13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA

K042718 · Siemens Medi Cal Solutions, Inc. · MOS · Nov 12, 2004 · Radiology

Device Facts

• Record ID: K042718
• Device Name: 13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA
• Applicant: Siemens Medi Cal Solutions, Inc.
• Product Code: MOS · Radiology
• Decision Date: Nov 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The 13C/1H occipital headcoil for MAGNETOM Allegra is a transmit/receive surface coil type headcoil double resonant on carbon (13C) and proton (1H) frequencies. Used in the Allegra system it is indicated for use as a diagnostic imaging device for internal structures of the head. In addition, 13C spectra can be obtained within the same session without changing the coil. The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. The parameters that determine the image and spectra appearance are spin density, spin-latice 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 13C/1H occipital headcoil is a transmit/receive surface coil for the MAGNETOM Allegra MRI system. It features double resonance on carbon (13C) and proton (1H) frequencies, enabling both 1H imaging and 13C spectroscopy in a single session. The device consists of a resonator and an electronic box for switching transmit/receive and signal amplification, including proton decoupling. Used in clinical settings by trained physicians, the coil captures magnetic resonance signals from head tissues. The resulting images and spectra, based on spin density, T1, T2, and resonance frequency, are interpreted by physicians to assist in clinical diagnosis. The device provides non-invasive metabolic and structural information, potentially benefiting patients by allowing advanced spectroscopic analysis without requiring additional coil changes.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by the device's design as a specialty coil for spectroscopy and existing scientific literature regarding the utility of 13C spectroscopy.

Technological Characteristics

Transmit/receive surface headcoil; double resonant on 13C and 1H frequencies; quadrature design. Includes resonator and electronic box for switching and proton decoupling. Operates as an accessory to the MAGNETOM Allegra MRI system. No specific materials or software algorithm class specified.

Indications for Use

Indicated for diagnostic imaging of internal head structures and acquisition of 13C spectra in patients undergoing MRI/MRS examinations.

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

• 31P/1H heart/liver coil for Clinical Phosphorus Spectroscopy Option MAGNETOM Vision (K962627)
• 31P/1H heart/liver coil included in syngo MR 2002B (K020991)
• Signa 1.5T Phosphorus Transmit/Receive Flex Coil (K983139)

Submission Summary (Full Text)

{0}------------------------------------------------

# Section 1: 510(k) Summary

42718

This summary of 510(k) safety and effectiveness information is being submitted in accordance with
er and of the first for 1900 - - LA GED & 907 03 I his summary of 510(x) sa.65) sa.65 - 1.990 and 21 CFR § 807.92.

| I. General Information | | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Device Name | Trade Name: | 13C/1H occipital headcoil for<br>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<br>Rudolf-Plank-Straße 23<br>D-76275 Ettlingen, Germany | |
| Registration Number | 9612385 | |
| Initial Importer/<br>Distributor | Siemens Medical Solutions, Inc.<br>51 Valley Stream Parkway<br>Malvern, PA 19355 | |
| Registration Number | 2240869 | |
| Contact Person | Nealie Hartman<br>Technical Specialist, Regulatory Affairs<br>Siemens Medical Solutions<br>51 Valley Stream Parkway E-50<br>Malvern, PA 19355<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Performance<br>Standards | None established under Section 514 the Food, Drug, and Cosmetic Act. | |

{1}------------------------------------------------

## II. Safety and Effectiveness Supporting Substantial Equivalence

#### Device Description

Device Description
The 13C/1H occipital headcoil for MAGNETOM Allegra is a transmit/receive surface coil type 1H-The 13C/IT occipian headcoil double resonant on carbon (13C) and proton (1H) frequencies. It is quadrature) . C mical neader dodore rsoctanscopy potentially including proton decoupling.

The coil consists of the resonator and an electronic box which serves for switching transmit/receive, I he consists of the resoliation and an envolvening in the receive pathway. The latter being essential for proton decoupling.

#### Intended Use

The 13C/IH occipital headcoil for MAGNETOM Allegra is a transmit/receive surface coil type headcoil double resonant on carbon (13C) and proton (1H) frequencies.

Used in the Allegra system it is indicated for use as a diagnostic imaging device 1H Osed in the Anegra system it is in internal structures of the head. In addition, 13C spectra can be obtained within the same session without changing the coil.

The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. The mages produced for ophich the nucleus under investigation is contained to be Specula "anow" the "moreoarer that determine the image and spectra appearance are spin density, spin-latice relaxation time (TI), 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

Bulbstantial Equivalence 13C/IH occipital headcoil for MAGNETOM Allegra is substantially equivalent to three coils:

| Coil Name | Premaket Notification | Clearance Date |
|---------------------------------------------------------------------------------------------------------------------|-----------------------|----------------------|
| Siemens Medical Solutions<br>31P/1H heart/liver coil for Clinical Phosphorus<br>Spectroscopy Option MAGNETOM Vision | K962627 | March 04, 1997 |
| Siemens Medical Solutions<br>31P/1H heart/liver coil included in syngo MR 2002B | K020991 | June 13, 2002 |
| GE Medical Systems<br>Signa 1.5T Phosphorus Transmit/Receive Flex Coil | K983139 | February 19,<br>1999 |

Although these coils are designed for non-invasive in vivo detection of phosphorus-31-metabolites instead of the carbon-13-metabolites detectable with the coil described in this submission, we believe that they are substantially equivalent Magnetic Resonance Specialty Coils for spectroscopy of nuclei other than protons (1H), the latter being used for magnetic resonance imaging (MRI).

There are numerous publications by researchers worldwide to support the usefulness of 13C spectroscopy. No risks different to standard MRI occur for the patient during these investigations.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### NOV 1 2 2004

Ms. Nealie Hartman Technical Specialist, Regulatory Affairs Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 MALVERN PA 19355

Re: K042718

Trade/Device Name: 13C/1H occipital 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 29, 2004 Received: September 30, 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 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.