BODY ARRAY COIL

K013594 · Usa Instruments, Inc. · MOS · Jan 22, 2002 · Radiology

Device Facts

• Record ID: K013594
• Device Name: BODY ARRAY COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Jan 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Body Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the abdomen, pelvis and lumbar spine regions in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Body Array Coil is designed for use with the Siemens Rhapsody 1.0Tesla MRI by Siemens Medical scanner manufactured Systems, Inc. The Siemens Rhapsody 1.0Tesla 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.

Device Story

Body Array Coil is a receive-only, four-element phased array RF coil; used for torso, abdomen, and lumbar spine MRI. Device consists of upper and lower sections positioned around patient torso; latched together during imaging. Operates as passive accessory to Siemens Rhapsody 1.0Tesla MRI scanner; does not transmit RF power. Employs RF chokes and switching diodes for decoupling to isolate elements from RF fields, preventing RF burns and resonant loops. Enclosed in high-impact, fire-rated plastic housing. Used in clinical imaging environments by trained technicians/physicians. Output is raw RF signal processed by host MRI system into diagnostic images; assists physicians in soft tissue structure visualization and clinical diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness supported by comparison of design, materials, and electrical characteristics to legally marketed predicate devices.

Technological Characteristics

Receive-only phased array RF coil; 4-element design. Materials: Royalite R59 ABS plastic, polyurethane. Decoupling: RF chokes with switching diodes. Form factor: Two-part (upper/lower) torso housing. Energy: Passive (receives RF signal only). Connectivity: Dedicated interface for Siemens Rhapsody 1.0Tesla MRI system.

Indications for Use

Indicated for patients requiring MRI of the torso, including abdomen, chest, and lumbar/thoracic spine. Used for diagnostic imaging of soft tissue structures via proton density, T1, and T2 parameters. Prescription use only.

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

• Insight Plus 9000 Torso and Pelvis Coil (K001209)
• Vision 5000 Phased Array Torso Coil (K002482)

Submission Summary (Full Text)

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## JAN 2 2 2002

## SUMMARY OF SAFETY AND EFFECTIVENESS

Body Array Coil

Class II

K013594
page 1 of 2

1. Device Name:

Magnetic Resonance Imaging Accessory

2. Proprietary Name:

3. Classification:

4. Establishment Registration #:

5. Manufacture Facility Location:

6. Performance Standard:

7. Intended Use:

8. Device Description:

1529041 USA Instruments, Inc., 1515 Danner Drive Aurora, Ohio 44202, USA

Telephone: [phone]; Fax: [phone].

No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.

The Body Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the abdomen, pelvis and lumbar spine regions in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Body Array Coil is designed for use with the Siemens Rhapsody 1.0Tesla MRI by Siemens Medical scanner manufactured Systems, Inc.

The Body Array Coil is a four-element receive-only phased array RF coil. The coil consists of two sections: upper and lower sections, which are positioned above and below the patient torso respectively. The upper section is latched on to the former bottom during imaging. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have a high impact and tensile strength.

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## 9. Safety and Effectiveness

| Body Array Coil<br>Product Features | Comparison to Predicate or other 510(k) cleared<br>products |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>Torso Imaging including abdomen,<br>chest, lumbar and thoracic spine | -Similar to Insight Plus 9000 Torso and Pelvis Coil<br>manufactured by USA Instruments, Inc. (K001209)<br>-Similar to Vision 5000 Phased Array Torso Coil<br>manufactured by USA Instruments, Inc. (K002482) |
| Indications for Use<br>Identical to routine MRI imaging | -Similar to Vision 5000 Phased Array Torso Coil<br>manufactured by USA Instruments, Inc. (K002482) |
| Coil Material<br>Royalite R59™ ABS Plastic<br>Polyurethane | -Similar to Vision 5000 Phased Array Torso Coil<br>manufactured by USA Instruments, Inc. (K002482) |
| Coil Design<br>Receive-only phased array design | -Similar to Vision 5000 Phased Array Torso Coil<br>manufactured by USA Instruments, Inc. (K002482) |
| Decoupling<br>RF Chokes with Switching Diodes | -Similar to Vision 5000 Phased Array Torso Coil<br>manufactured by USA Instruments, Inc. (K002482)<br>-Similar to Insight Plus 9000 Torso and Pelvis Coil<br>manufactured by USA Instruments, Inc. (K001209) |
| Prevention of RF Burns<br>Does not transmit RF Power,<br>Decoupling isolates the coil elements<br>from RF fields during RF transmission,<br>Coil elements and circuitry<br>are enclosed in a non-conductive<br>housing. | -Similar to Vision 5000 Phased Array Torso Coil<br>manufactured by USA Instruments, Inc. (K002482) |
| Radio Frequency Absorption<br>Coil is a receive only coil and does not<br>transmit RF power | -Similar to Vision 5000 Phased Array Torso Coil<br>manufactured by USA Instruments, Inc. (K002482) |
| Formation of Resonant Loops<br>Decoupling isolates coil elements from<br>RF fields during RF transmission,<br>Length of cable and stiffness does not<br>permit looping | -Similar to Vision 5000 Phased Array Torso Coil<br>manufactured by USA Instruments, Inc. (K002482) |

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 2 2 2002

Mr. Rony Thomas Vice President, Marketing and Programs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202

Re: K013594 Trade/Device Name: Body Array Coil MRI Specialty Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 31, 2001 Received: October 30, 2001

Dear Mr. Thomas:

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 application (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. Iisting 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 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.

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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 (21 CFR Part 801), please contact the Office of Compliance 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 by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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510(k) Number (if known):__K 01 35 94

Device Name: Body Array Coil

Indications for Use: The Body Array Coil is designed to provide Magnetic Resonance Images of the torso region including the abdomen, thoracic, and lumbar spine anatomy. The Body Array Coil is designed for use with the Siemens Rhapsody 1.0Tesla scanner.

> Anatomic Regions: Torso, Abdomen and Spine Anatomy Nuclei Excited: Hydrogen

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

The Siemens Rhapsody 1.0Tesla 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)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">✓</div> | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------------------------------|----------------------------------------------------|----|--------------------------------------------------|
| (Division Sign-Off) | <div style="text-align:left;">Tanya Brighton</div> | | |
| Division of Reproductive, Abdominal,<br>and Radiological Devices | | | |
| 510(k) Number | K013594 | | |