The 5000 Compact Series Ultrasound Systems
Device Facts
| Record ID | K242800 |
|---|---|
| Device Name | The 5000 Compact Series Ultrasound Systems |
| Applicant | Philips Ultrasound, LLC |
| Product Code | IYN · Radiology |
| Decision Date | Nov 15, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | AI/ML, Real-World Evidence, Pediatric |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K242800 · Nov 15, 2024 | The 5000 Compact Series Ultrasound Systems | Philips Ultrasound, LLC | Anonymized transthoracic echocardiography DICOM data and metadata from routine clinical practice (2010-2021) | Retrospective clinical data from 20 centers across 16 countries was used to train and validate the performance of the Auto Measure AI/ML software detectors. The automated measurements were compared against manual measurements performed by clinicians during routine diagnostic care. | AI/ML; Retrospective data; Echocardiography; Performance validation |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Auto Measure Performance Report; Retrospective analysis of routine clinical echocardiographic data; Follow-up/Duration: Not applicable; Study Period: 2010-2021 | Adult subjects (200 normal, 300 with confirmed pathology); Sample Size: 500 studies (total training pool > 6000 studies); Number of Sites: 20 centers in 16 countries | Manual measurements performed by clinical experts during routine care | Limits of Agreement (LoA) between automated detector output and manual ground truth |
AI Performance
| Output | Algorithm | Acceptance | Observed | Dev DS | Dev Readers | Test DS | Test Readers |
|---|---|---|---|---|---|---|---|
| Ao Sinus Diameter | CNN | Limits of Agreement [-35.0%, 35.0%] | [-11.0022%, 11.2816%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| Ao STJ Diameter | CNN | Limits of Agreement [-35.0%, 35.0%] | [-11.4181%, 13.1139%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| Asc Ao Diameter | CNN | Limits of Agreement [-35.0%, 35.0%] | [-14.7794%, 15.9598%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| IVSd | CNN | Limits of Agreement [-35.0%, 35.0%] | [-33.2114%, 28.1632%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| LVIDd | CNN | Limits of Agreement [-35.0%, 35.0%] | [-14.1564%, 12.4223%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| LVIDs | CNN | Limits of Agreement [-35.0%, 35.0%] | [-23.4752%, 26.0242%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| LVOT Diameter | CNN | Limits of Agreement [-35.0%, 35.0%] | [-17.729%, 16.1588%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| LVPWd | CNN | Limits of Agreement [-35.0%, 35.0%] | [-33.1364%, 29.9544%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| RV Base | CNN | Limits of Agreement [-35.0%, 35.0%] | [-16.1373%, 25.9079%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| RV Mid | CNN | Limits of Agreement [-35.0%, 35.0%] | [-25.0913%, 30.2573%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| RV Length | CNN | Limits of Agreement [-35.0%, 35.0%] | [-14.6089%, 13.3871%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| TV Annulus | CNN | Limits of Agreement [-35.0%, 35.0%] | [-19.3628%, 18.0347%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| MV Decel. Time | CNN | Limits of Agreement [-25.0%, 25.0%] | [-23.5717%, 22.8591%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| MV Peak A Vel | CNN | Limits of Agreement [-24.0%, 24.0%] | [-12.3694%, 15.2363%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| MV Peak E Vel | CNN | Limits of Agreement [-24.0%, 24.0%] | [-9.2081%, 9.1223%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| AV VTI | CNN | Limits of Agreement [-22.0%, 22.0%] | [-21.5393%, 19.8925%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| LVOT VTI | CNN | Limits of Agreement [-22.0%, 22.0%] | [-17.267%, 17.2093%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
| PV VTI | CNN | Limits of Agreement [-22.0%, 22.0%] | [-20.6140%, 21.0567%] | More than 6000 studies from 20 centers and 16 countries | >1 (sonographers and physicians) | 500 studies (200 normal, 300 pathology) | >1 (sonographers and physicians) |
Indications for Use
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.
Device Story
5000 Compact Series Ultrasound Systems are diagnostic imaging devices used in clinical settings (hospitals, clinics, point-of-care) by trained healthcare professionals. This submission introduces 'Auto Measure Version 2', an optional AI/ML-based software feature for semi-automated echocardiography measurements. The system takes 2D and Doppler ultrasound images (with ECG input) as input. The Auto Measure algorithm, trained via machine learning, initializes caliper positions on the image/waveform. The user reviews, edits, accepts, or rejects these measurements. The output is a set of standardized cardiac measurements (e.g., IVSd, LVIDd, LVOT VTI) aligned with ASE guidelines. This workflow improvement accelerates manual measurement procedures, potentially reducing inter-observer variability and increasing efficiency. The device is 'locked' and does not change with use.
Clinical Evidence
Bench testing only. Performance of Auto Measure Version 2 was validated using a dataset of 500 studies (200 normal, 300 pathological) comprising anonymized transthoracic echocardiography DICOM data. Automated measurements were compared against manual ground truth established by clinical experts. Performance metrics (Limits of Agreement) were compared against acceptance criteria derived from published human inter-observer variability data. All detectors met pre-defined acceptance criteria.
Technological Characteristics
Diagnostic ultrasound system; pulsed Doppler/echo imaging; software-based AI/ML measurement feature. Operates on VM platform. Compatible with existing S5-1 and S4-2 transducers. Software follows IEC 62304 life cycle processes. Locked algorithm; no hardware changes required. Connectivity via standard DICOM/metadata.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in adult and pediatric patients across abdominal, cardiac, vascular, obstetric, gynecological, musculoskeletal, ophthalmic, and urological applications. Used in hospitals, clinics, and point-of-care settings by trained healthcare professionals.
Regulatory Classification
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.
Predicate Devices
- 5000 Compact Series Diagnostic Ultrasound Systems (K222648)
Reference Devices
- Philips Affiniti Series Diagnostic Ultrasound System VM 9.0 (K211597)
Submission Summary (Full Text)
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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.
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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
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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
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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)
K242800
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)
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### 510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.
## 510(k) Number: K242800
Date Prepared: September 16, 2024
### l. Submitter
| Manufacturer Name and<br>Address | Philips Ultrasound LLC<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 USA |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Suresh Kumar Alagarsamy<br>Senior Specialist I - Regulatory Affairs<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 USA<br>+91 97401 63840 |
| Secondary Contact | Erdit Gremi<br>Director, Regulatory Affairs - Software & Al<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 USA<br>1-617-798-8092 |
### II. Device
| Proprietary Name | 5000 Compact Series Ultrasound Systems<br>Auto Measure | | |
|------------------------|---------------------------------------------------------------------|----------|--------------|
| Common Name | Diagnostic Ultrasound System and Transducers | | |
| Regulation Description | Classification Description | 21 CFR § | Product Code |
| | <b>Primary</b> | | |
| | System, imaging, pulsed doppler, ultrasonic | 892.1550 | IYN |
| | <b>Secondary</b> | | |
| | 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 | | |
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### 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.
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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
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### 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 Compact<br>Ultrasound Systems with Auto<br>Measure Version 2 | Series 5000 Compact<br>(K 222648 )<br>Primary predicate device | Series Affiniti Diagnostic Ultrasound<br>System VM9.0<br>(K211597)<br>Reference Device | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | Abdominal,<br>Cardiac Adult,<br>Cardiac Pediatric,<br>Carotid,<br>Cerebral Vascular,<br>Cephalic (Adult),<br>Cephalic (Neonatal),<br>Fetal Echo,<br>Fetal/Obstetric,<br>Gynecological,<br>Intraoperative (Vascular),<br>Lung,<br>Musculoskeletal (Conventional),<br>Musculoskeletal (Superficial),<br>Ophthalmic,<br>Pediatric,<br>Peripheral Vessel,<br>Small Parts<br>Transesophageal (Cardiac),<br>Transrectal,<br>Transvaginal, and<br>Urology. | Abdominal,<br>Cardiac Adult,<br>Cardiac Pediatric,<br>Carotid,<br>Cerebral Vascular,<br>Cephalic (Adult),<br>Cephalic (Neonatal),<br>Fetal Echo,<br>Fetal/Obstetric,<br>Gynecological,<br>Intraoperative (Vascular),<br>Lung,<br>Musculoskeletal (Conventional),<br>Musculoskeletal (Superficial),<br>Ophthalmic,<br>Pediatric,<br>Peripheral Vessel,<br>Small Organ (Breast, Thyroid,<br>Testicle),<br>Transesophageal (Cardiac),<br>Transrectal,<br>Transvaginal, and<br>Urology. | Abdominal,<br>Cardiac Adult,<br>Cardiac Other (Fetal),<br>Cardiac Pediatric,<br>Cerebral Vascular,<br>Cephalic (Adult),<br>Cephalic (Neonatal),<br>Fetal/Obstetric,<br>Gynecological,<br>Intraoperative (Vascular),<br>Intraoperative (Cardiac),<br>Musculoskeletal (Conventional),<br>Musculoskeletal (Superficial),<br>Other:<br>Urology,<br>Pediatric,<br>Peripheral Vessel,<br>Small Organ (Breast, Thyroid,<br>Testicle),<br>Transesophageal (Cardiac),<br>Transrectal,<br>Transvaginal,<br>Lung | Identical to Predicate<br>Small Parts and Small Organs are<br>same. To align with terminology in<br>Compact 5000 Systema and User<br>Manual,<br>Updated to Small Parts |
| Intended<br>Users | Trained healthcare professionals<br>Intended for sonographers, | Trained healthcare professionals<br>Intended for sonographers, | Trained healthcare professionals<br>Intended for sonographers, | Identical to Predicate |
| Feature | 5000 Compact<br>Ultrasound Systems with Auto<br>Measure Version 2 | Series 5000 Compact<br>(K 222648 )<br>Primary predicate device | Series Affiniti Diagnostic Ultrasound<br>System VM9.0<br>(K211597)<br>Reference Device | Comparison |
| | physicians, and biomedical<br>engineers who operate and<br>maintain your product.<br>Trained healthcare Professional | physicians, and biomedical<br>engineers who operate and<br>maintain your product.<br>Trained healthcare Professional | physicians, and biomedical<br>engineers who operate and<br>maintain your product.<br>Trained healthcare Professional | |
| | Before use of the system and<br>user information, the user must<br>be familiar with ultrasound<br>techniques. Sonography training<br>and clinical procedures are not<br>included in the User Manual or<br>with the 5000 Compact Series<br>Ultrasound Systems. | Before use of the system and<br>user information, the user must<br>be familiar with ultrasound<br>techniques. Sonography training<br>and clinical procedures are not<br>included in the User Manual or<br>with the 5000 Compact Series<br>Ultrasound Systems. | Before use of the system and user<br>information, the user must be<br>familiar with ultrasound techniques.<br>Sonography training and clinical<br>procedures are not included in the<br>User Manual or with the Affiniti<br>Diagnostic Ultrasound<br>System. | |
| Intended User<br>Environment | Clinics, hospitals, and clinical<br>point-of-care for diagnosis of<br>patients. | Clinics, hospitals, and clinical<br>point-of-care for diagnosis of<br>patients. | Clinics, hospitals, and clinical point-<br>of-care for diagnosis of patients. | Identical to Predicate |
| USA<br>FDA<br>Classification | Class II | Class II | Class II | Identical to Predicate |
| Primary<br>Product Code | IYN | IYN | IYN | Identical to Predicate |
| Primary<br>Regulation<br>Number | 21 CFR 892.1550 | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to Predicate |
| Secondary<br>Product<br>Codes | ITX<br>IYO<br>QIH | ITX<br>IYO | ITX<br>IYO<br>QIH | 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 892.1570<br>21 CFR 892.1560<br>21 CFR 892.2050 | 21 CFR 892.1570<br>21 CFR 892.1560 | 21 CFR 892.1570<br>21 CFR 892.1560<br>21 CFR 892.2050 | Identical to Predicate |
| Software Platform | VM | VM | VM | Identical to Predicate |
| Auto Measure Software Version | 2 | Not available | 1 | Difference No.1<br>The 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.<br>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 |
| | 5000<br>Compact Series | Compact | Series Affiniti Diagnostic Ultrasound | |
| Feature | Ultrasound Systems with Auto Ultrasound Systems<br>Measure Version 2 | (K 222648 )<br>Primary predicate device | System VM9.0<br>(K211597)<br>Reference Device | Comparison |
| Duration of use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical to Predicate |
| Application<br>Description | Auto Measure is an optional<br>software feature on the 5000<br>Compact Series<br>Ultrasound System that<br>provides the end user with<br>semiautomated<br>echocardiography 2D and<br>Doppler measurements through<br>an Al-algorithm, training via<br>machine-learning techniques. It is<br>intended to be used with an Adult<br>Cardiology Transthoracic<br>transducer and acquisitions that<br>include an ECG<br>These measurements are<br>routinely collected during a<br>transthoracic ECG, per The<br>American Society of Echo<br>cardiography (ASE)<br>recommendations<br><br>2D modes include the following:<br>IVSd<br>LVIDd<br>LVPWd<br>LVIDs<br>Asc Ao Diam<br>LVOT Diam | The healthcare professional<br>performs 2D and Doppler<br>measurements during a<br>transthoracic echocardiogram<br>with Manually positioning the<br>adult calipers on the ultrasound's<br>and system waveform or image.<br><br>2D modes include the following:<br>IVSd<br>LVIDd<br>LVPWd<br>LVIDs<br>Asc Ao Diam | Auto Measure is an optional<br>software feature on the Affiniti<br>Series<br>Diagnostic Ultrasound System that<br>provides the end user with<br>semiautomated adult<br>echocardiography 2D and Doppler<br>measurements through an Al-<br>algorithm, training via machine-<br>learning techniques. It is intended<br>to be used with an Adult Cardiology<br>Transthoracic transducer and<br>acquisitions that include an ECG.<br>These measurements are routinely<br>collected during a transthoracic<br>ECG, per The American Society of<br>Echo<br>(ASE)<br>cardiography<br>recommendations<br><br>2D modes include the following:<br>IVSd | Difference No.2<br><br>Auto Measure is being included in<br>the subject submission with 5000<br>Compact Series Ultrasound<br>Systems |
| Feature | 5000 Compact<br>Ultrasound Systems with Auto<br>Measure Version 2 | Series 5000 Compact<br>Ultrasound Systems<br>(K 222648 )<br>Primary predicate device | Series Affiniti Diagnostic Ultrasound<br>System VM9.0<br>(K211597)<br>Reference Device | Comparison…
