The Dual Tuned Surface Coils 3T are surface type transmit/receive coils dual tuned on l H (proton) and either 31P (phosphorus), 23Na (sodium) or 13C (carbon) nuclei. The coils are indicated for use as a diagnostic imaging device accessory to Siemens MAGNETOM Trio, A Tim System 3T and MAGNETOM Verio 3T magnetic resonance diagnostic devices to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Device Description

The Dual Tuned Surface Coils 3 T are transmit/receive surface coils to detect radiofrequency (RF) signals of hydrogen (1H) nuclei in combination with either phosphorus (31P), carbon (13C) or sodium (23Na) nuclei. Each coil consists of two single concentric loops, one of which is always tuned to the proton frequency, the other being tuned to either phosphorus-31P, carbon-13C or sodium-23Na frequency. Additional components are housed in a separate interface housing box.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Dual Tuned Surface Coils 3T, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission acts as a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device rather than explicitly defining and meeting specific quantitative acceptance criteria in a pass/fail manner. Instead, the submission outlines parameters considered and states that the new device's performance results in these areas are "equivalent with the predicate devices."

Acceptance Criteria (Parameters Considered from FDA Guidance)	Reported Device Performance
Safety
Biocompatibility	No new materials in contact with patients; thus, no biocompatibility tests performed. Assumed equivalent to predicate.
RF Power Deposition	Tested; assumed acceptable.
Performance - Imaging
Signal to Noise Ratio (SNR)	Tested according to NEMA MS 6-2008; results "show that they are equivalent with the predicate devices."
Image Uniformity	Tested according to NEMA MS 6-2008; results "show that they are equivalent with the predicate devices."
Slice Profile, Thickness and Gap	Slice profile tests performed according to NEMA MS 5-2003; results "show that they are equivalent with the predicate devices."
Performance - Spectroscopy
Spectral Resolution	Spectroscopic tests on spectral resolution carried out; assumed acceptable.
Signal to Noise Ratio (SNR)	Spectroscopic tests on SNR carried out; assumed acceptable.
Decoupling	Spectroscopic tests on decoupling carried out; assumed acceptable.

Note: The document does not provide specific numerical values for the performance metrics, only stating equivalence to the predicate device or that tests were performed.

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

The provided text does not explicitly state a "test set" in the context of human subject data. The testing described appears to be primarily bench testing or phantom testing on the device itself and its interaction with MR systems. Therefore, there is no mention of human subject sample sizes or data provenance (country of origin, retrospective/prospective). The tests were performed on "the Siemens MAGNETOM Trio a Tim System" which is an MR scanner.

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

Not applicable. This device is an accessory (surface coil) for an MR diagnostic device. The ground truth for its performance tests (e.g., SNR, image uniformity, spectral resolution) would be derived from quantitative measurements based on standardized test methods (like NEMA standards), not expert interpretation of images/spectra for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the performance is assessed through quantitative measurements, not expert adjudication of diagnostic outcomes.

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 submission is for a hardware accessory (MR coil), not an AI-powered diagnostic software.

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

Not applicable. This is a hardware device. Its "performance" is inherently "standalone" in that it produces raw data/images/spectra, which are then interpreted by a human. The coil itself is not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the device's performance tests would be established through quantitative measurements against recognized industry standards (e.g., NEMA standards) or engineering specifications. For example, SNR would be measured directly from phantom images, spectral resolution from known chemical phantoms, etc. This is not a diagnostic device where pathology or expert consensus would establish ground truth for clinical decision-making.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not a machine learning algorithm that requires a "training set."

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

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

Summary

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K102348
p'/5

Section 8 510(k) Summary

DEC 2 2 2010

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

I. General Information

Date of summary preparation: December 22, 2010

Manufacturer

Rapid Biomedical GmbH Technologiepark Wuerzburg-Rimpar Kettelerstrasse 3-11 D-97222 Rimpar, Germany Germany

Registration number: 3005049692

Importer/Distributor

RAPID MR International, LLC 2236 CityGate Drive Columbus, Ohio 43219-3565 USA

Owner/operator number: 10033421

Contact Person

Mr. Armin Purea Rapid Biomedical GmbH Kettelerstrasse 3-11 D-97222 Rimpar, Germany

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K102348
$\rho^{2/5}$

Phone: +49 (9365) 8826-48 Fax: +49 (9365) 8826-99 e-mail: armin.purea@rapidbiomed.de

II. Classification and Device Name

Classification Panel:	Radiology
Classification Name:	Magnetic Resonance Diagnostic Device Accessory
Device Class:	Class II [21 CFR § 892.1000]
Product Code:	MOS
Product Nomenclature:	Coil, Magnetic Resonance, Specialty
Common Name:	Special Purpose Coil
Trade Name(s):	31P/1H Dual Tuned Surface Coil 3 T23Na/1H Dual Tuned Surface Coil 3 T13C/1H Dual Tuned Surface Coil 3 T

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III. Safety and Effectiveness Information Supporting Substantial Equivalence Intended Use

Device Description

Equivalency Information

Rapid Biomedical believes that the Dual Tuned Surface Coils 3 T are substantially equivalent to the cleared 31P/IH heart/liver coil by Siemens Healthcare (formerly Siemens Medical Solutions) which is described in the following submission:

Predicate Device Name	FDA Clearance Number	FDA Clearance Date
Siemens Medical Solutions 31P/IHheart/liver coil included in syngo MR2002B	K020991	Jun 13th, 2002

Summary of Technological Characteristics of the Principal Device as compared with the Predicate Device

In contrast to the predicate device, the Dual Tuned Surface Coils 3 T are designed for a field strength of 3 T. While the predicate device was only available as 31P//H coil, the new devices are also available as 23Na/1H and 13C/1H coils. Although the predicate coil is designed for non-invasive in vivo detection of 31P-metabolites instead of the additional 13C and 23Na metabolites detectable with the coils described in this submission, we believe that they are substantially equivalent Magnetic Resonance Specialty Coils for spectroscopy of nuclei other than protons. Numerous publications by researchers worldwide support the usefulness of 13C and 23Na spectroscopy. No risks different to standard MR occur for the patient during these investigations.

General Safety and Effectiveness Concerns

The following safety and performance parameters:

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KID2348 p4/5

[Safety]

Maximum Static Field
Rate of Change of Magnetic Field
Acoustic Noise Level

[Performance-Imaging]

Geometric Distortion
High Contrast Spatial Resolution

[Performance-Spectroscopy]

Spatial Localization Accuracy
Peak Assignment Accuracy
Solvent Suppression

specified by the FDA Guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification.

The following parameters were considered for the new Dual Tuned Surface Coils 3 T:

[Safety]

Biocompatibility
RF Power Deposition

[Performance-Imaging]

Signal to Noise Ratio
Image Uniformity
Slice Profile, Thickness and Gap

[Performance-Spectroscopy]

Spectral Resolution
Signal to Noise Ratio
Decoupling

The new devices conform to IEC 60601-1 and IEC 60601-2-33, 2nd edition. All safety tests are performed on the Siemens MAGNETOM Trio a Tim System. This is the

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most critical engine for safety and performance of the Siemens MAGNETOM 3T series. Passing these tests gives the Siemens approval for the complete MAGNETOM 3T series.

No new materials coming in contact with patients were used for the new Dual Tuned Surface Coils 3 T compared to the predicate device. Therefore no biocompatibility tests were performed. Signal to Noise Ratio (SNR) and image uniformity tests according to NEMA MS 6-2008 as well as slice profile tests according to NEMA MS 5-2003 were performed for the new Dual Tuned Surface Coils 3 T and the results presented in this submission show that they are equivalent with the predicate devices.

Furthermore, spectroscopic tests on SNR, spectral resolution and decoupling were carried out.

Conclusion as to Substantial Equivalence

Laboratory testing was performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Armin Purea Rapid Biomedical GmBH Kettelerstr 3-11 Rimpar. Bavario GERMANY 97222

DEC 2 2 2019

Re: K102348

Trade Name: 31P/1H Dual Tuned Surface Coil: 13C/1H Dual Tuned Surface Coil 3T; 23Na/1H Dual Tuned Surface Coil 3T Regulation Number: 21 CFR § 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 29, 2010 Received: December 1, 2010

Dear Mr. Purea:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Section 3

Indications for Use Statement

Indications for Use

DEC 2 2 2010

510(k) Number: K102348

Device Name: Dual Tuned Surface Coils 3T

Indications for Use:

The Dual Tuned Surface Coils 3T are surface type transmit/receive coils dual tuned on 1H (proton) and either 31P (phosphorus), 23Na (sodium) or 13C (carbon) nuclei. The coils are indicated for use as a diagnostic imaging device accessory to Siemens MAGNETOM Trio, A Tim System 3T and MAGNETOM Verio 3T magnetic resonance diagnostic devices to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart C)

(please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

(Difision Sign=Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K162348

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.