QSC-127-INT SHOULDER ARRAY COIL SET

K040288 · Mri Devices Corp. · MOS · Mar 5, 2004 · Radiology

Device Facts

• Record ID: K040288
• Device Name: QSC-127-INT SHOULDER ARRAY COIL SET
• Applicant: Mri Devices Corp.
• Product Code: MOS · Radiology
• Decision Date: Mar 5, 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 shoulder. To be operated by a trained physician.

Device Story

Model QSC-127-INT Shoulder Array Coil Set; accessory for Magnetic Resonance (MR) scanners. Device functions as radiofrequency (RF) receiver coil; captures MR signals from shoulder anatomy during imaging procedures. Operated by trained physicians/technicians in clinical MR environments. Output consists of raw signal data processed by host MR scanner into diagnostic images. Enhances signal-to-noise ratio for shoulder imaging; facilitates clinical diagnosis of shoulder pathology. Device is passive hardware component; no internal processing or software.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

RF receiver coil array for MRI. Passive hardware device. Materials and construction consistent with standard MR coil design. Dimensions and form factor optimized for shoulder anatomy. Connects to host MR scanner for signal acquisition. No software, no active electronics, no internal power source.

Indications for Use

Indicated for use in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder in patients requiring MRI examination, as determined 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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MAR - 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040288 Trade/Device Name: Model QSC-127-INT Shoulder Array Coil Set Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: February 4, 2004 Received: February 6, 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). 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 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 letter will allow you to begin marketing your device as described in your Section 510(k) I his iciter will and would finding of substantial equivalence of your device to a legally prematics notincation. "The stassification 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 spoolite at 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding Other or other motification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsible in 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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\$\sigma\$ 40258

Special 510(K) Application, Device Modification Special STO(T<) ApplicationIder Array Coil Sct, February 4, 2004

Page 3

## Section C -- Statement of Indications for Use:

Indications for Use

510(k) number (if known): Model QSC-127-INT Shoulder Array Coil Set Device Name:

Indications for use:

To be used in conjunction with a Magnetic Resonance Scanner to produce To be used in conjunction with a Mugicule Reserveted by a trained physician.

> Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-Off) Division of Reproduct and Radiological Devic 510(k) Number