OPTIMA MR 430S

K123068 · Ge Medical Systems, LLC · LNH · Nov 13, 2012 · Radiology

Device Facts

• Record ID: K123068
• Device Name: OPTIMA MR 430S
• Applicant: Ge Medical Systems, LLC
• Product Code: LNH · Radiology
• Decision Date: Nov 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Optima MR430s MRI Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique crosssectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.

Device Story

Optima MR430s is a stationary magnetic resonance imaging (MRI) system using a superconducting magnet. It acquires 2D single-slice, multi-slice, and 3D volume images of human limbs and joints. Operator selects pulse sequences including spin echo, fast spin echo, and 2D/3D gradient echo. System includes imaging options like inversion recovery, flow compensation, and fat/water suppression to mitigate physiological motion artifacts and enhance image quality. Operated by trained professionals in clinical settings; images are interpreted by medical experts to provide diagnostic information regarding internal limb/joint structures.

Clinical Evidence

No clinical data. The modification did not require clinical testing; substantial equivalence supported by non-clinical performance testing and validation.

Technological Characteristics

Superconducting magnet MRI system. Provides 2D/3D imaging with pulse sequences (spin echo, gradient echo). Includes artifact suppression (inversion recovery, flow compensation, fat/water suppression). Stationary form factor. Complies with voluntary standards.

Indications for Use

Indicated for MRI imaging of the leg (excluding thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. For use by medical experts to visualize internal limb and joint structures.

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

• Optima MR430s MRI Scanner (K103238)

Submission Summary (Full Text)

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### NOV 1 3 2012

GE Healthcare 510(k) Premarket Notification Submission

#### 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: September 19, 2012

GE Medical Systems, LLC (GE Healthcare) Submitter: 301 Ballardvale Street, Suite 4 Wilmington, MA 01887

Primary Contact Person:

Yuan Ma Regulatory Affairs Manager GE Medical Systems, LLC (GE Healthcare) Tel: [phone] Fax: [phone] [e-mail]

Secondary Contact Person:

Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC) [phone] [phone] [e-mail]

Establishment Registration Number:

3008193097

Optima MR430s Device Trade Name:

Common/Usual Name: Magnetic Resonance Imaging System

Classification 21 C.F.R. 892.1000 Magnetic Resonance Diagnostic Device · Names:Product Code: LNH

Predicate Device(s): K103238, Optima MR430s MRI Scanner

Device Description: The Optima MR430s MRI Scanner utilizes a superconducting magnet to acquire 2D single-slice and multi-slice and 3D volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, fast spin echo, 2D and 3D gradient echo acquisitions. Imaging options such as inversion recovery, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system is used as a stationary system.

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## GE Healthcare

510(k) Premarket Notification Submission

Intended Use:

The Optima MR430s MRI Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique crosssectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.

The modified Optima MR430s employs the same fundamental

scientific technology as the unmodified predicate device.

#### Technology:

Determination of Substantial Equivalence:

The Optima MR430s complies with voluntary standards as detailed in Sections 9 of this premarket submission. The following quality assurance measures were applied to the modification of the system:

- . Risk Analysis
- Requirements Reviews .

Summary of Non-Clinical Tests:

- . Design Reviews
- Performance Testing (Verification) ●
- System Validation Testing .

#### Summary of Clinical Tests:

The modification that prompted this submission did not require clinical testing.

Conclusion:

GE Healthcare considers the Optima MR430s to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

GE Medical Systems, LLC Speciality MR 301 Ballardvale Street Suite 4 Wilmington, MA 01887

NOV 1 3 2012

Re: K123068

Trade/Device Name: OPTIMA MR430s Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: October 01, 2012 Received: October 16, 2012

Dear Dr. Ma: .

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Yuan Ma

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 yours,

Michael D. O'hara 2012.11.09 15:33:15-05'00'

Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# K123068

510(k) Number (if known):

Device Name: Optima MR430s

Indications for Use:

The Optima MR430s MR Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.

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

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 123068

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