Who is the manufacturer of NeuTrace EP Mapping System v.2.1?

Anumana, Inc. filed the 510(k) submission for NeuTrace EP Mapping System v.2.1 (K233160).

What is the FDA product code for NeuTrace EP Mapping System v.2.1?

DQK. It is classified under 21 CFR 870.1425 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for NeuTrace EP Mapping System v.2.1?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like NeuTrace EP Mapping System v.2.1?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NeuTrace EP Mapping System v.2.1

K233160 · Anumana, Inc. · DQK · Nov 25, 2023 · Cardiovascular

Device Facts

Record ID	K233160
Device Name	NeuTrace EP Mapping System v.2.1
Applicant	Anumana, Inc.
Product Code	DQK · Cardiovascular
Decision Date	Nov 25, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1425
Device Class	Class 2

Intended Use

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 Story

NeuTrace EP Mapping System v2.1 is a 3D electroanatomical mapping (EAM) system for cardiac EP procedures. It uses magnetic-based localization to track compatible catheters (e.g., FlexAbility Sensor Enabled) within the right atrium. Input includes cardiac electrical signals (ECGs/EGMs) and catheter position data. The system processes these inputs to generate 3D cardiac models and overlays derived metrics, including Peak-to-Peak Voltage, Local Activation Time (LAT), Fractionation, and Minimum dV/dt. Used in clinical EP labs by physicians and trained staff; output is displayed on a workstation monitor to assist in mapping cardiac activity and guiding ablation procedures. The system supports lesion visualization and tagging. By providing real-time visualization of catheter location and electrical activity, it aids clinicians in diagnosing and treating cardiac arrhythmias, potentially improving procedural accuracy and patient outcomes.

Clinical Evidence

No human clinical data. Evidence consists of bench testing and a GLP animal study. Bench testing included software V&V, hardware verification (shift/drift/time delay), cybersecurity, EMC/EMI (IEC 60601-1/1-2), and comparative mapping analyses. GLP animal study verified system performance for accuracy, geometry, and mapping (LAT, voltage, fractionation). Results: ground-truth accuracy <1mm, shift <1mm, drift <2mm. Demonstrated equivalent 3D geometry and map generation compared to CARTO 3 and EnSite X systems.

Technological Characteristics

3D electroanatomical mapping system using magnetic-based localization. Components: workstation, sensor interface/control units, window field generator, interface switches. Compatible with FlexAbility Sensor Enabled ablation catheters. Connectivity: workstation-based. Software: NeuTrace Software Application v2.1 and Streaming Application Software v2.0. Standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for patients eligible for conventional catheter-based cardiac electrophysiological (EP) procedures in the right atrium. No special contraindications.

Regulatory Classification

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.

Predicate Devices

CARTO 3 EP Navigation System (K133916)

Reference Devices

EnSite X EP System (K202066)

Related Devices

K200484 — CARTO® 3 EP Navigation System with Signal Processing Unit · Biosense Webster, Inc. · Nov 25, 2020
K072202 — CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) · Biosense Webster, Inc. · Nov 19, 2007
K132782 — CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 · Biosense Webster, Inc. · Jan 24, 2014
K254085 — CARTO 3 EP Navigation System V9.0 with PIU Plus · Biosense Webster, Inc. · Jan 18, 2026
K130750 — RHYTHMIA MAPPING SYSTEM · Rhythmia Medical, Inc. · Jul 22, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. 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. {1}------------------------------------------------ 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, {2}------------------------------------------------ Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233160 Device Name NeuTrace EP Mapping System v.2.1 #### Indications for Use (Describe) 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. 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.qov "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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the word "anumana" in a sans-serif font. To the left of the word is a graphic consisting of a dot and two vertical lines of different lengths. The color of the text and graphic is a light shade of blue. The background is white. # 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 400 East Arcade 4th Floor, Cambridge MA 02142 | | Contact Persons: | Suzanne Goodman Vice President of Quality and Regulatory Sgoodman@nference.net (919) 608-6082 | | | Animesh Agarwal Vice President of Product Management animesh.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 {5}------------------------------------------------ ### 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. # Indications For Use 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. # 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 {6}------------------------------------------------ similar catheter compatibility. The NeuTrace System is compared to the predicate and reference devices in the table below. | | NeuTrace EP Mapping System v2.1 (NeuTrace System) Subject of this 510(k) | Biosense Webster's CARTO 3 EP Navigation System (CARTO 3 System) (Predicate Device) | EnSite X EP System (Reference Device) | Comments | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | 510(k) | K233160 | K133916 | K202066 | N/A | | Device class | II | II | II | Same | | Classification | Programmable diagnostic-computer Class II; 21 CFR, 870.1425 | Programmable diagnostic-computer Class II; 21 CFR, 870.1425 | Programmable Diagnostic Computer Class II; 21 CFR 870.1425 | Same | | Product code | DQK | DQK | DQK | Same | | Indications/ Intended use | 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. | The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System 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. The system has no special contraindications. | The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures. | Same | | | NeuTrace EP Mapping System v2.1 (NeuTrace System) Subject of this 510(k) | Biosense Webster's CARTO 3 EP Navigation System (CARTO 3 System) (Predicate Device) | EnSite X EP System (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 | | | System Components | 1. Sensor Interface Unit & Sensor Control Unit 2. Workstation with Graphic User Interface 3. Keyboard, and mouse 4. Power Supply 5. Monitor 6. Window Field Generator 7. Interface switches and conn. cables | 1. Patient Interface Unit (PIU) 2. Workstation with Graphic User Interface 3. Keyboard, and mouse 4. Power Supply 5. Monitor 6. Location Pad 7. Patches & Connection Box 8. Foot pedals | 1. Amplifier with associated modules 2. Workstation with monitors and isolation transformer 3. Optional printer 4. Field Frame Generator 5. Catheter Input Modules 6. Patient Reference Sensors 7. ECG cable. | Similar. The component differences do not affect the intended use. | | Principles of | Magnetic-based | Magnetic-based | Magnetic-Based | Less | | operation/ location technology | localization Secondary: n/a | localization Secondary: impedance-based localization | localization Secondary: impedance-based localization | accurate impedance mode is not required for the same | | | | | | intended use | | Compatible Catheters | 1. FlexAbilityTM Ablation Catheter, Sensor Enabled™ | 1.Specialized catheters with integrated magnetic sensor | 1.Specialized catheters with integrated magnetic sensor | 1.Same | | | 2. n/a | 2.Conventional catheters (w/o magnetic sensors) | 2.Conventional catheters (w/o magnetic sensors) | 2. Not req'd for the same intended use. | | Acquisition of data points | Manual or automatic | Manual or automatic | Manual or automatic | Same | | | NeuTrace EP Mapping System v2.1 (NeuTrace System) Subject of this 510(k) | Biosense Webster's CARTO 3 EP Navigation System (CARTO 3 System) (Predicate Device) | EnSite X EP System (Reference Device) | Comments | | 3D Geometry mapping | Yes | Yes | Yes | Same | | Electrograms for activation and voltage mapping | Yes. Local Activation Time maps, voltage maps, propagation maps, & fractionation maps | Yes, Local Activation Time maps, voltage maps, impedance maps, and propagation maps | Yes, Local Activation Time maps, voltage maps, impedance maps, and propagation maps | Similar - NeuTrace does not include the lower accuracy Impedance maps | | Ablation lesion visualization and tagging | Yes | Yes, optional (Visitag Module) | Yes | Same | | Compatible with an RF generator | Yes | Yes | Yes | Same | {7}------------------------------------------------ {8}------------------------------------------------ ### 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 {9}------------------------------------------------ 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