LINEAR SHOULDER COIL, MODEL 414GE-09

K991115 · Medical Advances, Inc. · MOS · Jun 8, 1999 · Radiology

Device Facts

• Record ID: K991115
• Device Name: LINEAR SHOULDER COIL, MODEL 414GE-09
• Applicant: Medical Advances, Inc.
• Product Code: MOS · Radiology
• Decision Date: Jun 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Magnetic resonance imaging (MRI) of the shoulder joint and surrounding tissue.

Device Story

Model 414GE-09 Linear Shoulder Coil is an accessory for the GE Signa Profile 0.2T MRI system. It functions as a radiofrequency (RF) coil to capture magnetic resonance signals from the shoulder joint and related structures. The coil is used in clinical settings by trained MRI technologists to facilitate 2D/3D imaging, including proton density, T1/T2 weighted, time-of-flight, and phase contrast sequences. The output is processed by the host MRI system to generate diagnostic images for physician review. The device does not alter the system's safety parameters (static magnetic field, RF power, acoustic noise) or imaging performance metrics (SNR, uniformity, resolution). It benefits patients by enabling high-quality diagnostic imaging of the shoulder joint.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of safety and imaging performance parameters against the host MRI system's established specifications.

Technological Characteristics

Linear RF coil for 0.2T MRI. Materials include plastic (UL 94 flammability rated). Complies with UL 2601-1 and IEC 601-1 safety standards. Passive hardware component; no internal software or active processing algorithms. Designed for integration with GE Signa Profile 0.2T systems.

Indications for Use

Indicated for patients requiring magnetic resonance imaging of the shoulder joint and surrounding tissue.

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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K991115

# JUN = 8 1999

## 510(k) Summary of Safety and Effectiveness

| Device Name | Model 414GE-09 Linear Shoulder Coil |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Applicability | Compatible with GE Signa Profile 0.2 T 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 414GE-09 Linear Shoulder Coil |
| Establishment Registration Number | 2183683 |
| Address of MFG Facility | IGC 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<br>weighted imaging. 2D, 3D time of flight, phase<br>contrast imaging. |
| Anatomic Regions | Shoulder and other related joint structures. |

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#### Standards

| Performance Standards | | None Established under Section 514 | |
|----------------------------|-----------|-----------------------------------------------------------------------------|--|
| Voluntary Safety Standards | UL 2601-1 | Medical Electrical Equipment,<br>Part 1: General Requirements for<br>Safety | |
| | UL 94 | Tests for Flammability of Plastic<br>Materials | |
| | IEC 601-1 | General Safety Requirements for<br>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 0.2T MRI system operated with the Medical Advances Linear Shoulder 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 GE Signa Profile 0.2T MRI system operated with the Medical Advances Linear Shoulder 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.

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Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

DEPARTMENT OF HEALTH & HUM

JUN

Medical Advances, Inc.

10437 Innovation Drive

Milwaukee, Wisconsin 53226

Thomas E. Tynes Vice President, Operations

RE:

K991115 Model 414GE-09 Linear Shoulder Coil 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 reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic 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 II (Special Controls) or 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 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/cdrh/dsmaldsmamain.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 ______________________

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Model 414GE Series: Linear Shoulder Coil

Indications for Use:

Magnetic resonance imaging (MRI) of the shoulder joint and surrounding tissue.

(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 | K991115 | |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |