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

Device Description

The Discovery LS 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 LS 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.

AI/ML Overview

This 510(k) summary for the GE Discovery LS System does not provide the specific details requested regarding acceptance criteria and a structured study demonstrating the device meets those criteria.

Here's an analysis of what is and isn't provided, based on the input text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided. The document describes the device's intended use and states that "Discovery LS bench and clinical data demonstrate the ability of Discovery LS to image injected radiopharmaceuticals..." However, it does not specify any quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, image quality metrics) or report specific performance values against such criteria.

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

Not provided. The document mentions "clinical data" but gives no indication of the number of patients or images included in any test set, nor the country of origin, or whether the data was retrospective or prospective.

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

Not provided. There is no mention of experts involved in establishing ground truth for any test set, their number, or their qualifications.

4. Adjudication Method for the Test Set:

Not provided. No information is given about any adjudication methods used, such as 2+1 or 3+1 consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not provided. The document mentions "bench and clinical data" but does not describe any MRMC study comparing human readers with and without AI assistance, nor does it report any effect sizes. The Discovery LS is an imaging system, not explicitly an AI-assisted diagnostic tool in the way a CAD system would be, so an MRMC study comparing human performance with and without AI might not be directly applicable in the terms typically associated with CAD.

6. Standalone (Algorithm Only) Performance Study:

Not provided. While the device can be used as a standalone CT or PET system, there is no mention of a standalone algorithm-only performance study demonstrating its diagnostic capabilities independent of expert interpretation. The "Discovery LS" itself is the device, not an algorithm being validated in isolation. The document focuses on the system's ability to produce images and integrate them.

7. Type of Ground Truth Used:

Implicitly clinical assessment (but not explicitly stated for a "ground truth" test set). The document states the device assists in "evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function." This implies that the 'ground truth' for validating the clinical utility of PET/CT imaging would ultimately be based on clinical outcomes, pathology, or expert clinical diagnosis, but it doesn't specify how ground truth was established for any specific study proving the device met acceptance criteria.

8. Sample Size for the Training Set:

Not applicable / Not provided. The Discovery LS is described as an integrated imaging system, not a device primarily based on a machine learning algorithm that requires a "training set" in the typical sense. It leverages established PET and CT technologies. Therefore, a training set sample size related to an algorithm is not a relevant concept for this device's description.

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

Not applicable / Not provided. As with point 8, the concept of a "training set" and establishing ground truth for it is not applicable to the description of the GE Discovery LS System as presented.

Summary of the Study Mentioned:

The document briefly mentions "Discovery LS bench and clinical data demonstrate the ability of Discovery LS to image injected radiopharmaceuticals for the assessment of metabolic (molecular) and physiologic functions of the body and the ability of Discovery LS to use integrated CT and PET images to localize metabolic activity and FDG uptake in the patient anatomy." It also cites "Numerous published medical and scientific articles document the use of PET and PET-CT in evaluation of cancer, cardiovascular disease, and brain dysfunction."

This suggests that the FDA submission primarily relies on:

Bench testing: To verify technical performance characteristics of the integrated system.
Clinical data: To show that the system can produce images and integrate them as intended for clinical applications. However, no specifics on this clinical data (e.g., patient numbers, study design, endpoints, performance metrics) are provided.
Predicate device equivalence and existing literature: The core argument for substantial equivalence appears to be that it's a modification of an already cleared device (K023988) with a revised intended use, and that the underlying technologies (PET and CT) have established clinical utility. The "summary of studies" seems to largely refer to the general body of knowledge supporting PET/CT rather than specific, detailed studies performed on this particular modified device to demonstrate new or specific acceptance criteria.

Summary

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K04077
fig2 of 2

APR = 7 2004

GE Medical Systems

General Endno Company P.O Box 414 Milwaukae, Wi 55201

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

Device Name Proprietary Device Name:

GE Discovery LS System

Establishment Name and Registration Number of Submitter

General Electric Medical Systems Name: 2126677 Registration Number: Larry Kroger Corresponding Official: General Electric Medical Systems P.O. Box 414 Milwaukee, WI 53201

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

K023988 GE Discovery LS System

Device Description

Description of Change or Modification

The Discovery LS CT-PET System is the same system as described in 510(k) K023988 except that the intended use has been revised for better definition.

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K040172

part int 2

GE Medical Systems

Discovery LS CT-PET System 510(k) Summary of Safety and Effectiveness Page 2

Intended Use of Device

The Discovery LS 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 LS to image injected radiopharmaceuticals for the assessment of metabolic (molecular) and physiologic functions of the body and the ability of Discovery LS to use integrated CT and PET images to 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 LS CT-PET System with the above revised intended use is substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery LS System, 510(k) K023988.

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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 features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing a globe, conveying the department's mission of protecting and promoting the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 2004

Mr. D. Duersteler Safety and Regulatory Engineering GE Medical Systems General Electric Company P.O. Box 414 MILWAUKEE WI 53201

Re: K040172

Trade/Device Name: GE Discovery LS 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: 90 KPS and JAK Dated: January 22, 2004 Received: January 26, 2004

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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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 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/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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STATEMENT OF INTENDED USE

510(k) Number (if known):

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: GE Discovery LS System

Intended Use

The Discovery LS 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) $\checkmark$

OR Over-The-Counter Use

Nancy C. Hodon

510(k) Number

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.