MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL

K032415 · Usa Instruments, Inc. · MOS · Aug 25, 2003 · Radiology

Device Facts

• Record ID: K032415
• Device Name: MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Aug 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Millennium III 4 Channel Neurovascular Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest in Magnetic Resonance Imaging Systems. The Millennium III 4 Channel Neurovascular Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems.

Device Story

Millennium III 4 Channel Neurovascular Coil is a receive-only phased array RF coil; used with 3.0T GE MRI systems. Device captures hydrogen nuclei signals to produce diagnostic images of brain, cervical spine, soft tissues, and vasculature of head, neck, and upper chest. Rigid plastic housing contains coil elements and accessory electronics; open design facilitates patient positioning and comfort. Coil utilizes switching diode decoupling to isolate elements from RF fields during transmission, preventing RF burns and resonant loop formation. Operated by MRI technicians/radiologists in clinical imaging environments. Output is displayed on MRI system console for physician interpretation to assist in clinical diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Receive-only phased array RF coil; 4-channel configuration. Materials: Flame retardant polyurethane, flame retardant polycarbonate, Delrin Acetal. Decoupling: Switching diode. Form factor: Rigid enclosure. Energy: Passive receive-only (no RF transmission). Connectivity: Dedicated to GE 3.0T MRI systems.

Indications for Use

Indicated for patients requiring MRI imaging of the brain, cervical spine, soft tissues, and vasculature of the head, neck, and upper chest. Used with 3.0T GE MRI systems to produce images based on proton density, T1, and T2 parameters for diagnostic interpretation by a physician.

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

• Millennium 9000 Phased Array Neurovascular coil (K001807)

Reference Devices

• Alpha 5000 Wrist coil (K031143)

Submission Summary (Full Text)

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

## AUG 2 5 2003

K032415
Page 1 of 2

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name: | Millennium III 4 Channel Neurovascular Coil |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc.<br>1515 Danner Drive<br>Aurora, Ohio 44202, USA<br>Telephone: [phone]; Fax: [phone]. |
| 6. Performance Standard: | No applicable performance standards have been<br>issued under Section 514 of the Food, Drug and<br>Cosmetic Act. |
| 7. Intended Use: | The Millennium III 4 Channel Neurovascular Coil is a<br>receive-only phased array RF coil, used for obtaining<br>diagnostic images of the brain, cervical spine, soft<br>tissues and vasculature of the head, neck and upper<br>chest in Magnetic Resonance Imaging Systems. The<br>Millennium III 4 Channel Neurovascular Coil is<br>designed for use with the 3.0T MRI systems<br>manufactured by GE Medical Systems. |
| 8. Device Description: | The Millennium III 4 Channel Neurovascular Coil is a<br>multi-element phased array receive only coil. The<br>coil has a rigid enclosure. The open, patient friendly<br>design eases patient handling and positioning and<br>maximizes patient comfort. The coil elements and<br>accessory electronics are enclosed in a rigid plastic<br>housing, which is fire rated and has a high impact<br>and tensile strength. |

USA Instruments, Inc.

1 - 1

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

K032415
Page 2 of 2

## 9. Safety and Effectiveness

| Millennium III 4 Channel Neurovascular<br>Coil product features | Comparison to predicate device or other 510(k)<br>cleared products |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the brain, cervical<br>spine, soft tissues and vasculature of the<br>head, neck, and upper chest | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA Instruments,<br>Inc. (K001807) |
| Indications for Use: Identical to routine<br>MRI imaging | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA Instruments,<br>Inc. (K001807) |
| Coil Enclosure Material:<br>Flame Retardant Polyurethane<br>Flame Retardant Polycarbonate<br>Delrin Acetal | -Similar to the Alpha 5000 Wrist coil manufactured by<br>USA Instruments, Inc. (K031143) |
| Coil Design: Receive-only phased array<br>coil | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA Instruments,<br>Inc. (K001807) |
| Decoupling: Switching diode decoupling | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA Instruments,<br>Inc. (K001807) |
| Prevention of RF Burns: Does not transmit<br>RF power: decoupling isolates the coil<br>elements from RF fields during RF<br>transmission; coil elements and circuitry are<br>enclosed in a non-conductive housing. | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA Instruments,<br>Inc. (K001807) |
| Radio Frequency Absorption: Coil is a<br>receive only coil and does not transmit RF<br>power | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA Instruments,<br>Inc. (K001807) |
| Formation of Resonant Loop: Decoupling<br>isolates the coil elements from RF fields<br>during RF transmission; length of cable and<br>stiffness does not permit looping | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA Instruments,<br>Inc. (K001807) |

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

Image /page/2/Picture/1 description: The image shows a black and white logo. The logo consists of three stylized birds in flight, arranged diagonally from the upper right to the lower left. The birds are enclosed within a circle, and the text "U.S. PUBLIC HEALTH SERVICE" is written around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2003

Ms. Christie Shumaker Manager, QA and Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202

Re: K032415 Trade/Device Name: Millennium III 4 Channel Neurovascular Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: August 1, 2003 Received: August 11, 2003

Dear Ms. Shumaker:

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, 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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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: Millennium III 4 Channel Neurovascular Coil

Indications for Use: The Millennium III 4 Channel Neurovascular Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. The Millennium III 4 Channel Neurovascular Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.

> Anatomic Regions: brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest Nuclei Excited: Hydrogen

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

The 3.0T MRI 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 (Per 21 CFR 801.109) OR

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

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devic

510(k) Number