(60 days)
Yes
The device description explicitly states that the VX1+ is a "machine and deep learning based-algorithm" and utilizes "machine learning and signal processing techniques."
No.
The device is designed to assist operators in the annotation of anatomical and electrical maps, not to provide therapy directly. It is a diagnostic support tool that helps identify areas of interest for potential subsequent therapeutic interventions, but it does not perform therapeutic action itself.
Yes
The device assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion. This process of identifying and characterizing a medical condition (spatiotemporal dispersion in electrograms) is a diagnostic function.
No
The device description explicitly states that the VX1+ is "composed of a computing platform and a software application" and includes hardware components like a connection cable, an analog-to-digital converter, and a computer with a display.
Based on the provided information, the VX1+ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- VX1+ Function: The VX1+ analyzes electrical signals (electrograms) from within the human heart. It assists operators in interpreting these signals and annotating 3D maps. It does not analyze biological specimens.
- Intended Use: The intended use is to assist operators in real-time annotation of anatomical and electrical maps based on electrogram characteristics, not to diagnose a condition based on the analysis of a biological sample.
- Device Description: The device description focuses on the hardware (computing platform, software, cables, data acquisition systems) and how it processes electrical signals. There is no mention of handling or analyzing biological specimens.
Therefore, the VX1+ falls under the category of a medical device that processes physiological signals, rather than an In Vitro Diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The VX1+ assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intracardiac 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
DQK
Device Description
The VX1+ is a machine and deep learning based-algorithm designed to assist operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of the human heart for the presence of electrograms exhibiting spatio-temporal dispersion, i.e., dispersed electrograms (DEs).
The VX1+ device is a non-sterile reusable medical device, composed of a computing platform and a software application. VX1+ works with all existing 510(k)-cleared catheters that meet specific dimension requirements and with one of the three specific data acquisition systems:
- two compatible EP recording systems (identical to VX1 (Volta Medical (K201298)): the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626),
- a 3D mapping system (novelty compared to VX1): EnSite X 3D mapping system (Abbott) (K221213).
A connection cable is used to connect the corresponding data acquisition system to the VX1+ system, depending on the type of communication used:
- Unidirectional analog communication with the EP recording systems via a custom-made cable (two different variants: DSUB, Octopus) and an Advantech PCI-1713U analog-todigital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the VX1+ software.
- -Bidirectional digital communication with the EnSite 3D mapping system via an ethernet cable (four different lengths: 20,10, 5 or 2m) which transmits the digital signals directly to the computer.
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 intracardiac 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 and/or on a secondary medical screen or on an operating room widescreen. The identified regions of interest are either manually (all configurations) or automatically (only available in digital bidirectional communication with the EnSite X 3D mapping system) tagged in the corresponding 3D mapping system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The VX1+ is a machine and deep learning based-algorithm
Displays and analyzes electrical maps such as intra-cardiac electrograms in real-time using machine learning and signal processing techniques
Input Imaging Modality
Not Found
Anatomical Site
human atria / human heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operators, operating room
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests:
The Volta Medical VX1+ was subjected to non-clinical testing including electromagnetic compatibility and electrical safety tests, rigorous software verification and validation testing including unitary testing of the main algorithm modules of VX1+ application. Specifically the Reader Study described in VX1's 510(k) (K201298) and intended to show that the algorithm's adjudications acceptably correlate with unlimited-time expert visual analysis, was replayed with VX1+ dispersion algorithm.
A usability verification and validation study was launched in a simulated environment at Volta Medical headquarters and in a clinical environment in the scope of the AMPERE study. Usability evaluation did not raise any safety issues and confirmed the relevance of the related risks identified.
Clinical Tests:
The Company supplied data from an OUS clinical study of the VX1+. The study was aimed at evaluating the reliability of VX1+ detection of dispersed electrograms and automatic tagging function, and involved 1 center, 4 operators, and 22 patients. The results indicate that VX1+ reliably assists operators in the detection and auto-tagging of regions harboring dispersed electrograms during AF/AT, with no associated additional risks or procedure time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Volta Medical, VX1 (K201298)
Reference Device(s)
LabSystem Pro EP Recording System (Boston Scientific) (K141185), MacLab CardioLab EP Recording System (General Electric) (K130626), EnSite X 3D mapping system (Abbott) (K221213)
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
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January 21, 2023
Volta Medical % Kristin Zielinski Duggan Partner Hogan Lovells US LLP 555 13 Street NW Washington, District of Columbia 20004
Re: K223516
Trade/Device Name: VX1+ Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: November 22, 2022 Received: November 22, 2022
Dear Kristin Zielinski Duggan:
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.
1
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 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.
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223516
Device Name VX1+
Indications for Use (Describe)
The VX1+ assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intral 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.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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 VOLTA MEDICAL's VX1+
Submitter
Volta Medical
65 Avenue Jules Cantini 13006 Marseille France
Phone: +33 7 68 02 54 99
Contact Person: Paola MILPIED
Date Prepared: November 22, 2022
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
Volta Medical, VX1 (K201298)
Device Description
The VX1+ is a machine and deep learning based-algorithm designed to assist operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of the human heart for the presence of electrograms exhibiting spatio-temporal dispersion, i.e., dispersed electrograms (DEs).
The VX1+ device is a non-sterile reusable medical device, composed of a computing platform and a software application. VX1+ works with all existing 510(k)-cleared catheters that meet specific dimension requirements and with one of the three specific data acquisition systems:
- two compatible EP recording systems (identical to VX1 (Volta Medical (K201298)): the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626),
- a 3D mapping system (novelty compared to VX1): EnSite X 3D mapping system (Abbott) (K221213).
4
A connection cable is used to connect the corresponding data acquisition system to the VX1+ system, depending on the type of communication used:
- Unidirectional analog communication with the EP recording systems via a custom-made cable (two different variants: DSUB, Octopus) and an Advantech PCI-1713U analog-todigital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the VX1+ software.
- -Bidirectional digital communication with the EnSite 3D mapping system via an ethernet cable (four different lengths: 20,10, 5 or 2m) which transmits the digital signals directly to the computer.
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 intracardiac 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 and/or on a secondary medical screen or on an operating room widescreen. The identified regions of interest are either manually (all configurations) or automatically (only available in digital bidirectional communication with the EnSite X 3D mapping system) tagged in the corresponding 3D mapping system.
Intended Use / Indications for Use
The VX1+ assists operators in the real-time manual or automatic 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
The VX1+ device is a new device manufactured by Volta Medical, based on the same concept (identification of electrograms dispersion) than predicate VX1.
VX1 and VX1+ are both software programs that work with standard electrophysiology catheters to aid in mapping the heart. Both devices aid operators by assisting in annotating complex electrical maps of the heart, and both devices process and output information via a computer and display that are operated by use of a keyboard / mouse. VX1 and VX1+ have the same input (intra-cardiac multipolar signals) and the same output (associated dispersion), with the addition of the 3D position of the corresponding electrodes available in VX1+.
VX1 and VX1+ support Electrophysiologists in the manual annotation of dispersed areas using a unidirectional analog communication. In addition, VX1+ brings the ability to connect to a
5
specific 3D mapping system through a bidirectional digital communication, which enables the operator to use the automatic tagging function.
The VX1+ indications for use are the same as for the VX1, with the addition of automatic annotation. The VX1+ displays an analysis of dispersed electrograms, just as VX1 and therefore, the intended use of the VX1+ and the VX1 are essentially the same.
| Regulation
Classification
Name
Product
Code
Indications
for Use
System Type
Primary
Feature | Volta Medical
VX1+ | Volta Medical
VX1
(K201298) |
|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 C.F.R. § 870.1425 | 21 C.F.R. § 870.1425 |
| Classification
Name | Programmable Diagnostic
Computer | Programmable Diagnostic
Computer |
| Product
Code | DQK | DQK |
| Indications
for Use | The VX1+ assists operators in the
real-time manual or automatic
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 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. |
| System Type | Signal processing based atrial
mapping system | Signal processing based atrial
mapping system |
| Primary
Feature | Displays and analyzes electrical
maps such as intra-cardiac
electrograms in real-time using
machine learning and signal
processing techniques | Displays and analyzes electrical
maps such as intra-cardiac
electrograms in real-time using
machine learning and signal
processing techniques |
| | Volta Medical
VX1+ | Volta Medical
VX1
(K201298) |
| 3D Location
Technology | Electroanatomic location is
performed by another commercially
available navigation system.
In bidirectional digital
communication, 3D Location is
shared by the 3D Mapping System
with VX1+. | Electroanatomic location is
performed by another commercially
available navigation system. |
| Compatible
Acquisition
Systems | LabSystem Pro EP Recording System (Boston Scientific) CardioLab EP Recording System (GE) EnSite X 3D Mapping System (Abbott) | LabSystem Pro EP Recording System (Boston Scientific) CardioLab EP Recording System (GE) |
| Compatible
Catheters
Display(s) | Any compatible mapping and
ablation catheter
Color monitor | Any compatible mapping and
ablation catheter
Color monitor |
| Multi-Display
Support | Yes, duplicate display on a
secondary medical screen or on an
operating room widescreen | Yes, duplicate display on a
secondary medical screen or on an
operating room widescreen |
| Control | Standard keyboard / mouse | Standard keyboard / mouse |
| Display
Timing | Real-time | Real-time |
| Inputs
Required | Analog or digital Intra-cardiac
signals
In digital mode, 3D locations of
corresponding electrodes bipoles | Analog Intra-cardiac signals |
| Output | Presence or absence of
electrogram dispersion at each
electrode bipole under
consideration
In digital mode, 3D locations of
corresponding electrodes bipoles
Computed values of mapping and
reference cycle length | Presence or absence of
electrogram dispersion at each
electrode bipole under
consideration
Computed values of mapping and
reference cycle length |
| Duration of
Electrogram
Recordings | 1.5 Seconds | 1.5 Seconds |
| Ouput
Display | The system generates color coded
symbol(s) that indicates to the
operator that the area under | The system generates color coded
symbol(s) that indicates to the
operator that the area under |
| | Volta Medical
VX1+ | Volta Medical
VX1
(K201298) |
| | investigation is one exhibiting
dispersion
In bidirectional digital
communication, validated
dispersion area can also be
automatically displayed in the 3D
mapping system as tags in the 3D
atrial shell | investigation is one exhibiting
dispersion |
| Signal
Information
Displayed | Acquired patient signals, including
body surface ECG and intra-cardiac
EGMs. | Acquired patient signals, including
body surface ECG and intra-cardiac
EGMs. |
| Computing
Platform | Computer with Intel Core i7-7700
CPU (8MB Cache, up to 4.20 GHz,
RAM 32 GB),
with integrated analog/digital
converter PCI card and TPM
(Trusted Platform Module)
Debian-based Linux OS | Computer with Intel Core i5-6500
CPU (6MB Cache, up to 3.60 GHz,
RAM 32 GB),
with integrated analog/digital
converter PCI card
Windows 10 or higher OS |
| Hardware
Design and
Materials | Computing platform, proprietary
software algorithm, monitor,
mouse/keyboard, custom-made
analog connection cable, ethernet
cable, acquisition system | Computing platform, proprietary
software algorithm, monitor,
mouse/keyboard, custom-made
analog connection cable,
acquisition system |
6
7
Performance Data - Nonclinical Tests:
The Volta Medical VX1+ was subjected to non-clinical testing including electromagnetic compatibility and electrical safety tests, rigorous software verification and validation testing including unitary testing of the main algorithm modules of VX1+ application. Specifically the Reader Study described in VX1's 510(k) (K201298) and intended to show that the algorithm's adjudications acceptably correlate with unlimited-time expert visual analysis, was replayed with VX1+ dispersion algorithm.
A usability verification and validation study was launched in a simulated environment at Volta Medical headquarters and in a clinical environment in the scope of the AMPERE study. Usability evaluation did not raise any safety issues and confirmed the relevance of the related risks identified.
8
Performance Data - Clinical Tests:
Since a full set of tests was performed, including a non-regression analysis of VX1+ versus VX1 with respect to dispersion adjudication, additional clinical data is not required to demonstrate substantial equivalence of the VX1+. However; for completeness, the Company supplied data from an OUS clinical study of the VX1+. The study was aimed at evaluating the reliability of VX1+ detection of dispersed electrograms and automatic tagging function, and involved 1 center, 4 operators, and 22 patients. The results indicate that VX1+ reliably assists operators in the detection and auto-tagging of regions harboring dispersed electrograms during AF/AT, with no associated additional risks or procedure time.
Conclusions
The VX1+ is as safe and effective as the VX1. The VX1+ has the same intended uses and same indications, and substantially similar technological characteristics, and principles of operation as its predicate device. The introduction of the automatic tagging feature does 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 (i.e., bidirectional communication with the acquisition system) 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 VX1. Thus, the VX1+ device is substantially equivalent.