The Dual Tuned Head Coils 3T are indicated for use as a diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Device Description

The Dual Tuned Head Coils 3T are transmit/receive volume 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 quadrature resonators, one of which is always tuned to the proton frequency, the other being tuned to either phosphorus, carbon or sodium frequency.

AI/ML Overview

The device in question is a component of an MRI system (Dual Tuned Head Coils 3T) and as such, its acceptance criteria and performance are focused on its technical contribution to image quality and safety, rather than diagnostic accuracy like an AI algorithm. Therefore, many of the requested points regarding diagnostic performance, ground truth, experts, and human-in-the-loop studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Parameter	Acceptance Criterion (implicitly met by equivalence)*	Reported Device Performance
Safety	Biocompatibility	No new materials in contact with patient.	Met (No new materials, no biocompatibility tests needed).
	RF Power Deposition (SAR)	Compliance with NEMA MS 8-2008	Performed according to NEMA MS 8-2008.
	Maximum Static Field	Unaffected by modifications	Unaffected.
	Rate of Change of Magnetic Field	Unaffected by modifications	Unaffected.
	Acoustic Noise Level	Unaffected by modifications	Unaffected.
Performance - Imaging	Signal to Noise Ratio (SNR)	Equivalent to predicate devices (NEMA MS 1-2008)	Showed equivalence with predicate devices.
	Image Uniformity	Equivalent to predicate devices (NEMA MS 1-2008)	Showed equivalence with predicate devices.
	Slice Profile, Thickness and Gap	Equivalent to predicate devices (NEMA MS 5-2003)	Showed equivalence with predicate devices.
	Geometric Distortion	Unaffected by modifications	Unaffected.
	High Contrast Spatial Resolution	Unaffected by modifications	Unaffected.
Performance - Spectroscopy	Spectral Resolution	Performed and results presented to demonstrate equivalence.	Carried out.
	Signal to Noise Ratio	Performed and results presented to demonstrate equivalence.	Carried out.
	Decoupling	Performed and results presented to demonstrate equivalence.	Carried out.
	Spatial Localization Accuracy	Unaffected by modifications	Unaffected.
	Peak Assignment Accuracy	Unaffected by modifications	Unaffected.
	Solvent Suppression	Unaffected by modifications	Unaffected.

Note: The document states that "the results presented in this submission show that they are equivalent with the predicate devices" for several performance parameters. This implies the acceptance criterion was to demonstrate equivalence to the predicate devices based on established NEMA standards or other tests.

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

Sample Size: Not explicitly stated. The tests conducted were laboratory-based performance tests on the device itself, rather than clinical studies involving human patients or a specific "test set" of images/data in the typical sense of an AI study.
Data Provenance: The tests were conducted in a laboratory setting by the manufacturer, Rapid Biomedical GmbH, in Germany. The data is thus internal to the manufacturer, from device testing.

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

Not Applicable. This device is a hardware component (MRI coil). The "ground truth" here is the physical performance and safety metrics of the coil itself, measured through standardized tests (e.g., NEMA standards) on a phantom or test object, not clinical interpretations by human experts.

4. Adjudication Method for the Test Set

Not Applicable. As per point 3, there was no "test set" requiring adjudication by human experts for diagnostic accuracy. The assessment was based on objective, quantifiable engineering and physics measurements.

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 is a hardware device (MRI coil), not an AI algorithm. No MRMC study was performed as it's not relevant to demonstrating the safety and effectiveness of an MRI coil.

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

Not Applicable. This is a hardware device (MRI coil), not an algorithm. Performance tests were done on the standalone device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on objective physical measurements against established standards (e.g., NEMA MS 1-2008, NEMA MS 3-2008, NEMA MS 5-2003, NEMA MS 8-2008) and comparison to the performance of predicate devices. For safety parameters (like static field, acoustic noise), the ground truth is adherence to general safety guidelines or the fact that modifications did not affect these parameters.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not Applicable. As per point 8, there is no training set for this hardware device.

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

The study involved a series of laboratory tests designed to evaluate the safety and performance of the Dual Tuned Head Coils 3T. These tests included:

RF Power Deposition (SAR) determination: Performed according to NEMA MS 8-2008.
Imaging Performance:
- Signal to Noise Ratio (SNR) tests according to NEMA MS 1-2008.
- Image Uniformity tests according to NEMA MS 3-2008.
- Slice Profile tests according to NEMA MS 5-2003.
Spectroscopy Performance:
- SNR tests.
- Spectral Resolution tests.
- Decoupling tests.

Additionally, biocompatibility was addressed by confirming that no new patient-contacting materials were used, thus precluding the need for new biocompatibility tests. Other general safety and performance parameters (Maximum Static Field, Rate of Change of Magnetic Field, Acoustic Noise Level, Geometric Distortion, High Contrast Spatial Resolution, Spatial Localization Accuracy, Peak Assignment Accuracy, Solvent Suppression) were deemed "unaffected by the modifications."

The results of these laboratory tests demonstrated "equivalence with the predicate devices," thereby supporting the manufacturer's claim of substantial equivalence and showing that the technological differences did not raise new questions pertaining to safety and effectiveness, as required for 510(k) clearance.

Summary

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MAY 1 3 2011

Section 8 510(k) Summary

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: September 20th, 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

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

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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 Head Coil 3T
	23Na/1H Head Coil 3T
	13C/1H Head Coil 3T

III. Safety and Effectiveness Information Supporting Substantial Equivalence Intended Use

Device Description

Equivalency Information

Rapid Biomedical believes that the Dual Tuned Head Coils 3T are substantially equivalent to the cleared 31P/IH heart/liver coil by Siemens Healthcare (formerly Siemens Medical Solutions) and the Tx/Rx Head Coil by USA Instruments which are described in the following submissions:

Predicate Device Name	FDA Clearance Number	FDA Clearance Date
Siemens Medical Solutions 31P/IHheart/liver coil included in syngo MR2002B	K020991	Jun 13th, 2002
MAGNETOM TRIO QUADRATURETX/RX HEAD COIL	K021330	May 25th,2002

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

The new devices feature a combination of both predicates: the ability to conduct spectroscopic examinations on non-proton nuclei is found in the 31P/1H Heart/Liver coil, while the fundamental coil design of a quadrature resonator is comparable to the

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Tx/Rx Head Coil. While the predicate device 31P/1H Heart/Liver was only available as 31P/1H 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 31Pmetabolites instead of the 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:

[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 Head Coils 3T:

[Safety]

Biocompatibility
RF Power Deposition

[Performance-Imaging]

Signal to Noise Ratio

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Image Uniformity
Slice Profile, Thickness and Gap

[Performance-Spectroscopy]

Spectral Resolution
Signal to Noise Ratio
Decoupling

No new materials coming in contact with patients were used for the new Dual Tuned Head Coils 3T compared to the predicate device. Therefore no biocompatibility tests were performed. Signal to Noise Ratio (SNR) and image uniformity tests according to NEMA MS 1-2008 and NEMA MS 3-2008 as well as slice profile tests according to NEMA MS 5-2003 were performed for the new Dual Tuned Head Coils 3T and the results presented in this submission show that they are equivalent with the predicate devices. SAR determination was performed according to NEMA MS 8-2008.

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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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Armin Purea Official Correspondent RAPID Biomedical GmbH Technologiepark Wuerzburg-Rimpar, Kettelerstr. 3-11 Rimpar. Bayern 97222 GERMANY

MAY 1 3 2011

Re: K102748

Trade/Device Name: Dual Tuned Head Coil 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 4, 2011 Received: April 4, 2011

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, listing 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.

Mary Pastel

Mary S. Pastel. Sc.D. 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 2 Indications for Use Statement

Indications for Use

510(k) Number (if known): K102748

Device Name: Dual Tuned Head Coils 3T

Indications for Use:

The Dual Tuned Head Coils 3T are indicated for use as a diagnostic imaging device accessory 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. 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 Device Evaluation

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostin Du

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.