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.

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.

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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "EnSite Velocity Cardiac Mapping System v5.0.1 with AutoMark Module v1.0.1". However, it does not include detailed information regarding specific acceptance criteria, a study proving the device meets those criteria, or quantitative performance metrics typically found in clinical validation studies for AI/CADe devices.

The document focuses on demonstrating substantial equivalence to predicate devices, software verification and validation, and risk management. It does not contain the kind of clinical study details requested in the prompt.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified.
Data provenance: Not specified (since no specific test set or study is detailed).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not specified.

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

Not mentioned. The document states "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." This indicates functional testing, not a comparative effectiveness study with human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document describes "Design verification activities for functional testing" and "software verification and validation." This implies standalone testing of the software's functionality, but no specific performance metrics like sensitivity/specificity are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not specified. The "AutoMark module automatically displays the lesion marks on the EnSite Velocity model during RF ablation when the user set criteria are met." The ground truth would likely relate to the accuracy of these displayed marks based on the user-defined criteria, but the method for establishing this is not detailed.

8. The sample size for the training set

Not specified.

9. How the ground truth for the training set was established

Not specified.

Summary

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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

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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

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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.

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.

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510KSUMMARY

510(k) Number	K160218
Date Prepared	October 18, 2016
Submitter Information
ManufacturerName/Address	St. Jude MedicalOne St. Jude Medical DriveSt. Paul, MN 55117
Contact Person	Melissa FrankSr. Regulatory Affairs SpecialistPhone (651) 756-2954Mfrank02@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 DeviceDescription:	The EnSite™ Velocity™ Cardiac Mapping System with software version 5.0.1 is acatheter 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 mapsof the cardiac chamber. The contoured surfaces of these three-dimensional maps arebased on the anatomy of the patient's own cardiac chamber.The EnSite Velocity™ Cardiac Mapping System, Model EE3000 consists of adisplay workstation subsystem (DWS) and an Amplifier subsystem. The EnSiteAmplifier collects the data from the patient connections and sends them to the DWSWorkstation. The Amplifier connects to the DWS through a fiber optic cable and amedia converter to convert the optical signals to digital signals. The EnSite™Velocity™ DWS software displays the cardiac signal data received from the

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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.

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	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 ModuleDevice 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 theEnSite Velocity model during RF ablation when the user set criteria are met. Thecolor, size, and ranges of the AutoMark are defined by the user.
Secondary PredicateDevice Descriptions	The following secondary predicate devices are provided to ensure that all features ofthe proposed AutoMark Module are demonstrated to be substantially equivalent tofeatures 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 TestingSummary	Design verification activities for functional testing were performed with theirrespective acceptance criteria to ensure that the software modifications do not affect
	the safety or effectiveness of the device. All testing performed met the establishedperformance specifications.
	Testing
	The AutoMark software module was developed and tested in accordance with thefollowing industry guidance documents and standards:
	FDA Reviewers and Compliance on Off-the-Shelf Software used in MedicalDevices and IEC 62304 OTS classification Guidance for the Content of Premarket Submissions for Software Containedin Medical Devices IEC 62304:2006 Medical Device Software - Software Life Cycle Processes Content of Premarket Submissions for Management of Cybersecurity inMedical Devices: Guidance for Industry and Food and Drug AdministrationStaff
	Software Documentation for a Major Level of Concern software per FDA's GuidanceDocument "Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices" is included as part of this submission.
	The changes to the optional AutoMark software module were evaluated throughsoftware verification and validation to show that the software is acceptable for useand meets the requirements.
	Risk Management
	The changes to the AutoMark software were evaluated through review of riskmanagement to ensure no new hazards have been introduced by this change. The riskanalysis was completed and risk controls were implemented to mitigate identifiedhazards.
	The AutoMark software module conforms to the Cybersecurity requirements throughthe cybersecurity risk management process comprised of a risk assessment, riskcontrol, and maintenance of cybersecurity activities.
Statement of	The technological characteristics for the device are the same as the predicate devices.

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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.
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Regulation Number and Section

§ 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).