(89 days)
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No
The description focuses on triggering based on contrast agent arrival, a standard imaging technique, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device triggers image acquisition based on a contrast agent and does not provide therapy.
No
Explanation: The device describes an imaging technique for triggering scan acquisition based on contrast agent arrival, which is a method of image acquisition control rather than a diagnostic function that interprets images or patient data to identify diseases or conditions.
No
The device description and performance studies indicate it is an optional imaging technique integrated into an MR system, which is a hardware device. The evaluation against IEC 601-2-33, a standard for Magnetic Resonance Systems, further supports this.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states that this device is an "optional imaging technique" for an MR system that triggers scans based on the arrival of a contrast agent within the patient's body. It's a diagnostic imaging tool, not a tool for analyzing samples taken from the body.
- The intended use is related to imaging procedures. The description focuses on enabling breath hold studies and triggered acquisition during MR scans, which are in vivo (within the living body) procedures.
- There is no mention of analyzing biological samples. The description does not mention blood, urine, tissue, or any other type of biological specimen being analyzed by this device.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SmartPreo IA option enables breath hold studies and trigger acquisition based on timing related to the arrival of a user injected exogenous contrast agent bolus.
Product codes
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Device Description
The SmartPrep IA Option is an optional imaging technique that results in a scan acquisition being triggered off of the arrival of a user injected bolus of contrast agent at a prescribed volume of interest.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
The SmartPrep IA Option was evaluated to the IEC 601-2-33 International medical equipment safety standard for Magnetic Resonance Systems. Evaluation testing confirmed the functionality of the software.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image is a black and white close-up of what appears to be a seal or emblem. The emblem is circular and has a complex design in the center, featuring curved lines and shapes that resemble stylized letters or symbols. The outer edge of the emblem is partially obscured, giving it a worn or incomplete appearance.
NOV 27 1996
GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
- This 510(k) summary of safety and effectiveness information is submitted in accordance o with the requirements of 21 CFR Part 807.87(h).
- o ldentification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, August 16, 1996
- 0 Identification of the Product SmartPrep IA
Manufactured by:
GE Medical Systems 3200 N. Grandview Blvd. Waukesha, Wi 53188
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o Marketed Device
The SmartPreo IA Option is a modification to the currently marketed Signa Horizon MR Systems. -
o Device Description
The SmartPrep IA Option is an optional imaging technique that results in a scan acquisition being triggered off of the arrival of a user injected bolus of contrast agent at a prescribed volume of interest.
o Indications for Use
SmartPreo IA option enables breath hold studies and trigger acquisition based on timing related to the arrival of a user injected exogenous contrast agent bolus.
o Comparison with Predicate
The SmartPrep IA Option is substantially equivalent to the currently marketed Signa Horizon HiSpeed MR System. The Fast Gradient Echo pulse sequence is modified by the insertion of an Infusion Advisor scan.
0 Summary of Studies
The SmartPrep IA Option was evaluated to the IEC 601-2-33 International medical equipment safety standard for Magnetic Resonance Systems. Evaluation testing confirmed the functionality of the software.
- 0 Conclusions
It is the opinion of GE that the SmartPrep IA Option is substantially equivalent to the currently marketed Signa Horizon Fast Gradient Echo pulse sequence. The option does not result in any new potential hazards.