(245 days)
Yes
The device description explicitly states that the Segmental Wall Motion (SWM) feature uses "machine learning algorithms".
No
The device is described as software applications for quantification and reporting of cardiovascular, fetal, and abdominal structures and function to support diagnosis, which is a diagnostic purpose, not a therapeutic one.
Yes
The device clearly states its indication for use as "quantification and reporting... to support the physician in the diagnosis." This directly aligns with the definition of a diagnostic device.
No
The device description explicitly states that the submission includes "compatibility of VeriSight ICE / Pro ICE Probe data with the subject device Ultrasound Workspace Version 6.0." It also mentions "Data Compatibility of the VeriSight ICE / Pro ICE Probe, transducers cleared for the EPIQ Series Diagnostic Ultrasound System (K202216), will be introduced for Ultrasound Workspace 6.0." This indicates the software is designed to process data from specific hardware components (ultrasound probes/transducers), making it dependent on and integrated with hardware, thus not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases or other conditions. They are used to examine specimens outside of the body.
- Device Function: The described device is a software application for an ultrasound system. It processes ultrasound images acquired from within the patient's body to quantify and report on anatomical structures and function.
- Input Data: The input data is ultrasound images, not biological samples.
- Intended Use: The intended use is to support physicians in diagnosis by providing quantitative information derived from in-vivo imaging.
Therefore, this device falls under the category of medical imaging software or image analysis software, not In Vitro Diagnostics.
No
The input letter 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.
Intended Use / Indications for Use
Indications for use of Ultrasound Workspace are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
QIH, LLZ, IYN
Device Description
The purpose of this Traditional 510(k) Pre-market Notification is to introduce the SWM, 3D Auto TV and 3D Auto CFQ software applications as well as compatibility of VeriSight ICE / Pro ICE Probe data with the subject device Ultrasound Workspace Version 6.0.
The semi-automated Segmental Wall Motion feature (SWM) evaluates the segmental (regional) function of the left ventricle (LV) from adult TTE echo examinations. It performs border detection and tracking to identify each of the LV seqments, provides segmental wall motion scores for each segments of the LV by using machine learning algorithms and calculates an overall wall motion score index (WMSI) as the average of the segmental scores.
3D Auto TV software enables semi-automated quantification of the tricuspid valve. At a high level, this is accomplished through automatically derived measurements from a segmented model of the tricuspid valve annulus formed by the software through model-based segmentation of the acquired ultrasound images.
3D Auto CFQ provides semi-automated quantification of Mitral Requrgitation (MR) volume and peak flow rate based on 3D color flow images. This application uses a known fluid dynamic model of flow that is adapted to the acquired color information. This allows quantitative assessment of mitral valve leakage during systole. The derived result supports the assessment of mitral regurgitation volume and peak flow rate.
Data Compatibility of the VeriSight ICE / Pro ICE Probe, transducers cleared for the EPIQ Series Diagnostic Ultrasound System (K202216), will be introduced for Ultrasound Workspace 6.0.
General software architecture of the previously cleared version TOMTEC-ARENA remains unchanged. Two new clinical application packages will be introduced with UWS6.0: 3D Auto TV and 3D Auto CFQ. An existing feature AutoStrain Left Ventricle (AutoStrain LV) gains additional functionality by integration of Segmental Wall Motion (SWM) feature. The module using AutoStrain LV together with SWM is named 2D Auto LV.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiovascular, fetal, and abdominal structures. Specifically, left ventricle (LV), tricuspid valve, mitral valve.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended User: licensed medical practitioners or assistant medical technicians.
Care Setting: inside and outside of Hospitals, Clinics, and Physician's offices.
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
Performance Data for Segmental Wall Motion (SWM)
Study Type: Retrospective data analysis study.
Sample Size: Not specified.
Data Source: Transthoracic (TTE) ultrasound clips obtained from subjects referred for clinical TTE exam.
Annotation Protocol: Performance of the integrated (subject) SWM algorithm compared to LVivo SWM (DiA Imaging Analysis) application (ground truth) in the quantification of WMSI for the same subjects' exams.
Performance Data for 3D Auto TV
Study Type: Study to evaluate the performance of the 3D Auto TV software.
Sample Size: Not specified.
Data Source: Transesophageal echocardiography (TEE) cardiac clips.
Annotation Protocol: TV annulus measurements by 3 clinical experts (reviewers) with the use of 3D Auto TV software and the results compared to manual measurements by the same reviewers performed within 4D Cardio-View application, used as a ground truth for the study.
Performance Data for 3D Auto CFQ
Study Type: Study to evaluate the performance of the 3D Auto CFQ software.
Sample Size: Not specified.
Data Source: Not specified, but implied to be 3D color flow images and cardiac magnetic resonance imaging (CMR) from subjects.
Annotation Protocol: Results were compared to cardiac magnetic resonance imaging (CMR) requrgitant volume (RVol), used as a ground truth for the study. Peak regurgitant flow output from 3D Auto CFQ was also validated against 2D PISA methodology on the same subjects.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data for Segmental Wall Motion (SWM)
Study Type: Retrospective data analysis study.
Sample Size: Not specified.
Key Results: The results showed a very strong correlation to the LVivo application for WMSI output (Pearsons's correlation coefficient of 0.957 (95%Cl 0.933, 0.972), thereby meeting the predefined acceptance criteria for the study. The 2D Auto LV application, including the Segmental Wall Scoring on Ultrasound Workspace, is found to be safe and effective to use through a summative evaluation. 16 target users completed the critical tasks of saving desired measurements with a success rate of 97.7%.
Performance Data for 3D Auto TV
Study Type: Performance evaluation study.
Sample Size: Not specified.
Key Results: The results of the primary endpoint analysis demonstrated high agreement of the 3D Auto TV software with the 4D Cardio-View software (ground truth). Confidence intervals for the limits of agreement were within the acceptance criteria ± 46% and ± 52% for annulus size and annulus shape. respectively, within TEE and TTE arms. Bias was also evaluated for automation performance, where relative bias based on inter-observer variability was met, specifically within +/- 17,37% for distance (size) and +/- 23.68% for circumference (shape). Mean relative error of the measurement primitives on the in-silico phantoms were within +/- 1%, with limits of agreement within acceptance criteria of +/- 5%.
Performance Data for 3D Auto CFQ
Study Type: Performance evaluation study.
Sample Size: Not specified.
Key Results: This study produced limits of agreement (LoA) of -49.29 (lower LoA) and 25.09 (upper LoA) and associated confidence intervals: lower end of 95% LoA (-58.37,-40.20) and upper end of 95% LoA (16.01,34.18). The primary endpoint acceptance criteria for maximum allowable difference was met, with a maximum allowable difference (Δ) of 61.6 ml. Bias was assessed where the acceptance criteria for mean difference (bias) within +/- 19.2ml was met. For both fully-automated and semi-automated 3D Auto CFQ, the upper and lower bounds of the 95% confidence interval for Pearson's correlation exceeded the acceptance criteria of > 0.8 when compared to 2D PISA. All acceptance criteria for the studies were met, and the results demonstrated clinically reasonable, relevant, meaningful performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Performance Data for Segmental Wall Motion (SWM)
Pearson's correlation coefficient of 0.957 (95%Cl 0.933, 0.972). Success rate of 97.7% for critical tasks.
Performance Data for 3D Auto TV
Confidence intervals for the limits of agreement were within the acceptance criteria ± 46% and ± 52% for annulus size and annulus shape. Relative bias based on inter-observer variability was met, specifically within +/- 17,37% for distance (size) and +/- 23.68% for circumference (shape). Mean relative error of the measurement primitives on the in-silico phantoms were within +/- 1%, with limits of agreement within acceptance criteria of +/- 5%.
Performance Data for 3D Auto CFQ
Limits of agreement (LoA) of -49.29 (lower LoA) and 25.09 (upper LoA). Lower end of 95% LoA (-58.37,-40.20) and upper end of 95% LoA (16.01,34.18). Mean difference (bias) within +/- 19.2ml. Pearson's correlation exceeded the acceptance criteria of > 0.8 when compared to 2D PISA.
Predicate Device(s)
K213544; TOMTEC-ARENA (TTA2.50)
Reference Device(s)
K240850; EPIQ Series Diagnostic Ultrasound System with SWM, K202216, EPIQ Series Diagnostic Ultrasound System with ICE/Pro ICI
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Philips Ultrasound LLC Petra Galgoczy Senior Regulatory Affairs Specialist 22100 Bothell Everett Hwy Bothell, Washington 98021
February 10, 2025
Re: K241659 Trade/Device Name: Ultrasound Workspace (UWS 6.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ, IYN Dated: June 10, 2024 Received: January 16, 2025
Dear Petra Galgoczy:
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 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/cfpm/pm.cfm identifies combination product submissions. The general controls 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.
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
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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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/unique-deviceidentification-system-udi-system.
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-reporting-mdr-how-report-medicaldevice-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/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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-deviceadvice-comprehensive-regulatory-assistance/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,
Jessica Lamb
Jessica Lamb, PhD Assistant Director, Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Ultrasound Workspace (UWS 6.0)
Indications for Use (Describe)
Indications for use of the product are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.
510(k) Number: _______________________K241659
Date Prepared: November 18, 2024
l. Submitter
| Manufacturer Name and
Address | Philips Ultrasound LLC
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Petra Galgoczy, PhD
Senior Regulatory Affairs Specialist
Freisinger Strasse 9
85716 Unterschleissheim Germany
+49 (89) 32175593 |
| Secondary Contact | Erdit Gremi
Director, Regulatory Affairs
Software & Al
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA
+1 (617) 77988092 |
ll. Device
Common Name
| Proprietary Name | Ultrasound Workspace (UWS 6.0) |
|---|---|
| ------------------ | -------------------------------- |
Picture archiving and communications system
| Regulation Description | Classification Description | 21 CFR § | Product Code |
|---|---|---|---|
| Primary | |||
| Automated Radiological Image | |||
| Processing Software | 892.2050 | QIH | |
| Secondary | |||
| Medical image management and | |||
| processing system | 892.2050 | LLZ | |
| System, imaging, pulsed doppler, | |||
| ultrasonic | 892.1550 | IYN |
| Device Class | Class II |
|---|---|
| Review Panel | Radiology |
| Predicate Device | K213544; TOMTEC-ARENA (TTA2.50) |
| Reference Devices | K240850; EPIQ Series Diagnostic Ultrasound System with SWM |
| K202216, EPIQ Series Diagnostic Ultrasound System with ICE/Pro ICI |
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III. Device Description
The purpose of this Traditional 510(k) Pre-market Notification is to introduce the SWM, 3D Auto TV and 3D Auto CFQ software applications as well as compatibility of VeriSight ICE / Pro ICE Probe data with the subject device Ultrasound Workspace Version 6.0.
The semi-automated Segmental Wall Motion feature (SWM) evaluates the segmental (regional) function of the left ventricle (LV) from adult TTE echo examinations. It performs border detection and tracking to identify each of the LV seqments, provides segmental wall motion scores for each segments of the LV by using machine learning algorithms and calculates an overall wall motion score index (WMSI) as the average of the segmental scores.
3D Auto TV software enables semi-automated quantification of the tricuspid valve. At a high level, this is accomplished through automatically derived measurements from a segmented model of the tricuspid valve annulus formed by the software through model-based segmentation of the acquired ultrasound images.
3D Auto CFQ provides semi-automated quantification of Mitral Requrgitation (MR) volume and peak flow rate based on 3D color flow images. This application uses a known fluid dynamic model of flow that is adapted to the acquired color information. This allows quantitative assessment of mitral valve leakage during systole. The derived result supports the assessment of mitral regurgitation volume and peak flow rate.
Data Compatibility of the VeriSight ICE / Pro ICE Probe, transducers cleared for the EPIQ Series Diagnostic Ultrasound System (K202216), will be introduced for Ultrasound Workspace 6.0.
General software architecture of the previously cleared version TOMTEC-ARENA remains unchanged. Two new clinical application packages will be introduced with UWS6.0: 3D Auto TV and 3D Auto CFQ. An existing feature AutoStrain Left Ventricle (AutoStrain LV) gains additional functionality by integration of Segmental Wall Motion (SWM) feature. The module using AutoStrain LV together with SWM is named 2D Auto LV.
IV. Intended Use and Indications for Use
Ultrasound Workspace Intended Use
Ultrasound Workspace is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.
Ultrasound Workspace Indications for Use
Indications for use of Ultrasound Workspace are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.
Intended Use Environments
Intended Use Environments are inside and outside of Hospitals, Clinics, and Physician's offices.
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Ultrasound Workspace is intended to be used only by licensed medical practitioners or assistant medical technicians.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by licensed medical practitioners or assistant medical technicians for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Note: There are no changes to the Ultrasound Workspace for Intended Use / Indications for Use due to the introduction of the SWM, 3D Auto TV and 3D Auto CFQ feature and usage of data derived from VeriSight ICE / Pro ICE data. SWM, 3D Auto TV and 3D Auto CFQ software is associated with the Cardiac Adult indication.
Comparison of Technological Characteristics with the Predicate and Reference Devices V.
The purpose of this Traditional 510(k) Pre-market Notification is to introduce the SWM. 3D Auto TV and 3D Auto CFQ software applications and compatibility of VeriSight ICE / Pro ICE Probe data with the Ultrasound Workspace Version 6.0 software package. The subject device is substantially equivalent to the predicate device (K213544).
The following tables provide an overview of the comparison of similarities and differences between the proposed device, the predicate and reference devices.
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Table 1: Comparison to Predicate and Reference Device for introduction of SWM onto UWS6.0
| Ultrasound Workspace | TOMTEC-ARENA | EPIQ Series Diagnostic | Comparison | |
|---|---|---|---|---|
| Feature | Version 6.0 (UWS6.0) | TTA2.50 | Ultrasound System | |
| Proposed Device | Predicate Device | Reference Device | ||
| K-number | Not available | K213544 | K240850 | Subject of this submission |
| is UWS6.0 | ||||
| Intended Use | The product is a clinical | |||
| software package | ||||
| designed for review, | ||||
| quantification and | ||||
| reporting of structures and | ||||
| function based on multi- | ||||
| dimensional digital | ||||
| medical data acquired with | ||||
| different modalities. The | ||||
| product is not intended to | ||||
| be used for reading of | ||||
| mammography images. | TOMTEC-ARENA | |||
| software is a clinical | ||||
| software package | ||||
| designed for review, | ||||
| quantification and | ||||
| reporting of structures and | ||||
| function based on multi- | ||||
| dimensional digital | ||||
| medical data acquired with | ||||
| different | ||||
| modalities. TOMTEC- | ||||
| ARENA is not intended to | ||||
| be used for reading of | ||||
| mammography images. | Abdominal, Cardiac Adult, | |||
| Cardiac other (Fetal), | ||||
| Cardiac Pediatric, | ||||
| Cerebral Vascular, | ||||
| Cephalic (Adult), Cephalic | ||||
| (Neonatal), | ||||
| Fetal/Obstetric, | ||||
| Gynecological, | ||||
| Intraoperative (Vascular), | ||||
| Intraoperative (Cardiac), | ||||
| intra-luminal, intra-cardiac | ||||
| echo, Musculoskeletal | ||||
| (Conventional), | ||||
| Musculoskeletal | ||||
| (Superficial), Ophthalmic, | ||||
| Other: Urology, Pediatric, | ||||
| Peripheral Vessel, Small | ||||
| Organ (Breast, Thyroid, | ||||
| Testicle), | ||||
| Transesophageal | ||||
| (Cardiac), Transrectal, | ||||
| Transvaginal, Lung. | Intended Use/Indications | |||
| for use of predicate and | ||||
| subject device are | ||||
| identical (unchanged) - | ||||
| except of the product | ||||
| name (bolded). | ||||
| Intended Use/Indications | ||||
| for use of reference device | ||||
| and subject device are | ||||
| similar and considered | ||||
| equivalent (specifically if | ||||
| compared for the clinical | ||||
| use case/workflow of the | ||||
| subject feature). | ||||
| Indications for Use | Indications for use of the | |||
| product are quantification | ||||
| and reporting of | ||||
| cardiovascular, fetal, and | ||||
| abdominal structures and | ||||
| function of patients with | ||||
| suspected disease to | ||||
| support the physician | ||||
| in the diagnosis. | Indications for use of | |||
| TOMTEC-ARENA TTA2 | ||||
| software are quantification | ||||
| and reporting of | ||||
| cardiovascular, fetal, | ||||
| abdominal structures and | ||||
| function of patients with | ||||
| suspected disease to | ||||
| support the physicians in | ||||
| the diagnosis | ||||
| Intended Users | The product is intended | |||
| to be used only by | TOMTEC-ARENA | |||
| software is intended to be | The product is intended to | |||
| be used only by licensed | Identical for predicate and | |||
| subject device -except of | ||||
| Feature | Ultrasound Workspace | |||
| Version 6.0 (UWS6.0) | TOMTEC-ARENA | |||
| TTA2.50 | EPIQ Series Diagnostic | |||
| Ultrasound System | Comparison | |||
| Proposed Device | Predicate Device | Reference Device | ||
| licensed medical | ||||
| practitioners or assistant | ||||
| medical | ||||
| technicians. | used only by licensed | |||
| medical practitioners or | ||||
| assistant medical | ||||
| technicians. | medical practitioners or | |||
| assistant medical | ||||
| technicians. | the product name | |||
| ( bolded ). | ||||
| Intended Users of | ||||
| reference device and | ||||
| subject device are similar | ||||
| and considered equivalent | ||||
| Intended User | ||||
| Environment | Intended Use | |||
| Environments are inside | ||||
| and outside of Hospitals, | ||||
| Clinics, and Physician's | ||||
| offices. | Intended Use | |||
| Environments are inside | ||||
| and outside of Hospitals, | ||||
| Clinics, and Physician's | ||||
| offices. | Clinics, hospitals, and | |||
| clinical point-of-care for | ||||
| diagnosis of patients. | Identical to predicate | |||
| device. | ||||
| Difference to reference | ||||
| device is due to the fact | ||||
| that subject and predicate | ||||
| devices are software only, | ||||
| whereas reference device | ||||
| includes the ultrasound | ||||
| device. | ||||
| USA FDA Classification | Class II | Class II | Class II | Identical |
| Primary Product Code | QIH | QIH | IYN | Identical to predicate |
| device | ||||
| Primary Regulation | ||||
| Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.1550 | Identical to predicate |
| device | ||||
| Primary Regulation | ||||
| Name | Automated Radiological | |||
| Image Processing | ||||
| Software | Automated Radiological | |||
| Image Processing | ||||
| Software | System, Imaging, Pulsed | |||
| Doppler, Ultrasonic | Identical to predicate | |||
| device | ||||
| Secondary Product | ||||
| Codes | LLZ | |||
| IYN | LLZ | ITX | ||
| IYO | ||||
| OBJ | ||||
| QIH | IYN is newly introduced | |||
| with this submission | ||||
| Secondary Regulation | ||||
| Number | 21 CFR 892.2050 | |||
| 21 CFR 892.1550 | 21 CFR 892.2050 | 21 CFR 892.1570 | ||
| 21 CFR 892.1560 | ||||
| 21 CFR 870.1200 | Identical to predicate | |||
| device. | ||||
| Feature | Ultrasound Workspace | |||
| Version 6.0 (UWS6.0) | TOMTEC-ARENA | |||
| TTA2.50 | EPIQ Series Diagnostic | |||
| Ultrasound System | Comparison | |||
| Proposed Device | Predicate Device | Reference Device | ||
| 21 CFR 892.2050 | IYN is newly introduced | |||
| with this submission | ||||
| Secondary Regulation | ||||
| Name | System, Image | |||
| Processing, Radiological | ||||
| System, Imaging, Pulsed | ||||
| Doppler, Ultrasonic | System, Image | |||
| Processing, Radiological | Diagnostic ultrasonic | |||
| transducer | ||||
| Ultrasonic pulsed echo | ||||
| imaging system | ||||
| Diagnostic intravascular | ||||
| catheter | ||||
| Automated Radiological | ||||
| Image Processing | ||||
| Software | Identical to predicate | |||
| device | ||||
| IYN is newly introduced | ||||
| with this submission | ||||
| Application Description | The SWM software | |||
| automatically evaluates | ||||
| the segmental (regional) | ||||
| function of the left | ||||
| ventricle (LV) from adult | ||||
| TTE echo examinations. | ||||
| Note: Per FDA Guidance | ||||
| Technical Performance | ||||
| Assessment of | ||||
| Quantitative Imaging in | ||||
| Radiological Device | ||||
| Premarket Submissions, | ||||
| the SWM software is a | ||||
| semi-automated | ||||
| quantitative imaging | ||||
| algorithm, as users are | ||||
| generally expected to | ||||
| review and concur with the | ||||
| initialization and | ||||
| generated results. The | The predicate TOMTEC- | |||
| ARENA does not currently | ||||
| have a dedicated software | ||||
| application containing the | ||||
| functionality introduced in | ||||
| the subject submission for | ||||
| (semi-) automated | ||||
| segmental wall motion | ||||
| evaluation of the left | ||||
| ventricle (LV). | Smart View Select is an | |||
| automated software | ||||
| feature that assists the | ||||
| user in selection of images | ||||
| for analysis with the | ||||
| existing Philips AutoStrain | ||||
| LV or 2D Auto LV | ||||
| application in Adult Echo | ||||
| Transthoracic (TTE) | ||||
| examination. | ||||
| The SWM software | ||||
| automatically evaluates | ||||
| the segmental (regional) | ||||
| function of the left | ||||
| ventricle (LV) from adult | ||||
| TTE echo examinations. | ||||
| Note: Per FDA Guidance | ||||
| Technical Performance | ||||
| Assessment of | SWM functionality is | |||
| missing in the predicate | ||||
| device. This feature is | ||||
| newly introduced with this | ||||
| submission. | ||||
| SWM in the subject and | ||||
| reference device is | ||||
| identical. | ||||
| In both cases SWM has | ||||
| been integrated in the | ||||
| existing feature AutoStrain | ||||
| LV. The module using | ||||
| AutoStrain LV together | ||||
| with SWM is named 2D | ||||
| Auto LV. | ||||
| Note: The Smart View | ||||
| Select feature described | ||||
| for the reference device is. | ||||
| Ultrasound Workspace | ||||
| Version 6.0 (UWS6.0) | TOMTEC-ARENA | |||
| TTA2.50 | EPIQ Series Diagnostic | |||
| Ultrasound System | Comparison | |||
| Feature | Proposed Device | Predicate Device | Reference Device | |
| users can also edit | ||||
| algorithm generated | ||||
| segmental wall motion | ||||
| scores for individual | ||||
| segments based on their | ||||
| clinical expertise. | Quantitative Imaging in | |||
| Radiological Device | ||||
| Premarket Submissions, | ||||
| the SWM software is a | ||||
| semi-automated | ||||
| quantitative imaging | ||||
| algorithm, as users are | ||||
| generally expected to | ||||
| review and concur with the | ||||
| initialization and | ||||
| generated results. The | ||||
| users can also edit | ||||
| algorithm generated | ||||
| segmental wall motion | ||||
| scores for individual | ||||
| segments based on their | ||||
| clinical expertise. | not included in the subject | |||
| device UWS6.0. | ||||
| SWM scoring | ||||
| adjustment | Users manually edit | |||
| scores using a drop-down | ||||
| selection | Not applicable - does not | |||
| contain functionality for | ||||
| segmental wall motion | Users manually edit | |||
| scores using a drop-down | ||||
| selection | Identical to reference | |||
| device | ||||
| Introduction of | ||||
| segmental wall motion | ||||
| scores / overall wall | ||||
| motion score index | ||||
| (WMSI) | Segmental wall motion | |||
| scores are indicated for 17 | ||||
| segments of the left | ||||
| ventricle. Overall wall | ||||
| motion score index | ||||
| (WMSI) is calculated. | Not applicable - does not | |||
| contain functionality for | ||||
| segmental wall motion | Segmental wall motion | |||
| scores are indicated for 17 | ||||
| segments of the left | ||||
| ventricle. Overall wall | ||||
| motion score index | ||||
| (WMSI) is calculated. | Identical to reference | |||
| device. | ||||
| Wall motion scores are an | ||||
| additional value for | ||||
| evaluating the segmental | ||||
| (regional) function of the | ||||
| left ventricle (LV) using | ||||
| TTE echo examinations in | ||||
| adults. | ||||
| Feature | Ultrasound Workspace Version 6.0 | |||
| (UWS6.0) | TOMTEC-ARENA | |||
| TTA2.50 - K213544 | Comparison | |||
| Proposed Device | Predicate Device | |||
| K-number | Not available | K213544 | Subject of this submission is UWS6.0 | |
| Application | ||||
| Description | ||||
| 3D Auto TV | 3D Auto TV software enables semi- | |||
| automated quantification of the tricuspid valve | ||||
| during transesophageal echocardiography | ||||
| (TEE) and transthoracic echocardiography | ||||
| (TTE) examinations. It applies artificial | ||||
| intelligence for model based segmentation. At | ||||
| a high level, this is accomplished through | ||||
| automatically derived measurements from a | ||||
| segmented model of the tricuspid valve | ||||
| annulus formed by the software through | ||||
| model-based segmentation of the acquired | ||||
| ultrasound images. | 3D Auto MV (formerly named 4D MV- | |||
| ASSESSMENT) is a semi-automated | ||||
| software application intended for the analysis | ||||
| of Mitral Valve (MV) anatomy and function. | ||||
| This application generates models of | ||||
| anatomical structures of interest such as the | ||||
| MV annulus, leaflets, and the closure line, | ||||
| which allows for quantification of pre- and | ||||
| post-operative valvular function and a | ||||
| comparison of morphology. | ||||
| 4D CARDIO-VIEW is an advanced analysis | ||||
| tool for 3D/4D echocardiography data. | ||||
| Anatomical structure visualization, volume | ||||
| measurements (LV and/or generic), and | ||||
| specified or manual measurements are | ||||
| possible for cardiac structures including, but | ||||
| not limited to, the tricuspid valve. Various | ||||
| tools are available for rendering that display | ||||
| 2- and 3-dimensional morphology and | ||||
| function for defined structures. | Similar to the predicate device features. | |||
| The functionality and workflow of the 3D Auto | ||||
| TV software is very similar to the 3D Auto | ||||
| MV tool, where measurement parameters are | ||||
| derived from models of the mitral valve (in the | ||||
| case of 3D Auto MV) and tricuspid valve (in | ||||
| the case of 3D Auto TV). Manual | ||||
| measurements are also able to be performed | ||||
| on both software applications. | ||||
| Comparing 3D Auto TV to 4D CARDIO- | ||||
| VIEW, both software have functionality for | ||||
| quantifying the tricuspid valve. The proposed | ||||
| 3D Auto TV allows semi-automated | ||||
| quantification, where the reference device is | ||||
| fully manual. As we demonstrate high | ||||
| agreement in the measurement outputs on | ||||
| the same patients when quantified using the | ||||
| proposed 3D Auto TV software and the | ||||
| reference 4D CARDIO-VIEW application | ||||
| (REF #4), there are no new questions raised | ||||
| of safety or effectiveness. | ||||
| The subject of this submission is introduction | ||||
| of semi-automated quantification via 3D Auto | ||||
| TV of UWS6.0. | ||||
| Feature | Ultrasound Workspace Version 6.0 | |||
| (UWS6.0) | ||||
| Proposed Device | TOMTEC-ARENA | |||
| TTA2.50 - K213544 | ||||
| Predicate Device | Comparison | |||
| Contour | ||||
| Generation | 3D surface model is created semi- | |||
| automatically using machine learning | ||||
| algorithm without user interaction. User is | ||||
| able to edit, accept, or reject the initial | ||||
| landmark proposals of the tricuspid valve | ||||
| anatomical locations. | 3D Auto MV: 3D surface model is created | |||
| semi-automatically using machine learning | ||||
| algorithm without user interaction. User is | ||||
| able to edit, accept, or reject the initial | ||||
| landmark proposals of the mitral valve | ||||
| anatomical locations. | ||||
| 4D CARDIO-VIEW: 3D surface model is | ||||
| created based on user defined anatomical | ||||
| landmarks. User is able to edit the contour of | ||||
| the surface model before proceeding with the | ||||
| workflow. | Subject device uses identical method for | |||
| contour generation as the 3D Auto MV | ||||
| application of the predicate device. The only | ||||
| difference is the algorithm is trained on | ||||
| tricuspid valve images, where the predicate | ||||
| device was trained using mitral valve images | ||||
| Measurements | ||||
| Performed | Semi-auto annulus results | |||
| • TV Ann Perimeter (3D) | ||||
| • TV Ann Perimeter (2D) | ||||
| • TV Ann Max Diam (2D) | ||||
| • TV Ann Min Diam (2D) | ||||
| • TV Ann Perimeter Derived Diam (2D) | ||||
| • TV Ann Height (3D) | ||||
| • TV Ann Area (2D) | ||||
| Manual device results | ||||
| • TV Ann AP Diam (2D) | ||||
| • TV Ann SL Diam (2D) | ||||
| • Subvalvular 5 Plane SL Diam | ||||
| • Subvalvular 5 Plane AP Diam | ||||
| • Supravalvular C-Shaped Perimeter | ||||
| • Supravalvular AV - AoCenter Diam | 3D Auto MV: | |||
| Standard MV Parameters | ||||
| • AP Diameter (cm) | ||||
| • AL-PM Diameter (cm) | ||||
| • Sphericity Index (AP / AL-PM) | ||||
| • Intertrigonal Distance (cm) | ||||
| • Commissural Diameter (cm) | ||||
| • D-Shaped Annulus Perimeter (cm) | ||||
| • Annulus Height (cm) | ||||
| • Non-planar Angle (degrees) | ||||
| • Tenting Volume (cm3) | ||||
| • Coaptation Depth (mm) | ||||
| • Tenting Area (cm2) | ||||
| • Angle AAo-AP (degrees) | ||||
| • Maximum Prolapse Height (mm) | ||||
| • Maximum Open Coaptation Gap (mm) | ||||
| • Maximum Open Coaptation Width (mm) | ||||
| • Anterior Leaflet Area (cm2) | ||||
| • Posterior Leaflet Area (cm2) | ||||
| • Distal Anterior Leaflet Angle (degrees) | ||||
| • Posterior Leaflet Angle (degrees) | ||||
| • Anterior Leaflet Length (cm) | ||||
| • Posterior Leaflet Length (cm) | Similar. The proposed 3D Auto TV software | |||
| enables a subset of very similar semi- | ||||
| automated measurements as the predicated | ||||
| software application 3D Auto MV, only for the | ||||
| tricuspid annulus. | ||||
| The proposed 3D Auto TV software adds | ||||
| additional TV annulus and device | ||||
| measurements from those available in 4D | ||||
| CARDIO-VIEW to further define the tricuspid | ||||
| valve anatomy. | ||||
| Both the proposed 3D Auto TV and the | ||||
| predicate 4D CARDIO-VIEW software allow | ||||
| manual, free-form measurements of the | ||||
| valve. | ||||
| Feature | Ultrasound Workspace Version 6.0 | |||
| (UWS6.0) | ||||
| Proposed Device | TOMTEC-ARENA | |||
| TTA2.50 - K213544 | ||||
| Predicate Device | Comparison | |||
| • C-Shaped Annulus (cm) | ||||
| 2D MV Parameters | ||||
| • D-Shaped Annulus Area (cm2) | ||||
| • Annulus Area (cm2) | ||||
| • Anterior Closure Line Length (cm) | ||||
| • Posterior Closure Line Length (cm) | ||||
| 3D MV Parameters | ||||
| • Saddle Shaped Annulus Area (cm2) | ||||
| • Saddle Shaped Annulus Perimeter (cm) | ||||
| • Total Open Coaptation Area (cm2) | ||||
| • Anterior Closure Line Length (cm) | ||||
| • Posterior Closure Line Length (cm) | ||||
| 4D CARDIO-VIEW: | ||||
| TAVR results | ||||
| • Ann-Ost left diam | ||||
| • Ann-Ost right diam | ||||
| • Annulus Area | ||||
| • Annulus dmin | ||||
| • Annulus dmax | ||||
| • Ao Ring diam | ||||
| • Ao SV diam | ||||
| • Ao STJ diam | ||||
| Volume results (not related to TV | ||||
| quantification) | ||||
| • EDV | ||||
| • EF | ||||
| • ESV | ||||
| • GenVol | ||||
| • Mass | ||||
| • SV |
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Table 2: Comparison to Predicate for Introduction of 3D Auto TV onto UWS6.0 For Indications for Use, Intended Use, Product Code Information, Classification please refer to Table 1.
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Table 3: Comparison to Predicate for Introduction of 3D Auto CFQ onto UWS6.0 For Indications for Use, Intended Use, Product Code Information, Classification please refer to Table 1.
| Feature | Ultrasound Workspace Version 6.0
(UWS6.0) | TOMTEC-ARENA
TTA2.50 - K213544 | Comparison |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed Device | Predicate Device | |
| K-number | Not available | K213544 | Subject of this submission is UWS6.0 |
| Application
Description
3D Auto CFQ | The 3D Auto CFQ is a new artificial
intelligence software which will be introduced
on the Ultrasound Workspace Software
system starting with Version 6.0. The
application provides semi-automated
quantification of Mitral Regurgitation (MR)
volume and peak flow rate based on 3D color
flow images acquired during
transesophageal echocardiography (TEE)
examinations. | The Proximal Isovelocity Surface Area (PISA)
methodology can be used currently on the
predicate device to quantify valvular
regurgitation. The technique utilizes 2D/Color
and Doppler images to allow the user to make
simple, manual measurements in a cascading
fashion to allow calculation of peak flow rate
and volumetric regurgitation.
3D Auto MV is a semi-automated software
application intended for the analysis of Mitral
Valve (MV) anatomy and function. This
application generates models of anatomical
structures of interest such as the MV annulus,
leaflets, and the closure line, which allows for
quantification of pre- and post-operative
valvular function and a comparison of
morphology. | Similar. The predicate device facilitates the
quantification of mitral regurgitation volume
and peak flow rate through a group of
measurements which are performed in a
cascading fashion manually by the user
according to the Proximal Isovelocity Surface
Area (PISA) methodology. The proposed 3D
Auto CFQ software application allows the
users to quantify the same measurements for
mitral regurgitation volume and peak flow rate
but in a semi-automated workflow.
3D Auto MV feature of the predicate does not
contain functionality for quantification of mitral
regurgitation. |
| Contour
Generation | 3D surface model is created semi-
automatically using machine learning
algorithm without user interaction. User is
able to edit, accept, or reject the initial
landmark proposals of the mitral valve
anatomical locations. | PISA: No standard contour generation
technology for the mitral valve, outside of 3D
Auto MV, included as part of the system.
3D Auto MV: 3D surface model is created
semi-automatically using machine learning | Subject device uses identical method for
contour generation as the 3D Auto MV
feature of the predicate device. |
| Feature | Ultrasound Workspace Version 6.0
(UWS6.0) | TOMTEC-ARENA
TTA2.50 - K213544 | Comparison |
| | Proposed Device | Predicate Device | |
| | The 3D Auto CFQ algorithm quantifies mitral
regurgitation volume and flow rate from | algorithm without user interaction. User is able
to edit, accept, or reject the initial landmark
proposals of the mitral valve anatomical
locations.
PISA:
The PISA methodology uses sequential | Similar. The PISA methodology of the
predicate device – used for quantifying MR |
| Quantification
Technology for
Mitral
Regurgitation | acquired 3D color flow images. The greyscale
information from these images is used to
generate a 3D model of the mitral valve,
which is used as an input along with the 3D
color data into the 3D Auto CFQ flow
algorithm. The 3D Auto CFQ algorithm uses a
fluid dynamic model of an incompressible
fluid (blood) traveling through an irregular-
shaped (i.e., nonround) orifice. In its initial
step, the algorithm generates a hypothetical
model of true blood flow velocities in the
proximal convergence zone based on all
measured Doppler velocities and the
underlying fluid dynamics model. The true
velocity model is then converted into the
corresponding apparent Doppler velocity
model ("synthetic apparent velocities") using
ultrasound physics (projection along the axial
dimension). These synthetic velocities are
subsequently compared to the acquired
velocities in the Color Flow (CF) data set.
Based on the outcome of this comparison,
the model is updated and reiterated to get
the best fit between the acquired velocities | acquisitions and manual measurements,
which are manually performed by the user:
MR Alias Velocity (from the 2D/Color)
MR Radius (from the 2D/Color)
MR Vmax (from the continuous wave
doppler)
MR VTI (from the continuous wave
doppler)
The outputs of these measurements go into
the equations for the derived measurements
including:
Mitral Regurgitant (MR) Flow Rate
MR Effective Regurgitant Orifice (ERO)
MR Volume
3D Auto MV:
N/A - does not contain technology for mitral
regurgitation quantification | volume and flow rate - utilizes sequential
measurements performed by the user and is
based on assumptions including there being
a single, round, constant flow orifice during
the entire systole.
3D Auto CFQ operates using 3D color to
address the spatial complexities seen in
mitral regurgitation and was developed to
evaluate the regurgitant flow at every frame in
systole, where the PISA methodology only
|
| | and the generated model. 3D Auto CFQ
determines the resulting regurgitant flow rate | | arrive at the outputs of mitral regurgitation
volume and peak flow rate. These outputs are |
| Feature | Ultrasound Workspace Version 6.0
(UWS6.0) | TOMTEC-ARENA
TTA2.50 - K213544 | Comparison |
| | Proposed Device | Predicate Device | |
| | for this frame. This process is repeated for
each frame included in the analysis, which in
most cases includes the entire systolic cycle.
In each frame, the size and shape of the
regurgitant orifice is not assumed but is
generated by this iterative loop between the
model and the CF data. | | the same as in the predicate, only the method
to arrive at the measurements differs in the
subject device. |
| | Semi-automated measurements performed
by the 3D Auto CFQ software application:
Mitral regurgitation (MR) volume [mL];
Peak flow rate [mL/s] | PISA:
Derived measurements which the user can
obtain through the PISA methodology include:
Mitral regurgitation (MR) volume [mL];
Peak flow rate [mL/s] | Similar. The measurements performed by the
proposed 3D Auto CFQ software application
can also be obtained by a user on the
predicate device using the PISA
methodology. |
| Measurements
Performed | | 3D Auto MV:
Standard MV Parameters
• AP Diameter (cm)
• AL-PM Diameter (cm)
• Sphericity Index (AP / AL-PM)
• Intertrigonal Distance (cm)
• Commissural Diameter (cm)
• D-Shaped Annulus Perimeter (cm)
• Annulus Height (cm)
• Non-planar Angle (degrees)
• Tenting Volume (cm3)
• Coaptation Depth (mm)
• Tenting Area (cm2)
• Angle AAo-AP (degrees)
• Maximum Prolapse Height (mm)
• Maximum Open Coaptation Gap (mm)
• Maximum Open Coaptation Width (mm)
• Anterior Leaflet Area (cm2)
• Posterior Leaflet Area (cm2)
• Distal Anterior Leaflet Angle (degrees)
• Posterior Leaflet Angle (degrees)
• Anterior Leaflet Length (cm)
• Posterior Leaflet Length (cm) | Substantiation of the performance of the 3D
Auto CFQ software's regurgitant volume
output was performed by comparison to
cardiac magnetic imaging with (CMR) images
with acceptance criteria of agreement within
the limits of agreement. While the PISA
methodology is a widely accepted method for
mitral regurgitation quantification and is a
recommended method by the American
Society of Echocardiography, the outputs
from 3D Auto CFQ were compared to those
from CMR (as opposed to PISA) as the
former is considered a gold standard for
mitral regurgitation quantification.
Acceptance criteria for 3D Auto CFQ was
based on agreement with CMR being within
predefined maximum limits of agreement. |
| Feature | Ultrasound Workspace Version 6.0
(UWS6.0)
Proposed Device | TOMTEC-ARENA
TTA2.50 - K213544
Predicate Device | Comparison |
| | | • C-Shaped Annulus (cm)
2D MV Parameters
• D-Shaped Annulus Area (cm2)
• Annulus Area (cm2)
• Anterior Closure Line Length (cm)
• Posterior Closure Line Length (cm)
3D MV Parameters
• Saddle Shaped Annulus Area (cm2)
• Saddle Shaped Annulus Perimeter (cm)
• Total Open Coaptation Area (cm2)
• Anterior Closure Line Length (cm)
• Posterior Closure Line Length (cm) | In addition to regurgitant volume, the peak
flow rate output of 3D Auto CFQ was
validated in comparison to manual PISA
method, where the correlation was very high.
3D Auto MV feature of the predicate device
facilitates anatomical measurements of the
mitral valve from the generated model of the
mitral valve but does not perform
measurements for quantifying mitral
regurgitation. |
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Table 4: Comparison to Predicate and Reference Device for Compatibility to VeriSight ICE / Pro ICE Probe on UWS6.0
| Feature | Ultrasound Workspace
Version 6.0 (UWS6.0) | TOMTEC-ARENA
TTA2.50 | EPIQ Series Diagnostic
Ultrasound System | Comparison |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| | Proposed Device | Predicate Device | Reference Device | |
| K-number | Not available | K213544 | K202216 | Subject of this submission
is UWS6.0 |
| Transducer Clinical
Application / cleared
compatibility | VeriSight ICE / Pro ICE
(Proposed Transducer) | N/A, compatibility to
VeriSight ICE / Pro ICE
has not been shown. | VeriSight ICE / Pro ICE
was introduced on EPIQ
via K202216. | Identical to reference
device. |
| | TEE (transesophageal)
transducer.
Intended for intracardiac
and intra-luminal
visualization of cardiac and
great vessel anatomy and
physiology as well as
visualization of other
devices in the heart. The
VeriSight ICE catheter
provides 2D ultrasound
imaging capabilities, while
the VeriSight Pro ICE
catheter provides 2D
and/or 3D ultrasound
imaging capabilities. | | TEE (transesophageal)
transducer.
Intended for intracardiac
and intra-luminal
visualization of cardiac and
great vessel anatomy and
physiology as well as
visualization of other
devices in the heart. The
VeriSight ICE catheter
provides 2D ultrasound
imaging capabilities, while
the VeriSight Pro ICE
catheter provides 2D
and/or 3D ultrasound
imaging capabilities. | |
| Data Compatibility | Compatibility to UWS6.0 is
subject of this submission. | N/A, for TTA2
compatibility for VeriSight
ICE / Pro ICE has not
been shown | VeriSight ICE / Pro ICE
was introduced on EPIQ
via K202216. | Identical to reference
device. |
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VI. Nonclinical Performance Data
The proposed modification of Ultrasound Workspace (UWS6.0) was tested in accordance with Philips internal procedures. Philips Ultrasound tested the subject devices per the following standards to ensure the continued safe and effective performance:
- . IEC 62304 Medical device software - Software life cycle processes, 2006 + A 2015
- . ISO 14971 Medical devices- Application of risk management to medical devices, 2019
The approach taken by Philips Ultrasound is in alignment with the following FDA guidance documents:
- . Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2023)
- . Content of Premarket Submissions for Device Software Functions (2023)
- Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket . Submissions (2022)
- . General Principles of Software Validation: Final Guidance for Industry and FDA Staff (2002)
Non-clinical verification testing was conducted to address the change and performance test data were provided to support the introduction of the subject SWM, 3D Auto TV and 3D Auto CFQ software feature and the VeriSight ICE / Pro ICE Probe compatibility. The activities to assure the safe and effective performance of the software revision included, but are not limited to, the following:
- . Requirements Review
- . Risk Analysis and Management Review
- . Product Specification Review
- . Design Reviews
Completion of all verification activities demonstrated that the subject device meets all design and performance requirements. Verification activities performed that the differences in the design did not adversely affect the safety and effectiveness of the subject device.
Non-clinical testing also included performance validation of the proposed SWM, 3D Auto TV and 3D Auto CFQ software applications:
Performance Data for Segmental Wall Motion (SWM)
A retrospective data analysis study was conducted to assess the use of Segmental Wall Motion (SWM), a machine learning- based feature in quantification of Wall Motion Score Index (WMS)) in transthoracic (TTE) ultrasound clips obtained from subjects referred for clinical TTE exam. The study evaluated the performance of the integrated (subject) SWM algorithm compared to LVivo SWM (DiA Imaging Analysis) application (ground truth) in the quantification of WMSI for the same subjects' exams.
A review of published literature within the cardiac assessment space and previous regulatory submissions (compare K240850) informed the acceptance criteria for the study to be defined as Lower Confidence Bound for the Pearson's correlation coefficient to be >0.8 for each endpoint. Acceptance criteria were defined prior to study execution. The results showed a very strong correlation to the LVivo application for WMSI output (Pearsons's correlation coefficient of 0.957 (95%Cl 0.933, 0.972), thereby meeting the predefined acceptance criteria for the study.
The 2D Auto LV application, including the Segmental Wall Scoring on Ultrasound Workspace, is found
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to be safe and effective to use through a summative evaluation. 16 target users completed the critical tasks of saving desired measurements with a success rate of 97.7%. Two steps comprise the critical task: 'Save Measurements' and 'Exclude Measurements'. These steps were evaluated 44 times, with only one failure by one participant during the 'Save Measurements' critical task. But the failure is not safety related, since the participant didn't save a desired result instead of saving an undesired result.
Performance Data for 3D Auto TV
For 3D Auto TV. A study was conducted to evaluate the performance of the 3D Auto TV software, where transesophageal echocardiography (TEE) cardiac clips were used for TV annulus measurements by 3 clinical experts (reviewers) with the use of 3D Auto TV software and the results compared to manual measurements by the same reviewers performed within 4D Cardio-View application, used as a ground truth for the study. Subjects whose clips contributed to the study represented a broad range of demographics, body habitus, and their severity of tricuspid regurgitation were representative of the intended population. The results of the primary endpoint analysis demonstrated high agreement of the 3D Auto TV software with the 4D Cardio-View software (ground truth). Confidence intervals for the limits of agreement were within the acceptance criteria ± 46% and ± 52% for annulus size and annulus shape. respectively, within TEE and TTE arms. Bias was also evaluated for automation performance, where relative bias based on inter-observer variability was met, specifically within +/- 17,37% for distance (size) and +/- 23.68% for circumference (shape). The accuracy and precision of the underlying measurement primitives were also evaluated through use of in silico phantoms with known dimensions. Mean relative error of the measurement primitives on the in-silico phantoms were within +/- 1%, with limits of agreement within acceptance criteria of +/- 5%.
Performance Data for 3D Auto CFQ
For 3D Auto CFQ, a study was conducted to evaluate the performance of the 3D Auto CFQ software. The results were compared to cardiac magnetic resonance imaging (CMR) requrgitant volume (RVol), used as a ground truth for the study. This study produced limits of agreement (LoA) of -49.29 (lower LoA) and 25.09 (upper LoA) and associated confidence intervals: lower end of 95% LoA (-58.37,-40.20) and upper end of 95% LoA (16.01,34.18). The acceptance criteria set for the study was defined as maximum allowable difference (Δ) of 61.6 ml. Based on the results of the lower end of the 95% Cl for LoA was -58.37 and the upper end of the 95% Cl for LoA was 34.18, therefore the primary endpoint acceptance criteria for maximum allowable difference were met. In addition, bias was assessed where the acceptance criteria for mean difference (bias) within +/- 19.2ml was met. Further, the peak regurgitant flow output from 3D Auto CFQ was also validated against 2D PISA methodology on the same subjects. For both fully-automated and semi-automated 3D Auto CFQ, the upper and lower bounds of the 95% confidence interval for Pearson's correlation exceeded the acceptance criteria of > 0.8 when compared to 2D PISA. All acceptance criteria for the studies were met, and the results of the study demonstrated clinically reasonable, relevant, meaningful performance of the 3D Auto CFQ software supporting clinicians' assessment of mitral valve regurgitant volume during cardiac TEE exam.
Since the subject device is software only, no acoustic output, cleaning and disinfectant, thermal, electrical, electromagnetic, mechanical safety and biocompatibility testing were required.
VII. Clinical Data
There was no clinical investigation needed for this premarket submission of the Ultrasound Workspace Version 6.0 with SWM, 3D Auto TV and 3D Auto CFQ features, also addition of data compatibility of the new probes did not trigger clinical investigation.
VIII. Sterilization
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Not applicable. Ultrasound Workspace is a software-only device.
IX. Conclusion
During the testing of the new features, all pre-determined acceptance criteria were met. Results of these tests show that the proposed subject device meets its intended use support a determination that the proposed subject device does not raise new questions of safety or effectiveness.
Therefore, the subject device is substantially equivalent to the predicate device in terms of indications for use, design, technological characteristics, modes of operations, safety, and effectiveness.
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