(89 days)
2D, 3D imaging, proton density, T1 and T2 weighted imaging. 2D, 3D time of flight, phase contrast imaging.
Model 675GE-64 Peripheral Vascular Coil consisting of Model 665GE-64 Lower Extremity Flexible Array and Model 538GE-64 Medium General Purpose Flex Coil. Compatible with GE Signa 1.5T MRI systems with Phased Array option.
This document is a 510(k) summary for a medical device (a Peripheral Vascular Coil for MRI systems) and does not include information about AI/ML device performance or a study design to meet specific acceptance criteria in the way a modern AI/ML submission would.
Therefore, I cannot extract the requested information points as they pertain to AI/ML device performance and testing. This document focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness in the context of hardware (an MRI coil), not software/AI performance for diagnostic tasks.
Here's why the requested information cannot be found:
- No AI/ML Component: The device described is a physical MRI coil. There is no mention of algorithms, artificial intelligence, machine learning, or any software that performs diagnostic analysis.
- Focus on Substantial Equivalence (Hardware): The entire summary is dedicated to proving that this new coil is "substantially equivalent" to an existing, legally marketed predicate device. This means it has the same intended use and technological characteristics without changing the safety or imaging performance parameters of the MRI system it connects to.
- "Acceptance Criteria" are for Safety Parameters: The "acceptance criteria" you might infer from this document are related to maintaining the safety parameters (e.g., maximum static magnetic field, RF power deposition) and imaging parameters (e.g., signal-to-noise ratio, image uniformity) of the existing MRI system when this new coil is attached. It's about ensuring the new coil doesn't degrade or alter the established performance of the MRI system itself, not about the coil achieving a specific diagnostic performance metric.
- No Diagnostic Performance Study: Since the coil doesn't perform diagnostic interpretation, there's no study to evaluate its diagnostic accuracy, sensitivity, specificity, or reader improvement.
If you have a document related to an AI/ML medical device, I would be happy to try and extract that information.
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FEB 26 1997
510(k) Summary of Safety and Effectiveness K96481 3
"
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| Device Name | Model 675GE-64 Peripheral Vascular Coil consistingof Model 665GE-64 Lower Extremity Flexible Arrayand Model 538GE-64 Medium General Purpose FlexCoil |
|---|---|
| Applicability | Compatible with GE Signa 1.5T MRI systems withPhased Array option |
| Reason for 510(k) | New device |
| Classification Name | Magnetic Resonance Diagnostic Device |
| Device Classification Panel | Radiology |
| Device Classification Number | 892.1000 |
| Product Code | 90LNH |
| Common Name | Magnetic Resonance Imaging Coil |
| Proprietary Name | Model 675GE-64 Peripheral Vascular Coil consistingof Model 665GE-64 Lower Extremity Flexible Arrayand Model 538GE-64 Medium General Purpose FlexCoil |
| Establishment Registration Number | 2183683 |
| Address of MFG Facility | Medical Advances, Inc.10437 Innovation DriveMilwaukee, WI 53226 |
| Point of Contact | Thomas E. TynesVice President - Operations(414) 258-3808 Ext. 407 |
| Classification | Class II |
| Intended Uses | |
| Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2 weightedimaging. 2D, 3D time of flight, phase contrastimaging. |
| Anatomic Regions | Vascular structures, soft tissue and musculosketealstructures in the lower extremities(mid-abdomen to mid-foot) |
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Standards
| Performance Standards | None Established under Section 514 | |
|---|---|---|
| Voluntary Safety Standards | UL 544 | Medical and Dental Equipment |
| UL 94 | Tests for Flammability of PlasticMaterials | |
| IEC 601-1 | General Safety Requirements forMedical Electrical Equipment | |
| CPAI-84 | Specification for Flame ResistantMaterial Used in Camping Tentage |
Overview
The Radiology Devices Panel considered potential concerns regarding the safe and effective operation of Magnetic Resonance Diagnostic Devices when they recommended reclassification to Class II on July 27, 1987. After reclassification, the FDA's Center for Devices and Radiological Health released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. The following is a summary of the information contained within this premarket notification that addresses these concerns:
The GE 1.5T Signa MRI system operated with the Medical Advances Peripheral Vascular Coil is substantially equivalent to the same system operated with the legally marketed predicate device listed in section 4.0, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels:
Safety Parameters
| Maximum Static Magnetic Field: | No change |
|---|---|
| Rate of Magnetic Field Strength Change: | No change |
| RF Power Deposition: | No change |
| Acoustic Noise Levels: | No change |
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Imaging Performance Parameters
| Specification Volume: | No change |
|---|---|
| Signal-to-Noise Ratio: | No change |
| Image Uniformity: | No change |
| Geometric Distortion: | No change |
| Slice Thickness and Gap: | No change |
| High Contrast Spatial Resolution: | No change |
General Safety and Effectiveness Concerns
The device contains instructions for use. It includes indications for use, precautions, cautions, contraindications, warnings and quality assurance testing. This information assures safe and effective use of the device.
Substantial Equivalence Summary
The GE 1.5T Signa MRI system operated with the Medical Advances Peripheral Vascular Coil addressed in this PMN, has the same intended use and technological characteristics as the same system operated with the identified legally marketed predicate device. The use of this coil does not affect the GE Signa system safety parameter specifications.
§ 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.