(59 days)
No
The summary describes a 3D electroanatomical mapping system that displays data and derived metrics, but there is no mention of AI or ML being used for analysis, interpretation, or decision support. The performance studies focus on accuracy and equivalency of mapping and geometry generation, not on AI/ML model performance.
No.
The device is for mapping and analysis of cardiac activity, providing diagnostic information about heart electrophysiology and catheter location, but it does not directly treat a condition.
Yes
The device provides information about the electrical activity of the heart and catheter location, and displays cardiac activity signals as waveforms (ECGs and EGMs), along with derived voltage and time metric overlays over cardiac models. This information is used to support electrophysiology procedures, which are diagnostic in nature.
No
The device description explicitly lists multiple hardware components in addition to the software applications.
Based on the provided information, the NeuTrace EP Mapping System v2.1 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- NeuTrace System Function: The NeuTrace system is used during a medical procedure (catheter-based cardiac electrophysiological procedures) to provide real-time information about the electrical activity of the heart and the location of catheters within the body. It does not analyze samples taken from the body.
The NeuTrace system is a medical device used for in vivo procedures, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
DQK
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
EP's and EP lab staff trained on the use of the system
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
§ 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).
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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.
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) |
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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 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 |
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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