ACQA

K113086 · Texas Medical Imaging Consultants · KPS · Jan 13, 2012 · Radiology

Device Facts

• Record ID: K113086
• Device Name: ACQA
• Applicant: Texas Medical Imaging Consultants
• Product Code: KPS · Radiology
• Decision Date: Jan 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ACQA system is a software on GE Advantage Windows workstation computers that allow the user to create averaged CT images for attenuation correction of the whole body or myocardial perfusion PET images, and to register CT images with myocardial perfusion PET images, and save registered CT images for attenuation correction of the myocardial perfusion PET images. The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physician read the original PET images.

Device Story

ACQA is a software application for GE Advantage Windows workstations; enables creation of averaged CT images for attenuation correction of whole body or myocardial perfusion PET images; performs registration of CT and PET images; saves registered CT images for attenuation correction. Used by radiologists, nuclear cardiologists, or nuclear medicine physicians in clinical settings. Operates on existing workstation hardware without requiring additional specialized consoles or respiratory gating hardware. Output serves as a secondary data set to assist physicians in reading original PET images; intended to improve clinical workflow efficiency by providing attenuation correction capabilities without the high cost of specific proprietary console upgrades.

Clinical Evidence

Bench testing and clinical data sets were used to validate the system. The submission states that all tests passed requirements and met specifications.

Technological Characteristics

Software application for GE Advantage Windows workstations. Performs image registration and calculation of averaged CT data for attenuation correction. Standalone software deployment on existing workstation hardware. Does not require specialized respiratory gating hardware.

Indications for Use

Indicated for use by qualified, licensed healthcare providers (radiologists, nuclear cardiologists, or nuclear medicine physicians) to assist in the interpretation of whole body or myocardial perfusion PET images by creating averaged CT images for attenuation correction and registering CT images with PET data.

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

• GE Discovery ST (K041543)
• GE Advantage 4D option (K032915)

Submission Summary (Full Text)

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K113086

## 510(K) Summary as per 21 CFR 807.92(c)

JAN 1 3 2012

Image /page/0/Picture/3 description: The image shows the logo for Texas Medical Imaging Consultants (TMIC). The logo consists of the letters "TMIC" in large, bold, sans-serif font. Below the letters, in a smaller font, are the words "TEXAS MEDICAL IMAGING CONSULTANTS."

General Information:

| A. Submitted by: | Texas Medical Imaging Consultants |
|------------------|-----------------------------------|
| | 4027 Underwood St. |
| | Houston, TX 77025 |
| | Tel: [phone] |

Tinsu Pan Contact Person:

Date Summary Prepared: 8/25/2011

- Device Trade Name: ACQA B.
Classification Code: KPS

System, Emission Computed Tomography (per 21 CFR 892 1200) Classification Name: Accessory to Emission Computed Tomography System

- C. Predicate Devices:
GE Healthcare Technologies (formerly GE Medical Systems) - GE Discovery ST-K041543 GE Medical Systems -- Advantage 4D option - K032915

- D. Device Description:
ACQA is a software application installed on GE Advantage Windows workstation computers which allows physicians and healthcare professionals (1) to create averaged CT images for attenuation correction of the whole body oncology or myocardial perfusion PET images, and (2) to register the averaged or helical CT images with their corresponding myocardial perfusion PET images, and save the registered CT images for attenuation correction of the myocardial perfusion PET images. Use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists, or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.

- Intended Use of the Device: ﻧﻨ
The ACQA system is a software on GE Advantage Windows workstation computers that allow the user to create averaged CT images for attenuation correction of the whole body or myocardial perfusion PET images, and to register CT images with myocardial perfusion PET images, and save registered CT images for attenuation correction of the myocardial perfusion PET images. The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physician read the original PET images.

- F. Comparison of Technical Characteristics to Predicate Device:
The ACQA system and its predicates, the GE DST (K041543) and the GE Advantage 4D-option (K032915) utilize the same type of data sets for analysis and data processing. The ACQA, applicable to all GE PET/CT scanners, accomplishes the tasks of registration of CT and PET, and calculation of averaged CT. The same function of ACQA is only supported on the GE PET/CT

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Image /page/1/Picture/1 description: The image shows the logo for TMIC, which stands for Texas Medical Imaging Consultants. The logo is in black and white, with the letters "TMIC" in large, bold font. Below the letters, the words "TEXAS MEDICAL IMAGING CONSULTANTS" are written in a smaller font. The logo is simple and professional, and it is likely used to represent the company on its website, marketing materials, and other communications.

scanners with Dimension console, and the Advantage 4D option. A summary of differences is provided in the following table.

| Functionality | GE Discovery ST | GE Advantage 4D option | ACQA |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1. Attenuation correction of<br>PET data with averaged CT<br>data<br>2. Registration of CT and<br>PET data | 1. Calculation of averaged<br>CT data with the VarianTM<br>respiratory gating<br>hardware | 1. Attenuation correction<br>of PET data with averaged<br>CT data<br>2. Registration of CT and<br>PET data<br>3. No VarianTM respiratory<br>gating hardware is<br>needed. |
| Applicable PET/CTs | GE PET/CT with Dimension<br>console | All GE PET/CT scanners | All GE PET/CT scanners |
| Advantages over ACQA | Both data processing and<br>data correction can be<br>performed on the<br>Dimension console | Can produce 10 phases of<br>4DCT images for Radiation<br>Oncology application | Data processing on the GE<br>Advantage Windows<br>workstation, and<br>attenuation correction of<br>PET data on the PET/CT<br>console. |
| ACQA Advantages over<br>GE predicate devices | No averaged CT data is<br>produced. The user can<br>perform either attenuation<br>correction by averaged CT<br>data or registration of<br>regular CT with PET data,<br>and cannot use both<br>options. | Can produce averaged CT<br>data. However, 4DCT<br>option is typically installed<br>for radiation oncology,<br>not for cardiology. | ACQA is the only software<br>that does not require the<br>Dimension console or<br>4DCT option (installation<br>of both costs > \$200k.) to<br>compute averaged CT data<br>for attenuation correction<br>of the PET data and<br>registration of the PET<br>data with either averaged<br>CT or helical CT data. |
| Large installed base of<br>Advantage Windows<br>workstation | Over 10,000 Advantage Windows workstations have been installed worldwide. It is<br>very likely that a clinic/hospital which wants to use the ACQA software is already with<br>an Advantage Windows workstation. In this case, ACQA software can be installed<br>without any addition of hardware. | | |

- G. Performance data: The tests with both laboratory and clinical data sets included in the submission passed the requirements and met specifications.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

## 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

Mr. Tinsu Pan Chief Technology Officer Texas Medical Imaging Consultants 4027 Underwood Street HOUSTON TX 77025

Re: K113086

Trade/Device Name: ACQA System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS & JAK Dated: October 12, 2011 Received: October 18, 2011

Dear Mr. Pan:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of

JAN 1 3 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office 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 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,

Mary S Patel

Mary S. Pastel, Sc.D. 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 Statement

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The ACQA system is a software on GE Advantage Windows workstation computers that allow the user to create averaged CT images for attenuation correction of the whole body or myocardial perfusion PET images, and to register CT images with myocardial perfusion PET images, and save registered CT images for attenuation correction of myocardial perfusion PET images. The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physicians read the original PET images.

Mary Pastel

ation and Safety Office of In

510K K113086