(70 days)
Not Found
Not Found
No
The summary describes a passive MRI coil, which is a hardware component and does not inherently incorporate AI/ML for image processing or analysis. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is an MRI coil, which is used for imaging and diagnosis, not for treating a condition.
No
The device is described as a Magnetic Resonance Imaging (MRI) coil used for imaging musculoskeletal structures. Its intended use is to acquire images, not to diagnose. Diagnosis would typically be made by a clinician interpreting the images generated using this device.
No
The device description explicitly states it is a "Linear Wrist Coil," which is a hardware component used in MRI systems.
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 Function: The description clearly states the device is a "Magnetic Resonance Imaging (MRI) Coil" used for "Magnetic resonance imaging (MRI) of the musculoskeletal structures and soft tissue of the Wrist and surrounding joints."
- Modality: 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.
Therefore, this device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Magnetic resonance imaging (MRI) of the musculoskeletal structures and soft tissue of the Wrist and surrounding joints.
Product codes (comma separated list FDA assigned to the subject device)
90LNH, 90MOS
Device Description
Model 414GE-09 Linear Wrist Coil
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Wrist and other related joint structures., musculoskeletal structures and soft tissue of the Wrist and surrounding joints.
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)
The GE Signa Profile 0.2 T MRI system operated with the Medical Advances Linear Wrist 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: Maximum Static Magnetic Field: No change, Rate of Magnetic Field Strength Change: No change, RF Power Deposition: No change, Acoustic Noise Levels: No change, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
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.
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JUN 1 0 1999
510(k) Summary of Safety and Effectiveness
| Device Name | Model 414GE-09 Linear Wrist Coil |
|---|---|
| Applicability | Compatible with GE Signa Profile 0.2 T MRI |
| Systems | |
| 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 440GE-09 Linear Wrist Coil |
| Establishment Registration Number | 2183683 |
| Address of MFG Facility | IGC 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 |
| Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2 |
| weighted imaging. 2D, 3D time of flight, phase | |
| contrast imaging. | |
| Anatomic Regions | Wrist and other related joint structures. |
1
Standards
| Performance Standards | None Established under Section 514 | ||
|---|---|---|---|
| Voluntary Safety Standards | UL 2601-1 | Medical Electrical Equipment, | |
| Part 1: General Requirements for | |||
| Safety | |||
| UL 94 | Tests for Flammability of Plastic | ||
| Materials | |||
| IEC 601-1 | General Safety Requirements for | ||
| Medical Electrical Equipment |
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 Signa Profile 0.2 T MRI system operated with the Medical Advances Linear Wrist 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 Signa Profile 0.2 T MRI system operated with the Medical Advances Linear Wrist 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 Profile 0.2T system safety parameter specifications.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 10 1999
Thomas E. Tynes Vice President, Operations Medical Advances, Inc. 10437 Innovation Drive Milwaukee, Wisconsin 53226 Re:
K991113 Linear Wrist Coil Model: 440GE Dated: March 25, 1999 Received: April 1, 1999 Regulatory Class: II 21 CFR 892.1000/procode: 90 MOS
Dear Mr. Tynes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also. please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page ___ 1___ of ___ 1________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: _ _ _ _ Model 440GE Series: Linear Wrist Coil
Indications for Use:
Magnetic resonance imaging (MRI) of the musculoskeletal structures and soft tissue of the Wrist and surrounding joints.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | ||
| 510(k) Number | K991113 | |
| Prescription Use (Per 21 CFR 801.109) ✓ | OR | Over-The-Counter Use ______ |
(Optional Format 1-2-96)