Q. FREEZE (MOTION VUE2)

K113408 · Ge Medical Systems, LLC · KPS · Feb 24, 2012 · Radiology

Device Facts

• Record ID: K113408
• Device Name: Q. FREEZE (MOTION VUE2)
• Applicant: Ge Medical Systems, LLC
• Product Code: KPS · Radiology
• Decision Date: Feb 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MotionVUE2 (Q.freeze) is a PET/CT, non- invasive image analysis software application designed to support the viewing and manipulation of medical images from PET and CT imaging modalities. MotionVUE2 (Q.freeze) offers processing tools to optimize workflow of respiratory gated exams for PET, CT and fused images of respiratory gated datasets for simultaneous viewing in multiplanar volumes and cine loops. MotionVUE2 (Q.freeze) allows the users to generate from their 4D-PET or 4D-PET/CT series a registered 4D-PET series used for quantification of lesions and analysis of functional activity. With MotionVUE2 (Q.freeze), users will have the possibility to compare static PET/CT, 4D-PET/CT, and registered 4DPET series including visual comparison, quantification of lesions, and analysis of functional activity. MotionVUE2 (Q.freeze) provides registration performance of up to 2 mm of center of mass motion when motion is no larger than the diameter of the object. MotionVUE2 (Q.freeze) provides comparable/equivalent improvement of quantification results (SUV and size) as 4D PET techniques. MotionVUE2 (Q.freeze) can be used for features with locally concentrated activity within the entire Thorax area. This area includes the organs where PET/CT imaging has the most challenges due to respiratory motion: Lung, Liver, Pancreas.

Device Story

Software application (MotionVUE2/Q.freeze) for Advantage Workstation platforms; processes respiratory-gated 4D-PET and 4D-PET/CT datasets. Inputs: gated PET/CT image series. Transformation: utilizes Non-Rigid Registration (NRR) to align gated images, compensating for respiratory motion. Output: registered 4D-PET series, multi-planar volumes, and cine loops. Used by clinicians to visualize, quantify lesions (SUV/size), and analyze functional activity in thoracic organs (lung, liver, pancreas). Benefits: reduces motion artifacts, improves quantification accuracy comparable to standard 4D PET techniques, and optimizes workflow for respiratory-gated exams.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological comparison and performance specifications regarding registration accuracy (up to 2 mm center of mass motion) and quantification improvement (SUV and size) compared to existing 4D PET techniques.

Technological Characteristics

Software-based image analysis application for Advantage Workstation. Features Non-Rigid Registration (NRR) for spatial normalization of PET gated images. Operates on respiratory-gated PET/CT datasets. Designed for thoracic imaging (lung, liver, pancreas).

Indications for Use

Indicated for patients undergoing PET/CT imaging of the thorax (lung, liver, pancreas) where respiratory motion impacts image quality. Used for viewing, manipulation, and quantification of 4D-PET/CT datasets to analyze functional activity and lesion size.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• MotionVue (K081496)

Reference Devices

• Discovery PET/CT 600 (K081496)
• Discovery PET/CT 690 (K081496)

Submission Summary (Full Text)

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K113408

FEB 2 4 2012 GE Healthcare

# 510(k) Summary of Safety and Effectiveness iin accordance to 21 CFR

807.87{h))

Device Name Proprietary Device Name: Date prepared:

Q.freeze Software November 18, 2011

### Establishment Name and Registration Number of Submitter

Name: Registration Number: Corresponding Official: GE Medical Systems LLC 2126677 D. Duersteler GE Healthcare P.O. Box 414 Milwoukee, WI 53201 Phone: [phone] FAX: · · 262-312-7144 Email: [e-mail]

Device Classification Classification Code: Panel Identification: Classification Name:

Common Name: Classification Class: Reason for 510(k) Submission:

ಡಿರಿ KPS Radiology Emission Computed Tomography System (Per 21CFR 892.1200) PET/CT Imaging Software Class II Product New device

#### Device Description

:

Motion VUE2 (Q.freeze) is a modification to the existing Motion VUE application. Motion VUE is a software application that provides review tools necessary for viewing, staging, planning and monitoring disease in respiratory gated PET and CT data sets. It is intended for use on Advantage Workstation platforms.

Motion VUE2 (Q.freeze) is product delivers the Non-Rigid Registration (NRR) function (Motion Freeze function) to the existing Motion VUE application on AW. The Motion VUE 2 program delivers:

- ് 1: 1: Non-Rigid Registration of PET Gated Images
- Visualization of Registered PET Gated Images 2.
- .3. Visualization of Registered Average PET Gated Images
- Presentation Layouts to display the Registered and Registered Average PET 4. lmaqes ్నా

(Non-rigid registration includes spatial normalization, which may be used to transform a patient data set to match a standardized anatomical space).

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## GE Healthcare

510(k) Summary of Safety and Effectiveness November 18. 2011 Page 2

#### ldentification of Legally Marketed Equivalent Devices

Discovery PET/CT 600 and 690

GE Medical Systems LLC

K081496

#### Comparison with Predicate Devices

MotionVUE2 (Q.freeze) PET Software is similar in design, materials, energy sources, and technology to the above predicate devices. All major features have been previously marketed, and intended uses are substantively the same. O.Freeze performs as well as currently marketed devices introduces no sianificant change in safety or effectiveness as compared to the predicate devices, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed MotionVue on GE Healthcare's Discoverv Series of products.

#### Indications for Use of Device

MotionVUE2 (Q.freeze) is a PET/CT, non-invasive image analysis software application designed to support the viewing and manipulation of medical images from PET and CT imaging modalities.

MotionVUE2 (Q.freeze) offers processing tools to optimize workflow of respiratory gated exams for PET, CT and fused images of respiratory gated datasets for simultaneous viewing in multi-planar volumes and cine loops.

MotionVUE2 (Q.freeze) allows the users to generate from their 4D-PET or 4D-PET/CT series a reaistered 4D-PET series used for quantification of lesions and analysis of functional activity. With MotionVUE2 (Q.freeze), users will have the possibility to compare static PET/CT, 4D-PET/CT, and reaistered 4DPET series including visual comparison, quantification of lesions, and analysis of functional activity.

MotionVUE2 (Q.freeze) provides registration performance of up to 2 mm of center of mass motion when motion is no larger than the diameter of the object.

MotionVUE2 (Q.freeze) provides comparable/equivalent improvement of quantification results (SUV and size) as 4D PET techniques.

MotionVUE2 (Q.freeze) can be used for features with locally concentrated activity within the entire Thorax area: This area includes the organs where PET/CT imaging has the most challenges due to respiratory motion: Lunq, Liver, Pancreas.

#### Conclusion

. . . . .

In the opinion of General Electric Medical Systems, the O.freeze Software is substantially the same in design, materials, energy sources, and technology, does not introduce new safety concerns, performs as well as currently marketed devices, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed MotionVUE (K081496).

ﻴﺮ,

General Electric Company P.O. Box 414 Milwaukee, W1 53201

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

FEB 2 4 2012

Mr. David Duersteler Safety and Regulatory Engineering GE medical Systems LLC 3000 N. Grandview Blvd. WAUKESHA WI 53188

Re: K113408

Trade/Device Name: GE Q.Freeze software Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: November 18, 2011 Received: November 28, 2011

#### Dear Mr. Duersteler:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrosure) to regarry thanks of the Medical Device Amendments, or to commerce prov to this 20, 1978, 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 I ou may, merelore, manel 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 class II (Special Controls), it may be subject to such II your device is classified (see above) into ena affecting your device can be found in Title 21, adultional controls. Disting mayor regates 800 to 895. In addition, FDA may publish further Ode of Pourial concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease be advised that I Dri 3 issuance or our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any I cachar statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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#### Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing pactice medical device-lefated develse events) (21 cegulation (21 CFR Part 820). This letter requirences as set form in the quality of enime ( ( described in your Section 510(k) premarket will anow you to begal mainen.org your antial equivalence of your device to a legally marketed nontication. The I Dr I minding of cassification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire specific advice of In Vitro Diagnostic Device Evaluation and Safety 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 Tou may obtain 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,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K113408

Device Name: GE Q.Freeze software

Indications for Use:

MotionVUE2 (Q.freeze) is a PET/CT, non- invasive image analysis software application designed to support the viewing and manipulation of medical images from PET and CT imaging modalities.

MotionVUE2 (Q.freeze) offers processing tools to optimize workflow of respiratory gated exams for PET, CT and fused images of respiratory gated datasets for simultaneous viewing in multiplanar volumes and cine loops.

MotionVUE2 (Q.freeze) allows the users to generate from their 4D-PET or 4D-PET/CT series a registered 4D-PET series used for quantification of lesions and analysis of functional activity. With MotionVUE2 (Q.freeze), users will have the possibility to compare static PET/CT, 4D-PET/CT, and registered 4DPET series including visual comparison, quantification of lesions, and analysis of functional activity.

MotionVUE2 (Q.freeze) provides registration performance of up to 2 mm of center of mass motion when motion is no larger than the diameter of the object.

MotionVUE2 (Q.freeze) provides comparable/equivalent improvement of quantification results (SUV and size) as 4D PET techniques.

MotionVUE2 (Q.freeze) can be used for features with locally concentrated activity within the entire Thorax area. This area includes the organs where PET/CT imaging has the most challenges due to respiratory motion: Lung, Liver, Pancreas.

ﻢ Prescription Use (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Mary Slott Post Janine Monia
(Division Sign-Off
Division of Radiological Devioce
Office of In Vitro Diagnostic Devics Evaluation and Safety