(20 days)
The 1.5T Pelvic Imaging System is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human colon, cervix or prostate and surrounding pelvic tissue. The purpose of the interface device for the 1.5T Pelvic Imaging System is to provide interface and support functions to allow the use of MEDRAD 1.5T disposable endorectal coils with GE Signa EXCITE 1.5T MRI scanner systems and body array coils. Only trained healthcare professionals are intended to operate this device.
The MEDRAD 1.5T Pelvic Imaging System Interface Device maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device. The device is a receive-only surface coil that interfaces with 1.5T GE Signa EXCITE scanners and MEDRAD 1.5T Endorectal Coils and GE 8- or 12-channel Body Array. It utilizes active and passive decoupling and performs RF signal pre-amplification for the Endorectal Coil.
This document provides a 510(k) summary for the MEDRAD 1.5T Pelvic Imaging System Interface Device, which is a medical device accessory used in Magnetic Resonance Imaging (MRI). The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics that would be typical for an AI/ML or diagnostic image analysis device.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable or cannot be extracted from the provided text, as this is a submission for a hardware interface device, not a diagnostic algorithm.
Here's an analysis of the provided information based on your request, highlighting what can and cannot be extracted:
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This submission is for a hardware interface device (an accessory for MRI coils), not a diagnostic algorithm with measurable performance metrics like sensitivity, specificity, or AUC. The "acceptance criteria" for such a device are typically related to safety, interoperability, and functional equivalence to a predicate device. The document states that the device "maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. There is no "test set" in the context of diagnostic image data for this hardware device. The comparison is feature-based against a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth, in the context of diagnostic performance, is not relevant for this hardware interface device.
4. Adjudication Method for the Test Set
Not applicable. No test set or expert adjudication is described for this hardware device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth for diagnostic performance is irrelevant for this hardware device. The "ground truth" for this submission is effectively the functional specification and performance of the predicate device, against which the new device is compared for equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a hardware device, not an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device Equivalence (from the document):
The submission demonstrates substantial equivalence by comparing the MEDRAD 1.5T Pelvic Imaging System Interface Device to its predicate, the MEDRAD, INC. 1.5T ATD-T Interface Device (K974438). The comparison table highlights the following:
| Feature | (Predicate) MEDRAD 1.5T ATD-T | (Proposed) MEDRAD Pelvic Imaging System Interface Device |
|---|---|---|
| Coil Type | Receive-only surface coil. | Receive-only surface coil. |
| Scanner Interface | 1.5T GE Signa scanners | 1.5T GE Signa EXCITE scanners |
| Coil Interfaces | MEDRAD 1.5T Endorectal Coils, GE 4-channel Torso Array | MEDRAD 1.5T Endorectal Coils, GE 8- or 12-channel Body Array |
| Decoupling | Active and passive | Active and passive |
| RF Signal Pre-Amplification | Performed by the scanner for both the Endorectal Coil and the Torso Array. | Performed by the interface device for the Endorectal Coil (RF output from Body Array is already preamplified). |
| Tuning | Requires tuning to be set in production since ATD-T uses system preamplifier for signal amplification. | Does not require tuning to be set in production since interface device has a preamplifier. |
Conclusion from FDA:
The FDA determined that the device is "substantially equivalent" to legally marketed predicate devices, which allows it to be marketed. This determination is based on the comparison of intended use, operational parameters, labeling, and how the device is used, as outlined in the submission. The key changes, such as the specific GE scanner model (EXCITE) and the pre-amplification location, were deemed not to raise new questions of safety or effectiveness.
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510(k) Summary
NOV 17 2005
KD53042
OFFICIAL CONTACT:
CLASSIFICATION NAME:
COMMON NAME(S):
PROPRIETARY NAME:
PREDICATE DEVICE:
INTENDED USE:
Lisa A. Ewing Regulatory Affairs Specialist MEDRAD, INC. One Medrad Drive Indianola, PA 15051 (412) 767-2400 Ext. 3780
Magnetic Resonance Diagnostic Device (21 CFR 892.1000, Product Code MOS)
Magnetic Resonance Diagnostic Accessory
MEDRAD 1.5T Pelvic Imaging System Interface Device
MEDRAD, INC. 1.5T ATD-T Interface Device (K974438)
The 1.5T Pelvic Imaging System is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution maqnetic resonance imaqing. includina spectroscopy, of the human colon, cervix or prostate and surrounding pelvic tissue. The purpose of the interface device for the 1.5T Pelvic Imaging System is to provide interface and support functions to allow the use of MEDRAD 1.5T disposable endorectal coils with GE Signa EXCITE 1.5T MRI scanner systems and body array coils. Only trained healthcare professionals are intended to operate this device.
DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE:
The MEDRAD 1.5T Pelvic Imaging System Interface Device maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device.
The following comparison table identifies the similarities and differences between the new device and the predicate device.
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Comparison of Features and Principles of Operation in MEDRAD 1.5T ATD-T (Predicate) and MEDRAD 1.5T Pelvic Imaging System Interface Device (Propser)
| Feature | (Predicate)MEDRAD 1.5T ATD-T | (Proposed)MEDRAD Pelvic ImagingSystem Interface Device |
|---|---|---|
| Coil Type | Receive-only surface coil. | Receive-only surface coil. |
| Scanner Interface | 1.5T GE Signa scanners | 1.5T GE Signa EXCITEscanners |
| Coil Interfaces | MEDRAD 1.5T Endorectal Coils,GE 4-channel Torso Array | MEDRAD 1.5T Endorectal Coils,GE 8- or 12-channel Body Array |
| Decoupling | Active and passive | Active and passive |
| RF SignalPre-Amplification | Performed by the scanner forboth the Endorectal Coil and theTorso Array. | Performed by the interfacedevice for the Endorectal Coil(RF output from Body Array isalready preamplified). |
| Tuning | Requires tuning to be set inproduction since ATD-T usessystem preamplifier for signalamplification. | Does not require tuning to be setin production since interfacedevice has a preamplifier. |
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Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of an eagle with three curved lines forming its body and wings. The emblem is positioned in the center of the circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." is arranged around the upper perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa A. Ewing Regulatory Affairs Specialist MEDRAD, Inc. One Medrad Drive INDIANOLA PA 15051-0780 Re: K053042
NOV 1 7 2005
Trade/Device Name: MEDRAD 1.5T Pelvic Imaging System Interface Device Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 27, 2005 Received: October 28, 2005
Dear Ms. Ewing:
...
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
K 053042
Device Name: MEDRAD 1.5T Pelvic Imaging System Interface Device
Indications for Use:
The 1.5T Pelvic Imaging System is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human colon, cervix or prostate and surrounding pelvic tissue. The purpose of the interface device for the Pelvic Imaging System is to provide interface and support functions to allow the use of MEDRAD 1.5T disposable endorectal coils with GE Signa EXCITE 1.5T MRI scanner systems and body array coils. Only trained healthcare professionals are intended to operate this device.
Prescription Use × (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Segerson
Division of Reproductive. 510(k) Numb
Page 1 of 1
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§ 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.