(240 days)
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No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML in medical imaging (e.g., training/test sets, AUC, standalone performance of an algorithm). The improvements mentioned are attributed to hardware and software modifications resulting in improved image quality and sensitivity, which is common in traditional imaging system upgrades.
No
The device is described as being used for "diagnostic imaging of organs and lesions" and is a "modification of a gamma camera system," which are functions of a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states, "This device is intended to be used for diagnostic imaging of organs and lesions."
No
The device description explicitly states that it includes adding hardware and software to a gamma camera system, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "diagnostic imaging of organs and lesions." This describes an in vivo (within a living organism) diagnostic procedure, not an in vitro (outside of a living organism, typically in a lab) diagnostic test.
- Device Description: It's a modification of a "gamma camera system," which is used for nuclear medicine imaging, an in vivo technique.
- Input Imaging Modality: "gamma camera system" confirms it's an imaging device used on a patient.
- Anatomical Site: "organs and lesions" refers to structures within the body.
IVD devices typically involve testing samples (like blood, urine, tissue) outside of the body to diagnose conditions. This device is clearly used for imaging the body directly.
N/A
Intended Use / Indications for Use
"This device is intended to be used for diagnostic imaging of organs and lesions."
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
"The PCD Option to the Prism Dual Head system is a modification of a gamma camera system. This device includes adding hardware and software to a gamma camera system."
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
"gamma camera system"
Anatomical Site
"organs and lesions"
Indicated Patient Age Range
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Intended User / Care Setting
"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)
"Laboratory tests have shown that the PCD option has improved image quality and sensitivity compared to a standard gamma camera. The product will perform in accordance with the development specifications. A matrix was enclosed comparing the PCD option to a predicate device and therefore we concluded that it is substantially equivalent to that legally marketed predicate device."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
"improved image quality and sensitivity"
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
Image /page/0/Picture/0 description: The image shows the text "SEP 12" followed by a solid black rectangle and the text "K960192". The text is in bold, black font and is slightly blurred. The "SEP 12" text is smaller than the "K960192" text.
PICKER INTERNATIONAL 510(k) NOTICE
PCD OPTION TO THE PRISM DUAL HEAD SYSTEM
E: SUMMARY 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 Positron Coincidence Option (PCD).
The PCD Option to the Prism Dual Head system is a modification of a gamma camera system. This device is intended to be used for diagnostic imaging of organs and lesions. There is no change of intended use from that of the predicate device. This device includes adding hardware and software to a gamma camera system.
Functional specifications and operator's instructions (preliminary) are included in the attachments. Final documentation will be provided with productions units.
The PCD option to the Prism Dual Head system is substantially equivalent to legally marketed devices. The PCD option will be operated by trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations. The PCD 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.
Laboratory tests have shown that the PCD option has improved image quality and sensitivity compared to a standard gamma camera. The product will perform in accordance with the development specifications. A matrix was enclosed comparing the PCD 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 PCD option. In addition, all information contained in this 510(k) Notice is accurate and complete.