(31 days)
Not Found
No
The summary describes an MRI coil and its physical modifications, with no mention of software, algorithms, or data processing that would typically involve AI/ML.
No
The device is described as an MRI coil used for imaging applications, not for treating conditions.
No
The device is an MRI coil used for imaging different anatomical regions, which is a tool for acquiring images, not for interpreting them to provide a diagnosis.
No
The device description explicitly states it is a "ten element phased array coil" and describes physical components like antenna loops, patient interface, MR safe cables, and a modified scanner interface connector. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The GORE-FLEX™ MP8 is an MRI coil. Its purpose is to receive radiofrequency signals emitted by the body during an MRI scan to create images. It is a component of an imaging system, not a device that analyzes biological samples.
- Intended Use: The intended use clearly states it's for "multiple imaging applications" with an MRI system to image anatomical structures within the body. This is an in vivo (within the living body) application, not in vitro (outside the living body).
Therefore, the GORE-FLEX™ MP8 is an imaging accessory for an MRI system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The applicant device, the GORE-FLEX™ MP8, is intended for multiple imaging applications with GE Signa® 1.5T MRI Systems, using EXCITE™ Technology. Its large field of view will allow for images of the complete thorax, including the heart, and its associated vasculature, the abdomen, pelvis, and spine. A specialized sub-array will provide high resolution images of the thoracic region.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The GORE-FLEX™ MP8, is a ten element phased array coil. It is for use on the upgraded GE Signa® 1.5T MRI System with EXCITE™ Technology. The applicant device, the GORE-FLEX™ MP8, has a modified Scanner Interface Connector. This modification allows the coil to take advantage of the 8 channel receiver system. Only the design of the connector box has been modified to allow up to 8 loops to be used as opposed to 4 loops. The antenna loops, patient interface, and MR safe cables remain unchanged. The GORE-FLEX™ MP8, the applicant device, is designed to maximize patient safety by using active decoupling, passive decoupling, and the MR safe cable, as does the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
thorax, heart, associated vasculature, abdomen, pelvis, spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Test data was acquired systematically on the GE Signa® 1.5T system with EXCITE™ Technology. The comparative images of the thorax and abdomen demonstrate that the GORE-FLEX™ MP8, the applicant device, has a substantially equivalent field-of-view, image clarity and signal-to-noise ratio as the Cardiovascular Array, the predicate device.
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
03/089
MAY = 8 2003
Image /page/0/Picture/2 description: The image shows the logo for GORE, with the words "GORE" in bold, sans-serif font. Above the word "GORE" is a right-pointing arrow shape. Below the word "GORE" are the words "Creative Technologies Worldwide" in a smaller, serif font. The logo is contained within a rectangular border.
W. L. GORE & ASSOCIATES. INC
750 OTTS CHAPEL ROAD • P.O. BOX 8038 • NEWARK, DE 19714-8038
PHONE: 302/368-2575 • FAX: 302/737-2819
Premarket Notification 510(k) Summary (K031089)
a. Submitter:
W. L. Gore and Associates, Inc. 750 Ott's Chapel Rd. Newark, DE 19713
800-441-7404 Phone:
Contact: Tracy Wolf
Date Prepared: May 5, 2003
- b. Name of Device:
Trade Name: GORE-FLEX™ MP8 Multipurpose Torso Array
Common Name: MRI Surface Coil
Device Name: Coil, Magnetic Resonance, Specialty
-
c. Identification of Predicate Devices:
The predicate device, the Cardiovascular Array, (K013810) is a ten element phased array coil. It was designed for use with GE Signa® 1.5 MRI Systems, which consist of four signal receivers. -
d. Description of the Applicant Device:
The GORE-FLEX™ MP8, is a ten element phased array coil. It is for use on the upgraded GE Signa® 1.5T MRI System with EXCITE™ Technology. The applicant device, the GORE-FLEX™ MP8, has a modified Scanner Interface Connector. This modification allows the coil to take advantage of the 8 channel receiver system.
e. Intended Use:
The applicant device, the GORE-FLEX™ MP8, is intended for multiple imaging applications with GE Signa® 1.5T MRI Systems, using EXCITE™ Technology. Its large field of view will allow for images of the complete thorax, including the heart, and its associated vasculature, the
1
abdomen, pelvis, and spine. A specialized sub-array will provide high resolution images of the thoracic region.
-
f. Technical Characteristics:
The applicant device, the GORE-FLEX™ MP8, is a ten element phased array coil for use with the upgraded GE Signa® 1.5T MRI System with EXCITE™ Technology. The applicant device, the GORE-FLEX™ MP8, has a modified Scanner Interface Connector. This modification allows the coil to take advantage of the 8 channel receiver system. Only the design of the connector box has been modified to allow up to 8 loops to be used as opposed to 4 loops. The antenna loops, patient interface, and MR safe cables remain unchanged. The GORE-FLEX™ MP8, the applicant device, is designed to maximize patient safety by using active decoupling, passive decoupling, and the MR safe cable, as does the predicate device. -
g. Summary of Testing:
Test data was acquired systematically on the GE Signa® 1.5T system with EXCITE™ Technology. The comparative images of the thorax and abdomen demonstrate that the GORE-FLEX™ MP8, the applicant device, has a substantially equivalent field-of-view, image clarity and signal-tonoise ratio as the Cardiovascular Array, the predicate device.
In summary, the GORE-FLEX™ MP8 Multipurpose Torso Array (applicant) and the Cardiovascular Array (predicate) utilize similar technology and materials. There are no patient safety concerns raised as a result of the clearance of the GORE-FLEX™ MP8 Multipurpose Torso Array.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tracy DeVan Wolf Regulatory Affairs W. L. Gore & Associates, Inc. 750 Otts Chapel Road P.O. Box 8038 NEWARK DE 19714-8038
Re: K031089
MAY - 8 2003
Trade/Device Name: Gore-Flex™ MP 8 Multipurpose Torso Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 3, 2003 Received: April 7, 2003
Dear Ms. Wolf:
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 vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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) 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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html.
Sincerely vours.
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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
GORE-FLEXTM MP8 Multipurpose Torso Array Device Name:
Indications For Use:
The GORE-FLEXTM:MP8 Multipurpose Torso Array is intended for multiple imaging applications with GE Signak 1.5T MRI Systems, using
EXCITEM Technology. Its large field of view will allow for images and in a some organ including the heart, and its associated
of the complete thorax, pelvis and spine. A specialized sub-array
vasculature, the abonen, pelvis and spine. I reg
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
David R. Brown
Prescription Use
(Division Sian-Off Division of Reproducts Abdomir and Radiological Der 510(k) Numb