GenIQ

K143368 · Ge Medical Systems, LLC · LLZ · Jul 29, 2015 · Radiology

Device Facts

• Record ID: K143368
• Device Name: GenIQ
• Applicant: Ge Medical Systems, LLC
• Product Code: LLZ · Radiology
• Decision Date: Jul 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

GenIQ is an automated post-processing software option that is indicated for use on dynamic magnetic resonance imaging data sets to generate parametric image intensity variations over time. This dynamic change in signal intensity is used to calculate functional parameters related to tissue flow and leakage of the contrast agent from the intravascular to the extracellular space. GenIQ provides information that when interpreted by a trained physician, can be useful for assessing tissue vascular properties.

Device Story

GenIQ is an automated post-processing software application for Dynamic Contrast Enhanced (DCE) MRI data. It performs pharmacokinetic analysis using a General Kinetic Model (GKM) to transform signal intensity variations over time into parametric images. Outputs include functional parameters describing tissue vascular properties, such as forward/backward transfer constants, plasma volume, and extracellular space volume. Used in clinical settings by trained physicians to interpret tissue vascularity; output assists in clinical decision-making regarding tissue characterization. Benefits include quantitative assessment of vascular properties derived from dynamic imaging.

Clinical Evidence

No clinical trials performed. Validation included bench testing using digital phantom data referenced by the Quantitative Imaging Biomarkers Alliance (QIBA) to demonstrate correct implementation of the General Kinetic Model. Additionally, anonymized MR contrast-enhanced clinical datasets were used for validation.

Technological Characteristics

Software-only post-processing application. Implements General Kinetic Model (GKM) for pharmacokinetic analysis. Complies with ISO 13485, ISO 14971, IEC 62304, and IEC 62366 standards. Operates on dynamic MRI data sets.

Indications for Use

Indicated for use on dynamic magnetic resonance imaging (MRI) data sets to calculate functional parameters related to tissue flow and contrast agent leakage for assessment of tissue vascular properties by a trained physician.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• MR Permeability Software (K130278)

Submission Summary (Full Text)

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

July 29, 2015

GE Medical Systems, LLC % Ms. Jenny Wong Regulatory Affairs Leader, Magnetic Resonance 3200 N. Grandview Blvd. WAUKESHA WI 53188

Re: K143368

Trade/Device Name: GenIO Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 7, 2015 Received: July 8, 2015

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'Hara

For

Robert Ochs, Ph.D. Acting 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) K143368

Device Name GenIQ

Indications for Use (Describe)

GenIQ is an automated post-processing software option that is indicated for use on dynamic magnetic resonance imaging data sets to generate parametric image intensity variations over time. This dynamic change in signal intensity is used to calculate functional parameters related to tissue flow and leakage of the contrast agent from the intravascular to the extracellular space.

GenIQ provides information that when interpreted by a trained physician, can be useful for assessing tissue vascular properties.

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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Section 5: 510(k) Summary

GenIQ

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## 510(k) Summary

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

Date: November 24, 2014

| Submitter: | GE Medical Systems SCS<br>283 Rue de la Miniere<br>Buc, France 78530<br>FDA Registration Number: 9611343 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Jenny Wong<br>Regulatory Affairs Leader, MR<br>GE Medical Systems, LLC<br>Phone [phone]<br>Fax [phone] |
| Secondary Contact Person: | Glen Sabin<br>Regulatory Affairs Director, MR<br>GE Medical Systems, LLC<br>Phone [phone]<br>Fax [phone] |
| Device: | GenIQ |
| Trade Name: | GenIQ |
| Common/Usual Name: | System, image processing, radiological- Picture archiving<br>and communications system. |
| Classification Names: | 21CFR 892.2050 |
| Product Code: | LLZ |

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| | Predicate Device(s): Predicate Device Name: MR Permeability Software |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate 510k Number: K130278 |
| | Predicate Manufacturer: Philips Medical Systems<br>Nederland B.V. |
| Device Description: | GenIQ is a software application used for the<br>pharmacokinetic analysis of Dynamic Contrast Enhanced<br>(DCE) MRI data sets. The application is used to perform a<br>General Kinetic Model (GKM)-based pharmacokinetic<br>modeling of DCE-MRI data. The goal of GenIQ is to<br>extract functional parameters describing tissue vascular<br>properties such as forward and backward transfer<br>constants, plasma volume, and volume of extra-cellular<br>space. |
| Indications for Use: | GenIQ is an automated post-processing software option<br>that is indicated for use on dynamic magnetic resonance<br>imaging data sets to generate parametric images from the |

image intensity variations over time. This dynamic change in signal intensity is used to calculate functional parameters related to tissue flow and leakage of the contrast agent from the intravascular to the extracellular space.

> GenIQ provides information that when interpreted by a trained physician, can be useful for assessing tissue vascular properties.

Comparison of The proposed medical device, GenIQ, employs the same Technological fundamental scientific technology as its predicate device, Characteristics with MR Permeability. The proposed device (GenIQ) is Predicate Device: substantially equivalent to the predicate device because it is a post-processing software option for use on dynamic contrast enhanced (DCE) MR image datasets.

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#### Summary of Non-Clinical and Clinical Tests: Determination of

Substantial Equivalence:

The GenIO and its applications comply with voluntary standards:

- . ISO 13485
- ISO 14971
- IEC 62304 ●
- IEC 62366

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)

Simulated use testing was performed on digital phantom data referenced by Quantitative Imaging Biomarkers Alliance (QIBA). This validation demonstrated good implementation of the General Kinetic Model. In addition, anonymized MR contrast-enhanced images were used as clinical datasets to validate the GenIQ application.

- GE Healthcare considers the GenIQ application to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device.
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