(119 days)
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No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-driven devices.
No
This device is intended for diagnostic brain imaging, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This device is intended to be used for diagnostic brain imaging." Additionally, the "Summary of Performance Studies" mentions, "Clinical tests have shown that the Xenon option is effective in diagnosing brain anomalies."
No
The device description explicitly states it includes hardware components such as a gamma camera system, xenon delivery system, xenon probe, and system interface, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "diagnostic brain imaging." This describes an in vivo (within the living body) diagnostic procedure, not an in vitro (outside the living body) test.
- Device Description: The device is a modification of a gamma camera system, which is used to detect radiation emitted from a radioactive tracer administered to the patient. This is a core component of in vivo nuclear medicine imaging. The xenon delivery system and xenon probe are also used in conjunction with the patient.
- Anatomical Site: The anatomical site is the brain, which is within the living body.
- Input Imaging Modality: Gamma camera imaging is an in vivo imaging technique.
IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the body to diagnose diseases or conditions. This device directly images the brain within the patient.
N/A
Intended Use / Indications for Use
"This device is intended to be used for diagnostic brain imaging."
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
"This device includes a gamma camera system, xenon delivery system, xenon probe, system interface, and the necessary software."
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Gamma camera system
Anatomical Site
Brain
Indicated Patient Age Range
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Intended User / Care Setting
"The Xenon option will be operated by trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations."
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"Clinical tests have shown that the Xenon option is effective in diagnosing brain anomalies. The product will perform in accordance with the development specifications."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
MAR 2 9 1996 PICKER INTERNATIONAL 510(k) NOTICE XENON OPTION TO THE PRISM 3000 SYSTEM E: SUMMAR'1 OF SAFETY AND EFFECTIVENESS
This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (DRAERD) of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 807.92(c) for the Xenon Option.
The Xenon Option to the Prism 3000 system is a modification of a gamma camera system. This device is intended to be used for diagnostic brain imaging. There is no change of intended use from that of the predicate device. This device includes a gamma camera system, xenon delivery system, xenon probe, system interface, and the necessary software.
Functional specifications and operator's instructions (preliminary) are included in the attachments. Final documentation will be provided with productions units.
The Xenon option to the Prism 3000 system is substantially equivalent to legally marketed devices. The Xenon option will be operated by trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations. The Xenon option will be certified to electrical safety standards (IEC-601) by a third party organization prior to use on human patients. Labeling (Product Bulletin and Operator's Manual) will be provided to the user of the equipment.
Clinical tests have shown that the Xenon option is effective in diagnosing brain anomalies. The product will perform in accordance with the development specifications. A matrix was enclosed comparing the Xenon option to a predicate device and therefore we concluded that it is substantially equivalent to that legally marketed predicate device.
Picker has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the Xenon option. In addition, all information contained in this 510(k) Notice is accurate and complete.