(83 days)
The Anzai eZ-Scope AN Portable Gamma Camera is indicated for use to image the distribution of radionuclides in the human body using planar imaging techniques. The eZ-Scope may be used intraoperatively or on pathological specimens if a protective sheath is used.
The Anzai EZ-Scope AN Portable Gamma Camera is a currently marketed portable gamma camera. utilizing a solid state detector. rather than a scintilator, to detect gamma rays. The cadmium-zinc-tellurium detector allows sharp energy discrimination and spatial resolution. The detector arrav is made from pixelized cadmium-zinc-telluride (CZT) crystals, with each of the 256 pixels having dimensions of 2 x 2 mm. The system is available in two configurations, eZ-Scope AN and eZ-Scope Light. These differ primarily in the computer, the former model using a desktop computer and the latter a laptop. In the desktop version, the computer is mounted on a cart, while the laptop version does not have a cart.
The present 510(k) is for an addition to the indications for use statement (see next section) pertaining to intraoperative use. The user manual has been modified to include instructions for disinfecting the camera head and covering it with a protective plastic sheath to prevent contamination of a sterile field in case of an accidental puncture of the sheath during intraoperative use.
The provided text states that "No new performance testing was necessary for the present submission." Therefore, it does not contain the information required to populate the acceptance criteria and study details. The submission is for an additional indication for use (intraoperative use) for an already legally marketed device, and the manufacturer claims substantial equivalence to predicate devices without the need for new performance testing.
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).