← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K042617 # 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA (K042617) _Siemens Medical Solutions USA, Inc. · MOS · Nov 5, 2004 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K042617 ## Device Facts - **Applicant:** Siemens Medical Solutions USA, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Nov 5, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The 31P/1H headcoil for MAGNETOM Allegra is a transmit/receive birdcage type headcoil double resonant on phosphorus (31P) and proton (1H) frequencies. Used in the Allegra system it is indicated for use as a diagnostic imaging device to produce 1H images and 1H spectra of the internal structures of the head. In addition, 31P spectra can be obtained within the same session without changing the coil. The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules, in which the nucleus under investigation is contained, to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), spin-spin echo time (T2) and resonance frequency of the corresponding nucleus. When interpreted by a trained physician, these images and spectra provide information that can be useful in determining diagnosis. ## Device Story The 31P/1H headcoil is a transmit/receive birdcage-type quadrature coil designed for the MAGNETOM Allegra MRI system. It operates at dual resonance frequencies for phosphorus (31P) and proton (1H) nuclei. The device includes a resonator and an electronic box for transmit/receive switching, quadrature splitting, preamplification, and lowpass filtering (for proton decoupling). It enables acquisition of 1H images and 1H/31P spectra during a single session without coil replacement. Operated by trained clinicians in a clinical MRI environment, the coil captures magnetic resonance signals from the head. The resulting images and spectra, reflecting spin density and relaxation times (T1, T2), are interpreted by physicians to assist in clinical diagnosis by visualizing internal head structures and analyzing metabolites. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Transmit/receive birdcage-type quadrature headcoil; dual-resonant for 31P and 1H frequencies. Includes electronic box for T/R switching, quadrature splitting, preamplification, and lowpass filtering. Designed for integration with MAGNETOM Allegra MRI system. ## 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 - Siemens Medical Solutions 31P/1H heart/liver coil for Clinical Phosphorus Spectroscopy Option MAGNETOM Vision ([K962627](/device/K962627.md)) - Siemens Medical Solutions 31P/1H heart/liver coil included in syngo MR 2002B ([K020991](/device/K020991.md)) - GE Medical Systems Signa 1.5T Phosphorus Transmit/Receive Flex Coil ([K983139](/device/K983139.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}------------------------------------------------ # Section 1: 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92. | I. General Information
Device Name | Trade Name: | 31P/1H headcoil for MAGNETOM Allegra | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| | | Classification Name: | Magnetic Resonance Diagnostic Device | | | CFR Section: | CFR § 892.1000 | | | Classification: | Class II | | | Product Code: | MOS - Magnetic Resonance Specialty Coil | | Manufacturer | Bruker BioSpin MRI GmbH
Rudolf-Plank-Straße 23
D-76275 Ettlingen, Germany | | | Registration Number | 9612385 | | | Initial Importer/
Distributor | Siemens Medical Systems, Inc.
51 Valley Stream Parkway
Malvern, PA 19355 | | | Registration Number | 2240869 | | | Contact Person | Nealie Hartman
Technical Specialist, Regulatory Affairs
Siemens Medical Solutions
51 Valley Stream Parkway E-50
Malvern, PA 19355
Phone: (610) 448-1769
Fax: (610) 448-1787
Email: nealie.hartman@siemens.com | | | Performance
Standards | | None established under Section 514 the Food, Drug, and Cosmetic Act. | {1}------------------------------------------------ ## II. Safety and Effectiveness Supporting Substantial Equivalence #### Device Description The 31P/1H headcoil for MAGNETOM Allegra is a transmit/receive birdcage type quadrature headcoil double resonant on phosphorus (31P) and proton (1H) frequencies. It is optimized for the main application: 31P spectroscopy potentially including also proton decoupling. The coil consists of the resonator and an electronic box, which serves for switching transmit/receive, quadrature splitting, preamplifying and lowpass filtering in the receive pathway. The latter being essential for proton decoupling. #### Intended Use The 31P/1H headcoil for MAGNETOM Allegra is a transmit/receive birdcage type headcoil double resonant on phosphorus (31P) and proton (1H) frequencies. Used in the Allegra system it is indicated for use as a diagnostic imaging device to produce 1H images and 1H spectra of the internal structures of the head. In addition, 31P spectra can be obtained within the same session without changing the coil. The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules, in which the nucleus under investigation is contained, to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), spin-spin echo time (T2) and resonance frequency of the corresponding nucleus. When interpreted by a trained physician, these images and spectra provide information that can be useful in determining diagnosis. #### Substantial Equivalence Bruker and Siemens believe that, within the meaning of the Safe Medical Device Act of 1990, the 31P/1H headcoil for MAGNETOM Allegra is substantially equivalent to three coils: | Coil Name | Premarket Notification | Clearance Date | |---------------------------------------------------------------------------------------------------------------------|------------------------|----------------------| | Siemens Medical Solutions
31P/1H heart/liver coil for Clinical Phosphorus
Spectroscopy Option MAGNETOM Vision | K962627 | March 04, 1997 | | Siemens Medical Solutions
31P/1H heart/liver coil included in syngo MR 2002B | K020991 | June 13, 2002 | | GE Medical Systems
Signa 1.5T Phosphorus Transmit/Receive Flex Coil | K983139 | February 19,
1999 | Besides 1H imaging, these coils allow the non-invasive in vivo analysis of 31P-metabolites such as phosphocreatine (PCr), inorganic phosphate (Pi) or adenosine triphosphate (ATP) relevant in energy metabolism. The regions applied are heart, liver, muscle, and head. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # NOV - 5 2004 Ms. Nealie Hartman · Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc., USA 51 Valley Stream Parkway MALVERN PA 19355 Re: K042617 Trade/Device Name: 31P/1H headcoil for MAGNETOM Allegra System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: September 23, 2004 Received: September 24, 2004 Dear Ms. Hartman: 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 tthe 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 (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 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 this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsma/dsmamain.httml 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}------------------------------------------------ Indications for Use Ko42617 510(k) Number (if known) __ 31P/1H headcoil for MAGNETOM Allegra System Device Name: ## Indications for Use: The 31P/1H headcoil for MAGNETOM Allegra is a transmit/receive birdcage type headcoil double resonant on phosphorus (31P) and proton (1H) frequencies. Used in the Allegra system it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique 1H images and 1H spectra of the internal structures of the head. In addition, 31P spectra can be obtained within the same session without changing the coil. The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules, in which the nucleus under investigation is contained, to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), spin-spin echo time (T2) of the corresponding nucleus. When interpreted by a trained physician, these images and spectra provide information that can be useful in determining diagnosis. (please do not write below this line- continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation Prescription Use_ OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ h ! '){k} Numbe --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K042617](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K042617) **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