(207 days)
Not Found
No
The description mentions a "mathematical algorithm" to solve the cardiac inverse problem and create a 3D rendering. While this involves complex calculations and data processing, the summary does not use terms like AI, ML, deep learning, neural networks, or describe any training or learning process that would indicate the use of AI/ML. The process described appears to be based on established mathematical models and image processing techniques.
No
The device is described as a pre-procedure planning tool that provides diagnostic information (3D mapping to aid in identifying the location of arrhythmias) and does not directly provide therapy.
Yes
The VIVO system is used to identify the general location of the origin of focal ventricular arrhythmias and displays the site of earliest activation, which is a diagnostic function for pre-procedure planning.
No
The device description explicitly states that the VIVO system requires and includes hardware components: "The VIVO system uses an off the shelf laptop computer and a handheld 3D camera." While the core functionality is software-based, the system is not solely software.
Based on the provided information, the VIVO device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- VIVO's Function: VIVO works by acquiring and analyzing in vivo data (ECG recordings from the body surface and anatomical images from MRI/CT scans). It does not examine specimens derived from the human body in a laboratory setting.
- VIVO's Purpose: VIVO's purpose is to provide a pre-procedure planning tool by creating a 3D map of the heart and identifying the likely origin of arrhythmias based on electrical signals measured from the body surface and anatomical imaging. This is a diagnostic aid based on external measurements and imaging, not laboratory analysis of biological specimens.
Therefore, VIVO falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VIVO is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
VIVO is intended to be used as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias.
Product codes (comma separated list FDA assigned to the subject device)
DOK
Device Description
The VIVO system is a noninvasive pre-procedure planning tool that provides a 3D mapping of the heart to aid in the identification of the general location of the origin of focal ventricular arrhythmias prior to electrophysiology procedures. VIVO requires acquisition of MRI or CT images and standard ECG recordings and lead (electrode) placement. Electrocardiographic potentials are measured from the torso using standard 12 lead electrocardiogram (ECG) sensors placed on the surface of the body. A DICOM image (CT or MR scan) of the thorax and heart is acquired and then segmented to provide a detailed, three-dimensional (3D) anatomy of the endocardial and epicardial surface of the heart. A 3D photograph of the patient's chest with the precise ECG lead positions used to acquire the 12 lead ECG is merged with the torso and heart model to determine the spatial relationship between the electrodes and the heart. From these data, the system uses a mathematical algorithm to use the geometrical information to transform the measured body surface potentials into myocardial potentials via solving the cardiac inverse problem. The VIVO system uses an off the shelf laptop computer and a handheld 3D camera. The VIVO software creates, displays, and stores a cardiac model that displays the site of earliest activation of ventricular arrhythmias.
To develop the cardiac model, VIVO requires the following inputs:
- MR or CT scan images in the DICOM file format are imported and combined with preloaded reference models in the VIVO software
- Standard 12-lead ECG recordings acquired during the arrhythmia are imported to VIVO software
- A 3D photograph of the placement of the ECG leads is created using the VIVO 3D camera
VIVO software is comprised of two software applications, VIVO Anatomy and VIVO Analysis.
VIVO Anatomy merges the imported cardiac MR/CT image data with a model to create a heart and torso model representative of a patient's specific anatomy. The MR/CT image data must be imported via a DVD containing the images in DICOM format (Note: VIVO does not have a web interface). The DICOM image is then overlayed on top of one of a number of preloaded anatomical models to fine tune the preloaded model. The model that best matches the patient's anatomical profile is chosen. Specific cardiac structures and tissues are identified by the User within the images to better match the patient anatomy. An outline of the chambers and tissue walls is automatically created by VIVO which is then finetuned by the User for a precise match to the patient's anatomy.
VIVO Analysis combines the heart and torso model generated from VIVO Anatomy with ECG data, and a 3D photograph of the ECG lead placement to identify the location of the arrhythmia foci. After ECG leads are placed on the patient, a 3D photograph of the patient's chest is captured to accurately record lead locations. Arrhythmic ECG signals are recorded from these electrodes and imported into the VIVO software. This data is combined and a mathematical algorithm is used create a 3D rendering of the patient's heart with superimposed color coding to indicate the area of earliest activation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, CT
Anatomical Site
Heart, Torso
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Clinical Study: A prospective, non-randomized study ("VIVO Accuracy Study") was completed at 6 US centers. This clinical evaluation was developed primarily to assess VIVO's ability to accurately determine the anatomical location of a particular ventricular origin. The VIVO Accuracy Study enrolled 51 patients and analyzed data from 45 patients presenting for PVC or VT ablation with structurally normal hearts and less than 10% scar.
The primary endpoint assessed the accuracy of VIVO to properly identify a PVC or VT foci in the right, left, or septal region of the heart. It was determined that the VIVO localization of the PVC/VT foci agreed (was a match) with the CARTO localization in 45 of the 45 subjects. Thus, the primary endpoint had an accuracy rate of 100% (95% Cl: 93.6%, 100%), which met the pre-specified performance goal.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy rate: 100% (95% Cl: 93.6%, 100%)
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.
Not Found
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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June 14, 2019
Catheter Precision, Inc. Karen Bannick Regulatory Affairs Consultant 500 International Drive Suite 333 Mt. Olive, New Jersey 07828
Re: K183195
Trade/Device Name: VIVO Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: May 9, 2019 Received: May 15, 2019
Dear Karen Bannick:
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 DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183195
Device Name VIVO
Indications for Use (Describe)
VIVO is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
VIVO is intended to be used as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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Image /page/3/Picture/1 description: The image shows the logo for Catheter Precision. The logo consists of a blue graphic on the left and the words "Catheter Precision" on the right. The graphic is made up of three curved lines that are stacked on top of each other. The words "Catheter Precision" are written in a sans-serif font.
| Applicant's Name | Catheter Precision, Inc. (Owner/Operator)
500 International Drive
Suite 333
Mt. Olive, NJ 07828
Telephone: (973) 691-2000
Establishment Registration No: 3010728615 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Mr. Steve Adler
Chief Executive Officer
Telephone: (973) 691-2000
Email: steve.adler@catheterprecision.com |
| Alternate Contact: | Ms. Karen Bannick
Regulatory Affairs Consultant
Bannick Consulting, LLC
Telephone: (320) 630-5171
Email: Karen@bannickconsulting.com |
| Trade Name: | VIVO™ |
| Common Name: | Electrophysiological cardiac mapping system |
| Classification Name: | Programmable diagnostic computer |
| Date Revised: | June 13, 2019 |
| Classification/Panel: | Class II, Cardiovascular |
| Product Code: | DQK |
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Regulation Number: 21 CFR 870.1425
Predicate Device: Medtronic CardioInsight® Cardiac Mapping System (K162440)
Device Description:
The VIVO system is a noninvasive pre-procedure planning tool that provides a 3D mapping of the heart to aid in the identification of the general location of the origin of focal ventricular arrhythmias prior to electrophysiology procedures. VIVO requires acquisition of MRI or CT images and standard ECG recordings and lead (electrode) placement. Electrocardiographic potentials are measured from the torso using standard 12 lead electrocardiogram (ECG) sensors placed on the surface of the body. A DICOM image (CT or MR scan) of the thorax and heart is acquired and then segmented to provide a detailed, three-dimensional (3D) anatomy of the endocardial and epicardial surface of the heart. A 3D photograph of the patient's chest with the precise ECG lead positions used to acquire the 12 lead ECG is merged with the torso and heart model to determine the spatial relationship between the electrodes and the heart. From these data, the system uses a mathematical algorithm to use the geometrical information to transform the measured body surface potentials into myocardial potentials via solving the cardiac inverse problem. The VIVO system uses an off the shelf laptop computer and a handheld 3D camera. The VIVO software creates, displays, and stores a cardiac model that displays the site of earliest activation of ventricular arrhythmias.
To develop the cardiac model, VIVO requires the following inputs:
- · MR or CT scan images in the DICOM file format are imported and combined with preloaded reference models in the VIVO software
- · Standard 12-lead ECG recordings acquired during the arrhythmia are imported to VIVO software
- A 3D photograph of the placement of the ECG leads is created using the VIVO 3D camera
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VIVO software is comprised of two software applications, VIVO Anatomy and VIVO Analysis.
VIVO Anatomy merges the imported cardiac MR/CT image data with a model to create a heart and torso model representative of a patient's specific anatomy. The MR/CT image data must be imported via a DVD containing the images in DICOM format (Note: VIVO does not have a web interface). The DICOM image is then overlayed on top of one of a number of preloaded anatomical models to fine tune the preloaded model. The model that best matches the patient's anatomical profile is chosen. Specific cardiac structures and tissues are identified by the User within the images to better match the patient anatomy. An outline of the chambers and tissue walls is automatically created by VIVO which is then finetuned by the User for a precise match to the patient's anatomy.
VIVO Analysis combines the heart and torso model generated from VIVO Anatomy with ECG data, and a 3D photograph of the ECG lead placement to identify the location of the arrhythmia foci. After ECG leads are placed on the patient, a 3D photograph of the patient's chest is captured to accurately record lead locations. Arrhythmic ECG signals are recorded from these electrodes and imported into the VIVO software. This data is combined and a mathematical algorithm is used create a 3D rendering of the patient's heart with superimposed color coding to indicate the area of earliest activation.
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Model Number of VIVO System: 9001.
Comparison of Technical Characteristics with Predicate Device
This submission is seeking the clearance of the VIVO system which, like the predicate device, provides a 3D mapping of the heart to aid in the identification of the general location of the origin of focal cardiac arrhythmias prior to electrophysiology procedures.
The predicate device and the VIVO system have the same intended use, fundamental technology, principal of operation and performance. Both VIVO and the predicate require a DICOM image and location data of the electrodes to create a patient specific model.
VIVO users review and adjust a merged 3D image of the 12 lead ECG electrode locations and the torso. Users of the predicate add and delete electrodes after the algorithm merges ECG location with the torso using a segmentation process.
Where there are technological differences, they do not affect the safety and effectiveness of the device when used as labeled. Table 1 provides a comparison of the technological characteristics for the VIVO system against the predicate device.
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| Characteristic | VIVO™
Subject Device | Medtronic
CardioInsight™
K162440 | Rationale for Difference
(if applicable) | |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DQK | DQK | Same | |
| Regulation | 21 CFR 870.1425 | 21 CFR 870.1425 | Same | |
| Intended Use | For individuals undergoing
an EP study for focal
ventricular arrhythmias. | For individuals undergoing
an EP study. | VIVO software has not
been validated for atrial
use. | |
| Indications for Use | VIVO is intended for
acquisition, analysis, display
and storage of cardiac
electrophysiological data
and maps for analysis by a
physician.
VIVO is intended to be used
as a pre-procedure planning
tool for patients with
structurally normal hearts
undergoing ablation
treatment for idiopathic
ventricular arrhythmias. | The Medtronic
CardioInsight Mapping
System is intended for
acquisition, analysis,
display and storage of
cardiac
electrophysiological data
and maps for analysis by a
physician. | | |
| System | Monitor, Core Processor,
Keyboard, and Mouse (all
part of the laptop
computer), 3D Camera
(Kinect™). | Cart, Monitor, Core
Processor, Keyboard,
Mouse, Isolation
Transformer, Cabling,
Sensor Array, Second
Monitor connection. | | |
| DICOM Compliance | Yes | Yes | Same | |
| Image Scan
Modalities Accepted | CT, MR | CT | | |
| Principles of
Operation | Electrocardiographic
potentials are measured
from standard 12-lead ECG.
VIVO establishes patient
torso geometry via
segmented DICOM images
and ECG electrode
placement via a 3D
photograph. From these
data, the system uses
mathematical algorithms to
use the geometrical
information to transform the
measured body surface
signals into epicardial signals
via solving the cardiac
inverse problem. | Electrocardiographic
potentials are measured
from the torso sensors on
the surface of the body. A CT
scan is segmented to obtain
the 3- dimensional location
of each sensor and the
detailed anatomy of the
epicardial surface of the
heart. From these data, the
system uses mathematical
algorithms to use the
geometrical information to
transform the measured
body surface signals into
epicardial signals via solving
the cardiac inverse problem. | | |
| Functional Overview | Basic Steps to Mapping:
- MR/CT images are
imported and used to
build 3D model of the
patient's heart and
torso - Overlay ECG
location via 3D
camera - Align torso/heart model
- Load ECG Data
- Analyze | Basic Steps to Mapping:
- CT images are
imported and used
to build 3D model of
the patient's heart - Capture 3D
geometry of
patient's torso
(from vest) - Overlay ECG
location during CT
image acquisition | The method of generating
the map does not impact
the final results. | |
| | | | 4. Align torso/heart
model | |
| | | | 5. Load ECG data | |
| | | | 6. Analyze | |
| | | | 7. Produce map | |
| ECG Acquisition | | Standard 12-lead surface
ECG output imported into
VIVO device | Proprietary vest with 252
electrodes for surface ECG
and recorded through
proprietary ECG
acquisition
hardware/firmware | VIVO uses a standard 12-
lead ECG and standard
lead placement. VIVO
captures the lead
locations relative
to the patient's torso
geometry using the Kinect |
| ECG Electrode
Identification/
Localization | | Standard 12 lead ECG
electrode locations acquired
with 3D imaging camera.
Algorithm merges the 3D
image of the 12 lead ECG
electrode locations with
torso. User manually
adjusts the electrode
position to the 3D image
for accuracy. | Custom 252 electrode
images acquired during CT
imaging.
Algorithm merges ECG
location with torso with a
segmentation process. User
manually adds and deletes
electrodes after merge. | 3D camera to obtain a 3D
photograph. The
predicate, CardioInsight
utilizes a 252 electrode
sensor-array vest to gather
the ECG and determine
the patient's torso
geometry. |
| Cardiac Maps
Provided | | Color coded map of earliest
activation point and
propagation of cardiac beat | Activation map, directional
activation map, phase map,
potential map, voltage
map, slew rate map,
propagation map | VIVO's color coded
activation map is provided
for illustrative purposes
only during pre-procedure
mapping. |
Table 1: Technological Characteristics Comparison
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Indications for Use:
VIVO is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
VIVO is intended to be used as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias.
Performance Data
Performance testing was completed on the VIVO system which verified that the device complies with the safety and specifications and performs as designed. VIVO is suitable for its intended use. Performance Testing included hardware testing, software verification and integration testing performed in compliance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and AAMI / ANSI / IEC 62304:2006, Medical Device Software -Software Life Cycle Processes, clinical testing, system verification and validation testing for functionality and performance in a simulated environment.
Clinical Study
A prospective, non-randomized study ("VIVO Accuracy Study") was completed at 6 US centers. This clinical evaluation was developed primarily to assess VIVO's ability to accurately determine the anatomical location of a particular ventricular origin. The VIVO Accuracy Study enrolled 51 patients and analyzed data from 45 patients presenting for PVC or VT ablation with structurally normal hearts and less than 10% scar.
Approximately 47% of subjects were male, and the average age was 56.4 years. Of the 45 subjects, 44 underwent an ablation procedure for PVCs and 1 underwent an ablation procedure for ventricular tachycardia (determined day of procedure). There was no subgroup analysis conducted.
Of the 45 subjects, 20% (N=9) had previous ablations and no subjects
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had a previous myocardial infarction (MI). Other arrhythmias were noted at baseline in 53.33% (24), and 15.56% (N=7) reported having no symptoms associated with their PVC or VT. The most common symptom was palpitations which was reported in 57.78% (N=26) of subjects.
The study results demonstrated acceptable clinical accuracy performance of VIVO. There were no adverse events. The primary endpoint assessed the accuracy of VIVO to properly identify a PVC or VT foci in the right, left, or septal region of the heart. It was determined that the VIVO localization of the PVC/VT foci agreed (was a match) with the CARTO localization in 45 of the 45 subjects. Thus, the primary endpoint had an accuracy rate of 100% (95% Cl: 93.6%, 100%), which met the pre-specified performance goal.
Conclusion
The data presented in this submission demonstrate that the VIVO system is substantially equivalent to the predicate device identified in intended use, device design, fundamental technology and performance.