(310 days)
The Visicoil MR Marker and the Pre-Loaded Visicoil MR Marker are indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Device Identification: the Visicoil MR is a helically wound coil of platinum wire. The product is available on a carrier for user-loaded implantation or pre-loaded in a needle.
Device Characteristics: The Visicoil MR is a linear fiducial marker. It is used for marking soft tissue for future therapeutic procedures.
Environment for Use: The Visicoil MR and Pre-Loaded Visicoil MR may be implanted in a healthcare facility, free standing clinic or physician's office.
Description of Device: The Visicoil MR Marker and the Pre-loaded Visicoil MR Marker is a sterile device, in the form of a platinum coil. Visicoil MR comes on a delivery system, packaged in a Mylar/Tyvek pouch, sterilized by gamma sterilization. The Pre-Loaded Visicoil MR comes in a 18, 19, 20, 21, or 22g 304 stainless steel needle and stylet with a beeswax plug at the tip, packaged in a Mylar/Tyvek pouch sterilized by EO sterilization.
The coils ranges in length from 0.3cm to 2cm and have an outside diameter that ranges between 0.3mm and 1.0mm. Platinum has a dense mass which allows for imaging in all x-ray based imaging devices and other electro-magnetic properties help to enhance visibility within Magnetic Resonance Imaging (MRI).
The device is a passive device and is permanently implanted in the patient.
This document describes a 510(k) premarket notification for the Visicoil MR Marker. It demonstrates substantial equivalence to predicate devices, but it does not contain information about an AI-powered device or a study proving that an AI device meets acceptance criteria.
The document is for a physical medical device (a radiographically visible marker for soft tissue) and focuses on changes in material composition (from gold to platinum) and its visibility under MRI, as well as biocompatibility and functional testing of the physical marker.
Therefore, I cannot provide an answer based on the prompt's requirements for acceptance criteria, study details, sample sizes, expert involvement, or AI performance, as this information is not present in the provided text.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.