LEO 7000 QUADRATURE KNEE COIL

K971246 · Usa Instruments, Inc. · MOS · Jun 20, 1997 · Radiology

Device Facts

• Record ID: K971246
• Device Name: LEO 7000 QUADRATURE KNEE COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Jun 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Leo 7000 Quadrature Knee Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the knee anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Knee Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.

Device Story

Leo 7000 Quadrature Knee Coil is a receive-only, bird-cage resonator RF coil for MRI systems; specifically GE Signa (1.5 Tesla). Device captures magnetic resonance signals from knee anatomy; transforms signals into diagnostic images via host MRI scanner. Used in clinical settings by trained MRI technicians/physicians. Coil features split-top design; polyurethane housing; RF chokes with switching diodes for decoupling. Receive-only operation prevents RF power transmission; decoupling isolates elements during RF transmission to prevent RF burns/resonant loops. Output provides soft tissue images for physician diagnosis of knee joint pathology.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics, design, and safety features against legally marketed predicate devices.

Technological Characteristics

Receive-only quadrature bird-cage resonator RF coil. Materials: flame-retardant polyurethane housing. Decoupling: RF chokes with switching diodes. Energy: passive receive-only (no RF transmission). Form factor: split-top knee coil. Compatibility: GE Signa 1.5T MRI scanner. Sterilization: N/A.

Indications for Use

Indicated for patients requiring diagnostic MRI imaging of the knee anatomy. Designed for use with GE Signa (1.5 Tesla) MRI scanners to produce images of proton distribution and soft tissue structure for physician interpretation.

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

• Lower Extremity Coil, OUTLOOK MRI System (K945827)
• MR Quadrature Knee Coils, Hitachi Medical Systems (K914263)
• Profile 7000 C-Spine Coils, US ASIA Instruments, Inc. (K943440)
• Flexible Phased Array Spine Coil, Picker International, Inc. (K960497)
• Quadrature head coil and Quadrature MRA coil, HI-STAR MRI system, Health Images, Inc. (K944724)

Submission Summary (Full Text)

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JUN 20 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS K971246

1. Device Name: Magnetic Resonance Imaging Accessory
2. Proprietary Name: Leo 7000 Quadrature Knee Coil
3. Classification: Class II
4. Establishment Registration #: 1529041
5. Manufacture Facility Location: USA Instruments, Inc., 675-B Alpha Drive, Highland Heights, Ohio 44143, USA Telephone: [phone]; Fax: [phone].
6. Performance Standard: No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.
7. Intended Use: The Leo 7000 Quadrature Knee Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the knee anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Knee Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.
8. Device Description: The Leo 7000 Quadrature Knee Coil is a bird-cage resonator. The electrical circuitry is enclosed in a durable housing assembly made of polyurethane material, which is fire rated and has high impact and tensile strength. The Leo 7000 Quadrature Knee Coil is a quadrature volume coil with a split-top design.

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9. Safety and Effectiveness

| Parameter | LEO 7000 Quadrature Knee Coil | Same as Predicate Device |
| --- | --- | --- |
| | | |
| Intended Use | Knee Imaging Applications | MR Quadrature Knee Coils
Hitachi Medical Systems
(K914263)

Lower Extremity Coil,
OUTLOOK MRI System
Picker International, Inc.
(K945827) |
| Indications for Use | Identical to routine MRI imaging | Lower Extremity Coil, OUTLOOK MRI System
Picker International, Inc.
(K945827)

Profile 7000 C-Spine Coils,
US ASIA Instruments, Inc.
(K943440) |
| Coil Body Former Material | Flame retardant Polyurethane | Lower Extremity Coil, Head Coil, and Vascular Head and Neck Coil, OUTLOOK MRI System
Picker International, Inc.
(K945827) |
| Coil Design | Quadrature receive-only, bird-cage resonator | Quadrature head coil and Quadrature MRA coil, HI-STAR MRI system, Health Images, Inc.
(K944724) |
| Decoupling | RF Chokes with Switching Diodes | Lower Extremity Coil, OUTLOOK MRI System
Picker International, Inc.
(K945827)

Flexible Phased Array Spine Coil, Picker International, Inc.
(K960497). |
| Prevention of RF Burns | Does not transmit RF Power
Decoupling isolates the coil elements from RF fields during RF transmission
Coil elements and circuitry are enclosed in a non-conductive housing. | Profile 7000 C-Spine Coils
US ASIA Instruments, Inc.
(K943440).

Lower Extremity Coil, OUTLOOK MRI System
Picker International, Inc.
(K945827) |
| Radio Frequency Absorption | Coil is a receive only coil and does not transmit RF power | Profile 7000 C-Spine Coils,
US ASIA Instruments, Inc.
(K943440) |
| Formation of Resonant Loops | Decoupling isolates coil elements from RF fields during RF transmission.
Length of cable and stiffness do not permit looping. | Profile 7000 C-Spine Coils,
US ASIA Instruments, Inc.
(K943440)

Flexible Phased Array Spine Coil
Picker International, Inc.
(K960497). |

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN 20 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

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

Re: K971246
Leo 7000 Quadrature Knee Coil
Dated: April 2, 1997
Received: April 3, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/cdrh/dsmamain.html".

Sincerely yours,

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

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510(k) Number (if known): K971246

Device Name: Leo 7000 Quadrature Knee Coil

Indications for Use: The Leo 7000 Quadrature Knee Coil is designed to provide Magnetic Resonance Images of the knee anatomy. The Leo 7000 Quadrature Knee Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner.

Anatomic Regions: Knee Joint
Nuclei Excited: Hydrogen

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

The GE Signa 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, and Radiological Devices
510(k) Number K971246

Prescription Use ☑
(Per 21 CFR 801.109)

OR

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