(114 days)
No
The summary describes a standard PET/CT system with an iterative reconstruction method (Q.Clear), which is a conventional image processing technique, not AI/ML. There are no mentions of AI, ML, or related concepts, nor are there descriptions of training or test sets typically associated with AI/ML development.
No
The device is described for imaging, evaluation, diagnosis, staging, restaging, and follow-up of conditions, and can assist in radiotherapy planning, all of which are diagnostic or planning functions rather than direct treatment.
Yes
The "Intended Use / Indications for Use" section states that the system can "assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function," and that it "can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems."
No
The device description explicitly states it consists of a "fully integrated 3D Positron Emission Tomography and multi-slice Computed Tomography scanner," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The GE PET/CT system is an imaging device. It uses Positron Emission Tomography (PET) and Computed Tomography (CT) to create images of the inside of the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "imaging the distribution of radiopharmaceuticals in the body" and "localization of emission activity in patient anatomy." This is an in-vivo (within the living body) process, not in-vitro (in glass/outside the body).
Therefore, the GE PET/CT system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
GE PET/CT systems are 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 systems are 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 in patients of all ages. 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. These devices can also assist in radiotherapy planning.
The systems can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems.
Product codes (comma separated list FDA assigned to the subject device)
KPS and JAK
Device Description
The Discovery™ PET/CT 710 Clarity Edition consists of a fully integrated 3D Positron Emission Tomography and multi-slice Computed Tomography scanner with all available CT diagnostic applications, except gantry tilt. Due to the overall length of the PET/CT. the patient table sits on a special base that drives the table between the PET and CT portions of the gantry. The PET/CT table is rated for a patient weight of 227 Kg (500 pounds) and the cradle travels up to 1700mm on standard systems, or up 2 meters on systems with the 2m scan range option.
Discovery™ PET/CT 710 Clarity Edition systems have a quantitation reconstruction method option called Q.Clear. This method iteratively reconstructs PET images to full convergence (Regularized Reconstruction) while maintaining acceptable image quality,
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Positron Emission Tomography (PET), Computed Tomography (CT)
Anatomical Site
head and whole body
Indicated Patient Age Range
patients of all ages
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)
Not Found.
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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MAR 21 2014
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Image /page/0/Picture/3 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' in a stylized font. The letters are connected and appear to be handwritten. The logo is partially obscured by what appears to be damage or wear, particularly on the left side.
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name Proprietary Device Name: Date prepared:
Discovery PET/CT 710 Clarity Edition November 27, 2013,
Establishment Name and Registration Number of Submitter
Name: Registration Number: Corresponding Official: GE Medical Systems LLC 2126677 David Duersteler GE Healthcare P.O. Box 414 Milwaukee, WI 53201 Phone: 262-312-7029 Email: david.duersteler@med.ge.com
Device Classification Classification Code: Panel Identification: Classification Name:
Common Name: Classification Class: Reason for 510(k) Submission: 90 KPS Radiology Emission Computed Tomography System (Per 21CFR 892.1200) PET/CT Imaging System Class II Product Modified device
Device Description
The Discovery™ PET/CT 710 Clarity Edition consists of a fully integrated 3D Positron Emission Tomography and multi-slice Computed Tomography scanner with all available CT diagnostic applications, except gantry tilt. Due to the overall length of the PET/CT. the patient table sits on a special base that drives the table between the PET and CT portions of the gantry. The PET/CT table is rated for a patient weight of 227 Kg (500 pounds) and the cradle travels up to 1700mm on standard systems, or up 2 meters on systems with the 2m scan range option.
Discovery™ PET/CT 710 Clarity Edition systems have a quantitation reconstruction method option called Q.Clear. This method iteratively reconstructs PET images to full convergence (Regularized Reconstruction) while maintaining acceptable image quality,
Identification of Legally Marketed Equivalent Devices
Discovery PET/CT 690
GE Medical Systems LLC
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K133657
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510(k) Summary of Safety and Effectiveness November 27, 2013 Page 2
Comparison with Predicate Devices
Both systems are PET/CT systems employ the same design, construction, materials, energy source, operating principles, and technology. Further, the regularized reconstruction (Q.clear) method is similar to existing iterative reconstruction methods except it is able to continue iterations to full convergence while maintaining image quality by using noise reduction.
Both systems consist of a fully integrated 3D Positron Emission Tomography and multislice Computed Tomography scanner with all available CT diagnostic applications, except gantry tilt. Due to the overall length of the PET/CT, the patient tables sit on a special base that drives the table between the PET and CT portions of the gantry. The PET/CT table is rated for a patient weight of 227 Kg (500 pounds) and the cradle travels up to 1700mm on standard systems, or up 2 meters on systems with the 2m scan range option.
Both systems are compliant with the same IEC, NEMA and related safety and performance standards.
Both systems use the same acquisition methods and attenuation correction methods. All major functions and features have been previously marketed, and intended uses are the same. Discovery Clarity Edition performs as well as currently marketed devices, introduces no significant change in safety or effectiveness as compared to the predicate devices, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed GE Healthcare Discovery PET/CT 690 product.
Indications for Use of Device
GE PET/CT systems are 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 systems are 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 in patients of all ages. This can assist in the evaluation, diagnosis, staging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning.
The systems can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems.
Conclusion
In the opinion of General Electric Medical Systems, the GE Discovery PET/CT 710 Clarity Edition system is substantially the same in design, materials, energy sources, and technology, does not introduce new safety concerns, performs as well as currently marketed devices, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery PET/CT 690 device. (K081496).
General Electric Company P.O. Box 414 Milwaukee, WI 53201
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2014
GE Medical Systems, LLC % Mr. David Duersteler Regulatory Affairs Leader 3000 N. Grandview Blvd. WAUKESHA WI 53188
Re: K133657
Trade/Device Name: Discovery PET/CT 710 Clarity Edition Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography Regulatory Class: II Product Code: KPS and JAK Dated: March 14, 2014 Received: March 18, 2014
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Mr. Duersteler
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K133657
Device Name: Discovery PET/CT 710 Clarity Edition
Indications for Use:
GE PET/CT systems are 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 systems are 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 in patients of all ages. 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. These devices can also assist in radiotherapy planning.
The systems can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh.7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) ======================================================================================================================================================================= K133657
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