(15 days)
The SK YLight Imaging System is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
The modified SKYLight Imaging System offers all the features of the existing SKYLight Imaging System (K000908) while adding an optional feature that provides the used option or ability to acquire a single head acquisition studies on two separate but simultaneous planar patients. The SKYLight is designed to provide extended imaging functionality relative to a ring style gantry. The SKYLight was designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes a gantry frame, two detector arms (with detectors), a collimator storage structure with an acquisition computer unit, a patient imaging table, and a remote hand controller. The modified SKYLight is capable of accommodating two separate patient tables. The gantry is "open" so that a high degree of imaging flexibility is available to image patients sitting, standing or lying down, with or without the included patient imaging table. The patient imaging tables are mechanized to allow for patient loading access and then raised to an imaging height. The tables do not move during imaging since the gantry is flexible enough to perform all required motions for noncircular orbits. The imaging pallet includes removable arm, leg, breast, and headrest supports for patient positioning during studies that require support.
SK YLight is an 'open frame' imaging system, the 'open frame' consisting of an overhead rectangular structure that is supported by 4 (or more) columns that are bolted to the imaging room floor. A detector arm support structure is mounted onto the open frame which allows for the detector arm support structure (and both detector arms) to move in the longitudinal motion (X-axis). Arms that can telescope up and down (Z-axis) support the detectors. These detector arms are supported by a structure that allows for each detector arm to move toward or away from each other (Y-axis). Each detector has the ability to rotate and acquire images independently.
The combination of these four motions (Z, Y, X, and detector rotate), permit the detectors to perform all standard non-circular and circular ECT studies in both the 90-degree and 180-degree relative position. The SkyLight uses the EPIC HP+ detectors. The detectors use standard EPIC collimators, or MCD shields, which may be exchanged using an automatic exchange unit.
The modified SKYLight acquisition computer uses the same acquisition software (subsystem) as existing SKYLight to acquire ECT imaging studies and interfaces with a Pegasys computer system (workstation). The acquisition CPU is used to install the camera software and to archive and restore acquisition parameters and correction tables. The acquisition software is used to complete pre-programmed gantry motions for setup of imaging studies and exchange of collimators; to perform quality assurance tests on the SK YLight system; and to program image parameters and gantry for clinical studies.
When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate), SKYLight can be used to perform static, dynamic, gated, total body, circular-orbit and non-circular orbit SPECT studies, coincidence studies, gated SPECT (circular and non-circular) studies, computerprogrammed protocol strings, and reference scans (dual detectors only). SPECT and total body acquisitions are routinely acquired with two detectors. There are some planar procedures such as bone statics and lung scan also use two detectors. There are many additional nuclear medicine procedures that only use one detector at a time. These single detector procedures are typically renal, gastric emptying, hepatobiliary, flow studies, GI bleed, thyroid, and delayed static views. This acquisition sub-system interfaces with a Pegasys computer system for entry into the database. The Pegasys workstation also includes software used for image processing, database utilities, and archiving utilities.
The provided 510(k) summary for the SKYLight Imaging System (K013496) does not contain information regarding acceptance criteria or a study proving the device meets said criteria.
This document describes a modification to an existing device (SKYLight Imaging System, K000908) where the only change is to the acquisition software, allowing for simultaneous planar acquisitions on two separate patients. The submission focuses on demonstrating substantial equivalence to the predicate device due to identical intended use, indications for use, and a technological comparison that asserts mechanical and electrical components are unchanged.
Therefore, I cannot provide the requested information from the given text. The provided document is a 510(k) summary for a substantial equivalence determination, not a detailed technical report demonstrating performance against specific acceptance criteria.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. 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 II.