(33 days)
The intended uses of the Biopsy M are mammographic procedures requiring stereotactic guidance, such as fine needle aspiration. needle biopsy and guide wire placement. The intended uses are identical to those of the predicate device.
The Biopsy-M device uses two stereo images on a film to determine the location of a lesion in three dimensions. Once the coordinates of the lesion are determined by the Biopsy-M they are used to position a needle holder such that when the physician inserts the needle or guide-wire, the tip will be precisely positioned at the pre-determined coordinates.
I am sorry, but the provided text does not contain information regarding the acceptance criteria, the study details (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information), or reported device performance for the Biopsy-M device. The document primarily describes the device's function, its comparison to a predicate device, and the FDA's 510(k) clearance letter.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.