INSIGHT 7000 PHASED ARRAY TORSO COIL

K972340 · Usa Instruments, Inc. · MOS · Aug 21, 1997 · Radiology

Device Facts

• Record ID: K972340
• Device Name: INSIGHT 7000 PHASED ARRAY TORSO COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Aug 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The Insight 7000 Phased Array Torso Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the torso region (chest, abdomen and hips anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Insight 7000 Phased Array Torso Coil is designed for use with the Esteem 1.5T MRI scanner manufactured by Elscint MR.

Device Story

Receive-only phased array RF coil; four-loop design; two-section configuration (upper/lower) positioned around patient torso. Input: RF signals from hydrogen nuclei during MRI scan. Operation: passive receive-only; decoupling via RF chokes and switching diodes isolates coil elements during RF transmission to prevent RF burns/resonant loops. Output: diagnostic MR images of torso anatomy. Used in clinical MRI suites; operated by MRI technicians/radiologists. Output interpreted by physicians for diagnosis. Benefits: improved signal reception for torso imaging.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing and comparison of technological characteristics, materials, and design specifications to predicate devices.

Technological Characteristics

Four-loop receive-only phased array coil. Materials: ABS plastic, Naughahyde, Cordura Plus fabric. Decoupling: RF chokes with switching diodes. Energy: passive RF receiver. Form factor: two-section (upper/lower) housing with foam padding. Connectivity: dedicated interface for Elscint Esteem 1.5T MRI scanner.

Indications for Use

Indicated for patients requiring diagnostic MRI imaging of the torso (chest, abdomen, hips). Used with Elscint Esteem 1.5T scanner to produce images based on proton density, T1, and T2 parameters for soft tissue structure visualization. For use by trained physicians.

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

• Phased Array Body Coil, Esteem 1.5T MRI System, Elscint MR (K962677)

Reference Devices

• General Purpose Flex Coil, Picker International (K944469)
• Flexible Phased Array Spine Coil, Picker International (K960497)

Submission Summary (Full Text)

{0}------------------------------------------------

## (972340

## SUMMARY OF SAFETY AND EFFECTIVENESS

AUG 21 1007

| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name : | Insight 7000 Phased Array Torso Coil |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 675-B Alpha Drive,<br>Highland Heights, Ohio 44143, USA<br>Telephone: [phone]; Fax: [phone]. |
| 6. Performance Standard: | No applicable performance standards have been issued<br>under Section 514 of the Food, Drug and Cosmetic Act. |
| 7. Intended Use: | The Insight 7000 Phased Array Torso Coil is a receive-<br>only phased array RF coil, used for obtaining diagnostic<br>images of the torso region (chest, abdomen and hips<br>anatomy) in Magnetic Resonance Imaging Systems. The<br>indications for use are the same as for standard MR<br>Imaging. The Insight 7000 Phased Array Torso Coil is<br>designed for use with the Esteem 1.5T MRI scanner<br>manufactured by Elscint MR. |
| 8. Device Description: | The Insight 7000 Phased Array Torso Coil is a four loop<br>receive-only coil. The coil consists of two sections: an<br>upper and lower section, which are positioned above<br>and below the patient torso respectively. The bottom<br>section, which contains two loop coils and the accessory<br>coil electronics, is enclosed in a vacuum formed housing<br>which is covered with a foam pad. The housing and foam<br>pad is entirely covered by a cover made of Naughahyde<br>and Cordura Plus® ( fabric material). The upper section,<br>which contains two upper loop coils, is covered by a<br>jacket made of identical materials as the bottom section. |

please turn over

l

-

.

r

{1}------------------------------------------------

## 9. Safety and Effectiveness

)

ﻧﻤﺴﺔ

| Parameter | Insight 7000 Phased Array<br>Torso Coil | Same as Predicate Device |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Torso Imaging including<br>abdomen, chest, hips | Phased Array Body Coil, Esteem 1.5T MRI System<br>Elscint MR<br>(K962677) |
| Indications for Use | Identical to routine MRI<br>imaging | Phased Array Body Coil, Esteem 1.5T MRI System<br>Elscint MR<br>(K962677) |
| Coil Material | ABS Plastic,<br>Naughahyde and Cordura Plus<br>(fabric material) | Phased Array Body Coil, Esteem 1.5T MRI System<br>Elscint MR<br>(K962677)<br>General Purpose Flex Coil<br>Picker International<br>(K944469) |
| Coil Design | Four coil receive-only phased<br>array design | Phased Array Body Coil, Esteem 1.5T MRI System<br>Elscint MR<br>(K962677) |
| Decoupling | RF Chokes with Switching<br>Diodes | Phased Array Body Coil, Esteem 1.5T MRI System<br>Elscint MR<br>(K962677) |
| Prevention of RF<br>Burns | Does not transmit RF Power<br>Decoupling isolates the coil<br>elements from RF fields during<br>RF transmission<br>Coil elements and circuitry<br>are enclosed in a non-<br>conductive housing. | Phased Array Body Coil, Esteem 1.5T MRI System<br>Elscint MR<br>(K962677) |
| Radio Frequency<br>Absorption | Coil is a receive only coil and<br>does not transmit RF power | Phased Array Body Coil, Esteem 1.5T MRI System<br>Elscint MR<br>(K962677) |
| Formation of Resonant<br>Loops | Decoupling isolates coil<br>elements from RF fields during<br>RF transmission.<br>Length of cable and stiffness<br>does not allow permit looping | Flexible Phased Array Spine Coil<br>Picker International<br>(K960497) |

1-2

।

l

-

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, which is a common symbol of the United States government. The logo is black and white.

Food and Drug Administration · 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 1997

Rony Thomas . . . . . . . . . . . Manager, Regulatory Affairs USA Instruments, Inc. 675-B Alpha Drive Highland Heights, Ohio 44143

Re:

K972340 Insight 7000 Phased Array Torso Coil Dated: May 6, 1997 Received: June 24, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Thomas:

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 against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (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 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 (2) CFR Part 801 and additionally 809.10 for in vitn 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/odth/dsmamain.html".

Sincerely yours,

ht 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

{3}------------------------------------------------

Page 1 of 1

510(k) Number (if known): K472340

Device Name: Insight 7000 Phased Array Torso Coil

Indications for Use: The Insight 7000 Phased Array Torso Coil is designed to provide Magnetic Resonance Images of the torso region. The Insight 7000 Phased Array Torso Coil is designed for use with the Elscint MR's Esteem 1.5T scanner.

> Anatomic Regions: Torso Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The Esteem 1.5T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|-----------------------------------------------------------------------|---------|--------------------------------------------------|
| (Division Sign-Off) | | |
| Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices | | |
| 510(k) Number | K972340 | |
| Prescription Use<br>(Per 21 CFR 801.109)<br>✓ | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |