MRGFUS PELVIC PA COIL MODEL 1.0

K111060 · Insightech, Ltd. · MOS · Sep 9, 2011 · Radiology

Device Facts

• Record ID: K111060
• Device Name: MRGFUS PELVIC PA COIL MODEL 1.0
• Applicant: Insightech, Ltd.
• Product Code: MOS · Radiology
• Decision Date: Sep 9, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MRgFUS Phase Array Pelvic Coil (the MRgFUS PA Coil) is a receive only RF coil, designed for MR imaging of the pelvis and hips. The MRgFUS Coil is designed for use with the GE 1.5 T MRI systems manufactured by GE Medical Systems. The Pelvic Phase Array Coil can be used in conjunction with the InSightec Focused UltraSound (MRgFUS) treatment.

Device Story

MRgFUS PA Pelvic Coil is a receive-only radiofrequency (RF) coil; designed for MR imaging of pelvis and hips. Operates as an accessory to GE 1.5T MRI systems; used in conjunction with InSightec Focused UltraSound (MRgFUS) treatment. Device captures RF signals from patient anatomy; transmits data to MRI system for image reconstruction. Used in clinical imaging environments by trained radiology or clinical staff. Provides high-resolution pelvic/hip images to assist clinicians in treatment planning and monitoring of MRgFUS procedures. Benefits include improved image quality for targeted ultrasound therapy.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Receive-only RF coil; designed for GE 1.5T MRI systems. Form factor: Pelvic Phase Array. Connectivity: Direct interface with GE MRI hardware. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring MR imaging of the pelvis and hips, including use in conjunction with InSightec Focused UltraSound (MRgFUS) treatment. No specific age or gender restrictions stated.

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

Mr. Ori Lubin Regulatory Affairs and Clinical Trials Manager InSightec 5 Nahum Heth St. Tirat Carmel 39120 ISRAEL

- 9 2011

Re: K111060

Trade/Device Name: MRgFUS PA Pelvic Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 28, 2011 Received: August 12, 2011

Dear Mr. Lubin:

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 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 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 Parts 801 and 809); medical device 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 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 (2) CFR Parts 801 and 809), please contact the Office of In Vitro 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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## INDICATIONS FOR USE STATEMENT

Following is the proposed intended use for the MRgFUS PA Pelvic Coil:

The MRgFUS Phase Array Pelvic Coil (the MRgFUS PA Coil) is a receive only RF coil, designed for MR imaging of the pelvis and hips.

The MRgFUS Coil is designed for use with the GE 1.5 T MRI systems manufactured by GE Medical Systems.

The Pelvic Phase Array Coil can be used in conjunction with the InSightec Focused UltraSound (MRgFUS) treatment.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

Mary Patel

510K Kilo D