(63 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and imaging performance of an MRI coil, with no mention of AI or ML algorithms for image processing or analysis.
No.
The device is an MRI coil, which is a diagnostic tool used for imaging, not for treating a condition. Its purpose is to assist in diagnosis by acquiring images.
Yes
The device is described as an MRI coil and the summary of performance studies explicitly states, "within the Class II definition of Magnetic Resonance Diagnostic Device."
No
The device is described as a "Quadrature Lower Extremity Coil," which is a hardware component used in MRI systems. The description focuses on its compatibility with a specific MRI system and its performance in imaging, not on software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states the device is a "Magnetic Resonance Imaging Coil" used for "Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities."
- Mechanism of Action: MRI coils are components of an MRI system that generate and receive radiofrequency signals to create images of the inside of the body. They do not analyze biological specimens.
- Intended Use: The intended use is to produce images of the lower extremities, not to analyze samples taken from the body.
The device is a component of an in vivo diagnostic imaging system (MRI), which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.
Product codes
90LNH
Device Description
Model 473SI-42D Quadrature Lower Extremity Coil compatible with Siemens 1.0T Magnetom Impact MRI systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Siemens 1.0T Magnetom Impact MRI system operated with the Medical Advances Quadrature Lower Extremity 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
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
)
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510(k) Summary of Safety and Effectiveness
1
| Device Name | Model 473SI-42D Quadrature Lower Extremity Coil | |
|---|---|---|
| Applicability | Compatible with Siemens 1.0T Magnetom Impact 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 473SI-42D Quadrature Lower Extremity 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 | Musculoskeletal structures, soft tissue and vascular | |
| structures of the lower extremities | ||
| 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 |
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 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 Siemens 1.0T Magnetom Impact MRI system operated with the Medical Advances Quadrature Lower Extremity 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 Siemens 1.0T Magnetom Impact MRI system operated with the Medical Advances Quadrature Lower Extremity 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 Siemens Magnetom Impact system safety parameter specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. Inside the circle is a stylized image of an eagle. The eagle is drawn with simple, curved lines, giving it a modern and abstract appearance. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 1998
Thomas E. Tynes Vice President - Operations Medical Advances, Inc. 10437 Innovation Drive Milwaukee, WI 53226
Re:
K982496 Model 473SI - 42D Quadrature Lower Extremity Coil Dated: July 14, 1998 Received: July 17, 1998 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 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). 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 vou might have under sections 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 vitro 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.gov/cdch/dsmadsmam.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health …
Enclosure
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ___ Model 473SI Series: Quadrature Lower Extremity Coil
Indications for Use:
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) 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)
Elind h. Segmon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use ______
(Optional Format 1-2-96)