CARDIOVASCULAR ARRAY

K013810 · W. L. Gore & Associates, Inc. · MOS · Nov 27, 2001 · Radiology

Device Facts

• Record ID: K013810
• Device Name: CARDIOVASCULAR ARRAY
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: MOS · Radiology
• Decision Date: Nov 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Cardiovascular Array is intended for multiple imaging applications with GE Signa® 1.5T MRI Systems. Its large field of view will allow for integrated images of the complete thorax, including vasculature, the abdomen, pelvis, spine and extremities. A specialized sub-array will provide high resolution images of the thoracic region.

Device Story

Cardiovascular Array is a receive-only phased array MRI surface coil; consists of 10 elements in flexible anterior and posterior 'paddle' configuration. Designed for use with GE Signa 1.5T MRI systems. Device conforms to various body sizes; large field of view enables imaging of thorax, vasculature, abdomen, pelvis, spine, and extremities without patient repositioning. Specialized sub-array provides high-resolution thoracic imaging. Operates via active and passive decoupling; includes MR-safe cable. Used by radiology technicians/physicians in clinical MRI settings to acquire diagnostic images; output is processed by the MRI system to assist clinicians in diagnostic decision-making.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Receive-only phased array MRI coil; 10-element flexible design. Materials: biocompatible closed cell polyethylene foam. Decoupling: active and passive. Connectivity: compatible with GE Signa 1.5T MRI systems. Includes MR-safe cable.

Indications for Use

Indicated for patients requiring MRI imaging of the thorax, vasculature, abdomen, pelvis, spine, and extremities using GE Signa 1.5T MRI systems.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• GE Cardiac Array (K013810)

Submission Summary (Full Text)

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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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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, :

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