OBC-085 BREAST ARRAY COIL

K993233 · Mri Devices Corp. · MOS · Oct 15, 1999 · Radiology

Device Facts

• Record ID: K993233
• Device Name: OBC-085 BREAST ARRAY COIL
• Applicant: Mri Devices Corp.
• Product Code: MOS · Radiology
• Decision Date: Oct 15, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

Device Story

The OBC-085 Breast Array Coil is a radiofrequency (RF) accessory for Magnetic Resonance (MR) scanners. It functions as a signal receiver, capturing electromagnetic signals from the breast, chest wall, and axillary tissues during an MRI procedure. The coil transforms these signals into raw data, which the MR scanner processes to generate diagnostic images. Used in clinical settings by radiologists and MRI technologists, the device enhances image quality for the visualization of breast anatomy. The resulting images assist physicians in diagnosing breast-related pathologies. The device is a passive hardware component that does not perform independent data analysis or automated decision-making.

Clinical Evidence

Bench testing only.

Technological Characteristics

RF receiver coil for MRI; designed for breast, chest wall, and axillary imaging; passive hardware component; compatible with standard MR scanner interfaces.

Indications for Use

Indicated for female patients requiring diagnostic imaging of the breast, chest wall, and axillary tissues via Magnetic Resonance Scanner.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three parallel lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1999

Thomas Schubert President MRI Devices Corporation N8 W22520-K Johnson Drive Waukesha. WI 53186

RE:

K993233 OBC-085 Breast Array Coil Dated: September 23, 1999 Received: September 27, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Schubert:

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 (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 Eederal 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/dsma/dsmamain.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

{1}------------------------------------------------

## Section C - Statement of Indications for Use:

Applicant: MRI Devices Corporation 510(k) number (if known): Device Name: Model OBC-085 Breast Array Coil

Indications for use:

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

or

Over-The-Counter Use

(Optional Format 1-2-96)

---

(Division Sign-Off) Division of Reproductive, Ahdarain and Radiological Devices 7 3 510(k) Number