GE DISCOVERY ST SYSTEM

K041220 · GE Medical Systems · KPS · Jun 15, 2004 · Radiology

Device Facts

• Record ID: K041220
• Device Name: GE DISCOVERY ST SYSTEM
• Applicant: GE Medical Systems
• Product Code: KPS · Radiology
• Decision Date: Jun 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The GE Discovery ST System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

Device Story

Integrated multi-slice CT and PET scanner; inputs include PET radiopharmaceutical tracers and CT contrast agents; transforms inputs into inherently registered anatomical and functional images; uses CT images to correct for non-uniform attenuation of PET images; localizes emission activity within patient anatomy. Used in clinical settings by trained healthcare professionals (physicians, technologists). Output displayed via integrated user interface; assists clinicians in evaluation, diagnosis, staging, restaging, and radiotherapy planning. Benefits include improved anatomical localization of metabolic activity and combined diagnostic capabilities.

Clinical Evidence

No new clinical studies were performed for this submission. The device relies on previously established clinical data for the Discovery LS system and published medical/scientific literature documenting the utility of PET and PET-CT in oncology, cardiovascular disease, and brain dysfunction.

Technological Characteristics

Integrated multi-slice CT and PET scanner. Provides stand-alone CT and PET imaging, and integrated PET/CT fusion. Supports all available PET tracers and CT contrast agents. System utilizes CT data for PET attenuation correction. Connectivity via integrated user interface.

Indications for Use

Indicated for head and whole body PET imaging and localization of emission activity in patients requiring assessment of metabolic and physiologic functions, including evaluation, diagnosis, staging, and restaging of lesions, cardiovascular disease, and brain dysfunction. Also indicated for radiotherapy planning and as a stand-alone multislice CT diagnostic imaging system. For use by trained healthcare professionals.

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 LS System (K040172)

Submission Summary (Full Text)

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# GE Healthcare

## JUN 1 5 2004

KC41220 May 4, 2004

510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))

#### Device Name

Proprietary Device Name:

GE Discovery ST System

### Establishment Name and Registration Number of Submitter

| Name: | General Electric Medical Systems |
|-------------------------|-------------------------------------------------------------|
| Registration Number: | 2126677 |
| Corresponding Official: | Larry Kroger |
| | General Electric Medical Systems |
| | P.O. Box 414 |
| | Milwaukee, WI 53201 |
| Device Classification | |
| Device Classification | |
| Classification Code: | 90 KPS |
| Panel Identification: | Radiology |
| Classification Name: | Emission Computed Tomography System<br>(per 21CFR 892.1200) |
| Common Name: | Nuclear Medicine Imaging system |
| Classification Class: | Class II Product |

### Reason for 510(k) Submission

Modification of legally marketed device.

#### Identification of Legally Marketed Equivalent Devices

K040172 GE Discovery LS System

#### Device Description

The Discovery ST is an integrated multi-slice Computed Tomography and Positron Emission Tomography scanner. 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 it uses integrated CT and PET images to localize emission activity in the patient anatomy. Discovery ST has capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently registered anatomical and functional information via an integrated user interface. It can also be used as a stand-alone head and whole body multislice computed tomography diagnostic imaging system.

#### Description of Change or Modification

The Discovery ST CT-PET System is the same system as described in 510(k) K022872 except that the intended use statement has been revised.

Image /page/0/Picture/18 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. There are three small, teardrop-shaped elements placed around the perimeter of the circle, evenly spaced. The logo is black and white.

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# GE Healthcare

510(k) Summary of Safety and Effectiveness May 4, 2004 Page 2

#### Intended Use of Device

The GE Discovery ST System is intended for head and whole body attenuation The OE Disorion Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

The Discovery ST is to be used by trained health care professionals for imaging the rne Broom of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, (frolloodial) and follow up of lesions, disease and organ function such as (but not Staging, rootaging, and ivascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.

The Discovery ST can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

#### Summary of Studies

Discovery LS bench and clinical data demonstrate the ability of Discovery ST to image injected radiopharmaceuticals for the assessment of metabolic (molecular) and infootod radiophantial of the body and the ability of Discovery ST to use integrated CT prryclored in the localize metabolic activity and FDG uptake in the patient anatomy.

Numerous published medical and scientific articles document the use of PET and PET-CT in evaluation of cancer, cardiovascular disease, and brain dysfunction.

#### Conclusion

In the opinion of General Electric Medical Systems, the Discovery ST System with the above revised intended use is substantially equivalent in terms of safety and affectiveness to the currently marketed Discovery LS System with the same intended use, 510(k) K040172.

Image /page/1/Picture/11 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters are stylized and connected, and there are three small, teardrop-shaped embellishments around the circle's perimeter.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## (JUN 1 5 2004

Mr. David Duersteler Safety and Regulatory Engineering GE Healthcare Technologies General Electric Company P.O. Box 414 MILWAUKEE WI 53201

Re: K041220

Trade/Device Name: GE Discovery ST System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulatory Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 KPS and JAK Dated: May 4, 2004 Received: May 10, 2004

Dear Mr. Duersteler:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your beceible of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreatives to tegans actment date of the Medical Device Amendments, or to commerce prior to May 2011 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic rice (716) that 80 hovice, subject to the general controls provisions of the Act. The I ou may, therefore, mainted 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 If your device is classinod (600 as 870) cols. Existing major regulations affecting your device can may oc subject to satil additions, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Obacements 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 that I DX has made a ceremanulations administered by other Federal agencies. You must comply or any I cochar statutes and reguirements, including, but not limited to: registration and listing (21 CFR Part with an the Ale - Foquirements, a
807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the 807), labeling (21 CFR Part 820), good 820); and if applicable, the electronic product quality Systems (QB) issions (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 ocgin marketing your antial equivalence of your device to a legally premarket notification. The PDA miding of besomments
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 If you desire specific advice for your dones on 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 Additionally, for questions on the promotion and Other of Compliance at (301) 37 1 1057. 1223) you may obtain. Other general by reletence to premarker (21 Section ) = (21 Section of Som the Division of Small information on your responsionities and one Assistance at its toll-free number [phone] or Mandiacturers, International and Geness http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: GE Discovery ST System

#### Indications for Use

The GE Discovery ST System is intended for head and whole body attenuation of The GE Discovery ST System to internety (PET) imaging and localization of corrected Position Enlission Tomography (Par) images of integrated PET and CT images.

The Discovery ST is to be used by trained health care professionals for imaging The Discovery of is to be assure ficals in the body for the assessment of the distribution of facilophiannesologic functions. This can assist in the metabolic (molecular) and priyologic renotic disease and evaluation, blaghosis, staging, restaging, che read capt over cardiovascular disease, and organ function. This device can also assist in radiotherapy planning.

The Discovery ST can also be used as a stand-alone head and whole body The Discovery Of Can Blography (CT) diagnostic imaging system.

(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_

David A. Syverson

(Division Sian-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number __