(211 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Small Organ, Transrectal, Transvaginal, Peripheral Vascular.
CLI 4900 6.5MHz Trans-vaginal (endocavity) probe: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transvaginal.
CLI 5000 6.5MHz Trans-rectal (endocavity) probe: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transrectal.
CLI 6000 12.5MHz Peripheral Vascular probe: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ, Peripheral Vascular.
CLI 7900 3.5MHz General Abdominal probe: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA to SonoVision Corporation regarding their SONADA Ultrasound System. It primarily outlines the substantial equivalence determination for the device and its transducers.
Crucially, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The FDA letter grants clearance based on the device being substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as an already cleared device, or if there are differences, those differences do not raise new questions of safety or effectiveness. The information provided is primarily about the categorization and clearance of the device for marketing, and not about the detailed performance studies you're asking for.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory clearance, not performance metrics.
- Sample size used for the test set and the data provenance: This information is not present. There's no mention of a specific test set or data sources for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method for the test set: This information is not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. The device is a diagnostic ultrasound system, implying human operation.
- The type of ground truth used: This information is not present.
- The sample size for the training set: This information is not present.
- How the ground truth for the training set was established: This information is not present.
The document mainly lists the transducers approved and their intended clinical applications (e.g., Abdominal, Transvaginal, Transrectal, Peripheral Vascular, Small Organ) with "P" indicating "previously cleared by FDA" for those applications. This implies that the substantial equivalence determination relied on prior clearances for similar devices performing these functions, rather than new, explicit performance studies detailed within this letter. The "postclearance special report" mentioned relates to acoustic output measurements based on production units, which is a post-market requirement, not a pre-market performance study.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.