Who is the manufacturer of The 5000 Compact Series Ultrasound Systems?

Philips Ultrasound, LLC filed the 510(k) submission for The 5000 Compact Series Ultrasound Systems (K242800).

What is the FDA product code for The 5000 Compact Series Ultrasound Systems?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for The 5000 Compact Series Ultrasound Systems?

510(k) clearance (submission type: Traditional).

Does The 5000 Compact Series Ultrasound Systems use AI or machine learning?

Yes. The 5000 Compact Series Ultrasound Systems (K242800) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for The 5000 Compact Series Ultrasound Systems?

5000 Compact Series Diagnostic Ultrasound Systems (K222648).

Who can help prepare an FDA 510(k) submission like The 5000 Compact Series Ultrasound Systems?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like The 5000 Compact Series Ultrasound Systems get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

The 5000 Compact Series Ultrasound Systems

K242800 · Philips Ultrasound, LLC · IYN · Nov 15, 2024 · Radiology

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, Pediatric

Intended 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)

Related Devices

K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System · Philips Medical Systems · Sep 8, 2021
K243794 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System · Philips Ultrasound, LLC · Feb 6, 2025
K233788 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System · Philips Ultrasound, LLC · Feb 13, 2024
K233676 — Us2.v2 · Eko.Ai Pte Ltd. D/B/A Us2.Ai · Apr 1, 2024
K210791 — Us2.v1 · Eko.Ai Pte Ltd. D/B/A Us2.Ai · Jul 27, 2021

Submission Summary (Full Text)

{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) 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) ## 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 and Address | Philips Ultrasound LLC 22100 Bothell Everett Hwy Bothell, WA 98021-8431 USA | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Information | Suresh Kumar Alagarsamy Senior Specialist I - Regulatory Affairs 22100 Bothell Everett Hwy Bothell, WA 98021-8431 USA +91 97401 63840 | | Secondary Contact | Erdit Gremi Director, Regulatory Affairs - Software & Al 22100 Bothell Everett Hwy Bothell, WA 98021-8431 USA 1-617-798-8092 | ### II. Device | Proprietary Name | 5000 Compact Series Ultrasound Systems Auto 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 Compact Ultrasound Systems with Auto Measure Version 2 | Series 5000 Compact (K 222648 ) Primary predicate device | Series Affiniti Diagnostic Ultrasound System VM9.0 (K211597) Reference Device | Comparison | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. | 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, and Urology. | 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 Predicate Small Parts and Small Organs are same. To align with terminology in Compact 5000 Systema and User Manual, Updated to Small Parts | | Intended Users | Trained healthcare professionals Intended for sonographers, | Trained healthcare professionals Intended for sonographers, | Trained healthcare professionals Intended for sonographers, | Identical to Predicate | | Feature | 5000 Compact Ultrasound Systems with Auto Measure Version 2 | Series 5000 Compact (K 222648 ) Primary predicate device | Series Affiniti Diagnostic Ultrasound System VM9.0 (K211597) Reference Device | Comparison | | | physicians, and biomedical engineers who operate and maintain your product. Trained healthcare Professional | physicians, and biomedical engineers who operate and maintain your product. Trained healthcare Professional | physicians, and biomedical engineers who operate and maintain your product. Trained healthcare Professional | | | | Before use of the system and user information, the user must be familiar with ultrasound techniques. Sonography training and clinical procedures are not included in the User Manual or with the 5000 Compact Series Ultrasound Systems. | Before use of the system and user information, the user must be familiar with ultrasound techniques. Sonography training and clinical procedures are not included in the User Manual or with the 5000 Compact Series Ultrasound Systems. | Before use of the system and user information, the user must be familiar with ultrasound techniques. Sonography training and clinical procedures are not included in the User Manual or with the Affiniti Diagnostic Ultrasound System. | | | Intended User Environment | Clinics, hospitals, and clinical point-of-care for diagnosis of patients. | Clinics, hospitals, and clinical point-of-care for diagnosis of patients. | Clinics, hospitals, and clinical point- of-care for diagnosis of patients. | Identical to Predicate | | USA FDA Classification | Class II | Class II | Class II | Identical to Predicate | | Primary Product Code | IYN | IYN | IYN | Identical to Predicate | | Primary Regulation Number | 21 CFR 892.1550 | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to Predicate | | Secondary Product Codes | ITX IYO QIH | ITX IYO | ITX IYO 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 21 CFR 892.1560 21 CFR 892.2050 | 21 CFR 892.1570 21 CFR 892.1560 | 21 CFR 892.1570 21 CFR 892.1560 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 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. 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 Compact Series | Compact | Series Affiniti Diagnostic Ultrasound | | | Feature | Ultrasound Systems with Auto Ultrasound Systems Measure 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 | | Application Description | Auto Measure is an optional software feature on the 5000 Compact Series Ultrasound System that provides the end user with semiautomated echocardiography 2D and Doppler measurements through an Al-algorithm, training via machine-learning techniques. It is intended to be used with an Adult Cardiology Transthoracic transducer and acquisitions that include an ECG These measurements are routinely collected during a transthoracic ECG, per The American Society of Echo cardiography (ASE) recommendations 2D modes include the following: IVSd LVIDd LVPWd LVIDs Asc Ao Diam LVOT Diam | The healthcare professional performs 2D and Doppler measurements during a transthoracic echocardiogram with Manually positioning the adult calipers on the ultrasound's and system waveform or image. 2D modes include the following: IVSd LVIDd LVPWd LVIDs Asc Ao Diam | Auto Measure is an optional software feature on the Affiniti Series Diagnostic Ultrasound System that provides the end user with semiautomated adult echocardiography 2D and Doppler measurements through an Al- algorithm, training via machine- learning techniques. It is intended to be used with an Adult Cardiology Transthoracic transducer and acquisitions that include an ECG. These measurements are routinely collected during a transthoracic ECG, per The American Society of Echo (ASE) cardiography recommendations 2D modes include the following: IVSd | Difference No.2 Auto Measure is being included in the subject submission with 5000 Compact Series Ultrasound Systems | | 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…