The NeuTrace EP Mapping System v2.1 is indicated for catheter-based cardiac electrophysiological (EP) procedures. The NeuTrace EP Mapping System v2.1 provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure in the right atrium. The system has no special contraindications.

Device Description

The NeuTrace EP Mapping System v2.1 (NeuTrace System) is an advanced 3D electroanatomical mapping (EAM) and analysis system capable of:

Displaying catheter location during electrophysiology mapping procedures
Displaving 3D images of cardiac structures
Displaying cardiac activity signals as waveforms (ECGs and EGMs)
Displaying derived voltage and time metric overlays over cardiac models -. including Peak-to-Peak Voltage, Local Activation Time (LAT), Fractionation, and Minimum dV/dt

The NeuTrace System comprises the following software and hardware components:

NeuTrace Workstation
Window field generator
System control unit
System interface unit
Interface switches and connection cables
NeuTrace Software Application v2.1
NeuTrace Streaming Application Software v2.0 0

The NeuTrace System is used together with compatible recording systems and compatible catheters listed in the device labeling to perform its intended use to support electrophysiology procedures in the right atrium.

AI/ML Overview

Here's an analysis of the provided text, extracting information related to the acceptance criteria and the study proving the device meets those criteria:

Device Name: NeuTrace EP Mapping System v.2.1
Product Code: DQK
Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a formal "acceptance criteria" table with pre-defined thresholds. Instead, it describes performance metrics that were measured and the results achieved, which implicitly serve as the "met criteria." The "Comments" column indicates whether the observed performance meets or aligns with expectations for substantial equivalence.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance	Comments
Ground-truth Accuracy	Expected to be low (e.g., < 1mm) and comparable to predicate/reference devices.	Statistically demonstrated as `< 1mm`	Meets implicit criterion. Demonstrates high accuracy essential for EP mapping systems.
Shift	Expected to be low (e.g., < 1mm).	`< 1mm`	Meets implicit criterion. Indicates stability of localization.
Drift	Expected to be low (e.g., < 2mm).	`< 2mm`	Meets implicit criterion. Indicates stability of localization over time.
3D Geometry Generation	Equivalent generation of 3D geometries compared with the predicate (CARTO 3 System).	Equivalent generation of 3D geometries compared with CARTO 3 System	Demonstrated equivalence to the predicate, indicating comparable functionality for creating anatomical models.
Map Generation (Voltage, LAT, Fractionation)	Equivalent performance compared with the reference (EnSite X System) for relevant maps.	Equivalent accuracy and performance compared with EnSite X System (using FlexAbility™ Ablation Cathether, Sensor Enabled™) for peak-to-peak voltage maps, Local Activation Time (LAT) maps, and fractionation maps.	Demonstrated equivalence to the reference device for key electrophysiological maps, ensuring comparable diagnostic information. Note: NeuTrace does not include impedance maps, which were present in reference devices, but this is stated as not required for their intended use.
System Performance (Overall)	Meets all specifications and user requirements. Operates as intended for catheter-based cardiac EP procedures.	Passed all testing and met all design specifications and user requirements.	Overall system performance verified through comprehensive testing.
Software Verification & Validation	Compliant with software development standards and functional requirements.	Performed	Assures software quality and reliability.
Hardware Verification	Meets specifications for shift, drift, and intrinsic time delay.	Includes 4-hour shift and drift testing and intrinsic time delay testing.	Ensures hardware robustness and accurate timing.
Cybersecurity Risk Management & Testing	Compliant with cybersecurity standards for medical devices.	Performed	Addresses potential cybersecurity vulnerabilities.
EMC/EMI Testing	Compliant with IEC 60601-1 and IEC 60601-1-2 standards.	Performed per IEC 60601-1 and IEC 60601-1-2	Ensures electromagnetic compatibility and safety.
NeuTrace-EnSite accuracy and equivalency testing	Accuracy and performance equivalent to EnSite X System.	Performed; demonstrated equivalent accuracy and performance.	Confirms performance parity with a key reference device.
NeuTrace-CARTO geometry and mapping equivalency analyses	Geometry and mapping generation equivalent to CARTO 3 System.	Performed; demonstrated equivalent generation of 3D geometries and maps.	Confirms performance parity with the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample size (e.g., number of cases, number of data points) used for the bench testing or the GLP animal study. It only states that a GLP animal study was performed.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified, but a "GLP animal study" implies prospective data collection under Good Laboratory Practice principles. Bench testing is inherently prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide any information on the number of experts used or their qualifications for establishing ground truth, especially for the animal study.
The "ground-truth accuracy" results (e.g., < 1mm) suggest that a highly precise physical measurement system was used as the ground truth, rather than human expert interpretation of images or data.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1 consensus) for the test set. Given the context of a 3D electroanatomical mapping system and the nature of the performance metrics (accuracy, shift, drift, geometric equivalence), the ground truth seems to be derived from physical measurements or direct comparisons to established systems/methods rather than interpretations requiring human consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done involving human readers improving with AI vs. without AI assistance.
This device is an EP mapping system, providing objective electrical and anatomical data, not an AI-assisted diagnostic imaging interpretation tool that would typically undergo MRMC studies. Its function is to provide information for the clinician, not to make a diagnosis or interpretation in place of one.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

The performance data presented (accuracy, shift, drift, geometry, and map generation) are inherently standalone performance of the system's ability to localize and generate data. The system itself generates the maps and measurements; it's not a human-in-the-loop scenario where a human is assisted by AI to perform a task. The NeuTrace system provides the foundational spatial and electrical data directly.

7. Type of Ground Truth Used

The type of ground truth used appears to be based on highly precise physical measurements and direct comparisons to established, validated predicate/reference systems.
- For accuracy, shift, and drift: Likely precise physical measurement systems (e.g., optical tracking, high-precision fiducial markers) were used in conjunction with the device's own measurements.
- For 3D geometry and map generation: The ground truth was established by direct comparison to the performance of the predicate (CARTO 3 System) and reference (EnSite X System) devices, which are already considered established and validated standards in the field.

8. Sample Size for the Training Set

The document does not specify any sample size for a training set. This makes sense given that the NeuTrace EP Mapping System v.2.1 is described as an "advanced 3D electroanatomical mapping (EAM) and analysis system" that relies on "Magnetic-based localization" and "derived voltage and time metric overlays." This suggests an algorithmic or physics-based system, rather than a machine learning/AI system that requires a dedicated training set to learn from data.

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned (implying a non-ML/AI driven system), there is no information provided on how ground truth for a training set was established.

Summary

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November 25, 2023

Anumana, Inc. Animesh Agarwal VP of Product Management 1 Main St. East Arcade, 4th Floor Cambridge, Massachusetts 01242

Re: K233160

Trade/Device Name: NeuTrace EP Mapping System v.2.1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK Dated: September 27, 2023 Received: September 27, 2023

Dear Animesh Agarwal:

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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology,

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Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233160

Device Name NeuTrace EP Mapping System v.2.1

Indications for Use (Describe)

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)

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510k Summary K233160 Neutrace EP Mapping System v.2.1

510(k) Number	K233160
510(k) Type	Traditional
Date Prepared	November 22, 2023
Applicant:	Anumana Inc.One Main Street, Suite 400East Arcade 4th Floor, Cambridge MA 02142
Contact Persons:	Suzanne GoodmanVice President of Quality and RegulatorySgoodman@nference.net(919) 608-6082
	Animesh AgarwalVice President of Product Managementanimesh.agarwal@nference.net(267) 945-3387
Trade Name	NeuTrace EP Mapping System v.2.1
Common Name	Programmable diagnostic computer
Class	II
Regulation Number	21 CFR 870.1425 Computer, diagnostic, programmable
Product Code	DQK
Predicate Device	CARTO 3 EP Navigation System (K133916)
Reference Device:	EnSite X EP System (K202066)

K233160 – 510(k) Summary

Page 1 of 6

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Device Description

The NeuTrace EP Mapping System v2.1 (NeuTrace System) is an advanced 3D electroanatomical mapping (EAM) and analysis system capable of:

Displaying catheter location during electrophysiology mapping procedures ●
Displaving 3D images of cardiac structures ●
Displaying cardiac activity signals as waveforms (ECGs and EGMs)
Displaying derived voltage and time metric overlays over cardiac models -. including Peak-to-Peak Voltage, Local Activation Time (LAT), Fractionation, and Minimum dV/dt

The NeuTrace System comprises the following software and hardware components:

NeuTrace Workstation
Window field generator ●
System control unit ●
System interface unit ●
Interface switches and connection cables
NeuTrace Software Application v2.1
NeuTrace Streaming Application Software v2.0 0

Indications For Use

Predicate Comparison

The predicate device chosen for the NeuTrace EP Mapping System v2.1 (NeuTrace System) is the Biosense Webster CARTO 3 EP Navigation System (K133916). The selected reference device for the NeuTrace System is the Abbott EnSite X EP System (K202066). The NeuTrace System has the same intended use, technological characteristics, and principles of operation as the CARTO 3 EP Navigation System. The EnSite X EP System was added as a reference device to the NeuTrace System because it is a Class II electroanatomical navigation and mapping system under the same regulatory classification, utilizes similar magnetic-based localization, and has

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similar catheter compatibility. The NeuTrace System is compared to the predicate and reference devices in the table below.

	NeuTrace EPMapping Systemv2.1(NeuTrace System)Subject of this510(k)	Biosense Webster'sCARTO 3 EPNavigation System(CARTO 3 System)(Predicate Device)	EnSite X EPSystem(Reference Device)	Comments
510(k)	K233160	K133916	K202066	N/A
Device class	II	II	II	Same
Classification	Programmablediagnostic-computerClass II; 21 CFR,870.1425	Programmablediagnostic-computerClass II; 21 CFR,870.1425	ProgrammableDiagnostic ComputerClass II; 21 CFR870.1425	Same
Product code	DQK	DQK	DQK	Same
Indications/Intended use	The NeuTrace EPMapping Systemv2.1 is indicated forcatheter-basedcardiacelectrophysiological(EP) procedures. TheNeuTrace EPMapping Systemv2.1 providesinformation aboutthe electrical activityof the heart andabout catheterlocation during theprocedure. Thesystem can be usedon patients who areeligible for aconventionalelectrophysiologicalprocedure in theright atrium. Thesystem has nospecialcontraindications.	The intended use ofthe CARTO 3 Systemis catheter-basedcardiacelectrophysiological(EP) procedures. TheCARTO 3 Systemprovides informationabout the electricalactivity of the heartand about catheterlocation during theprocedure. Thesystem can be usedon patients who areeligible for aconventionalelectrophysiologicalprocedure. Thesystem has no specialcontraindications.	The EnSite™ X EPSystem is a suggesteddiagnostic tool inpatients for whomelectrophysiologystudies have beenindicated. TheEnSite™ X EPSystem providesinformation about theelectrical activity ofthe heart and displayscatheter locationduring conventionalelectrophysiological(EP) procedures.	Same
	NeuTrace EPMapping Systemv2.1(NeuTrace System)Subject of this510(k)	Biosense Webster'sCARTO 3 EPNavigation System(CARTO 3 System)(Predicate Device)	EnSite X EPSystem(Reference Device)	Comments
Intended	EP's and EP lab staff	EP's and EP lab staff	EP's and EP lab staff	Same
users	trained on the use of	trained on the use of	trained on the use of
	the system	the system	the system
SystemComponents	1. Sensor InterfaceUnit & SensorControl Unit2. Workstation withGraphic UserInterface3. Keyboard, andmouse4. Power Supply5. Monitor6. Window FieldGenerator7. Interface switchesand conn. cables	1. Patient InterfaceUnit (PIU)2. Workstation withGraphic UserInterface3. Keyboard, andmouse4. Power Supply5. Monitor6. Location Pad7. Patches &Connection Box8. Foot pedals	1. Amplifier withassociated modules2. Workstation withmonitors andisolationtransformer3. Optional printer4. Field FrameGenerator5. Catheter InputModules6. Patient ReferenceSensors7. ECG cable.	Similar. Thecomponentdifferencesdo not affectthe intendeduse.
Principles of	Magnetic-based	Magnetic-based	Magnetic-Based	Less
operation/locationtechnology	localizationSecondary:n/a	localizationSecondary:impedance-basedlocalization	localizationSecondary:impedance-basedlocalization	accurateimpedancemode is notrequired forthe same
				intended use
CompatibleCatheters	1. FlexAbilityTMAblation Catheter,Sensor Enabled™	1.Specialized catheterswith integratedmagnetic sensor	1.Specialized catheterswith integratedmagnetic sensor	1.Same
	2. n/a	2.Conventionalcatheters (w/omagnetic sensors)	2.Conventionalcatheters (w/omagnetic sensors)	2. Not req'dfor the sameintendeduse.
Acquisitionof datapoints	Manual or automatic	Manual or automatic	Manual or automatic	Same
	NeuTrace EPMapping Systemv2.1(NeuTrace System)Subject of this510(k)	Biosense Webster'sCARTO 3 EPNavigation System(CARTO 3 System)(Predicate Device)	EnSite X EPSystem(Reference Device)	Comments
3D Geometrymapping	Yes	Yes	Yes	Same
Electrogramsfor activationand voltagemapping	Yes. LocalActivation Timemaps, voltage maps,propagation maps, &fractionation maps	Yes, Local ActivationTime maps, voltagemaps, impedancemaps, andpropagation maps	Yes, Local ActivationTime maps, voltagemaps, impedancemaps, andpropagation maps	Similar -NeuTrace doesnot include thelower accuracyImpedancemaps
Ablationlesionvisualizationand tagging	Yes	Yes, optional(Visitag Module)	Yes	Same
Compatiblewith an RFgenerator	Yes	Yes	Yes	Same

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Performance Data

Bench testing and a GLP animal study were performed to assure the NeuTrace EP Mapping System v2.1 meets all specifications and user requirements and to demonstrate substantial equivalence with the predicate and reference devices.

Bench Testing

. Software Verification and Validation
Hardware Verification including 4-hour shift and drift testing and intrinsic time ● delay testing
Cybersecurity Risk Management & Testing ●
EMC/EMI testing per IEC 60601-1 and IEC 60601-1-2 ●
NeuTrace-EnSite accuracy and equivalency testing .
NeuTrace-CARTO geometry and mapping equivalency analyses .

GLP Animal Study

System performance verification and validation for accuracy, shift, drift, . geometry, peak-to-peak voltage maps, local activation time maps, fractionation maps, and summative usability.
Overall, the NeuTrace EP Mapping System v2.1 passed all testing and met all design specifications and user requirements. Ground-truth accuracy was statistically demonstrated as < 1mm, shift < 1 mm, and drift < 2mm. Equivalent generation of 3D

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geometries and maps compared with the predicate CARTO 3 System was demonstrated. Equivalent accuracy and performance compared with the reference EnSite X System using the FlexAbility™ Ablation Catheter, Sensor Enabled™ catheter was demonstrated.

Statement of Equivalence

The NeuTrace EP Mapping System v2.1. Biosense Webster's CARTO 3 EP Navigation System (predicate device), and EnSite X EP System (reference device) all have substantially equivalent intended use, technological characteristics, principles of operation, and ground-truth performance. Bench test data and In-vivo preclinical data for the subject device, predicate device, and reference device have been performed to demonstrate substantial equivalence and ground-truth performance. The testing completed and submitted in this Traditional 510(k) provides objective evidence the NeuTrace System is at least as safe and effective and substantially equivalent to the CARTO 3 System.

Anumana, Inc. · One Main Street, Suite 400, East Arcade 4th Floor, Cambridge, MA 02142

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).