. The system uses respiration gating to compensate to the end-pointof the respiration cycle using magnetic data to determine respiration phase. | |
| The EnSite Precision™ Module consists of hardware to support magnetic navigation. Thehardware components consist of the EnSite Precision™ Link, EnSite Precision™ FieldFrame, and EnSite Precision™ Patient Reference Sensors. | |
| Expansion Module | The EnSite Precision Cardiac Mapping System includes the following optional expansion |
| Device Description | software modules:1. EnSite™ Verismo™ Segmentation Tool - an optional expansion module used ingenerating 3D models from CT, MR or rotational angiography DICOM image data anddisplaying images on the EnSite™ Velocity™ Cardiac Mapping System. The EnSite™Verismo™ Segmentation Tool accepts DICOM images from CT and MRI scanners andconverts the images into a 3D model of cardiac structures. |
| 2. EnSite™ Derexi™ Module - an optional expansion module that that allows the EnSiteVelocity System to interface with the WorkMate™ Recording System to support theexchange of mapping point data and patient setup information between the two systems. | |
| 3. EnSite™ Courier™ Module - The EnSite™ Courier™ Module is an optional expansionmodule that allows the EnSite™ Velocity™ Cardiac Mapping System to communicate withthe hospital PACS (Picture Archiving and Communication System) server for the purposesof storing and retrieving patient data in DICOM format. | |
| Expansion Module | 4. EnSite™ Fusion™ Registration Module - an optional expansion module that providesnon-fluoroscopic navigation, mapping, and labeling on a Digital Image Fusion (DIF) model.The module is used with the EnSite™ NavX™ Navigation and Visualization TechnologySurface Electrode Kit and CT or MR scans segmented into a compatible file format. 3Dmodels created from digital images from CT and MRI data can be imported onto theEnSite™ Velocity™ System. |
| Device Description(continued) | 5. EnSite™ Contact Force Module - an optional expansion module that provides thedisplay of information from the TactiSys Quartz System. The EnSite Velocity System'sEnSite Contact Force Module is intended to provide visualization of force information fromcompatible catheters. |
| 6. EnSite™ AutoMap Module - an optional module that automatically collects mappingpoints based on criteria set by the user. | |
| 7. AutoMark Module - module allows the user to set parameters and the softwareautomatically 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 AmpereGenerator, and the WorkMate Claris™ System which is displayed on the AutoMark Moduleas lesion marks on the during RF ablation. The color, size, and ranges of the AutoMark aredefined by the user. | |
| Indications for Use | EnSite™ Velocity™ Cardiac Mapping System |
| The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool in patients forwhom electrophysiology studies have been indicated. When used with EnSite™ ArrayCatheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in theright atrium of patients with complex arrhythmias that may be difficult to identify usingconventional 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 conventionalelectrophysiology (EP) catheters in the heart. | |
| EnSite Precision™ Cardiac Mapping System | |
| The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patientsfor whom electrophysiology studies have been indicated. The EnSite Precision™ Systeminterfaces to either the MediGuide™ Technology System or the EnSite Precision™ Moduleto combine and display magnetic processed patient positioning and navigation mappinginformation. 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 complexarrhythmias 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 conventionalelectrophysiology (EP) catheters in the heart. | |
| EnSite™ Verismo™ Segmentation Tool | |
| The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models fromCT, MR or rotational angiography DICOM image data. Generated models are intended to bedisplayed 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 patientinformation. | |
| EnSite™ Courier™ Module | |
| When used with EnSite Courier Module allows the patient data to be archived to, andretrieved from, a DICOM conformant PACs server. | |
| EnSite™ Fusion™ Registration Module | |
| EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomicmodels, derived from CT scans, of the four individual cardiac chambers. | |
| Indications for Use(continued) | EnSite™ Contact Force Module |
| When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is |
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Image /page/5/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue stylized letter "a" on the left and the word "Abbott" in black bold font on the right. The logo is simple and modern.
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Image /page/6/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue stylized letter 'A' on the left and the word 'Abbott' in black bold font on the right. The blue 'A' symbol is a modern, abstract design, while the word 'Abbott' is clear and legible.
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| intended to provide visualization of force information from compatible catheters. | |||||
|---|---|---|---|---|---|
| EnSite™ AutoMap Module | |||||
| When used with the EnSite AutoMap Module, the EnSite System is intended toautomatically collect mapping points based on criteria set by the user. | |||||
| AutoMark Module | |||||
| When used with compatible hardware, the AutoMark Module is intended to automaticallycatalog and display various parameters associated with RF information on the 3D model inreal-time. | |||||
| Submission History | Pre-sub submission Q191312 was completed with the FDA on August 29th, 2019. | ||||
| Predicate Comparison | |||||
| Comparison | Both the subject and predicate devices have the same intended use, indications for use, andoperate using the same fundamental scientific technology to facilitate catheter position andorientation, as well as cardiac mapping and model creation. The proposed EnSite VelocitySurface Electrode Kit and the EnSite Precision Surface Electrode Kit have been tested toequivalent hardware and electrical requirements as the predicate and have been found metall testing requirements. | ||||
| There are no new or increased risks that result from the proposed modifications presentedwithin the submission, and the changes do not raise any new questions of safety andeffectiveness in regards to the subject device. | |||||
| Non-Clinical TestingSummary | Design verification activities were performed with their respective acceptance criteria toensure that the proposed modifications do not affect the safety or effectiveness of the device.All testing performed met the established performance specifications. | ||||
| TestingThe EnSite Velocity Cardiac Mapping System and the EnSite Precision Cardiac MappingSystem was developed and tested in accordance with the following industry guidancedocuments and standards: | |||||
| Guidance for the Content of Premarket Submissions for Software Contained in Medical-Devices | |||||
| Content of Premarket Submissions for Management of Cybersecurity in Medical-Devices: Guidance for Industry and Food and Drug Administration Staff | |||||
| EN ISO 14971:2012 Medical Devices – Application of Risk Management to Medical-Devices | |||||
| Types of Testing Performed | |||||
| Packaging- | |||||
| Visual InspectionO | |||||
| Bubble Leak TestO | |||||
| Pouch Seal StrengthO | |||||
| Shelf Life- | |||||
| Electrode Gel AdhesionO | |||||
| Electrode Impedance & CapacitanceO | |||||
| Non-Clinical Testing | Impedance StabilityO | ||||
| Summary | Electrode Temperature & Current DispersionO | ||||
| (continued) | Cable PulloutO | ||||
| Electrode IdentificationO | |||||
| Animal Testing- |
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Image /page/8/Picture/1 description: The image shows the Abbott logo. The logo consists of a stylized letter "a" in blue, followed by the word "Abbott" in black. The letter "a" is designed with rounded corners and a gap in the upper right, giving it a modern and abstract appearance.
| ○ | Design Validation | |
|---|---|---|
| – | Nominal Design Verification | |
| ○ | Impedance Tests | |
| ○ | Electrical Safety | |
| ○ | Adhesion Testing | |
| Risk ManagementThe changes to the EnSite Velocity™ Cardiac Mapping System and the EnSite Precision™Cardiac Mapping System was evaluated through review of risk management to ensure nonew hazards have been introduced by this change. | ||
| Statement ofEquivalence | The technological characteristics for the subject device, and the indications for use are thesame as the predicate device. Based on this and the data provided in this pre-marketnotification, the subject device and predicate device have been demonstrated to besubstantially equivalent. |
§ 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).