OBC-300 BREAST ARRAY COIL

K993776 · Mri Devices Corp. · MOS · Dec 3, 1999 · Radiology

Device Facts

• Record ID: K993776
• Device Name: OBC-300 BREAST ARRAY COIL
• Applicant: Mri Devices Corp.
• Product Code: MOS · Radiology
• Decision Date: Dec 3, 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 breast and axillary tissues that can be interpreted by a trained physician.

Device Story

Model OBC-300 Breast Array Coil is a specialized radiofrequency (RF) coil designed for use with Magnetic Resonance (MR) scanners. The device functions as a receiver to detect MR signals from breast and axillary tissues. These signals are processed by the host MR scanner to generate diagnostic images. The coil is operated by trained radiology technicians or physicians in a clinical imaging environment. The resulting images are reviewed by a physician to assist in the diagnosis of breast and axillary pathologies. The device provides high-resolution imaging capabilities, facilitating improved visualization of anatomical structures compared to standard body coils, thereby aiding clinical decision-making and patient management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

The device is a specialized RF receiver coil for MR imaging. It interfaces with standard MR scanner hardware. No specific materials, software algorithms, or connectivity protocols are detailed in the provided documentation.

Indications for Use

Indicated for patients requiring diagnostic imaging of breast and axillary tissues via Magnetic Resonance Scanner. For prescription use only.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 3 1999

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

Re:

K993776 Magnetic Resonance Specialty Coil Dated: November 2, 1999 Received: November 8, 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 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 (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 requlatory 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/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

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## Section C – Statement of Indications for Use:

Applicant: MRI Devices Corporation ર પંપ 510(k) number (if known):_ Device Name: Model OBC-300 Breast Array Coil

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number 993776

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

or