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.

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,

AI/ML Overview

The provided text is a 510(k) Summary for the GE Discovery PET/CT 710 Clarity Edition, which is a submission to the FDA. The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and either the same technological characteristics or different technological characteristics that do not raise new questions of safety and effectiveness.

This document does not describe a study involving acceptance criteria and device performance in the way a clinical trial or algorithm performance study would. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Discovery PET/CT 690) by comparing design, materials, energy sources, operating principles, technology, and compliance with standards.

Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance are not present in this type of submission.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in this 510(k) summary. The document focuses on demonstrating substantial equivalence rather than presenting specific quantitative performance metrics against predefined acceptance criteria for the new "Clarity Edition" feature (Q.Clear). It states that the "Discovery Clarity Edition performs as well as currently marketed devices," but without specific metrics.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable or not provided. This 510(k) does not detail a "test set" in the context of an algorithm performance study. The substantial equivalence argument relies on comparing the device's technological characteristics and overall safety and effectiveness with the predicate, rather than a clinical study with a specific test dataset for a new feature like Q.Clear.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable or not provided. Ground truth establishment for a test set is specific to performance studies involving diagnostic accuracy or image quality assessment by human readers. This document does not describe such a study.

4. Adjudication Method for the Test Set:

Not applicable or not provided.

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 or not provided. An MRMC study is not mentioned. The device's new feature, Q.Clear, is an iterative reconstruction method, but its impact on human reader performance is not quantified in this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not explicitly detailed as a standalone performance study. The document describes the Q.Clear method as a "quantitation reconstruction method option" that "iteratively reconstructs PET images to full convergence (Regularized Reconstruction) while maintaining acceptable image quality." This implies an assessment of image quality, but no specific standalone algorithm performance metrics (e.g., SNR, contrast, resolution) or the study demonstrating them are provided in this summary.

7. The Type of Ground Truth Used:

Not applicable or not provided.

8. The Sample Size for the Training Set:

Not applicable or not provided. The Q.Clear method is a reconstruction algorithm, not a machine learning algorithm in the typical sense that would require a "training set." While such algorithms are developed and optimized using various datasets, this 510(k) summary does not provide details of such development.

9. How the Ground Truth for the Training Set was Established:

Not applicable or not provided.

Summary of available information regarding the "study" (in the context of substantial equivalence):

The submission acts as the "study" by comparing the new device, Discovery PET/CT 710 Clarity Edition, to its predicate, Discovery PET/CT 690.

Acceptance Criteria (Implied for Substantial Equivalence): The implicit acceptance criteria for this 510(k) submission is that the new device, including its Q.Clear feature, performs "as well as currently marketed devices" and introduces "no significant change in safety or effectiveness" compared to the predicate device.
Reported Device Performance:
- The new device "employs the same design, construction, materials, energy source, operating principles, and technology" as the predicate.
- The 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 are "compliant with the same IEC, NEMA and related safety and performance standards."
- Both systems "use the same acquisition methods and attenuation correction methods."
- "Discovery Clarity Edition performs as well as currently marketed devices."

In conclusion, this 510(k) summary provides a regulatory argument for substantial equivalence rather than a detailed scientific study with specific performance metrics against acceptance criteria for the new Q.Clear feature. The "study" is the comparison itself, aiming to show that the new device is as safe and effective as the predicate.

Summary

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K133657

MAR 21 2014

Page 1 of 2

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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

Identification of Legally Marketed Equivalent Devices

Discovery PET/CT 690

GE Medical Systems LLC

K081496

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K133657
Page 2 of 2

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

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

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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

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Indications for Use

510(k) Number (if known): K133657

Device Name: Discovery PET/CT 710 Clarity Edition

Indications for Use:

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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Regulation Number and Section

§ 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.