(12 days)
The Cardiovascular Array is intended for multiple imaging applications with GE Sigua(R) 1.5T MRI Systems. Its large field of view will allow with GE Sigual(R) 1.51 MK. Systems. Including the heart, and its associated for images of the complete chords, and spine. A specialized sub-array vasculature, the abdomen, pervis and open and of the thoracic region, :
The Cardiovascular Array is a receive only phased array coll, + 2009 and a posterior "paddle." The phased array design includes 10 elements in a flexible coil, which array design mendatibody sizes. The coil produces high conforms to different GE Signa® 1.5T MRI Systems.
The provided text is a 510(k) Premarket Notification summary for the Cardiovascular Array, an MRI surface coil. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a new medical device is safe and effective through comprehensive clinical trials with pre-defined acceptance criteria and study designs in the way that, for example, a new drug would be.
Therefore, many of the requested elements (e.g., specific acceptance criteria, detailed study design with sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details) are not typically included or required in a 510(k) summary focused on substantial equivalence. The focus is on comparing technical characteristics and intended use to an existing device.
Here's an analysis based on the provided text, addressing what can be inferred and explicitly stating what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of this 510(k) submission. Acceptance criteria and specific performance metrics for this device are not defined in the document as it's a submission for substantial equivalence to a predicate device. The performance is deemed "sufficient to demonstrate substantial equivalence" based on descriptive information and data, but no specific quantitative criteria are listed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for this 510(k) submission. The objective is substantial equivalence to a predicate device, not meeting predefined quantitative performance criteria. | Performance demonstrated to be substantially equivalent to the predicate device based on "descriptive information and performance data" submitted, but specific metrics are not publicly detailed in this summary. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified. The submission refers to "performance data," but details on the nature, origin (e.g., country), or whether it was retrospective or prospective are not provided in this summary. It's likely bench testing and potentially some phantom or volunteer imaging data, typical for device equivalence, rather than a large patient study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The concept of "ground truth" established by experts for a test set is typically relevant for studies evaluating diagnostic accuracy, often with an AI component. This 510(k) submission is for an MRI surface coil, a hardware component, where the assessment is primarily about its imaging capabilities (e.g., signal-to-noise ratio, image quality) and safety compared to a predicate device, not its diagnostic interpretation accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to reach consensus on diagnostic labels, which is not the primary focus of a 510(k) for an MRI coil.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an MRI surface coil, not an AI or software algorithm that assists human readers. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an MRI surface coil, not an algorithm. Standalone performance as an algorithm is not relevant. The "standalone" performance for a coil would refer to its physical imaging characteristics, which are implicitly compared to the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the typical sense. For an MRI coil, "ground truth" would relate to objective physical measurements of image quality parameters (e.g., SNR, uniformity, resolution) and safety (e.g., heating, SAR), compared against established engineering standards or the performance of the predicate device. It would not involve diagnostic ground truth like pathology or outcomes data.
8. The sample size for the training set
Not applicable. This device is a hardware component (MRI coil), not a software algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as a training set for an algorithm is not relevant for this device.
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NOV 2 7 2001
7. Premarket Notification 510(k) Summary
a. Submitter:
W. L. Gore and Associates, Inc. 1901 Barksdale Rd. Newark, DE 19711
800-441-7404 Phone:
Tracy Wolf Contact:
Date Prepared: October 17, 2001
- b. Name of Device:
Cardiovascular Array Trade Name:
Common Name: MRI Surface Coil
Coil, Magnetic Resonance, Speciality Device Name:
-
c. Identification of Predicate Devices:
on of Predicate Devices.
The GE Cardiac Array is the predicate device which was found The OL Cardial Afray is any processions the premarket notification to be substainmally oquit receive only, phased array surface process. These for use with GE Signa® 1.5T MRI Systems. -
d. Description of the Applicant Device:
I of the Applicant Dorios:
The Cardiovascular Array is a receive only phased array coll, The Cardiovasourar + 2009 and a posterior "paddle." The phased array design includes 10 elements in a flexible coil, which array design mendatibody sizes. The coil produces high conforms to different GE Signa® 1.5T MRI Systems. -
e. Intended Use:
The Cardiovascular Array is intended for multiple imaging applications with GE Signa® 1.5T MRI Systems. Its large field applications with OD organise of the complete thorax, including of view will allow for integrated vasculature, the abdomen, pelvis, spine and extremities. A specialized sub-array will provide high resolution images of the thoracic region. The predicate ingh icsolution miages of as a me areas of anatomy, but must be repositioned on the patient, between images. The Cardiovascular array with its large field of view can image these areas without repositioning.
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The Cardiovascular Array is substantially equivalent to the predicate device with regard to intended use, by imaging a variety of anatomical locations using phased array, receive only surface coils. The descriptive information and performance data contained within this Premarket Notification submission are sufficient to demonstrate substantial equivalence of the applicant device (Cardiovascular Array) to the predicate device (GE Cardiac Array).
- f. Technical Characteristics
The Cardiovascular Array uses the same mode of operation, a receive only coil, as the predicate device. It utilizes active decoupling as does the predicate device. The Cardiovascular Array further enhances patient safety by including passive decoupling, and the MR safe cable.
The materials are similar, the patient contact areas for both the applicant and predicate devices, are composed of a biocompatible closed cell polyethylene foam.
In summary, the Cardiovascular Array (applicant) and the GE Cardiac Array (predicate) utilize similar technology and materials. There are no patient safety concerns raised as a result of the clearance of the Cardiovascular Array.
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Image /page/2/Picture/1 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 an eagle with three lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 7 2001
W.L. Gore & Associates, Inc. c/o Mr. Mark Job TUV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K013810
Trade/Device Name: Cardiovascular Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 13, 2001 Received: November 15, 2001
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 310(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosale) to regally the enactment date of the Medical Device American by and Drug commerce prior to May 20, 1976, the exactions of the Federal Food, Drug, 1994, Drug, devices that have been icclassince in accera approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merciole, market also as the Act include requirements for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (500 a0010) in Existing major regulations affecting your device can be it may be subject to additional controlial Linking may on 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 I lease be advised that I Dri 3 issualited on our device complies with other requirements of the Act that I DA has made a decidinations administered by other Federal agencies. You must of any I ederal statutes and roginnents, including, but not limited to: registration and listing compry with an the Act 3 requirements, modeling, a
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), labornig (21 CFR Part 820); and if applicable, the electronic fordint in the quality systems (20) -18)
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 510(k) pręmarket I notification. The FDA finding of substantial equivalence of your device to a legally marketed noutheation. The I Drice 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 It you dosite tpositive at one of the following numbers, based on the regulation number at the top of this 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 Other of Somphares to premarket notification" (21 CFR Part 807.97). Other general information on by releveloo to promation the Act may be obtained from the Division of Small Manufacturers, Jour responseering of the many of 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 yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KC013810
Page 1_of_1
510(k) Number (if known): __________________________________________________________
Coil, Magnetic Resonance, Speciality Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Cardiovascular Array is intended for multiple imaging applications with GE Sigua(R) 1.5T MRI Systems. Its large field of view will allow with GE Sigual(R) 1.51 MK. Systems. Including the heart, and its associated for images of the complete chords, and spine. A specialized sub-array vasculature, the abdomen, pervis and open and of the thoracic region, :
Nov 15 3 21 PM '01
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rate Phillips he nccs
(Optional Format 3-10-98)
RA
II
SK4J
§ 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.