(85 days)
The intended use of the eZono 3000, as defined by FDA guidance documents, are: Ophthalmic, Musculo-skeletal (Conventional), Fetal (as enumerated in the IFU Tables), Musculo-skeletal (Superficial), Abdominal, Retroperitoneum, Pediatric, Female reproductive system and foetus, Small Organ (breast, thyroid, testicle), Cardiac (Adult), Invasive diagnostic or therapeutic procedures, Cardiac (Pediatric), Peripheral vessel.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (e.g. testicles, lymph nodes, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Invasive diagnostic or therapeutic procedures (e.g. biopsies, punctures, free fluid detection, regional anesthesia, vascular access), Superficial structures & pathologies (incl. Lungs), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Other (Specify), Peripheral vessel.
eZono 3000
The provided document is a 510(k) premarket notification from the FDA for the eZono 3000 ultrasound system. It primarily focuses on defining the indications for use for various transducers associated with the device and establishing substantial equivalence to previously marketed predicate devices.
Crucially, this document does NOT contain information about acceptance criteria for device performance, the results of a study proving the device meets these criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC).
The "performance" described here is solely in terms of the clinical applications and modes of operation for which the device (with specific transducers) is cleared for use, noting whether these indications are "new" (N) or "previously cleared" (P) based on existing predicate devices. This is a regulatory filing stating what the device can be used for, not a report on its quantitative diagnostic performance.
Therefore, I cannot provide the requested information from this document. The document's purpose is to establish regulatory clearance based on substantial equivalence, not to present a detailed performance study with acceptance criteria and results.
§ 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.