SV DBS VRAIN ARRAY

K111259 · Midwest Rf, LLC · MOS · Jul 5, 2011 · Radiology

Device Facts

• Record ID: K111259
• Device Name: SV DBS VRAIN ARRAY
• Applicant: Midwest Rf, LLC
• Product Code: MOS · Radiology
• Decision Date: Jul 5, 2011
• 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 GE Medical Signa HDx 1.5 T closed, horizontal bore MRI system capable of utilizing at least 8 channel Phased Array receive-only coils with integrated pre-amplifiers.

Device Story

The SV DBS Brain Array (Model 1500SV-GEMS64) is a receive-only phased array coil designed for MRI imaging of the human head, brain, and brain-stem. It functions as an accessory to GE Medical Signa HDx 1.5T closed, horizontal bore MRI systems. The device captures radiofrequency signals from the patient's anatomy during MRI procedures, utilizing integrated pre-amplifiers to enhance signal quality. It is operated by trained MRI technologists or radiologists in a clinical setting. The output is processed by the host MRI system to generate 2D and 3D diagnostic images, which are then interpreted by a physician to assist in clinical diagnosis and treatment planning. The device benefits patients by providing high-resolution anatomical imaging of the brain.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Receive-only phased array coil; 8-channel configuration; integrated pre-amplifiers; compatible with GE Medical Signa HDx 1.5T MRI systems; hardware-based signal acquisition.

Indications for Use

Indicated for 2D and 3D MRI of human head, brain, and brain-stem anatomy. Used with GE Medical Signa HDx 1.5T MRI systems.

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.

Reference Devices

• GE Medical Signa HDx 1.5 T MRI system

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The seal features a stylized human figure and a circular border with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

JUL - 5 2011

Mr. Helmut Keidl President Midwest RF, LLC P.O. Box 348 1015 Walnut Ridge Drive HARTLAND WI 53029

Re: K111259

Trade/Device Name: SV DBS Brain Array Model # 1500SV-GEMS64 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 26, 2011 Received: May 4. 2011

Dear Mr. Keidl:

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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish firther. 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. Your must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter 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 renarketed predicate device results in a classification for your device and thus, permits your dry ince to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Attachment 3 Statement of Indication for Use

510(K) Number (if known): K 111259

Device Name: SV Brain Array, Model # 1500SV-GE64

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 GE Medical Signa HDx 1.5 T closed, horizontal bore MRI system capable of utilizing at least 8 channel Phased Array receive-only coils with integrated pre-amplifiers.

Prescription Use (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 In Vitro Diagnostic Device Evaluation & Safety

Michael D'Orazio
(Division Sign Off)

Office of In Vitro Diagnostic Device Evaluation and Safety

510K K 111259

SV Brain Array

Attachment 3 Indication for Use Page 1 of 1