(161 days)
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No
The document describes a computer simulation device using "proprietary computational modeling technology" and "finite element analysis" (implied by the nature of deformation simulation), but does not mention AI or ML. The validation is based on comparing simulation results to clinical outcomes, which is typical for computational modeling, not necessarily AI/ML training or validation.
No
The device is a software solution used for procedural planning by simulating TAVR procedures; it does not directly treat or diagnose a medical condition.
No
The device is described as a "patient-specific simulations of Transcatheter Aortic Valve Replacement (TAVR) during procedural planning" and "predicts implant frame deformation after implantation of a Transcatheter Heart Valve (THV) device". It is clear that its purpose is for procedural planning and prediction, not for diagnosing a medical condition. The information provided is "not intended in any way to eliminate, replace, or substitute for, in part, the healthcare provider's judgment and analysis of the patient's condition."
Yes
The device is described as a "post processing software solution" and a "computer simulation device". It takes 2D medical images as input and provides a report with 3D visualization as output, accessed via a web browser. There is no mention of any accompanying hardware component that is part of the medical device itself. The 3D model generation and report generation are performed by trained operators using an established workflow, further indicating a software-centric process.
Based on the provided information, PrecisionTAVI is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- PrecisionTAVI's Function: PrecisionTAVI is a software solution that performs simulations based on medical images (CT scans) of the patient's anatomy. It does not analyze biological samples from the patient.
- Intended Use: The intended use is for procedural planning of TAVR by simulating valve deployment and predicting deformation. This is a planning tool based on imaging data, not a diagnostic test performed on a biological sample.
Therefore, PrecisionTAVI falls under the category of medical device software used for planning and simulation, not as an IVD.
N/A
Intended Use / Indications for Use
PrecisionTAVI is an optional, non-invasive, post processing software solution that is indicated for patient-specific simulations of Transcatheter Aortic Valve Replacement (TAVR) during procedural planning.
The software performs computer simulation to predict post TAVR in vivo valve frame deformation of clinician selected Transcatheter Heart Valve (THV) device types and sizes.
The information provided by PrecisionTAVI is intended for use by cardiologists, and clinical specialists, and is not intended in any way to eliminate, replace, or substitute for, in part, the healthcare provider's judgment and analysis of the patient's condition receiving the images retains the responsibility for interpreting and validating all information and making all patient treatment decisions.
PrecisionTAVI is not intended to replace the simulated device's instructions for use for final TAVR device selection and placement.
Product codes (comma separated list FDA assigned to the subject device)
QQI
Device Description
DASI Simulations PrecisionTAVI is a computer simulation device that predicts implant frame deformation after implantation of a Transcatheter Heart Valve (THV) device. The simulation combines a predefined THV device model and size with a patient-specific model of the patient's anatomy thereby predicting the post deployment deformation of the THV and the anatomy. The simulation results are intended to be used by qualified clinicians as additional information for planning transcatheter aortic valve replacement (TAVR).
PrecisionTAVI conducts TAVR device deployment simulation using proprietary computational modeling technology.
The input for the simulation is a 3D model of the patient anatomy. The 3D model is generated from 2D medical images of the patient anatomy (multi-slice Cardiac Computed Tomography).
The simulation output is a report with 3D visualization capability to depict the predicted deformed THV in the deformed patient-specific anatomy of the aortic valve and root.
The 3D model generation and the report generation from the simulation is performed by trained operators at DASI Simulations using an established workflow. The report is accessible to the end user as a download from the DASI Simulations portal with a standard web browser.
Mentions image processing
PrecisionTAVI is an optional, non-invasive, post processing software solution that is indicated for patient-specific simulations of Transcatheter Aortic Valve Replacement (TAVR) during procedural planning.
Mentions AI, DNN, or ML
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Input Imaging Modality
2D medical images of the patient anatomy (multi-slice Cardiac Computed Tomography).
Anatomical Site
aortic valve and root
Indicated Patient Age Range
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Intended User / Care Setting
cardiologists, and clinical specialists
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
DASI Simulations PrecisionTAVI has been validated against post-TAVR CT images of 89 patients and with a registered error of 80%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Quantitative Measurements:
- 100% of cases showed less than ± 2mm difference in THV diameter at inflow.
- 97% of cases showed less than ± 2mm difference in THV diameter at waist.
- 98% of cases showed less than ± 2mm difference in THV diameter at outflow.
- 97% of cases showed less than ±0.1 difference in THV aspect ratio for out-of-round deformation at inflow.
- 98% of cases showed less than ±0.1 difference in THV aspect ratio for out-of-round deformation at waist.
- 98% of cases showed less than ±0.1 difference in THV aspect ratio for out-of-round deformation at outflow.
Qualitative Assessments:
- Clinicians: 96% of all case evaluations (48/50) were found to be in agreement. 90.5% (181/200) cut planes tested successfully.
- Engineers: 97% of cases were found to be in agreement in eccentricity. 99% of cases were found to be in agreement in apposition of the THV stent.
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).
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§ 870.1405 Interventional cardiovascular implant simulation software device.
(a)
Identification. An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient's cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software verification, validation, and hazard analysis, with identification of appropriate mitigations, must be performed, including a full verification and validation of the software according to the predefined software specifications.
(2) Computational modeling verification and validation activities must be performed to establish the predictive capability of the device for its indications for use.
(3) Performance validation testing must be provided to demonstrate the accuracy and clinical relevance of the modeling methods for the intended implantation simulations, including the following:
(i) Computational modeling results must be compared to clinical data supporting the indications for use to demonstrate accuracy and clinical meaningfulness of the simulations;
(ii) Agreement between computational modeling results and clinical data must be assessed and demonstrated across the full intended operating range (
e.g., full range of patient population, implant device sizes and patient anatomic morphologies). Any selection criteria or limitations of the samples must be described and justified;(iii) Endpoints (
e.g., performance goals) and sample sizes established must be justified as to how they were determined and why they are clinically meaningful; and(iv) Validation must be performed and controls implemented to characterize and ensure consistency (
i.e., repeatability and reproducibility) of modeling outputs:(A) Testing must be performed using multiple qualified operators and using the procedure that will be implemented under anticipated conditions of use; and
(B) The factors (
e.g., medical imaging dataset, operator) must be identified regarding which were held constant and which were varied during the evaluation, and a description must be provided for the computations and statistical analyses used to evaluate the data.(4) Human factors evaluation must be performed to evaluate the ability of the user interface and labeling to allow for intended users to correctly use the device and interpret the provided information.
(5) Device labeling must be provided that describes the following:
(i) Warnings that identify anatomy and image acquisition factors that may impact simulation results and provide cautionary guidance for interpretation of the provided simulation results;
(ii) Device simulation inputs and outputs, and key assumptions made in the simulation and determination of simulated outputs; and
(iii) The computational modeling performance of the device for presented simulation outputs, and the supporting evidence for this performance.
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May 30, 2023
DASISimulations Lakshmi Dasi Chief Technology Officer 5115 Parkcenter Ave Suite 205 Dublin, Ohio 43017
Re: K223809
Trade/Device Name: PrecisionTAVI (v1.1) Regulation Number: 21 CFR 870.1405 Regulation Name: Interventional cardiovascular implant simulation software device Regulatory Class: Class II Product Code: QQI Dated: December 19, 2022 Received: April 26, 2023
Dear Dr. Dasi:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
Jaime Raben -S
Jaime Raben, PhD Acting Director DHT2B: Division of Circulatory Support, Structural and Vascular 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) K223809
Device Name PrecisionTAVI v1.1
Indications for Use (Describe)
PrecisionTAVI is an optional, non-invasive, post processing software solution that is indicated for patient-specific simulations of Transcatheter Aortic Valve Replacement (TAVR) during procedural planning.
The software performs computer simulation to predict post TAVR in vivo valve frame deformation of clinician selected Transcatheter Heart Valve (THV) device types and sizes.
The information provided by PrecisionTAVI is intended for use by cardiologists, and clinical specialists, and is not intended in any way to eliminate, replace, or substitute for, in part, the healthcare provider's judgment and analysis of the patient's condition receiving the images retains the responsibility for interpreting and validating all information and making all patient treatment decisions.
PrecisionTAVI is not intended to replace the simulated device's instructions for use for final TAVR device selection and placement.
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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K223809 510(K) SUMMARY
SUBMITTER
| Company Name: | DASI Simulations |
|---|---|
| Address: | 5115 Parkcenter Ave Suite |
| Dublin OH 43017 United States | |
| Contact: | Lakshmi Prasad Dasi |
| Phone number: | 614-586-6760 |
| Email: | lakshmi.dasi@dasisim.com |
| Date prepared | May 26, 2023 |
DEVICE
| Device Name: | PrecisionTAVI |
|---|---|
| Classification Name: | Interventional Cardiovascular Implant Simulation Software Device |
| Regulation Number: | 870.1405 |
| Product Code: | QQI |
PREDICATE DEVICE
| Predicate # | K214066 |
|---|---|
| Device Name: | FEops HEARTguide |
| Product Code: | QQI |
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DEVICE DESCRIPTION
DASI Simulations PrecisionTAVI is a computer simulation device that predicts implant frame deformation after implantation of a Transcatheter Heart Valve (THV) device. The simulation combines a predefined THV device model and size with a patient-specific model of the patient's anatomy thereby predicting the post deployment deformation of the THV and the anatomy. The simulation results are intended to be used by qualified clinicians as additional information for planning transcatheter aortic valve replacement (TAVR).
PrecisionTAVI conducts TAVR device deployment simulation using proprietary computational modeling technology.
The input for the simulation is a 3D model of the patient anatomy. The 3D model is generated from 2D medical images of the patient anatomy (multi-slice Cardiac Computed Tomography).
The simulation output is a report with 3D visualization capability to depict the predicted deformed THV in the deformed patient-specific anatomy of the aortic valve and root.
The 3D model generation and the report generation from the simulation is performed by trained operators at DASI Simulations using an established workflow. The report is accessible to the end user as a download from the DASI Simulations portal with a standard web browser.
INDICATIONS FOR USE
PrecisionTAVI is an optional, non-invasive, post processing software solution that is indicated for patient-specific simulations of Transcatheter Aortic Valve Replacement (TAVR) during procedural planning.
The software performs computer simulation to predict post TAVR in vivo valve frame deformation of clinician selected Transcatheter Heart Valve (THV) device types and sizes.
The information provided by PrecisionTAVI is intended for use by cardiologists, and clinical specialists, and is not intended in any way to eliminate, replace, or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition. The clinician receiving the images retains the responsibility for interpreting and validating all information and making all patient treatment decisions.
PrecisionTAVI is not intended to replace the simulated device's instructions for use for final TAVR device selection and placement.
INDICATIONS FOR USE COMPARISON
PrecisionTAVI has similar indications and the same intended use in comparison to the predicate device. The difference in indications for use is attributed to the different disease/anatomy (aortic valve vs. left atrial appendage).
TECHNOLOGICAL COMPARISON
-
- Technical Method: Both the subject and predicate devices perform simulations to predict the
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post-implantation device deformation by combining a predefined device model with a patient specific model of the patient anatomy.
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- Target Area: The predicate device's target area is left atrial appendage, while the subject device's target area is the aortic valve/aortic root.
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- Functionality: Both the subject and predicate device enable visualization of CT scan images (2D and 3D), generate patient specific anatomical models of aortic root (subject device) and left atrial appendage (predicate device); enable visualization of post-deployment device deformation: Transcatheter Heart Valve device (subject device) and Transcatheter Atrial Appendage Occlusion device (predicate device). The predicate device has measurement tools in addition to the functionality described above.
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- Interpretation of Images: Both the subject and predicate devices outputs are interpreted by health care professionals.
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- Modeling Strategy: Both the subject and predicate devices provide simulation outputs of the mechanical interaction between the device specific computational model and patient specific anatomical model.
- Software Architecture: Both subject and predicate devices have DICOM data provided by 6. clinical users as input, while the simulations results are prepared by qualified engineers/ analysts and made available with the use of web-based viewers.
- Simulated Devices: Subject device provides simulation for the Balloon-expandable Edwards 7. SAPIEN 3 or Ultra devices, while the predicate device provides simulation results for Boston Scientific WATCHMAN, Boston Scientific WATCHMAN FLX, and Abbott Amplatzer Amulet devices.
TESTING SUMMARY
PrecisionTAVI performance has been validated against post-TAVR CT images of 89 patients and with a registered error of 80%.
CONCLUSIONS
The characteristics that determine the functionality and performance of DASI Simulations PrecisionTAVI, the subject device, are substantially equivalent to the predicate device. The testing indicates that the subject device is as safe, as effective, and performs as well as the predicate.