QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D

K982496 · Medical Advances, Inc. · MOS · Sep 18, 1998 · Radiology

Device Facts

• Record ID: K982496
• Device Name: QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D
• Applicant: Medical Advances, Inc.
• Product Code: MOS · Radiology
• Decision Date: Sep 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.

Device Story

Model 473SI-42D Quadrature Lower Extremity Coil is an accessory for Siemens 1.0T Magnetom Impact MRI systems. Device functions as a radiofrequency (RF) coil to receive signals during MRI/MRA procedures. Used in clinical settings by trained MRI technologists/radiologists. Coil captures anatomical data from lower extremities, transforming signals into images for diagnostic assessment of musculoskeletal, soft tissue, and vascular structures. Does not alter system safety parameters (static magnetic field, RF power, acoustic noise) or imaging performance (SNR, uniformity, resolution) compared to predicate. Benefits include high-quality diagnostic imaging of lower extremity anatomy.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of safety and imaging performance parameters against the predicate system.

Technological Characteristics

Quadrature RF coil for 1.0T MRI. Materials: plastic (UL 94 flammability rated). Safety standards: UL 544, IEC 601-1. Passive hardware component; no software or active electronics requiring external power beyond system interface. Form factor designed for lower extremity imaging.

Indications for Use

Indicated for patients requiring MRI or MRA imaging of musculoskeletal, soft tissue, and vascular structures of the lower extremities. Prescription use only.

Regulatory Classification

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).

Special Controls

*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.

Submission Summary (Full Text)

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K982496

# 510(k) Summary of Safety and Effectiveness

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| Device Name | Model 473SI-42D Quadrature Lower Extremity Coil | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Applicability | Compatible with Siemens 1.0T Magnetom Impact MRI<br>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.<br>10437 Innovation Drive<br>Milwaukee, WI 53226 | |
| Point of Contact | Thomas E. Tynes<br>Vice President - Operations<br>[phone] Ext. 407 | |
| Classification | Class II | |
| Intended Uses | | |
| Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2 weighted<br>imaging. 2D, 3D time of flight, phase contrast<br>imaging. | |
| Anatomic Regions | Musculoskeletal structures, soft tissue and vascular<br>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<br>Materials |
| | IEC 601-1 | General Safety Requirements for<br>Medical Electrical Equipment |

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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 |

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# 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)