FLOW 7000 PERIPHERAL VASCULAR COIL

K982339 · Usa Instruments, Inc. · MOS · Sep 4, 1998 · Radiology

Device Facts

• Record ID: K982339
• Device Name: FLOW 7000 PERIPHERAL VASCULAR COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Sep 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The Flow 7000 Peripheral Vascular Coil is a receive-only quadrature-phased array RF coil, used for obtaining diagnostic images of the vasculature and soft tissue anatomy, extending from the abdomen to the foot region in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Flow 7000 Peripheral Vascular Coil is designed for use with the 1.5T Signa MRI scanner manufactured by GE Medical Systems.

Device Story

Flow 7000 Peripheral Vascular Coil is a 12-element, quadrature, phased-array, receive-only RF coil; used with GE Signa 1.5T MRI scanners. Device consists of upper and lower sections positioned around patient's lower torso and legs; captures hydrogen nuclei signals for diagnostic imaging of vasculature and soft tissue. Coil is receive-only; does not transmit RF power; utilizes RF chokes with switching diodes for decoupling to prevent RF burns and resonant loops. Operated by MRI technicians/radiologists in clinical settings. Output is raw signal data processed by the MRI system into diagnostic images; assists physicians in clinical diagnosis. Enclosed in non-conductive housing to ensure patient safety.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness are supported by comparison of design, materials, and electrical characteristics (decoupling, RF absorption, resonant loop prevention) to legally marketed predicate devices.

Technological Characteristics

12-element quadrature phased-array receive-only RF coil. Materials: Flame retardant ABS/PVC plastic alloy, flame retardant polyurethane plastic, flame retardant vinyl fabric. Decoupling: RF chokes with switching diodes. Energy: Passive receive-only (no RF transmission). Form factor: Two-section (upper/lower) enclosure. Connectivity: Proprietary interface for GE Signa 1.5T MRI scanner.

Indications for Use

Indicated for patients requiring MRI imaging of the abdominal aorta, peripheral vasculature, and soft tissue anatomy. Used with GE Signa 1.5T MRI scanners 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

• Peripheral Vascular Coil, Medical Advances Inc. (K964813)
• Insight 7000 Phased Array Torso Coil, USA Instruments (K972340)

Reference Devices

• Profile 7000 Volume Neck Coil, USA Instruments (K964531)
• Leo 7000 Quadrature Knee Coil, USA Instruments (K971246)
• General Purpose Flex Coil, Picker International (K944469)
• Phased Array C/T/L Spine Coil, USA Instruments (K980157)

Submission Summary (Full Text)

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## SEP

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name : | Flow 7000 Peripheral Vascular Coil |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 1515 Danner Drive,<br>Aurora, Ohio 44202, 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 Flow 7000 Peripheral Vascular Coil is a receive-<br>only quadrature-phased array RF coil, used for obtaining<br>diagnostic images of the vasculature and soft tissue<br>anatomy, extending from the abdomen to the foot region<br>in Magnetic Resonance Imaging Systems. The indications<br>for use are the same as for standard MR Imaging. The<br>Flow 7000 Peripheral Vascular Coil is designed for use<br>with the 1.5T Signa MRI scanner manufactured by GE<br>Medical Systems. |
| 8. Device Description: | The Flow 7000 Peripheral Vascular Coil is a 12 element<br>quadrature, phased array, receive-only coil. The coil<br>consists of two sections: an upper and lower section,<br>which are positioned above and below the patient's body<br>(lower torso and legs). The coil sections which contain<br>the coil elements and accessory coil electronics, is<br>enclosed to prevent any exposure to the patient or<br>environment. |

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## 9. Safety and Effectiveness

| Parameter | Flow 7000 Phased Array<br>Peripheral Vascular Coil | Same as Predicate Device |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Imaging of vasculature and tissue extending from the torso to the feet. | Peripheral Vascular Coil, Medical Advances Inc.<br>(K964813) |
| Indications for Use | Identical to routine MRI imaging | Peripheral Vascular Coil, Medical Advances Inc.<br>(K964813) |
| Coil Material | Flame Retardant ABS/PVC Plastic alloy,<br>Flame retardant Polyurethane Plastic<br>Flame retardant Vinyl fabric | Profile 7000 Volume Neck Coil, USA Instruments<br>(K964531)<br>Profile 7000 Volume Neck Coil, USA Instruments<br>(K964531)<br>Leo 7000 Quadrature Knee Coil, USA Instruments<br>(K971246)<br>General Purpose Flex Coil, Picker International<br>(K944469) |
| Coil Design | Receive-only phased array design | Insight 7000 Phased Array Torso Coil, USA Instruments<br>(K972340)<br>Phased Array C/T/L Spine Coil, USA Instruments<br>(K980157) |
| Decoupling | RF Chokes with Switching Diodes | Insight 7000 Phased Array Torso Coil, USA Instruments<br>(K972340) |
| Prevention of RF Burns | Does not transmit RF Power<br>Decoupling isolates the coil elements from RF fields during RF transmission<br>Coil elements and circuitry are enclosed in a non-conductive housing. | Insight 7000 Phased Array Torso Coil, USA Instruments<br>(K972340) |
| Radio Frequency<br>Absorption | Coil is a receive only coil and does not transmit RF power | Insight 7000 Phased Array Torso Coil, USA Instruments<br>(K972340) |
| Formation of Resonant<br>Loops | Decoupling isolates coil elements from RF fields during RF transmission.<br>Length of cable and stiffness does not permit looping | Insight 7000 Phased Array Torso Coil, USA Instruments<br>(K972340) |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/2 description: The image shows a partial view of a seal or emblem, featuring stylized bird-like figures in black. The text "DEPARTMENT OF HEALTH" is partially visible, curving along the edge of the emblem. The overall impression is of an official or organizational symbol, possibly related to a health department.

EP - 4 1998

Rony Thomas Manager, Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive Aurora, Ohio 44202

Re:

K982339 Flow 7000 Peripheral Vascular Coil Dated: June 22, 1998 Received: July 6, 1998 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 542 of the Act for devices under the Electronic Product 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 (21 CFR Part 801 and additionally 809.10 for in vitro 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.ida.gov/cdrh/dsmaldsmamain.html".

Sincerely vours

Radiological Health

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

Enclosure

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510(k) Number (if known):

Device Name: Flow 7000 Phased Array Peripheral Vascular Coil

Indications for Use: The Flow 7000 Phased Array Peripheral Vascular Coil is designed to provide Magnetic Resonance Images of the abdominal aorta,peripheral vasculature and soft tissue anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR's Signa 1.5T scanner.

> Anatomic Regions: Abdominal Vasculature, Peripheral Vasculature and soft tissue Nuclei Excited: Hydrogen

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

The Signa 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.

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| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|--------------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K982339 |

Prescription Use (Per 21 CFR 801.109)

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