(25 days)
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.
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.
Expansion Module Device Description:
- 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.
The provided document does not contain information about a study that proves a device meets acceptance criteria for an AI/ML-based medical device. Instead, it is a 510(k) clearance letter for the EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac Mapping System v2.2, which are described as programmable diagnostic computer systems. These systems are used for catheter navigation and mapping in electrophysiology studies.
The document discusses validation activities for functional testing related to hardware and software modifications, as well as verification testing against industry standards. However, it does not detail a clinical study with acceptance criteria and performance metrics typically associated with proving the effectiveness of an AI/ML diagnostic tool, such as sensitivity, specificity, accuracy, or human-AI comparative performance.
Therefore, I cannot extract the requested information to fill in the table and describe the study as it pertains to AI/ML device performance. The testing described largely relates to electrical safety, electromagnetic compatibility, basic system function, system-level accuracy, and software/hardware verification after proposed modifications.
To answer your request, if this were an AI/ML device, the study would typically involve:
- A table of acceptance criteria and the reported device performance: This would list specific thresholds for metrics like sensitivity, specificity, AUC, or agreement rates, and the actual performance achieved by the AI device.
- Sample size used for the test set and data provenance: Details on the number of medical images/cases in the test set, their origin (e.g., specific hospitals, geographical regions), and whether the data was collected retrospectively or prospectively.
- Number of experts used to establish the ground truth and qualifications: How many, and what level of experience (e.g., board-certified radiologists with X years of experience in the specific domain), defined the true labels for the test data.
- Adjudication method for the test set: How disagreements among experts were resolved (e.g., majority vote, senior expert review).
- MRMC comparative effectiveness study: If human readers were involved, how their performance changed with and without AI assistance (e.g., increase in true positives, decrease in false negatives).
- Standalone performance: The performance of the algorithm without any human intervention.
- Type of ground truth: Whether ground truth was established by expert consensus, biopsy/pathology results, clinical follow-up data, or other definitive methods.
- Sample size for the training set: The number of cases used to train the AI model.
- How the ground truth for the training set was established: Similar to the test set, how the true labels for the training data were determined.
The provided document, while comprehensive for a 510(k) submission for a non-AI/ML device, does not contain these specific details.
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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 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.
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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
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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.
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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 real-time.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
.
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| 510(k) Information | |
|---|---|
| 510(k) Number | K182644 |
| 510(k) Type | Special 510(k) |
| Date Prepared | September 20, 2018 |
| Submitter Information | |
| ManufacturerName/Address | AbbottOne St. Jude Medical DriveSt. Paul, MN 55117 |
| Contact Person | Cody JohnsonRegulatory Affairs Specialist IIcody.johnson@abbott.com |
| Device Information | |
| Trade Name | EnSite™ Velocity™ Cardiac Mapping System v5.2EnSite 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 acatheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as wellas displaying cardiac electrical activity as waveform traces and as dynamic 3-Disopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiacchamber.The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic toolin electrophysiology (EP) Studies. An EP study involves the introduction of oneor more electrode catheters into the heart to record its electrical activity. Thesecatheters connect to the EnSite™ Velocity™ Cardiac Mapping System throughspecialized catheter input modules (CIMs). The EnSite™ Velocity™ CardiacMapping System v5.2 is designed for use in the EP laboratory in conjunctionwith other equipment. |
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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.
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| Expansion ModuleDevice Description | The EnSite™ Velocity™ Cardiac Mapping System v5.2 includes the followingoptional 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. |
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| Indications for Use | EnSite™ Velocity™ Cardiac Mapping System v5.2 |
|---|---|
| The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool inpatients for whom electrophysiology studies are indicated. | |
| When used with EnSite™ Array Catheter, the EnSite™ Velocity™ CardiacMapping System is intended to be used in the right atrium of patients withcomplex arrhythmias that may be difficult to identify using conventionalmapping system alone. | |
| or | |
| When used with the EnSite™ Velocity™ Surface Electrode Kit, the EnSite™Velocity™ Cardiac Mapping System is intended to display the position ofconventional electrophysiology (EP) catheters in the heart. | |
| EnSite Precision™ Cardiac Mapping System v2.2 | |
| The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic toolin 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 displaymagnetic processed patient positioning and navigation mapping information. | |
| When used with the EnSite™ Array™ Catheter, the EnSite Precision™ CardiacMapping System is intended to be used in the right atrium of patients withcomplex arrhythmias that may be difficult to identify using conventionalmapping systems alone. | |
| or | |
| When used with an EnSite Precision™ Surface Electrode Kit, the EnSitePrecision™ Cardiac Mapping System is intended to display the position ofconventional electrophysiology (EP) catheters in the heart. | |
| EnSite™ Verismo™ Segmentation Tool | |
| The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3Dmodels from CT, MR or rotational angiography DICOM image data. Generatedmodels are intended to be displayed on the EnSite Velocity System. | |
| EnSite™ Derexi™ Module | |
| When used with EnSite Derexi ™ Module, the EnSite System interfaces to theEP-WorkMate™ System / WorkMate Claris™ System for synchronizing anddisplay of patient information | |
| EnSite™ Courier™ Module | |
| When used with EnSite Courier Module allows the patient data to be archivedto, and retrieved from, a DICOM conformant PACs server. | |
| EnSite™ Fusion™ Registration Module | |
| EnSite Fusion is indicated for registering the EnSite NavX navigation system toanatomic models, derived from CT scans, of the four individual cardiacchambers | |
| Indications for Use(continued) | EnSite™ Contact Force ModuleWhen used with the SJM Contact Force Unit, the EnSite™ Contact ForceModule is intended to provide visualization of force information fromcompatible catheters.EnSite™ AutoMap ModuleWhen used with the EnSite AutoMap Module, the EnSite System is intended toautomatically collect mapping points based on criteria set by the userAutoMark ModuleWhen used with compatible hardware, the AutoMark Module is intended toautomatically catalog and display various parameters associated with RFinformation on the 3D model in real-time. |
| Submission History | No prior submissions have been made to FDA for the device that is the subjectof this submission. |
| Predicate Comparison | Both the subject and predicate devices operate using the same fundamentalscientific technology to facilitate catheter position and orientation, as well ascardiac mapping and model creation. The proposed EnSite Precision 12-CoilField Frame is a hardware design change. The resulting firmware update isrequired to support functionality of the new 12-Coil Field Frame.There are no new or increased risks that result from the proposed modificationspresented within the submission, and the changes do not raise any newquestions of safety and effectiveness in regards to the subject device. |
| Non-Clinical Testing Summary | Design verification activities for functional testing were performed with theirrespective acceptance criteria to ensure that the proposed modifications do notaffect the safety or effectiveness of the device. All testing performed met theestablished performance specifications.TestingThe EnSite™ Velocity™ Cardiac Mapping System v5.2 / EnSite Precision™Cardiac Mapping System v2.2 was developed and tested in accordance with thefollowing 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 + AM1:2012Medical Electrical Equipment-Part 1: General requirements for basic safetyand essential performance | |
| IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: Generalrequirements for basic safety and essential performance – Collateralstandard: electromagnetic disturbance – requirements and tests | |
| EN ISO 14971:2012 Medical Devices – Application of Risk Managementto Medical Devices | |
| Types of Testing Performed | |
| System level verification testing which consisted of electrical safety andelectromagnetic compatibility (EMC), basic system function, and systemlevel accuracy. | |
| Hardware verification testing to ensure the EnSite Cardiac MappingSystem hardware continues to meet requirements following the proposedmodifications | |
| Software verification testing to ensure the software continues to meetrequirements following the proposed modifications | |
| Design validation studies to ensure the installation process for updating theapplicable software and firmware components meets requirements and thatthe system remains compatible with common electrophysiology labequipment. | |
| Risk Management | |
| The changes to the Ensite™ Velocity™ Cardiac Mapping System / EnSitePrecision™ Cardiac Mapping System were evaluated through review of riskmanagement to ensure no new hazards have been introduced by this change. | |
| Statement ofEquivalence | The technological characteristics for the devices are the same as the predicatedevices. Based on this and the data provided in this pre-market notification, thesubject devices and predicate devices have been demonstrated to besubstantially equivalent |
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§ 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).