(30 days)
Yes
The device description explicitly states that the Volta AF-Xplorer is a "machine and deep learning based-algorithm" and that it "Displays and analyzes electrical maps such as intra-cardiac electrograms in real-time using machine learning and signal processing techniques".
No.
The device assists in identifying areas of interest for ablation but is not directly involved in the therapeutic intervention itself; its clinical significance in identifying areas for catheter ablation has not been established.
Yes
The device analyzes patient electrograms to assist operators in identifying areas of interest for atrial regions, presenting the results graphically, which aligns with the function of a diagnostic device by providing insights into the patient's condition based on medical data.
No
The device description explicitly states it is "composed of a computing platform and a software application" and details the use of connection cables, an analog-to-digital converter, and a computer with a display, indicating hardware components are part of the system.
Based on the provided information, the Volta AF-Xplorer is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Volta AF-Xplorer analyzes real-time electrical signals (electrograms) directly from the human atria during a procedure. It does not process samples like blood, tissue, or urine.
- The device's function is to assist in the real-time annotation of electrical maps. This is a process performed in vivo (within the living body) during a medical procedure, not in vitro (in a lab setting).
- The device interacts with other medical devices used during the procedure (EP recording systems and 3D mapping systems). This further indicates its role in a clinical procedure rather than a laboratory diagnostic test.
The Volta AF-Xplorer is a medical device used to assist clinicians during a procedure, specifically for analyzing and annotating electrical activity within the heart. This falls under the category of devices used for diagnosis or treatment in vivo, not in vitro diagnostics.
No
The provided text does not contain any explicit statements indicating that the FDA has reviewed, 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 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.
Product codes
DQK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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.
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operators
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
| Prescription Use (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:
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FORM FDA 3881 (6/20)
PSC Publishing Services (301) 443-6740 EF
4
K232616
510(k) SUMMARY
VOLTA MEDICAL's Volta AF-Xplorer
Submitter
Volta Medical 65 Avenue Jules Cantini 13006 Marseille France
Phone: +33 7 68 02 54 99 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
Volta AF-Xplorer
(subject) | Volta Medical
VX1+
(K223516) | Volta Medical
VX1
(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
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 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 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. |
| Indications for Use | 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. | 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 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 atria
fibrillation, has not been established by
clinical investigations. |
| System Type | Signal processing based atrial
mapping system | 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 | Displays and analyzes electrical maps
such as intra-cardiac electrograms in real-
time using machine learning and signal
processing techniques |
| | Volta Medical
Volta AF-Xplorer
(subject) | Volta Medical
VX1+
(K223516) | 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 Volta AF-
Xplorer. | 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) EnSite X 3D Mapping System
(Abbott) | LabSystem Pro EP Recording
System (Boston Scientific) CardioLab EP Recording System (GE) |
| Compatible
Catheters | Any compatible mapping and ablation
catheter | Any compatible mapping and
ablation catheter | Any compatible mapping and ablation
catheter |
| Display(s) | Color monitor | Color monitor | 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 | Yes, duplicate display on a secondary
medical screen or on an operating room
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
In digital mode, 3D locations of
corresponding electrodes bipoles | 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 | Presence or absence of
electrogram dispersion at each
electrode bipole under
consideration | Presence or absence of electrogram
dispersion at each electrode bipole under
consideration |
| | Volta Medical
Volta AF-Xplorer
(subject) | Volta Medical
VX1+
(K223516) | Volta Medical
VX1
(K201298) |
| | Computed values of mapping and
reference cycle length | In digital mode, 3D locations of
corresponding electrodes bipoles
Computed values of mapping and
reference cycle length | Computed values of mapping and
reference cycle length |
| Duration of
Electrogram
Recordings | 1.5 Seconds | 1.5 Seconds | 1.5 Seconds |
| Ouput Display | The system generates color coded
symbol(s) that indicates to the operator
that the area under 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 | The system generates color coded
symbol(s) that indicates to the
operator that the area under
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 | The system generates color coded
symbol(s) that indicates to the operator
that the area under 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. | 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 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 PC
card
Windows 10 or higher OS |
| | Volta Medical
Volta AF-Xplorer
(subject) | Volta Medical
VX1+
(K223516) | Volta Medical
VX1
(K201298) |
| 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, ethernet
cable, acquisition system | Computing platform, proprietary software
algorithm, monitor, mouse/keyboard,
custom-made analog connection cable,
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.