The Head Coil is indicated for use as diagnostic device extension for a Philips, Siemens or GE 3.0 T MR system to provide cross-sectional 1H and/or any X nucleus images, spectroscopic images and/or spectra in any orientation of the internal structure of the head of the patient. These images when interpreted by a trained physician yield information that may assist in diagnosis.

Device Description

The Head Coil is used in Magnetic Resonance Imaging and Spectroscopy (MRI, MRS). The Head Coil has been designed to be used on Siemens, Philips or GE 3.0 T MR systems. The Head Coil is a transmit/receive coil to excite and detect radiofrequency (RF) signals of hydrogen (1H) nuclei in combination with either phosphorus (31P), carbon (13C) or sodium (23 Na) nuclei. Excitation of the nuclei is achieved by applying an RF magnetic field. The detected signal is an RF voltage being induced in the Head Coil by the nuclei observed. The Head Coil mainly offers passive antenna technology for linking the MR system to the patient (and reverse).

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil). It describes the device, its intended use, and why it is considered substantially equivalent to a previously cleared predicate device.

However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:

A table of acceptance criteria and reported device performance. The document mentions "equivalent or better SNR and Image Uniformity performance" but doesn't provide specific quantitative criteria or results in a table format.
Sample size used for the test set and data provenance. The document states "Nonclinical tests were performed on a phantom" and "Clinical images were acquired," but does not specify the sample size for either (e.g., number of phantoms, number of clinical cases/patients). It also doesn't specify data provenance beyond "in vivo" for clinical images.
Number of experts used to establish ground truth and qualifications. This information is absent. Ground truth is only mentioned conceptually for image interpretation by a "trained physician" for diagnosis, not for a test set validation.
Adjudication method for the test set. Not mentioned.
Multi-reader multi-case (MRMC) comparative effectiveness study. Not mentioned.
Standalone (algorithm-only) performance. This is not relevant here as the device is a hardware coil, not an AI algorithm.
Type of ground truth used. For non-clinical tests, physical phantom measurements are the "ground truth." For clinical images, it mentions "images when interpreted by a trained physician," but this isn't a formalized ground truth establishment for a study.
Sample size for the training set. There's no mention of a training set as this is a hardware device submission, not an AI algorithm.
How ground truth for the training set was established. Not applicable.

The document primarily focuses on demonstrating substantial equivalence through:

Comparison of Indications for Use and Intended Use: Stating they are the same or very similar to the predicate.
Technological Characteristics: Highlighting similarities in coil technology and safety.
Nonclinical Tests: Phantom studies for SNR and Image Uniformity, showing "equivalent or better" performance, and compliance with NEMA standards (NEMA MS 1-2008 and NEMA MS 3-2008). It also mentions ESD tests per IEC 60601-2-33.
Clinical Images: Stating that "adequate image quality (SNR, penetration depth, contrast, resolution and robustness against artifacts) as well as scan time and patient comfort are good."

In summary, the provided text describes a medical device (an MRI coil) submission, which relies on demonstrating substantial equivalence to a predicate device through non-clinical performance data and compliance with relevant standards. It does not present a formal clinical study with detailed acceptance criteria, ground truth establishment, or reader studies typical for AI/software-as-a-medical-device (SaMD) submissions.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.

RAPID Biomedical GmbH % Marius Berthel Regulatory Affairs Specialist Kettelerstr. 3-11 Rimpar, Bavaria 97222 Germany

February 1, 2023

Re: K213480

Trade/Device Name: 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: January 2, 2023 Received: January 3, 2023

Dear Marius Berthel:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is by NINGZHI LI. The date of the signature is 2023.02.01, and the time is 13:14:38 -05'00'. The name NINGZHI LI is also present on the left side of the image.

for Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213480

Device Name 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows a logo for "Rapid Biomedical". The word "RAPID" is in large, bold, white letters, stacked above the word "Biomedical", which is also in white letters, but smaller and less bold. The background is a teal color.

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.

General Information

Date of summary preparation: 2022-03-22

1. Manufacturer RAPID Biomedical GmbH Kettelerstrasse 3-11 97222 Rimpar, Bavaria, Germany FEI: 3005049692

2. Distributed by

Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mail Code 65-1A Malvern, PA 19355, USA FEI: 2240869

Philips Medical Systems Nederland BV

Veenpluis 4-6 5684 PC Best, Netherlands FEI: 3003768277 GE Healthcare 3200 Grandview Blvd Waukesha, WI 53188

FEI: 2124823

3. Contact Person

Mr. Marius Berthel RAPID Biomedical GmbH Kettelerstr. 3-11 97222 Rimpar, Bavaria, Germany Phone: +49-9365-8826-0 Fax: +49-9365-8826-99 email: marius.berthel@rapidbiomed.de

Type of Submission 4. Traditional 510(k) Premarket Notification

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Classification and Device Name 5.

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 Names: 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil Proprietary Name: Dual Tuned Head Coil 3T

Safety and Effectiveness Information Supporting Substantial Equivalence

Indications for Use

These images when interpreted by a trained physician yield information that may assist in diagnosis.

Intended Population

Adolescent (from 12 years to 18 years of age) Transitional Adolescent A (18 through 21 years of age) Transitional Adolescent B (18 through 21 years of age) Adults (greater than 21 years of age)

Device Description

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Equivalency Information

RAPID Biomedical believes that the SUBJECT DEVICE is substantially equivalent to the cleared PREDICATE DEVICE which is described in the following submission:

DUAL TUNED HEAD COIL 3T	Clearance Number	Date
31P/1H Head Coil 3T23Na/1H Head Coil 3T13C/1H Head Coil 3T	K102748	2011-05-13

Summary of Technological Characteristics of the SUBJECT DEVICE as compared with the PREDICATE DEVICE

The proposed labelling is adjusted compared to the PREDICATE DEVICE with respect to differing MR systems, changes in the currently applicable standards and for better usability.

Overall, the indications for use, the intended use and the coil technology and safety are substantially equivalent.

General Safety and Effectiveness Concerns

The safety and performance parameters for SUBJECT DEVICE according to the FDA Guidance Document "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued on Nov. 18, 2016" are equivalent or better than for the PREDICATE DEVICE.

Nonclinical Tests

Nonclinical tests were performed on a phantom to evaluate the SUBJECT DEVICE with regard to the applicable imaging parameters Signal to Noise Ratio (SNR) and Image Uniformity. Tests were conducted following NEMA Standards. Moreover and following the principle of reciprocity the transmit efficiency (which is applicable to transmit / receive coils) was compared between SUBJECT DEVICE and PREDICATE DEVICE. Test results show an equivalent or better SNR and Image Uniformity performance of the SUBJECT DEVICE.

ESD-Tests have been performed and successfully passed according to the requirements of IEC 60601-2-33 Ed. 3.2 b:2015, Chapter 202.8.101.

The SUBJECT DEVICE is conforming to:

Recognition number 19-4: AAMI / ANSI ES60601-1:2005/(R)2012 and . A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for safety and essential performance (IEC 60601-1:2005, mod). (General II (ES/EMC)).
Recognition number 12-295: IEC 60601-2-33 Ed. 3.2 b:2015: Medical . electrical equipment - Part 2-33: Particular requirements for the basic safety

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and essential performance of magnetic resonance equipment for medical diagnosis.

Recognition Number 12-188: NEMA MS 1-2008 (R2020) Determination of 0 Signal-to-Noise Ratio (SNR) in Diagnostic Resonance Imaging
Recognition Number 12-187: NEMA MS 3-2008 (R2020) Determination of ● Image Uniformity in Diagnostic Magnetic Resonance Images

All relevant safety tests were performed on the workbench and, where applicable and necessary, on Siemens, Philips and GE 3.0T MR systems.

Clinical Images

Clinical images were acquired in order to check image quality in vivo. Gradient and spin echo sequences which are typical for diagnosis were applied with standard scan parameters and image orientations (axial, sagittal and coronal). These tests show that the SUBJECT DEVICE provides adequate image quality (SNR, penetration depth, contrast, resolution and robustness against artifacts) as well as scan time and that patient comfort are good.

Conclusion as to Substantial Equivalence

Testing was performed to support this claim of substantial equivalence and to show that the modifications do not raise any new questions pertaining to safety and effectiveness.

The modifications did not affect the Indications for Use, the Intended Use and did not alter the Fundamental Scientific Technology.

RAPID Biomedical therefore believes the SUBJECT DEVICE and the PREDICATE DEVICE to be Substantially Equivalent (SE).

Rimpar, 2022-12-21

Signature:

Name:

Dr. Titus Lanz (Manager Development)

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.