(319 days)
No
The description focuses on signal acquisition, processing, and display, with the AutoMark module providing automated cataloging and display based on user-defined criteria, not learned patterns or complex decision-making characteristic of AI/ML.
No
The device is a diagnostic tool used for electrophysiology studies to map cardiac electrical activity, not to provide therapy.
Yes
The "Indications for Use" section explicitly states: "The EnSite™ Velocity™ Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies are indicated." The "Device Description" also reinforces this by stating: "The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic tool in electrophysiology (EP) Studies." The system collects and displays electrical activity, critical for diagnosing cardiac arrhythmias.
No
The device description explicitly details hardware components such as a display workstation subsystem (DWS), Amplifier subsystem, monitors, isolation transformer, printer, NavLink, ArrayLink, CathLink, GenConnect, RecordConnect, and ECG cable. The software runs on and interacts with this dedicated hardware.
Based on the provided information, the EnSite™ Velocity™ Cardiac Mapping System v5.0.1 and the AutoMark Module v1.0.1 are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The EnSite™ Velocity™ Cardiac Mapping System and the AutoMark Module are used in vivo (within the living body). They are used in electrophysiology studies to map the electrical activity of the heart and display the position of catheters within the heart. The AutoMark Module specifically helps in visualizing ablation points during a procedure.
- Indications for Use: The indications clearly state their use as a "suggested Diagnostic tool in patients for whom electrophysiology studies are indicated" and for displaying the position of catheters in the heart. This is an in vivo application.
- Device Description: The description details the system's components, including catheters, surface electrodes, and an amplifier that collects electrical signals from the patient. This further confirms its in vivo nature.
- Lack of Specimen Handling: There is no mention of collecting, preparing, or examining specimens from the human body.
Therefore, these devices are considered medical devices used for diagnosis and guidance during procedures within the patient, not IVDs.
N/A
Intended Use / Indications for Use
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™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping system alone. OR When used with the EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart
Device Name: AutoMark Module v1.0.1
Indications for Use: When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The EnSite™ Velocity™ Cardiac Mapping System with software version 5.0.1 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 as described in the labeling.
Expansion Module Device Description: The AutoMark Module is an optional add-on module to the EnSite™ Velocity™ System v5.0.1. The software module allows the user to set criteria for ablation-related parameters and the software automatically displays the lesion marks on the EnSite Velocity model during RF ablation when the user set criteria are met. The color, size, and ranges of the AutoMark are defined by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, right atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, EP laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification activities for functional testing were performed with their respective acceptance criteria to ensure that the software modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications. The AutoMark software module was developed and tested in accordance with the following industry guidance documents and standards: FDA Reviewers and Compliance on Off-the-Shelf Software used in Medical Devices and IEC 62304 OTS classification Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices IEC 62304:2006 Medical Device Software - Software Life Cycle Processes Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff. Software Documentation for a Major Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as part of this submission. The changes to the optional AutoMark software module were evaluated through software verification and validation to show that the software is acceptable for use and meets the requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a bird or eagle in flight, composed of three overlapping profiles facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 13, 2016
St. Jude Medical Melissa Frank Senior Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, Minnesota 55117
Re: K160218
Trade/Device Name: EnSite Velocity Cardiac Mapping System v5.0.1 with AutoMark Module v1.0.1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: September 20, 2016 Received: September 21, 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.
Mule Jellm
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160218
Device Name
EnSite™ Velocity™ Cardiac Mapping System v5.0.1 with AutoMark 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™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping system alone.
OR
When used with the EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart
Device Name: AutoMark Module v1.0.1
Indications for Use:
When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510KSUMMARY
| 510(k) Number | K160218 |
|---|---|
| Date Prepared | October 18, 2016 |
| Submitter Information | |
| Manufacturer | |
| Name/Address | St. Jude Medical |
| 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 AutoMark Module 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 | WorkMate Claris™ System (K151911) |
| Reference Devices | EnSite™ Velocity™ Cardiac Mapping System v5.0.1 with AutoMap Module v1.0.1 |
| (K160187) | |
| EnSite Precision™ Cardiac Mapping System v2.0.1 (K160210) | |
| Base System Device | |
| Description: | 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 |
4
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
5
| 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 | |
| as described in the labeling. | |
| Expansion Module | |
| Device Description: | The AutoMark Module is an optional add-on module to the EnSite™ Velocity™ |
| System v5.0.1. The software module allows the user to set criteria for ablation- | |
| related parameters and the software automatically displays the lesion marks on the | |
| EnSite Velocity model during RF ablation when the user set criteria are met. The | |
| color, size, and ranges of the AutoMark are defined by the user. | |
| Secondary Predicate | |
| Device Descriptions | The following secondary predicate devices are provided to ensure that all features of |
| the proposed AutoMark Module are demonstrated to be substantially equivalent to | |
| features of currently cleared medical devices | |
| WorkMate Claris System | |
| The WorkMate Claris™ System is a fully computerized system for capturing and | |
| measuring physiological data in the clinical electrophysiology (EP) laboratory. It | |
| provides digital signal acquisition and display of those electrical signals on high | |
| resolution monitors. | |
| The WorkMate Claris System is connected to electrophysiology catheters that are | |
| guided into various locations within the heart, and to surface electrocardiogram | |
| (ECG) cables. Intracardiac and ECG signals are then acquired from electrodes on the | |
| indwelling catheters and ECG leads connected to the amplifier, which amplifies and | |
| conditions the signals before they are received by the WorkMate Claris System | |
| computer for display, measurement and storage. | |
| During the procedure, cardiac signals are acquired and an automated software | |
| waveform detector (trigger) performs online recognition of cardiac activation on | |
| preselected leads. Temporal interval measurements are computed on a beat-by-beat | |
| basis on multiple channels and dynamically posted on the Real Time display. | |
| Intervals are calculated between waveforms from the same source on a specific | |
| channel (intra-channel measurements) and from multi-source signals across two or | |
| more channels (inter-channel measurements). | |
| Signals are also presented on a review monitor for measurement and analysis. | |
| Continuous capture of the digitized signals can be invoked, and the user can also | |
| retrieve and display earlier passages of the current study without interruption of the | |
| real-time display. The system can also acquire, display and record data from other | |
| interfaced devices in use during the procedure, such as imaging devices and ablation | |
| generators. | |
| Base System | 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 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 System is | |
| intended to display the position of conventional electrophysiology (EP) catheters in | |
| the heart | |
| Expansion Module | Device Name: AutoMark Module v1.0.1 |
| Indications for Use | When used with compatible hardware, the AutoMark Module is intended to |
| automatically catalog and display various parameters associated with RF information | |
| on the 3D model in real-time. | |
| Submission History | No prior submissions have been made to FDA for the device subject of this |
| submission. | |
| Predicate Comparison | |
| Comparison | The AutoMark module was developed to provide additional functionality to the |
| predicate devices in allowing the user to set parameters and the software | |
| automatically displays the lesion marks on the EnSite Velocity model during RF | |
| ablation. The proposed AutoMark Module has the same intended use and | |
| fundamental scientific technology as the predicate devices, EnSite™ Velocity™ | |
| Cardiac Mapping System v4.0.2 and WorkMate Claris™ System | |
| Non-Clinical Testing | |
| Summary | Design verification activities for functional testing were performed with their |
| respective acceptance criteria to ensure that the software modifications do not affect | |
| the safety or effectiveness of the device. All testing performed met the established | |
| performance specifications. | |
| Testing | |
| The AutoMark software module was developed and tested in accordance with the | |
| following industry guidance documents and standards: | |
| FDA Reviewers and Compliance on Off-the-Shelf Software used in Medical | |
| Devices and IEC 62304 OTS classification Guidance for the Content of Premarket Submissions for Software Contained | |
| in Medical Devices IEC 62304:2006 Medical Device Software - Software Life Cycle Processes Content of Premarket Submissions for Management of Cybersecurity in | |
| Medical Devices: Guidance for Industry and Food and Drug Administration | |
| Staff | |
| Software Documentation for a Major Level of Concern software per FDA's Guidance | |
| Document "Guidance for the Content of Premarket Submissions for Software | |
| Contained in Medical Devices" is included as part of this submission. | |
| The changes to the optional AutoMark software module were evaluated through | |
| software verification and validation to show that the software is acceptable for use | |
| and meets the requirements. | |
| Risk Management | |
| The changes to the AutoMark software 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 AutoMark software module 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 device are the same as the predicate devices. |
6
7
8
| Equivalence: | Based on this and the data provided in this pre-market notification, the subject device and predicate devices have been shown to be substantially equivalent. |
|---|---|
| -------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------- |