(245 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Philips Ultrasound Workspace (UWS 6.0) based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Segmental Wall Motion (SWM) | ||
| Pearson's correlation coefficient for WMSI (compared to LVivo SWM) | Lower Confidence Bound > 0.8 | 0.957 (95%CI 0.933, 0.972). Met acceptance criteria. |
| 3D Auto TV | ||
| Limits of Agreement (LoA) for annulus size (distance) (compared to 4D Cardio-View) | Within ± 46% | LoA for annulus size within acceptance criteria. |
| Limits of Agreement (LoA) for annulus shape (circumference) (compared to 4D Cardio-View) | Within ± 52% | LoA for annulus shape within acceptance criteria. |
| Relative bias for distance (size) (compared to inter-observer variability) | Within +/- 17.37% | Met. |
| Relative bias for circumference (shape) (compared to inter-observer variability) | Within +/- 23.68% | Met. |
| Mean relative error of measurement primitives on in-silico phantoms | Within +/- 1% | Met. |
| Limits of Agreement for measurement primitives on in-silico phantoms | Within +/- 5% | Met. |
| 3D Auto CFQ | ||
| Maximum allowable difference (Δ) for regurgitant volume (compared to CMR) | 61.6 mL | Lower end of 95% Cl for LoA was -58.37, upper end of 95% Cl for LoA was 34.18. Met acceptance criteria. |
| Mean difference (bias) for regurgitant volume (compared to CMR) | Within +/- 19.2 mL | Met. |
| Pearson's correlation for peak regurgitant flow (compared to 2D PISA) | Upper and lower bounds of 95% confidence interval > 0.8 | Exceeded acceptance criteria. Met acceptance criteria. |
2. Sample Size and Data Provenance
-
Segmental Wall Motion (SWM):
- Test Set Sample Size: Not explicitly stated as a number, but the study involved "subjects referred for clinical TTE exam."
- Data Provenance: Retrospective, from transthoracic (TTE) ultrasound clips. Country of origin not specified.
-
3D Auto TV:
- Test Set Sample Size: Not explicitly stated as a number, but involved "subjects whose clips contributed to the study." These subjects "represented a broad range of demographics, body habitus, and their severity of tricuspid regurgitation."
- Data Provenance: Not explicitly stated as retrospective or prospective, but used "transesophageal echocardiography (TEE) cardiac clips." Country of origin not specified.
-
3D Auto CFQ:
- Test Set Sample Size: Not explicitly stated as a number, but involved "the same subjects" for comparisons between 3D Auto CFQ and 2D PISA.
- Data Provenance: Not explicitly stated as retrospective or prospective. Used "acquired 3D color flow images" and compared to Cardiac Magnetic Resonance Imaging (CMR). Country of origin not specified.
3. Number of Experts and Qualifications for Test Set Ground Truth
- Segmental Wall Motion (SWM): Not applicable for SWM's primary validation as it was compared against another software application (LVivo SWM) as ground truth.
- 3D Auto TV: 3 clinical experts (reviewers). Qualifications for these experts are not explicitly stated beyond "clinical experts (reviewers)."
- 3D Auto CFQ: Not applicable for 3D Auto CFQ's primary validation as it was compared against CMR as ground truth, and for peak flow, against 2D PISA methodology.
4. Adjudication Method for the Test Set
- Segmental Wall Motion (SWM): Not applicable, as the comparison was algorithm-to-algorithm.
- 3D Auto TV: No explicit mention of an adjudication method among the three experts. The text states "results compared to manual measurements by the same reviewers performed within 4D Cardio-View application, used as a ground truth." This implies individual expert measurements were used for comparison, but not necessarily adjudicated for consensus beyond the individual performing the manual measurement.
- 3D Auto CFQ: Not applicable, as the comparison was against objective measures (CMR) and an accepted methodology (2D PISA).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is mentioned that measures the effect size of how much human readers improve with AI vs without AI assistance. The studies performed were for standalone performance (SWM, 3D Auto TV, 3D Auto CFQ algorithms) compared to established ground truths or other methods. A summative evaluation for 2D Auto LV, including SWM, indicated that "16 target users completed the critical tasks... with a success rate of 97.7%," but this is a user experience/usability study, not a comparative effectiveness study measuring improved human performance with AI.
6. Standalone (Algorithm Only) Performance Study
- Yes, standalone performance studies were done for each new feature:
- SWM: The SWM algorithm's performance was evaluated against the LVivo SWM application ("ground truth"). This is a standalone algorithm-to-algorithm comparison.
- 3D Auto TV: The 3D Auto TV software's performance was evaluated by comparing its derived measurements to manual measurements performed by clinical experts using the 4D Cardio-View application ("ground truth"). Although experts performed the "ground truth" measurements, the focus was on the algorithm's accuracy relative to these manual measurements.
- 3D Auto CFQ: The 3D Auto CFQ software's performance was evaluated by comparing its regurgitant volume output to Cardiac Magnetic Resonance Imaging (CMR) ("ground truth") and its peak regurgitant flow output to the 2D PISA methodology. These are standalone evaluations of the algorithm's outputs.
7. Type of Ground Truth Used
- Segmental Wall Motion (SWM): Ground truth was established by comparing the SWM algorithm's output to the LVivo SWM (DiA Imaging Analysis) application. This is an algorithm-to-algorithm comparison where the comparator software is considered the ground truth.
- 3D Auto TV: Ground truth was established by manual measurements performed by clinical experts within the 4D Cardio-View application. This represents expert-derived measurements from a reference software application. In-silico phantoms with known dimensions were also used for accuracy and precision of underlying measurement primitives.
- 3D Auto CFQ:
- For regurgitant volume: Cardiac Magnetic Resonance Imaging (CMR) regurgitant volume (RVol) was used. This is considered an outcomes data/reference standard.
- For peak regurgitant flow: 2D PISA methodology was used. This is an expert-derived methodology/reference method.
8. Sample Size for the Training Set
- The document does not explicitly state the sample sizes used for training the machine learning algorithms for SWM, 3D Auto TV, or 3D Auto CFQ. It only refers to the retrospective nature of some of the test data.
9. How the Ground Truth for the Training Set Was Established
- The document does not explicitly describe how the ground truth for the training set was established for any of the machine learning algorithms. It mentions the "use of machine learning algorithms" but focuses on the validation (test set) ground truth.
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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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Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The font is sans-serif and appears to be a standard typeface.
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 andAddress | Philips Ultrasound LLC22100 Bothell Everett HwyBothell, WA 98021-8431 USA |
|---|---|
| Contact Information | Petra Galgoczy, PhDSenior Regulatory Affairs SpecialistFreisinger Strasse 985716 Unterschleissheim Germany+49 (89) 32175593 |
| Secondary Contact | Erdit GremiDirector, Regulatory AffairsSoftware & Al22100 Bothell Everett HwyBothell, 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 ImageProcessing Software | 892.2050 | QIH | |
| Secondary | |||
| Medical image management andprocessing 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 SWMK202216, 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 submissionis UWS6.0 |
| Intended Use | The product is a clinicalsoftware packagedesigned for review,quantification andreporting of structures andfunction based on multi-dimensional digitalmedical data acquired withdifferent modalities. Theproduct is not intended tobe used for reading ofmammography images. | TOMTEC-ARENAsoftware is a clinicalsoftware packagedesigned for review,quantification andreporting of structures andfunction based on multi-dimensional digitalmedical data acquired withdifferentmodalities. TOMTEC-ARENA is not intended tobe used for reading ofmammography 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-cardiacecho, Musculoskeletal(Conventional),Musculoskeletal(Superficial), Ophthalmic,Other: Urology, Pediatric,Peripheral Vessel, SmallOrgan (Breast, Thyroid,Testicle),Transesophageal(Cardiac), Transrectal,Transvaginal, Lung. | Intended Use/Indicationsfor use of predicate andsubject device areidentical (unchanged) -except of the productname (bolded).Intended Use/Indicationsfor use of reference deviceand subject device aresimilar and consideredequivalent (specifically ifcompared for the clinicaluse case/workflow of thesubject feature). |
| Indications for Use | Indications for use of theproduct are quantificationand reporting ofcardiovascular, fetal, andabdominal structures andfunction of patients withsuspected disease tosupport the physicianin the diagnosis. | Indications for use ofTOMTEC-ARENA TTA2software are quantificationand reporting ofcardiovascular, fetal,abdominal structures andfunction of patients withsuspected disease tosupport the physicians inthe diagnosis | ||
| Intended Users | The product is intendedto be used only by | TOMTEC-ARENAsoftware is intended to be | The product is intended tobe used only by licensed | Identical for predicate andsubject device -except of |
| Feature | Ultrasound WorkspaceVersion 6.0 (UWS6.0) | TOMTEC-ARENATTA2.50 | EPIQ Series DiagnosticUltrasound System | Comparison |
| Proposed Device | Predicate Device | Reference Device | ||
| licensed medicalpractitioners or assistantmedicaltechnicians. | used only by licensedmedical practitioners orassistant medicaltechnicians. | medical practitioners orassistant medicaltechnicians. | the product name( bolded ).Intended Users ofreference device andsubject device are similarand considered equivalent | |
| Intended UserEnvironment | Intended UseEnvironments are insideand outside of Hospitals,Clinics, and Physician'soffices. | Intended UseEnvironments are insideand outside of Hospitals,Clinics, and Physician'soffices. | Clinics, hospitals, andclinical point-of-care fordiagnosis of patients. | Identical to predicatedevice.Difference to referencedevice is due to the factthat subject and predicatedevices are software only,whereas reference deviceincludes the ultrasounddevice. |
| USA FDA Classification | Class II | Class II | Class II | Identical |
| Primary Product Code | QIH | QIH | IYN | Identical to predicatedevice |
| Primary RegulationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.1550 | Identical to predicatedevice |
| Primary RegulationName | Automated RadiologicalImage ProcessingSoftware | Automated RadiologicalImage ProcessingSoftware | System, Imaging, PulsedDoppler, Ultrasonic | Identical to predicatedevice |
| Secondary ProductCodes | LLZIYN | LLZ | ITXIYOOBJQIH | IYN is newly introducedwith this submission |
| Secondary RegulationNumber | 21 CFR 892.205021 CFR 892.1550 | 21 CFR 892.2050 | 21 CFR 892.157021 CFR 892.156021 CFR 870.1200 | Identical to predicatedevice. |
| Feature | Ultrasound WorkspaceVersion 6.0 (UWS6.0) | TOMTEC-ARENATTA2.50 | EPIQ Series DiagnosticUltrasound System | Comparison |
| Proposed Device | Predicate Device | Reference Device | ||
| 21 CFR 892.2050 | IYN is newly introducedwith this submission | |||
| Secondary RegulationName | System, ImageProcessing, RadiologicalSystem, Imaging, PulsedDoppler, Ultrasonic | System, ImageProcessing, Radiological | Diagnostic ultrasonictransducerUltrasonic pulsed echoimaging systemDiagnostic intravascularcatheterAutomated RadiologicalImage ProcessingSoftware | Identical to predicatedeviceIYN is newly introducedwith this submission |
| Application Description | The SWM softwareautomatically evaluatesthe segmental (regional)function of the leftventricle (LV) from adultTTE echo examinations.Note: Per FDA GuidanceTechnical PerformanceAssessment ofQuantitative Imaging inRadiological DevicePremarket Submissions,the SWM software is asemi-automatedquantitative imagingalgorithm, as users aregenerally expected toreview and concur with theinitialization andgenerated results. The | The predicate TOMTEC-ARENA does not currentlyhave a dedicated softwareapplication containing thefunctionality introduced inthe subject submission for(semi-) automatedsegmental wall motionevaluation of the leftventricle (LV). | Smart View Select is anautomated softwarefeature that assists theuser in selection of imagesfor analysis with theexisting Philips AutoStrainLV or 2D Auto LVapplication in Adult EchoTransthoracic (TTE)examination.The SWM softwareautomatically evaluatesthe segmental (regional)function of the leftventricle (LV) from adultTTE echo examinations.Note: Per FDA GuidanceTechnical PerformanceAssessment of | SWM functionality ismissing in the predicatedevice. This feature isnewly introduced with thissubmission.SWM in the subject andreference device isidentical.In both cases SWM hasbeen integrated in theexisting feature AutoStrainLV. The module usingAutoStrain LV togetherwith SWM is named 2DAuto LV.Note: The Smart ViewSelect feature describedfor the reference device is. |
| Ultrasound WorkspaceVersion 6.0 (UWS6.0) | TOMTEC-ARENATTA2.50 | EPIQ Series DiagnosticUltrasound System | Comparison | |
| Feature | Proposed Device | Predicate Device | Reference Device | |
| users can also editalgorithm generatedsegmental wall motionscores for individualsegments based on theirclinical expertise. | Quantitative Imaging inRadiological DevicePremarket Submissions,the SWM software is asemi-automatedquantitative imagingalgorithm, as users aregenerally expected toreview and concur with theinitialization andgenerated results. Theusers can also editalgorithm generatedsegmental wall motionscores for individualsegments based on theirclinical expertise. | not included in the subjectdevice UWS6.0. | ||
| SWM scoringadjustment | Users manually editscores using a drop-downselection | Not applicable - does notcontain functionality forsegmental wall motion | Users manually editscores using a drop-downselection | Identical to referencedevice |
| Introduction ofsegmental wall motionscores / overall wallmotion score index(WMSI) | Segmental wall motionscores are indicated for 17segments of the leftventricle. Overall wallmotion score index(WMSI) is calculated. | Not applicable - does notcontain functionality forsegmental wall motion | Segmental wall motionscores are indicated for 17segments of the leftventricle. Overall wallmotion score index(WMSI) is calculated. | Identical to referencedevice.Wall motion scores are anadditional value forevaluating the segmental(regional) function of theleft ventricle (LV) usingTTE echo examinations inadults. |
| Feature | Ultrasound Workspace Version 6.0(UWS6.0) | TOMTEC-ARENATTA2.50 - K213544 | Comparison | |
| Proposed Device | Predicate Device | |||
| K-number | Not available | K213544 | Subject of this submission is UWS6.0 | |
| ApplicationDescription3D Auto TV | 3D Auto TV software enables semi-automated quantification of the tricuspid valveduring transesophageal echocardiography(TEE) and transthoracic echocardiography(TTE) examinations. It applies artificialintelligence for model based segmentation. Ata high level, this is accomplished throughautomatically derived measurements from asegmented model of the tricuspid valveannulus formed by the software throughmodel-based segmentation of the acquiredultrasound images. | 3D Auto MV (formerly named 4D MV-ASSESSMENT) is a semi-automatedsoftware application intended for the analysisof Mitral Valve (MV) anatomy and function.This application generates models ofanatomical structures of interest such as theMV annulus, leaflets, and the closure line,which allows for quantification of pre- andpost-operative valvular function and acomparison of morphology.4D CARDIO-VIEW is an advanced analysistool for 3D/4D echocardiography data.Anatomical structure visualization, volumemeasurements (LV and/or generic), andspecified or manual measurements arepossible for cardiac structures including, butnot limited to, the tricuspid valve. Varioustools are available for rendering that display2- and 3-dimensional morphology andfunction for defined structures. | Similar to the predicate device features.The functionality and workflow of the 3D AutoTV software is very similar to the 3D AutoMV tool, where measurement parameters arederived from models of the mitral valve (in thecase of 3D Auto MV) and tricuspid valve (inthe case of 3D Auto TV). Manualmeasurements are also able to be performedon both software applications.Comparing 3D Auto TV to 4D CARDIO-VIEW, both software have functionality forquantifying the tricuspid valve. The proposed3D Auto TV allows semi-automatedquantification, where the reference device isfully manual. As we demonstrate highagreement in the measurement outputs onthe same patients when quantified using theproposed 3D Auto TV software and thereference 4D CARDIO-VIEW application(REF #4), there are no new questions raisedof safety or effectiveness.The subject of this submission is introductionof semi-automated quantification via 3D AutoTV of UWS6.0. | |
| Feature | Ultrasound Workspace Version 6.0(UWS6.0)Proposed Device | TOMTEC-ARENATTA2.50 - K213544Predicate Device | Comparison | |
| ContourGeneration | 3D surface model is created semi-automatically using machine learningalgorithm without user interaction. User isable to edit, accept, or reject the initiallandmark proposals of the tricuspid valveanatomical locations. | 3D Auto MV: 3D surface model is createdsemi-automatically using machine learningalgorithm without user interaction. User isable to edit, accept, or reject the initiallandmark proposals of the mitral valveanatomical locations.4D CARDIO-VIEW: 3D surface model iscreated based on user defined anatomicallandmarks. User is able to edit the contour ofthe surface model before proceeding with theworkflow. | Subject device uses identical method forcontour generation as the 3D Auto MVapplication of the predicate device. The onlydifference is the algorithm is trained ontricuspid valve images, where the predicatedevice was trained using mitral valve images | |
| MeasurementsPerformed | 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 softwareenables a subset of very similar semi-automated measurements as the predicatedsoftware application 3D Auto MV, only for thetricuspid annulus.The proposed 3D Auto TV software addsadditional TV annulus and devicemeasurements from those available in 4DCARDIO-VIEW to further define the tricuspidvalve anatomy.Both the proposed 3D Auto TV and thepredicate 4D CARDIO-VIEW software allowmanual, free-form measurements of thevalve. | |
| Feature | Ultrasound Workspace Version 6.0(UWS6.0)Proposed Device | TOMTEC-ARENATTA2.50 - K213544Predicate 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 TVquantification) | ||||
| • 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-ARENATTA2.50 - K213544 | Comparison |
|---|---|---|---|
| Proposed Device | Predicate Device | ||
| K-number | Not available | K213544 | Subject of this submission is UWS6.0 |
| ApplicationDescription3D Auto CFQ | The 3D Auto CFQ is a new artificialintelligence software which will be introducedon the Ultrasound Workspace Softwaresystem starting with Version 6.0. Theapplication provides semi-automatedquantification of Mitral Regurgitation (MR)volume and peak flow rate based on 3D colorflow images acquired duringtransesophageal echocardiography (TEE)examinations. | The Proximal Isovelocity Surface Area (PISA)methodology can be used currently on thepredicate device to quantify valvularregurgitation. The technique utilizes 2D/Colorand Doppler images to allow the user to makesimple, manual measurements in a cascadingfashion to allow calculation of peak flow rateand volumetric regurgitation.3D Auto MV is a semi-automated softwareapplication intended for the analysis of MitralValve (MV) anatomy and function. Thisapplication generates models of anatomicalstructures of interest such as the MV annulus,leaflets, and the closure line, which allows forquantification of pre- and post-operativevalvular function and a comparison ofmorphology. | Similar. The predicate device facilitates thequantification of mitral regurgitation volumeand peak flow rate through a group ofmeasurements which are performed in acascading fashion manually by the useraccording to the Proximal Isovelocity SurfaceArea (PISA) methodology. The proposed 3DAuto CFQ software application allows theusers to quantify the same measurements formitral regurgitation volume and peak flow ratebut in a semi-automated workflow.3D Auto MV feature of the predicate does notcontain functionality for quantification of mitralregurgitation. |
| ContourGeneration | 3D surface model is created semi-automatically using machine learningalgorithm without user interaction. User isable to edit, accept, or reject the initiallandmark proposals of the mitral valveanatomical locations. | PISA: No standard contour generationtechnology for the mitral valve, outside of 3DAuto MV, included as part of the system.3D Auto MV: 3D surface model is createdsemi-automatically using machine learning | Subject device uses identical method forcontour generation as the 3D Auto MVfeature of the predicate device. |
| Feature | Ultrasound Workspace Version 6.0(UWS6.0) | TOMTEC-ARENATTA2.50 - K213544 | Comparison |
| Proposed Device | Predicate Device | ||
| The 3D Auto CFQ algorithm quantifies mitralregurgitation volume and flow rate from | algorithm without user interaction. User is ableto edit, accept, or reject the initial landmarkproposals of the mitral valve anatomicallocations.PISA:The PISA methodology uses sequential | Similar. The PISA methodology of thepredicate device – used for quantifying MR | |
| QuantificationTechnology forMitralRegurgitation | acquired 3D color flow images. The greyscaleinformation from these images is used togenerate a 3D model of the mitral valve,which is used as an input along with the 3Dcolor data into the 3D Auto CFQ flowalgorithm. The 3D Auto CFQ algorithm uses afluid dynamic model of an incompressiblefluid (blood) traveling through an irregular-shaped (i.e., nonround) orifice. In its initialstep, the algorithm generates a hypotheticalmodel of true blood flow velocities in theproximal convergence zone based on allmeasured Doppler velocities and theunderlying fluid dynamics model. The truevelocity model is then converted into thecorresponding apparent Doppler velocitymodel ("synthetic apparent velocities") usingultrasound physics (projection along the axialdimension). These synthetic velocities aresubsequently compared to the acquiredvelocities in the Color Flow (CF) data set.Based on the outcome of this comparison,the model is updated and reiterated to getthe 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 wavedoppler)MR VTI (from the continuous wavedoppler)The outputs of these measurements go intothe equations for the derived measurementsincluding:Mitral Regurgitant (MR) Flow RateMR Effective Regurgitant Orifice (ERO)MR Volume3D Auto MV:N/A - does not contain technology for mitralregurgitation quantification | volume and flow rate - utilizes sequentialmeasurements performed by the user and isbased on assumptions including there beinga single, round, constant flow orifice duringthe entire systole.3D Auto CFQ operates using 3D color toaddress the spatial complexities seen inmitral regurgitation and was developed toevaluate the regurgitant flow at every frame insystole, where the PISA methodology only |
| and the generated model. 3D Auto CFQdetermines the resulting regurgitant flow rate | arrive at the outputs of mitral regurgitationvolume and peak flow rate. These outputs are | ||
| Feature | Ultrasound Workspace Version 6.0(UWS6.0) | TOMTEC-ARENATTA2.50 - K213544 | Comparison |
| Proposed Device | Predicate Device | ||
| for this frame. This process is repeated foreach frame included in the analysis, which inmost cases includes the entire systolic cycle.In each frame, the size and shape of theregurgitant orifice is not assumed but isgenerated by this iterative loop between themodel and the CF data. | the same as in the predicate, only the methodto arrive at the measurements differs in thesubject device. | ||
| Semi-automated measurements performedby the 3D Auto CFQ software application:Mitral regurgitation (MR) volume [mL];Peak flow rate [mL/s] | PISA:Derived measurements which the user canobtain through the PISA methodology include:Mitral regurgitation (MR) volume [mL];Peak flow rate [mL/s] | Similar. The measurements performed by theproposed 3D Auto CFQ software applicationcan also be obtained by a user on thepredicate device using the PISAmethodology. | |
| MeasurementsPerformed | 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 3DAuto CFQ software's regurgitant volumeoutput was performed by comparison tocardiac magnetic imaging with (CMR) imageswith acceptance criteria of agreement withinthe limits of agreement. While the PISAmethodology is a widely accepted method formitral regurgitation quantification and is arecommended method by the AmericanSociety of Echocardiography, the outputsfrom 3D Auto CFQ were compared to thosefrom CMR (as opposed to PISA) as theformer is considered a gold standard formitral regurgitation quantification.Acceptance criteria for 3D Auto CFQ wasbased on agreement with CMR being withinpredefined maximum limits of agreement. | |
| Feature | Ultrasound Workspace Version 6.0(UWS6.0)Proposed Device | TOMTEC-ARENATTA2.50 - K213544Predicate 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 peakflow rate output of 3D Auto CFQ wasvalidated in comparison to manual PISAmethod, where the correlation was very high.3D Auto MV feature of the predicate devicefacilitates anatomical measurements of themitral valve from the generated model of themitral valve but does not performmeasurements for quantifying mitralregurgitation. |
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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 WorkspaceVersion 6.0 (UWS6.0) | TOMTEC-ARENATTA2.50 | EPIQ Series DiagnosticUltrasound System | Comparison |
|---|---|---|---|---|
| Proposed Device | Predicate Device | Reference Device | ||
| K-number | Not available | K213544 | K202216 | Subject of this submissionis UWS6.0 |
| Transducer ClinicalApplication / clearedcompatibility | VeriSight ICE / Pro ICE(Proposed Transducer) | N/A, compatibility toVeriSight ICE / Pro ICEhas not been shown. | VeriSight ICE / Pro ICEwas introduced on EPIQvia K202216. | Identical to referencedevice. |
| TEE (transesophageal)transducer.Intended for intracardiacand intra-luminalvisualization of cardiac andgreat vessel anatomy andphysiology as well asvisualization of otherdevices in the heart. TheVeriSight ICE catheterprovides 2D ultrasoundimaging capabilities, whilethe VeriSight Pro ICEcatheter provides 2Dand/or 3D ultrasoundimaging capabilities. | TEE (transesophageal)transducer.Intended for intracardiacand intra-luminalvisualization of cardiac andgreat vessel anatomy andphysiology as well asvisualization of otherdevices in the heart. TheVeriSight ICE catheterprovides 2D ultrasoundimaging capabilities, whilethe VeriSight Pro ICEcatheter provides 2Dand/or 3D ultrasoundimaging capabilities. | |||
| Data Compatibility | Compatibility to UWS6.0 issubject of this submission. | N/A, for TTA2compatibility for VeriSightICE / Pro ICE has notbeen shown | VeriSight ICE / Pro ICEwas introduced on EPIQvia K202216. | Identical to referencedevice. |
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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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§ 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).