NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL

K042103 · Mri Devices Corporation · MOS · Aug 16, 2004 · Radiology

Device Facts

• Record ID: K042103
• Device Name: NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL
• Applicant: Mri Devices Corporation
• Product Code: MOS · Radiology
• Decision Date: Aug 16, 2004
• 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 head and neck, that can be interpreted by a trained physician.

Device Story

The NVA-63-8-A and NVA-63-16-A Neurovascular Array Coils are radiofrequency (RF) receiver coils designed for use with Magnetic Resonance (MR) scanners. The device captures RF signals emitted by the patient's anatomy (head and neck) during an MRI procedure. These signals are transformed by the MR scanner's internal processing system into diagnostic images. The coils are used in clinical settings by trained medical professionals (radiologists/technicians) to facilitate high-resolution imaging of neurovascular structures. The output is a visual image used by physicians to aid in clinical diagnosis. The device benefits patients by providing detailed anatomical information for medical assessment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Neurovascular array coils (8-channel and 16-channel configurations). Functions as an RF receiver coil for MRI systems. Operates within the magnetic resonance diagnostic device framework (21 CFR 892.1000).

Indications for Use

Indicated for use with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck for interpretation by a trained physician.

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

## AUG 1 6 2004

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

Re: K042103

Trade/Device Name: NVA-63-8-A and NVA-63-16-A Neurovascular Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS

Dated: August 2, 2004 Received: August 4, 2004

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). and Obsincere for , too) year 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 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 that i 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 Section 5 10(k) I his letter will anow you to ocgin maneeting your device of your device to a legally premarket nothcation. The PDA miding of become 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 If you desire specific advice for your dones on one of the following numbers, based on the regulation number at the top of the 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 Adultionally, for questions on the promote the regulation entitled, "Misbranding Other of Comphance at (301) 59 1 489 (21CFR Part 807.97) you may obtain. Other general by reletection on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Solless http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

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):_____________________________________________________________________________________________________________________________________________________ Device Name: Model NVA-63-8-A and NVA-63-16-A Neurovascular Array Coils

Indications for use:

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

The indications for use of the device have not changed as a result of the modification described in this Special 510(k).

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Optional Format 1-2-96)

Nancy Brogdon

(Division Sign-Off) Coursion of Reproductive, Ab a Radiological Devices ו (((k) Number