(479 days)
No
The description focuses on 3D mapping, navigation, and electrogram display using electromagnetic and impedance tracking. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a mapping and navigation system used for displaying catheter position and cardiac electrical activity, not for directly treating a condition.
Yes
The device displays cardiac electrical activity as waveform traces and electroanatomical maps, measures cardiac electrogram (EGM) information, and generates patient-specific images of the heart, all of which are used to provide information about a patient's physiological state. Additionally, the predicate devices are described as "Cardiac Mapping Systems" and "Diagnostic Catheter," further supporting its diagnostic nature.
No
The device description explicitly states it is a "catheter navigation and mapping system" that utilizes "electromagnetic tracking and impedance tracking" and a "Coronary Sinus (CS) catheter with both electromagnetic sensors and electrodes." These are hardware components, not solely software.
Based on the provided information, the CardioNXT iMap™ 3D Mapping & Navigation System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The CardioNXT iMap™ System is a catheter navigation and mapping system used during conventional electrophysiological procedures. It displays the position of catheters and cardiac electrical activity within the patient's body.
- Lack of Sample Analysis: The system does not analyze samples taken from the body. It directly interacts with and measures electrical signals within the heart.
Therefore, the CardioNXT iMap™ 3D Mapping & Navigation System falls under the category of a medical device used for guiding procedures and displaying real-time physiological data, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CardioNXT iMap™ 3D Mapping & Navigation System is intended for the display of compatible electrophysiology catheter position and cardiac electrical activity when used with the MultiLink CS Catheter during conventional electrophysiological procedures.
The MultiLink CS Catheter is used for electrogram recording and as a navigation reference during conventional electrophysiological procedures.
Product codes
DQK, DRF
Device Description
The CardioNXT iMap™ 3D Mapping and Navigation System (iMap™ 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 electroanatomical maps of the cardiac chamber. The contoured surfaces of these threedimensional maps are based on the anatomy of the patient's cardiac chamber. The iMap™ System utilizes electromagnetic tracking and impedance tracking to track conventional catheters and paint the surfaces of cardiac chambers in 3D to generate a patient-specific image of the heart, also called a geometry. The iMap System measures cardiac electrogram (EGM) information from navigated catheter electrodes throughout the heart and displays this information on the patient-specific geometry. The iMap System utilizes a Coronary Sinus(CS)catheter with both electromagnetic sensors and electrodes as a reference for its navigation coordinate system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart / Cardiac chamber
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed cardiac electrophysiologist physicians
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 and animal testing were completed.
The iMap™ 3D Mapping & Navigation System meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device as evidenced by the following testing:
- CardioNXT iMap System verification testing
- GLP animal study
- Bench Testing demonstrating substantially equivalent safety, performance, and accuracy to predicate
- Electrical Safety Testing (ANSI/AAMI ES60601-1:2005/A1:2012)
- Electrical Safety Testing (IEC 60601-2-2:2017)
- Electromagnetic Compatibility Testing (IEC 60601-1-2:2014, EN 55011:2009)
- Biocompatibility Testing (ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-4:2017, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017)
- Cleaning and Sterilization Testing per Final Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Healthcare Settings: Validation Methods and Labeling
- Storage and Transport Testing (ISTA 2A)
- Diagnostic Intravascular Catheter Testing (ISO 10555-1:2013)
- Software verification and validation testing per IEC 62304/FDA Guidance
- Compatibility testing in a cardiac electrophysiology lab environment
- Usability testing demonstrating usability by licensed cardiac electrophysiologist physicians
Key Results: Bench testing demonstrates the iMap™ 3D Mapping & Navigation System meets performance specifications. Validation testing through a GLP controlled animal study further demonstrated performance of the iMap™ 3D Mapping & Navigation System and substantial equivalence to the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 16, 2021
CardioNXT, Inc. Jerome Edwards President 12011 Tejon Street, Suite 700 Westminster, Colorado 80234
Re: K201094
Trade/Device Name: iMap™ 3D Mapping & Navigation System (iMap™ System) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DRF Dated: August 13, 2021 Received: August 16, 2021
Dear Jerome Edwards:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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 Deoras Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201094
Device Name
iMap™ 3D Mapping & Navigation System (iMap™ System)
Indications for Use (Describe)
The CardioNXT iMap™ 3D Mapping & Navigation System is intended for the display of compatible electrophysiology catheter position and cardiac electrical activity when used with the MultiLink CS Catheter during conventional electrophysiological procedures.
The MultiLink CS Catheter is used for electrogram recording and as a navigation reference during conventional electrophysiological procedures.
| 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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3
510(k) Summary
iMap™ 3D Mapping & Navigation System
K201094
1. Submission Sponsor
CardioNXT, Inc. 12011 Tejon Street, Suite 700 Westminster, Colorado 80234 USA Contact: Jerome Edwards Title: Chief Executive Officer Phone: 615.473.9012 Email: jerome.edwards(@cardionxt.com
2. Date Prepared
August 13, 2021
3. Device Identification
| Trade/Proprietary Name: | iMapTM 3D Mapping & Navigation System (iMapTM System) |
|---|---|
| Common/Usual Name: | Programmable diagnostic computer |
| Classification Name: | Computer, Diagnostic, Programmable |
| Regulation Number: | 21 CFR §870.1425 |
| Product Code: | DQK; Computer, Diagnostic, Programmable |
| Device Class: | Class II |
| Classification Panel: | Cardiovascular |
4. Predicate Device Information
| Predicate Device | Primary or
Secondary
Predicate | Manufacturer | 510(k) No. |
|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------|------------|
| EnSite Precision™ Cardiac Mapping System | Primary | Abbott St. Jude | K160210 |
| EnSite™ Velocity Cardiac Mapping System with EnSite™
Velocity Surface Electrode Kit (Commonly known as
the NavX System) | Secondary | Abbott St. Jude | K160186 |
| IBI Inquiry Diagnostic Catheter (Secondary Predicate) | Secondary | Abbott St. Jude | K961924 |
4
5. Indication for Use Statement
The CardioNXT iMap™ 3D Mapping & Navigation System is intended for the display of compatible electrophysiology catheter position and cardiac electrical activity when used with the MultiLink CS Catheter during conventional electrophysiological procedures. The MultiLink CS Catheter is used for electrogram recording and as a navigation reference during conventional electrophysiological procedures.
6. Device Description
The CardioNXT iMap™ 3D Mapping and Navigation System (iMap™ 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 electroanatomical maps of the cardiac chamber. The contoured surfaces of these threedimensional maps are based on the anatomy of the patient's cardiac chamber. The iMap™ System utilizes electromagnetic tracking and impedance tracking to track conventional catheters and paint the surfaces of cardiac chambers in 3D to generate a patient-specific image of the heart, also called a geometry. The iMap System measures cardiac electrogram (EGM) information from navigated catheter electrodes throughout the heart and displays this information on the patient-specific geometry. The iMap System utilizes a Coronary Sinus(CS)catheter with both electromagnetic sensors and electrodes as a reference for its navigation coordinate system.
7. Substantial Equivalence Discussion
The following tables compares the iMap™ 3D Mapping & Navigation System and Multilink CS Catheter to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Manufacturer | Subject Device:
CardioNXT, Inc. | Primary Predicate:
Abbott / St. Jude | Secondary Predicate:
Abbott / St. Jude | Device
Comparison |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | iMapTM 3D Mapping
and Navigation
System | EnSiteTM Precision
Cardiac Mapping
System V2.0.1 | EnSiteTM Velocity
Cardiac Mapping
System v4.0.2 with
EnSiteTM Velocity
Surface Electrode Kit | |
| 510(k) Number | K201094 | K160210 | K160186 (with patches) | Not applicable |
| Product Code | DQK | DQK | DQK | Same |
| Regulation
Number | 21 CFR 870.1425 | 21 CFR 870.1425 | 21 CFR 870.1425 | Same |
| Regulation
Name | Programmable Diagnostic
Computer | Programmable
Diagnostic Computer | Programmable Diagnostic
Computer | Same |
| Indications for
Use | The CardioNXT iMap 3D
Mapping & Navigation | The EnSiteTM Precision
Cardiac Mapping | The EnSiteTM VelocityTM
Cardiac Mapping System | Similar with
minor variation. |
| Manufacturer | Subject Device:
CardioNXT, Inc. | Primary Predicate:
Abbott / St. Jude | Secondary Predicate:
Abbott / St. Jude | Device
Comparison |
| Trade Name | iMap™ 3D Mapping
and Navigation
System | EnSite™ Precision
Cardiac Mapping
System V2.0.1 | EnSite™ Velocity
Cardiac Mapping
System v4.0.2 with
EnSite™ Velocity
Surface Electrode Kit | |
| | System is intended for the
display of compatible
electrophysiology catheter
position and cardiac
electrical activity when
used with the MultiLink
CS Catheter during
conventional
electrophysiological
procedures.
The MultiLink CS
Catheter is used for
electrogram recording and
as a navigation reference
during conventional
electrophysiological
procedures. | System is a suggested
diagnostic tool in
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
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.
OR
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. | is a suggested diagnostic
tool in patients for whom
electrophysiology studies
have been indicated.
When used with the
EnSite™ Array™
Catheter, the EnSite™
Velocity™ Cardiac
Mapping System is
intended to be used in the
right atrium of patients
with complex arrhythmias
that may be difficult to
identify using
conventional mapping
systems alone.
OR
When used with an
EnSite™ Velocity™
Surface Electrode Kit, the
EnSite™ Velocity™
Cardiac Mapping System
is intended to display the
position of conventional
electrophysiology (EP)
catheters in the heart. | While the exact
wording of the
indications for
use is not
identical, all
elements of the
indications for
the CardioNXT
iMap System are
contained within
the indications
for use for the
predicate devices. |
| Physical Characteristics | | | | |
| System
Components to | iMap Controller
iMap Field Generator
(NDI) | Ensite Precision™ Link
(NDI) | Ensite™ Amplifier
NavLink
GenConnect | Similar
components |
| Manufacturer | Subject Device:
CardioNXT, Inc. | Primary Predicate:
Abbott / St. Jude | Secondary Predicate:
Abbott / St. Jude | Device
Comparison |
| Trade Name | iMap™ 3D Mapping
and Navigation
System | EnSite™ Precision
Cardiac Mapping
System V2.0.1 | EnSite™ Velocity
Cardiac Mapping
System v4.0.2 with
EnSite™ Velocity
Surface Electrode Kit | |
| Achieve
Intended Use | iMap Patient Interface
iMap Ablation Adapter
iMap RF Ground Filter
iMap Power Unit
iMap Computer
workstation
Monitor, keyboard, and
mouse | Ensite™ Field Frame
(NDI)
Ensite™ Amplifier
NavLink
GenConnect
Computer workstation
Monitor, keyboard, and
mouse | Computer workstation
Monitor, keyboard, and
mouse | |
| Patient Patches | 6 external patches plus
electromagnetic
references. | 6 external patches with
one reference patch, plus
electromagnetic
references. | 6 external patches with
one reference patch | Similar |
| Catheters | Compatible EP catheters
and Multilink CS Catheter | Compatible EP catheters
and at least one
magnetic sensor-based
catheter; Advisor FL
Circular Mapping
Catheter | Compatible EP catheters | Similar |
| Technology | | | | |
| Principle of
Operation | Measure the impedance
position and
electromagnetic position
of catheters and display
position of both on a
computer screen.
Measure EGMs and
display that information
as tracings and as 3D
model information based
on a patient's cardiac
chamber. | Measure the impedance
position and
electromagnetic position
of catheters and display
position of both on a
computer screen.
Measure EGMs and
display that information
as tracings and as 3D
model information based
on a patient's cardiac
chamber. | Measure the impedance
position of catheters and
display position on a
computer screen.
Measure EGMs and
display that information
as tracings and as 3D
model information based
on patient's cardiac
chamber. | Technological
and performance
characteristics are
similar. |
| Localization
Technology | Proprietary
Patch to Electrode
Impedance measurement
Northern Digital (NDI) –
Aurora electromagnetic
Window Field Generator | Proprietary
Patch to Electrode
Impedance measurement
Northern Digital (NDI)
— Aurora
electromagnetic
Window Field Generator | Proprietary
Patch to Electrode
Impedance measurement | Similar
Impedance
Localization.
Same
Electromagnetic
localization. |
| 3D Geometry
of Endocardial
Surface | Chamber surface
(Geometry) gathered by
navigated catheter | Chamber surface
(Geometry) gathered by
navigated catheter | Chamber surface
(Geometry) gathered by
navigated catheter. | Same. |
| Manufacturer | Subject Device:
CardioNXT, Inc. | Primary Predicate:
Abbott / St. Jude | Secondary Predicate:
Abbott / St. Jude | Device
Comparison |
| Trade Name | iMap™ 3D Mapping
and Navigation
System | EnSite™ Precision
Cardiac Mapping
System V2.0.1 | EnSite™ Velocity
Cardiac Mapping
System v4.0.2 with
EnSite™ Velocity
Surface Electrode Kit | |
| Contact
Electro-
anatomical
Mapping | Activation and Voltage. | Activation and Voltage. | Activation and Voltage. | Same. |
| Simultaneous
Navigation of
multiple
catheters | Multiple catheters, with at
least Multilink CS
Catheter | Multiple catheters, with
at least one magnetic
sensor-based catheter. | Multiple catheters. | Similar. |
5
6
7
| Manufacturer | Subject Device:
CardioNXT, Inc. | Primary Predicate:
Abbott / St. Jude / Irvine
Biomedical Inc. | Device
Comparison |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | MultiLink CS Catheter | IBI Inquiry Diagnostic
Electrophysiology Catheter | |
| 510(k) Number | K201094 | K961924 | Not applicable |
| Product Code | DRF | DRF | Same |
| Regulation Number | 21 CFR 870.1220 | 21 CFR 870.1220 | Same |
| Indications for Use | The CardioNXT iMap 3D Mapping &
Navigation System is intended for the
display of compatible electrophysiology
catheter position and cardiac electrical
activity when used with the MultiLink
CS Catheter during conventional
electrophysiological procedures.
The MultiLink CS Catheter is used for
electrogram recording and as a
navigation reference during
conventional electrophysiological
procedures. | The InquiryTM fixed curve and
steerable electrophysiology catheters
are used for electrogram recording
and cardiac stimulation during
diagnostic electrophysiology studies.
The catheters are commonly placed at
the high right atrium, right
ventricular apex, and HIS bundle. | Similar. While
the exact
wording of the
indications for
use is not
identical, all
elements of the
indications for
the MultiLink
CS Catheter are
contained within
the indications
for use for the
predicate device. |
| Device Description | Steerable 6 Fr. decapolar (plus two
additional proximal electrodes and
electromagnetic sensors)
electrophysiology recording catheter. | Steerable 6 Fr. decapolar
electrophysiology recording catheter. | Similar |
| Physical Characteristics | | | |
| Shaft and
Electrodes | 110cm shaft, 6Fr, 10 electrodes with 2-
5-2 spacing and 2 electrodes along
proximal curve. | 110cm shaft, 6Fr, 10 electrodes with
2-5-2 spacing. | Same, Multilink
has 2 additional
electrodes |
8
| Manufacturer | Subject Device:
CardioNXT, Inc. | Primary Predicate:
Abbott / St. Jude / Irvine
Biomedical Inc. | Device
Comparison |
|--------------|--------------------------------------------------------------|---------------------------------------------------------------------|----------------------|
| Trade Name | MultiLink CS Catheter | IBI Inquiry Diagnostic
Electrophysiology Catheter | |
| Handle | Push/Pull knob, uni-directional
deflection with connector | Push/Pull knob, uni-directional
deflection with connector | Similar |
8. Performance Data
As part of demonstrating safety, effectiveness, and substantial equivalence of the iMap™ 3D Mapping & Navigation System, CardioNXT, Inc. completed bench and animal testing. The iMap™ 3D Mapping & Navigation System meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device as evidenced by the following testing:
- CardioNXT iMap System verification testing
- . GLP animal study
- Bench Testing demonstrating substantially equivalent safety, performance, and accuracy to predicate
- Electrical Safety Testing (ANSI/AAMI ES60601-1:2005/A1:2012) ●
- . Electrical Safety Testing (IEC 60601-2-2:2017)
- Electromagnetic Compatibility Testing (IEC 60601-1-2:2014, EN 55011:2009) .
- . Biocompatibility Testing (ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-4:2017, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017)
- . Cleaning and Sterilization Testing per Final Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Healthcare Settings: Validation Methods and Labeling
- Storage and Transport Testing (ISTA 2A)
- . Diagnostic Intravascular Catheter Testing (ISO 10555-1:2013)
- Software verification and validation testing per IEC 62304/FDA Guidance
- . Compatibility testing in a cardiac electrophysiology lab environment
- Usability testing demonstrating usability by licensed cardiac electrophysiologist physicians
9. Conclusions
Bench testing demonstrates the iMap™ 3D Mapping & Navigation System meets performance specifications. Validation testing through a GLP controlled animal study further demonstrated performance of the iMap™ 3D Mapping & Navigation System and substantial equivalence to the predicate. As such, this collection of testing demonstrates the substantial equivalence of the iMap System to the predicate device.