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 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.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, a 31P/1H headcoil for a MAGNETOM Allegra MRI system. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a novel diagnostic algorithm.

Therefore, much of the requested information regarding "acceptance criteria" and "device performance" in the context of a study analyzing diagnostic accuracy (e.g., sensitivity, specificity, AUC) is not explicitly detailed in the provided content. The clearance for this device is based on its similarity to existing, cleared devices for performing MR imaging and spectroscopy.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Formal, quantifiable acceptance criteria in the sense of diagnostic performance metrics (e.g., specific sensitivity or specificity thresholds) are not provided in this 510(k) summary. The "acceptance" here is the FDA's determination of substantial equivalence to predicate devices. The performance is implicitly accepted as being similar to that of the predicate devices.

Acceptance Criterion (Implied for Substantial Equivalence to Predicates)	Reported Device Performance (Summary of device capabilities)
Safety: Safe for use in MRI environment.	"Device is a transmit/receive birdcage type quadrature headcoil double resonant on phosphorus (31P) and proton (1H) frequencies."
	"Optimized for the main application: 31P spectroscopy potentially including also proton decoupling."
Effectiveness: Capable of producing diagnostic quality 1H images and 31P spectra of the head.	"Indicated for use as a diagnostic imaging device to produce 1H images and 1H spectra of the internal structures of the head."
	"31P spectra can be obtained within the same session without changing the coil."
	"Images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules... to be distinguished."
Compatibility: Operates with the MAGNETOM Allegra system as intended.	"Used in the Allegra system..."
Performance Characteristics: Similar NMR properties (spin density, T1, T2, resonance frequency) of corresponding nuclei as predicate devices.	Implicitly similar to predicates. The device's description highlights its ability to distinguish molecules based on NMR properties.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical study with a "test set" in the context of evaluating a diagnostic algorithm's performance on a specific dataset. The evaluation is based on technical specifications and comparison to predicate devices, not on a dataset of patient scans used for performance metrics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. As there is no "test set" for diagnostic performance evaluation of an algorithm, there are no experts establishing ground truth for such a set described in this document.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a hardware component (MRI coil), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done

Not applicable. This is a hardware component, not a standalone AI algorithm.

7. The Type of Ground Truth Used

Not applicable in the typical sense of a diagnostic algorithm validation. The "ground truth" for this device's functionality would be its ability to produce technically sound 1H images and 31P spectra that are consistent with known physics and expected in vivo results, as assessed through engineering tests and comparison to established predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a hardware component, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, this is a hardware device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) premarket notification process for substantial equivalence. Instead of a clinical trial demonstrating specific performance metrics against a "ground truth," the manufacturer, Bruker BioSpin MRI GmbH (and initial importer Siemens Medical Systems, Inc.), demonstrated that the 31P/1H headcoil for MAGNETOM Allegra is substantially equivalent to three previously cleared predicate devices:

Siemens Medical Solutions 31P/1H heart/liver coil for Clinical Phosphorus Spectroscopy Option MAGNETOM Vision (K962627, cleared March 04, 1997)
Siemens Medical Solutions 31P/1H heart/liver coil included in syngo MR 2002B (K020991, cleared June 13, 2002)
GE Medical Systems Signa 1.5T Phosphorus Transmit/Receive Flex Coil (K983139, cleared February 19, 1999)

The basis of this equivalence is that the new device shares the same intended use (diagnostic imaging of the head for 1H images and spectra, and 31P spectra) and similar technological characteristics (transmit/receive birdcage type headcoil, double resonant on 31P and 1H frequencies) as the predicate devices. The submission likely included technical specifications, engineering test results, and a comparison of performance characteristics (e.g., coil geometry, resonant frequencies, image quality metrics) to demonstrate that the new coil performs similarly to the predicate devices and raises no new questions of safety or effectiveness. The FDA's review and clearance (K042617) signify their agreement with this claim of substantial equivalence.

Summary

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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 InformationDevice 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 GmbHRudolf-Plank-Straße 23D-76275 Ettlingen, Germany
Registration Number	9612385
Initial Importer/Distributor	Siemens Medical Systems, Inc.51 Valley Stream ParkwayMalvern, PA 19355
Registration Number	2240869
Contact Person	Nealie HartmanTechnical Specialist, Regulatory AffairsSiemens Medical Solutions51 Valley Stream Parkway E-50Malvern, PA 19355Phone: (610) 448-1769Fax: (610) 448-1787Email: nealie.hartman@siemens.com
PerformanceStandards		None established under Section 514 the Food, Drug, and Cosmetic Act.

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II. Safety and Effectiveness Supporting Substantial Equivalence

Device Description

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.

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 Solutions31P/1H heart/liver coil for Clinical PhosphorusSpectroscopy Option MAGNETOM Vision	K962627	March 04, 1997
Siemens Medical Solutions31P/1H heart/liver coil included in syngo MR 2002B	K020991	June 13, 2002
GE Medical SystemsSigna 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.

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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.

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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

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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.

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

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.