Yes
The device description explicitly states that the VX1 is a "machine and deep learning based-algorithm".
No.
The device is described as assisting operators in the real-time manual annotation of 3D anatomical and electrical maps, and its clinical significance for catheter ablation has not been established. It aids in identification and analysis rather than directly treating a condition.
Yes
The device assists operators in the real-time manual annotation of 3D anatomical and electrical maps for the presence of spatiotemporal dispersion in intra-cardiac atrial electrograms, which is a process of identifying and characterizing a condition.
No
The device description explicitly states that the VX1 software works with existing 510(k) cleared catheters and data acquisition systems, and requires a connection cable and an analog-to-digital converter to transmit data to the computer hosting the software. While the core functionality is software-based, it relies on and integrates with specific hardware components for data acquisition and transmission, making it more than just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens derived from the human body. The VX1 analyzes electrical signals (electrograms) acquired directly from within the human atria using intra-cardiac catheters. It does not analyze blood, tissue, urine, or other bodily fluids or substances that are typically considered specimens for IVD testing.
- The device's function is real-time analysis of electrical activity. The description clearly states the VX1 assists in the "real-time manual annotation of 3D anatomical and electrical maps" and "analyzes the patient's electrograms to cue operators in real-time." This is a direct analysis of physiological signals, not a laboratory test performed on a specimen.
- The device works with existing cardiac mapping and acquisition systems. The description mentions compatibility with the LabSystem Pro and MacLab CardioLab Acquisition Systems, which are used for acquiring and displaying electrophysiological data during cardiac procedures. This further supports its role in analyzing real-time electrical signals within the body.
While the device uses machine and deep learning algorithms and performs analysis, the nature of the input data (real-time intra-cardiac electrograms) and its intended use (assisting in the annotation of electrical maps during a procedure) place it outside the scope of an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" explicitly states "Not Found".
Intended Use / Indications for Use
The VX1 assists operators in the real-time manual annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.
The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The VX1 "" is a machine and deep learning based-algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria for the presence of electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia", i.e., dispersed intra-cardiac atrial electrograms (DEs). The device works with all existing 510(k) cleared catheters that meet specific dimension requirements and with two data acquisition systems: the LabSystem Pro Acquisition System (Boston Scientific) (K141185) and the MacLab CardioLab Acquisition System (General Electric) (K130626). A connection cable is used to connect the data acquisition system with an Advantech PCI-1713U analog-to-digital converter, which transmits the acquired information to a nearby computer that hosts the VX1 software. The computer and its attached display are located outside the sterile operating room area. The VX1 software analyzes the patient's electrograms to cue operators in real-time to intra-cardiac electrograms of interest for atrial regions harboring DEs as well as a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the attached computer display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The VX1 "" is a machine and deep learning based-algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria for the presence of electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia", i.e., dispersed intra-cardiac atrial electrograms (DEs).
Specifically, VX1 methods rely on conceptualizing a discriminant algorithm, which, during training, drew on anonymized information from a very large database of 1.5 second snippets of multipolar intra-cardiac atrial electrograms located on a dedicated data server. In actual commercial use, however, the trained machine and deep learning models are incorporated into the stand alone local software application which is not connected to a network.
Input Imaging Modality
Not Found
Anatomical Site
Human atria
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operators in a cardiac electrophysiology laboratory.
Description of the training set, sample size, data source, and annotation protocol
A k-fold cross-validation of VX1 algorithm was performed on the training database of 275,020 1.5 second annotated electrograms.
Description of the test set, sample size, data source, and annotation protocol
(1) A Reader Study to evaluate the level of inter-operator agreement after unlimited-time physician visual intra-cardiac atrial DE annotation and determine whether algorithm-enabled classification acceptably correlates with physician annotation. A dataset of 14,370 electrograms were adjudicated by three independent experts and VX1 for the presence or absence of dispersed intra-cardiac atrial electrograms.
(2) A period estimation algorithm testing to assess the performance of the VX1 software against two alternative period estimation approaches: a sophisticated auto-correlation (AC) algorithm and a Fast Fourier Transform (FFT) with Blackman window processing across a dataset of 2,550 electrograms.
(4) Limited time annotation testing in which 1,020 electrograms were classified by two annotating experts who were allowed unlimited time to make a classification determination and reach a consensus as to the presence or absence of intra-cardiac atrial dispersion. VX1 performance was compared to the performance of 28 cardiac electrophysiologists who underwent a full-day seminar on spatiotemporal dispersion. The cardiac electrophysiologists each classified 1,020 electrograms as either dispersed or non-dispersed with 17 seconds allotted for each classification.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests:
(1) A Reader Study to evaluate the level of inter-operator agreement after unlimited-time physician visual intra-cardiac atrial DE annotation and determine whether algorithm-enabled classification acceptably correlates with physician annotation. A dataset of 14,370 electrograms were adjudicated by three independent experts and VX1 for the presence or absence of dispersed intra-cardiac atrial electrograms. The study demonstrated that the expert readers both strongly agreed with one another as to the presence or absence of dispersed intra-cardiac atrial electrograms in the evaluated electrogram recordings and that they, similarly, independently agreed with the VX1 adjudication of the presence or absence of intra-cardiac atrial DEs.
(2) A period estimation algorithm testing to assess the performance of the VX1 software against two alternative period estimation approaches: a sophisticated auto-correlation (AC) algorithm and a Fast Fourier Transform (FFT) with Blackman window processing across a dataset of 2,550 electrograms. Overall, the VX1 period estimation algorithm outperformed both the FFT-based and the AC-based algorithms for evaluating noisy and non-periodic electrograms and for estimating the period on the period estimation dataset.
(3) A k-fold cross-validation of VX1 algorithm was performed on the training database of 275,020 1.5 second annotated electrograms. 5-fold cross validation was performed on the model with a resulting accuracy of over 89%.
(4) Limited time annotation testing in which 1,020 electrograms were classified by two annotating experts who were allowed unlimited time to make a classification determination and reach a consensus as to the presence or absence of intra-cardiac atrial dispersion. VX1 performance was compared to the performance of 28 cardiac electrophysiologists who underwent a full-day seminar on spatiotemporal dispersion. The cardiac electrophysiologists each classified 1,020 electrograms as either dispersed or non-dispersed with 17 seconds allotted for each classification. The VX1 algorithm demonstrated superior performance (agreement to the annotating experts) to the cardiac electrophysiologists in identifying dispersed and non-dispersed intra-cardiac atrial electrograms.
Clinical Tests:
An OUS clinical study was performed to evaluate the performance of the VX1 in the detection of intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during a catheter ablation procedure for atrial fibrillation or atrial tachycardia. The study was aimed at evaluating the usability and efficacy of VX1 for detecting DEs and involved 8 centers. 18 operators, and 300 patients. The results indicate that the implementation of VX1 in a cardiac electrophysiology laboratory is not associated with additional risk or procedure time. Also, the VX1 device demonstrated comparable performance in locating electrical signal transmission pattern disruptions as the predicate's CFAE module.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Training accuracy: over 89% (from 5-fold cross validation).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 16, 2020
Volta Medical % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K201298
Trade/Device Name: VX1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DOK Dated: August 17, 2020 Received: August 17, 2020
Dear Janice Hogan:
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
1
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 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 (QS) 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 medical devices and radiation-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,
Mark Fellman Assistant Director 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
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510(k) Number (if known)
Device Name
VX1
Indications for Use (Describe)
The VX1 assists operators in the real-time manual annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.
The clinical significance of utilizing the VX1 software to help identify areas with intra-cardial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY VOLTA MEDICAL's VX1 K201298
Submitter
Volta Medical 29 Boulevard de Louvain 13008 Marseille France Phone: (+33) 6 52 57 96 94
Contact Person: Théophile Mohr Durdez Date Prepared: September 15, 2020
| Name of Device: | VX1 |
|---|---|
| Common or Usual Name: | Cardiac mapping system |
| Classification Name: | Programmable Diagnostic Computer |
| Regulatory Class: | 21 C.F.R. § 870.1425 |
| Product Code: | DQK |
| Predicate Devices: | Biosense Webster, Inc.'s CARTO® XP V10 System |
| (K093566) |
Device Description:
The VX1 "" is a machine and deep learning based-algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria for the presence of electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia", i.e., dispersed intra-cardiac atrial electrograms (DEs). The device works with all existing 510(k) cleared catheters that meet specific dimension requirements and with two data acquisition systems: the LabSystem Pro Acquisition System (Boston Scientific) (K141185) and the MacLab CardioLab Acquisition System (General Electric) (K130626). A connection cable is used to connect the data acquisition system with an Advantech PCI-1713U analog-to-digital converter, which transmits the acquired information to a nearby computer that hosts the VX1 software. The computer and its attached display are located outside the sterile operating room area. The VX1 software analyzes the patient's electrograms to cue operators in real-time to intra-cardiac electrograms of interest for atrial regions harboring DEs as well as a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the attached computer display.
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Intended Use / Indications for Use:
The VX1 assists operators in the real-time manual annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.
The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.
Summary of Technological Characteristics Compared to the Predicate Device:
The VX1 device and its predicate (the CARTO® XP V10 System; K093566) both work with standard electrophysiology catheters to aid in mapping the atria. The predicate device contains several functional modules that are not included in the VX1 device; however, as described in the table below. these functions can generally be performed by another (compatible) device that can be used during the same procedure that includes the VX1 device. Whether these functions are bundled in one device (as with the predicate device) or performed by separate devices during the same procedure does not affect the subject device performance nor raise different questions of safety or effectiveness. Because mapping can be used independently, the provision of a separate functionality in the VX1 versus an integrated functionality in the predicate does not raise new types of questions or otherwise adversely impact performance, as confirmed in the submitted testing.
In particular, the VX1 performs an equivalent function to the CFAE Module of the predicate device. Both devices aid operators by assisting in annotating complex electrical maps of the atria, and both devices process and output information via a computer and display that are operated by use of a keyboard / mouse. Additionally, the signals identified by the VX1 device are of the same nature (multipolar atrial electrograms) as those identified by the CFAE module of CARTO, as demonstrated in the definition of dispersion which partly relies on the definition of CFAE. Both devices also have the same input (intra-cardiac signals) and output (associated dispersion / fractionation).
The CARTO CFAE module: however, performs analysis of individual per-procedural data sets, whereas VX1 includes analytical parameters that pertain to previous similar procedures. Specifically, VX1 methods rely on conceptualizing a discriminant algorithm, which, during training, drew on anonymized information from a very large database of 1.5 second snippets of multipolar intra-cardiac atrial electrograms located on a dedicated data server. In actual commercial use, however, the trained machine and deep learning models are incorporated into the stand alone local software application which is not connected to a network.
Like the predicate device, the VX1 assists in the real-time annotation of complex 3D anatomical and electrical maps of the human atria, including the presence of multipolar electrograms. Thus, both the subject and predicate device have the same intended use,
The indications for use of the CARTO® XP V10 System, while broader, specify that it "displays Complex Fractionated Atrial Electrograms (CFAE)." Spatiotemporal dispersed Intra-cardiac atrial electrograms are a non-exclusive subset of CFAEs in which the
5
fractionation occurs in a non-simultaneous fashion at neighboring electrode locations (temporal dispersion) and are organized in well-defined clusters (spatial dispersion). Thus, the predicate CFAE technology relates to the same cardiac phenomena for which the VX1 is indicated for use.
Neither device is intended for directing treatment or affecting the outcome of any particular heart arrhythmia.
The difference in indications therefore does not alter the intended diagnostic effect, and therefore the first criterion for a finding of substantial equivalence is satisfied.
| | Volta Medical
VX1 | CARTO® XP System with
CARTOXPRESS™ Module
(V10)
K093566 | Comments |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 C.F.R. § 870.1425
Programmable
Diagnostic Computer
Product Code: DQK | 21 C.F.R. § 870.1425
Programmable Diagnostic
Computer
Product Code: DQK | Same |
| Indications
for Use | The VX1 assists
operators in the real-
time manual
annotation of 3D
anatomical and
electrical maps of
human atria for the
presence of multipolar
intra-cardiac atrial
electrograms exhibiting
spatiotemporal
dispersion during atrial
fibrillation or atrial
tachycardia.
The clinical
significance of utilizing
the VX1 software to
help identify areas with
intra-cardiac atrial
electrograms exhibiting
spatiotemporal
dispersion for catheter
ablation of atrial
arrhythmias, such as
atrial fibrillation, has
not been established
by clinical
investigations. | The intended use of the
CARTO® XP System with
CARTOXPRESS™ Module
(V10) is catheter-based
atrial and ventricular
mapping.
The CARTO® XP System
with CARTOXPRESS™
Module (V10) allows real-
time display of cardiac
maps in a number of
different formats. Maps
may be displayed as
cardiac electrical activation
maps, cardiac electrical
propagation maps, cardiac
electrical potential maps,
impedance maps, and
cardiac chamber geometry
maps. The acquired patient
signals, including body
surface EGG and intra-
cardiac electrograms may
also be displayed in real-
time on the system display
screen.
CARTO® XP System with
CARTOXPRESS™ Module
(V10) includes the
CARTOMERGE® capability
to import, register, and | Like the predicate device,
the VX1 assists in the real-
time annotation of complex
3D anatomical and
electrical maps of the
human atria, including the
presence of multipolar
electrograms. Thus, both
the subject and predicate
device have the same
intended use.
The indications for use of
the CARTO® XP V10
System, while broader,
specify that it "displays
Complex Fractionated
Atrial Electrograms
(CFAE)." Spatiotemporal
dispersed intra-cardiac
atrial electrograms are a
non-exclusive subset of
CFAEs in which the
fractionation occurs in a
non-simultaneous fashion
at neighboring electrode
locations (temporal
dispersion) and are
organized in well-defined
clusters (spatial
dispersion). Thus, the
predicate CFAE technology
relates to the same cardiac |
| | Volta Medical
VX1 | CARTO® XP System with
CARTOXPRESSTM Module
(V10)
K093566 | Comments |
| | | merge CT or MRI structural
images with CARTO Maps
physiological information
and real-time catheter
navigation. CARTO® XP
System with
CARTOXPRESSTM Module
(V10) also allows the
integration of intra-cardiac
echo (ICE) 2D images to
provide 3D combined maps.
CARTO® XP System with
CARTOXPRESSTM Module
(V10) includes Fast
Anatomical Mapping (FAM)
that is a method for quick
creation of cardiac
anatomical volumes using
catheters with magnetic
location sensors, supports
the LASSO® NAV Catheter
with location sensors,
displays Complex
Fractionated Atrial
Electrograms (CFAE), and
adds Pace-Mapping
Software (PaSo) ECG
signal correlation tool. | phenomena for which the
VX1 is indicated for use.
Neither device is intended
for directing treatment or
affecting the outcome of
any particular heart
arrhythmia.
Additional CARTO® XP
System with
CARTOXPRESSTM Module
(V10) functions can be
accomplished by other
(compatible) devices used
in the same procedure as
the VX1.
Thus, the difference in
indications does not alter
the intended diagnostic
effect. |
| System Type | Signal processing-
based atrial mapping
system. | Electromagnetic and
catheter-based atrial and
ventricular mapping system. | Similar catheter-based
systems. The lack of
ventricular mapping in the
subject device does not
affect its performance
relative to its atrial mapping
functionality. Further, use
of the VX1 does not
preclude the use of other
mapping systems during
the same procedure which
can perform broad
mapping features (e.g.,
ventricular mapping). The
VX1 simply provides
complementary additional
information regarding
dispersed intra-cardiac
atrial electrograms to the
user in addition to the |
| | Volta Medical
VX1 | CARTO® XP System with
CARTOXPRESS™ Module
(V10)
K093566 | Comments |
| | | | information provided by
traditional mapping
systems. Thus, there are
no different questions of
safety or effectiveness
raised by the VX1 system. |
| Display(s)
Control | Color monitor
Standard keyboard /
mouse | Color monitor
Standard keyboard / mouse | Same
Same |
| Inputs
Required | Intra-cardiac atrial
electrograms that are
recorded with
catheters, amplified
and redirected to an
acquisition system on
which they are
displayed. | ECG and electrogram data
from the patient captured
with proprietary and non-
proprietary catheters and
patches. | Comparable inputs to
those captured by the
CARTO XP System (e.g.,
ECG and EGM data) can
be captured by compatible
devices used during the
same procedure that
includes VX1.
Whether these functions
are bundled in one device
(as with the predicate
device) or performed by
separate devices during
the same procedure does
not affect the subject
device performance nor
raise different questions of
safety or effectiveness.
Use of the VX1 does not
preclude the use of other
mapping systems during
the same procedure which
can provide appropriate
input (ECG and patches). |
| Principal
Mapping
Output | Displays adjudications
as visual cues after
analyzing intra-cardiac
atrial electrograms in
real-time using signal
processing techniques. | Displays anatomical and
electrical maps such as
activation and voltage maps
of the human heart in real-
time using magnetic
navigation techniques and
ECG-EGM analysis. | Use of the VX1 does not
preclude the use of other
mapping systems during
the same procedure which
can perform these
additional mapping
features. Thus, there is no
effect on safety or
effectiveness. |
| Map Types
Generated | Real-time Dispersed
Electrogram (DE)
subtype of multipolar
electrogram map- The
operator is provided
with display of the | Real-time 3D cardiac
maps including: cardiac
electrical activation maps,
cardiac electrical
propagation maps,
impedance maps, and | VX1 provides real-time
adjudications of dispersion
without providing
corresponding 3D mapping
information. The use of the
VX1 does not preclude the |
| | Volta Medical
VX1 | CARTO® XP System with
CARTOXPRESS™ Module
(V10)
K093566 | Comments |
| | electrode locations
where dispersed or
non-dispersed
electrograms have
been recorded during
atrial fibrillation or atrial
tachycardia. | cardiac chamber geometry
maps.
Complex Fractionated Atrial
Electrograms (CFAE) are
displayed on maps that are
colored according to the
duration and repetitions of
fragmented electrograms. | use of other mapping
systems during the same
procedure which can
perform 3D cardiac
maps including: cardiac
electrical activation maps,
cardiac electrical
propagation maps,
impedance maps, and
cardiac chamber geometry
maps. |
| Compatible
Catheters | Any compatible
catheter meeting the
requirements listed
below:
Compatibility
Requirements:
Mapping catheter:
- Electrode size : 1 mm
- Inter-electrode
Spacing : 2 - 3 mm - Number of selected
dipoles : 10
Coronary sinus
catheter: - Electrode size: 1 mm
- Inter-
electrode Spacing : 2 -
3 mm - Number of selected
dipoles : 5 | Supports the Biosense
Webster NAVISTAR® family
of catheters with built-in
magnetic sensor for real-
time navigation, including
the LASSO® NAV Catheter
(K093376) with location
sensors and the ability to
display the catheter's
circular loop based on the
position of magnetic single
axial sensors (SAS) and
provide selective pacing
through the loop electrodes.
Supports the CARTO
SOUNDSTAR 3D
ultrasound catheter; a
location sensing
Intracardiac Echo (ICE)
catheter with an acoustic
array embedded in the
catheter tip that allows the
acquisition of real time
ultrasound images. The
location sensor enables the
accurate location of the
U/S-observed intracardiac
anatomies in the CARTO
XP EP Navigation System
spatial coordinates. | The CARTO proprietary
and non-proprietary
catheters perform identical
electromagnetic sensing
functions to the catheters
that are compatible for use
with VX1.
Other systems' catheters
may be used to provide
real time navigation and/or
catheter loop display,
selective pacing through
the loop electrodes, or
ultrasound integration.
The difference in specific
catheters does not affect
the device performance or
raise different questions of
safety or effectiveness. |
| Hardware
Design and
Materials | Off-the-shelf analog /
digital converter,
computer and monitor,
connection cable,
acquisition system,
proprietary software | Off-the-shelf information
technology (IT) hardware:
computer and monitor,
proprietary catheters,
patient interface unit and
accessories. | Equivalent, but with certain
compatible vs. proprietary
equipment (e.g.,
catheters). |
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Performance Data - Nonclinical Tests:
The Volta Medical VX1 was subjected to extensive non-clinical testing including rigorous verification and validation testing. The Company additionally conducted the following studies:
(1) A Reader Study to evaluate the level of inter-operator agreement after unlimited-time physician visual intra-cardiac atrial DE annotation and determine whether algorithm-enabled classification acceptably correlates with physician annotation. A dataset of 14,370 electrograms were adjudicated by three independent experts and VX1 for the presence or absence of dispersed intra-cardiac atrial electrograms. The study demonstrated that the expert readers both strongly agreed with one another as to the presence or absence of dispersed intra-cardiac atrial electrograms in the evaluated electrogram recordings and that they, similarly, independently agreed with the VX1 adjudication of the presence or absence of intra-cardiac atrial DEs.
(2) A period estimation algorithm testing to assess the performance of the VX1 software against two alternative period estimation approaches: a sophisticated auto-correlation (AC) algorithm and a Fast Fourier Transform (FFT) with Blackman window processing across a dataset of 2,550 electrograms. Overall, the VX1 period estimation algorithm outperformed both the FFT-based and the AC-based algorithms for evaluating noisy and non-periodic electrograms and for estimating the period on the period estimation dataset.
(3) A k-fold cross-validation of VX1 algorithm was performed on the training database of 275,020 1.5 second annotated electrograms. 5-fold cross validation was performed on the model with a resulting accuracy of over 89%.
(4) Limited time annotation testing in which 1,020 electrograms were classified by two annotating experts who were allowed unlimited time to make a classification determination and reach a consensus as to the presence or absence of intra-cardiac atrial dispersion. VX1 performance was compared to the performance of 28 cardiac electrophysiologists who underwent a full-day seminar on spatiotemporal dispersion. The cardiac electrophysiologists each classified 1,020 electrograms as either dispersed or non-dispersed with 17 seconds allotted for each classification. The VX1 algorithm demonstrated superior performance (agreement to the annotating experts) to the cardiac electrophysiologists in identifying dispersed and non-dispersed intra-cardiac atrial electrograms.
Performance Data - Clinical Tests:
An OUS clinical study was performed to evaluate the performance of the VX1 in the detection of intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during a catheter ablation procedure for atrial fibrillation or atrial tachycardia. The study was aimed at evaluating the usability and efficacy of VX1 for detecting DEs and involved 8 centers. 18 operators, and 300 patients. The results indicate that the implementation of VX1 in a cardiac electrophysiology laboratory is not associated with additional risk or procedure time. Also,
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the VX1 device demonstrated comparable performance in locating electrical signal transmission pattern disruptions as the predicate's CFAE module.
Conclusions:
The VX1 device and its predicate both work with standard electrophysiology catheters to aid in mapping the human atria. The predicate device contains several functional modules that are not included in the VX1 device; however, these functions can generally be performed by another device that can be used during the same procedure as the VX1 device. Because mapping can be used independently, the provision of a separate functionality in the VX1 versus an integrated functionality in the predicate does not raise new types of questions or otherwise adversely impact performance, as confirmed in the submitted testing.
Specifically, the VX1 device is substantially equivalent to the CARTO® XP System with CARTOXPRESS™ Module. In particular, the VX1 performs an equivalent function to the CFAE Module of the predicate device, and works with mapping systems and compatible catheters to form a system which is equivalent to the predicate system. The VX1 and CFAE module have similar technological characteristics and principles of operation. The signals identified by the VX1 device are of the same nature (multipolar electrograms), and have the same input (intra-cardiac atrial signals) and output (associated dispersion / fractionation). The VX1 has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended use of the device as an electrophysiological evaluation tool and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the VX1 and its predicate device raise no new issues of safety or effectiveness. Performance data, as described above, demonstrate that the VX1 device is as safe and effective as the predicate. Thus, the VX1 device is substantially equivalent.