(36 days)
No
The document describes a standard integrated PET/CT scanner and its functionalities, such as attenuation correction and image localization, which are typical features of such devices and do not inherently require AI/ML. There are no mentions of AI, ML, or related terms like deep learning or neural networks. The performance studies and key metrics sections are also devoid of any indicators of AI/ML model evaluation.
No.
The device is used for imaging, assessment, and diagnosis, not for treating or providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device can "assist in the evaluation, diagnosis, and follow up of lesions, disease and organ function" and also notes that it "can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system."
No
The device description explicitly states it is an "integrated multi-slice Computed Tomography and Positron Emission Tomography scanner," which are hardware components.
Based on the provided information, the GE Discovery ST System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- Discovery ST Function: The Discovery ST System is an imaging device that uses PET and CT technologies to visualize the distribution of radiopharmaceuticals within the patient's body and to provide anatomical information. It directly images the patient, not specimens taken from the patient.
- Intended Use: The intended use clearly states it's for "head and whole body attenuation of Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images." This describes an in-vivo imaging process.
Therefore, the GE Discovery ST System falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
90 KPS, JAK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Positron Emission Tomography (PET)
Anatomical Site
head and whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.
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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 |
| (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.
3
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 (800) 638-2041 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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Image /page/4/Picture/0 description: The image contains the words "STATEMENT OF INTENDED USE" and "Indication for". The words are written in a bold, sans-serif font. The words "INTENDED" have a line through them.
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 __