Discovery MR750 3.0T

K142361 · Ge Medical Systems, LLC · LNH · Dec 5, 2014 · Radiology

Device Facts

• Record ID: K142361
• Device Name: Discovery MR750 3.0T
• Applicant: Ge Medical Systems, LLC
• Product Code: LNH · Radiology
• Decision Date: Dec 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Discovery MR750 3.0T system 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, TMI, 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 MR750 3.0Tsystem 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

Superconducting 3.0T MRI scanner; utilizes time-varying magnetic field gradients and RF transmissions to map spatial distribution/molecular environment of nuclei. Features multi-drive RF transmit technology for head and body imaging; supports up to 32 independent receive channels. Operated by trained clinicians in clinical settings; produces images/spectra for physician interpretation to assist in diagnosis. System includes host computer and reconstruction engine; supports DICOM standards. Benefits include high-resolution imaging, high signal-to-noise ratio, and reduced scan times.

Clinical Evidence

No external clinical studies required. Internal scans conducted for validation of workflow and image quality regarding the multi-drive RF transmit feature. Results demonstrated imaging performance equivalent to predicate device (K132376).

Technological Characteristics

3.0 Tesla superconducting magnet; multi-drive RF transmit technology; 32-channel data acquisition system. Connectivity: DICOM (NEMA PS3.1-3.20). Hardware: host computer and reconstruction engine. Software: version DV25. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33.

Indications for Use

Indicated for whole-body diagnostic MR imaging, including head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions. Produces axial, sagittal, coronal, oblique images, spectroscopic images, parametric maps, and spectra. Contrast agents may be used.

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 MR750 3.0T (K132376)
• Discovery MR750w 3.0T (K132376)

Submission Summary (Full Text)

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December 5, 2014

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Regulatory Affairs Leader, Magnetic Resonance

Re: K142361

GE Medical Systems, LLC

3200 N. Grandview Blvd. WAUKESHA WI 53188

% Ms. Jenny Wong

Trade/Device Name: Discovery MR750 3.0T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 21, 2014 Received: November 24, 2014

Dear Ms. Wong:

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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/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)

K142361

Device Name Discovery MR750 3.0T

#### Indications for Use (Describe)

The Discovery MR750 3.0T system 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, TMI, 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 MR750 3.0Tsystem 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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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: August 22, 2014

| Submitter: | GE Healthcare, (GE Medical Systems, LLC)<br>3200 N Grandview Blvd.<br>Waukesha, WI 53188 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Jenny Wong<br>Regulatory Affairs Leader, MR<br>GE Healthcare, (GE Medical Systems, LLC)<br>Phone: [phone]<br>Fax: [phone] |
| Secondary Contact Person: | Glen Sabin<br>Regulatory Affairs Director, MR<br>GE Healthcare, (GE Medical Systems, LLC)<br>Phone: [phone]<br>Fax: [phone] |
| Device:<br>Trade Name: | Discovery MR750 3.0T |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names: | 892.1000 |
| Product Code: | LNH |
| Predicate Device(s): | Discovery MR750 3.0T and Discovery MR750w 3.0T [K132376] |
| Device Description: | The Discovery MR750 3.0T features a superconducting magnet<br>operating at 3.0 Tesla. The data acquisition system accommodates up to<br>32 independent receive channels in various increments, and multiple<br>independent coil elements per channel during a single acquisition<br>series. The system uses a combination of time-varying magnetic fields<br>(gradients) and RF transmissions to obtain information regarding the<br>density and position of elements exhibiting magnetic resonance. The<br>system can image in the sagittal, coronal, axial, oblique and double<br>oblique planes, using various pulse sequences and reconstruction<br>algorithms. The Discovery MR750 3.0T uses multi-drive RF transmit<br>for imaging of the head and body regions. |

The Discovery MR750 3.0T is designed to conform to NEMA DICOM

up to

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# GE Healthcare 510(k) Premarket Notification Submission

### standards.

Intended Use: The Discovery MR750 3.0T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-tonoise 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 MR750 3.0T system 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.

- Technology: The Discovery MR750 3.0T employs the same fundamental scientific technology as its predicate devices.
The following is a summary of the differences between the proposed Discovery MR750 3.0T and its predicate Discovery MR750 3.0T and Discovery MR750w 3.0T (K132376).

- New base software (version DV25) ●
- . Software and hardware modifications to enable of the multidrive RF transmit technology for body and head
- Hardware modifications to the host computer and reconstruction engine for obsolescence and compatibility with a new operating system
- . Revised and updated labeling to support new feature

| Determination of Substantial<br>Equivalence: | Summary of Non-Clinical Tests: |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Discovery MR750 3.0T system with the addition of the new multi-drive RF transmit function complies with the following voluntary standards:<br>IEC 60601-1 IEC 60601-1-2 |

- IEC 60601-2-33

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# GE Healthcare 510(k) Premarket Notification Submission

In addition, the Discovery MR750 3.0T system in compliance with the applicable NEMA standards, including NEMA PS3.1-3.20 for DICOM conformance.

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

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

The non-clinical tests have been summarized in the verification testing that was completed for the addition of the multi-drive RF transmit mode. The testing was completed with passing results per the pass/fail criteria defined in the test cases. This supports substantial equivalence to its predicates because it was also developed under quality assurance Design Controls. In addition, Discovery MR750 3.0T is in compliance to the same Standards.

## Summary of Clinical Tests:

The subject of this premarket submission, Discovery MR750 3.0T, did not require external clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality for the addition of the new feature. The clinical results demonstrated that the Discovery MR750 3.0T maintains the same imaging performance results as its predicate device (K132376). Sample clinical images are included in this submission.

- Conclusion: GE Healthcare considers the Discovery MR750 3.0T to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).