(14 days)
The GE Discovery VCT 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 VCT 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 (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.
The Discovery VCT can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
The Discovery VCT is an integrated multi-slice Computed Tomography and Positron Emission Tomography System. It uses 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 VCT has capabilities for imaging all available PET tracers and of concurrently providing anatomical and functional information via an integrated graphical user interface. The Discovery VCT can also be used as a stand-alone head and whole body multislice CT diagnostic imaging system.
This 510(k) submission (K050559) for the GE Discovery VCT System is a modification of a legally marketed device, the GE Discovery ST System (K041543 and K042257). The core of the submission argues for substantial equivalence to the predicate device, rather than providing a study demonstrating specific performance metrics against pre-defined acceptance criteria for a novel device.
Therefore, the information typically found in novel device submissions regarding acceptance criteria and performance studies, such as specific accuracy, sensitivity, or specificity values, sample sizes for test sets, expert consensus details, and standalone algorithm performance, is not present within the provided text.
The acceptance criteria for a substantial equivalence submission are primarily demonstrated by showing that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device. The "study" that proves this is the comparison to the predicate device.
Here's how the requested information maps to the provided text, and where it is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (from text) |
|---|---|
| Intended Use Equivalence: The Discovery VCT System must have the same intended use as the predicate Discovery ST System. | Met: "The GE Discovery VCT 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." This matches the general scope and applications of the predicate device. "The Discovery VCT can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system." This function is also consistent with typical CT systems. The submission explicitly states, "the Discovery VCT System is substantially the same in design, materials, energy sources, and technology, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery ST System." |
| Technological Characteristics Equivalence: The Discovery VCT System must be substantially similar in design, materials, energy sources, and technology to the predicate Discovery ST System. Any differences must not raise new questions of safety or effectiveness. | Met: "The Discovery VCT PET/CT System is the same as the Discovery ST system described in 510(k)s K041543 and K042257 except that the PET system is integrated with a different CT system, the GE LightSpeed VCT system." This explicitly addresses the primary difference and implies that this change does not raise new safety or effectiveness concerns, as it's a known CT platform. |
| Safety and Effectiveness Equivalence: The Discovery VCT System must be as safe and effective as the predicate Discovery ST System. | Met: The explicit statement: "In the opinion of General Electric Medical Systems, the Discovery VCT System is substantially the same in design, materials, energy sources, and technology, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery ST System." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Present: This information is typically found in studies for novel devices or significant performance claims. Since this is a substantial equivalence submission based on a modification of an existing device by integrating a different CT system, no new clinical performance study with a test set, in the traditional sense, is conducted or presented in the provided summary. The comparison is primarily based on technical specifications and established performance of the integrated components rather than a new clinical trial dataset for evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Present: As no specific test set clinical study is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Present: No test set or associated adjudication method is described within the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable/Not Present: This submission predates the widespread regulatory review of AI-assisted diagnostic devices (dated March 2005). The device described is a PET/CT imaging system, not an AI-enabled diagnostic tool in the sense of an MRMC study comparison.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable/Not Present: The device is an imaging system, not a standalone algorithm. Its performance is inherent to its imaging capabilities, which are considered substantially equivalent to the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Present: As no specific clinical test-set study is presented, there's no mention of the type of ground truth used. The ground truth for the equivalence claim is the established safety and effectiveness of the existing predicate device and the technical specifications of the integrated components.
8. The sample size for the training set
- Not Applicable/Not Present: This device is an imaging system, not a machine learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- Not Applicable/Not Present: As above, this information is not relevant to an imaging system that is not a machine learning algorithm.
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Technologies
MAR 1 7 2005
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name Proprietary Device Name:
GE Discovery VCT System
February 1, 2005
P.O. Box 414
Milwaukee, Wi 53201 Phone: 262-544-3894 FAX: 262-548-4768
Date prepared:
Establishment Name and Registration Number of Submitter GE Healthcare Technologies Name: (Formerly GE Medical Systems) 2126677 Registration Number: Larry Kroger Corresponding Official: GE Healthcare Technologies
Device Classification Classification Code: Panel Identification: Classification Name:
90 KPS/90 JAK Radiology Emission Computed Tomography System/ Computed Tomography System (Per 21CFR 892.1200 and 21CFR 892.1750) PET/CT Imaging System Class II Product
Common Name: Classification Class:
Reason for 510(k) Submission Modification of a legally marketed device.
Identification of Legally Marketed Equivalent Devices K041543 GE Discovery ST System GE Discovery ST System with Alternate Detector Option K042257
Device Description
Device Describetion
The Discovery VCT is an integrated multi-slice Computed Tomography and Positron The Discovery VOT 15 an innes. It uses CT images to correct for non-uniform Emission Tomography Seamers and it uses integrated CT and PET images to localize accenduction of the FET images and tomy. Discovery VCT has capabilities for imaging all emission activity in the patient and can provide inherently registered available I ET tracers and of concreation via an integrated graphical user interface. anatomical and ranetional when as a stand-alone head and whole body multislice CT diagnostic imaging system.
General Electric Company P.O. Box 414
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Technologies
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510(k) Summary of Safety and Effectiveness February 1, 2005 Page 2
Description of Change or Modification
The Discovery VCT PET/CT System is the same as the Discovery ST system described in 510/k)s K041543 and K042257 except that the PET system is integrated with a different CT system, the GE LightSpeed VCT system.
Indications for Use of Device
The GE Discovery VCT 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 VCT 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 (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.
The Discovery VCT can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
Conclusion
In the opinion of General Electric Medical Systems, the Discovery VCT System is substantially the same in design, materials, energy sources, and technology, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery ST System.
General Electric Company P.O. Box 414 Milwaukee, WI 53201
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized image of an eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 17 2005
Re: K050559
GE Healthcare Technologies % Mr. Tamas Borsai Medical Division Manager, Third Party Review Program TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Trade/Device Name: GE Discovery VCT System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: KPS and JAK Dated: March 3, 2005 Received: March 3, 2005
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have tevewed your bettler ove (1) }
above and have determined the device is substantially equivalent (for the stated in above and nave decemined the ad predicate devices marketed in interstate commerce prior to the enclosure) to tegally manteled problem. Device Amendments, or to devices that have been May 20, 1770, the onlaominent with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation with me ket approval application (PMA). You may, therefore, market the do not require approval of a premants 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 (Premarket If your device is olashilos (500 as the additional controls. Existing major regulations affecting your Apploval), it they be saoject to and regulations, Title 21, Parts 800 to 898. In addition, FDA device can be round announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease be advised that i Driver 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 I cacral statues and regularing but not limited to registration and listing (21 CFR Part 807); labeling Act STEQuirements, modeling practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); 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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
Nancy C. Hogdon
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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STATEMENT OF INDICATIONS FOR USE
K050557 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: GE Discovery VCT System
Indications for Use
The GE Discovery VCT System is intended for head and whole body attenuation The GE Discovery VOT Oystom in internation of PET) imaging and localization of Contected Tostion Enlission Tomography (1) (1) of the orated PET and CT images.
The Discovery VCT is to be used by trained health care professionals for The Discovery VOT is to be assure armaceuticals in the body for the assessment imaging the diothbuttar) and physiologic functions. This can assist in the of metabolic (moleoular) and prystaging, and follow up of lesions, disease and evaluation, diagnosis, blaging, rootaging, and organ function. This device can also assist in radiotherapy planning.
The Discovery VCT can also be used as a stand-alone head and whole body multislice computed tomography (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
Nancy C. Hodson
(Division Sign-Off Division of Reproductive, Al and Radiological Devices 510(k) Number
§ 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.