(30 days)
The 3.0T Prostate 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 prostate gland and surrounding pelvic tissue. The 3.0T Prostate Imaging System is intended for use with Siemens 3.0T Trio scanner platforms only. Only trained healthcare professionals are intended to operate this device.
The MEDRAD 3.0T Prostate Imaging System maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate devices. The device is a receive-only surface coil.
The provided text is a 510(k) summary for the MEDRAD 3.0T Prostate Imaging System. This document focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found for a novel device or software. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods is not present in this type of submission.
Here's a breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a new device performing a diagnostic task. Instead, the "acceptance criteria" are implied by the comparison to predicate devices, focusing on maintaining similar intended use, operational parameters, and safety.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: | |
| Receive-only coil type maintained | Receive-only surface coil. |
| Region of Interest maintained (prostate gland and pelvic tissue) | Prostate gland and surrounding tissue. |
| Fixed tuning in production | Fixed tuning set in production. |
| Compatibility: | |
| Compatible with 3.0T MRI scanner platforms | Compatible with 3.0T MRI scanner platforms. |
| Compatible with Siemens 3.0T Trio MRI scanners | Compatible with Siemens 3.0T Trio MRI scanners. |
| Safety: | |
| Patient-contacting materials similar to predicate | Outer balloon (Natural Latex), Shaft (PVC), Shrink tubing (Teflon (FEP)), Migration stop (PVC) are the same as predicate. |
| Operational Parameters: | |
| Decoupling mechanism (passive; active and passive in interface) | Passive (endorectal coil); active and passive (interface device). |
| RF Signal Pre-Amplification performed by interface device | Performed by the interface device. |
| Endorectal Coil Inner Balloon Inflation Compatibility (Air/fluid) | Air or fluid. |
2. Sample size used for the test set and data provenance:
- Not Applicable / Not Provided. This document is for a physical medical device (an MRI coil), not an AI/software device. There is no "test set" in the context of diagnostic performance or algorithmic evaluation. The evaluation is based on engineering specifications and comparison to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. See point 2.
4. Adjudication method for the test set:
- Not Applicable / Not Provided. See point 2.
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 / Not Provided. This device is a passive MRI coil and does not incorporate AI. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance would be relevant or performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided. This device is a physical MRI coil and does not involve any algorithms.
7. The type of ground truth used:
- Not Applicable / Not Provided. As this is a physical medical device (an MRI coil), the "ground truth" concept in the context of diagnostic accuracy is not directly applicable. The evaluation relies on engineering specifications, material compatibility, and performance characteristics (e.g., signal reception quality, compatibility with scanner).
8. The sample size for the training set:
- Not Applicable / Not Provided. See point 2 and 6.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided. See point 2, 6, and 8.
Summary of Device and Approval Basis:
The MEDRAD 3.0T Prostate Imaging System is a receive-only magnetic resonance coil intended for high-resolution MRI and spectroscopy of the prostate gland. Its approval (K051349) was based on substantial equivalence to existing predicate devices: the MEDRAD MRInnervu Endorectal Prostate Coil (K926571) and the MEDRAD Flex Interface Device (K971380).
The primary differences and the basis for establishing equivalence were:
- Operating field strength: The new device is designed for 3.0T MRI scanners, whereas the predicates were for 1.5T.
- Scanner compatibility: Siemens 3.0T Trio MRI scanners for the new device, compared to Siemens Vision 1.5T MRI scanners for the predicates.
- RF Signal Pre-Amplification: The new device performs pre-amplification in the interface device, while the predicate relied on the scanner.
- Endorectal Coil Inner Balloon Inflation Compatibility: The new device allows for air or fluid, while the predicate only specified air.
The submission confirms that the intended use, operational parameters, and patient-contacting materials (natural latex, PVC, Teflon) are similar to or equivalent to the predicate devices, thereby ensuring safety and effectiveness for its specified use. The FDA deemed this sufficient for 510(k) clearance, indicating that detailed performance studies related to diagnostic accuracy (as would be seen for AI/software) were not required given the nature of the device and the substantial equivalence claim.
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Ko51349
510(k) Summary
JUN 2 3 2005
| OFFICIAL CONTACT: | Lisa A. EwingRegulatory Affairs SpecialistMEDRAD, Inc.One Medrad DriveIndianola, PA 15051(412) 767-2400 Ext. 3780 |
|---|---|
| CLASSIFICATION NAME: | Magnetic Resonance Diagnostic Device(21 CFR 892.1000, Product Code MOS) |
| COMMON NAME(S): | Magnetic Resonance Coil |
| PROPRIETARY NAME: | 3.0T Prostate Imaging System |
| PREDICATE DEVICES: | MEDRAD MRInnervu Endorectal Prostate Coilwith Probe Interface Device (K926571)MEDRAD Flex Interface Device (K971380) |
| INTENDED USE: | The 3.0T Prostate Imaging System is a receive-only coil intended for use as a MagneticResonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, includingspectroscopy, of the human prostate gland andsurrounding pelvic tissue. The 3.0T ProstateImaging System is intended for use with Siemens3.0T Trio scanner platforms only. Only trainedhealthcare professionals are intended to operatethis device. |
DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE:
The MEDRAD 3.0T Prostate Imaging System maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate devices.
The following comparison tables identify the similarities and differences between the new device and the predicate devices.
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Comparison of Features and Principles of Operation in MEDRAD 1.5T Endorectal Prostate Coil and Flex Interface Device (Predicates) and MEDRAD 3.0T Prostate Imaging System (Proposed)
| Feature | (Predicates)MEDRAD 1.5T Endorectal Coiland MEDRAD Flex InterfaceDevice | (Proposed)3.0T Prostate Imaging System |
|---|---|---|
| Coil Type | Receive-only surface coil. | Receive-only surface coil. |
| Region of Interest | Prostate gland and surrounding tissue. | Prostate gland and surrounding tissue. |
| System connection | 6-pin DIN connector frominterface device to scanner. | Circular RF keyed connectorfrom interface device toscanner. |
| Endorectal CoilCompatibility | 1.5T MRI scanner platforms. | 3.0T MRI scanner platforms. |
| Interface DeviceCompatibility | Siemens Vision 1.5T MRIscanners. | Siemens 3.0T Trio MRIscanners. |
| Decoupling | Active and passive (interfacedevice). | Passive (endorectal coil); activeand passive (interface device). |
| Tuning | Fixed tuning set in production. | Fixed tuning set in production. |
| RF SignalPre-Amplification | Performed by the scanner. | Performed by the interfacedevice. |
| Endorectal Coil InnerBalloon InflationCompatibility | Air. | Air or fluid. |
Comparison of Patient-Contacting Materials in MEDRAD 1.5T Endorectal Prostate Coil (Predicate) and MEDRAD 3.0T Endorectal Prostate Coil (Proposed)
| (Predicate)MEDRAD 1.5T EndorectalProstate Coil | (Proposed)MEDRAD 3.0T EndorectalProstate Coil | |
|---|---|---|
| Outer balloon | Natural Latex | Natural Latex |
| Shaft | PVC | PVC |
| Shrink tubing | Teflon (FEP) | Teflon (FEP) |
| Migration stop (affixes toshaft) | PVC | PVC |
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
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
Re: K051349 Trade/Device Name: MEDRAD 3.0T Prostate Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device -Regulatory Class: II Product Code: MOS Dated: May 23, 2005 Received: May 24, 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.
JUN 2 3 2005
:
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) This letter will anow you to begin matters. 37 your device of your device to a legally prematket noutication: "The PDF maing or our 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 If you desire specific acrree to your be 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 Also, prease note the regulation entitled, to mation on your responsibilities under the Act from the 807.77). Tournal 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. Brogdon
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
K051349 510(k) Number:
Device Name:
MEDRAD 3.0T Prostate Imaging System
Indications for Use:
The 3.0T Prostate 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 prostate gland and surrounding pelvic tissue. The 3.0T Prostate Imaging System is intended for use with Siemens 3.0T Trio scanner platforms only. 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)
Nancy Broadon
(Division Sign-Off)
Division of Reproductive, Abdo and Radiological Devices 510(k) Number _
Page 1 of 1
§ 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.