(28 days)
Not Found
No
The document describes a receive-only coil and interface device for MRI, focusing on hardware and compatibility. There is no mention of AI, ML, or image processing capabilities that would suggest the use of such technologies.
No
The device is described as a "Magnetic Resonance Diagnostic Device (MRDD)" and its purpose is for "high-resolution magnetic resonance imaging," indicating its use for diagnosis rather than therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as a Magnetic Resonance Diagnostic Device (MRDD)".
No
The device description explicitly states it is a "receive-only surface coil with active and passive decoupling and RF signal pre-amplification," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Function: The eCoil Imaging System is a Magnetic Resonance Diagnostic Device (MRDD). It is a receive-only coil used in conjunction with an MRI scanner to acquire images of the human prostate and surrounding pelvic tissue directly from the body. It does not analyze samples taken from the body.
The description clearly states its purpose is for "high-resolution magnetic resonance imaging, including spectroscopy, of the human prostate and surrounding pelvic tissue." This is an in-vivo (within the living body) imaging technique, not an in-vitro (in glass/outside the body) diagnostic test.
N/A
Intended Use / 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 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.
Product codes
MOS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
human prostate and surrounding pelvic tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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.
1
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 Imaging
System Interface Device | (Predicate)
MEDRAD 3.0T Prostate Imaging
System Interface Device | (Proposed)
MEDRAD 3.0T eCoil Imaging
System Interface Device |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Coil Type | Receive-only surface coil | Receive-only surface coil | Receive-only surface coil |
| Scanner Interface | 1.5T GE Signa EXCITE
scanners | 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 Signal
Pre-Amplification | Performed by the interface
device for the Endorectal Coil
(RF output from Body Array is
already preamplified). | Performed by the interface
device for the Endorectal Coil | Performed by the interface
device for the Endorectal Coil
(RF output from Torso Array is
already preamplified). |
| Tuning | Does not require tuning to be set
in production since interface
device has a preamplifier. | Fixed tuning set in production. | Does not require tuning to be set
in production since interface
device has a preamplifier. |
2
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.
3
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
4
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)
- 6 -
David A. Syam
(Division Sign-Off)
Division of Reproductive, Abdom and Radiological Devices 510(k) Number _
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