PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64

K983222 · Medical Advances, Inc. · MOS · Oct 8, 1998 · Radiology

Device Facts

• Record ID: K983222
• Device Name: PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64
• Applicant: Medical Advances, Inc.
• Product Code: MOS · Radiology
• Decision Date: Oct 8, 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 cervical spine, soft tissue and vascular structures of the neck.

Device Story

The Model 125GE-64 Phased Array Cervical Spine Coil is an accessory for GE Signa 1.5T MRI systems. It functions as a radiofrequency (RF) receiver coil to capture magnetic resonance signals from the cervical spine, neck soft tissues, and vascular structures. The coil is used in a clinical MRI environment by trained radiology personnel. It supports 2D/3D imaging, proton density, T1/T2 weighted imaging, time-of-flight, and phase contrast imaging. The device does not alter the safety parameters (static field, RF power, acoustic noise) or imaging performance specifications (SNR, uniformity, resolution) of the host GE Signa system. It benefits patients by enabling high-quality diagnostic imaging of the cervical region.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Phased array RF receiver coil. Materials include plastics compliant with UL 94 flammability standards. Safety compliance includes UL 544, IEC 601-1, and CPAI-84 for flame resistance. Designed for integration with GE Signa 1.5T MRI systems. No internal software or active electronic processing algorithms.

Indications for Use

Indicated for patients requiring MRI or MRA imaging of the cervical spine, soft tissue, and vascular structures of the neck.

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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# 182222

## 510(k) Summary of Safety and Effectiveness

Device Name

Applicability

Reason for 510(k)

Classification Name

Device Classification Panel

Device Classification Number

Product Code

Common Name

Proprietary Name

Establishment Registration Number

Address of MFG Facility

Point of Contact

Classification

Intended Uses

Diagnostic Uses

Anatomic Regions _____________________________________________________________________________________________________________________________________________________________

Model 125GE-64 Phased Array Cervical Spine Coil

Compatible with GE Signa 1.5T MRI systems with Phased Array option

New device

Magnetic Resonance Diagnostic Device

Radiology

892.1000

90LNH

Magnetic Resonance Imaging Coil

Model 125GE-64 Phased Array Cervical Spine Coil

2183683

Medical Advances, Inc. 10437 Innovation Drive Milwaukee, WI 53226

Thomas E. Tynes Vice President - Operations [phone] Ext. 407

Class II

2D, 3D imaging, proton density, T1 and T2 weighted imaging. 2D, 3D time of flight, phase contrast imaging.

Cervical spine, soft tissue and vascular structures of the neck.

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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 Cervical Spine Coil is substantially equivalent to the same system 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 Cervical Spine Coil 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 this coil 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 a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1098 OCT

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

Re: K983222

Phased Array Cervical Spine Coil (Model 125GE-64) Dated: September 14, 1998 Received: September 15, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Tynes:

We have reviewed your Section 510/12 notification of intent to market the device referenced above and we have deiermined 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 (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drag 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/odri/dsmaldsmamain.html".

Sincerely yours,

William Yin

Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page ___ 1___ of ___ 1 ___ 1

510(k) Number (if known): _ 《98 3 2 2 2 2 - --------

Device Name:___________ Model 125 Series: Phased Array Cervical Spine Coil

Indications for Use:

Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the cervical spine, soft tissue and vascular structures of the neck.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Symm

(Division Sign-Off) 4 Division of Reproductive, Abdominal, ENT, and Radiological Devis 510(k) Number

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)