CARDIAC PHASED ARRAY COIL

K971667 · GE Medical Systems · MOS · Jul 23, 1997 · Radiology

Device Facts

• Record ID: K971667
• Device Name: CARDIAC PHASED ARRAY COIL
• Applicant: GE Medical Systems
• Product Code: MOS · Radiology
• Decision Date: Jul 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging

Device Story

Cardiac Phased Array Coil is a receive-only MRI surface coil consisting of anterior and posterior sections. Used in clinical MRI environments to acquire magnetic resonance signals from the heart and mediastinum. Operates as a passive component within an MRI system; signals are processed by the host MRI scanner to generate 2D and 3D images for diagnostic review by physicians. Benefits include improved signal reception for cardiac and mediastinal imaging.

Clinical Evidence

Bench testing only. Evaluated against NEMA performance standard MS#6 for Special Purpose Coils and IEC 601-1 international medical equipment safety standard. No clinical data provided.

Technological Characteristics

Receive-only phased array surface coil; two-section (anterior/posterior) design. Complies with NEMA MS#6 and IEC 601-1 standards. Passive hardware component for MRI systems.

Indications for Use

Indicated for 2D and 3D Magnetic Resonance imaging of the heart and mediastinum regions.

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

• ScanMed Cardiac/Vascular Coil
• GE Pelvic Phased Array Coil

Submission Summary (Full Text)

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K971667

GE Medical Systems

P.O. Box 414. W-709 Milwaukee, WI 53201 USA

July 23, 1997

## SUMMARY OF SAFETY AND EFFECTIVENESS

- This 510(k) summary of safety and effectiveness information is submitted in o accordance with the requirements of 21 CFR Part 807.87(h).
- o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, April 29, 1997
- o Identification of the Product Cardiac Phased Array Coil

Manufacturer Address:

GE Medical Systems 3200 N. Grandview Blvd. Waukesha, Wi 53188

- o Marketed Device The Cardiac Phased Array Coil is substantially equivalent to the currently marketed ScanMed Cardiac/Vascular Coil and the GE Pelvic Phased Array Coil.
- 0 Device Description The Cardlac Phased Array Coil is a receive only coil with two separate coils matched with a front and a back (anterior and posterior) section.
- 0 Indications for Use It is intended to be used in the heart and mediastinum regions for 2D and 3D imaging.
- o Comparison with Predicate

The Cardiac Phased Array Coll is similar in construction to the both predicate devices. The circuitry on the Cardiac Phased Array Coil is similar to the circuitry of the GE Pelvic Phased Array Coil.

- o Summary of Studies
The Cardiac Phased Array Coil was evaluated to NEMA performance standard MS#6 for Special Purpose Coils as well as the IEC 601-1 International medical equipment safety standard. The Coil is comparable to the predicate devices.

- 0 Conclusions
It is the opinion of GE that the Cardiac Phased Array Coil is substantially equivalent to the ScanMed CardiacVascular Coll and the GE Pelvic Phased Array Coil. The use of this Coil does not result in any new potential hazards.

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Image /page/1/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 1997

Larry A. Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201

Re: K971667

Cardiac Phased Array Surface Coil Dated: April 29, 1997 Received: May 6, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Dr. Kroger:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 sgainst misbranding and adulteration.

If your device is classified (see above) into either class II (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally market 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 809.10 for in yim diagnostic devices), please contact the Office of Compliance at [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 by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain html".

Sincerely yours,

h. Niau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K 97 1467

Device Name: Cardiac Phased Array Coil

Indications For Use:

ﺎ ﺍﻟﻤﺠﺎ

It is intended to be used in the heart and mediastinum regions for 2D and 3D .. . . . . . . Magnetic Resonance imaging

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Grayson

(Division Sign-Off) (Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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