EXTRA LARGE BODY COIL

K023442 · GE Medical Systems · MOS · Nov 5, 2002 · Radiology

Device Facts

• Record ID: K023442
• Device Name: EXTRA LARGE BODY COIL
• Applicant: GE Medical Systems
• Product Code: MOS · Radiology
• Decision Date: Nov 5, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Signa Ovation (formerly known as MFO/I) system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa Ovation system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa Ovation system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. Due to the 'open' design of the system, the Signa Ovation may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display, and MR safe biopsy needles.

Device Story

Signa Ovation is an open, whole-body magnetic resonance imaging (MRI) system. The device utilizes magnetic resonance to detect spatial distribution of protons (hydrogen nuclei) to generate transverse, sagittal, coronal, and oblique images. The system is modified with an 'Extra Large Body Coil' to support imaging. Operated by trained clinicians in a clinical setting, the system produces images interpreted by physicians to assist in diagnosis. The open architecture allows for use during interventional procedures when paired with MR-compatible accessories like biopsy needles and in-room displays. The device benefits patients by providing high-resolution diagnostic imaging and enabling interventional guidance.

Clinical Evidence

Bench testing only. Testing was performed to demonstrate that the design modifications to the Extra Large Body Coil meet predetermined acceptance criteria.

Technological Characteristics

Magnetic resonance diagnostic device (21 CFR 892.1000). System includes an open, whole-body scanner and a flexible extra large body coil. Operates via magnetic resonance imaging principles (proton density, T1, T2, flow).

Indications for Use

Indicated for diagnostic imaging of internal structures and organs of the entire body (musculoskeletal, vascular, cardiac, neuro) in patients requiring MR imaging. May be used for interventional procedures with MR-compatible devices. Prescription use only.

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

• GE Signa MFO/i MR system (K002611)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized font, enclosed within a circle. There are decorative swirls or flourishes around the circle, adding to the logo's design. The logo is black and white.

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GE Medical Systems

General Electric Company P.O. Box 414, Milwaukee, WI 53201

## 510(k) Summary

K02342

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).

| Submitter: | GE Medical Systems<br>PO Box 414<br>Milwaukee, WI 53201 |
|-----------------|---------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.<br>Manager, Regulatory Programs |
| Telephone: | 262- 544-3894 |
| Fax: | 262- 548-4768 |
| Date Prepared: | October 8 2002 |

#### Device Name:

Signa Ovation with Extra Large Body Coil Magnetic Resonance Coil, 21 CFR 892.1000, 90-MOS

#### Marketed Device:

The Signa Ovation system with Extra Large Body Coil is substantially equivalent to the currently marketed GE Signa MFO/i MR system (K002611).

### Device Description:

The Extra Large Body Coil is a modification to the Signa MFO/i MR System (K002611) which includes the addition of a flexible extra large body coil.

### Indications for Use:

The Signa Ovation (formerly known as MFO/I) system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa Ovation system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa Ovation system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Due to the 'open' design of the system, the Signa Ovation may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display, and MR safe biopsy needles.

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are in black, contrasting with the white background. The logo is a well-known symbol representing the multinational conglomerate.

General Electric Company P.O. Box 414, Milwaukee, WI 53201

#### Comparison with Predicate Device:

GE Medical Systems intends to begin marketing the Signa Ovation with Extra Large Body Coil. The Extra Large Body Coil is a modification of the Signa MFO/i MR System (K002611) with the main differences being the addition of a flexible extra large body coil. Signa MFO/i MR System has the same basic technological characteristics, and, uses similar design, construction, and materials.

#### Summary of Studies:

Testing was performed to demonstrate that the design modifications to the Extra Large Body Coil meet predetermined acceptance criteria.

#### Conclusion:

It is the opinion of GE that the Signa Ovation with Extra Large Body Coil is substantially equivalent to the GE Signa MFO/i MR System (K002611). Usage of the Extra Large Body Coil does not result in any new potential hazards.

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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird with three curved lines representing its wings or feathers. The bird is facing to the right. The words "DEPARTMENT OF" are written vertically along the left side of the logo, following the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

・、

5 2002 NOV

Larry Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems General Electric Company P.O. Box 414 MILWAUKEE WI 53201

Re: K023442

Trade/Device Name: Extra Large Body Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II

Product Code: 90 MOS Dated: October 8, 2002 Received: October 15, 2002

Dear Dr. Kroger:

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 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. Brydon

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): KO234 + 2

Device Name: Extra Large Body Coil

#### Indications For Use:

The Signa Ovation (formerly known as MFO/I) system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa Ovation system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa Ovation system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Due to the 'open' design of the system, the Signa Ovation may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display, and MR safe biopsy needles.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use OR

David G. Ingram

ological Devic