HRW WRIST ARRAY COIL

K993477 · Mri Devices Corp. · MOS · Nov 1, 1999 · Radiology

Device Facts

• Record ID: K993477
• Device Name: HRW WRIST ARRAY COIL
• Applicant: Mri Devices Corp.
• Product Code: MOS · Radiology
• Decision Date: Nov 1, 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 wrist and hand, that can be interpreted by a trained physician.

Device Story

The HRW Wrist Array Coil is a specialized radiofrequency (RF) coil designed for use with Magnetic Resonance (MR) scanners. It functions as an accessory to capture MR signals from the wrist and hand anatomy. The device is operated by trained radiology staff in a clinical imaging environment. By receiving RF signals and transmitting them to the MR scanner, the coil enables the generation of high-resolution diagnostic images. These images are reviewed by physicians to assist in clinical decision-making and diagnosis of wrist and hand pathologies. The device provides a dedicated interface to improve signal-to-noise ratio for localized imaging of the wrist/hand region.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a radiofrequency (RF) array coil designed for wrist and hand imaging. It functions as a passive signal receiver for MR scanners. It is a class II device under 21 CFR 892.1000.

Indications for Use

Indicated for use with MRI scanners to produce diagnostic images of the wrist and hand for interpretation by a trained physician. No specific patient population or contraindications provided.

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 a circular logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized depiction of three wavy lines, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 1999

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

RE:

K993477 HRW Wrist Array Coil Dated: September 24, 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 redassified 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 of the Act include requirements for annual registration. Isting 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 requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication submission does not affect any obliation 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 HRW Wrist Array Coil

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jarid L. Respon
Division Sign Off

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

Prescription Use Over-The-Counter Use_ or (Per 21 CFR 801.109)

(Optional Format 1-2-96)