SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64

K090267 · Midwest Rf, LLC · MOS · Mar 16, 2009 · Radiology

Device Facts

• Record ID: K090267
• Device Name: SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64
• Applicant: Midwest Rf, LLC
• Product Code: MOS · Radiology
• Decision Date: Mar 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The 2D and 3D Magnetic Resonance Imaging of the anatomy of human head, brain and brain-stem. This device is used in conjunction with a Siemens Medical Systems 1.5 Tesla MRI Scanner with Total imaging matrix (Tim) option.

Device Story

SV Brain Array (Model 1500SV-SMS64) is a radiofrequency (RF) coil array designed for use with Siemens 1.5T MRI scanners. Device functions as a signal receiver for magnetic resonance imaging of human head, brain, and brain-stem anatomy. Operated by trained MRI technologists in clinical radiology settings. Device captures RF signals from patient anatomy during MRI procedures; signals are processed by the host MRI scanner to generate 2D/3D diagnostic images. Output is viewed by radiologists to assist in clinical diagnosis of neurological conditions. Benefits include high-resolution imaging of brain structures.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

RF coil array for 1.5T MRI; compatible with Siemens Total imaging matrix (Tim) systems. Form factor: head/brain array. Passive hardware component; no software or active electronic processing within the coil itself.

Indications for Use

Indicated for 2D and 3D MRI of human head, brain, and brain-stem anatomy. For use with Siemens 1.5T MRI scanners equipped with Total imaging matrix (Tim) option.

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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the serpent and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 1 6 2009

Mr. David M. Peterson Director of Operations Midwest RF, LLC P.O. Box 348 1015 Walnut Ridge Drive HARTLAND WI 53029

Re: K090267

Trade/Device Name: SV Brain Array, Model# 1500SV-SMS64 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device. Regulatory Class: II Product Code: MOS Dated: January 19, 2009 Received: February 10, 2009

Dear Mr. Peterson:

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.

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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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Lamme B. Morris

Tanine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## 5.0 Attachment 3:

## Statement of Indication for Use

510(K) Number (if known): K090267

Device Name: SV Brain Array, Model # 1500SV-SMS64

Indications For Use:

The 2D and 3D Magnetic Resonance Imaging of the anatomy of human head, brain and brain-stem. This device is used in conjunction with a Siemens Medical Systems 1.5 Tesla MRI Scanner with Total imaging matrix (Tim) option.

Prescription Use X (Per 21 CFR 801. Subpart D)

AND/OR

Over-the Counter Use (Per 21 CFR 801. Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

SV Brain Array

Attachment 3 Indication for Use Page 1 of 1