(210 days)
No
The description focuses on quantitative analysis using ROI count methods and comparisons to a database of asymptomatic controls. There is no mention of AI, ML, or related concepts like training or test sets for model development.
No
This device is for quantitative analysis and comparison of brain scans, providing information for assessment rather than direct treatment or diagnosis.
Yes
The device performs quantitative analysis of brain scans, compares activity in brain regions to a database of asymptomatic controls, and calculates differences between two studies. This process provides information to aid in the assessment of human brain scans, which directly supports diagnosis.
Yes
The device description explicitly states it is a "Program" developed to run in a software environment (IDL operating system) and processes image data. There is no mention of any accompanying hardware component that is part of the regulated device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The NeuroQ™-PET DP program analyzes images of the brain obtained from PET and CT scans. It performs quantitative analysis on these images to assess brain activity and compare it to control groups or previous scans.
- Lack of Biological Sample Analysis: The device does not process or analyze any biological samples taken from the patient. Its input is imaging data, not biological material.
Therefore, while it is a medical device used for diagnostic purposes, it falls under the category of medical image analysis software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroQ™-PET DP program is indicated to perform a quantitative analysis of FDG-PET brain scans using a ROI count method.
NeuroQ™ 3.0 provides added functionality which allows for analyzing the difference between two FDG-PET brain studies for the same patient, calculating values within user defined regions of interest, and displaying CT and PET brain studies for the patient.
Product codes
KPS
Device Description
NeuroQ™ 3.0 has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can also be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. This program was developed to run in the IDL operating system environment, which can be executed on any nuclear medicine computer systems which support the IDL software platform. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
Mentions image processing
The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
FDG-PET brain scans, CT data
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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)
The safety of this program has been determined through the various stages of software development which included the initial design, coding, debugging, testing, and validation. The effectiveness of the initial program, NeuroQ™ - PET DP, has been established in in-house testing and clinical validation studies submitted in our previous 510(k) K041022. Specific details and results concerning the validation of the NeuroQ™ 3.0 program are listed in Item F, Testing & Validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NeuroQ™ - PET DP, Ref.510(k)#: K041022
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
(072307
MAR 1 4 2008
ITEM G
510(k) SUMMARY
Safety and Effectiveness
- Medical Device Establishment:
Syntermed. Inc. Registration No. 1066019 Owner Operator I.D. 9041128 Device Regulation Number: 892.1200 Classification Panel: Radiology Voice: (714) 281-1256, FAX: (714) 281-1290 Contact person: Kenneth F. Van Train Address: Syntermed. Inc. Tower Place Center 3340 Peachtree Road, NE Suite 1800 Atlanta, GA 30326 Email: vantrain@syntermed.com Date Summary Prepared: August 15, 2007
- Medical Device:
NeuroQ 3.0 -- Display and Analysis program for PET Brain studies.
Classification Name - System, Tomography, Computed, Emission
- Medical Device Equivalence:
NeuroQ™ - PET DP, Ref.510(k)#: K041022
- Device Description:
NeuroQ™ 3.0 has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can also be used to compare activity in brain regions of individual scans between two studies
1
from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. This program was developed to run in the IDL operating system environment, which can be executed on any nuclear medicine computer systems which support the IDL software platform. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
5. Intended Use and Potential Adverse Effect on Health:
The intended use of this program was to provide the physician with a program which would allow him to co-register and display brain PET scans and compare the patients study to a reference database. The program can also be used to compare the activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. This program serves merely as a display and processing program to aid in the diagnostic interpretation of a patient's study. It was not meant to replace or eliminate the standard visual analysis of the PET brain scan. The physician should integrate all of the patients' clinical and diagnostic information, i.e. patients' history, quality control images, visual interpretation of the PET brain scan, and quantitative results, prior to making his final interpretation. This comprehensive processing technique (as with all diagnostic imaging) is not perfect, and will be associated with some false positive and false negative results. The previous validation of the program can be found in the 510(k) submission for NeuroQ™ - PET DP, Ref. 510(k) #: K041022. The validation for modifications in version 3.0 can be found in Item F, Testing & Validation of this 510(k) and the physician should be aware of the accuracy when integrating the quantitative results for his final interpretation. Therefore, this program has no direct adverse effect on health since the results represent only a part of the information, which the physician will utilize for his final interpretation. The final responsibility for interpretation of the study lies with the physician.
6. Marketing History:
There have been other medical device programs marketed in the past which perform similar functions to those performed by the NeuroQ™ 3.0 program. Most Nuclear Medicine manufacturers have programs that can co-register SPECT/PET data and some of them have programs for comparison of the patient's data to a reference database. NeuroQ™ 3.0 provides a program which executes in the IDL operating system environment and we believe is substantially equivalent to our previous version of NeuroQ™ - PET DP K041022. To our knowledge there have been no safety problems with NeuroQ™ - PET DP K041022 which has been in the marketplace since June 2004.
7. Conclusions:
The safety of this program has been determined through the various stages of software development which included the initial design, coding, debugging, testing, and validation. The effectiveness of the initial program, NeuroQ™ - PET DP, has been established in in-house testing and clinical validation studies submitted in our previous 510(k) K041022. Specific details and results concerning the validation of the
2
NeuroQ™ 3.0 program are listed in Item F, Testing & Validation. We contend that the method employed for the development and the final in-house validation results of this medical display software program, NeuroQ™ 3.0, have proven its safety and effectiveness. In our opinion, NeuroQ™ 3.0 program is substantially equivalent to our previous version of NeuroQ™ - PET DP program which has been cleared for marketing. NeuroQ™ 3.0 program is intended for the same purpose and raises no new issues of safety or effectiveness.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its head facing left. The eagle is composed of three curved lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAR 1 4 2008
Mr. Kenneth F. Van Train President Syntermed, Incorporated 245 Owens Drive ANAHEIM CA 92808
Re: K072307
Trade/Device Name: NeuroQTM 3.0 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: December 13, 2007 Received: December 14, 2007
Dear Mr. Van Train:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in cursive. There are also some star symbols at the bottom of the logo.
roloxing and Promoting Public Halth
4
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
510(k) NUMBER (IF KNOWN): K072307
DEVICE NAME: NeuroQTM 3.0
INDICATION FOR USE:
The NeuroQ™-PET DP program is indicated to perform a quantitative analysis of FDG-PET brain scans using a ROI count method.
NeuroQ™ 3.0 provides added functionality which allows for analyzing the difference between two FDG-PET brain studies for the same patient, calculating values within user defined regions of interest, and displaying CT and PET brain studies for the patient.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
Loya M. White
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.