GE SIGNA MR ONCOLOGY PACKAGE

K081916 · Ge Medical Systems, LLC · LNH · Jul 22, 2008 · Radiology

Device Facts

• Record ID: K081916
• Device Name: GE SIGNA MR ONCOLOGY PACKAGE
• Applicant: Ge Medical Systems, LLC
• Product Code: LNH · Radiology
• Decision Date: Jul 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The GE Signa® MR Oncology Package is a patient positioning package intended for use with GE Signa® MR Systems. The Signa® MR Oncology Package when used with a Signa® MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa® MR Oncology Package is indicated for use as a diagnostic imaging device axial, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® MR System with Signa® MR Oncology Package reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The Signa® MR Oncology Package provides an additional patient table for Signa® MR systems that allows patients to be imaged on a flat surface. The flat patient surface enables Signa® MR systems to acquire images in patient positions similar to other modalities that also utilize a flat patient surface such as X-Ray, CT, PET, and radiation therapy. The Signa® MR system with Signa® MR Oncology Package may also be used with MR-compatible patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.

Device Story

GE Signa® MR Oncology Package is a patient positioning accessory for GE Signa® MR systems. It consists of a modified detachable patient table providing a flat surface, enabling patient positioning consistent with other modalities like CT, PET, and radiation therapy. Used in clinical imaging environments by trained physicians and technologists; the device supports the use of MR-compatible immobilization accessories to ensure consistent patient alignment across multiple imaging sessions. The system does not alter the underlying MR imaging process; it facilitates diagnostic imaging by providing a stable, flat platform for the patient. The output is standard MR diagnostic images/spectra interpreted by physicians to assist in clinical diagnosis and treatment planning. Benefits include improved workflow integration with radiation therapy and other flat-table modalities.

Clinical Evidence

Bench testing only. The device was evaluated for safety per IEC 60601-1 and biocompatibility per ISO 10993-1, -5, and -10. Clinical image comparisons were performed to demonstrate that the modified table maintains the same imaging performance as the predicate Signa® HDx MR System.

Technological Characteristics

Patient table accessory for MR systems; provides a flat patient surface. Materials evaluated for biocompatibility per ISO 10993. Compatible with existing GE Signa® 1.5T and 3.0T MR systems. No changes to MR imaging energy source or sensing principles. Designed for use with MR-compatible immobilization accessories.

Indications for Use

Indicated for use as a diagnostic imaging device for whole-body MRI (head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, musculoskeletal) to produce axial, sagittal, coronal, oblique, and spectroscopic images/spectra. Intended for patients requiring consistent positioning across multiple imaging sessions, including those undergoing radiation therapy planning.

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 1.5T and 3.0T Signa® HDx MR System (K052293)

Reference Devices

• MR-compatible patient immobilization accessories (K080072)

Submission Summary (Full Text)

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KOSI916

# GE Healthcare

GE Signa® MR Oncology Package 510(k) Premarket Notification

# 510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92.

| Submitter: | GE Medical Systems, LLC<br>3200 N. Grandview Blvd.<br>Waukesha, WI 53188 | JUL 2 2 2008 |
|----------------------|--------------------------------------------------------------------------|--------------|
| Contact Person: | Daniel T. Biank<br>Regulatory Affairs Leader | |
| Telephone: | 262 - 521 - 6467 | |
| Fax: | 262 - 521 - 6379 | |
| Email: | [e-mail] | |
| Date Prepared: | June 5, 2008 | |
| Device Name: | | |
| Proprietary Name: | GE Signa® MR Oncology Package | |
| Common Name: | Patient Positioning Accessory for Magnetic Resonance Imaging System | |
| Classification Name: | Magnetic Resonance Diagnostic Device, (21 C.F.R. 892.1000, LNH) | |
| Predicate Devices: | | |

GE 1.5T and 3.0T Signa® HDx MR System (K052293)

### Device Description:

The GE Signa® MR Oncology Package includes a patient table that can be used with a GE Signa® MRcompatible patient positioning and immobilization devices. The Signa® Oncology Table is similar to the existing detachable patient table offered with Signa® MR Systems. It utilizes the detachable table system to offer a flat patient surface. The flat surface enables patients to be positioned similar to other diagnostic and therapeutic devices that also utilize flat patient surfaces. Also, the Signa® MR Oncology Package may be used with MR-compatible patient immobilization accessories to assist in consistent positions throughout multiple imaging sessions.

### Intended Use:

The GE Signa® MR Oncology Package is a patient positioning package intended for use with GE Signa® MR Systems.

The Signa® MR Oncology Package when used with a Signa® MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa® MR Oncology Package is indicated for use as a diagnostic imaging device axial, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® MR System with Signa® MR Oncology Package reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The Signa® MR Oncology Package provides an additional patient table for Signa® MR systems that allows patients to be imaged on a flat surface. The flat patient surface enables Signa® MR systems to acquire images in patient positions similar to other modalities that also utilize a flat patient surface such as X-Ray, CT, PET, and radiation therapy. The Signa® MR system with Signa® MR Oncology Package may also be used with MR-compatible patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.

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# GE Healthcare

#### Comparison with Predicate Devices:

The GE Signa® MR Oncology Package is an accessory for the previously cleared GE 1.5T and 3.0T Signa® HDx MR System and MRI systems utilizing the same removable patient table. The primary difference is a modification to the removable patient table to offer a flat patient surface. The immobilization devices are previously cleared devices (K080072), and are not altered when packaged with the GE Signa® Oncology Table.

#### Summary of Studies:

The GE Signa® MR Oncology Package has been evaluated to the appropriate clauses of IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety standard. Also, the patient contacting surface has been evaluated using the methodology and appropriate parts of 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing and the related 10993-5 and 10993-10 for Biocompatibility.

The Signa® MR Oncology Package is an accessory for the currently marketed 1.5T and 3.0T Signa® HDx MR System. The modified table has been verified to function with the Signa® HDx MR System. Additionally, clinical image comparisons demonstrate that the Signa® MR Oncology Package maintains the same imaging performance as the Signa® HDx MR System with existing patient table.

#### Conclusion:

It is the opinion of GE that the GE Signa® MR Oncology Package is substantially equivalent to the currently marketed GE 1.5T and 3.0T Signa® HDx MR System and the patient table used with these systems.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 2 2008

GE Medical Systems, LLC % Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services NA. Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K081916

Trade/Device Name: GE Signa® MR Oncology Package Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 3, 2008 Received: July 7, 2008

### Dear Mr. Kogoma:

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. Iisting 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 such 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.

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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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely vours.

Nancy 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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GE Signa® MR Oncology Package 510(k) Premarket Notification

## Indications for Use

510(k) Number (if known):

Device Name:

GE Signa® MR Oncology Package

### Indications for Use:

The GE Signa® MR Oncology Package is a patient positioning package intended for use with GE Signa® MR Systems.

The Signa® MR Oncology Package when used with a Signa® MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa® MR system with Signa® MR Oncology Package is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® MR system with Signa® MR Oncology Package reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The Signa® MR Oncology Package provides an additional patient table for Signa® MR systems that allows patients to be imaged on a flat surface. The flat patient surface enables Signa® MR systems to acquire images in patient positions similar to other modalities that also utilize a flat patient surface such as X-Ray, CT, PET, and radiation therapy. The Signa® MR system with Signa® MR Oncology Package may also be used with MR-compatible patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.

Prescription Use X AND/OR (21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ion of Reproductive, Abdominal and 510(k) Number

GE Signa® MR Oncology Package 510(k)