(132 days)
K924349, K911806A
K924349, K911806A
No
The description focuses on the physical design and function of an MRI coil for signal reception, with no mention of AI or ML for image processing or other functions.
No
The device is described as a receive-only coil for use with an MRI scanner for imaging purposes, not for treating any medical condition.
Yes
The device is a component of an MRI system, which is used to produce images for diagnostic purposes. The "Intended Use / Indications for Use" section explicitly states its use in "magnetic resonance imaging," which is a diagnostic imaging modality. The "Device Description" also mentions its purpose to "give better imaging quality," implying its role in enhancing the diagnostic utility of the MRI system.
No
The device description explicitly details a physical coil made of flexible, fabric-covered material with figure-eight shaped coils and flexible straps, indicating it is a hardware device.
No, 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 Function: The Miniflex Coil is a medical device used in magnetic resonance imaging (MRI). It is a receive-only coil that physically interacts with the patient's body to improve the quality of the MRI scan. It does not analyze samples taken from the body.
- Intended Use: The intended use is for imaging specific body parts using MRI, not for analyzing biological samples.
Therefore, based on the provided information, the Miniflex Coil is a medical device used for imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Miniflex Coil is indicated for use in magnetic resonance imaging of the elbow, wrist, ankle, foot, orbits, or other body parts where a flexible coil may be employed.
Product codes
Not Found
Device Description
The Miniflex Coil is a receive-only coil designed for use with General Electric Medical System's 1.5T SIGNA MRI Scanner. The coil is designed to give better imaging quality than would be possible with the Body Coil, by maximizing signal reception by closely conforming to the specific body part to be imaged.
The physical structure of the antenna consists of two figure-eight shaped coils in a flexible, fabric-covered material. This allows the coil to bend, making it easy to wrap around the anatomy of interest. The coil is fastened to the patient with flexible straps. All patient-contact materials are biocompatible and were chosen to maximize patient comfort. User instructions are contained in the User Manual provided with each device
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging
Anatomical Site
elbow, wrist, ankle, foot, orbits, or other body parts where a flexible coil may be employed.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K924349, K911806A
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
K961628 (Miniflex Coil) - Requested Information W.L. Gore & Associates, Inc. August 21, 1996 Confidential Information
PREMARKET NOTIFICATION SUMMARY
- Applicant: W.L. Gore & Associates, Inc. 1. 4747 Beautiful Lane, Bldg II Phoenix, AZ 85044 Phone: 602-431-0077
- Contact: Dawn Lopez, Associate Date of Preparation: August 20, 1996
-
- Applicant Device: Miniflex Coil
Common Name: MRI Surface Coil
Classification Magnetic Resonance Imaging Accessory Name:
3. Predicate Devices:
For the purposes of determining substantial equivalence cites the following as predicate devices:
| Predicate Device | Reference | Manufacturer |
|---|---|---|
| General Purpose Flex Coil | K924349 | General Electric Medical |
| System | ||
| Phased Array Torso Coil | K911806A | General Electric Medical |
| System |
ব . Applicant Device Description:
The Miniflex Coil is a receive-only coil designed for use with General Electric Medical System's 1.5T SIGNA MRI Scanner. The coil is designed to give better imaging quality than would be possible with the Body Coil, by maximizing signal reception by closely conforming to the specific body part to be imaged.
The physical structure of the antenna consists of two figure-eight shaped coils in a flexible, fabric-covered material. This allows the coil to bend, making it easy to wrap around the anatomy of interest. The coil is fastened to the patient with flexible straps. All patient-contact materials are biocompatible
1
Kib 102f
and were chosen to maximize patient comfort. User instructions are contained in the User Manual provided with each device
ട്. Intended Use:
The Miniflex Coil is indicated for use in magnetic resonance imaging of the elbow, wrist, ankle, foot, orbits, or other body parts where a flexible coil may be employed.
6. Technological Characteristics:
The table below presents some of the basic comparative characteristics of the applicant device and its cited predicate devices:
| Parameter | Applicant Device:
Miniflex Coil | Predicate Device:
General Purpose
Flex Coil | Predicate Device:
Phased Array
Torso Coil |
|--------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------|-------------------------------------------------|
| Method of Market
Entry | K961628 | K924349 | K911806A |
| Patient-Contact
Material | GORE-TEX®
Fabric | Same | Same |
| Compatible MRI
System | GE SIGNA 1.5T
MRI Scanner | Same | Same |
| Mode of
Operation | Receive Only | Same | Same |
| Method of
Decoupling | Active or passive
diode decoupling | Active diode
decoupling | Active diode
decoupling |
| Formation of
resonant loops | Length of cable is
sized to prevent
formation of
resonant loops | Same | Same |
| Potential for RF
burns | Coil does not
transmit RF -
decoupling isolates
elements from
transmitted RF | Same | Same |
| Imaging Quality | Good to Excellent,
compared to
predicate devices | N/A | N/A |