(75 days)
The iU22 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging, Harmonics (Tissue and Contrast) and Elastography modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Ophthalmic Fetal Intra-operative Abdominal Laparoscopic Pediatric Small Organ Adult and Neonatal Cephalic Trans-rectal Trans-vaginal Musculoskeletal Urology Cardiac (Adult, Pediatric, Trans-esophageal) Fetal Echo Peripheral Vessel
The clinical environments where the iU22 3.7 system can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.
The subject of this 510(k) notification, the iU22 ultrasound system and transducer(s), function in a manner identical to all diagnostic ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse. which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow.
The iU22 system gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used by competent healthcare professionals to make a diagnosis.
The provided document is a 510(k) Premarket Notification for the Philips iU22 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving efficacy or a specific performance metric against acceptance criteria through a clinical study in the way an AI/ML device submission might.
Therefore, the document does not contain information about acceptance criteria for device performance, a study to prove those criteria, sample sizes for a test set, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as typically sought for AI/ML or novel clinical device evaluations.
The "studies" referenced are primarily those that demonstrate the device meets safety and effectiveness standards comparable to the predicate devices, such as acoustic output levels, quality systems, biosafety, and electrical/physical safety standards. These are not performance studies in the sense of demonstrating a clinical outcome or a specific diagnostic accuracy.
Here's an analysis based on the information provided, highlighting what is and is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for diagnostic performance, nor does it report device performance against such criteria. The "acceptance criteria" for a 510(k) submission like this are centered on demonstrating substantial equivalence to predicate devices, focusing on:
- Intended Use: The iU22 system's intended uses are comparable to predicate devices.
- Operating Principles/Technology: The iU22 functions in a manner identical to diagnostic ultrasound systems.
- Safety Features: Acoustic output levels are below FDA limits, equivalent quality systems are used, materials have equivalent biosafety, and the system adheres to the same electrical and physical safety standards as predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
No information regarding a "test set" in the context of clinical performance evaluation (like for an algorithm) is provided. This 510(k) is not based on a clinical performance study with a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
No MRMC study is mentioned. The submission is about establishing substantial equivalence, not comparative effectiveness.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
Not applicable. The iU22 is a diagnostic ultrasound system, not an algorithm. Its performance is inherent to its hardware and software for image acquisition and display, which are always used with a human operator.
7. The Type of Ground Truth Used:
Not applicable. The "ground truth" in this context would be the established safety and effectiveness of the existing predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device with a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary based on the provided document:
The Philips iU22 Diagnostic Ultrasound System's 510(k) submission (K093563) demonstrates substantial equivalence to predicate devices (Philips iU22 K042540, Siemens Acuson S2000 K072786, Philips QLAB K021966, K023877).
The criteria for this substantial equivalence are listed as:
- Identical intended use: Diagnostic ultrasonic imaging and fluid flow analysis.
- Same gray-scale and Doppler capabilities.
- Acoustic output levels below Track 3 FDA limits.
- Manufactured under equivalent quality systems.
- Manufactured of materials with equivalent biosafety (evaluated and found safe).
- Designed and manufactured to the same electrical and physical safety standards.
The document does not describe any specific clinical studies or performance data against numerical acceptance criteria for diagnostic accuracy, sensitivity, or specificity, as it relies on the predicate devices' established safety and effectiveness.
§ 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.