The GE Discovery MI Gen2 is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages.

Discovery MI Gen2 is intended to image the whole body, head, heart, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning, therapy guidance and monitoring, and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion).

When used with radiopharmaceuticals approved by the regulatory in the country of use, the raw and image data is an aid in; detection, localization, evaluation, diagnosis, staging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology. Examples of which are:

Cardiology:

Cardiovascular disease
Myocardial perfusion
Myocardial viability
Cardiac inflammation
Coronary artery disease

Neurology:

Epilepsy
Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, and frontotemporal dementia
Movement disorders, such as Parkinson's and Huntington's disease
Tumors
Inflammation
Cerebrovascular disease such as acute stroke, chronic and acute ischemia
Traumatic Brain Injury (TBI)

Oncology/Cancer:

Non-Small Cell Lung Cancer
Small Cell Lung Cancer
Breast Cancer
Prostate Cancer
Hodgkin's disease
Non-Hodgkin's lymphoma
Colorectal Cancer
Melanoma

Discovery MI Gen2 is also intended for stand-alone, diagnostic CT imaging in accordance with the stand-alone CT system's cleared indications for use.

Device Description

GE's Discovery MI (DMI) Gen2, same as the unmodified predicate device, is a hybrid digital PET/CT diagnostic imaging system combining a GE Positron Emission Tomography (PET) System and a GE Computed Tomography (CT) System. The DMI Gen2 is intended for CT attenuation corrected, anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. lt is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The system is also intended for stand-alone, diagnostic CT imaging.

GE has modified the cleared Discovery MI (K161574) within our design controls to include a 6ring configuration that provides 30 cm Axial Field of View (AFOV) coverage. DMI Gen2 employs the same detector design architecture and manufacturing process as in the predicate to offer scalable ring configurations (3-ring, 4-ring, 5-ring and 6-ring) to have scalable AFOV coverage (15cm, 20cm, 25cm and 30cm) and corresponding imaging performances.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the GE Discovery MI Gen2 PET/CT system. It does not include a description of acceptance criteria or a detailed study proving the device meets specific performance metrics in a clinical setting. Instead, it states that clinical testing was not required due to the nature of the changes to the device and the use of established engineering and physics-based performance testing.

Therefore, many of the requested items related to clinical study design and ground truth are explicitly stated as not applicable or not performed in this submission.

Here's a breakdown based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

Absent. The document does not provide specific acceptance criteria or reported performance metrics in a tabular format for clinical outcomes. It focuses on engineering and image performance evaluation testing, but no specific values or acceptance thresholds are given. The mention of "better detectability of small lesions" and "higher AFOV coverage... allows a patient to be scanned using fewer field of views" are general claims of improvement, not specific performance metrics against an acceptance criterion.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This was a non-clinical study. The summary states: "Clinical Testing: Discovery MI Gen2 is designed and built entirely from existing and cleared systems, subsystems, components, and technologies of its Predicate Device (Discovery MI). This type of change in Discovery MI Gen 2 is supported using scientific, established/standardized, engineering/physics-based performance testing, without inclusion of clinical images, to demonstrate that the device is as safe and as effective as the predicate devices. Given the above information and the type and scope of the changes, particularly the addition of the 30 cm, 6-ring, AFOV configuration, clinical testing is not required to demonstrate that the Discovery MI Gen 2 is as safe and as effective as the legally marketed predicate device."
"Image Performance evaluation testing used a variety of test methods and phantoms covering a broad base of relevant imaging performance and image quality test cases..." This indicates the test set consisted of phantoms, not patient data.

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. No human experts were used for ground truth because the testing was non-clinical, using phantoms, and relied on "mathematical and physics analysis" and "scientific methods that are standardized (e.g. NEMA, FDA Guidance), well established, and/or reviewed in previous GE's PETCT or Nuclear Medicine clearances."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No human review or adjudication was performed as it was a non-clinical performance study.

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

No. An MRMC study was not performed as clinical testing with human readers was not part of this 510(k) submission. No AI component is mentioned.

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

Partially applicable, but not for a clinical algorithm. The testing was "algorithm only" in the sense that it assessed the device's performance using phantoms and engineering methods, independent of human interpretation in a clinical setting. However, it's a PET/CT system, not an AI algorithm in the context of diagnostic assistance. The document refers to "Deep Learning Image Reconstruction (DLIR) K193170" for the CT System component, suggesting an AI component is involved in image generation, but this submission focuses on the full PET/CT system and does not detail performance data specific to DLIR.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Engineering/Physics-based Standards and Phantoms. The ground truth was established through "scientific methods that are standardized (e.g. NEMA, FDA Guidance)" and "phandoms" [sic] with known properties, along with "mathematical and physics analysis."

8. The sample size for the training set

Not applicable / Not explicitly stated. This document describes the clearance of a medical imaging device (PET/CT system), not a new AI algorithm that requires a separate training set. While the CT component mentions "Deep Learning Image Reconstruction (DLIR)," the training data and methods for DLIR (K193170) are outside the scope of this specific 510(k) summary. For the overall PET/CT system, there isn't a "training set" in the sense of a machine learning model, but rather a design and development process based on existing technologies.

9. How the ground truth for the training set was established

Not applicable / Not explicitly stated. As above, no training set for a new AI algorithm specific to this 510(k) is discussed. For the DLIR component (from K193170, mentioned as part of the CT system), the ground truth for its training would have been established in its own separate clearance, likely through high-quality, low-noise CT scans.

Summary

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GE Medical Systems, LLC. % Ms. Laura Turner Regulatory Affairs Leader 3000 North Grandview Blvd WAUKESHA WI 53188

Re: K211846

Trade/Device Name: Discovery MI Gen2 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, JAK Dated: June 14, 2021 Received: June 15, 2021

Dear Ms. Turner:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211846

Device Name Discovery MI Gen2

Indications for Use (Describe)

Cardiology:

Cardiovascular disease
· Myocardial perfusion
· Myocardial viability
Cardiac inflammation
· Coronary artery disease

Neurology:

· Epilepsy
· Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, and frontotemporal dementia
· Movement disorders, such as Parkinson's and Huntington's disease
Tumors
· Inflammation
· Cerebrovascular disease such as acute stroke, chronic and acute ischemia
· Traumatic Brain Injury (TBI)

Oncology/Cancer:

Non-Small Cell Lung Cancer
Small Cell Lung Cancer
Breast Cancer
· Prostate Cancer
· Hodgkin's disease
Non-Hodgkin's lymphoma
· Colorectal Cancer
Melanoma

Discovery MI Gen2 is also intended for stand-alone, diagnostic CT imaging in accordance with the stand-alone CT

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Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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K211846

510(k) SUMMARY OF SAFETY AND EFFECTIVNESS

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h):

Date:	June 14, 2021
Submitter:	GE Medical Systems, LLC3000 North Grandview BlvdWaukesha, WI 53188
Primary Contact:	Laura TurnerRegulatory Affairs LeaderGE HealthcarePhone 262-200-1044Email: laura.turner@ge.com
Secondary Contacts:	John JaeckleChief Regulatory Affairs StrategistGE HealthcareTel: 262-424-9547Email: john.jaeckle@med.ge.comHelen PengRegulatory Affairs DirectorGE Healthcare

PRODUCT IDENTIFICTION

Device Name:	Discovery MI Gen 2Also marketed as Discovery MI, Discovery MI Gen2, Discovery Maxand Discovery Max+
Regulation number/Product Code	Emission Computed Tomography System per 21CFR 892.1200Computed Tomography X-ray System per 21 CFR892.1750 / 90 KPSand 90 JAK

Email: hong.peng@med.ge.com

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Device Classification Class II

Predicate Device Information:

Device Name	Discovery MI
Manufacturer	GE Medical System, LLC.
	3000 North Grandview Blvd
	Waukesha, WI 53188
510(k) number	K161574 cleared on August 11, 2016
Regulation number/product Code	Emission Computed Tomography System per 21CFR 892.1200Computed Tomography X-ray System per 21 CFR892.1750 / 90 KPSand 90 JAK

Device Description:

The introduction of the 30 cm configuration comes with several clinical benefits. The higher AFOV coverage, compared to other Discovery MI configurations, allows a patient to be scanned using fewer field of views, which could allow for scanning in shorter time. Additionally, sensitivity of the 30 cm system is higher compared to other configurations, like the Discovery MI 25 cm, which assists in dose reduction and better detectability of small lesions. These claims are not clinical instructions/recommendations to a physician on how their patient(s) should be scanned. Rather, they are system imaging performance-related claims.

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This modified system has the same intended use and indications for use as its predicate device. The modified system employs the same basic fundamental operating principles as the existing marketed product Discovery MI, and is of comparable type and substantially equivalent to its predicate device.

Intended Use

The Discovery MI Gen2 PET/CT system is intended for CT attenuation corrected, anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. It is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The system is also intended for stand-alone, diagnostic CT imaging.

Indications for Use

The GE Discovery MI Gen2 is a PET/CT system for producing attenuation corrected PET images. lt is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages.

Discovery MI Gen2 is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning, therapy guidance and monitoring, and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion).

When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the raw and image data is an aid in; detection, evaluation, diagnosis, staging, restaging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology. Examples of which are:

Cardiology:

Cardiovascular disease
Myocardial perfusion
Myocardial viability
Cardiac inflammation
Coronary artery disease

Neurology:

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Epilepsy
. Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, and frontotemporal dementia
Movement disorders, such as Parkinson's and Huntington's disease
Tumors
. Inflammation
Cerebrovascular disease such as acute stroke, chronic and acute ischemia
Traumatic Brain Injury (TBI)

Oncology/Cancer:

Non-Small Cell Lung Cancer
Small Cell Lung Cancer
Breast Cancer
Prostate Cancer
Hodgkin's disease
Non-Hodgkin's lymphoma
Colorectal Cancer
. Melanoma

Discovery MI Gen2 is also intended for stand-alone, diagnostic CT imaging in accordance with the stand-alone CT system's cleared indications for use

Technology

Discovery MI Gen2 employs the same basic operating principles and fundamental technologies as the predicate device.

The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device:

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GE Healthcare 510(k) Premarket Notification Submission

Specification/Attribute	Predicate Device	Proposed Device
	Discovery MI K161574
PET Gantry	Multiple detector ring sizeconfigurations (15, 20, 25 cm axialFOV)	Multiple detector ring sizeconfigurations (15, 20, 25, 30 cmaxial FOV).
Detector Unit	SiPM-based light sensor with ASIC	Same
	LYSO scintillator crystal	LYSO or LGSO scintillator crystals
CT System	Revolution EVO - Full suite of clearedCT application software withmodifications (K131576)	Revolution EVO - Full suite of clearedCT application software withmodifications including DeepLearning Image Reconstruction(DLIR) K193170
Whole BodyDynamic Acquisition(WBDA)	Whole body dynamic acquisitioncapability enabled by manuallyperforming multiple passes that arealso referred as static scans of apatient	Whole body dynamic acquisitioncapability with automation to helpthe user to perform the scan withadequate user interface anddedicated tools to improve the userexperience
AutoIN	-	Allows the operator to move thepatient table from the operatorconsole within the operator room,rather than from the gantry controlpanel for landmarking

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Determination of Substantial Equivalence

Discovery MI Gen2 has completed testing and is in compliance with IEC 60601-1 Ed. 3, 21CFR Subchapter J, and NEMA XR-25, XR-26, XR-28 and XR-29. The proposed device has successfully completed all testing per our quality system as well as comparison testing to the predicate device. It was designed and is manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the system:

Risk Analysis
Required Reviews
· Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
· Performance testing (Verification)
· Safety testing (Verification)
· Simulated use testing (Validation)

GE believes the Discovery MI Gen2 system is of comparable type and substantially equivalent to our currently marketed system Discovery MI (K161574).

The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.

Summary of Additional Testing

A broad range of engineering tollowing GEHC's quality management system has been completed to demonstrate that the design outputs of the proposed device meet the design inputs, and the changes as compared to the predicate device do not raise new questions about safety and effectiveness.

In addition to the standards certification testing and system verification and validation testing successfully completed, additional engineering (non-Clinical testing) was performed to provide the requisite data to substantiate performance claims and ultimately substantial equivalence to the legally marketed predicate device.

Non-Clinical Testing

Image Performance evaluation testing used a variety of test methods and phantoms covering a broad base of relevant imaging performance and image quality test cases that demonstrate Discovery MI Gen2's ability to provide diagnostic and clinically relevant images across the full range of its expected use cases and patient populations. Mathematical and physics analysis

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were performed to demonstrate that each performance claim was successfully verified and substantiated.

All testing was performed using scientific methods that are standardized (e.g. NEMA, FDA Guidance), well established, and/or reviewed in previous GE's PETCT or Nuclear Medicine clearances.

Clinical Testing

Discovery MI Gen2 is designed and built entirely from existing and cleared systems, subsystems, components, and technologies of its Predicate Device (Discovery MI).

This type of change in Discovery MI Gen 2 is supported using scientific, established/standardized, engineering/physics-based performance testing, without inclusion of clinical images, to demonstrate that the device is as safe and as effective as the predicate devices.

Given the above information and the type and scope of the changes, particularly the addition of the 30 cm, 6-ring, AFOV configuration, clinical testing is not required to demonstrate that the Discovery MI Gen 2 is as safe and as effective as the legally marketed predicate device.

Substantial Equivalence Conclusion:

Based on the conformance to standards, development under our quality system, and the engineering testing provided, GE Healthcare believes that the Discovery MI Gen2 is as safe and effective, and performs in a substantially equivalent manner to the predicate device Discovery MI (K161574).

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.