MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL

{0}------------------------------------------------ 8 2002 NOV ## KO23596 ## Special 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | Submitter's Name: | Medrad Inc. | |----------------------|--------------------------------------------------------| | Submitter's Address: | One Medrad Drive, Indianola, PA 15051 USA | | Telephone Number: | (412) 767-2400, ext. 3326 | | Fax Number: | (412) 767-2475 | | Contact Person: | Jim Ferguson, Jr. | | Date: | October 25, 2002 | | Proprietary Name: | Medrad 8-Receiver Phased Array Neurovascular Coil | | Common Name: | MR Imaging Surface Coil | | Classification: | Class II, 892.1000 | | Classification Name: | Magnetic Resonance Diagnostic device | | Predicate Device: | Medrad 1.5T Phased Array Neurovascular Coil<br>K984257 | Substantial Equivalence: The information provided in this premarket notification demonstrates that the proposed device is substantially equivalent to a legally marketed device. The proposed 8-Receiver Phased Array Neurovascular Coil is substantially equivalent to the 1.5T Phased Array Neurovascular Coil (K984257) The Medrad 8-Receiver Phased Array Neurovascular Coil maintains the same intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device. Like the Medrad 4-Receiver Neurovascular Coil, the Medrad 8-Receiver Neurovascular Coil is a receive-only coil intended to be used with the General Electric Superconducting MRI scanners for MR imaging of the intracranial Neurovascular, skull base and C-Spine without moving the patient or the coil, i.e., no scan room intervention Medrad has established, as part of its Quality System, design controls in compliance with FDA's Quality System Regulations (QSRs). These design controls are applied to all Medrad product development processes and product design changes. These design controls were applied to the development of the Stellant CT Injector and meet the requirements of the FDA's QSRs. As part of the design control a risk analysis was performed, and design verification and validation testing was conducted to support the conclusion drawn by the risk analysis. Test results demonstrate that the design specifications for the Medrad 8-Receiver Phased Array Neurovascular Coil were met and that the Medrad 8-Receiver Phased Array Neurovascular Coil meets the applicable requirements of the international standards cited. Therefore, it has been determined that the Medrad 8-Receiver Phased Array Neurovascular Coil is substantially equivalent to the predicate device, its predecessor, for its intended use when used as prescribed in the User Operation Manual. A comparison of features and principles of operation between the proposed device and predicate device is provided in the table below. {1}------------------------------------------------ | Feature | (Proposed) Medrad 1.5T 8-<br>Receiver Neurovascular | Medrad 1.5T Neurovascular<br>Array Coil (Predicate) | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Coil type | Phased Array Receive-Only Coil | Phased Array Receive-only<br>Quadrature coil. | | Region of Interest | Vertex of the skull to the aortic<br>arch. | Vertex of the skull to the aortic<br>arch. | | 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. | All phased array GEMS 1.5T<br>Signa Horizon platforms All Signa<br>System pulse sequences and<br>appropriate imaging options<br>excluding parallel imaging. | | 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 the recommended<br>anatomy of interest. | | 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>Neurovascular, C-Spine (user<br>optional), Volume Neck (user<br>optional), High resolution Head<br>and C-Spine (user optional) | High resolution Head, Fast<br>Brain, Neurovascular, C-Spine<br>(user optional), Volume Neck<br>(user optional), High<br>resolution Head and C-Spine<br>(user optional) | | Patient contacting materials comparison information | | | |-----------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | | Medrad 1.5T Neurovascular (Proposed) | Medrad 1.5T Neurovascular Array Coil (Predicate) | | Housing | The housing material is made from Polyurethane; Fire Rated UL 94V-0 | The housing material is made from Glass Filled Polyurethane; Fire Rated UL 94V-0 and Kydex, Fire Rated UL 94V-0 | | Comfort Pad | Comfort Pad material is made with a cotton material embedded with urethane and is fire rated to CAL 117 | Comfort Pad material is made with a cotton material embedded with urethane and is fire rated to CAL 117 | : 、* {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a partial view of the Department of Health & Human Services logo. The logo features the department's emblem, which is a stylized representation of an eagle with three lines extending from its body. The text "DEPARTMENT OF HEALTH &" is partially visible, curved along the left side of the emblem. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 8 2002 NOV Re: K023596 Trade/Device Name: Medrad 8 Receiver Phased Array Neurovascular Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 25, 2002 Received: October 28, 2002 Dear Mr. Ferguson: Mr. Jim Ferguson, Jr. One Medrad Drive Medrad, Inc. Regulatory Affairs Analyst INDIANOLA PA 15051 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 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. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 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 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: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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 {4}------------------------------------------------ Intended Use ## Indications for Use Statement 510(k) Number: KO23596 Device Name: Medrad 8-Receiver Phased Array Neurovascular Coil Indications for Use: The Medrad Phased Array Neurovascular coil is a receive-only coil intended to be used with the General Electric Superconducting MRI scanners. The coil will facilitate complete MR imaging of the intracranial/extracranial Neurovascular, skull base and C-Spine without moving the patient or the coil, i.e., no scan room intervention. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David L. Simpson (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K023596 Prescription Use / OR Over-The-Counter Use _ (Per 21 CFR 801.109) · Medrad, Inc. · Special 510(k) Premarket Submission · 8-Receiver Neurovascular · Confidential ·