(221 days)
Not Found
No
The description focuses on a mathematical algorithm to solve the cardiac inverse problem and does not mention AI or ML. The performance testing also does not indicate the use of AI/ML.
No.
The device is a pre-procedure planning tool that provides diagnostic information (3D mapping of the heart, cardiac activation map) to a physician to aid in identifying the origin of cardiac arrhythmias. It does not directly treat or alleviate a disease or condition.
Yes.
The device acquires, analyzes, displays, and stores cardiac electrophysiological data and maps for analysis by a physician, and is used as a pre-procedure planning tool to aid in identifying the origin of cardiac arrhythmias. This process of using data to identify a medical condition or its origin clearly falls under the definition of diagnostics.
No
The device description explicitly states that the VIVO system includes an off-the-shelf laptop computer and a handheld 3D camera, in addition to the software. Performance testing also includes verification of the Laptop PC function and 3D camera function.
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 to be used 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 concerning a congenital abnormality, or to determine the safety and compatibility of potential donors, 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 then uses a mathematical algorithm to transform this in vivo data into a 3D map of the heart's electrical activity.
- No Specimen Examination: VIVO does not examine specimens derived from the human body in vitro. It directly interacts with the patient (via ECG electrodes and imaging) and processes data obtained from these interactions.
Therefore, VIVO falls under the category of a medical device that processes and analyzes in vivo data for diagnostic and planning purposes, but it does not meet the definition of an In Vitro Diagnostic.
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)
DQK
Device Description
The VIVO system is a noninvasive pre-procedure planning tool that provides a 3D mapping of the heart to aid in identifying the origin of cardiac arrhythmias prior to electrophysiology procedures. VIVO requires acquisition of MRI or CT images combined with standard ECG recordings and electrode placement. Electrocardiographic potentials are measured from the torso using standard 12 lead electrocardiogram (ECG) electrodes 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 patient specific, three-dimensional (3D) anatomy of the endocardial and epicardial surfaces of the heart. A 3D photograph of the patient's chest with the precise ECG lead locations and positioning patches that were used to acquire the ECG is merged with the torso and heart model to determine the spatial relationship between them. From these data, the system uses a mathematical algorithm to assimilate the geometrical information and transform the measured body surface signals into epicardial signals by solving the cardiac inverse problem. VIVO software creates, displays, and stores a cardiac activation map that displays the site of earliest activation of ventricular arrhythmias.
The VIVO system includes an off the shelf laptop computer and a handheld 3D camera. The preloaded software takes data from previously acquired cardiac and thoracic images, standard 12-lead ECG recording made during an arrhythmia and 3D picture of the ECG leads and positioning patches. This information, obtained prior to the procedure, can be used during pre-procedure planning by a qualified physician.
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, pre-procedure planning
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
Bench testing was performed to confirm the ability of the system to collect the position of the patches and electrodes.
User Validation Testing was conducted to address the use related with using/navigating the software and successful rendering of an accurate image; in particular to evaluate the usability of the new software workflow and the User's ability to generate a 3D model. Critical and essential tasks were identified and data collected included task performance (pass, fail, close call/serious difficulty), with pass/fail criteria clearly defined.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was completed on the VIVO Model 9002 system in the same manner as the predicate device. Performance testing, adapted where necessary to evaluate minor technical changes, included product system testing, software verification and integration testing performed in compliance with "FDA's Guidance for the Content of Premarket Submissions for Software in Medical Devices" and AAMI / ANSI / IEC 62304:2006, Medical Device Software - Software Life Cycle Processes, system verification and validation testing for functionality and performance in a simulated environment.
Testing included:
Performance Testing - System Testing to verify that the device met system requirements and the component operation and performance. The testing included the assembled VIVO Model 9002 device met the specified requirements. This included the accessing the VIVO software, Laptop PC function and 3D camera function (with positioning patches). Conclusion: System performance specifications were successfully verified to meet design outputs at the end of the bench testing.
Bench testing was performed to confirm the ability of the system to collect the position of the patches and electrodes.
User Validation Testing was conducted to address the use related with using/navigating the software and successful rendering of an accurate image; in particular to evaluate the usability of the new software workflow and the User's ability to generate a 3D model. Critical and essential tasks were identified and data collected included task performance (pass, fail, close call/serious difficulty), with pass/fail criteria clearly defined. Conclusion: The user validation testing supporting the accuracy of the user to generate a 3D model by the simplified workflow, and that the design has mitigated user error to an acceptable level.
Biocompatibility Testing: Biocompatibility testing was performed to demonstrate that the positioning patches conform to ISO 10993-1. The results demonstrate that the device is biocompatible.
Shelf Life Testing: Shelf life testing was performed to demonstrate a one-year shelf life for the positioning patches.
Clinical Testing: Not required to demonstrate substantial equivalence to the predicate device.
Conclusion of Performance Testing: Performance testing verified that the VIVO system complies with the safety and specifications and performs as designed. Therefore, VIVO is suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Catheter Precision VIVO™ (K183195)
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a bold, sans-serif font and the full name, "U.S. Food & Drug Administration," written below it in a smaller font.
September 14, 2020
Catheter Precision, Inc. Steve Adler CEO 500 International Drive, Suite 255 Mt. Olive, New Jersey 07828
Re: K200313
Trade/Device Name: VIVO™M Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: July 30, 2020 Received: August 5, 2020
Dear Steve Adler:
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 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
1
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 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).
Sincerely.
Mark Fellman Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200313
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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Catheter Precision, Inc. 510(k): K200313
- 510(k) Summary
4
((Catheter
| Applicant's Name | Catheter Precision, Inc. (Owner/Operator)
500 International Drive, Suite 255
Mt Olive, NJ 07828 USA
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 McQuoid
Regulatory Affairs Consultant
Bannick, LLC
Telephone: (612) 310-4529
Email: karen@bannickprimary.com |
| Trade Name: | VIVO™ |
| Common Name: | Electrophysiological cardiac mapping system |
| Classification Name: | Programmable diagnostic computer |
| Date Prepared: | |
| Classification/Panel: | Class II, Cardiovascular |
| Product Code: | DQK |
| Regulation Number: | 21 CFR 870.1425 |
| Predicate Device: | Catheter Precision VIVO™
(K183195) |
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Device Description:
The VIVO system is a noninvasive pre-procedure planning tool that provides a 3D mapping of the heart to aid in identifying the origin of cardiac arrhythmias prior to electrophysiology procedures. VIVO requires acquisition of MRI or CT images combined with standard ECG recordings and electrode placement. Electrocardiographic potentials are measured from the torso using standard 12 lead electrocardiogram (ECG) electrodes 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 patient specific, three-dimensional (3D) anatomy of the endocardial and epicardial surfaces of the heart. A 3D photograph of the patient's chest with the precise ECG lead locations and positioning patches that were used to acquire the ECG is merged with the torso and heart model to determine the spatial relationship between them. From these data, the system uses a mathematical algorithm to assimilate the geometrical information and transform the measured body surface signals into epicardial signals by solving the cardiac inverse problem. VIVO software creates, displays, and stores a cardiac activation map that displays the site of earliest activation of ventricular arrhythmias.
The VIVO system includes an off the shelf laptop computer and a handheld 3D camera. The preloaded software takes data from previously acquired cardiac and thoracic images, standard 12-lead ECG recording made during an arrhythmia and 3D picture of the ECG leads and positioning patches. This information, obtained prior to the procedure, can be used during pre-procedure planning by a qualified physician.
Model Number of VIVO System: 9002.
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.
Comparison of Technical Characteristics with Predicate Device
This submission is seeking the clearance of the VIVO Model 9002 system which, like the predicate device the VIVO Model 9001, 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 VIVO Model 9002 system has the same intended use, fundamental technology, principles of operation and performance as the predicate device. Where there are minor technological differences, they do not affect procedure, how the device is used, performance, function or safety compared to the predicate. Two changes include a smaller camera and the inclusion of positioning patches. VIVO Model 9002 includes an improved Graphical Use Interface (GUI) workflow during the Anatomy, 3D Image and
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ECG functions; however, the Analysis algorithm is identical to VIVO Model 9001. The fundamental Analysis algorithm creates, displays and stores a cardiac activation map that identifies the localization of the earliest activation of an arrhythmic heartbeat.
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™ Model 9002 | VIVO™ Model 9001 | Rationale for Differences (if
applicable) |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | K183195 | | |
| Product Code | DQK | DQK | Identical |
| Regulation | 21 CFR 870.1425 | 21 CFR 870.1425 | Identical |
| Intended Use | For individuals undergoing an EP
study for ventricular arrhythmias. | For individuals undergoing an EP
study for ventricular arrhythmias. | Identical |
| Indications for Use | VIVO is intended for the acquisition,
analysis, display and storage of
cardiac electrophysiological data and
maps for analysis by a physician. | VIVO is intended for the acquisition,
analysis, display and storage of
cardiac electrophysiological data and
maps for analysis by a physician. | Identical |
| System Components | Monitor, Core Processor, Keyboard,
and Mouse (all part of the laptop
computer), positioning patches. | Monitor, Core Processor, Keyboard,
and Mouse (all part of the laptop
computer). | Minor Technical Difference:
Positioning patches are included in
the 3D Image. |
| 3D Camera | 3D Camera (Intel® RealSense™), | 3D Camera (Kinect™). | Minor Technical Difference:
The 3D camera has been replaced
with a smaller camera. Output
images used by VIVO are equivalent. |
| Manufacturer | Intel | Microsoft | |
| RGB Camera resolution
(pixels) | 1920 x 1080 | 1920 x 1080 | |
| Frame rate (fps) | 30 | 30 | |
| Depth Camera
resolution (pixels) | 1280 x 720 | 512 x 424 | |
| Frame rate (fps) | 90 | 30 | |
| Color field of view:
horiz/vert (degrees) | 74 x 62 | 70 x 60 | |
| Characteristic | VIVO™ Model 9002 | VIVO™ Model 9001 | Rationale for Differences (if
applicable) |
| Connector | USB 3.1 type C | USB 2.0 type A | |
| Size (mm) | 90 x 25 x 25 | 249 x 66 x 67 | |
| Weight | 0.6 oz | 3.1 lbs. | |
| Graphical User Interface | Functions are on display, dialog boxes
and pop-up messages, sliders, menus
structure for simplification and
improved workflow | Many functions require use of
mouse/key shortcuts | Minor Technical Differences:
Changes with VIVO Model 9002
simplify the user interface. |
| DICOM Compliance | Yes | Yes | Identical |
| Image Scan Modalities
Accepted | CT, MR | CT, MR | Identical |
| Principles of Operation | Electrocardiographic potentials are
measured from the torso electrodes
on the surface of the body. A CT or
MRI scan is segmented to obtain the
detailed anatomy of the epicardial
and endocardial surface of the heart
and torso geometry. The exact
location of the ECG leads to the heart
are then identified within the
software. 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 electrodes
on the surface of the body. A CT or
MRI scan is segmented to obtain the
detailed anatomy of the epicardial
and endocardial surface of the heart
and torso geometry. The exact
location of the ECG leads to the heart
are then identified within the
software. 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. | Minor Technical Differences:
VIVO Model 9002 establishes patient
torso geometry via semi-automated
segmentation or manual DICOM
images compared to manual with
VIVO Model 9001.
VIVO Model 9002 has eight 3-D
models compared to 2 with VIVO
Model 9001 |
| Functional Overview | Steps to Mapping:
- MR/CT images are imported
and used to build 3D model | Steps to Mapping: - MR/CT images are imported
and used to build 3D model | Minor Technical Difference:
Positioning patches facilitate
merging of the 3D image and
heart/torso model. |
| Characteristic | VIVO™ Model 9002 | VIVO™ Model 9001 | Rationale for Differences (if applicable) |
| | of the patient's heart and torso - Overlay ECG and positioning patch location via 3D camera
- Align torso/heart model
- Load ECG Data
- Analyze
- Produce map | of the patient's heart and torso
- Overlay ECG location via 3D camera
- Align torso/heart model
- Load ECG Data
- Analyze
- Produce map | |
| Software / Firmware / Algorithm | Create patient recordsSegment heart and electrodesAcquire ECG dataCreate and review maps | Create patient recordsSegment heart and electrodesAcquire ECG dataCreate and review maps | Minor Technical Differences:
Simplified clinical workflow, combined two software applications into one, and improved user interface. |
| ECG Compatible Formats | Expanded ECG formats: mat, UNI, XML, inf, zip, csv, txt | inf, and mat (Bard conversion) | Minor Technical Difference:
VIVO Model 9002 allows additional ECG formats. |
| Report Generation | PNG image as screen shot, and VTK export | None | Minor Technical Difference:
VIVO Model 9002 has added a report generation function which can be created and exported. |
8
9
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Performance Data
Performance testing was completed on the VIVO Model 9002 system in the same manner as the predicate device. Performance testing, adapted where necessary to evaluate minor technical changes, included product system testing, software verification and integration testing performed in compliance with "FDA's Guidance for the Content of Premarket Submissions for Software in Medical Devices" and AAMI / ANSI / IEC 62304:2006, Medical Device Software - Software Life Cycle Processes, system verification and validation testing for functionality and performance in a simulated environment.
Testing included:
Performance Testing
System Testing to verify that the device met system requirements and the component operation and performance. The testing included the assembled VIVO Model 9002 device met the specified requirements. This included the accessing the VIVO software, Laptop PC function and 3D camera function (with positioning patches). Conclusion: System performance specifications were successfully verified to meet design outputs at the end of the bench testing.
Bench testing was performed to confirm the ability of the system to collect the position of the patches and electrodes.
User Validation Testing was conducted to address the use related with using/navigating the software and successful rendering of an accurate image; in particular to evaluate the usability of the new software workflow and the User's ability to generate a 3D model. Critical and essential tasks were identified and data collected included task performance (pass, fail, close call/serious difficulty), with pass/fail criteria clearly defined. Conclusion: The user validation testing supporting the accuracy of the user to generate a 3D model by the simplified workflow, and that the design has mitigated user error to an acceptable level.
Biocompatibility Testing
Biocompatibility testing was performed to demonstrate that the positioning patches conform to ISO 10993-1. The results demonstrate that the device is biocompatible.
Shelf Life Testing Shelf life testing was performed to demonstrate a one-year shelf life for the positioning patches.
Clinical Testing Not required to demonstrate substantial equivalence to the predicate device.
Conclusion of Performance Testing:
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Performance testing verified that the VIVO system complies with the safety and specifications and performs as designed. Therefore, VIVO is suitable for its intended use.
Conclusion
The data presented demonstrate that the VIVO system is substantially equivalent to the predicate device identified in intended use, device design, fundamental technology and performance.