(30 days)
Not Found
No
The summary describes a receive-only coil for MRI and does not mention any AI or ML components or functionalities.
No
The device is described as a "Magnetic Resonance Diagnostic Device (MRDD)" and its intended use is for "high-resolution magnetic resonance imaging, including spectroscopy," which are diagnostic rather than therapeutic functions.
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," which is a hardware component used in MRI systems.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that this device is a "receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging... of the human prostate gland and surrounding pelvic tissue." This means it's used on the patient's body to acquire images using magnetic resonance technology.
- Imaging Modality: The input imaging modality is Magnetic Resonance, which is an in vivo (within the living body) imaging technique, not an in vitro technique.
Therefore, based on the provided information, this device is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
human prostate gland 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Ko51349
510(k) Summary
JUN 2 3 2005
| 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 Coil |
| PROPRIETARY NAME: | 3.0T Prostate Imaging System |
| PREDICATE DEVICES: | MEDRAD MRInnervu Endorectal Prostate Coil
with 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 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. |
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.
1
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 Coil
and MEDRAD Flex Interface
Device | (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 from
interface device to scanner. | Circular RF keyed connector
from interface device to
scanner. |
| Endorectal Coil
Compatibility | 1.5T MRI scanner platforms. | 3.0T MRI scanner platforms. |
| Interface Device
Compatibility | Siemens Vision 1.5T MRI
scanners. | Siemens 3.0T Trio MRI
scanners. |
| Decoupling | Active and passive (interface
device). | Passive (endorectal coil); active
and passive (interface device). |
| Tuning | Fixed tuning set in production. | Fixed tuning set in production. |
| RF Signal
Pre-Amplification | Performed by the scanner. | Performed by the interface
device. |
| Endorectal Coil Inner
Balloon Inflation
Compatibility | 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 Endorectal
Prostate Coil | (Proposed)
MEDRAD 3.0T Endorectal
Prostate Coil |
|--------------------------------------|--------------------------------------------------------|-------------------------------------------------------|
| Outer balloon | Natural Latex | Natural Latex |
| Shaft | PVC | PVC |
| Shrink tubing | Teflon (FEP) | Teflon (FEP) |
| Migration stop (affixes to
shaft) | PVC | PVC |
2
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.
3
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
4
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