MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY

K983109 · Medical Advances, Inc. · MOS · Oct 6, 1998 · Radiology

Device Facts

• Record ID: K983109
• Device Name: MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY
• Applicant: Medical Advances, Inc.
• Product Code: MOS · Radiology
• Decision Date: Oct 6, 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 bones, soft tissue, musculoskeletal structures and vascular structures of the upper and lower extremities.

Device Story

The Model 545GE-64 Phased Array Musculoskeletal Flex Coil Package consists of two flexible MRI coils (Model 543GE-64 for upper extremities and Model 544GE-64 for lower extremities). Designed for use with GE Signa 1.5T MRI systems, these coils function as signal receivers to capture magnetic resonance data from anatomical structures. The device is operated by trained radiology personnel in a clinical setting. The coils transform received RF signals into image data, which are processed by the host MRI system to produce 2D/3D images, including proton density, T1/T2 weighted, time-of-flight, and phase contrast imaging. The output is displayed for physician review to assist in the diagnosis of musculoskeletal and vascular conditions. The flexible design allows for improved positioning around extremities, potentially enhancing image quality and diagnostic utility compared to rigid coils.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Phased array MRI coil package; flexible form factor. Materials: plastic (UL 94 compliant). Safety standards: UL 544, IEC 601-1, CPAI-84. Connectivity: compatible with GE Signa 1.5T MRI systems. Non-invasive, passive signal reception.

Indications for Use

Indicated for MRI and MRA of bones, soft tissue, musculoskeletal, and vascular structures of upper and lower extremities.

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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K983/09

## 510(k) Summary of Safety and Effectiveness

| Labels | Values |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Model 545GE-64 Phased Array Musculoskeletal Flex Coil Package consisting of Model 543GE-64 Phased Array Upper Extremity Flex Coil and Model 544GE-64 Phased Array Lower Extremity Flex Coil |
| Applicability | Compatible with GE Signa 1.5T MRI systems with Phased Array option |
| 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 545GE-64 Phased Array Musculoskeletal Flex Coil Package consisting of Model 543GE-64 Phased Array Upper Extremity Flex Coil and Model 544GE-64 Phased Array Lower Extremity Flex 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 [phone] 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. |

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Anatomic Regions

Bones, soft tissue, musculoskeletal structures and * vascular structures in the upper and lower extremities

Standards

| 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 |
| | CPAI-84 | Specification for Flame Resistant<br>Material Used in Camping Tentage |

#### 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 1.5T Signa MRI system operated with the Medical Advances Phased Array Musculoskeletal Flex Coil Package is substantially equivalent to the same system operated with the legally marketed predicate devices 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 1.5T Signa MRI system operated with the Medical Advances Phased Array Musculoskeletal Flex Coil Package addressed in this PMN, has the same intended use and technological characteristics as the same system operated with the identified legally marketed predicate devices. The use of these coils does not affect the GE Signa system safety parameter specifications.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract design of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 10008

Thomas E. Tynes Vice President-Operations Medical Advances. Inc. 10437 Innovation Drive Milwaukee, WI 53226

Re: K983109

Model 545GE-64 Phased Array Musculoskeletal Flex Coil Package consisting of Model 543GE-64 Dated: September 3, 1998 Received: September 4, 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 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 Fecteral 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 Ouality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic OS 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 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. "Misoranding 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/oddfb/dsmaldsmam.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph, D. Director, Division of Reproductive 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): 长983009

Device Name: Model 545 Series: Phased Array Musculoskeletal Flex Coil Package consisting of 543 Series Phased Array Upper Extremity Flex Coil and 544 Series Phased Array Lower Extremity Coil

Indications for Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Gamil H. Siganon

(Division Sign-Off) Division of Reproductive, Abdominal, B and Radiological Deyi 510(k) Number

Prescription Use _ X (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)