(3 days)
To detect and image the distribution of high-energy photons from an administered positron-emitting radioactive agent (radionuclides) in the human body, specifically cardiac imaging. The Ultra-High Energy General Purpose Collimator (UHGP) will be used on the dual detector Forte Gamma Camera (K982911) and on the dual detector Vertex Gamma Camera (K922080).
The Ultra-High Energy General Purpose Collimator (UHGP) is an optional device for the Forte™ and Vertex™ gamma camera systems, similar to conventional low energy collimators. It was developed to collimate the gamma rays emitted perpendicularly from a patient to a gamma ray detector, so that a proper image can be formed. This design concept is essentially the same as other conventional lower energy collimators used in Nuclear Medicine clinics, except that the current device is intended for ultra-high energy (511 keV) radiopharmaceuticals. Hence, the focus of the design elements are 1) proper hole size and thickness to provide proper spatial resolution and sensitivity for clinical use and 2) a proper mechanical mechanism to ensure safety. The UHGP collimator consists of three major components: the collimation core, collimator frame, and collimator cover. The weight of this collimator is 300 pounds. The collimator core is made of lead. The hole size, the septal length, and septal thickness are 2.7, 60 and 2.3 mm, respectively. The collimator frame is used to support the core and connect to the detector buckets. For the Forte and Vertex systems, the frame and core size are the same as shown by the specification for the imaging Field of View (FOV). The collimator cover is used to prevent direct patient contact with the lead core. More importantly, it has a collision sensor to prevent any unexpected detector motion resulting in collimator contact with patient, including un-intended detector radius move-in by operators.
The provided text describes the acceptance criteria and the study for the Ultra-High Energy General Purpose Collimator (UHGP).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the UHGP collimator are primarily its performance characteristics in comparison to a predicate device (Picker UHE collimator) and NEMA NU1 standards. The critical performance metrics are resolution and sensitivity.
| Specification | Acceptance Criteria (Predicate Device K963406) | Reported Device Performance (UHGP Collimator) |
|---|---|---|
| Intrinsic Resolution | 3.9 | ≤3.5 |
| Planar Resolution (0 cm) | 7.01 mm | ≤6.0 mm |
| Planar Resolution (5 cm) | 10.65 mm | ≤8.0 mm |
| Planar Resolution (10 cm) | 14.53 mm | ≤10.0 mm |
| Planar Resolution (15 cm) | 18.50 mm | ≤14.5 mm |
| Planar Resolution (20 cm) | 22.51 mm | ≤17.0 mm |
| Sensitivity (511keV) | 435 cpm/μCi |
§ 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.