1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS

K093689 · Mr Medical Solutions, LLC · MOS · Aug 31, 2010 · Radiology

Device Facts

• Record ID: K093689
• Device Name: 1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS
• Applicant: Mr Medical Solutions, LLC
• Product Code: MOS · Radiology
• Decision Date: Aug 31, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil intended to be used with 1.5T Siemens superconducting MRI scanners. The coil is intended to facilitate complete MR imaging of the intracranial/extracranial neurovasculature and skull base. The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil and is indicated for use only under the supervision of a physician or certified MR technologist who is trained in the field of Diagnostic Resonance Imaging.

Device Story

Receive-only phased-array head coil; designed for 1.5T Siemens superconducting MRI scanners. Captures MR signals from head and skull base anatomy; transforms signals into high-resolution images via scanner processing. Used in clinical imaging environments; operated by physicians or certified MR technologists. No scan room intervention required; coil connects via phased-array quick disconnect port. Provides diagnostic visualization of neurovasculature and skull base; assists clinicians in diagnostic decision-making. Benefits patients through non-invasive, high-resolution imaging of intracranial structures.

Clinical Evidence

Bench testing only. Design verification and validation testing performed in compliance with FDA Quality System Regulations (QSRs) and risk analysis.

Technological Characteristics

Phased-array receive-only coil. Housing: Polycarbonate (UL 94V-0). Comfort pad: Cotton/urethane (CAL 117). Connectivity: Phased-array quick disconnect port. Compatibility: 1.5T Siemens superconducting MRI scanners. No external tuning/matching required.

Indications for Use

Indicated for patients requiring MR imaging of intracranial/extracranial neurovasculature and skull base. Use restricted to supervision by physician or certified MR technologist trained in Diagnostic Resonance Imaging.

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.

Predicate Devices

• Medrad 1.5 Tesla 8-Receiver Neurovascular Coil (K023596)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

AUG 3 1 2010

Submitter's Name: Submitter's Address: Telephone number: Fax number: Official Correspondent: Date:

MR Medical Solutions 310 Vista Park Drive, Pittsburgh PA 15205 412-787-3454 412-787-3490 Fahad Alradady November 13, 2009

Trade/Proprietary Name: Common Name: Classification Number:

1.5 Tesla 16-Channel Receive-only Phased-array Head Coil for Siemans MR Imaging Surface Coil 21 CFR 892.1000

Predicate Device:

1.5 Tesla 8-Receiver Neurovascular Coil, 510(k) number K023596

Substantial Equivalence: The information provided in this premarket notification demonstrates that the proposed device, the MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array, Head Coil, is substantially equivalent to a legally marketed predicate device, the Medrad 1.5 Tesla 8-Receiver Neurovascular Coil, when the Medrad device images a subset of the bodily regions it is intended to image; the proposed MR Medical Solutions device images the (a) Intracranial/extracranial neurovasculature and (b) skull base, whereas the predicate device images the (a) intracranial neurovasculature, (b) skull base and (c) C-spine.

The MR Medical Solutions device (1) maintains the same intended use for imaging the intracranial/extracranial neurovasculature and skull base of the predicate device, (2) has similar operational parameters, (3) has similar labeling and (4) is used in a manner similar to the predicate device.

The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil intended to be used with 1.5T Siemens superconducting MRI scanners. The predicate device is a receive-only coil intended to be used with General Electric MRI Superconducting Scanner Systems.

Like the predicate device, the proposed device is indicated to be used only under the supervision of a physician or certified MR technologist who is trained in the field of Diagnostic Magnetic Resonance Imaging. Both devices are designed to be used with similar scanners for imaging similar regions of the body without moving the patient or the coil. No scan room intervention is required.

MR Medical Solutions has established, as part of its Quality System, design controls in compliance with FDA's Quality System Regulations (QSRs). These design controls were applied to the development of the 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil and meet the requirements of the FDA's QSRs. Design verification and validation testing was performed as part of product development and in response to risk analysis.

Analysis of the collective set of data led to the conclusion that the MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is substantially equivalent to the predicate device for its intended use when used as prescribed in the User Manual.

A comparison of features and principles of operation between the proposed device and predicate device is provided in the following table.

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| | Predicate:<br>Medrad 1.5 Tesla 8-Receiver<br>Neurovascular Coil<br>(K023596) | Proposed:<br>1.5 Tesla 16-Channel Receive-<br>only Head Coil |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Feature | | |
| Coil Type | Phased Array Receive-Only Coil | Phased Array Receive-Only Coil |
| Region of Interest | Vertex of the skull to the aortic<br>arch | Head and base of skull |
| Compatibility | All phased array GEMS 1.5T<br>Signa Excite platforms with 8-<br>Receiver capability. All Signa<br>System pulse sequences and<br>appropriate imaging options. | 1.5 Tesla Siemens Medical<br>Systems MRI Scanner |
| Tuning | No external tuning, or matching,<br>is necessary since the coil is<br>matched to the recommended<br>anatomy of interest. | No external tuning, or matching, is<br>necessary since the coil is<br>matched to imaging the head and<br>skull base. |
| System connection | The coil plugs into the MRI<br>System by way of the Phased<br>Array quick disconnect port | The coil plugs into the MRI System<br>by way of the Phased Array quick<br>disconnect port. |
| Imaging configurations | High resolution Head, Parallel<br>imaging Fast Brain,<br>Neurovasculature, C-Spine (user<br>optional), Volume Neck (user<br>optional), High resolution Head<br>and C-Spine (user optional) | High resolution of Head and skull<br>base, and Parallel Imaging Fast<br>Brain. |

| Patient-contacting-materials comparison information | | |
|-----------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Feature | Medrad 1.5 Tesla 8-Receiver<br>Neurovascular Coil | 1.5 Tesla 16-Channel Receive-<br>only Head Coil |
| Housing materials | Polyurethane; Fire rated UL<br>94V-0 | Polycarbonate; Fire rated UL 94V-<br>0 |
| Comfort pad | Cotton material embedded with<br>urethane and fire rated to CAL<br>117. | Cotton material embedded with<br>urethane and fire rated to CAL<br>117. |

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling human figures or birds in flight.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Fahad Alradady President and CEO MR Medical Solutions LLC 310 Vista Park Drive PITTSBURG PA 15205

AUG 3 1 2010

Re: K093689

Trade/Device Name: 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil for Siemens Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 12, 2010 Received: August 12, 2010

Dear Mr. Alradady:

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 (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 (21 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 the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Amell Jt. R

Donald J. St.Pierre Acting 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

510(k) Number (if known): K693689

Device Name: 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil for Siemens

Indications for Use:

The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil intended to be used with 1.5T Siemens superconducting MRI scanners. The coil is intended to facilitate complete MR imaging of the intracranial/extracranial neurovasculature and skull base.

The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil and is indicated for use only under the supervision of a physician or certified MR technologist who is trained in the field of Diagnostic Resonance Imaging.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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