Ultrasound Workspace (UWS 6.0)
Device Facts
| Record ID | K241659 |
|---|---|
| Device Name | Ultrasound Workspace (UWS 6.0) |
| Applicant | Philips Ultrasound, LLC |
| Product Code | QIH · Radiology |
| Decision Date | Feb 10, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | AI/ML, Software as a Medical Device, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K241659 · Feb 10, 2025 | Ultrasound Workspace (UWS 6.0) | Philips Ultrasound, LLC | Retrospective transthoracic (TTE) ultrasound clinical examination clips | A retrospective study was conducted to evaluate the performance of the SWM machine learning-based feature in quantifying Wall Motion Score Index (WMSI) using clinical TTE clips from patients referred for routine exams. | Retrospective study; TTE ultrasound; Wall motion score index; Machine learning |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Retrospective data analysis study for SWM; Retrospective data analysis | Subjects referred for clinical TTE exams | LVivo SWM (DiA Imaging Analysis) application | Wall Motion Score Index (WMSI) quantification |
AI Performance
| Output | Algorithm | Acceptance | Observed | Dev DS | Dev Readers | Test DS | Test Readers |
|---|---|---|---|---|---|---|---|
| Left Ventricle Wall Motion Score Index | Machine learning algorithm | Lower Confidence Bound for Pearson's correlation coefficient > 0.8 | Pearson's correlation coefficient of 0.957 (95% CI 0.933, 0.972) | — | — | Retrospective data analysis study of TTE ultrasound clips. | — |
| Tricuspid Valve Annulus Measurements | Machine learning algorithm for model-based segmentation | Limits of agreement within +/- 46% for annulus size and +/- 52% for annulus shape | Relative bias within +/- 17.37% for distance and +/- 23.68% for circumference | — | — | Performance evaluation study using TEE cardiac clips. | 3 (clinical experts) |
| Mitral Regurgitation Volume and Peak Flow Rate | Fluid dynamic model-based flow algorithm | Maximum allowable difference (Δ) of 61.6 ml; Pearson's correlation coefficient > 0.8 | Bias within +/- 19.2 ml; Pearson's correlation coefficient > 0.8 | — | — | Performance evaluation study using TEE cardiac clips compared to CMR ground truth. | — |
Indications for 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.
Device Story
Ultrasound Workspace (UWS 6.0) is a clinical software package for review, quantification, and reporting of medical images. It processes multi-dimensional digital data from various modalities, including TTE and TEE ultrasound examinations. New features include: Segmental Wall Motion (SWM) for LV function assessment using machine learning; 3D Auto TV for semi-automated tricuspid valve annulus quantification; and 3D Auto CFQ for semi-automated mitral regurgitation volume/flow rate quantification using fluid dynamic models. The device also adds data compatibility for VeriSight ICE/Pro ICE probes. Used in hospitals, clinics, and physician offices by licensed medical practitioners or assistant technicians, the software provides automated measurements that clinicians review and edit. These outputs support diagnostic decision-making, potentially improving assessment accuracy for cardiovascular structures and function.
Clinical Evidence
No clinical investigation performed. Bench testing included: SWM retrospective study (n=subjects referred for TTE) showing Pearson's correlation 0.957 vs LVivo SWM; 3D Auto TV study comparing software to manual 4D Cardio-View measurements (limits of agreement within ±46% for size, ±52% for shape); 3D Auto CFQ study comparing regurgitant volume to CMR (LoA -49.29 to 25.09) and peak flow to 2D PISA (Pearson's >0.8). Summative usability evaluation with 16 users showed 97.7% success rate for critical tasks.
Technological Characteristics
Software-only medical device. Features machine learning-based algorithms for segmental wall motion, model-based segmentation for valve quantification, and fluid dynamic modeling for flow analysis. Operates on multi-dimensional digital medical data. Compliant with IEC 62304 (software lifecycle) and ISO 14971 (risk management). No hardware components; no sterilization required.
Indications for Use
Indicated for quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- TOMTEC-ARENA (TTA2.50) (K213544)
Reference Devices
- EPIQ Series Diagnostic Ultrasound System with SWM (K240850)
- EPIQ Series Diagnostic Ultrasound System with ICE/Pro ICI (K202216)
Submission Summary (Full Text)
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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)
K241659
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)
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K241659
# 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<br>Address | Philips Ultrasound LLC<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 USA |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Petra Galgoczy, PhD<br>Senior Regulatory Affairs Specialist<br>Freisinger Strasse 9<br>85716 Unterschleissheim Germany<br>+49 (89) 32175593 |
| Secondary Contact | Erdit Gremi<br>Director, Regulatory Affairs<br>Software & Al<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 USA<br>+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<br>Processing Software | 892.2050 | QIH |
| | Secondary | | |
| | Medical image management and<br>processing system | 892.2050 | LLZ |
| | System, imaging, pulsed doppler,<br>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<br>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<br>is UWS6.0 |
| Intended Use | The product is a clinical<br>software package<br>designed for review,<br>quantification and<br>reporting of structures and<br>function based on multi-<br>dimensional digital<br>medical data acquired with<br>different modalities. The<br>product is not intended to<br>be used for reading of<br>mammography images. | TOMTEC-ARENA<br>software is a clinical<br>software package<br>designed for review,<br>quantification and<br>reporting of structures and<br>function based on multi-<br>dimensional digital<br>medical data acquired with<br>different<br>modalities. TOMTEC-<br>ARENA is not intended to<br>be used for reading of<br>mammography images. | Abdominal, Cardiac Adult,<br>Cardiac other (Fetal),<br>Cardiac Pediatric,<br>Cerebral Vascular,<br>Cephalic (Adult), Cephalic<br>(Neonatal),<br>Fetal/Obstetric,<br>Gynecological,<br>Intraoperative (Vascular),<br>Intraoperative (Cardiac),<br>intra-luminal, intra-cardiac<br>echo, Musculoskeletal<br>(Conventional),<br>Musculoskeletal<br>(Superficial), Ophthalmic,<br>Other: Urology, Pediatric,<br>Peripheral Vessel, Small<br>Organ (Breast, Thyroid,<br>Testicle),<br>Transesophageal<br>(Cardiac), Transrectal,<br>Transvaginal, Lung. | Intended Use/Indications<br>for use of predicate and<br>subject device are<br>identical (unchanged) -<br>except of the product<br>name (bolded).<br>Intended Use/Indications<br>for use of reference device<br>and subject device are<br>similar and considered<br>equivalent (specifically if<br>compared for the clinical<br>use case/workflow of the<br>subject feature). |
| Indications for Use | Indications for use of the<br>product are quantification<br>and reporting of<br>cardiovascular, fetal, and<br>abdominal structures and<br>function of patients with<br>suspected disease to<br>support the physician<br>in the diagnosis. | Indications for use of<br>TOMTEC-ARENA TTA2<br>software are quantification<br>and reporting of<br>cardiovascular, fetal,<br>abdominal structures and<br>function of patients with<br>suspected disease to<br>support the physicians in<br>the diagnosis | | |
| Intended Users | The product is intended<br>to be used only by | TOMTEC-ARENA<br>software is intended to be | The product is intended to<br>be used only by licensed | Identical for predicate and<br>subject device -except of |
| Feature | Ultrasound Workspace<br>Version 6.0 (UWS6.0) | TOMTEC-ARENA<br>TTA2.50 | EPIQ Series Diagnostic<br>Ultrasound System | Comparison |
| | Proposed Device | Predicate Device | Reference Device | |
| | licensed medical<br>practitioners or assistant<br>medical<br>technicians. | used only by licensed<br>medical practitioners or<br>assistant medical<br>technicians. | medical practitioners or<br>assistant medical<br>technicians. | the product name<br>( <b>bolded</b> ).<br>Intended Users of<br>reference device and<br>subject device are similar<br>and considered equivalent |
| Intended User<br>Environment | Intended Use<br>Environments are inside<br>and outside of Hospitals,<br>Clinics, and Physician's<br>offices. | Intended Use<br>Environments are inside<br>and outside of Hospitals,<br>Clinics, and Physician's<br>offices. | Clinics, hospitals, and<br>clinical point-of-care for<br>diagnosis of patients. | Identical to predicate<br>device.<br>Difference to reference<br>device is due to the fact<br>that subject and predicate<br>devices are software only,<br>whereas reference device<br>includes the ultrasound<br>device. |
| USA FDA Classification | Class II | Class II | Class II | Identical |
| Primary Product Code | QIH | QIH | IYN | Identical to predicate<br>device |
| Primary Regulation<br>Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.1550 | Identical to predicate<br>device |
| Primary Regulation<br>Name | Automated Radiological<br>Image Processing<br>Software | Automated Radiological<br>Image Processing<br>Software | System, Imaging, Pulsed<br>Doppler, Ultrasonic | Identical to predicate<br>device |
| Secondary Product<br>Codes | LLZ<br>IYN | LLZ | ITX<br>IYO<br>OBJ<br>QIH | IYN is newly introduced<br>with this submission |
| Secondary Regulation<br>Number | 21 CFR 892.2050<br>21 CFR 892.1550 | 21 CFR 892.2050 | 21 CFR 892.1570<br>21 CFR 892.1560<br>21 CFR 870.1200 | Identical to predicate<br>device. |
| Feature | Ultrasound Workspace<br>Version 6.0 (UWS6.0) | TOMTEC-ARENA<br>TTA2.50 | EPIQ Series Diagnostic<br>Ultrasound System | Comparison |
| | Proposed Device | Predicate Device | Reference Device | |
| | | | 21 CFR 892.2050 | IYN is newly introduced<br>with this submission |
| Secondary Regulation<br>Name | System, Image<br>Processing, Radiological<br>System, Imaging, Pulsed<br>Doppler, Ultrasonic | System, Image<br>Processing, Radiological | Diagnostic ultras…
