HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL

K050622 · Mri Devices Corporation · MOS · Apr 8, 2005 · Radiology

Device Facts

• Record ID: K050622
• Device Name: HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL
• Applicant: Mri Devices Corporation
• Product Code: MOS · Radiology
• Decision Date: Apr 8, 2005
• 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

Models HRW-63-8 and HRW-127-8 are wrist array coils designed for use with magnetic resonance (MR) scanners. These coils function as radiofrequency (RF) receivers to capture MR signals from the wrist and hand anatomy. The captured signals are processed by the MR scanner to generate diagnostic images. The device is intended for clinical use in a radiology setting, operated by trained medical professionals. The resulting images assist physicians in diagnosing pathologies of the wrist and hand. The device provides a specialized interface to improve image quality for these specific anatomical regions compared to general-purpose coils.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiofrequency receiver coil array for MRI. Designed for wrist and hand imaging. Compatible with standard MR scanner interfaces. Passive hardware component; no internal software or active processing circuitry.

Indications for Use

Indicated for patients requiring diagnostic magnetic resonance imaging of the wrist and hand. For use by trained physicians.

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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Public Health Service

2005 APR 8

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas Schubert Chief Technology Officer MRI Devices Corporation N27 W23676 Paul Rd PEWAUKEE WI 53072

Re: K050622 Trade/Device Name: Models HRW-63-8 and HRW-127-8 Wrist Array Coils Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 7, 2005 Received: March 10, 2005

Dear Mr. Schubert:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This Ictter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Koro622

Special 5 10(K) Application, Device Modification Special 510(K) Application, Device Modification
Models HRW-63-8 and HRW-127-8 Wrist Array Coils, March 7, 2005

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## Section C – Statement of Indications for Use

Applicant: MRI Devices Corporation 510(k) number (if known): 510(k) number (if known): ____________________________________________________________________________________________________________________________________________________

Indications for use:

To be used in conjunction with a Magnetic Resonance Scanner to producediagnostic
To be used in control be a be interpreted by a trained physician. To be used in conjunction with a Magictic Resolulios bearn
images of the wrist and hand that can be interpreted by a trained physician.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use or

(Per 21 CFR 801.109) (Optional Format 1-2-96)

Nancy Boydon

(Division Sign-Off) ( Division of Reproductive. Abdominal, ano Radiological Devices DSDG 510(k) Number __