(17 days)
Not Found
No
The summary describes a receive-only phased array coil for MR imaging, with no mention of AI, ML, image processing, or any algorithms that would suggest the use of such technologies. The focus is on the hardware design and its ability to produce high-resolution images.
No
The device is described as a "receive only phased array coil" intended for "multiple imaging applications" and producing "high resolution images." Its purpose is to aid in acquiring images for diagnosis, not to provide therapy.
No
The device is described as a receive-only phased array coil for MR imaging, used to produce high-resolution images of various anatomical sites. It functions as an imaging accessory, not a device that processes or analyzes images to provide a diagnosis.
No
The device description explicitly states it is a "receive only phased array coil, consisting of an anterior and a posterior 'paddle'" and describes physical components ("4 elements in a flexible coil"). This indicates a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Gore 3.0T Torso Array is a receive-only phased array coil used with an MR system. Its purpose is to acquire images of internal body structures (thorax, abdomen, pelvis, spine) using magnetic resonance technology.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It interacts directly with the patient's body to generate images.
Therefore, based on the provided information, the Gore 3.0T Torso Array is a component of an imaging system used for diagnostic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Gore 3.0T Torso Array is intended for multiple imaging applications with GE Signa® 3.0T MR Systems. It will allow for high resolution images of the thorax, abdomen, pelvis, and spine.
Product codes
90 MOS
Device Description
The Gore 3.0T Torso Array is a receive only phased array coil, consisting of an anterior and a posterior "paddle." The phased array design includes 4 elements in a flexible coil, which conforms to different body sizes. The coil produces high resolution images with GE Signa® 3.0T MR Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
thorax, abdomen, pelvis, and 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)
The Gore 3.0T Torso Array is substantially equivalent to the predicate devices with regard to intended use. This has been demonstrated by imaging a variety of anatomical locations and comparing the clinical images. The descriptive information and performance data contained within this Premarket Notification submission are sufficient to demonstrate substantial equivalence of the Gore 3.0T Torso Array (applicant device) to the GE 3.0T Transmit/Receive Body Imaging Coil and GE 1.5T Torso Array (predicate devices).
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.
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7. Premarket Notification 510(k) Summary
NOV 1 8 2002
- a. Submitter:
W. L. Gore and Associates, Inc. 750 Ott's Chapel Road Newark, DE 19713
Telephone: 800-441-7404
Tracy Wolf Contact:
Date Prepared: October 4, 2002
- b. Name of Device:
Trade Name: Gore 3.0T Torso Array
Common Name: MRI Surface Coil
Device Name: Coil, Magnetic Resonance, Specialty
- c. Identification of Predicate Devices:
The GE 3.0T Transmit/Receive Body Imaging Coil (K003613) and the GE 1.5T Torso Array (K911806) are the predicate devices. which were found to be substantially equivalent through the premarket notification process. The GE 3.0T Transmit/Receive Body Imaging Coil represents a coil that is compatible with a 3 Tesla field strength MR system, capable of imaging the neck, spine, abdomen, thorax, and extremities. The body coil is built into the GE 3.0T Signa® Magnetic Resonance system, as part of the patient couch.
The GE 1.5T Torso Array represents a 4 loop phased array designed for use with GE Signa® 1.5T MR Systems, to image the thorax, abdomen, pelvis, and spine.
- d. Description of the Applicant Device:
The Gore 3.0T Torso Array is a receive only phased array coil, consisting of an anterior and a posterior "paddle." The phased array design includes 4 elements in a flexible coil, which conforms to different body sizes. The coil produces high resolution images with GE Signa® 3.0T MR Systems.
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e. Intended Use:
The Gore 3.0T Torso Array is intended for multiple imaging applications with GE Signa® 3.0T MR Systems. It will allow for high resolution images of the thorax, abdomen, pelvis, and spine. -
f. Technical Characteristics
The Gore 3.0T Torso Array is substantially equivalent to the predicate devices with regard to intended use. This has been demonstrated by imaging a variety of anatomical locations and comparing the clinical images. The descriptive information and performance data contained within this Premarket Notification submission are sufficient to demonstrate substantial equivalence of the Gore 3.0T Torso Array (applicant device) to the GE 3.0T Transmit/Receive Body Imaging Coil and GE 1.5T Torso Array (predicate devices).
The Gore 3.0T Torso Array uses the same mode of operation, a receiving coil, as the predicate devices can employ. The GE 3.0T Transmit/Receive Body Imaging Coil can also operate as a transmitting coil. The Gore 3.0T Torso Array utilizes active decoupling as do the predicate devices. The Gore 3.0T Torso Array further enhances patient safety by including passive decoupling, and the MR safe cable.
The materials of the Gore 3.0T Torso Array (applicant) are similar to those used in the GE 1.5T Torso Array (predicate). The patient contact areas for both coils are composed of a biocompatible closed cell polyethylene foam.
In summary, the Gore 3.0T Torso Array (applicant) utilizes similar technology and materials as does the GE 3.0T Transmit/Receive Body Imaging Coil (predicate) and the GE 1.5T Torso Array and is, therefore, substantially equivalent to these devices. There are no patient safety concerns raised as a result of the clearance of the Gore 3.0T Torso Array.
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Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
DEC 1 2 2002
W. L. Gore & Associates, Inc % Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K023679 Trade/Device Name: Gore 3.0T Torso Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 31, 2002 Received: November 1, 2002
Dear Mr. Job:
This letter corrects our substantially equivalent letter of November 18, 2002 regarding the company name in the address.
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 (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 (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
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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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4654. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address
http://www.fda.qov/cdrh/dsma/dsmamain.html.
Sincerely yours.
David A. Syron
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number (if known); 10236
Gore 3.0T Torso Array Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Gore 3.0T Torso Array is intended for multiple imaging applications with GE Signa(R) 3.0T MR Systems. It will allow for high resolution images of the thorax, abdomen, pelvis, and spine.
(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)
Vorst. A. Lyoon
(Division Sign-Off) ion of Reproductive
Prescription Use