INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL

K023650 · Usa Instruments, Inc. · MOS · Jan 24, 2003 · Radiology

Device Facts

• Record ID: K023650
• Device Name: INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Insight Plus 9000 Phased Array Torso and Pelvis Coil is a receive only phased array RF coil, used for obtaining diagnostic images of the torso and pelvic regions, including the abdomen, chest, and hips, in Magnetic Resonance Imaging Systems. The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed for use with the Philips Infinion 1.5T MRI system manufactured by Philips Medical Systems, Inc. The indications for use are the same as for standard MR Imaging. The 1.5T 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.

Device Story

Receive-only phased array RF coil; 8-element design; captures hydrogen proton NMR signals from torso/pelvic regions (abdomen, chest, hips). Used in clinical MRI settings; operated by trained MRI technicians/physicians. Device connects to Philips 1.5T MRI scanner; utilizes switching diode decoupling to isolate elements during RF transmission, preventing RF burns and resonant loop formation. Enclosed in semi-flexible, fire-rated, high-impact housing. Output is raw RF signal processed by MRI system into diagnostic images for physician interpretation. Benefits include high-quality soft tissue visualization for clinical diagnosis.

Clinical Evidence

No clinical data. Bench testing only. Device safety and effectiveness established through comparison of technical specifications, materials, and design principles to legally marketed predicate devices.

Technological Characteristics

8-element receive-only phased array coil. Materials: Flame retardant polyurethane, vinyl coated EVA foam, chlorinated polyethylene foam, flame retardant polycarbonate. Decoupling: Switching diode. Form factor: Semi-flexible housing. Energy: Passive receive-only (no RF transmission). Connectivity: Dedicated interface for Philips 1.5T MRI system.

Indications for Use

Indicated for patients requiring diagnostic MRI of torso and pelvic regions, including abdomen, chest, and hips. Compatible with Philips 1.5T MRI systems. No specific age or gender contraindications stated beyond standard MRI safety protocols.

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 Phased Array Torso and Pelvis Coil (K001209)
• Flow 7000 Peripheral Vascular Coil (K010730)

Reference Devices

• Mark 5000 Quadrature Shoulder coil (K013854)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

Ko23650

| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name : | Insight Plus 9000 Phased Array Torso and Pelvis<br>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 Insight Plus 9000 Phased Array Torso and<br>Pelvis Coil is a receive only phased array RF coil,<br>used for obtaining diagnostic images of the torso<br>and pelvic regions, including the abdomen, chest,<br>and hips, in Magnetic Resonance Imaging Systems.<br>The Insight Plus 9000 Phased Array Torso and<br>Pelvis Coil is designed for use with the Philips<br>Infinion 1.5T MRI system manufactured by Philips<br>Medical Systems, Inc. The indications for use are<br>the same as for standard MR Imaging. |
| 8. Device Description: | The Insight Plus 9000 Phased Array Torso and<br>Pelvis Coil is an eight element receive only phased<br>array coil. The coil elements and associated<br>circuitry are enclosed in a semi-flexible housing,<br>which is fire rated and has a high impact and tensile<br>strength. |
| | |

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## 9. Safety and Effectiveness

| Insight Plus 9000 Phased Array Torso and<br>Pelvis Coil Product Features | Comparison to predicate device or other 510(k)<br>cleared products |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the torso and<br>pelvic regions, including abdomen, chest<br>and hips. | -Similar to the Insight Plus 9000 Phased Array Torso<br>and Pelvis Coil manufactured by USA Instruments, Inc.<br>(K001209)<br>-Similar to the Flow 7000 Peripheral Vascular Coil<br>manufactured by USA Instruments, Inc. (K010730) |
| Indications for Use: Identical to routine<br>MRI imaging. | -Similar to the Insight Plus 9000 Phased Array Torso<br>and Pelvis Coil manufactured by USA Instruments, Inc.<br>(K001209)<br>-Similar to the Flow 7000 Peripheral Vascular Coil<br>manufactured by USA Instruments, Inc. (K010730) |
| Coil Enclosure Material:<br>Flame Retardant Polyurethane<br>Vinyl Coated EVA Foam | - Similar to the Mark 5000 Quadrature Shoulder coil<br>manufactured by USA Instruments, Inc. (K013854) |
| Chlorinated Polyethylene Foam<br>Flame Retardant Polycarbonate | -Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil manufactured by USA Instruments, Inc.<br>(K010730) |
| Coil Design: Receive-only phased<br>array<br>coil. | -Similar to the Insight Plus 9000 Phased Array Torso<br>and Pelvis Coil manufactured by USA Instruments, Inc.<br>(K001209)<br>-Similar to the Flow 7000 Peripheral Vascular Coil<br>manufactured by USA Instruments, Inc. (K010730) |
| Decoupling: Switching diode decoupling. | -Similar to the Insight Plus 9000 Phased Array Torso<br>and Pelvis Coil manufactured by USA Instruments, Inc.<br>(K001209)<br>-Similar to the Flow 7000 Peripheral Vascular Coil<br>manufactured by USA Instruments, Inc. (K010730) |
| 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 Insight Plus 9000 Phased Array Torso<br>and Pelvis Coil manufactured by USA Instruments, Inc.<br>(K001209)<br>-Similar to the Flow 7000 Peripheral Vascular Coil<br>manufactured by USA Instruments, Inc. (K010730) |
| Radio Frequency Absorption: Coil is a<br>receive only coil and does not transmit RF<br>power. | -Similar to the Insight Plus 9000 Phased Array Torso<br>and Pelvis Coil manufactured by USA Instruments, Inc.<br>(K001209)<br>-Similar to the Flow 7000 Peripheral Vascular Coil<br>manufactured by USA Instruments, Inc. (K010730) |
| 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 Insight Plus 9000 Phased Array Torso<br>and Pelvis Coil manufactured by USA Instruments, Inc.<br>(K001209)<br>-Similar to the Flow 7000 Peripheral Vascular Coil<br>manufactured by USA Instruments, Inc. (K010730) |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized emblem. The emblem consists of a symbol resembling a bird or an abstract human figure, composed of three curved lines, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 2 4 2003

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

Re: K023650

Trade/Device Name: Insight Plus 9000 Phased Array Torso and Pelvis Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 28, 2002 Received: October 30, 2002

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.

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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 vours.

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):_____________________________________________________________________________________________________________________________________________________

Device Name: Insight Plus 9000 Phased Array Torso and Pelvis Coil

Indications for Use: The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed to provide Magnetic Resonance Images of the torso and pelvic regions, including the abdomen, chest, and hips. The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed for use with the Philips Intera 1.5T MRI scanner manufactured by Philips Medical Systems, Inc.

> Anatomic Regions: Torso and pelvic regions, including the abdomen, chest, and hips. Nuclei Excited: Hydrogen

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

The 1.5T 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)

Nancy C. Srodon

Division of Reprodu and Radiological Devices 510(k) Number