QUANTITATIVE NEUROQ 3.0

K072307 · Syntermed, Inc. · KPS · Mar 14, 2008 · Radiology

Device Facts

• Record ID: K072307
• Device Name: QUANTITATIVE NEUROQ 3.0
• Applicant: Syntermed, Inc.
• Product Code: KPS · Radiology
• Decision Date: Mar 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

NeuroQ 3.0 is a software program for display and analysis of PET brain scans; inputs include patient FDG-PET brain scans and CT data. Device performs automated quantification of mean pixel values in 240 brain regions; compares regional activity against a reference database of asymptomatic controls; enables longitudinal comparison of two studies from same patient; facilitates image fusion of PET and CT data. Used in clinical settings by physicians to aid diagnostic interpretation. Output provided as quantitative metrics and visual displays; physician integrates these results with clinical history and visual scan interpretation for final diagnosis. Benefits include standardized quantitative assessment of brain activity to support clinical decision-making.

Clinical Evidence

Bench testing only. Effectiveness established through in-house testing and validation studies. Previous validation data referenced from K041022; additional validation for version 3.0 modifications documented in submission.

Technological Characteristics

Software-based display and analysis program. Operates within the IDL (Interactive Data Language) environment on nuclear medicine computer systems. Supports PET and CT image data. Automated processing with manual verification capability.

Indications for Use

Indicated for quantitative analysis of FDG-PET brain scans to aid in assessment of human brain scans. Used to compare patient scans against a reference database of asymptomatic controls or between two studies from the same patient. No specific age or gender restrictions stated.

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

• NeuroQ™ - PET DP (K041022)

Submission Summary (Full Text)

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# (072307

MAR 1 4 2008

# ITEM G

# 510(k) SUMMARY

# Safety and Effectiveness

1. Medical Device Establishment:

Syntermed. Inc. Registration No. 1066019 Owner Operator I.D. 9041128 Device Regulation Number: 892.1200 Classification Panel: Radiology Voice: [phone], FAX: [phone] Contact person: Kenneth F. Van Train Address: Syntermed. Inc. Tower Place Center 3340 Peachtree Road, NE Suite 1800 Atlanta, GA 30326 Email: [e-mail] Date Summary Prepared: August 15, 2007

2. Medical Device:

NeuroQ 3.0 -- Display and Analysis program for PET Brain studies.

Classification Name - System, Tomography, Computed, Emission

3. Medical Device Equivalence:

NeuroQ™ - PET DP, Ref.510(k)#: K041022

4. 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

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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

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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.

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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.

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roloxing and Promoting Public Halth

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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 [phone] or [phone] 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

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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.

K072307

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.