(268 days)
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™ 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
Intended Use for the EnSite™ Velocity™ Cardiac Mapping System optional expansion software modules:
EnSite™ Verismo™ Segmentation Tool (K101697) - 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 (K110549) - 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 (K101419) - 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 (K082467) - 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 (K141050) - When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.
VeriSense System Software Module (K130727) - When used with the VeriSense System Software Module, the EnSite System is intended for monitoring catheter tip-to-tissue electrical coupling, which may be indicative of catheter tip-to-tissue contact during cardiac electrophysiology procedures via a proprietary Electrical Coupling Index (ECI)
• 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
The EnSite™ Velocity™ Cardiac Mapping System with software version 5.0.1 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, Model EE3000 consists of a display workstation subsystem (DWS) and an Amplifier subsystem. The EnSite Amplifier collects the data from the patient connections and sends them to the DWS Workstation. The Amplifier connects to the DWS through a fiber optic cable and a media converter to convert the optical signals to digital signals. The EnSite™ Velocity™ DWS software displays the cardiac signal data received from the Amplifier on the workstation monitors and stores it for later retrieval.
Display Work Station (DWS) Subsystem
DWS - The DWS houses the system software and connects all the components together.
Monitors - Two monitors display patient information. One monitor is positioned near the workstation and keyboard for system operation, and the physician places the second monitor near the patient table for use.
Isolation transformer - All system components on the DWS connect to line power through a medical-grade isolation transformer.
Printer - Allows for printing study data
Amplifier Subsystem
Amplifier - contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software application via fiber Ethernet. The Amplifier converts these signals to a digital format and sends them to the workstation for processing.
NavLink - Connects surface electrodes and the system reference surface electrode to the Amplifier.
ArrayLink - Connects the EnSite Array Multi-electrode Diagnostic Catheter to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode.
CathLink - Connects the diagnostic catheters to the Amplifier
GenConnect - Connects the ablation catheter and dispersive surface electrodes to the Amplifier.
RecordConnect - The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier.
ECG cable - The ECG cable connects standard ECG electrodes to the Amplifier.
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 v5.0.1 is designed for use in the EP laboratory in conjunction with other equipment.
Expansion Module Device Description:
The EnSite™ Velocity™ Cardiac Mapping System v5.0 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™ Velocity™ System VeriSense System Software Module - an optional expansion module that allows the EnSite Velocity System to interface with St. Jude Medical's VeriSense Kit to display the graphical representation of Electrical Coupling Index (ECI).
EnSite™ AutoMap Module - a new optional module that automatically collects mapping points based on criteria set by the user
Based on the provided text, the document is a 510(k) summary for the EnSite™ Velocity™ Cardiac Mapping System v5.0.1 with EnSite™ AutoMap Module v1.0.1.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria and reported device performance for the EnSite™ Velocity™ Cardiac Mapping System v5.0.1 or its EnSite™ AutoMap Module v1.0.1.
Instead, it broadly states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional testing acceptance criteria (to ensure software modifications do not affect safety or effectiveness, and meet established performance specifications). | "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." |
| Evaluation of software changes and operating system along with the addition of the optional software module (to show the application software is acceptable for use and meets requirements). | "The changes to the application software and operating system along with addition of the optional software module were evaluated through software verification and validation to show that the application software is acceptable for use and meets requirements." |
| Review of risk management (to ensure no new hazards have been introduced by the change, and mitigate identified hazards). | "The changes to the application software and operating system along with addition of the optional software module were evaluated through review of risk management to ensure no new hazards have been introduced by this change. The risk analysis was completed and risk controls were implemented to mitigate identified hazards." |
| Cybersecurity requirements (conformance to risk management process: risk assessment, risk control, and maintenance of cybersecurity activities). | "The Ensite™ Velocity™ Cardiac Mapping System conforms to the Cybersecurity requirements through the cybersecurity risk management process comprised of a risk assessment, risk control, and maintenance of cybersecurity activities." |
| Substantial Equivalence to predicate devices (based on technological characteristics and data provided, to be at least as safe and effective). This is the overarching "acceptance criteria" for 510(k) clearance, and the document serves as the manufacturer's claim that this criterion is met. | "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 shown to be substantially equivalent." (This is the ultimate conclusion of the 510(k) submission, rather than a quantifiable performance metric for the device itself). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for any specific performance tests. The testing described is primarily software verification and validation, and risk management, rather than performance evaluation against a clinical or representative dataset of patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for a test set. The validation described is focused on internal software testing and risk management, not a clinical study requiring expert ground truth.
4. Adjudication Method
No adjudication method is mentioned, as there is no indication of a study requiring expert review or consensus for ground truth.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not describe an MRMC comparative effectiveness study, nor does it mention any assessment of how much human readers improve with or without AI assistance. The EnSite™ AutoMap Module is an "optional module that automatically collects mapping points based on criteria set by the user," suggesting an automated function rather than an AI-assisted human reading task.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document implies standalone software testing (software verification and validation), but it does not present quantifiable "standalone performance" metrics in the context of, for example, diagnostic accuracy. The "AutoMap Module" suggests an automated function, which could be considered a standalone algorithm for collecting mapping points, but no specific performance data for this module is provided. The testing mentioned is at a functional level ("met established performance specifications").
7. The Type of Ground Truth Used
The document does not specify the "type of ground truth" (expert consensus, pathology, outcomes data, etc.). The testing described is primarily functional and software-level verification and validation against pre-defined specifications and requirements, rather than against external, medically derived ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. The EnSite™ AutoMap Module is described as automatically collecting mapping points "based on criteria set by the user," which does not necessarily imply a machine learning model that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned, there is no information on how its ground truth would have been established.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2016
St. Jude Medical Melissa Frank Senior Regulaotry Affairs Specialist One St. Jude Medical St. Paul, Minnesota 55117
Re: K160187
Trade/Device Name: Ensite™ Velocity™ Cardiac Mapping System V5.0.1, Ensite™ AutoMap Module V1.0.1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: October 17, 2016 Received: October 18, 2016
Dear Melissa Frank:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mude Jellm
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) K160187
Device Name
EnSite(TM) Velocity(TM) Cardiac Mapping System v5.0.1 with EnSite(TM) AutoMap Module v1.0.1
Indications for Use (Describe)
Device Name: EnSite™ Velocity™ Cardiac Mapping System v5.0.1
Indications for Use:
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™ 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
| 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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510KSUMMARY
| 510(k) Number | K160187 |
|---|---|
| Date Prepared | October 20, 2016 |
| Submitter Information | |
| Manufacturer | St. Jude Medical |
| Name/Address | One St. Jude Medical Drive |
| St. Paul, MN 55117 | |
| Contact Person | Melissa Frank |
| Sr. Regulatory Affairs Specialist | |
| Phone (651) 756-2954 | |
| Mfrank02@sjm.com | |
| Device Information | |
| Trade Name | EnSite™ Velocity™ Cardiac Mapping System v5.0.1 with EnSite™ AutoMapModule v1.0.1 |
| Common Name | Programmable Diagnostic Computer |
| Class | II |
| Classification Name | 870.1425, computer, diagnostic, programmable |
| Product Code | DQK |
| Predicate Device | EnSite™ Velocity™ Cardiac Mapping System (K141050) |
| Secondary Predicates | The EnSite™ Velocity™ Cardiac Mapping System v5.0.1 includes thefollowing optional expansion software modules:EnSite™ Verismo™ Segmentation Tool (K101697)EnSite™ Derexi™ Module (K110549)EnSite™ Courier™ Module (K101419)EnSite™ Fusion™ Registration Module (K082467)EnSite™ Contact Force Module (K141050)VeriSense System Software Module (K130727) |
| Reference Applications | EnSite™ Velocity™ Surface Electrode Kit (K160186) |
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| ST. Jude Medical | |
|---|---|
| 510(k) Number | K160187 |
|---|---|
| Base System Device Description: | The EnSite™ Velocity™ Cardiac Mapping System with software version 5.0.1is 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, Model EE3000 consists of a display workstation subsystem (DWS) and an Amplifier subsystem. The EnSite Amplifier collects the data from the patient connections and sends them to the DWS Workstation. The Amplifier connects to the DWS through a fiber optic cable and a media converter to convert the optical signals to digital signals. The EnSite™ Velocity™ DWS software displays the cardiac signal data received from the Amplifier on the workstation monitors and stores it for later retrieval.Display Work Station (DWS) SubsystemDWS - The DWS houses the system software and connects all the components together. Monitors - Two monitors display patient information. One monitor is positioned near the workstation and keyboard for system operation, and the physician places the second monitor near the patient table for use. Isolation transformer - All system components on the DWS connect to line power through a medical-grade isolation transformer. Printer - Allows for printing study data Amplifier Subsystem Amplifier - contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software application via fiber Ethernet. The Amplifier converts these signals to a digital format and sends them to the workstation for |
| 510(k) Number | K160187 |
| processing. NavLink - Connects surface electrodes and the system reference surface electrode to the Amplifier. ArrayLink - Connects the EnSite Array Multi-electrode Diagnostic Catheter to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode. CathLink - Connects the diagnostic catheters to the Amplifier GenConnect - Connects the ablation catheter and dispersive surface electrodes to the Amplifier. RecordConnect - The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier. ECG cable - The ECG cable connects standard ECG electrodes to the Amplifier. 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 v5.0.1 is designed for use in the EP laboratory in conjunction with other equipment. | |
| Expansion ModuleDevice Description: | The EnSite™ Velocity™ Cardiac Mapping System v5.0 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. |
| 510(k) Number | K160187 |
| EnSite™ Derexi™ Module - an optional expansion module that thatallows the EnSite Velocity System to interface with the WorkMate™Recording System to support the exchange of mapping point data andpatient setup information between the two systems. EnSite™ Courier™ Module - The EnSite™ Courier™ Module is anoptional expansion module that allows the EnSite™ Velocity™ CardiacMapping System to communicate with the hospital PACS (PictureArchiving and Communication System) server for the purposes of storingand retrieving patient data in DICOM format. EnSite™ Fusion™ Registration Module - an optional expansion modulethat provides non-fluoroscopic navigation, mapping, and labeling on aDigital Image Fusion (DIF) model. The module is used with the EnSite™NavX™ Navigation and Visualization Technology Surface Electrode Kitand CT or MR scans segmented into a compatible file format. 3D modelscreated from digital images from CT and MRI data can be imported ontothe EnSite™ Velocity™ System. EnSite™ Contact Force Module - an optional expansion module thatprovides the display of information from the TactiSys Quartz System. TheEnSite Velocity System's EnSite Contact Force Module is intended toprovide visualization of force information from compatible catheters. EnSite™ Velocity™ System VeriSense System Software Module - anoptional expansion module that allows the EnSite Velocity System tointerface with St. Jude Medical's VeriSense Kit to display the graphicalrepresentation of Electrical Coupling Index (ECI). EnSite™ AutoMap Module - a new optional module that automaticallycollects mapping points based on criteria set by the user | |
| Base SystemIndications for Use | Device Name: EnSite™ Velocity™ Cardiac Mapping System v5.0.1The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool inpatients for whom electrophysiology studies are indicated. |
| 510(k) Number | K160187 |
| 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.ORWhen 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 | |
| Expansion ModuleIFU Statement | Intended Use for the EnSite™ Velocity™ Cardiac Mapping System optionalexpansion software modules:EnSite™ Verismo™ Segmentation Tool (K101697) - The EnSiteVerismo™ Segmentation Tool is indicated for use in generating 3D modelsfrom CT, MR or rotational angiography DICOM image data. Generatedmodels are intended to be displayed on the EnSite Velocity System. EnSite™ Derexi™ Module (K110549) - 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 (K101419) - When used with EnSite CourierModule allows the patient data to be archived to, and retrieved from, aDICOM conformant PACS server. EnSite™ Fusion™ Registration Module (K082467) - EnSite Fusion isindicated for registering the EnSite NavX navigation system to anatomicmodels, derived from CT scans, of the four individual cardiac chambers EnSite™ Contact Force Module (K141050) - When used with the SJMContact Force Unit, the EnSite™ Contact Force Module is intended toprovide visualization of force information from compatible catheters. VeriSense System Software Module (K130727) - When used with theVeriSense System Software Module, the EnSite System is intended formonitoring catheter tip-to-tissue electrical coupling, which may beindicative of catheter tip-to-tissue contact during cardiac electrophysiologyprocedures via a proprietary Electrical Coupling Index (ECI) |
| 510(k) Number | K160187 |
| • EnSite™ AutoMap Module – When used with the EnSite AutoMapModule, the EnSite System is intended to automatically collect mappingpoints based on criteria set by the user | |
| Submission History | No prior submissions have been made to FDA for the device that is the subjectof this submission. |
| Predicate Comparison | |
| Non-Clinical Testing Summary | Design verification activities for functional testing were performed with theirrespective acceptance criteria to ensure that the software modifications do notaffect the safety or effectiveness of the device. All testing performed met theestablished performance specifications. |
| TestingThe Ensite™ Velocity™ Cardiac Mapping System software was developedand tested in accordance with the following industry guidance documents andstandards: FDA Reviewers and Compliance on Off-the-Shelf Software used inMedical Devices and IEC 62304 OTS classification Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices IEC 62304:2006 Medical Device Software - Software Life CycleProcesses Content of Premarket Submissions for Management of Cybersecurityin Medical Devices: Guidance for Industry and Food and DrugAdministration Staff | |
| Software Documentation for a Major Level of Concern software per FDA'sGuidance Document “Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices” is included as part of this submission. | |
| The changes to the application software and operating system along withaddition of the optional software module were evaluated through softwareverification and validation to show that the application software is acceptable | |
| 510(k) Number | K160187 |
| for use and meets requirements. | |
| Risk Management | |
| The changes to the application software and operating system along with | |
| addition of the optional software module were evaluated through review of risk | |
| management to ensure no new hazards have been introduced by this change. | |
| The risk analysis was completed and risk controls were implemented to | |
| mitigate identified hazards. | |
| The Ensite TM Velocity TM Cardiac Mapping System conforms to the | |
| Cybersecurity requirements through the cybersecurity risk management | |
| process comprised of a risk assessment, risk control, and maintenance of | |
| cybersecurity activities. | |
| Statement of | The technological characteristics for the devices are the same as the predicate |
| Equivalence: | devices. Based on this and the data provided in this pre-market notification, the |
| subject devices and predicate devices have been shown to be substantially | |
| equivalent. |
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ST. Jude Medical
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r. Jude Medical
§ 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).