PREMIER III PHASED ARRAY CTL SPINE COIL

K013595 · Usa Instruments, Inc. · MOS · Jan 22, 2002 · Radiology

Device Facts

• Record ID: K013595
• Device Name: PREMIER III PHASED ARRAY CTL SPINE 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 Premier III Phased Array CTL Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Premier III Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla MRI scanner. The GE Medical Systems 3.0Tesla 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

Receive-only phased array RF coil; conforms to spine contours; used with GE 3.0T MRI scanner. Inputs: RF signals from hydrogen nuclei in patient spine. Operation: multi-element phased array circuitry; RF chokes/switching diodes for decoupling; non-conductive plastic housing prevents RF burns. Output: raw signal data processed by MRI system into diagnostic images. Used in clinical imaging settings by trained MRI technicians/physicians. Benefits: high-quality diagnostic images of spine anatomy; aids physician diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through comparison of design, materials, and safety features to predicate devices.

Technological Characteristics

Receive-only phased array RF coil; ABS and polycarbonate plastic housing; RF chokes and switching diodes for decoupling; non-conductive enclosure; designed for 3.0T MRI field strength.

Indications for Use

Indicated for patients requiring diagnostic MRI of the spine (cervical, thoracic, lumbar). Used with GE 3.0T MRI scanners to visualize soft tissue structures based on proton density, T1, and T2 parameters.

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

• Premier 7000 C/T/L Spine Coil (K980157)
• Magna 5000 CTL Spine Coil (K994345)

Submission Summary (Full Text)

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

## JAN 2 2 2002

## SUMMARY OF SAFETY AND EFFECTIVENESS

K013595
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:

Premier III Phased Array CTL Spine Coil

Class II

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 Premier III Phased Array CTL Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Premier III Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla MRI scanner.

The Premier III Phased Array CTL Spine Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the spine and has been designed to maximize comfort and ease of use. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.

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

## 9. Safety and Effectiveness

| Premier III Phased Array CTL Spine<br>Coil Product Features | Comparison to predicate device or other 510(k)<br>cleared product |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the spine. | -Similar to the Premier 7000 C/T/L Spine Coil<br>manufacture by USA Instruments, Inc. (K980157)<br>-Similar to the Magna 5000 CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K994345) |
| Indications for Use: Identical to routine<br>MRI imaging | -Similar to the Premier 7000 C/T/L Spine Coil<br>manufacture by USA Instruments, Inc. (K980157)<br>-Similar to the Magna 5000 CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K994345) |
| Coil Material:<br>ABS Plastic<br>Polycarbonate Plastic | -Similar to the Premier 7000 C/T/L Spine Coil<br>manufacture by USA Instruments, Inc. (K980157)<br>-Similar to the Magna 5000 CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K994345) |
| Coil Design: Receive-only phased array<br>design | -Similar to the Premier 7000 C/T/L Spine Coil<br>manufacture by USA Instruments, Inc. (K980157)<br>-Similar to the Magna 5000 CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K994345) |
| Decoupling: RF Chokes with Switching<br>Diodes | -Similar to the Premier 7000 C/T/L Spine Coil<br>manufacture by USA Instruments, Inc. (K980157)<br>-Similar to the Magna 5000 CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K994345) |
| Prevention of RF Burns: Does not<br>transmit RF Power, Decoupling isolates<br>the coil elements from RF fields during<br>RF transmission, Coil elements and<br>circuitry are enclosed in a non-<br>conductive housing. | -Similar to the Premier 7000 C/T/L Spine Coil<br>manufacture by USA Instruments, Inc. (K980157)<br>-Similar to the Magna 5000 CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K994345) |
| Radio Frequency Absorption: Coil is a<br>receive only coil and does not transmit<br>RF power | -Similar to the Premier 7000 C/T/L Spine Coil<br>manufacture by USA Instruments, Inc. (K980157)<br>-Similar to the Magna 5000 CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K994345) |
| Formation of Resonant Loops:<br>Decoupling isolates coil elements from<br>RF fields during RF transmission. Length<br>of cable and stiffness<br>does not permit looping | -Similar to the Premier 7000 C/T/L Spine Coil<br>manufacture by USA Instruments, Inc. (K980157)<br>-Similar to the Magna 5000 CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K994345) |

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administratio 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: K013595 Trade/Device Name: Premier III Phased Array CTL Spine Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 26, 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 for associated in the encreased of 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, 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 (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.

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

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/dsma/dsmamain.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

{4}------------------------------------------------

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Premier III Phased Array CTL Spine Coil

Indications for Use: The Premier III Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier III Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla scanner.

> Anatomic Regions: Spine Nuclei Excited: Hydrogen

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

The GE Medical Systems 3.0Tesla 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 | V |
|----------------------|---|
| (Per 21 CFR 801.109) | |

Over-The-Counter Use (Optional Format 1-2-96)

Nancy Brodkin
(Division Sign-Off)

OR

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________