(98 days)
Not Found
No
The summary describes image processing and registration techniques, specifically Non-Rigid Registration (NRR), but does not mention AI, ML, or related concepts like deep learning, training data, or performance metrics typically associated with AI/ML devices.
No.
This device is an image analysis software application used for viewing, manipulating, and quantifying medical images. It does not provide any therapy or treatment.
Yes
The device is a non-invasive image analysis software application used for viewing, manipulating, and processing medical images from PET and CT modalities to quantify lesions and analyze functional activity, which are diagnostic activities.
Yes
The device is described as a "software application" that provides image analysis and processing tools for existing medical images. There is no mention of accompanying hardware components or hardware-specific functions beyond its integration with an "Advantage Workstation platforms," which is a general computing platform for medical imaging.
Based on the provided information, this device is NOT an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that MotionVUE2 (Q.freeze) is an image analysis software application that processes and analyzes medical images (PET and CT) obtained from patients. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device description focuses on image processing and visualization. The core functions described are non-rigid registration of images, visualization of registered images, and presentation layouts. These are all related to manipulating and displaying medical images, not analyzing biological specimens.
- The intended use is for supporting the viewing and manipulation of medical images for clinical purposes. While the software aids in the analysis of functional activity and quantification of lesions, this is done through the interpretation of medical images, not through in vitro testing of biological samples.
Therefore, MotionVUE2 (Q.freeze) falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 multi-planar 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.
Product codes (comma separated list FDA assigned to the subject device)
KPS
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
- .3. Visualization of Registered Average PET Gated Images
- Presentation Layouts to display the Registered and Registered Average PET 4. lmaqes
(Non-rigid registration includes spatial normalization, which may be used to transform a patient data set to match a standardized anatomical space).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, CT, fused images of respiratory gated datasets
Anatomical Site
Thorax area, Lung, Liver, Pancreas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Registration performance of up to 2 mm of center of mass motion.
Improvement of quantification results (SUV and size).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.
0
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: 262-312-7029 FAX: · · 262-312-7144 Email: david.duersteler@med.ge.com
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).
1
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
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
2
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
3
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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
4
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