(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal/Obstetric, Abdominal, Intra-operative (vascular/epicardial), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (thyroid, scrotum, prostate, breast), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intra-luminal, Musculo-skel (conventional), Musculo-skel (superficial), Other (Gynecological), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Other (Fetal), Peripheral vessel, Other (Specify).
The CX50 is a compact diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducers.
The provided text describes a 510(k) premarket notification for the Philips CX50 Diagnostic Ultrasound System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies with specific acceptance criteria and performance metrics against a ground truth.
Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to this 510(k) submission.
The core of this submission is to show that the CX50 system is as safe and effective as existing, cleared ultrasound systems without presenting primary performance data against predefined acceptance criteria.
Here's why the requested information is absent and why this submission works differently:
- Substantial Equivalence (510(k) pathway): The FDA's 510(k) pathway for medical device clearance is based on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness and is as safe and effective as the predicate.
- No New Clinical Studies Required: In most 510(k) submissions, new clinical performance studies are not required to establish safety and effectiveness. Instead, the focus is on comparing the new device's specifications, technological features, and indications for use to those of the predicate device(s).
- Focus on Comparison, Not Absolute Performance: The document predominantly compares the CX50 to existing Philips HD11 and General Electric Vivid-i ultrasound systems, highlighting similarities in:
- Intended use (diagnostic ultrasound imaging and fluid flow analysis).
- Gray-scale and Doppler capabilities.
- Imaging, Doppler, and signal processing technologies.
- Acoustic output limits (below Track 3 FDA limits).
- Manufacturing quality systems and biosafety of materials.
- Electrical and physical safety standards.
In summary, there is no study described in this document that proves the device meets specific acceptance criteria in the way one might expect for a de novo or PMA submission. The "proof" here is the argument for substantial equivalence to already cleared devices.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.