MAVRIC SL

K113394 · Ge Medical Systems, LLC · LNH · Dec 11, 2012 · Radiology

Device Facts

• Record ID: K113394
• Device Name: MAVRIC SL
• Applicant: Ge Medical Systems, LLC
• Product Code: LNH · Radiology
• Decision Date: Dec 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

MAVRIC SL is a combination of an acquisition technique and post-processing software intended for use on GE 1.5T and 3.0T MR systems. MAVRIC SL is suitable for use on all patients with passive MR Conditional orthopedics implants that are scanned according to the conditions of safe use for the specific MR Conditional implant being scanned. In addition, MAVRIC SL is suitable for use on patients without implants that are cleared for MR exams. MAVRIC SL helps reduce artifacts caused by presence of metal in both in-plane and through-plane dimensions compared to conventional MR imaging techniques. Thus MAVRIC SL allows visualizing more tissue in the vicinity of MR Conditional implanted metal instrumentation. When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.

Device Story

MAVRIC SL is a software option for GE 1.5T and 3.0T MR scanners; functions as an acquisition technique and post-processing software. Device addresses image artifacts caused by metal implants; utilizes 3D Multi-Spectral Imaging (MSI) technique based on 2D-FSE; incorporates view-angle-tilting and additional phase-encoding in slice-selective dimension. Individually encoded spectral images overlap in frequency domain to span spectrum of spins near metal; software combines these into final image. Used in clinical settings by radiologists/physicians to visualize tissue near metal instrumentation; aids in diagnostic decision-making by reducing in-plane and through-plane artifacts.

Clinical Evidence

Clinical testing included application validation and clinical imaging to demonstrate the technique's ability to reduce metal-induced artifacts and improve tissue visualization near implants. No specific sensitivity/specificity metrics provided; bench testing confirmed compliance with safety parameters including acoustic noise, dB/dt, and SAR.

Technological Characteristics

Software option for GE 1.5T/3.0T MR systems. Employs 3D Multi-Spectral Imaging (MSI) technique; FSE-based; utilizes view-angle-tilting and additional phase-encoding. Post-processing combines individually encoded spectral images. Complies with voluntary safety standards for acoustic noise, dB/dt, and SAR.

Indications for Use

Indicated for patients with passive MR Conditional orthopedic implants (scanned per implant safety conditions) and patients without implants cleared for MR exams.

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

• PROPELLER Imaging Option for MRI (K031230)

Submission Summary (Full Text)

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K113394

# GE Healthcare

510(k) Premarket Notification Submission

### 510(k) Summary

## DEC 1 1 2012

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

November 09, 2011 .. Date:

Submitter:

GE Healthcare (GE Medical Systems, LLC 3200 N. Grandview Blvd. Waukesha, WI 53188 USA

Primary Contact Person:

Yuan Ma Regulatory Affairs Leader GE Healthcare (GE Medical Systems, LLC [phone] [phone]fax

Secondary Contact Person:

Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC [phone] [phone] fax

::

MAVRIC SL Trade Name: Device: Common/Usual Name:

. . .

Software Option for Magnetic Resonance Imaging System

Classification Names: 21 C.F.R. 892.1000 Magnetic Resonance Diagnostic Device

> LNH Product Code:

Predicate Device(s):

PROPELLER Imaging Option for MRI, K031230

Device Description:

MAVRIC SL is a software application offered as an option for GE MR scanners. MAVRIC SL is based upon conventional 2D-FSE and then adds view-angle-tilting and additional phase-encoding in the slice-selective dimension. As a result, MAVRIC SL has reduced image artifacts and provides adequate spectral coverage in the presence of metal implants.

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# GE Healthcare

510(k) Premarket Notification Submission

MAVRIC SL is a combination of an acquisition technique and post-processing software intended for use on GE 1.5T and 3.0T MR systems. MAVRIC SL is suitable for use on all patients cleared for MR exams.

MAVRIC SL helps reduce artifacts caused by presence of metal in both in-plane and through-plane dimensions compared to conventional MR imaging techniques. Thus MAVRIC SL allows visualizing tissue in the vicinity of implanted metal instrumentation.

When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.

Imaging technique. Individually encoded spectral images in the MAVRIC SL technique overlap in the frequency

MAVRIC SL is an FSE-based, 3D Multi-Spectral

#### Technology:

Intended Use:

final image by
spectral image
MAVRIC SL :
fundamental se

## Determination of Substantial Equivalence:

domain and together span a wide spectrum of spins located near metal implants. MAVRIC SL generates a final image by combining the individually encoded spectral images in a post-processing step. MAVRIC SL software option employs the same

fundamental scientific technology as its predicate device.

### Summary of Non-Clinical Tests:

The MAVRIC SL software option complies with voluntary standards as detailed in Section 9, 11, 16 and 18 of this premarket submission. The following quality assurance measures were applied to the development of the system:

- Risk Analysis
- Requirements Reviews
- Design Reviews .
- Design Verification
- Safety Testing

The following safety parameters were measured:

- Acoustic Noise
- dB/dt >
- > SAR

The non-clinical tests outlined above have been executed with acceptable results. Refer to Sections 9, 16, and 18 of this submission for testing results.

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# GE Healthcare

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510(k) Premarket Notification Submission

## Summary of Clinical Tests:

·

The following clinical testing has been performed to validate the MAVRIC SL technique:

: : : .

- Application validation く
- Clinical imaging .

Conclusion:

GE Healthcare considers the MAVRIC SL software option to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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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 20993-002

December 11, 2012

GE Medical System, LLC C/O Mr. Yuan Ma Regualtory Affairs Leader, MR 3200 N. Grandview Blvd. W-828 WAUKESHA. WI 53188

Re: K113394

Trade/Device Name: MAVRIC SL Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 8, 2012 Received: November 9, 2012

Dear Mr. 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. 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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Page 2-Mr. Ma

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Janine M. Morris -S

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): K113394

Device Name: MAVRIC SL

Indications for Use:

MAVRIC SL is a combination of an acquisition technique and post-processing software intended for use on GE 1.5T and 3.0T MR systems. MAVRIC SL is suitable for use on all patients with passive MR Conditional orthopedics implants that are scanned according to the conditions of safe use for the specific MR Conditional implant being scanned. In addition, MAVRIC SL is suitable for use on patients without implants that are cleared for MR exams.

MAVRIC SL helps reduce artifacts caused by presence of metal in both in-plane and through-plane dimensions compared to conventional MR imaging techniques. Thus MAVRIC SL allows visualizing more tissue in the vicinity of MR Conditional implanted metal instrumentation.

When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Janine M. Morris -5 2012.12.12 08:02:20 -05'00' (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K113394 510(k)

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