(28 days)
The eCoil Imaging System for the GE 3.0T family of scanners 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 and surrounding pelvic tissue. The purpose of the interface device for the eCoil Imaging System is to provide interface and support functions to allow the use of MEDRAD 3.0T disposable endorectal coils with GE 3.0T family of scanner systems and Torso Array coils. Only trained healthcare professionals are intended to operate this device.
The MEDRAD 3.0T eCoil 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 with active and passive decoupling and RF signal pre-amplification. It interfaces with 3.0T GE family of scanners and MEDRAD 3.0T Endorectal Coils and GE 8-channel Torso Array. It does not require tuning to be set in production since the interface device has a preamplifier.
The provided text does not contain information about acceptance criteria, device performance, or a study specifically designed to demonstrate the device meets acceptance criteria. The document is a 510(k) summary for a premarket notification for the MEDRAD 3.0T eCoil Imaging System, focusing on establishing substantial equivalence to predicate devices. It clearly states that the device is "substantially equivalent" rather than providing a performance study against specific acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study proving the device meets these criteria based on the provided text.
Here's an explanation of why the requested information is not available and what the document does provide:
Why the requested information is not in the document:
This document is a 510(k) summary. For devices like the MEDRAD 3.0T eCoil Imaging System (a magnetic resonance diagnostic accessory, product code MOS), the FDA's 510(k) pathway primarily focuses on demonstrating substantial equivalence to a predicate device that is already legally marketed. This means showing that the new device is as safe and effective as a legally marketed predicate device.
To achieve this, manufacturers typically:
- Identify predicate devices.
- Compare the new device's technological characteristics, intended use, and performance to the predicate(s).
- Provide data (often non-clinical, such as engineering tests, bench tests, and sometimes limited clinical data) to support the claim of equivalence.
It generally does not require a full-scale clinical trial with predefined acceptance criteria for performance metrics like sensitivity, specificity, or AUC, especially for accessories like an MRI coil. The evaluation is more about ensuring the new coil functions as intended, integrates safely with the specified MRI scanners, and does not introduce new risks or questions of effectiveness compared to existing technology.
What the document does provide regarding equivalence, not performance against acceptance criteria:
The document focuses on comparing the new device's features and principles of operation to predicate devices to establish substantial equivalence. Key points are:
- Intended Use: The eCoil Imaging System is a receive-only coil for high-resolution MR imaging, including spectroscopy, of the human prostate and surrounding pelvic tissue on GE 3.0T scanners. The interface device allows use of MEDRAD 3.0T disposable endorectal coils with these GE systems and Torso Array coils.
- Comparison to Predicates: The core of the submission is a comparison table showing similarities and differences with two predicate devices (MEDRAD 1.5T Pelvic Imaging System Interface Device and MEDRAD 3.0T Prostate Imaging System Interface Device).
- Similarities: All are receive-only surface coils, use active and passive decoupling, and have pre-amplification for endorectal coils.
- Differences: Primarily relate to the scanner interface (1.5T GE vs. 3.0T Siemens Trio vs. 3.0T GE family), specific coil interfaces (MEDRAD 1.5T vs. 3.0T endorectal coils, and GE 8- or 12-channel Body Array vs. GE 8-channel Torso Array), and tuning specifics. The proposed device's tuning does not require setting in production due to a preamplifier, similar to one predicate.
To summarize, this 510(k) is about demonstrating the new coil's engineering and functional equivalence to similar marketed coils, not about proving diagnostic performance against quantitative metrics.
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Koco401
MAR 1 5 2006
510(k) Summary
OFFICIAL CONTACT: Lisa A. Ewing Regulatory Affairs Specialist MEDRAD, INC. One Medrad Drive Indianola, 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 Diagnostic Accessory PROPRIETARY NAME: MEDRAD 3.0T eCoil Imaging System PREDICATE DEVICES: MEDRAD, INC. 1.5T Pelvic Imaging System Interface Device (K053042) MEDRAD, INC. 3.0T Prostate Imaging System (K051349) INTENDED USE: The eCoil Imaging System for the GE 3.0T family of scanners 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 and surrounding pelvic tissue. The purpose of the interface device for the eCoil Imaging System is to provide interface and support functions to allow the use of MEDRAD 3.0T disposable endorectal coils with GE 3.0T family of scanner systems and Torso Array coils. Only trained healthcare professionals are intended to operate this device.
DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE:
The MEDRAD 3.0T eCoil 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 table identifies 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 Pelvic Interface Device for GE (Predicate)
MEDRAD 3.0T Prostale Imaging System Interface Device for Siemens
| Feature | (Predicate)MEDRAD 1.5T Pelvic ImagingSystem Interface Device | (Predicate)MEDRAD 3.0T Prostate ImagingSystem Interface Device | (Proposed)MEDRAD 3.0T eCoil ImagingSystem Interface Device |
|---|---|---|---|
| Coil Type | Receive-only surface coil | Receive-only surface coil | Receive-only surface coil |
| Scanner Interface | 1.5T GE Signa EXCITEscanners | 3.0T Siemens Trio scanners | 3.0T GE family of scanners |
| Coil Interfaces | MEDRAD 1.5T Endorectal Coils,GE 8- or 12-channel Body Array | MEDRAD 3.0T Endorectal Coils | MEDRAD 3.0T Endorectal Coils,GE 8-channel Torso Array |
| Decoupling | Active and passive | Active and passive | Active and passive |
| RF SignalPre-Amplification | Performed by the interfacedevice for the Endorectal Coil(RF output from Body Array isalready preamplified). | Performed by the interfacedevice for the Endorectal Coil | Performed by the interfacedevice for the Endorectal Coil(RF output from Torso Array isalready preamplified). |
| Tuning | Does not require tuning to be setin production since interfacedevice has a preamplifier. | Fixed tuning set in production. | 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 the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.
Public Health Service
MAR 15 2006
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: K060401 Trade/Device Name: MEDRAD 3.0T eCoil Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: February 14, 2006 Received: February 15, 2006
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 complive of the Act s requirements, including, but not limited to registration and listing (21 CFR Part 807) valueling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality of your (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 mumber 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/industrv/support/index.html.
Sincerely vours.
. Nancy C. Brigdon
Namey 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
KOG 0401 510(k) Number:
Device Name: MEDRAD 3.0T eCoil Imaging System
Indications for Use:
The eCoil Imaging System for the GE 3.0T family of scanners is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for highresolution magnetic resonance imaging, including spectroscopy, of the human prostate and surrounding pelvic tissue. The purpose of the interface device for the eCoil Imaging System is to provide interface and support functions to allow the use of MEDRAD 3.0T disposable endorectal coils with GE 3.0T family of scanner systems and Torso 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)
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David A. Syam
(Division Sign-Off)
Division of Reproductive, Abdom 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.