NEUROQ - PET DP

K041022 · Syntermed, Inc. · KPS · Jun 17, 2004 · Radiology

Device Facts

• Record ID: K041022
• Device Name: NEUROQ - PET DP
• Applicant: Syntermed, Inc.
• Product Code: KPS · Radiology
• Decision Date: Jun 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

NeuroQ™ - PET DP Program is indicated to: 1) assist with regional assessment of human brain scans, through automated quantification of mean pixel values lying within standardized regions of interest (S-ROI's), and 2) assist with comparisons of the activity in brain regions of individual scans relative to normal activity values found for brain regions in FDG-PET scans, through quantitative and statistical comparisons of S-ROI's.

Device Story

NeuroQ™-PET DP is a software program for nuclear medicine computer systems; processes human brain FDG-PET scans. Inputs: patient PET scan data. Operation: automated quantification of mean pixel values within standardized regions of interest (S-ROI); statistical comparison of regional activity against a reference database of asymptomatic controls. Output: quantified relative activity in brain regions; measures of magnitude and statistical significance of regional differences from normal values. Used in clinical settings by physicians to aid diagnostic interpretation. Physician integrates output with clinical/diagnostic information for final diagnosis. Benefits: provides objective quantitative data to support visual assessment of PET brain scans.

Clinical Evidence

Bench testing only. Validation performed in-house through design, coding, debugging, and software testing to establish safety and effectiveness. No clinical trial data provided.

Technological Characteristics

Software-based display and analysis program. Operates within the IDL (Interactive Data Language) operating system environment. Compatible with nuclear medicine computer systems supporting IDL. Performs automated quantification and statistical comparison of PET scan pixel values.

Indications for Use

Indicated for assisting clinicians in the regional assessment and quantitative comparison of human brain FDG-PET scans against a database of asymptomatic controls to aid in diagnostic interpretation.

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

• Mirage/Modification to Mirage (NeuroGam™) (K972886, K010726)

Submission Summary (Full Text)

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JUN 1 7 2004

K041022
Page 1 of 2

### ITEM I

# 510(k) SUMMARY

# Safety and Effectiveness

1. Medical Device Establishment:

Syntermed, Inc. Registration No. 1066019 Owner Operator 1.D. 9041128 Voice &FAX: [phone] Contact person: Kenneth Van Train Email: [e-mail] Date Summary Prepared: April 13, 2004

2. Medical Device:

NeuroQ™ - PET DP Program is indicated to:

- 1) assist with regional assessment of human brain scans, through automated quantification of mean pixel values lying within standardized regions of interest (S-ROI's), and
- 2) assist with comparisons of the activity in brain regions of individual scans relative to normal activity values found for brain regions in FDG-PET scans, through quantitative and statistical comparisons of S-ROI's.

#### 3. Medical Device Equivalence:

Mirage/Modification to Mirage (NeuroGam™) Ref. 510(K) #'s:K972886 and K010726.

### 4. Device Description:

The NeuroQ™ - PET DP Display and Analysis Program 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 and your 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.

This program was developed to run in the IDL operating system environment, which can be rms program any nuclear medicine computer systems which support the IDL software

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platform. The program processes the studies automatically, nowever, user verification plations. The program 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 The Intended use of this program was to promos the paya compare the patients study to a
allow him to co-register and display brain PET scans and compare the passess of allow him to co-register and display brun. F = . ov as a display and processing program to reference database. This program of a patient's study. It was not meant to replace of a aid in the diagnosuc interpretation of a patient of the PET brain scan. The physician should integrate all of the patients' clinical and diagnostic information, i.e. patients' newton, scies aries integrate an of the patientis of the PET brain scan, and quantitative results, prior to control interpretation. Interpretation of the comprehensive processing technique (as with alleo making his linal interpretation. diagnosuc imaging) is not pencol, and will be accorded and be found in Item H, Testing & Sho hegative results. The expected doorder of the accuracy when integrating the validation and the physician Should "be "Life" of "Life" of this program has no direct adverse " effect on health since the results represent only a part of the information, which the ellect on Theath's Since The Toodito Top: South of Span Stallity 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™ - PET DP program. Most Similar luncilishe to those ponentions programs that can co-register SPECT/PET Nuclear Medicine manufacturers nave programs for comparison of the patient's data to a data and some of them have program which executes in the IDL operating system environment and we believe is substantially equivalent to IDL operating system onlines (NeuroGam™) Ref. 510(k) #'s.K972886 and the wiragentiouslion to there have been no safety problems with the co-Rurorzo. To bur knowlouge thereference database for the Mirage NeuroGam™ registration and as been in the marketplace for over two years.

#### 7. Conclusions:

The safety of this program has been determined through the various stages of The Salely of this program nas book a initial design, coding, debugging, testing, sontware development which there of the program has been established in in-house and validation. The clibouroneous one progific details and results concerning the validation of the NeuroQ™ - PET DP program are listed in Item H, Testing & Validation of the Noard that the method employed for the development and the final in-house validation results of this medical display software program, NeuroQ™ - PET In have proven its safety and effectiveness. In our opinion, NeuroQ™ - PET DP Dr., have proven to builty and enote the Mirage NeuroGam™ program which has program is substantially equivalors to the mireg marger is intended for the same purpose and raises no new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around a stylized eagle-like symbol. The symbol is composed of three curved lines that suggest the shape of a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUN 1 7 2004

Mr. Kenneth F. Van Train President Syntermed, Inc. Tower Place Center 3340 Peachtree Road, NE Suite 1800 ATLANTA GA 30326

Re: K041022 Trade/Device Name: NeuroQ-PET DP Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: April 17, 2004 Received: April 20, 2004

Dear Mr. Van Train:

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 ferenced above and nave determines and marketed predicate devices marketed in interstate for use stated in the encrosure) to tegally manation of the Medical Device American Fig. In to commerce pror to that 20, 1978, the ecordance with the provisions of the Federal Food, Drug, devices that have been recure an accorres approval of a premarket approval application (PMA). and Cosmetic Act (11ct) that do not required to the general controls provisions of the Act. The I ou may, therefore, marres the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classince (soc aboro) ans eExisting major regulations affecting your device can
may be subject to such additional controls. Existing major regulations a Pr may be subject to satin adated eegulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oouv cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri shosames over device complies with other requirements of the Act that I DA has made a decommandiality and Jministered by other Federal agencies . You must comply or any I cacar statures and regarationing, but not limited to: registration and listing (21 CFR Part with an the Ace 3 requirements, measons and acturing practice requirements as set forth in the 807), laboning (21 CFR Part 820), and if applicable, the electronic product quality Systems (QU) regular(Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manceing your antial equivalence of your device to a legally premarket nothcation. The PDA miding of dassification 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 If you desire specific advice for your dones on the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Adultionally, 10r questions on the promotion and ... ......................................................................................................................... Other of Comphanes at (301) 97 - on" (21CFR Part 807.97) you may obtain. Other general by reletence to premarket notification (21 cc may be obtained from the Division of Small information on your responsionalists and crisistance at its toll-free number [phone] or 1901) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brigden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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S10(k) NUMBER (if KNOWN): ____________________________________________________________________________________________________________________________________________________

DEVICE NAME: NeuroQ™ - PET DP

INDICATION FOR USE:

NeuroQ™ - PET DP Program is indicated to:

- 1) assist with regional assessment of human brain scans, through automated assist with regional assessment of namaly within standardized regions of interest (S-ROI's), and
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- 2) assist with comparisons of the activity in brain regions of individual scans assist with compansoris of the activity for brain regions in FDG-PET scans, telative to normal astrily fittistical comparisons of S-ROI's.
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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block; vertical-align:top;">✓</div> | OR | Over-the-Counter Use |
|----------------------|----------------------------------------------------------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |

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(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K041022 |
|---------------|---------|
|---------------|---------|