GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM

K030199 · General Electric Co. · KPS · Feb 11, 2003 · Radiology

Device Facts

• Record ID: K030199
• Device Name: GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
• Applicant: General Electric Co.
• Product Code: KPS · Radiology
• Decision Date: Feb 11, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The GE Mobile Discovery ST PET CT Imaging System is intended for use in head and whole body attenuation corrected Positron Emission Tomography (PET) imaging, facilitating localization of emission activity in the patient anatomy by means of integrated CT and PET images, and stand alone head and whole body multislice X-ray computed tomography diagnostic imaging.

Device Story

The GE Mobile Discovery ST PET CT Imaging System integrates a Positron Emission Tomography (PET) system and a LightSpeed Ultra CT system into a mobile van for transportability between diagnostic imaging sites. The device acquires PET and CT data; CT images are used to correct for non-uniform attenuation in PET images and to facilitate anatomical localization of emission activity. The system provides both integrated PET/CT and stand-alone CT diagnostic imaging. It is operated by trained imaging professionals. Healthcare providers use the fused or stand-alone images to assist in clinical diagnosis and localization of pathology. The mobile configuration allows for diagnostic imaging services to be provided at multiple clinical locations.

Clinical Evidence

No clinical data. Bench testing only, including electrical and radiation safety evaluations, was performed to demonstrate compliance with applicable medical device safety standards.

Technological Characteristics

Integrated PET and multislice X-ray CT imaging system. Mobile van configuration. Uses CT data for PET attenuation correction and anatomical localization. Conforms to 21 CFR 820, ISO 9001, and EN 46001 quality systems.

Indications for Use

Indicated for head and whole body attenuation-corrected PET imaging and stand-alone head and whole body multislice X-ray CT diagnostic imaging in patients requiring diagnostic imaging.

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 CT-PET System (K022872)

Reference Devices

• GE Discovery LS CT-PET System

Submission Summary (Full Text)

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K030199

FEB 1 1 2003

## Attachment B:

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

GE Medical Systems

General Electric Company P.O. Box 414. Milwaukee. WI 53201

| Submitter: | GE Medical Systems<br>PO Box 414<br>Milwaukee, WI 53201 |
|------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | D. Duersteler<br>Safety and Regulatory Engineering<br>Telephone: [phone]; Fax: [phone] |
| Date Prepared: | January 17, 2003 |
| Device Name: | GE Mobile Discovery ST PET CT Imaging System.<br>Emission Computed Tomography System, 21 CFR 892.1200, 90-KPS |
| Marketed Device: | GE Medical Systems Discovery ST PET CT Imaging System, 510(k) Number<br>K022872, currently in commercial distribution. |

Device Description: The GE Mobile Discovery ST PET CT Imaging System integrates a GE Positron Emission Tomography system and a GE LightSpeed Ultra CT System. In addition to providing CT and PET stand-alone capabilities, it uses the CT images to correct for non-uniform attenuation of the PET images and to facilitate localization of the emission activity in the patient anatomy. It is designed for use in a mobile van for transportability between diagnostic imaging sites.

Indications for Use: The GE Mobile Discovery ST PET CT Imaging System is intended for use in head and whole body attenuation corrected Positron Emission Tomography (PET) imaging, facilitating localization of emission activity in the patient anatomy by means of integrated CT and PET images, and stand alone head and whole body multislice X-rav computed tomography diagnostic imaging.

Comparison with Predicate Device: The GE Mobile Discovery ST PET CT Imaging System is of a comparable type and substantially equivalent to the currently marketed GE Discovery ST CT-PET System. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended uses as the predicate device.

Summary of Studies: The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards.

Clinical Tests: None required.

Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA quidelines, and established methods of patient examination. Intended uses and fundamental scientific technology are the same as the legally marketed GE Discovery LS CT-PET System. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance. Therefore, it is the opinion of GE Medical Systems that the GE Mobile Discovery ST PET CT Imaging System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol consisting of three stylized human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2003

Mr. David Duersteler Safety and Regulatory Engineer General Electric Company GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201

Re: K030199

Trade/Device Name: GE mobile Discovery ST PET CT Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: January 17, 2003 Received: January 21 2003

Dear Mr. Duersteler:

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 (PMA), it may be subject to 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.

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.

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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 Office of Compliance at one of 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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

Enclosure

Page 2

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Special 510(k) Premarket Notification GE Medical Systems - GE Discovery ST Mobile PET CT System January 17, 2003

## STATEMENT OF INTENDED USE

030199 510(k) Number (if known):

Device Name: GE Mobile Discovery ST PET CT Imaging System

## Indications for Use

The GE Mobile Discovery ST PET Imaging System is intended for use in head and whole body attenuation corrected Positron Emission Tomography (PET) imaging, facilitating localization of emission activity in the patient anatomy by means of integrated CT and PET images, and stand alone head and whole body multislice X-ray computed tomography diagnostic imaging.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Prescription Use<br>(Per 21 CFR 801-109) | |
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Concurrence of CDRH, Office of Device Evaluation (ODE)

| OR Over-The-Counter Use | |
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David h. Segram

(Division Sian-Off Division of Reproductive. and Radiological Dr 510(k) Number