← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K031089 # GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY (K031089) _W. L. Gore & Associates, Inc. · MOS · May 8, 2003 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K031089 ## Device Facts - **Applicant:** W. L. Gore & Associates, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** May 8, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The applicant device, the GORE-FLEX™ MP8, is intended for multiple imaging applications with GE Signa® 1.5T MRI Systems, using EXCITE™ Technology. Its large field of view will allow for images of the complete thorax, including the heart, and its associated vasculature, the abdomen, pelvis, and spine. A specialized sub-array will provide high resolution images of the thoracic region. ## Device Story GORE-FLEX™ MP8 is a 10-element phased array MRI surface coil; designed for use with GE Signa® 1.5T MRI systems featuring EXCITE™ technology. Device captures magnetic resonance signals from the thorax, heart, vasculature, abdomen, pelvis, and spine. Modification from predicate involves a scanner interface connector, enabling utilization of an 8-channel receiver system (vs 4-channel in predicate). Operates via active and passive decoupling; utilizes MR-safe cables. Used in clinical imaging environments by radiology staff. Output consists of raw MR signal data processed by the MRI system into diagnostic images. Benefits include high-resolution imaging of thoracic region and large field-of-view for torso applications. ## Clinical Evidence Bench testing only. Comparative imaging studies performed on GE Signa® 1.5T system with EXCITE™ technology. Evaluated field-of-view, image clarity, and signal-to-noise ratio against the predicate Cardiovascular Array. ## Technological Characteristics 10-element phased array MRI surface coil. Features modified scanner interface connector for 8-channel receiver compatibility. Employs active and passive decoupling for patient safety. Uses MR-safe cables. Designed for GE Signa® 1.5T MRI systems with EXCITE™ technology. ## Regulatory 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 - Cardiovascular Array ([K013810](/device/K013810.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 03/089 MAY = 8 2003 Image /page/0/Picture/2 description: The image shows the logo for GORE, with the words "GORE" in bold, sans-serif font. Above the word "GORE" is a right-pointing arrow shape. Below the word "GORE" are the words "Creative Technologies Worldwide" in a smaller, serif font. The logo is contained within a rectangular border. ## W. L. GORE & ASSOCIATES. INC 750 OTTS CHAPEL ROAD • P.O. BOX 8038 • NEWARK, DE 19714-8038 PHONE: 302/368-2575 • FAX: 302/737-2819 ## Premarket Notification 510(k) Summary (K031089) a. Submitter: W. L. Gore and Associates, Inc. 750 Ott's Chapel Rd. Newark, DE 19713 800-441-7404 Phone: Contact: Tracy Wolf Date Prepared: May 5, 2003 - b. Name of Device: Trade Name: GORE-FLEX™ MP8 Multipurpose Torso Array Common Name: MRI Surface Coil Device Name: Coil, Magnetic Resonance, Specialty - c. Identification of Predicate Devices: The predicate device, the Cardiovascular Array, (K013810) is a ten element phased array coil. It was designed for use with GE Signa® 1.5 MRI Systems, which consist of four signal receivers. - d. Description of the Applicant Device: The GORE-FLEX™ MP8, is a ten element phased array coil. It is for use on the upgraded GE Signa® 1.5T MRI System with EXCITE™ Technology. The applicant device, the GORE-FLEX™ MP8, has a modified Scanner Interface Connector. This modification allows the coil to take advantage of the 8 channel receiver system. ## e. Intended Use: The applicant device, the GORE-FLEX™ MP8, is intended for multiple imaging applications with GE Signa® 1.5T MRI Systems, using EXCITE™ Technology. Its large field of view will allow for images of the complete thorax, including the heart, and its associated vasculature, the {1}------------------------------------------------ abdomen, pelvis, and spine. A specialized sub-array will provide high resolution images of the thoracic region. - f. Technical Characteristics: The applicant device, the GORE-FLEX™ MP8, is a ten element phased array coil for use with the upgraded GE Signa® 1.5T MRI System with EXCITE™ Technology. The applicant device, the GORE-FLEX™ MP8, has a modified Scanner Interface Connector. This modification allows the coil to take advantage of the 8 channel receiver system. Only the design of the connector box has been modified to allow up to 8 loops to be used as opposed to 4 loops. The antenna loops, patient interface, and MR safe cables remain unchanged. The GORE-FLEX™ MP8, the applicant device, is designed to maximize patient safety by using active decoupling, passive decoupling, and the MR safe cable, as does the predicate device. - g. Summary of Testing: Test data was acquired systematically on the GE Signa® 1.5T system with EXCITE™ Technology. The comparative images of the thorax and abdomen demonstrate that the GORE-FLEX™ MP8, the applicant device, has a substantially equivalent field-of-view, image clarity and signal-tonoise ratio as the Cardiovascular Array, the predicate device. In summary, the GORE-FLEX™ MP8 Multipurpose Torso Array (applicant) and the Cardiovascular Array (predicate) utilize similar technology and materials. There are no patient safety concerns raised as a result of the clearance of the GORE-FLEX™ MP8 Multipurpose Torso Array. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Tracy DeVan Wolf Regulatory Affairs W. L. Gore & Associates, Inc. 750 Otts Chapel Road P.O. Box 8038 NEWARK DE 19714-8038 Re: K031089 MAY - 8 2003 Trade/Device Name: Gore-Flex™ MP 8 Multipurpose Torso Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 3, 2003 Received: April 7, 2003 Dear Ms. Wolf: 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 vour 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 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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 vours. 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}------------------------------------------------ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ GORE-FLEXTM MP8 Multipurpose Torso Array Device Name: Indications For Use: The GORE-FLEXTM:MP8 Multipurpose Torso Array is intended for multiple imaging applications with GE Signak 1.5T MRI Systems, using EXCITEM Technology. Its large field of view will allow for images and in a some organ including the heart, and its associated of the complete thorax, pelvis and spine. A specialized sub-array vasculature, the abonen, pelvis and spine. I reg (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98) David R. Brown *Prescription Use* (Division Sian-Off Division of Reproducts Abdomir and Radiological Der 510(k) Numb --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K031089](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K031089) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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