DISCOVERY MR750W 3.0T

K130115 · Ge Medical Systems, LLC · LNH · May 23, 2013 · Radiology

Device Facts

• Record ID: K130115
• Device Name: DISCOVERY MR750W 3.0T
• Applicant: Ge Medical Systems, LLC
• Product Code: LNH · Radiology
• Decision Date: May 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Discovery MR750w 3.0T is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750w 3.0T reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Device Story

Discovery MR750w 3.0T is a whole-body magnetic resonance imaging (MRI) system utilizing a 3.0 Tesla superconducting magnet. System acquires signals via up to 32 independent receive channels and multiple coil elements. Operates by applying time-varying magnetic field gradients and RF transmissions to excite nuclei; captures spatial distribution and molecular environment data. Features multi-drive RF transmit technology for head and body imaging. Operated by trained clinicians in clinical settings. Output consists of axial, sagittal, coronal, oblique, and spectroscopic images, parametric maps, and dynamic images. Physician interprets output to assist in clinical diagnosis. Benefits include high-resolution imaging, high signal-to-noise ratio, and reduced scan times.

Clinical Evidence

No clinical studies required. Substantial equivalence supported by bench testing, including module verification, system integration testing, performance testing, safety testing, and simulated use validation. Internal scans confirmed imaging performance is equivalent to the predicate.

Technological Characteristics

3.0T superconducting magnet; multi-drive RF transmit; up to 32 independent receive channels; NEMA DICOM compliant. Complies with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-33, and NEMA MS1-MS5, MS8, MS9, PS3.1-3.18 standards. Software-based control for multi-drive RF transmit.

Indications for Use

Indicated for diagnostic imaging of the entire body, including head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions in patients requiring MR imaging. Contrast agents may be used. 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

• Discovery MR750w 3.0T (K103327)

Submission Summary (Full Text)

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K130115

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GE Healthcare 510(k) Premarket Notification Submission

#### 510(k) Summary

# MAY 2 3 2013

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

Date: January 11, 2013

GE Healthcare (GE Medical Systems, LLC) Submitter: 3200 N. Grandview Blvd Waukesha, WI 53188

Primary Contact Person:

Michelle Huettner Regulatory Affairs Leader, Magnetic Resonance GE Healthcare (GE Medical Systems, LLC) Phone: [phone] Fax: [phone]

Secondary Contact Person:

Glen Sabin Regulatory Affairs Director, Magnetic Resonance GE Healthcare (GE Medical Systems, LLC) Phone: [phone]

Fax: [phone]

Discovery MR750w 3.0T Device Trade Name:

Magnetic Resonance Imaging System

Classification Names: Magnetic Resonance Diagnostic Device

> Product Code: LNH

Predicate Device(s):

Device Description:

Common/Usual Name:

Discovery MR750w 3.0T (K103327)

The Discovery MR750w 3.0T features a superconducting magnet operating at 3.0 Tesla. The data acquisition system accommodates up to 32 independent receive channels in various increments, and multiple independent coil elements per channel during a single acquisition series. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms. The Discovery MR750w 3.0T uses multi-drive RF transmit for imaging of the head and body regions. The Discovery MR750w 3.0T is designed to conform to NEMA DICOM standards.

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## GE Healthcare 510(k) Premarket Notification Submission

Intended Use:

The Discovery MR750w 3.0T is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750w 3.0T reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The Discovery MR750w 3.0T employs the same Technology: fundamental scientific technology as its predicate device Discovery MR750w 3.0T (K103327). It is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It employs the same multi-drive RF transmit technology as its predicate. The modified device enables multi-drive RF transmit for head scanning, in addition to body scanning. There have been no hardware changes to enable multi-drive RF transmit for head scanning, it is solely a software change.

Summary of Non-Clinical Tests: Determination of

Substantial Equivalence:

The Discovery MR750w 3.0T and its applications comply with the following voluntary standards:

- IEC 60601-1 ●
- IEC 60601-1-1 .
- IEC 60601-1-2 .
- IEC 60601-1-4

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# GE Healthcare 510(k) Premarket Notification Submission

#### IEC 60601-2-33 .

In addition, this MR scanner is in compliance with the applicable NEMA standards, including NEMA MS1, NEMA MS2, NEMA MS3, NEMA MS4, NEMA MS5, NEMA MS8, NEMA MS9, and NEMA PS3.1-3.18.

The following quality assurance measures were applied to the development of the system: -

- . Requirements Reviews
- Design Reviews ●
- Testing on unit level (Module verification) ●
- Integration testing (System verification) ●
- Performance testing (Verification) .
- Safety testing (Verification .
- Simulated use testing (Validation) .

In addition, numerical simulations were conducted to demonstrate the safety of the multi-drive RF transmit system.

The non-clinical tests have been summarized in the Verification testing that was completed for the modified Discovery MR750w 3.0T System. The testing was completed with passing results per the pass/fail criteria defined in the test cases. This supports substantial equivalence to its predicate (Discovery MR750w 3.0T K103327} because it was also developed under quality assurance Design Controls. In addition, it is in compliance to the same Standards.

## Summary of Clinical Tests:

The subject of this premarket submission, Discovery MR750w 3.0T, did not require clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality. The

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## K130115 Page 4 of 4

# GE Healthcare

#### 510(k) Premarket Notification Submission

clinical results demonstrated that the Discovery MR750w 3.0T maintains the same imaging performance results as its predicate device, the Discovery MR750w 3.0T (K103327). Sample clinical images are included in this submission.

### Indications for Use:

、

The indications for use and intended use for the modified device are identical to the unmodified device.

GE Healthcare considers the Discovery MR750w 3.0T to. Conclusion: be as safe, as effective, and performance is substantially equivalent to the predicate device.

Image /page/3/Picture/7 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular shape. The logo is black and white.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609

Silver Spring, MD 20993-0002

May 23, 2013

Public Health Service

GE Medical Systems, LLC (dba GE Healthcare) % Ms. Michelle Huettner Regulatory Affairs Leader, Magnetic Resonance 3200 N. Grandview Blvd. WAUKESHA WI 53188

Re: K130115

Trade/Device Name: Discovery MR750w 3.0T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: April 22, 2013 Received: April 23, 2013

Dear Ms. Huettner:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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. 1

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Page 2 - Ms. Huettner

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Michael D. O'Hara for

Janine M. 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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# Indications for Use

510(k) Number (if known):

Device Name:

Discovery MR750w 3.0T

Indications for Use:

The Discovery MR750w 3.0T is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750w 3.0T reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

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

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 In Vitro Diagnostics and Radiological Health (OIR)

Michael O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K130115

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