Volta AF-Xplorer

K232616 · Volta Medical · DQK · Sep 27, 2023 · Cardiovascular

Device Facts

• Record ID: K232616
• Device Name: Volta AF-Xplorer
• Applicant: Volta Medical
• Product Code: DQK · Cardiovascular
• Decision Date: Sep 27, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

The Volta AF-Xplorer 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 Volta AF-Xplorer 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.

Device Story

Volta AF-Xplorer is a machine/deep learning-based software system assisting electrophysiologists in identifying dispersed electrograms during atrial fibrillation or tachycardia. Input: intra-cardiac multipolar signals (analog or digital) from compatible catheters and EP recording systems (LabSystem Pro, MacLab CardioLab) or 3D mapping systems (EnSite X). Operation: system analyzes 1.5-second electrogram segments to detect spatiotemporal dispersion; computes cycle lengths. Output: real-time visual cues on a display; manual or automatic tagging of regions of interest on 3D atrial maps. Used in clinical electrophysiology labs; operated by physicians/technicians. Benefits: assists in identifying potential ablation targets; clinical significance for ablation outcomes not established.

Clinical Evidence

Bench testing only. Software verification and validation performed; processing performance demonstrated to be equivalent to predicate devices VX1 and VX1+ using established acceptance criteria. No clinical data provided.

Technological Characteristics

Non-sterile reusable system comprising a computing platform (Intel Core i7-7700, 32GB RAM, Debian-based Linux) and software. Connectivity: unidirectional analog (via Advantech PCI-1713U converter) or bidirectional digital (Ethernet) to EP recording/mapping systems. Sensing: intra-cardiac multipolar signals. Algorithm: machine/deep learning-based for dispersion detection. Output: real-time visual display and 3D map tagging.

Indications for Use

Indicated for operators performing 3D anatomical and electrical mapping of human atria during atrial fibrillation or atrial tachycardia to identify multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Volta Medical, VX1+ (K223516)
• Volta Medical, VX1 (K201298)

Reference Devices

• LabSystem Pro EP Recording System (Boston Scientific) (K141185)
• MacLab CardioLab EP Recording System (General Electric) (K130626)
• EnSite X 3D mapping system (Abbott) (K221213)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 27, 2023

Volta Medical % Kristin Duggan Partner Hogan Lovells US LPP 555 13th St. NW Washington, District of Columbia 20004

Re: K232616

Trade/Device Name: Volta AF-Xplorer Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: August 28, 2023 Received: August 28, 2023

Dear Kristin 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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

{2}------------------------------------------------

Sincerely,

# Hetal B. Odobasic -S

for

Aneesh Deoras 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

{3}------------------------------------------------

| Indications for Use Statement |
|-------------------------------|
|-------------------------------|

| Indications for Use Statement | |
|-----------------------------------------|--|
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
| Food and Drug Administration | |
| Indications for Use | |

| Form Approved: OMB No. 0910-0120 |
|----------------------------------|
| Expiration Date: 06/30/2023 |
| See PRA Statement on last page |

| 510(k) Number (if known) | K232616 |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Volta AF-Xplorer |
| Indications for Use (Describe) | The Volta AF-Xplorer 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 Volta AF-Xplorer 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) | |
| <span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

| FOR FDA USE ONLY | |
|------------------------------------------------------------------------------|--|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data

including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

PSC Publishing Services [phone] EF

{4}------------------------------------------------

#### K232616

#### 510(k) SUMMARY

#### VOLTA MEDICAL's Volta AF-Xplorer

#### Submitter

Volta Medical 65 Avenue Jules Cantini 13006 Marseille France

Phone: [phone] Contact Person: Paola MILPIED

Date Prepared: August 28, 2023

Name of Device: Volta AF-Xplorer

Common or Usual Name: Cardiac Mapping System

Classification Name: Programmable Diagnostic Computer

Regulatory Class: 21 C.F.R § 870.1425

Product Code: DQK

#### Primary Predicate Device

Volta Medical, VX1+ (K223516)

#### Predicate Device

Volta Medical, VX1 (K201298)

#### Purpose of the Special 510(k) notice

The Volta AF-Xplorer is a modification to the VX1+ (K223516) device which incorporates the preprocessing from the VX1 (K201298).

#### Intended Use / Indications for Use

The Volta AF-Xplorer 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 Volta AF-Xplorer software to help identify areas with intracardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

{5}------------------------------------------------

## Device Description

The Volta AF-Xplorer is a machine and deep learning based-algorithm designed to assist operators in the real-time manual or automation of 3D anatomical and electrical maps of the human heart for the presence of electrograms exhibiting spatio-temporal dispersion, i.e., dispersed electrograms.

The Volta AF-Xplorer device is a non-sterile reusable medical device, composed of a computing platform and a software application. Volta AF-Xplorer 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 and VX1+ (Volta Medical (K201298, । K223516)): the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626),
- a 3D mapping system (new compared to VX1 and identical to VX1+): EnSite X 3D mapping system -(Abbott) (K221213).

A connection cable is used to connect the corresponding data acquisition system to the Volta AF-Xplorer system, depending on the type of communication used:

- -Unidirectional analog communication with the EP recording systems via a custom-made cable (two diferent variants: DSUB, Octopus) and an Advantech PCI-1713U analog-to-digital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the Volta AF-Xplorer 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 Volta AF-Xplorer software analyzes the patient's electrograms to cue operators in real-time to intra-cardiac electrograms of interest for atrial regions harboring dispersed electrograms 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.

### Technological Characteristics

The Volta AF-Xplorer device is a modified device manufactured by Volta Medical, based on the same concept (identification of electrograms dispersion) than predicates VX1+ and VX1.

Volta AF-Xplorer, VX1+ and VX1 are software programs that work with standard electrophysiology catheters to aid in mapping the heart. All three devices aid operators by assisting in annotating complex electrical maps of the heart, and process and output information via a computer and display that are operated by use of a keyboard / mouse. Volta AF-Xplorer, 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 Volta AF-Xplorer and VX1+.

{6}------------------------------------------------

Volta AF-Xplorer, VX1+ and VX1 support Electrophysiologists in the manual annotation of dispersed areas using a unidirectional analog communication. Both Volta AF-Xplorer and VX1+ have the ability to connect to a specific 3D mapping system through a bidirectional digital communication, which enables the operator to use the automatic tagging function.

The Volta AF-Xplorer indications for use are identical to the VX1+ and the VX1. The Volta AF-Xplorer displays an analysis of dispersed electrograms, just as VX1 and therefore, the intended use of the Volta AF-Xplorer and the VX1+ and the VX1 are identical.

{7}------------------------------------------------

| | Volta Medical<br>Volta AF-Xplorer<br>(subject) | Volta Medical<br>VX1+<br>(K223516) | Volta Medical<br>VX1<br>(K201298) |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 C.F.R. § 870.1425 | 21 C.F.R. § 870.1425 | 21 C.F.R. § 870.1425 |
| Classification Name | Programmable Diagnostic Computer | Programmable Diagnostic Computer | Programmable Diagnostic Computer |
| Product Code | DQK | DQK | DQK |
| | The Volta AF-Xplorer assists operators<br>in the real-time manual or automatic<br>annotation of 3D anatomical and<br>electrical maps of human atria for the<br>presence of multipolar intra-cardiac<br>atrial electrograms exhibiting<br>spatiotemporal dispersion during atrial<br>fibrillation or atrial tachycardia. | The VX1+ assists operators in the<br>real-time manual or automatic<br>annotation of 3D anatomical and<br>electrical maps of human atria for<br>the presence of multipolar intra-<br>cardiac atrial electrograms<br>exhibiting spatiotemporal dispersion<br>during atrial fibrillation or atrial<br>tachycardia. | The VX1 assists operators in the real-time<br>manual annotation of 3D anatomical and<br>electrical maps of human atria for the<br>presence of multipolar intra-cardiac atrial<br>electrograms exhibiting spatiotemporal<br>dispersion during atrial fibrillation or atrial<br>tachycardia. |
| Indications for Use | The clinical significance of utilizing the<br>Volta AF-Xplorer software to help<br>identify areas with intra-cardiac atrial<br>electrograms exhibiting spatiotemporal<br>dispersion for catheter ablation of atrial<br>arrhythmias, such as atrial fibrillation,<br>has not been established by clinical<br>investigations. | The clinical significance of utilizing<br>the VX1+ software to help identify<br>areas with intra-cardiac atrial<br>electrograms exhibiting<br>spatiotemporal dispersion for<br>catheter ablation of atrial<br>arrhythmias, such as atrial<br>fibrillation, has not been established<br>by clinical investigations. | The clinical significance of utilizing the VX1<br>software to help identify areas with intra-<br>cardiac atrial electrograms exhibiting<br>spatiotemporal dispersion for catheter<br>ablation of atrial arrhythmias, such as atria<br>fibrillation, has not been established by<br>clinical investigations. |
| System Type | Signal processing based atrial<br>mapping system | Signal processing based atrial<br>mapping system | Signal processing based atrial mapping<br>system |
| Primary Feature | Displays and analyzes electrical maps<br>such as intra-cardiac electrograms in<br>real-time using machine learning and<br>signal processing techniques | Displays and analyzes electrical<br>maps such as intra-cardiac<br>electrograms in real-time using<br>machine learning and signal<br>processing techniques | Displays and analyzes electrical maps<br>such as intra-cardiac electrograms in real-<br>time using machine learning and signal<br>processing techniques |
| | Volta Medical<br>Volta AF-Xplorer<br>(subject) | Volta Medical<br>VX1+<br>(K223516) | Volta Medical<br>VX1<br>(K201298) |
| 3D Location<br>Technology | Electroanatomic location is performed<br>by another commercially available<br>navigation system.<br>In bidirectional digital communication,<br>3D Location is shared by the 3D<br>Mapping System with Volta AF-<br>Xplorer. | Electroanatomic location is<br>performed by another commercially<br>available navigation system.<br>In bidirectional digital<br>communication, 3D Location is<br>shared by the 3D Mapping System<br>with VX1+. | Electroanatomic location is performed by<br>another commercially available navigation<br>system. |
| Compatible<br>Acquisition<br>Systems | LabSystem Pro EP Recording<br>System (Boston Scientific) CardioLab EP Recording System<br>(GE) EnSite X 3D Mapping System<br>(Abbott) | LabSystem Pro EP Recording<br>System (Boston Scientific) CardioLab EP Recording<br>System (GE) EnSite X 3D Mapping System<br>(Abbott) | LabSystem Pro EP Recording<br>System (Boston Scientific) CardioLab EP Recording System (GE) |
| Compatible<br>Catheters | Any compatible mapping and ablation<br>catheter | Any compatible mapping and<br>ablation catheter | Any compatible mapping and ablation<br>catheter |
| Display(s) | Color monitor | Color monitor | Color monitor |
| Multi-Display<br>Support | Yes, duplicate display on a secondary<br>medical screen or on an operating<br>room widescreen | Yes, duplicate display on a<br>secondary medical screen or on an<br>operating room widescreen | Yes, duplicate display on a secondary<br>medical screen or on an operating room<br>widescreen |
| Control | Standard keyboard / mouse | Standard keyboard / mouse | Standard keyboard / mouse |
| Display Timing | Real-time | Real-time | Real-time |
| Inputs Required | Analog or digital Intra-cardiac signals<br>In digital mode, 3D locations of<br>corresponding electrodes bipoles | Analog or digital Intra-cardiac<br>signals<br>In digital mode, 3D locations of<br>corresponding electrodes bipoles | Analog Intra-cardiac signals |
| Output | Presence or absence of electrogram<br>dispersion at each electrode bipole<br>under consideration<br>In digital mode, 3D locations of<br>corresponding electrodes bipoles | Presence or absence of<br>electrogram dispersion at each<br>electrode bipole under<br>consideration | Presence or absence of electrogram<br>dispersion at each electrode bipole under<br>consideration |
| | Volta Medical<br>Volta AF-Xplorer<br>(subject) | Volta Medical<br>VX1+<br>(K223516) | Volta Medical<br>VX1<br>(K201298) |
| | Computed values of mapping and<br>reference cycle length | In digital mode, 3D locations of<br>corresponding electrodes bipoles<br><br>Computed values of mapping and<br>reference cycle length | Computed values of mapping and<br>reference cycle length |
| Duration of<br>Electrogram<br>Recordings | 1.5 Seconds | 1.5 Seconds | 1.5 Seconds |
| Ouput Display | The system generates color coded<br>symbol(s) that indicates to the operator<br>that the area under investigation is one<br>exhibiting dispersion<br>In bidirectional digital communication,<br>validated dispersion area can also be<br>automatically displayed in the 3D<br>mapping system as tags in the 3D<br>atrial shell | The system generates color coded<br>symbol(s) that indicates to the<br>operator that the area under<br>investigation is one exhibiting<br>dispersion<br>In bidirectional digital<br>communication, validated<br>dispersion area can also be<br>automatically displayed in the 3D<br>mapping system as tags in the 3D<br>atrial shell | The system generates color coded<br>symbol(s) that indicates to the operator<br>that the area under investigation is one<br>exhibiting dispersion |
| Signal Information<br>Displayed | Acquired patient signals, including<br>body surface ECG and intra-cardiac<br>EGMs. | Acquired patient signals, including<br>body surface ECG and intra-cardiac<br>EGMs. | Acquired patient signals, including body<br>surface ECG and intra-cardiac EGMs. |
| Computing Platform | Computer with Intel Core i7-7700 CPU<br>(8MB Cache, up to 4.20 GHz, RAM 32<br>GB),<br>with integrated analog/digital converter<br>PCI card and TPM (Trusted Platform<br>Module)<br>Debian-based Linux OS | Computer with Intel Core i7-7700<br>CPU (8MB Cache, up to 4.20 GHz,<br>RAM 32 GB),<br>with integrated analog/digital<br>converter PCI card and TPM<br>(Trusted Platform Module)<br>Debian-based Linux OS | Computer with Intel Core i5-6500 CPU<br>(6MB Cache, up to 3.60 GHz, RAM 32<br>GB),<br>with integrated analog/digital converter PC<br>card<br>Windows 10 or higher OS |
| | Volta Medical<br>Volta AF-Xplorer<br>(subject) | Volta Medical<br>VX1+<br>(K223516) | Volta Medical<br>VX1<br>(K201298) |
| Hardware Design<br>and Materials | Computing platform, proprietary<br>software algorithm, monitor,<br>mouse/keyboard, custom-made analog<br>connection cable, ethernet cable,<br>acquisition system | Computing platform, proprietary<br>software algorithm, monitor,<br>mouse/keyboard, custom-made<br>analog connection cable, ethernet<br>cable, acquisition system | Computing platform, proprietary software<br>algorithm, monitor, mouse/keyboard,<br>custom-made analog connection cable,<br>acquisition system |

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

The hardware and software differences to the subject device do not introduce new questions of safety or effectiveness.

# Performance Data

Software design verfication was performed on the subject Volta AF-Xplorer that included the same processing as cleared in VX1 and the same post-processing specifications as cleared in VX1+. The testing and acceptance criteria are the same as those in the predicate VX1+ and VX1 devices. Bench testing was previously conducted in the VX1+ (K201298) to demonstrate rigorous software verification testing including unitary testing of the main algorithm modules. The processing was evaluated and demonstrated equivalent performance with the acceptance criteria from the VX1+ and VX1 studies.

# Conclusions

ilə qalınmışdır. Bu mərkəzi vahidində bir mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının m

The Volta AF-Xplorer is as safe and effective as the VX1. The Volta AF-Xplorer has the same intended uses and same indications, and substantially similar technological characteristics, and principles of operation as its predicate devices VX1+ and VX1. The modification to the same pre-processing specification as cleared in VX1 and the same post-processing specifications as cleared in VX1+ does not alter the intended use of the device as an electrophysiological evaluation tool and effectiveness when used as labeled. Performance data, as described above, demonstrate that the Volta AF-Xplorer device is as she VX1+ and the VX1. Thus, the Volta AF-Xplorer device is substantially equivalent.