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.

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.

Device Description

The EnSite Precision™ Cardiac Mapping System is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber.

The EnSite Precision™ Cardiac Mapping System with version 2.0 software is a new module that is designed to allow the system to interface to the EnSite Precision™ Module, Sensor Enabled, which is an alternative magnetic field-based medical positioning hardware kit for magnetic field scaling functionality.

AI/ML Overview

This document does not contain the detailed acceptance criteria and study results in the format requested. While it outlines the device, its intended use, and that verification/validation activities were performed, it does not provide specific metrics or performance tables.

Here's what can be extracted and what is missing:

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

Missing. The document states "Design verification/validation activities were performed with their respective acceptance criteria to ensure that the modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." However, it does not specify what those acceptance criteria were or what the measured performance results were against those criteria.

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

Partially Missing. The document mentions "Dynamic Wetlab Bench Comparative and Preclinical Animal testing."
- Sample Size: Not specified.
- Data Provenance: "Wetlab Bench" and "Preclinical Animal testing" suggest laboratory/animal studies, which are prospective. Country of origin not specified.

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 Applicable / Missing. This device is a cardiac mapping system for electrophysiology studies. The "ground truth" in this context would likely be precise catheter location measurements, which are typically established through highly accurate measurement systems, not expert consensus in the same way an image diagnosis would be. The document describes "magnetic field-based catheter localization" and "impedance locations" as mechanisms for determining position, suggesting instrumental ground truth rather than expert interpretation.

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

Not Applicable / Missing. As the ground truth is instrumental (catheter position) rather than interpretive (e.g., diagnosing an image), adjudication methods by human readers are not relevant here.

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:

No. This document describes a K160210 submission for a cardiac mapping system, focusing on its technical performance and equivalence to predicate devices, not on AI assistance for human readers in diagnostic interpretation. The testing involved comparisons of model rendering and catheter electrode localization between the subject and predicate devices, and workflow performance.

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

Yes, implicitly. The testing described ("Electrical, Mechanical, Accuracy and Repeatability, Packaging, shelf life, Biocompatibility, Preclinical Animal Studies") focuses on the device's technical performance. The "accuracy testing for use with the magnetic field scaling feature" and comparisons of "model rendering and location of catheter electrodes" are examples of standalone performance evaluation of the system's ability to accurately map and localize.

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

The ground truth would be based on highly accurate physical measurements for catheter positions in the wetlab/animal studies. The document states "magnetic field-based catheter localization used for field scaling during model creation involves sensing of the magnetic fields generated through small coil sensors embedded inside the enabled device." This implies a physical, instrumental ground truth for position validation.

8. The sample size for the training set:

Not Applicable / Missing. This document describes a device approval, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" here refers to the device's development and validation, which uses various engineering and animal studies.

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

Not Applicable / Missing. See point 8. The ground truth for validation testing (such as catheter position) would be established through precise physical measurement techniques in the wetlab or animal models.

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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles, stacked one behind the other.

December 13, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

St. Jude Medical Marlene Peterson Sr. Regulatory Affairs Manager One St. Jude Medical Dr St. Paul, Minnesota 55117

Re: K160210

Trade/Device Name: EnSite Precision Cardiac Mapping System V2.0.1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: September 23, 2016 Received: September 26, 2016

Dear Marlene Peterson:

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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 vours.

Mude Yellman
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) K160210

Device Name

EnSite Precision™ Cardiac Mapping System, v2.0.1

Indications for Use (Describe)

The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510K SUMMARY

510(k) Number	K160210
Date Prepared	October 25, 2016
Submitter Information
Manufacturer	St. Jude Medical
Name/Address	One St. Jude Medical DriveSt. Paul, MN 551177
Contact Person	Marlene PetersonSr. Regulatory Affairs ManagerPhone (651) 756-3268mpeterson07@sjm.com
Device Information
Trade Name	EnSite Precision™ Cardiac Mapping System, v2.0.1
Common Name	Programmable Diagnostic Computer
Class	II
Classification Name	870.1425, computer, diagnostic, programmable
Product Code	DQK
Predicate Device	EnSite™ Velocity™ Cardiac Mapping System K141050MediGuide Technology K120301
Reference Files	K160187 - EnSite™ Velocity™ Cardiac Mapping System v5.0EnSite Precision™ v2.0 is a software module that runs on EnSite™Velocity™ Cardiac Mapping System v5.0 base software which is inparallel review under K160187.K160186 - EnSite™ Velocity™ Surface Electrode KitA branding name change was made to the Indications for Use withinthis submission in relation to the NavX Surface Electrode Kit. Thename was changed to the EnSite Precision™ Electrode Kit. TheEnSite Precision™ Electrode Kit contains a special convenience kitwhich includes the magnetic sensor patches (which are part of the newhardware introduced in this submission) under review for thissubmission. The modified EnSite™ Velocity™ Surface Electrode Kitis in parallel review under K160186.K160335 - Advisor™ FL, Circular Mapping Catheter, Sensor Enabled™The Advisor™ FL, Circular Mapping Catheter, Sensor Enabled™ is asensor-enabled steerable electrophysiology catheter used for recordingintracardiac signals and cardiac stimulation during diagnosticelectrophysiology studies. The catheter can be used to map the atrialregions of the heart. The catheter will be used with the subject deviceto achieve its intended use.
510(k) Number	K160210
Device Description	The EnSite Precision™ Cardiac Mapping System is a catheter navigation andmapping system capable of displaying the three-dimensional (3D) position ofconventional electrophysiology catheters, as well as displaying cardiacelectrical activity as waveform traces and as dynamic 3-D isopotential maps ofthe cardiac chamber. The contoured surfaces of these three-dimensional mapsare based on the anatomy of the patient's own cardiac chamber.The EnSite Precision™ Cardiac Mapping System with version 2.0 software isa new module that is designed to allow the system to interface to the EnSite
	Precision™ Module, Sensor Enabled, which is an alternative magnetic field-based medical positioning hardware kit for magnetic field scaling functionality.
Indications for Use	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™Cardiac Mapping System is intended to be used in the right atrium of patientswith complex 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.
Submissions History	No prior submissions have been made for the subject device.
Predicate Comparison	The proposed EnSite Precision™ Cardiac Mapping System with Precision™software version 2.0 and associated accessories has the same intended use andfundamental scientific technology as the predicate devices, the EnSite™Velocity™ Cardiac Mapping System, version 4.0.2 software, cleared underK141050, and MediGuide Technology, cleared under K120301.
	The upgrade to the EnSite Precision™ Cardiac Mapping System withPrecision™ version 2.0 software and associated the EnSite Precision™Module, Sensor Enabled hardware has 3 main objectives:
	1. Introduce a new software module called EnSite Precision™ v2.0,2. Introduce a new compatible magnetics hardware called the EnSitePrecision™ Module, Sensor Enabled , and3. Update the amplifier firmware to allow communication andsynchronization to the new hardware.
510(k) Number	K160210
	Both the subject and predicate devices operate using the same fundamentalscientific technology to display catheter location and navigation. The subjectdevice uses the new compatible magnetic hardware, the EnSite Precision™Module, Sensor Enabled as an alternate to the MediGuide™ System clearedunder K120301 as a source for generating a magnetic field to facilitate fieldscaling for model optimization. Both apply a known magnetic field to thecardiac region to monitor induced current on a small coil type magnetic sensorembedded in an enabled device. The magnetic field-based catheter localizationused for field scaling during model creation involves sensing of the magneticfields generated through small coil sensors embedded inside the enableddevice.
	Both the MediGuide Technology and the new compatible magnetics hardwareinterface to the EnSite Precision Cardiac Mapping System to provide the userthe ability to import, combine and display magnetic positioning and orientationinformation. The frequencies used for collecting sensor positions usedbetween the MediGuide Technology and the new compatible magneticshardware differ. However, There is no impact to safety and effectiveness asboth sets of transmitted frequencies are specifically chosen for theircharacteristics of being above the biological signal frequency band and thusnot interfering with other lab equipment. Safety and effectiveness isdemonstrated per International Commission on Non-Ionizing RadiationProtection (ICNIRP) Guidelines for Limiting Exposure to Time-varyingElectric, Magnetic and Electromagnetic Fields (up to 300GHz) – 1998 and theverification and validation testing performed which includes accuracy testingfor use with the magnetic field scaling feature.
	There are differences between the proposed system and the MediGuideTechnology in terms of catheter positioning error. In the subject devicemagnetic data from either the EnSite Precision™ Module, Sensor Enabled orMediGuide Technology is used in relation to the NavX generated impedancelocations which has lower precision. In the MediGuide Technology System,MediGuide magnetic data is used to project onto an x-ray image with higherprecision.While the accuracy requirements for the subject and predicate devices aredifferent, both must meet the same system level accuracy requirement formagnetic field scaling. Since magnetic field scaling is a correction factorapplied to the impedance coordinate system, once the proposed device (EnSitePrecision™ Module, Sensor Enabled™ hardware) magnetic accuracyrequirements are met the impedance coordinates themselves become thelimiting factor to the correction and further differences between the twosystem's magnetics coordinate errors are no longer significant with respect tomagnetic field scaling.
510(k) Number	K160210
Non-Clinical TestingSummary	Design verification/validation activities were performed with their respectiveacceptance criteria to ensure that the modifications do not affect the safety oreffectiveness of the device. All testing performed met the establishedperformance specifications.
	Testing
	The Ensite Precision™ Cardiac Mapping System was developed and tested inaccordance with the following industry guidance documents and standards:
	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 IEC 62366:2012 Medical Devices – Part 1: Application of UsabilityEngineering to Medical Devices Content of Premarket Submissions for Management of Cybersecurityin Medical Devices: Guidance for Industry and Food and DrugAdministration Staff IEC 60601-1 (2005 + COOR.1 (2006) + COOR.2 (2007) MedicalElectrical Equipment-Part 1: General requirements for basic safety andessential performance IEC 60601-1-2 2007 Medical Electrical Equipment - Part 1-2: Generalrequirements for basic safety and essential performance – Collateralstandard: electromagnetic disturbance – requirements and tests ISO 10993-1:2009 Biological Evaluation of Medical Devices EN ISO 14971:2012 Medical Devices – Application of RiskManagement to Medical Devices
	Software Documentation for a Moderate 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.
	Software Documentation for OTS software classified as a Moderate Level ofConcern, Class B according the FDA guidance, FDA Reviewers andCompliance on Off-the-Shelf Software used in Medical Devices and IEC62304 OTS classification is included as part of this submission.
	Design verification and validation testing of the EnSite Precision™ CardiacMapping System including the EnSite Precision™ Module Sensor Enabled™hardware and accessories was conducted to ensure that the proposed systemmeets requirements and is suitable for its intended use. Testing included:
	Electrical, Mechanical, Accuracy and Repeatability, Packaging, shelf life,
510(k) Number	K160210
	Biocompatibility, Preclinical Animal Studies
	Both Dynamic Wetlab Bench Comparative and Preclinical Animal testing wascompleted utilizing the subject device and the predicate devices in support of asubstantial equivalence determination. The testing included the following:
	Comparisons between the subject and predicate devices in regards toboth model rendering and location of catheter electrodes with magneticfield scaling applied. Comparisons between the subject and predicate devices in regards tocatheter electrode localization where Respiration Gating was turned onin the subject device and Respiration Gating was not available in thepredicate devices. Comparisons between the subject and predicate devices in regards toworkflow and system performance when Positional Reference Tool(PRT) with EnGuide Stability Monitor is active in the subject devicewhile only PRT is active in the predicate devices.
	The results demonstrated that the features of the subject device aresubstantially equivalent to the existing functionality of the predicate devices,and that the new technological characteristics of the subject device do not raisenew questions regarding safety and effectiveness compared to those of thepredicate devices.
	The results of the verification and validation testing met acceptance criteriademonstrating that the proposed system continues to meet all requirementsaffected by the device modifications described herein, is suitable for itsintended use, and is substantially equivalent to the listed predicate devices.
	Risk Management
	The changes were evaluated through review of risk management to ensure nonew hazards have been introduced by this change. The risk analysis wascompleted and risk controls were implemented to mitigate identified hazards.
	The EnSite Precision™ Cardiac Mapping System conforms to theCybersecurity requirements through the cybersecurity risk managementprocess comprised of a risk assessment, risk control, and maintenance ofcybersecurity activities.
Statement ofEquivalence:	The technological characteristics for the device 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 shown to be substantiallyequivalent.

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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).