(235 days)
The Endorectal Coil is indicated for use as diagnostic device extension 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, displaying the internal structure of the prostate.
These images when interpreted by a trained physician, yield information that may assist in diagnosis.
The Endorectal Coil (1.5T Endorectal Coil O-HLE-015-01899, 1.5T Endorectal Coil O-HLE-015-01946, 3.0T Endorectal Coil O-HLE-030-01900 and ER Coil Support ZUB-01955) 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 reusable receive-only coil for high resolution MR examination of the prostate.
The coil housing is minimum sized and drop-shaped for better patient comfort. It features a flat top to minimize the distance of the inside receive coil electronics to the prostate. The coil is receive-only (Rx) and consists of a single loop coil element with an integrated low noise preamplifier and a connector to the GE 1.5 T MR-System or GE 3.0 T MR-System. The coil is fixed tuned and matched to the typical loading condition of a prostate examination 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 the single loop element providing a decoupling from the Body Coil of the MR System during transmission of the RF excitation pulse.
It is recommended to employ an Endorectal Coil Model in combination with the additional available ER Coil Support. The ER Coil Support is designed for use with any Endorectal Coil Model (1.5T Endorectal Coil O-HLE-015-01899, 1.5T Endorectal Coil O-HLE-015-01946 and 3.0T Endorectal Coil O-HLE-030-01900). It supports stabilizing the Endorectal Coil in any position required by each individual endorectal MR examination. The ER Coil Support features a collet for acceptance of the Endorectal Coil. The Endorectal Coil is fixated inside the collet by tightening of a knurled screw. It offers five degrees of freedom to align the position of the collet with the required spatial position of the Endorectal Coil housing. Two additional knurled screws allow the lock the ER Coil Support in the desired alignment.
The provided document is a 510(k) summary for MRI Endorectal Coils (1.5T and 3.0T) and an ER Coil Support. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a study report demonstrating the device meets those criteria for clinical AI/ML-based diagnostic devices.
The information sought in your request (acceptance criteria, specific study details with sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance, training set details) is typically found in detailed clinical validation reports for AI/ML diagnostic tools. The submitted document for the Endorectal Coil, being a device accessory used to produce images, focuses on performance metrics like Signal-to-Noise Ratio (SNR) and Image Uniformity, safety standards compliance, and clinical image quality in vivo. It does not describe a study involving an AI algorithm making diagnoses or clinical decisions based on these images.
Therefore, many of the specific questions you've asked about AI/ML device validation cannot be answered from this document. However, I can extract information related to the device's technical performance and the nature of the "tests" conducted to support its substantial equivalence.
Here's an attempt to answer based on the available information, noting the limitations due to the nature of the device and the document:
Acceptance Criteria and Study for RAPID Biomedical Endorectal Coils
This submission pertains to an MRI accessory (endorectal coil), not an AI/ML diagnostic device that provides interpretations or diagnoses. Therefore, the "acceptance criteria" and "study" described are focused on the coil's technical performance, fundamental safety, and generation of adequate image quality for human interpretation, rather than the diagnostic accuracy of an AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied/Explicit) | Reported Device Performance |
|---|---|---|
| Technical Performance (Phantom Studies) | Signal to Noise Ratio (SNR) and Image Uniformity evaluated following NEMA Standards Publication MS 6-2008 (R2014). The implicit acceptance criteria would be either demonstrating equivalence or superiority to the predicate device, or meeting established industry standards for these parameters. | SNR: Enhanced performance compared to the PREDICATE DEVICE. Image Uniformity: Compares well to the results from the PREDICATE DEVICE. |
| Clinical Image Quality (In Vivo Studies) | Adequate image quality across various parameters (SNR, penetration depth, contrast, resolution, robustness against artifacts) for typical diagnostic sequences (T2 weighted, Propeller, DWI) with standard scan parameters. Scan time and patient comfort also assessed as "good." The implicit acceptance criteria would be that the images are clinically usable and comparable to or better than those from the predicate device for human interpretation. | Image Quality: Provides adequate image quality (SNR, penetration depth, contrast, resolution, and robustness against artifacts). Scan Time & Patient Comfort: Good. Image Types: Typical sequences for diagnosis were applied (T2 weighted, Propeller, DWI) with standard scan parameters and image orientations. |
| Safety and Compatibility | Compliance with relevant electrical safety and medical device standards (AAMI / ANSI ES60601-1, IEC 60601-2-33). Full system compatibility with GE MR Systems. | Standards Compliance: Conforming to AAMI / ANSI ES60601-1, IEC 60601-2-33, and NEMA MS 6-2008. System Compatibility: All safety tests performed on GE MR Systems were approved by GE, proving full system compatibility. |
| Substantial Equivalence (Overall) | Indications for Use, Intended Use, and coil technology and safety are substantially equivalent to the predicate device. Modifications should not raise new questions pertaining to safety and effectiveness, nor alter the Fundamental Scientific Technology. | The manufacturer believes the SUBJECT DEVICE is substantially equivalent (SE) as testing supports this claim, and modifications did not affect Indications for Use, Intended Use, or Fundamental Scientific Technology. |
2. Sample size used for the test set and the data provenance:
- Nonclinical Tests (Phantom): No specific number provided for the "sample size" of phantoms or tests conducted. It involved "a phantom" (singular).
- Clinical Tests (In Vivo): No specific number of patients or images provided. The document states "Clinical tests were performed in order to check image quality in vivo." and "Sample clinical images in DICOM format are provided as part of the discussion of the clinical tests submitted." This implies a limited, likely small, number of cases for qualitative assessment.
- Data Provenance: Not explicitly stated, but given the manufacturer (RAPID Biomedical GmbH) is in Germany, and the device is for GE MR Systems, the testing likely occurred in a European or US setting, possibly at GE's facilities or collaborating sites. Retrospective/Prospective is not specified, but in vivo testing would inherently involve prospective patient imaging or use of existing image datasets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable in the context of this submission. The device is a hardware accessory (an endorectal coil) that produces images; it does not generate a diagnostic output requiring comparison to an expert-established ground truth for performance evaluation in the way an AI diagnostic algorithm would. The "interpretation by a trained physician" is mentioned in the Indications for Use, implying that human experts are the ones making diagnoses from the images produced by the coil, but their role in establishing "ground truth" for the coil's performance itself is not described.
4. Adjudication method for the test set:
Not applicable. There is no diagnostic output from the device itself to adjudicate.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. MRMC studies are typically performed for diagnostic devices (especially AI/ML software) to evaluate the impact of the device on human reader performance. This submission is for an MRI coil, which is hardware for image acquisition.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is hardware. It is explicitly stated that the images it produces are "when interpreted by a trained physician, yield information that may assist in diagnosis." This indicates a human-in-the-loop workflow for diagnosis, as the device itself is not making a diagnosis.
7. The type of ground truth used:
- Nonclinical (Phantom): The "ground truth" for technical performance (SNR, Image Uniformity) is comparison against established engineering standards (NEMA) and the performance of the predicate device, using objective measurements on a phantom.
- Clinical (In Vivo): The "ground truth" for adequacy of image quality in vivo is likely a qualitative assessment by experienced personnel/physicians as to whether the images show sufficient detail, contrast, and lack of artifacts for diagnostic purposes. This is not "ground truth" in the sense of a confirmed clinical diagnosis (e.g., pathology report) but rather an evaluation of the image's technical and clinical usability.
8. The sample size for the training set:
Not applicable. This is an MRI coil (hardware), not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable. (See #8)
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is the acronym FDA in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 31, 2020
RAPID Biomedical GmbH % Mr. Christian Zimmermann Ouality Management & Official Correspondent Kettelerstrasse 3-11 97222 Rimpar, Bavaria GERMANY
Re: K191539
Trade/Device Name: 1.5T Endorectal Coil. O-HLE-015-01899 and O-HLE-015-01946. 3.0T Endorectal Coil, O-HLE-030-01900; ER Coil Support, ZUB-01955 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: September 17, 2019 Received: December 23, 2019
Dear Mr. 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 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).
Sincerely,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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)
Device Name
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/0 description: The image shows a logo for Rapid Biomedical. The word "RAPID" is in large, bold, black letters at the top. Below that, the word "Biomedical" is in smaller, bold, black letters. At the bottom, in a smaller font, it says "MR Coils - Made to Measure".
510(k)#: K [For a new submission, leave the 510(k) number blank.]
1.5T Endorectal Coil - O-HLE-015-01899 and O-HLE-015-01946 3.0T Endorectal Coil - O-HLE-030-01900
510(k) Summary K191539
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: 2019-06-03
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: +49-9365-8826-0 Fax: +49-9365-8826-99 email: christian.zimmermann@rapidbiomed.de
-
- Type of Submission Traditional 510(k) Premarket Notification
- 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: 1.5T Endorectal Coil and 3.0T Endorectal 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, black letters, with the word "Biomedical" underneath in a smaller font. Below that, the text "MR Coils - Made to Measure" is visible in a smaller font size.
510(k)#: K [For a new submission, leave the 510(k) number blank.]
MR Coils - Made to Measure
1.5T Endorectal Coil - O-HLE-015-01899 and O-HLE-015-01946 3.0T Endorectal Coil - O-HLE-030-01900
Safety and Effectiveness Information Supporting Substantial Equivalence
Indications for Use
The Endorectal Coil is indicated for use as diagnostic device extension 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, displaying the internal structure of the prostate.
These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Device Description
The Endorectal Coil (1.5T Endorectal Coil O-HLE-015-01899, 1.5T Endorectal Coil O-HLE-015-01946, 3.0T Endorectal Coil O-HLE-030-01900 and ER Coil Support ZUB-01955) 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 reusable receive-only coil for high resolution MR examination of the prostate.
The coil housing is minimum sized and drop-shaped for better patient comfort. It features a flat top to minimize the distance of the inside receive coil electronics to the prostate. The coil is receive-only (Rx) and consists of a single loop coil element with an integrated low noise preamplifier and a connector to the GE 1.5 T MR-System or GE 3.0 T MR-System. The coil is fixed tuned and matched to the typical loading condition of a prostate examination 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 the single loop element providing a decoupling from the Body Coil of the MR System during transmission of the RF excitation pulse.
It is recommended to employ an Endorectal Coil Model in combination with the additional available ER Coil Support. The ER Coil Support is designed for use with any Endorectal Coil Model (1.5T Endorectal Coil O-HLE-015-01899, 1.5T Endorectal Coil O-HLE-015-01946 and 3.0T Endorectal Coil O-HLE-030-01900). It supports stabilizing the Endorectal Coil in any position required by each individual endorectal MR examination. The ER Coil Support features a collet for acceptance of the Endorectal Coil. The Endorectal Coil is fixated inside the collet by tightening of a knurled screw. It offers five degrees of freedom to align the position of the collet with the required spatial position of the Endorectal Coil housing. Two additional knurled screws allow the lock the ER Coil Support in the desired alignment.
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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. Below that, the word "Biomedical" is in smaller, bold, black letters with a line underneath. Underneath that, the text "MR Coils - Made to Measure" is in a smaller, black font.
510(k)#: K [For a new submission, leave the 510(k) number blank.]
1.5T Endorectal Coil - O-HLE-015-01899 and O-HLE-015-01946 3.0T Endorectal Coil - O-HLE-030-01900
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 | Clearance Number | Date |
|---|---|---|
| MEDRAD 3.0T eCoil Imaging System | K060401 | 03/15/2006 |
| MEDRAD 1.5T Pelvic Imaging SystemInterface Device | K053042 | 11/17/2005 |
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 concerning applicable imaging parameters Signal to Noise Ratio (SNR) and Image Uniformity. Tests 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. 3.2 b:2015: Medical electrical equipment Part 2-33: Particular . requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. FDA Recognition number: #12-295.
- 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.
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Image /page/6/Picture/0 description: The image is a logo for Rapid Biomedical. The logo has the word "RAPID" in large, bold, black letters on the top line. The word "Biomedical" is in a smaller font size and is located below the word "RAPID". The phrase "MR Coils - Made to Measure" is located at the bottom of the logo.
510(k)#: K [For a new submission, leave the 510(k) number blank.]
1.5T Endorectal Coil - O-HLE-015-01899 and O-HLE-015-01946 3.0T Endorectal Coil - O-HLE-030-01900
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 in order to check image quality in vivo. Typical sequences for diagnosis were applied (T2 weighted, Propeller, DWI) with standard scan parameters and image orientations (axial and sagittal). Clinical 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 patient comfort are good.
Sample clinical images in DICOM format are provided as part of the discussion of the clinical tests submitted.
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, 2019-06-04
Signature:
Name:
Christian Zimmermann (Quality Management & Official Correspondent)
§ 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.