MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA

K982921 · Medrad, Inc. · MOS · Nov 3, 1998 · Radiology

Device Facts

• Record ID: K982921
• Device Name: MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA
• Applicant: Medrad, Inc.
• Product Code: MOS · Radiology
• Decision Date: Nov 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Medrad Breast Coil is a receive only coil intended to be used with the General Electric Superconducting MRI Scanners. This coil is intended to facilitate complete MR imaging of the breast anatomy. The Medrad Breast Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.

Device Story

Medrad Breast Coil is a receive-only surface coil for MRI systems; designed to enhance breast anatomy imaging. Device receives hydrogen nuclei signals during 2D/3D MR imaging. Operates as a passive accessory to GE superconducting MRI scanners; positioned by technicians/radiologists. Output is raw MR signal data processed by the host MRI system into diagnostic images. Used in clinical radiology settings. Benefits include improved signal-to-noise ratio for breast diagnostics. Device is mechanically and electrically identical to the predicate; primary change is manufacturer labeling.

Clinical Evidence

Bench testing included Signal-to-Noise Ratio (SNR) comparison, NEMA standard image uniformity evaluation, and assessment of geometric/RF field distortion. Clinical images were provided to demonstrate effectiveness for the 1.5T coil; SNR results were used to extrapolate performance for .5T and 1.0T models. No significant artifacts or distortion observed.

Technological Characteristics

Receive-only surface coil; hydrogen nuclei excitation; compatible with GE superconducting MRI systems. Materials identical to predicate. Includes blocking network to prevent induced currents. Dimensions/form factor designed for breast anatomy. Standalone accessory; no software/firmware.

Indications for Use

Indicated for use in MRI scanner systems for imaging of breast anatomy under the supervision of a physician trained in diagnostic resonance imaging.

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.

Predicate Devices

• General Electric (GE) Breast Coil (K923025)

Submission Summary (Full Text)

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3 1998 NOV

# K982921

#### 510(k) SUMMARY MEDRAD .5T, 1.0T, 1.5T BREAST COILS

| OFFICIAL CONTACT: | Jim Ferguson, Jr.<br>Sr. Regulatory Affairs Associate<br>Medrad, Inc.<br>One Medrad Drive<br>Indianola, PA 15051<br>[phone] Ext. 3326 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Magnetic Resonance Diagnostic Accessory<br>[21 CFR 892.1000} |
| COMMON/USUAL NAME: | MR Imaging Surface Coil |
| PROPRIETARY NAME: | Medrad Breast Coil |
| PREDICATE DEVICES: | General Electric (GE) Breast Coil |

DEVICE DESCRIPTION:

The Medrad Breast Coil is a receive only coil designed to enhance the MR lmaging of the breast anatomy. This coil is designed to be used optimally with either a conventional Signa 1.5T system, or a system including the Phased Array upgrade.

## INTENDED USE:

The Medrad Breast Coil is a receive only coil intended to be used with the General Electric Superconducting MRI Scanners. This coil is intended to facilitate complete MR imaging of the breast anatomy.

| Anatomical Region: | Breast anatomy |
|--------------------|-------------------|
| Nuclei Excited: | Hydrogen |
| Diagnostic Uses: | 2D and 3D Imaging |

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510(k) Summary Medrad Breast Coil Page 2 of 3

## PROPOSED MEDRAD BREAST COIL TECHNICAL COMPARISON TO PREDICATE DEVICES:

The following table compares the predicate GE Breast Coil and the proposed Medrad Breast Coil.

| GE Breast Coil (K923025) | Breast Coil<br>0 00 0 0 0 0 0 0 0 0 0 0 0 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>oo laheling | Medrad labeling |

Medrad was responsible for the design and manufacturing of the predicate device, and will remain responsible for the design and manufacturing for the proposed device. The device will be labeled and marketed as "Medrad Product". This is the only change to the device.

# PROPOSED MEDRAD BREAST TECHNICAL COMPARISON TO PREDICATE DEVICES(Cont.):

| Patient contacting materials comparison information | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| GE Breast Coil | Medrad Breast Coil |
| Reference K 923025 for<br>material information | All materials used are the<br>same as the GE Breast coil.<br>(Predicate device) |
| Certification: Medrad, Inc. certifies that the patient<br>contacting materials and formulations for<br>the proposed Medrad Breast Coils are<br>unchanged from currently marketed<br>devices. | |

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## PERFORMANCE TEST DATA:

#### SIGNAL TO NOISE RATIO (SNR)

A Signal to Noise Ratio(SNR) study was conducted to generate a Signal -To-Noise ratio comparison between the proposed Medrad Breast coil and the predicate GE Breast Coil.

IMAGE UNIFORMITY - The Medrad Breast Coil was evaluated using NEMA Standards to characterize the non-uniformity of the proposed coil. Contours of the images obtained with the coil were constructed for the axial image, sagittal imaqe.

GEOMETRIC DISTORTION: None. Static magnetic field distortion results from the use of magnetic materials in the construction of a surface coil. This device contains slightly magnetic materials or components. However, such-components have been positioned within the surface coil so that no observable distortion of the static magnetic field is present.

TRANSMIT RF FIELD [B1] DISTORTION - Analysis of the electrical design of the coil and its blocking network demonstrates that no significant currents are induced. No artifacts of any type were observed during imaging.

RESOLUTION. SLICE THICKNESS. AND CONTRAST - These performance parameters are not affected by the use of a surface coil and were not separately tested in the performance evaluation of the proposed Medrad Breast Coil.

CLINICAL EVALUATION - Clinical images for the proposed 1.5T Breast Coil have been provided with this submission to demonstrate the clinical effectiveness of the breast coils. Based on these results, and the SNR results for the proposed .5T and 1.0T breast Coils, Medrad concludes that the proposed .5T and 1.0T breast Coils will produce similar clinical image results.

CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate GE device. (K 923025). Mechanically and electrically the devices are identical. This labeling change is the only change to the device. The proposed device is deemed by Medrad to be substantially equivalent.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread, with three human profiles superimposed on the eagle's body. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

10008 3 NOV

Jim Ferguson, Jr. Sr. Regulatory Affairs Associate Medrad, Inc. One Medrad Drive Indianola, PA 15051

Re: K982921 Medrad Breast Coil Models M21BRC, M42BRA and M64BRA Dated: August 18, 1998 Received: August 19, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Ferguson:

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 Quality System Regulation (OS) 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/cdri/dsmadsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D Director, Division of Reprodu Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN): KUS290

Medrad Breast Coil DEVICE NAME:

INDICATIONS FOR USE:

The Medrad Breast Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the breast anatomy.

The Medrad Breast Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

くな Over-The-Counter-Use (Optional Format 1-2-96)

Division Sign Off

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