← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K972592 # 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) (K972592) _Elscint, Inc. · MOS · Sep 15, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K972592 ## Device Facts - **Applicant:** Elscint, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Sep 15, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use Magnetic Resonance Imaging of small extremity joints. ## Device Story Flexible MRI coil designed for imaging small extremity joints including elbow, hand, ankle, and foot. Device functions as passive receiver coil for MRI systems. Operates by capturing magnetic resonance signals from anatomy positioned within coil; signals processed by host MRI system to generate diagnostic images. Used in clinical radiology settings by trained MRI technicians or physicians. Provides improved signal-to-noise ratio (SNR) and image uniformity compared to standard shoulder coils for small extremity applications. Benefits patient by enabling high-quality diagnostic imaging of small joints. ## Clinical Evidence Bench testing only. Comparison of image uniformity and signal-to-noise ratio (SNR) between subject Flex Coils and predicate Shoulder Coils on 0.5T and 2T systems. Results indicate subject device provides higher SNR and improved image quality. ## Technological Characteristics Passive MRI receiver coil. Materials identical to predicate K944331. Enclosures comply with IEC-601-1 (Clause 16 electrical safety, Clause 23 mechanical design). Flame rating exceeds CPAI-84. Frequency tuned for 0.5T and 2T MRI systems. No software or active electronic components. ## 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 - Flexible Coil ([K944331](/device/K944331.md)) - 2T Prestige ([K945791](/device/K945791.md)) - Privilege ([K954039](/device/K954039.md)) - Gyrex V-EP ([K962618](/device/K962618.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}------------------------------------------------ ## SUMMARY OF SAFETY AND EFFECTIVENESS K972592 1. Device Name: Flex Coil for the Prestige, Privilege, and Gyrex V-EP. 1.2 Classification Name: Magnetic Resonance Diagnostic Device 1.3 Submitter: Elscint, Inc., 505 Main St., Hackensack, NJ 07601 1.4 510(k) Number:____________________________________________________________________________________________________________________________________________________________ SEP 1 5 127 2. Device Modification Description The modification is the addition of a flexible coil to image the elbow, hand, ankle, foot, and other small extremity joints. The coil is similar in design to the predicate device, a legally marketed Flexible Coil (k944331). The only significant modification is with respect to the frequency for the 2 Tesla model because the predicate device was designed only for 0.5T, 1.0T and 1.5T systems. 3. Predicate Devices: The predicate devices are the 2T Prestige (k945791), Privilege (k954039), and Gyrex V-EP (k962618) systems with their shoulder coils, and the General Purspose Flex Coil (k944331). ## 4. Safety - The MRI safety parameters, SAR, dB/dt, Bo, and acoustic noise, do not apply to . passive coils. - Electric shock hazards are avoided by enclosures designed to comply with clause . 16 of the IEC-601-1 safety standard. - Rough surfaces and sharp corners and edges which may cause injury or damage . are avoided by design according to clause 23 of the IEC-601-1 standard. - . The coil enclosures and protective covers are flame rated better than CPAI-84. - . No software modifications have been made. - . All of the patient contacting materials are identical to those used in the predicate Flexible Coil (k944331). - The current modifications do not affect the site planning, installation, or service . manuals, and do not require any new safety labeling. ## 5. Effectiveness The Elscint 0.5T and 2T Flex Coils have acceptable uniformity and higher SNR than the Shoulder Coil. The images produced by the Flex Coils are better than those produced using the Shoulder Coils on the same systems. ## 6. Substantial Equivalency Statement Based on the above, it is Elscint's opinion that the 2T-Prestige, Privilege, and Gyrex V-EP systems with their new Flex Coils are substantially, equivalent to the predicate devices in terms of safetv and effectiveness. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like shapes, suggesting movement or flight. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle. Re: Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 5 1997 Benv Sherer Safety Officer Elscint, Inc. 505 Main Street Hackensack, NJ 07601 K972592 Flex Coil for Gyrex 0.5T and 2.0T MRI System Dated: July 10, 1997 Received: July 11, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS Dear Mr. Sherer: We have reviewed your Section SI0(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations. 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours W. Liao Yu Lillian Yiu, Ph.D. Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ . Page ____ of ____ of__________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Flex Coil for Gyrex 0.5T and 2T Systems Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: Magnetic Resonance Imaging of small extremity joints. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |------------------------------------------------------------------------------------|----------------------------------------------------------| |
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(Division Sign-Off) | | | Division of Reproductive, Abdominal, ENT, and Radiological Devices | | | 510(k) Number | K972592 | | Prescription Use (Per 21 CFR 801.109) Check Mark | OR Over-The-Counter Use _______ (Optional Format 1-2-96) | --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K972592](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K972592) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com