(59 days)
The intended use of the 5000 Compact series ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:Abdominal, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral Vascular, Cephalic (Adult),Cephalic (Neonatal), Fetal Echo, Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Lung, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, Small Parts, Transesophageal (Cardiac), Transrectal, Transvaginal, and Urology.
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto Measure Artificial Intelligence-Machine Learning software feature onto the 5000 Compact Series Ultrasound Systems.
The Auto Measure feature utilizes machine learning to provide a subset of semi-automated and editable measures during an echocardiography or when reviewing an already acquired echocardiography. When Auto Measure Version 2 is enabled, the healthcare professional performs an echocardiography with a workflow that provides the user with a semi-automated measurement that can be edited, accepted, or rejected.
Philips has designed Auto Measure as a "locked" algorithm prior to marketing. As defined by FDA in the discussion paper Proposed Requlatory Framework for Modifications to AI/ML Based Software as a Medical Device (SaMD) published April 2, 2019, this "locked" algorithm provides the same result each time the same input is applied to it and does not change with use.
The Auto Measure software feature does not introduce new modes, presets, measurements, or system components (e.g. transducers) to the Philips 5000 Compact Series Ultrasound Systems K222648.
No hardware changes to the 5000 Compact Series Ultrasound Systems K222648 are required when using the Auto Measure feature, and existing, commercialized Philips transducers are used for the Auto Measure feature.
5000 Compact Series Ultrasound Systems are part of the VM platform product family, The Auto Measure Version 1 feature was originally cleared (K211597) on EPIQ and Affiniti models running software version 9.0 (VM9.0). The Auto Measure feature is also available to all software releases following VM9.0.
Since the initial Auto Measure feature initial clearance (Version 1.0), a subset of integrated measurement detectors has been trained with additional training data in the Auto Measure feature (Version 2) which is scope of this submission
Auto Measure for this premarket notification utilizes the same software version platform VM as the Reference Device, Affiniti Diagnostic Ultrasound Systems K211597.
This document describes the Philips 5000 Compact Series Ultrasound Systems with the new Auto Measure Version 2 AI-Machine Learning software feature. The information provided focuses on the performance data to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each measurement detector are based on the Checked Limits of Agreement (LoAs), derived from clinical literature on human interobserver variability. The reported device performance is the Measured Limits of Agreement (LoA) between the detector's prediction and the manual ground truth. Each detector met its specified acceptance criteria.
| Parameter | Detector | N (Sample Size) | Checker Limits of Agreement (LoAs) | Measured Limits of Agreement (LoA) (detector prediction vs manual ground truth) |
|---|---|---|---|---|
| Ao Sinus Diameter | DETECTOR_ID_BMOD E_AO_AOSV | 308 | [-35.0%, 35.0%] | [-11.0022%, 11.2816%] |
| Ao STJ Diameter | DETECTOR_ID_BMOD E_AO_AOSTJ | 301 | [-35.0%, 35.0%] | [-11.4181%, 13.1139%] |
| Asc Ao Diameter | DETECTOR_ID_BMOD E_AO_AOASC | 204 | [-35.0%, 35.0%] | [-14.7794%, 15.9598%] |
| IVSd | DETECTOR_ID_BMOD E_LV_LVDISTANCE_S AME_LINE | 305 | [-35.0%, 35.0%] | [-33.2114%, 28.1632%] |
| LVIDd | DETECTOR_ID_BMOD E_LV_LVDISTANCE_S AME_LINE | 457 | [-35.0%, 35.0%] | [-14.1564%, 12.4223%] |
| LVIDs | DETECTOR_ID_BMOD E_LV_LVID_ES | 469 | [-35.0%, 35.0%] | [-23.4752%, 26.0242%] |
| LVOT Diameter | DETECTOR_ID_BMOD E_LV_LVOT | 453 | [-35.0%, 35.0%] | [-17.729%, 16.1588%] |
| LVPWd | DETECTOR_ID_BMOD E_LV_LVDISTANCE_S AME_LINE | 305 | [-35.0%, 35.0%] | [-33.1364%, 29.9544%] |
| RV Base | DETECTOR_ID_BMOD E_RV_RVD_BASE | 302 | [-35.0%, 35.0%] | [-16.1373%, 25.9079%] |
| RV Mid | DETECTOR_ID_BMOD E_RV_RVD_MID | 243 | [-35.0%, 35.0%] | [-25.0913%, 30.2573%] |
| RV Length | DETECTOR_ID_BMOD E_RV_RVL | 117 | [-35.0%, 35.0%] | [-14.6089%, 13.3871%] |
| TV Annulus | DETECTOR_ID_BMOD E_RV_TVANN | 53 | [-35.0%, 35.0%] | [-19.3628%, 18.0347%] |
| MV Decel. Time | DETECTOR_ID_DOPPLER_MV_DECEL_E_DURATION | 136 | [-25.0%, 25.0%] | [-23.5717%, 22.8591%] |
| MV Peak A Vel | DETECTOR_ID_DOPPLER_MV_VMAX_A_VELOCITY | 229 | [-24.0%, 24.0%] | [-12.3694%, 15.2363%] |
| MV Peak E Vel | DETECTOR_ID_DOPPLER_MV_VMAX_E_VELOCITY | 136 | [-24.0%, 24.0%] | [-9.2081%, 9.1223%] |
| AV VTI | DETECTOR_ID_DOPPLER_AV_VTI | 247 | [-22.0%, 22.0%] | [-21.5393%, 19.8925%] |
| LVOT VTI | DETECTOR_ID_DOPPLER_LVOT_VTI | 234 | [-22.0%, 22.0%] | [-17.267%, 17.2093%] |
| PV VTI | DETECTOR_ID_DOPPLER_PV_VTI | 66 | [-22.0%, 22.0%] | [-20.6140%, 21.0567%] |
2. Sample Sizes Used for the Test Set and Data Provenance
The test set consisted of a total of 500 studies, with one study per subject. This included 200 known normal subjects and 300 patients with a confirmed pathology.
The data provenance is described as:
- Anonymized transthoracic echocardiography DICOM data and metadata.
- Data recorded by multiple sonographers and physicians qualified in echocardiography.
- Large sample of adults of various ethnicities.
- Echocardiographic recordings acquired according to guideline-standard echocardiographic procedures between 2010 and 2021.
- Data collected from 20 centers and 16 countries.
The number of studies used for validation (N) per specific detector varied, as not all measurements are performed in all studies, ranging from 53 to 469 as shown in the table above.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the test set was established by clinical experts during routine care. While the exact number is not specified for the test set's ground truth, it is stated that "All detector models were trained from the ground up... Training of the detectors was based on manual measurements performed by human experts done for diagnostic purpose." This implies the ground truth for both training and testing was established by qualified human experts performing manual measurements for diagnostic purposes. The data was collected by "multiple sonographers and physicians qualified in echocardiography."
4. Adjudication Method for the Test Set
The adjudication method is not explicitly described as a formal 'X+Y' consensus method. The document states that the Auto Measure results were "compared to ground truth measurements established by clinical experts during routine care." This suggests that the established clinical measurements served as the ground truth directly for comparison, rather than a separate adjudication process of multiple readers for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly detailed in this summary. The study focuses on evaluating the standalone performance of the Auto Measure feature against expert manual measurements, using human-human interobserver variability data from clinical studies as a benchmark for acceptance criteria, not for direct comparison of human performance with and without AI assistance. The document mentions that the feature is a "workflow improvement" and that "the operator is responsible for the final result and has to apply manual edits to the automated output whenever required."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance study was done. The "Detector performance results" table directly compares the "detector prediction" against "manual ground truth." The text further clarifies: "Auto Measure analyzed a set of new, previously images, and its automated results were compared to ground truth measurements established by clinical experts during routine care. Both the manual and automated measurements were performed on the same images without any adjustments to the software's output or the clinical data used as ground truth." This indicates a direct evaluation of the algorithm's output without human intervention in the Auto Measure readings during the test phase.
7. The Type of Ground Truth Used
The ground truth used was expert consensus / manual measurements performed by clinical experts during routine care for diagnostic purposes. These manual measurements are considered the "current gold standard" against which the Auto Measure output is compared.
8. The Sample Size for the Training Set
The total training pool comprises more than 6000 studies.
9. How the Ground Truth for the Training Set Was Established
The ground truth for the training set was established through manual measurements performed by human experts for diagnostic purposes. The data was collected by "qualified medical [personnel] in echocardiography using TTA software (versions TTA2.31.00 and TTA2.50.00) or various Philips ultrasound systems annotation and following established guidelines (Mitchel et al 2019)." These data were then used for training and tuning in a cross-validation framework.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 15, 2024
Philips Ultrasound LLC Suresh Kumar Alagarsamy Senior Specialist I - Regulatory Affairs 22100 Bothell Everett Highway Bothell, Washington 98021
Re: K242800
Trade/Device Name: The 5000 Compact Series Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH Dated: September 16, 2024 Received: September 17, 2024
Dear Suresh Kumar Alagarsamy:
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 provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
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 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-regulatory-information/postmarketing-safety-reportingcombination-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-advicecomprehensive-regulatory-assistance/unique-device-identification-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-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
{2}------------------------------------------------
the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, YANNA S. KANG -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
The 5000 Compact Series Ultrasound Systems
Indications for Use (Describe)
The intended use of the 5000 Compact series ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:Abdominal, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral Vascular, Cephalic (Adult),Cephalic (Neonatal), Fetal Echo, Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Lung, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, Small Parts, Transesophageal (Cardiac), Transrectal, Transvaginal, and Urology.
The clinical environments where the systems can be used include physicians' offices, clinics.hospitals, surgical suites, and clinical point-of-care for diagnosis of patients. The System is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed.
However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in blue letters. The letters are bold and sans-serif. The background is white.
510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.
510(k) Number: K242800
Date Prepared: September 16, 2024
l. Submitter
| Manufacturer Name andAddress | Philips Ultrasound LLC22100 Bothell Everett HwyBothell, WA 98021-8431 USA |
|---|---|
| Contact Information | Suresh Kumar AlagarsamySenior Specialist I - Regulatory Affairs22100 Bothell Everett HwyBothell, WA 98021-8431 USA+91 97401 63840 |
| Secondary Contact | Erdit GremiDirector, Regulatory Affairs - Software & Al22100 Bothell Everett HwyBothell, WA 98021-8431 USA1-617-798-8092 |
II. Device
| Proprietary Name | 5000 Compact Series Ultrasound SystemsAuto Measure | ||
|---|---|---|---|
| Common Name | Diagnostic Ultrasound System and Transducers | ||
| Regulation Description | Classification Description | 21 CFR § | Product Code |
| Primary | |||
| System, imaging, pulsed doppler, ultrasonic | 892.1550 | IYN | |
| Secondary | |||
| System, imaging, pulsed echo, ultrasonic | 892.1560 | IYO | |
| Transducer, ultrasonic, diagnostic | 892.1570 | ITX | |
| Automated Radiological Image Processing Software | 892.2050 | QIH | |
| Device Class | Class II | ||
| Review Panel | Radiology | ||
| Predicate Device | K222648 5000 Compact Series Diagnostic Ultrasound Systems | ||
| Reference Device | K211597 Philips Affiniti Series Diagnostic Ultrasound System VM 9.0 |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is a light gray or white color, providing contrast to the blue text.
III. Device Description
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto Measure Artificial Intelligence-Machine Learning software feature onto the 5000 Compact Series Ultrasound Systems.
The Auto Measure feature utilizes machine learning to provide a subset of semi-automated and editable measures during an echocardiography or when reviewing an already acquired echocardiography. When Auto Measure Version 2 is enabled, the healthcare professional performs an echocardiography with a workflow that provides the user with a semi-automated measurement that can be edited, accepted, or rejected.
Philips has designed Auto Measure as a "locked" algorithm prior to marketing. As defined by FDA in the discussion paper Proposed Requlatory Framework for Modifications to AI/ML Based Software as a Medical Device (SaMD) published April 2, 2019, this "locked" algorithm provides the same result each time the same input is applied to it and does not change with use.
The Auto Measure software feature does not introduce new modes, presets, measurements, or system components (e.g. transducers) to the Philips 5000 Compact Series Ultrasound Systems K222648.
No hardware changes to the 5000 Compact Series Ultrasound Systems K222648 are required when using the Auto Measure feature, and existing, commercialized Philips transducers are used for the Auto Measure feature.
5000 Compact Series Ultrasound Systems are part of the VM platform product family, The Auto Measure Version 1 feature was originally cleared (K211597) on EPIQ and Affiniti models running software version 9.0 (VM9.0). The Auto Measure feature is also available to all software releases following VM9.0.
Since the initial Auto Measure feature initial clearance (Version 1.0), a subset of integrated measurement detectors has been trained with additional training data in the Auto Measure feature (Version 2) which is scope of this submission
Auto Measure for this premarket notification utilizes the same software version platform VM as the Reference Device, Affiniti Diagnostic Ultrasound Systems K211597.
IV. Intended Use and Indications for Use
5000 Compact Series Intended Use_
The intended use of 5000 Compact Ultrasound System is diagnostic ultrasound imaging and fluid flow analysis of the human body.
5000 Compact Series Indications for Use:
The 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W) are intended for diagnostic Ultrasound imaging in B (or 2D), 3D/4D, Color Doppler, Continuous Wave Doppler, Tissue Doppler, Tissue Doppler, M-mode (including anatomical M-mode), Harmonics (Tissue and Contrast), Color Power Angio (CPA), and Combined modes.
The intended use of the 5000 Compact series ultrasound system is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following indications for use: Abdominal. Cardiac Adult. Cardiac Pediatric, Carotid, Cerebral Vascular, Cephalic (Adult) , Cephalic (Neonatal),Fetal Echo, Fetal/Obstetric, Gynecological, Intraoperative(Vascular),Lung, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Peripheral Vessel, Small Parts, Transesophageal (Cardiac), Transrectal, Transvaginal and Urology.
The clinical environments where the 5000 Compact Series Ultrasound Systems can be used include physicians' office, clinics, hospitals, surgical suites and clinical point-of-care for diagnosis of patients.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background behind the word is white, providing a strong contrast that makes the brand name stand out.
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. However, nothing stated in the user information reduces the user's responsibility for sound clinical judgment and best clinical procedure. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.
However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure
Note: There are no changes to the 5000 Compact Ultrasound System Indications for Use due to the introduction of the Auto Measure Version 2
{7}------------------------------------------------
V. Comparison of Technological Characteristics with the Predicate
The purpose of the submission is to introduce the Auto Measure Version 2 feature to the 5000 Compact Series Ultrasound System. The subject devices are substantially equivalent to the predicate devices K222648 & Reference Device K211597
| Feature | 5000 CompactUltrasound Systems with AutoMeasure Version 2 | Series 5000 Compact(K 222648 )Primary predicate device | Series Affiniti Diagnostic UltrasoundSystem VM9.0(K211597)Reference Device | Comparison |
|---|---|---|---|---|
| Indicationsfor Use | Abdominal,Cardiac Adult,Cardiac Pediatric,Carotid,Cerebral Vascular,Cephalic (Adult),Cephalic (Neonatal),Fetal Echo,Fetal/Obstetric,Gynecological,Intraoperative (Vascular),Lung,Musculoskeletal (Conventional),Musculoskeletal (Superficial),Ophthalmic,Pediatric,Peripheral Vessel,Small PartsTransesophageal (Cardiac),Transrectal,Transvaginal, andUrology. | Abdominal,Cardiac Adult,Cardiac Pediatric,Carotid,Cerebral Vascular,Cephalic (Adult),Cephalic (Neonatal),Fetal Echo,Fetal/Obstetric,Gynecological,Intraoperative (Vascular),Lung,Musculoskeletal (Conventional),Musculoskeletal (Superficial),Ophthalmic,Pediatric,Peripheral Vessel,Small Organ (Breast, Thyroid,Testicle),Transesophageal (Cardiac),Transrectal,Transvaginal, andUrology. | Abdominal,Cardiac Adult,Cardiac Other (Fetal),Cardiac Pediatric,Cerebral Vascular,Cephalic (Adult),Cephalic (Neonatal),Fetal/Obstetric,Gynecological,Intraoperative (Vascular),Intraoperative (Cardiac),Musculoskeletal (Conventional),Musculoskeletal (Superficial),Other:Urology,Pediatric,Peripheral Vessel,Small Organ (Breast, Thyroid,Testicle),Transesophageal (Cardiac),Transrectal,Transvaginal,Lung | Identical to PredicateSmall Parts and Small Organs aresame. To align with terminology inCompact 5000 Systema and UserManual,Updated to Small Parts |
| IntendedUsers | Trained healthcare professionalsIntended for sonographers, | Trained healthcare professionalsIntended for sonographers, | Trained healthcare professionalsIntended for sonographers, | Identical to Predicate |
| Feature | 5000 CompactUltrasound Systems with AutoMeasure Version 2 | Series 5000 Compact(K 222648 )Primary predicate device | Series Affiniti Diagnostic UltrasoundSystem VM9.0(K211597)Reference Device | Comparison |
| physicians, and biomedicalengineers who operate andmaintain your product.Trained healthcare Professional | physicians, and biomedicalengineers who operate andmaintain your product.Trained healthcare Professional | physicians, and biomedicalengineers who operate andmaintain your product.Trained healthcare Professional | ||
| Before use of the system anduser information, the user mustbe familiar with ultrasoundtechniques. Sonography trainingand clinical procedures are notincluded in the User Manual orwith the 5000 Compact SeriesUltrasound Systems. | Before use of the system anduser information, the user mustbe familiar with ultrasoundtechniques. Sonography trainingand clinical procedures are notincluded in the User Manual orwith the 5000 Compact SeriesUltrasound Systems. | Before use of the system and userinformation, the user must befamiliar with ultrasound techniques.Sonography training and clinicalprocedures are not included in theUser Manual or with the AffinitiDiagnostic UltrasoundSystem. | ||
| Intended UserEnvironment | Clinics, hospitals, and clinicalpoint-of-care for diagnosis ofpatients. | Clinics, hospitals, and clinicalpoint-of-care for diagnosis ofpatients. | Clinics, hospitals, and clinical point-of-care for diagnosis of patients. | Identical to Predicate |
| USAFDAClassification | Class II | Class II | Class II | Identical to Predicate |
| PrimaryProduct Code | IYN | IYN | IYN | Identical to Predicate |
| PrimaryRegulationNumber | 21 CFR 892.1550 | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to Predicate |
| SecondaryProductCodes | ITXIYOQIH | ITXIYO | ITXIYOQIH | Identical to Predicate |
| Feature | 5000 Compact Ultrasound Systems with Auto Measure Version 2 | Series 5000 Compact Ultrasound Systems (K 222648 ) Primary predicate device | Series Affiniti Diagnostic Ultrasound System VM9.0 (K211597) Reference Device | Comparison |
| Secondary Regulation Name | System, imaging, pulsed echo, ultrasonic Transducer, ultrasonic, diagnostic Automated Radiological Image Processing Software | System, imaging, pulsed echo, ultrasonic Transducer, ultrasonic, diagnostic Automated Radiological Image Processing Software | System, imaging, pulsed echo, ultrasonic Transducer, ultrasonic, diagnostic Automated Radiological Image Processing Software | Identical to Predicate |
| Secondary Regulation Number | 21 CFR 892.157021 CFR 892.156021 CFR 892.2050 | 21 CFR 892.157021 CFR 892.1560 | 21 CFR 892.157021 CFR 892.156021 CFR 892.2050 | Identical to Predicate |
| Software Platform | VM | VM | VM | Identical to Predicate |
| Auto Measure Software Version | 2 | Not available | 1 | Difference No.1The detectors for a subset of measurements available with the Auto Measure feature have undergone additional training since the original release of the feature on Affiniti Series Ultrasound SystemVM9.0.Architecture of all detectors training procedure and acceptance criteria for the additional training data are identical to Auto Measure Version 1 |
| Reusable | Yes | Yes | Yes | Identical to Predicate |
| 5000Compact Series | Compact | Series Affiniti Diagnostic Ultrasound | ||
| Feature | Ultrasound Systems with Auto Ultrasound SystemsMeasure Version 2 | (K 222648 )Primary predicate device | System VM9.0(K211597)Reference Device | Comparison |
| Duration of use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical to Predicate |
| ApplicationDescription | Auto Measure is an optionalsoftware feature on the 5000Compact SeriesUltrasound System thatprovides the end user withsemiautomatedechocardiography 2D andDoppler measurements throughan Al-algorithm, training viamachine-learning techniques. It isintended to be used with an AdultCardiology Transthoracictransducer and acquisitions thatinclude an ECGThese measurements areroutinely collected during atransthoracic ECG, per TheAmerican Society of Echocardiography (ASE)recommendations2D modes include the following:IVSdLVIDdLVPWdLVIDsAsc Ao DiamLVOT Diam | The healthcare professionalperforms 2D and Dopplermeasurements during atransthoracic echocardiogramwith Manually positioning theadult calipers on the ultrasound'sand system waveform or image.2D modes include the following:IVSdLVIDdLVPWdLVIDsAsc Ao Diam | Auto Measure is an optionalsoftware feature on the AffinitiSeriesDiagnostic Ultrasound System thatprovides the end user withsemiautomated adultechocardiography 2D and Dopplermeasurements through an Al-algorithm, training via machine-learning techniques. It is intendedto be used with an Adult CardiologyTransthoracic transducer andacquisitions that include an ECG.These measurements are routinelycollected during a transthoracicECG, per The American Society ofEcho(ASE)cardiographyrecommendations2D modes include the following:IVSd | Difference No.2Auto Measure is being included inthe subject submission with 5000Compact Series UltrasoundSystems |
| Feature | 5000 CompactUltrasound Systems with AutoMeasure Version 2 | Series 5000 CompactUltrasound Systems(K 222648 )Primary predicate device | Series Affiniti Diagnostic UltrasoundSystem VM9.0(K211597)Reference Device | Comparison |
| Ao STJ DiamRV Base, RV Mid, RV LengthTV AnnulusDoppler modes include thefollowing:MV Peak E Vel, MV Peak A VelMV Inflow (MV Dec Time, MVPeak E Vel, MV Peak A Vel)LVOT VTI, LVOT VmaxAV VTI, AV VmaxPV VTI, PV VmaxTR VmaxLat E' Vel, Lat A' VelLat Vel (Lat E' Vel, Lat A' Vel)Med E' Vel, Med A' VelMed Vel (Med E' Vel, Med A' Vel)RV S Vel | Ao Sinus DiamAo STJ DiamRV Base, RV Mid, RV LengthTV AnnulusDoppler modes include thefollowing:MV Peak E Vel, MV Peak A VelMV Inflow (MV Dec Time, MVPeak E Vel, MV Peak A Vel)LVOT VTI, LVOT VmaxAV VTI, AV VmaxPV VTI, PV VmaxTR VmaxLat E' Vel, Lat A' VelLat Vel (Lat E' Vel, Lat A' Vel)Med E' Vel, Med A' VelMed Vel (Med E' Vel, Med A' Vel)RV S Vel | LVPWdLVIDsAsc Ao DiamLVOT DiamAo Sinus DiamAo STJ DiamRV Base, RV Mid, RV LengthTV AnnulusDoppler modes include thefollowing:MV Peak E Vel, MV Peak A VelMV Inflow (MV Dec Time, MVPeak E Vel, MV Peak A Vel)LVOT VTI, LVOT VmaxAV VTI, AV VmaxPV VTI, PV VmaxTR VmaxLat E' Vel, Lat A' VelLat Vel (Lat E' Vel, Lat A' Vel)Med E' Vel, Med A' VelMed Vel (Med E' Vel, Med A' Vel)RV S Vel | ||
| CompatibletransducersforAutoMeasure | S5-1 and S4-2 | S5-1 and S4-2 | S5-1 and S4-2, x5-1, x5-1c | Identical to Predicate |
| Feature | 5000 Compact SeriesUltrasound Systems with AutoMeasure Version 2 | 5000 Compact Series(K 222648 )Primary predicate device | Affiniti Diagnostic UltrasoundSystem VM9.0(K211597)Reference Device | Comparison |
| Version2 | ||||
| UserInterfacePresentation | User selects an adultechocardiography 2D or Dopplermeasurement to perform then thecaliper positions are initializedbased on the output of the AIdetection algorithm.The user can edit, accept, orreject the measurements.Alternately The healthcareprofessional performs 2D andDoppler measurements during atransthoracic echocardiogram byManually positioning the caliperson the ultrasound's systemwaveform or image. | The healthcare professionalperforms 2D and Dopplermeasurements duringtransthoracic echocardiogram byManually positioning the caliperson the ultrasound's systemwaveform or image. | User selects an adultechocardiography 2D or Dopplermeasurement to perform then thecaliper positions are initializedbased on the output of the AIdetection algorithm.The user can edit, accept, or rejectthe measurements.Alternately The healthcareprofessional performs 2D andDoppler measurements during atransthoracic echocardiogram byManually positioning the caliperson the ultrasound's systemwaveform or image. | Difference No.2Auto Measure is being included inthe subject submission with 5000Compact Series UltrasoundSystems |
| Feature | 5000 Compact Series Ultrasound SystemSubject Devices | Affiniti Diagnostic Ultrasound System(K211597)Reference Device | Comparison | |
| USA FDA Classification | Class II | Class II | Identical to Predicate | |
| Primary Product Code | IYN | IYN | Identical to Predicate | |
| Secondary ProductCodes | IYOITX*QIH | IYOITXQIH | Identical to Predicate*QIH is new for 5000 Compact Series UltrasoundSystems | |
| Primary RegulationNumber | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to Predicate | |
| Software VersionBaseline | Compact 2.0 (VM11.0) | VM9.0 | Similar, 5000 Compact Series Ultrasound systemsmoving to VM11.0 software to gain access to AutoMeasure feature. | |
| Marketing Name ofApplication | Auto Measure Version 2 | Auto Measure Version 1 | Similar. No new measurements areintroduced in Auto Measure v2. Subset ofintegrated measurement detectors have beentrained with additional training data. CNNarchitecture of all detectors, training procedure andall acceptance criteria for the additional trainingdata are identical to Auto Measure v1. | |
| Application Description | Auto Measure is an optionalsoftware feature on the 5000 Compact SeriesUltrasound Systems that provides the end userwith semiautomated adult echocardiography 2Dand Doppler measurements through an Al-algorithm, training via machine-learningtechniques. It is intended to be used with an AdultCardiology Transthoracic transducer andacquisitions that include an ECG. Thesemeasurements are routinely collected during atransthoracic ECG, per The American Society ofEchocardiography (ASE) recommendations(Attachment 049_Literature References)2D modes include the following:IVSdLVIDdLVPWd | Auto Measure is an optionalsoftware feature on the 5000 Compact SeriesUltrasound Systems that provides the end user withsemiautomated adult echocardiography 2D andDoppler measurements through an Al-algorithm,training via machine-learning techniques. It isintended to be used with an Adult CardiologyTransthoracic transducer and acquisitions thatinclude an ECG. These measurements areroutinely collected during a transthoracic ECG, perThe American Society of Echocardiography (ASE) recommendations(Attachment 049_Literature References)2D modes include the following:IVSdLVIDdLVPWdLVIDs | Identical to Predicate | |
| Feature | 5000 Compact Series Ultrasound SystemSubject Devices | Affiniti Diagnostic Ultrasound System(K211597)Reference Device | Comparison | |
| LVIDsAsc Ao DiamLVOT DiamAo Sinus DiamAo STJ DiamRV Base, RV Mid, RV LengthTV Annulus | Asc Ao DiamLVOT DiamAo Sinus DiamAo STJ DiamRV Base, RV Mid, RV LengthTV Annulus | |||
| Doppler modes include thefollowing:MV Peak E Vel, MV Peak A VelMV Inflow (MV Dec Time, MVPeak E Vel, MV Peak A Vel)LVOT VTI, LVOT VmaxAV VTI, AV VmaxPV VTI, PV VmaxTR VmaxLat E' Vel, Lat A' VelLat Vel (Lat E' Vel, Lat A' Vel)Med E' Vel, Med A' VelMed Vel (Med E' Vel, Med A' Vel)RV S Vel | Doppler modes include thefollowing:MV Peak E Vel, MV Peak A VelMV Inflow (MV Dec Time, MVPeak E Vel, MV Peak A Vel)LVOT VTI, LVOT VmaxAV VTI, AV VmaxPV VTI, PV VmaxTR VmaxLat E' Vel, Lat A' VelLat Vel (Lat E' Vel, Lat A' Vel)Med E' Vel, Med A' VelMed Vel (Med E' Vel, Med A' Vel)RV S Vel | |||
| User InterfacePresentation | User selects an adult echocardiography 2D orDoppler measurement to perform then the caliperpositions are initialized based on the output of theAl detection algorithm.The user can edit, accept, or reject themeasurements. | User selects an adult echocardiography 2D orDoppler measurement to perform then the caliperpositions are initialized based on the output of theAl detection algorithm.The user can edit, accept, or reject themeasurements. | Identical to Predicate | |
| Compatible transducers | S5-1 and S4-2 are already commercially available andcompatible with the 5000 Compact SeriesUltrasound Systems.No new transducers.Transducer modes for Auto Measure: 2D,Doppler. No new transducer modes. | S5-1, X5-1, and S4-2 are already commerciallyavailable and compatible with the Affiniti UltrasoundSystem.No new transducers.Transducer modes for Auto Measure: 2D, Doppler,No new transducer modes. | Identical, with exemption of X5-1 transducer,which is not currently available to 5000 CompactSeries Ultrasound Systems. | |
| Feature | 5000 Compact Series Ultrasound SystemSubject Devices | Affiniti Diagnostic Ultrasound System(K211597)Reference Device | Comparison | |
| Semi-AutomationTechnology | Semi-automated adultechocardiography 2D and Dopplermeasurements are generated usingan artificial intelligence (AI)detection algorithm without userinteraction. After measurement isgenerated, the user can edit(manually adjust the caliperpositions), accept, or reject themeasurements. The automation of measurementsis constrained to the specific imaging mode (2D,Doppler) as recommended by ASEguidelines (Attachment 049_LiteratureReferences). | Semi-automated adultechocardiography 2D and Dopplermeasurements are generated usingan artificial intelligence (AI)detection algorithm without userinteraction. After measurement isgenerated, the user can edit(manually adjust the caliperpositions), accept, or reject themeasurements. The automation of measurementsis constrained to the specific imaging mode (2D,Doppler) as recommended by ASEguidelines (Attachment 049_LiteratureReferences). | Identical to Predicate |
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
Comparison of subject device and secondary predicate with AI/ML capabilities
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is a light gray or white color, providing contrast to the blue letters.
{14}------------------------------------------------
{15}------------------------------------------------
VI. Safety Considerations
The proposed 5000 Compact Series Ultrasound Systems, including the Auto Measure, and compatible transducers and comply with the referenced standards as well as the FDA ultrasound guidance for Industry and FDA Staff – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued in February 2023.
VII. Performance Data
The proposed introduction of the subject Philips Auto Measure with Philips internal processes.
The proposed modification of the 5000 Compact Ultrasound Systems (addition of Auto Measure) was tested in accordance with Philips internal procedures. Philips Ultrasound tested the subject devices 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
Design Control activities to assure the safe and effective performance of the Auto Measure Version 2 include but are not limited to the following:
- Requirements Review .
- Risk Analysis and Management .
- Product Specifications .
{16}------------------------------------------------
- Design Reviews
- Software Verification
The software documentation is presented in accordance for Content of Premarket Submissions for Device Software Functions issued June 14, 2023.
Details of performance study
Since this is a software-only change and no new hardware was added, no acoustic output, cleaning and clectrical, electromagnetic, and mechanical safety testing were required. Biocompatibility testing is not needed for the subject 5000 Compact Series Diagnostic Ultrasound Systems with Auto Measure. The transducer patient contact materials and manufacturing processes are not impacted by the release of the Auto Measure.
The performance of Auto Measure in 5000 Compact Series is substantiated in Auto Measure Performance Report
Feature Performance
Automated measurements are designed to operate on transthoracic acquisitions of adult subjects with typical diagnostic image quality following known guidelines (Guidelines for Performing a Comprehensive Echocardiographic Examination in Adults: Recommendations from the American Society of Echocardiography or equivalent). Only trained personnel that is able to perform the selected automated measurement manually is supposed to use this feature as a workflow improvement. The operator is responsible for the final result and has to apply manual edits to the automated output whenever required. Automated must not be applied to images where an appropriate manual measurement cannot be performed. As this feature has been designed to accelerate the manual measurement procedure with high success rates, no additional automated image quality assessment prevents the application of an automated measurement to inadequate images.
The Auto Measure software feature was developed to provide automated measurements in echocardiography that align closely with the accuracy of manual measurements, the current gold standard. To verify its performance, we conducted testing based on humanhuman interobserver data from clinical studies, which serves as a benchmark by representing the tween expet clinicians. In our evaluation, Auto Measure analyzed a set of new, previously images, and its automated results were compared to ground truth measurements established by clinical experts during routine care. Both the manual and automated measurements were performed on the same images without any adjustments to the siftware's output or the clinical data used as ground truth. The limits of agreement (LoA) used to assess performance were derived from published human interobserver variability data. The table below presents the test reach measurement detector compaing the automated outputs to the clinical ground truth, along with the acceptance criteria for each detectors met the acceptance criteria informed by clinical literature, supporting the accuracy and reliability of the Auto Measure feature.
{17}------------------------------------------------
Detector performance results of Auto Measure detectors
| Parameter | Detector | N(SampleSize) | Z score (A.Carkeet) | Measured Limits of Agreement (LoA)(detector prediction vs manual groundtruth) " | Checked Limitsof Agreement(LoAs) |
|---|---|---|---|---|---|
| Ao SinusDiameter | DETECTOR_ID_BMODE_AO_AOSV | 308 | 2.1320 | [-11.0022%, 11.2816%] | [-35.0%, 35.0%] |
| Ao STJDiameter | DETECTOR_ID_BMODE_AO_AOSTJ | 301 | 2.1342 | [-11.4181%, 13.1139%] | [-35.0%, 35.0%] |
| Asc AoDiameter | DETECTOR_ID_BMODE_AO_AOASC | 204 | 2.1769 | [-14.7794%, 15.9598%] | [-35.0%, 35.0%] |
| IVSd | DETECTOR_ID_BMODE_LV_LVDISTANCE_SAME_LINE | 305 | 2.1330 | [-33.2114%, 28.1632%] | [-35.0%, 35.0%] |
| LVIDd | DETECTOR_ID_BMODE_LV_LVDISTANCE_SAME_LINE | 457 | 2.0984 | [-14.1564%, 12.4223%] | [-35.0%, 35.0%] |
| LVIDs | DETECTOR_ID_BMODE_LV_LVID_ES | 469 | 2.0965 | [-23.4752%, 26.0242%] | [-35.0%, 35.0%] |
| LVOTDiameter | DETECTOR_ID_BMODE_LV_LVOT | 453 | 2.0991 | [-17.729%, 16.1588%] | [-35.0%, 35.0%] |
| LVPWd | DETECTOR_ID_BMODE_LV_LVDISTANCE_SAME_LINE | 305 | 2.1330 | [-33.1364%, 29.9544%] | [-35.0%, 35.0%] |
| RV Base | DETECTOR_ID_BMODE_RV_RVD_BASE | 302 | 2.1339 | [-16.1373%, 25.9079%] | [-35.0%, 35.0%] |
| RV Mid | DETECTOR_ID_BMODE_RV_RVD_MID | 243 | 2.1564 | [-25.0913%, 30.2573%] | [-35.0%, 35.0%] |
| RV Length | DETECTOR_ID_BMODE_RV_RVL | 117 | 2.2599 | [-14.6089%, 13.3871%] | [-35.0%, 35.0%] |
| TV Annulus | DETECTOR_ID_BMODE_RV_TVANN | 53 | 2.4511 | [-19.3628%, 18.0347%] | [-35.0%, 35.0%] |
| MV Decel.Time | DETECTOR_ID_DOPPLER_MV_DECEL_E_DURATION | 136 | 2.2343 | [-23.5717%, 22.8591%] | [-25.0%, 25.0%] |
| MV Peak AVel | DETECTOR_ID_DOPPLER_MV_VMAX_A_VELOCITY | 229 | 2.1631 | [-12.3694%, 15.2363%] | [-24.0%, 24.0%] |
| MV Peak EVel | DETECTOR_ID_DOPPLER_MV_VMAX_E_VELOCITY | 136 | 2.2343 | [-9.2081%, 9.1223%] | [-24.0%, 24.0%] |
| AV VTI | DETECTOR_ID_DOPPLER_AV_VTI | 247 | 2.1546 | [-21.5393%, 19.8925%] | [-22.0%, 22.0%] |
| LVOT VTI | DETECTOR_ID_DOPPLER_LVOT_VTI | 234 | 2.1607 | [-17.267%, 17.2093%] | [-22.0%, 22.0%] |
| PV VTI | DETECTOR_ID_DOPPLER_PV_VTI | 66 | 2.3864 | [-20.6140%, 21.0567%] | [-22.0%, 22.0%] |
{18}------------------------------------------------
Performance validation data have been extracted from a total auf 500 studies, one study per subject. Of these 500 studies, 200 are known normal subjects and 300 patients had a confirmed pathology). In clinical routine, not all measurements are performed in all studies. The available data per detector are listed in column 3 above. Demographic distribution for all validation studies is as follows:
| Age | $52.4 \pm 15.5$ years |
|---|---|
| Gender | Male: 49.6 % Female: 50.4 % |
| Ethnicity | Asian: 30.2 % Black: 26.4 % White: 36.2 Other: 7.3 % |
| Body Surface Area | $1.9 m^2 \pm 0.2 m^2$ |
| Weight | $76.8 kg \pm 17.0 kg$ |
All detector models were trained from the ground up and no pre-trained model weights were used. Training of the detectors was based on manual measurements performed by human experts done for diagnostic purpose. No additional non-standard was required.
Data pool for semi-automated cardiac measurement consists of anonymized transthoracyc echocardiography DICOM data and metadata. The data was recorded by multiple sonographers and physicians qualified in echocardiography in a large sample of adults of various ethnicities. Echocardiographic recordings were acquired according to guideline-standard echocardiographic procedures between 2010 and 2021 in 20
{19}------------------------------------------------
Image /page/19/Picture/0 description: The image shows the word "PHILIPS" in blue, block letters against a white background. The font is bold and sans-serif, giving the word a strong and clear presence. The letters are evenly spaced and aligned, creating a balanced and professional look.
centers and 16 countries. Qualified medical in echocardiography using TTA software (versions TTA2.31.00 and TTA2.50.00) or various Philips ultrasound systems annotation and following established quideines (Mitchel et al 2019),
The total training pool comprises more than 6000 studion, cardially healthy individuals as well as from patients having indications for receiving an echocarding our standard operating procedure for Al based algorithm development, validation data have been randomly sampled from then separated before detector development. Remaining data have been used for training and tuning in a cross-validation framework.
VIII. Clinical Data
Clinical investigations were not required for this 500 Compact Series Diagnostic Ultrasound Systems with Auto Measure software feature
IX. Sterilization
Not applicable. The ultrasound transducers are not supplied sterile.
X. Conclusion
Results of the testing show that the proposed subject device and supports a determination that the proposed subject device does not raise new questions of safety or effectiveness.
Therefore, the subject device is substantially equivale device in terms of incications for use, design, technological characteristics, modes of operations, safety, and effectiveness.
XI. References
Human-human inter-observer variability:
Bannas P. Rybczynski M. Sheikhzadeh S. von Kodolitsch Y. Deriin T. Yamanura J. Lund G. Adam G. Groth M. Comparison of Cine-MRI and Transhoracy Echocadiography for the Assessment of Actions with Suspected Marfan Syndrome. Rot. 2015 Nov: 18 (11):102-8. doi: 10.1055(s-0035-1553224. Epub 2015 Jun 22. PMID: 26098252.
• Cawley PJ, Hamilton-Craig C, Owens DS, Kreger EV, Strugnell WE, Mitsunori L, D'Jang CL, Schwaegler RG, Nguyen B, Maki JH, Otto CM. Prospective comparison of valve regurgitation by cardias magnetic resonance imaging and transhoracy . Circ Cartiovasc lmaging. 2013 Jan 1;6(1):48-57. doi: 10.1161/CIRCIMAGING:112.975623. Epub 2012 Dec 4. PMID: 23212272.
· Carket A. Exact parametric confidence intervals for Bland-Alman Vis Sci. 2015 Mar,92(3):e7-80. doi: 10.1097/OPX.0000000000000000000000000013. PMID: 25650900.
• Ferrara F. Gargani L. Contaldi C. Argiento P. Armstrono WF. Bandera F. Catematiri F. Citadin A. Cocchia R. D'Alto M. D'Andrea A. Douschan P, Ghio S, Grünig E, Guazzi M, Guida T, Limongell G, Marra AM, Mazzola M, Mauro C, Moreo A, Pieri F, Pratali L, Pugliese NR, Raciti M, Ranieri B, Rudski L, Sara W, Stanziola AA, Vannan M, Voilliot D, Virz O, Wierzbowska-Drabik K, Naejie R, Bossone E; RIGHT Heat International NETwork (Rivetigators. A multicentric study of exercise Dopler echocardiography of the
{20}------------------------------------------------
Image /page/20/Picture/0 description: The image shows the word "PHILIPS" in blue letters. The letters are bold and sans-serif. The background is white.
right heart and the pulmonary croulation. The RIGHT Heart (RIGHT-NET). Cardiovac Utrasound. 2021 Jan 20,10(1):3. doi. 10.1186/s12947-021-00238-1. PMID: 33472662; PMCID: PMC7819251.
• Janos RA, Kahlet P, Picht B, Wendt D, Eggebrecht H, Erbel R, Buck T. Measurement of the antilus size by real-time three-dimensional transesphageal echocardiography. Minim Invasive Ther Allied Technol. 2011 Apr,20(2):85-94. doi: 10.3109/13646706.2011.557385. PMD: 21417841.
· Knight DS, Schwaiger JP, Krupickova S, Davar J, Muthurangu V, Coghlan JG, Accuracy and Test-Retest Reproductibility of Two-Dimensional Knowledge-Based Volumetic Reconstruction of the Right Venticle in Purnonay Hypetension. J Am Soc Echocardion, 2015 Aug.28(8):989-8. doi: 10.1016/j.echo.2015.02.020. Epub 2015 Apr 6. PMID: 25857546; PMCID: PMC4533235.
• Kopena D, Briongos S, Castillo H, Moreno C, Recio M, Narso-Gomez A, Obieta-Fresnedo I, Femández-Golfin C, Zanorano J., Jiménez D: PROTECT investigators, Interphsered realing and for promosication of normotensive patients with pulmonary embolism, Carliovasc Ultrasound. 2014 Aug 4:12:29. doi: 10.1186/1476-7120-12-29. PMID: 25092465; PMCID: PMC4126908.
· Lang RM, Addetia K, Miyoshi T, Kebed K, Blitz A, Schreckerberg M, Hitschich N, Mor-Avi V, Asch FM. Use of Machine Learning to Improve Echocardio mage Interpretation Workfow: A Disupive Paradigm Change? J Am Soc Echocardiogr. 2020 Dec 1:508947317(20)3072-0. doi: 10.1016/j.echo.2020.11.017. Epub ahead of print. PMID: 33276079.
· Medvedofsky D, Addetia K, Hamilton J, Leon Jimenez J, Lang RM, Mor-Avi V, Semi-automated echocardiographic quantification of right ventricular size and function. Int J Cardiovasc Imaging. 2015 Aug.31(6):1149-57. doi: 10.1007/s10554-015-0672-4. Epub 2015 May 7. PMD: 25948160.
· Mortach C, Gelbrich G, Breunig M, Tiffe T, Wagner M, Heuschmann PU, Störk S. Impact of acquisition on total inter-observer variability in echocardiggaphy: results from the quality assurance program of the STAAB cohor study. Int J Cardiovasc maging, 2018 July 2017-1005. doi. 10.1007/s10554-018-1315-3. Epub 2018 Feb 14. PMID: 29445974.
· Nejatian A. Yu J. Geva T. White MT. Prakash A. Anto Measurements in Patients with Aortopathy are Larger and More Reproducible by Cardia: Magnetic Resonance Compared with Echocardion 2015 Dec36(8):1761-73. doi: 10.1007/00246-015-1231-4. Epub 2015 Jul 15. PMID: 26174757.
· Paelinck BP, Van Herck PL, Rodrigus I, Clarizel PM, Vints CJ, Bosmans JM. Comparison of magnetic resonance imaging of antic valve stenosis and antic rot to multimodality imagineer actic valve implantation candidates. Am J Cardiol. 2011 Jul 1,108(1).92-8. doi: 10.1016/j.amjcard.2011.02.348. Epub 2011 Apr 27. PMID: 21529729.
· Pereira JB, Essa M, Ugonabo I, Hur DJ, Crandal I, Vaccarell M, Sugenq L. The feasibility of contrast echocardion in the assessment of right ventricular size and function. Echocardiography. 2019 Nov:36(11):1979-1988. doi: 10.1111/echo.14504. Epub 2019 Oct 21. PMD: 31633241.
· Ren B, de Groot-de Laat LE, McGhie J, Vetter WB, Ten Cate F, Geleinse M. Geometic errors of the pussitiving degenerative mitral valve regurgitation: a three-dingraphy study, J Am Soc Echocardiogr. 2013 Mar;26(3);261-9. doi: 10.1016/j.echo.2012.10.011. Epub 2012 Dec 7. PMID: 23228655.
· Schenk P. Globits S. Koller J. Brunner C. Arention O. Accuracy of echocardiographic right ventricular parameters in patients with different end-stage lung transplantation. J Heart Lung Transplant. 2000 Feb;19(2):145-54. doi: 10.1016/s1053-248(99)00/21-7. PMID: 10703690.
• Schoenmaker NJ, van der Lee JH, Groothoff JW, van beren GG, From •Muder IM. Low agrement between cardiologists diagnosing left ventricular hypertophy in childen with end-stage renal disease. BMC Nephrol. 2013 Aug 214:170. doi: 10.1186/1471-2369-14-170. PMID: 23915058; PMCID: PMC3737015.
• Snelder SM, Younge JO, Dereci A, van Velzen JE, Akkerhuis IM, de Groot-de Laat LE, Zilstra F, van Dalen BM, Feasibility of Transthoracic Echocardiography in Obese Patients. J Am Soc Echocardiogr. 2019 Nov 1493.65. doi: 10.1016/1, ecub 2019.019. Eub 2019 Sep 25. PMID: 31563438.
{21}------------------------------------------------
DHILDS
• Tzikas A. Schultz CJ. Pizza N. Moelker NM. Nus RJ. van Geuns RJ. Geleijnse M., Serrys PW. de Jaeqere PP. Assessment of the antic annulus by multislice computed tomorrably, and trans-thoracy echocardiography in patients referred for transatheter antic valve implantation. Catheter Cardiovasc Interv. 2011 May 1:77(6):868-75. doi: 10.1002/ccd.22761. Epub 2011 Apr 14. PMD: 20824762.
• van der Linde D, Rossi A, Yap SC, McGhie JS, van den Bosch AE, Kirschbaum SW, Russo B, van Dijk AP, Moelker A, Koss-Hesselink JW. Ascending aortic diameters in cardiac magnetic resonance versus transthoracic echocardiography. Echocardiography. 2013 May;30(5):497-504. doi: 10.1111/echo.12086. Epub 2013 Jan 11. PMID: 23305528.
· van der Zwaan HB, Gelejinse ML, McGhie WA, Meijboom FJ, Roos-Hesselink JW, Right ventricular quantification in clincal practice: two-dimensional vs. three-dimensional echocardic resonance imaging. Eur J Echocardiog. Eur J Echocardiogr. 2011 Sep 12(9):566-64. doi: 10.1093/ejechocard/jer107. Epub 2011 Aug 2. PMID: 21810828.
· Vignola PA, Bloch A, Kaplan AD, Maker H, Chicelis PN, Myers GS. Interobserver variability in echocardiography. J. Clin Ultrasound. 1977 Aug5(4):28-42. doi: 10.1002/jcu.1870050405. PMID: 407252.
• Volpato V, Lang RM, Yamat M, Veronesi F, Weiner M, Fusini L, Pepi M, Genovese D, Mor-Avi V, Adetia K. Echocardiographi: Assessment of the Tricuspid Annulus The Effects of the Third Dimension and Measurement Methodoogy, J Am Soc Echocardion: 2019 Feb:32(2):28-247. doi: 10.1016/j.echo.2018.09.008. Epub 2018 Nov 17. PMID: 30459122.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.