(12 days)
Not Found
Not Found
No
The summary describes an MRI coil, which is a hardware component used for signal acquisition. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on hardware characteristics like SNR and image uniformity.
No.
The device is described as an MRI coil used for imaging musculoskeletal, soft tissue, and vascular structures of the lower extremities, which is a diagnostic function, not a therapeutic one.
No
Explanation: This device is an MRI coil, which is a component used with an MRI system to acquire images. It does not perform image interpretation or diagnosis itself; it is an imaging accessory.
No
The device description explicitly states it is a "Phased Array Lower Extremity Coil," which is a hardware component used in MRI systems. The performance studies also focus on hardware-related metrics like Signal-to-Noise Ratio and Image Uniformity.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this device is a "Magnetic resonance imaging (MRI) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities." It's a coil used in an MRI system to acquire images of the body.
- No Sample Analysis: The device does not analyze any samples taken from the body. It's a component of an imaging system that interacts with the patient's body directly to generate images.
Therefore, based on the intended use and device description, this is an imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Magnetic resonance imaging (MRI) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.
Product codes
90MOS
Device Description
Model 475 8 Channel T/R Phased Array Lower Extremity Coil, compatible with GE and Siemens 1.5T and 3.0T MR Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Device
Anatomical Site
Musculoskeletal structures, soft tissue and vascular structures of the lower extremities.
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
The device was evaluated for safety parameters (Maximum Static Magnetic Field, Rate of Magnetic Field Strength Change, RF Power Deposition, Acoustic Noise Levels, Biocompatibility) and imaging performance parameters (Specification Volume, Signal-to-Noise Ratio, Image Uniformity, Geometric Distortion, Slice Thickness and Gap, High Contrast Spatial Resolution, Fast Imaging Protocol Compatible).
Key Results:
- Safety parameters: No change due to coil for Static Magnetic Field, Rate of Magnetic Field Strength Change, Acoustic Noise Levels, and Biocompatibility. RF Power Deposition was improved.
- Imaging Performance Parameters: Specification Volume of 15-16 cm typical FOV all planes. 3 Times Improvement over predicate device in peripheral regions for Signal-to-Noise Ratio. No change for Image Uniformity, Geometric Distortion, Slice Thickness and Gap, and High Contrast Spatial Resolution. Compatible with Fast Imaging Protocol.
Key Metrics
Signal-to-Noise Ratio: 3 Times Improvement over predicate device in peripheral regions
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
MAR 2 2 2004
510(k) Summary of Safety and Effectiveness
| Device Name | Model 475 8 Channel T/R Phased Array Lower
Extremity Coil | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Applicability | Compatible with GE and Siemens 1.5T and 3.0T
MR Systems | |
| Reason for 510(k) | New device | |
| Classification Name | Magnetic Resonance Diagnostic Device | |
| Device Classification Panel | Radiology | |
| Device Classification Number | 892.1000 | |
| Product Code | 90MOS | |
| Common Name | Magnetic Resonance Imaging Coil | |
| Proprietary Name | Model 475 8 Channel T/R Phased Array Lower
Extremity Coil | |
| Establishment Registration Number | 2183683 | |
| Address of MFG Facility | IGC-Medical Advances Inc.
10437 Innovation Drive
Milwaukee, WI 53226 | |
| Point of Contact | Anthony Dietzler
Quality Assurance Engineer
(414) 258-3808 Ext. 255 | |
| 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 | Musculoskeletal structures, soft tissue and vascular
structures of the lower extremities. | |
| Performance Standards | None Established under Section 514 | |
| Voluntary Safety Standards | UL 2601-1 | Medical Electrical Equipment, Part I
General Requirements for Safety |
| | UL 94 | Tests for Flammability of Plastic
Materials |
| | IEC 601-1 | General Safety Requirements for
Medical Electrical Equipment |
:
1
Standards
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 (CDRH) released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. Due to considerable technological advances in MRDDs, CDRH issued an updated guidance document on November 14, 1998. The following is a summary of the information contained within this premarket notification that addresses these concerns:
The GE and Siemens 1.5T and 3.0T MRI systems, operated with the Medical Advances 8 Channel T/R Phased Array Lower Extremity Coil, are substantially equivalent to the GE Signa 1.5T system operated with the legally marketed predicate devices listed in scction 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 due to coil |
|---|---|
| Rate of Magnetic Field Strength Change: | No change due to coil |
| RF Power Deposition: | Improved |
| Acoustic Noise Levels: | No change due to coil |
| Biocompatibility: | No change |
2
Imaging Performance Parameters
| Specification Volume: | 15-16 cm typical FOV all planes
(submitted device) vs. 15-20 cm
typical FOV all planes (predicate
device) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Signal-to-Noise Ratio: | 3 Times Improvement over predicate
device in peripheral regions |
| Image Uniformity: | No change |
| Geometric Distortion: | No change |
| Slice Thickness and Gap: | No change |
| High Contrast Spatial Resolution: | No change |
| Fast Imaging Protocol Compatible: | Yes |
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 and Siemens 1.5T and 3.0T MRI systems operated with the Medical Advances 8 Channel T/R Phased Array Lower Extremity Coils addressed in this Pre-Market Notification, have the same intended use and technological characteristics as the GE Signa 1.5T system operated with the identified legally marketed predicate device. The use of these coils does not affect the GE or Siemens 1.5T and 3.0T system safety parameter specifications.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle-like emblem with three stylized lines representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2004
IGC-Medical Advances, Inc. % Mr. Daniel W. Lehtonen Staff Engineer-Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K040640
Trade/Device Name: Model 475: 8 Channel T/R Phased Array Lower Extremity Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: March 4, 2004 Received: March 10, 2004
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), 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 II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Bugden
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page ੀ 1
510(k) Number (if known): K C 4 0640
Model 475: 8 Channel T/R Phased Array Lower Extremity Coil Device Name:
Indications for Use:
Magnetic resonance imaging (MRI) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number .