(27 days)
The intended use of EPIQ Series Diagnostic Utrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
• Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transectal, Transrectal, Transvaginal, Lung.
· The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
· When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the X11-4t transducer:
The X11-4t is a 2500 element phased array 3D (three dimensional) transesophageal (TEE) cardiac transducer for patients 5 kg and greater. This transducer is supported by all EPIQ platform systems running software version 11.0 or higher including the EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, and EPIQ 5. X11-4t supports Cardiac Adult, Cardiac Pediatric, and Transesophageal (Cardiac) indications. The X11-4t has a frequency of 4-11 MHz.
The provided text is a 510(k) Summary for the Philips EPIQ Series Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria related to AI performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth for an AI device are not available in this document. The device in question is a diagnostic ultrasound system and a new transducer (X11-4t), not an AI/ML-enabled medical device.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific performance acceptance criteria for AI or a detailed report of device performance against such criteria. Instead, it states:
| Criterion Type | Description / Reported Performance |
|---|---|
| Overall Acceptance | "For testing, all pre-determined acceptance criteria were met." (This is a general statement about all non-clinical performance testing, not specific to AI.) |
| Intended Use | "Results of these tests show that the proposed EPIQ Series Diagnostic Ultrasound System, including X11-4t, met the intended use." |
| Safety and Effectiveness | The submission asserts that substantial equivalence was demonstrated based on "Design features, Indications for use, Fundamental scientific technology, Non-clinical performance testing, Safety and effectiveness." The differences between the proposed device and the predicate do not "raise new questions of safety and/or effectiveness." |
| Standards Compliance | Complies with ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, and ISO 10993-1. Also complies with FDA ultrasound guidance document, "Guidance for Industry and FDA Staff - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued in February 2023." |
The following information is not applicable or not provided in the document as it pertains to AI/ML device performance studies:
- 2. Sample size used for the test set and the data provenance: Not applicable. The document discusses non-clinical performance testing (e.g., electrical safety, electromagnetic compatibility, biological evaluation), not a clinical test set with patient data for AI evaluation.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of what the document confirms:
This 510(k) submission is for a traditional diagnostic ultrasound system and a new transducer. It primarily addresses safety and effectiveness through mechanical, electrical, and biological testing, and comparison to a predicate device. It does not include information about AI/ML algorithm performance, ground truth establishment, or clinical studies involving human readers with AI assistance. The non-clinical performance tests conducted confirmed the device met its intended use and safety standards.
§ 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.