(19 days)
The GE Discovery ST System with the alternate detector option is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
The Discovery ST with alternate detector option is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.
The Discovery ST with alternate detector option can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
The Discovery ST PET/CT Imaging System an with alternate detector option integrates a GE Positron Emission Tomography system and a GE LightSpeed CT System. In addition to providing CT and PET stand-alone capabilities, it uses the CT images to correct for non-uniform attenuation of the PET images and to facilitate localization of the emission activity in the patient anatomy.
The provided submission does not include any acceptance criteria or a study that proves the device meets specific acceptance criteria in the traditional sense of a clinical performance study. This is a 510(k) submission for a Special 510(k) for the Discovery ST PET/CT Imaging System with an alternate detector option.
Here's why the requested information is absent:
- Type of Submission: A Special 510(k) is used when a device modification does not affect the device's fundamental scientific technology or its intended use, and the modification does not raise new questions of safety and effectiveness.
- "Clinical Tests: None required.": The document explicitly states "Clinical Tests: None required." This indicates that no new human clinical studies were performed to demonstrate performance against specific acceptance criteria because the device modification was considered minor and substantially equivalent to a predicate device already on the market (K010641).
- Focus on Substantial Equivalence: The entire submission focuses on demonstrating substantial equivalence to the predicate device (GE Discovery ST PET/CT System, K010641) both in terms of technological characteristics and safety/effectiveness features. The rationale is that if it's substantially equivalent to a device already cleared, it doesn't need new clinical data.
- Safety and Performance Evaluation: The evaluation appears to have focused on electrical and radiation safety, conformity with applicable medical device safety standards, and compliance with quality systems (21 CFR 820, ISO 9001, ISO 13485).
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details because such information is not present in the provided text. The document clearly states that clinical tests were not required, and the basis for clearance was substantial equivalence, not performance against new quantitative acceptance criteria established via a clinical study.
§ 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.