(24 days)
No
The summary describes a receive-only coil and an interface device for MRI, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No
The device is described as a "Magnetic Resonance Diagnostic Device (MRDD)" and its purpose 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 coil" and an "interface device," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "Magnetic Resonance Diagnostic Device (MRDD)" for imaging specific anatomical sites. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (which is the core definition of an IVD).
- Device Description: The description reinforces that it's a receive-only coil for MRI and an interface device to support the use of endorectal coils with MRI scanners. This aligns with imaging technology, not in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the eCoil Imaging System is a medical device used for diagnostic imaging, specifically MRI, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The eCoil Imaging System for Philips MR 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 colon, cervix or 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 disposable endorectal coils with Philips MRI scanner systems. Only trained healthcare professionals are intended to operate this device.
Product codes
MOS
Device Description
The MEDRAD eCoil Imaging System 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 proposed device and the predicate device.
TABLE 1 Comparison of Features and Principles of Operation in MEDRAD 3.0T Prostate Imaging System Interface Device for Siemens (Predicate) and MEDRAD 3.01)
Imaging System Interface Device for Siemens (Predicate) and MEDRAD eCoil Imaging System Interface Device for Philips (Proposed)
| Feature | (Predicate)MEDRAD 3.0T Prostate Imaging System Interface Device | (Proposed)MEDRAD eCoil Imaging System Interface Device |
|---|---|---|
| Coil Type | Receive-only surface coil | Receive-only surface coil |
| Scanner Interface | 3.0T Siemens Trio scanners | 1.5T and 3.0T Philips scanners |
| Coil Interfaces | MEDRAD 3.0T Endorectal Coils | MEDRAD 1.5T and 3.0T Endorectal Coils |
| Decoupling | Active and passive | Active and passive |
| RF Signal Pre-Amplification | Performed by the interface device | Performed by the interface device |
| Tuning | Fixed tuning set in production. | Fixed tuning set in production. |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
human colon, cervix or 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
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
510(k) Summary
NOV 3 U 2006
| OFFICIAL CONTACT: | Lisa A. Ewing
Senior 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 eCoil Imaging System for Philips |
| PREDICATE DEVICES: | MEDRAD, INC. 3.0T Prostate Imaging System
(K051349) |
| INTENDED USE: | The eCoil Imaging System for Philips MR
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
colon, cervix or 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 |
support functions to allow the use of MEDRAD disposable endorectal coils with Philips MRI scanner systems. Only trained healthcare professionals are intended to operate this device.
DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE:
The MEDRAD eCoil Imaging System 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 proposed device and the predicate device.
1
TABLE 1 Comparison of Features and Principles of Operation in MEDRAD 3.0T Prostate Imaging System Interface Device for Siemens (Predicate) and MEDRAD 3.01)
Imaging System Interface Device for Siemens (Predicate) and MEDRAD eCoil Imaging System Interface Device for Philips (Proposed)
| Feature | (Predicate)
MEDRAD 3.0T Prostate Imaging System Interface Device | (Proposed)
MEDRAD eCoil Imaging System Interface Device |
|--------------------------------|---------------------------------------------------------------------|------------------------------------------------------------|
| Coil Type | Receive-only surface coil | Receive-only surface coil |
| Scanner Interface | 3.0T Siemens Trio scanners | 1.5T and 3.0T Philips scanners |
| Coil Interfaces | MEDRAD 3.0T Endorectal Coils | MEDRAD 1.5T and 3.0T Endorectal Coils |
| Decoupling | Active and passive | Active and passive |
| RF Signal
Pre-Amplification | Performed by the interface device | Performed by the interface device |
| Tuning | Fixed tuning set in production. | Fixed tuning set in production. |
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a human figure. The figure is composed of three curved lines that represent the head, body, and legs.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Lisa A. Ewing Senior Regulatory Affairs Specialist Medrad, Inc. One Medrad Drive INDIANOLA PA 15051-0780
NOV 3 0 2006
Re: K063342
Trade/Device Name: MEDRAD eCoil Imaging for Philips Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 3, 2006 Received: November 6, 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906-1906" are printed. Below the letters, the word "Centennial" is printed in a cursive font. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
3
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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. B rogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K063342 510(k) Number:
Device Name:
MEDRAD eCoil Imaging System for Philips
Indications for Use:
The eCoil Imaging System for Philips MRI 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 colon, cervix or 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 disposable endorectal coils with Philips MRI scanner systems. trained healthcare professionals are intended to operate this device. Only
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
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)
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K063342 |
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