The 16Ch Diagnostic Breast Coils are indicated for use as diagnostic imaging device extensions for GE 1.5 T MR Systems and GE 3.0 T MR Systems to produce transverse, sagittal, coronal and oblique images and/ or spectra, and that displays the internal structure of the breast. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Device Description

The 16Ch Diagnostic Breast Coil (1.5 T 16Ch Diagnostic Breast Coil and 3.0 T 16Ch Diagnostic Breast Coil) is designed for use with a magnetic resonance (MR) system. The coil is designed to work in unison with the Body Coil (BC) of the MR system, which will excite the hydrogen (1H) nuclei with radio frequency (RF) magnetic fields, so that the coil may receive the resultant RF signal from the excited nuclei. The coil is designed as a receive-only coil for high resolution MR examination of breast.

The coil housing features a curved surface for better adaption to the anatomical region of interest. The coil is receive-only (Rx) and consists of 16 independent single loop coil elements with integrated low noise preamplifiers and a connector to the GE 1.5 T MR Systems or the GE 3.0 T MR Systems. The coil is fixed tuned and matched to the typical load of a breast at the Larmor frequency of 1H at 1.5 T (63.9 MHz) or 3.0 T (127.7 MHz) respectively. Decoupling circuits are integrated in each single loop element providing a decoupling from the Body Coil of the MR System during transmission of the RF excitation pulse. The coil provides both, unilateral and bilateral images (Left, Right and Both) of the anatomy of interest.

AI/ML Overview

The provided document is a 510(k) premarket notification for a magnetic resonance breast coil accessory, not a detailed study report for an AI device. As such, it does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML clinical validation.

Here's an analysis of what can be extracted and what information is missing:

Information Extracted:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicit from regulatory standards): The device adheres to safety and performance parameters outlined in the FDA Guidance Document "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued on Nov. 18, 2016." It also conforms to specific international standards for medical electrical equipment (AAMI/ANSI ES60601-1, IEC 60601-2-33) and NEMA standards for MRI coil performance (MS 6-2008, MS 9-2008).
- Reported Device Performance:
  - Nonclinical Tests (Loading phantom): "Test results show an enhanced SNR performance of the subject device, while determined Image Uniformity compares well to the results from the predicate device."
  - Clinical Tests (Volunteers): "Clinical test show that the subject device provides adequate image quality (SNR, penetration depth, contrast, resolution and robustness against artifacts) as well as scan time and patient comfort are good."
Sample size used for the test set and the data provenance:
- Sample Size: Not specified for non-clinical (phantom) or clinical (volunteer) tests.
- Data Provenance: Clinical tests were performed on "volunteers." No country of origin is specified. The tests appear to be prospective, as they were "performed... in order to check image quality in vivo."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not provided. This device is an MRI coil, not an AI diagnostic algorithm, so there's no mention of "ground truth" derived from expert consensus for diagnostic accuracy. The "indications for use" state images "when interpreted by a trained physician, yield information that may assist in diagnosis," but this refers to the end-user, not experts establishing ground truth for a study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not provided for the reasons stated above.
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:
- No MRMC study was mentioned. The device is a breast coil, not an AI assistance tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
The type of ground truth used:
- Not applicable in the typical sense of AI/ML validation (e.g., pathology, outcomes data). The evaluation criteria for this MRI coil focused on technical image quality parameters (e.g., SNR, uniformity, contrast, resolution, artifacts) and patient comfort.
The sample size for the training set:
- Not applicable; this is not an AI/ML device requiring a training set.
How the ground truth for the training set was established:
- Not applicable; no training set.

Summary of Missing Information for AI/ML Context:

The document is a premarket notification for an MRI coil, a hardware accessory. The information requested in the prompt, such as "number of experts," "adjudication method," "MRMC study," "standalone performance," "training set," and "ground truth establishment" (in the context of diagnostic accuracy), are standard requirements for the validation of Artificial Intelligence/Machine Learning (AI/ML) powered diagnostic devices or software. This document is not for such a device, and therefore these details are not present.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 16, 2018

RAPID Biomedical GmbH Christian Zimmermann OM & Official Correspondent Kettelerstrasse 3-11 97222 RIMPAR, BAVARIA, GERMANY

Re: K181948

Trade/Device Name: 1.5 T 16Ch Diagnostic Breast Coil - P-H16LE-015-01811, 3.0 T 16Ch Diagnostic Breast Coil - P-H16LE-030-01630 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: August 2, 2018 Received: September 17, 2018

Dear Christian Zimmermann:

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

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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); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hole 2. Nils

for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K181948
Device Name
1.5 T 16Ch Diagnostic Breast Coil - P-H16LE-015-01811
3.0 T 16Ch Diagnostic Breast Coil - P-H16LE-030-01630

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows the logo for Rapid Biomedical. The logo has the word "RAPID" in large, bold, black letters on top of the word "Biomedical" in a smaller font. Below the words is the phrase "MR Coils - Made to Measure" in a small font.

Traditional 510(k) Premarket Notification K181948

1.5 T 16Ch Diagnostic Breast Coil - P-H16LE-015-01811 3.0 T 16Ch Diagnostic Breast Coil - P-H16LE-030-01630

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: 2018-11-15

1. Manufacturer

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

2. Distributed by

GE Healthcare 3200 Grandview Blvd Waukesha, WI 53188 FEI: 2124823

3. . Contact Person

Mr. Christian Zimmermann RAPID Biomedical GmbH Kettelerstr. 3-11 97222 Rimpar, Bavaria, Germany Phone: +49-9365-8826-44 Fax: +49-9365-8826-99 email: christian.zimmermann@rapidbiomed.de

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

5. 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 Names: 1.5 T 16Ch Diagnostic Breast Coil and 3.0 T 16Ch Diagnostic Breast Coil

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Image /page/4/Picture/0 description: The image shows a logo for "RAPID Biomedical". The word "RAPID" is in large, bold, red letters, and the word "Biomedical" is in smaller, black letters below it. Underneath that, the text "MR Coils - Made to Measure" is in smaller, black letters.

Traditional 510(k) Premarket Notification K181948 1.5 T 16Ch Diagnostic Breast Coil - P-H16LE-015-01811

3.0 T 16Ch Diagnostic Breast Coil - P-H16LE-030-01630

Safety and Effectiveness Information Supporting Substantial Equivalence

Indications for Use

The 16Ch Diagnostic Breast Coils are indicated for use as diagnostic imaging device extensions for GE 1.5 T MR Systems and GE 3.0 T MR Systems to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that display the internal structure of the breast. These images when interpreted by a trained physician yield information that may assist in diagnosis.

Device Description

Equivalency Information

RAPID Biomedical believes that the Subject Device is substantially equivalent to the cleared Predicate Device which is described in the following submission.

Predicate Device Name	Clearance Number	Date
16ch Al Breast Coil 1.5T and 16ch AlBreast Coil 3T	K083255	2008-11-21

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.

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Image /page/5/Picture/0 description: The image shows a logo for "RAPID Biomedical". The word "RAPID" is in large, bold, black letters, with the word "Biomedical" underneath it in a smaller font. A horizontal line separates the two words. Below the word "Biomedical" is the phrase "MR Coils - Made to Measure" in a smaller font.

Traditional 510(k) Premarket Notification K181948

1.5 T 16Ch Diagnostic Breast Coil - P-H16LE-015-01811 3.0 T 16Ch Diagnostic Breast Coil - P-H16LE-030-01630

General Safety and Effectiveness Concerns

The safety and performance parameters according to the FDA Guidance Document "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued on Nov. 18, 2016" are unaffected by the modifications described within this notification.

Nonclinical Tests

Nonclinical tests were performed on a loading phantom to evaluate the subject device concerning applicable imaging parameters Signal to Noise Ratio (SNR) and Image Uniformity. Test were conducted following NEMA Standards. Test results show an enhanced SNR performance of the subject device, while determined Image Uniformity compares well to the results from the predicate device.

The subject device is conforming to:

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)). FDA Recognition number: #19-4
IEC 60601-2-33 Ed. 3.1:2013, medical electrical equipment part 2-33: particular . requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. (Radiology). FDA Recognition number: #12-271
NEMA Standards Publication MS 6-2008 (R2014) Determination of Signal-to-Noise . Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging. FDA Recognition number: #12-195
NEMA Standards Publication MS 9-2008 (R2014) Standards Publication 0 Characterization of Phased Array Coils for Diagnostic Resonance Images. FDA Recognition number: #12-288

All safety tests were performed on GE MR Systems. The test results are approved by GE for proving the full system compatibility.

Clinical Tests

Clinical tests were performed on volunteers in order to check image quality in vivo. Typical sequences for diagnosis were applied (Vibrant, DWI, CUBE T2-flex, FSE T2 with Aspir, FSPGR-T1) with standard scan parameters and image orientations (axial and sagittal). Clinical test show that the subject device provides adequate image quality (SNR, penetration depth, contrast, resolution and robustness against artifacts) as well as scan time and patient comfort are good.

Sample clinical images (Dicoms) are provided as part of the discussion of the clinical tests submitted.

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Image /page/6/Picture/0 description: The image shows the logo for Rapid Biomedical. The logo has the word "RAPID" in large, bold, sans-serif font on the top line. Below that is the word "Biomedical" in a smaller, bold, sans-serif font. The tagline "MR Coils - Made to Measure" is at the bottom of the logo in a smaller, regular font.

Traditional 510(k) Premarket Notification K181948

1.5 T 16Ch Diagnostic Breast Coil - P-H16LE-015-01811 3.0 T 16Ch Diagnostic Breast Coil - P-H16LE-030-01630

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 devices and the Predicate Devices to be substantially equivalent (SE).

Rimpar, 2018-11-15

Signature:

Name:

Christian Zimmermann (Official Correspondent)

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.