HAC-420 HEAD ARRAY COIL

K013322 · Mri Devices Corp. · MOS · Oct 16, 2001 · Radiology

Device Facts

• Record ID: K013322
• Device Name: HAC-420 HEAD ARRAY COIL
• Applicant: Mri Devices Corp.
• Product Code: MOS · Radiology
• Decision Date: Oct 16, 2001
• 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 images that can be interpreted by a trained physician.

Device Story

HAC-420 Head Array Coil is an accessory for Magnetic Resonance Imaging (MRI) systems. Device functions as a radiofrequency (RF) receiver coil designed to detect magnetic resonance signals from the head. Signals are processed by the host MRI scanner to generate diagnostic images. Used in clinical radiology settings by trained MRI technologists and physicians. Output is viewed by radiologists to assist in clinical diagnosis. Benefits include improved signal-to-noise ratio or spatial resolution for head imaging compared to standard coils.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

RF receiver coil for MRI. Passive hardware component. Dimensions and form factor specific to head imaging. Connects to host MRI scanner via standard interface. No active software or internal processing algorithms.

Indications for Use

Indicated for use with a Magnetic Resonance Scanner to produce images for interpretation by a trained physician. No specific patient population, age, or disease state 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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 6 2001

Mr. Thomas Schubert President MRI Devices Corporation 1515 Paramount Drive WAUKESHA WI 53186

Re: K013322

Trade/Device Name: HAC-420 Head Array Coil Magnetic Resonance Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 1, 2001 Received: October 5, 2001

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 (PMA), it may be subject to 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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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## Section C – Statement of Indications for Use:

Applicant: MRI Devices Corporation 510(k) number (if known): ____________________________________________________________________________________________________________________________________________________ Model HAC-420 Head Array Coil Device Name:

Indications for use:

To be used in conjunction with a Magnetic Resonance Scanner to produce 16 be abod in confully that can be interpreted by a trained physician.

David Lee Segears

4
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K013372

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Optional Format 1-2-96)