(89 days)
Not Found
Not Found
No
The summary describes a passive MRI coil and does not mention any software or processing capabilities that would suggest the use of AI/ML.
No
The device is described as a "Peripheral Vascular Coil" for "Magnetic Resonance Imaging," which are tools for diagnostic imaging, not for treatment or therapy. Its intended use focuses on "2D, 3D imaging" of anatomical structures.
Yes
The device is a peripheral vascular coil for MRI systems, which are used for imaging vascular, soft tissue, and musculoskeletal structures. Imaging is a fundamental component of diagnostic procedures, allowing clinicians to visualize internal body structures to identify abnormalities or diseases. While this specific device is a component of an imaging system, its intended use for producing images for proton density, T1 and T2 weighted imaging, and time of flight/phase contrast imaging directly supports diagnostic evaluations.
No
The device description explicitly states it is a "Peripheral Vascular Coil consisting of Model 665GE-64 Lower Extremity Flexible Array and Model 538GE-64 Medium General Purpose Flex Coil," which are hardware components used in Magnetic Resonance Imaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states this is a "Peripheral Vascular Coil" for use with an "MRI system." MRI is an imaging modality that uses magnetic fields and radio waves to create images of the inside of the body. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes imaging of anatomical structures within the body (vascular structures, soft tissue, musculoskeletal structures). This is consistent with an imaging device, not an IVD.
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
Intended Uses: 2D, 3D imaging, proton density, T1 and T2 weighted imaging. 2D, 3D time of flight, phase contrast imaging. Anatomic Regions: Vascular structures, soft tissue and musculosketeal structures in the lower extremities (mid-abdomen to mid-foot)
Product codes
90LNH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Vascular structures, soft tissue and musculosketeal structures in the lower extremities (mid-abdomen to mid-foot)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
FEB 26 1997
510(k) Summary of Safety and Effectiveness K96481 3
"
.
| Device Name | Model 675GE-64 Peripheral Vascular Coil consisting
of Model 665GE-64 Lower Extremity Flexible Array
and Model 538GE-64 Medium General Purpose Flex
Coil |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicability | Compatible with GE Signa 1.5T MRI systems with
Phased 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 consisting
of Model 665GE-64 Lower Extremity Flexible Array
and Model 538GE-64 Medium General Purpose Flex
Coil |
| Establishment Registration Number | 2183683 |
| Address of MFG Facility | Medical Advances, Inc.
10437 Innovation Drive
Milwaukee, WI 53226 |
| Point of Contact | Thomas E. Tynes
Vice President - Operations
(414) 258-3808 Ext. 407 |
| Classification | Class II |
| Intended Uses | |
| Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2 weighted
imaging. 2D, 3D time of flight, phase contrast
imaging. |
| Anatomic Regions | Vascular structures, soft tissue and musculosketeal
structures in the lower extremities
(mid-abdomen to mid-foot) |
1
Standards
| Performance Standards | None Established under Section 514 | |
|---|---|---|
| Voluntary Safety Standards | UL 544 | Medical and Dental Equipment |
| UL 94 | Tests for Flammability of Plastic | |
| Materials | ||
| IEC 601-1 | General Safety Requirements for | |
| Medical Electrical Equipment | ||
| CPAI-84 | Specification for Flame Resistant | |
| Material 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 |
2
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.