The GE NM/CT 850 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging of tumors; and planning, guiding, and monitoring therapy.

NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). Imaging modes include single photon, multi peak frame, with data stored frame/list mode. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.

CT System: Intended specifically for attenuation correction and anatomical localization.

NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration, and fusion).

The GE NM/CT 850 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include digital processing of data and images, including display, quality check, transfer, and processing, to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to obtain additional images, imaging planes, and uptake quantitation. The system may be used for patients of all ages.

NM/CT 850 does not support standalone CT operation.

The GE NM/CT 860 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging of tumors; and planning, guiding, and monitoring therapy.

NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT), Imaging modes include single photon, multi-isotope, and multipeak, with data stored in frame/list mode. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.

CT System: produces Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different and planes, including Axial. Cine and Helical acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body and vascular X-Ray Computed Tomography applications

The GE NM/CT 860 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include digital processing of data and images, including display, quality check, transfer, and processing, to produce images in a variety of trans-axial and reformatted planes., The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages.

Device Description

NM/CT 850 and NM/CT 860 consist of 2 back-to-back gantries (i.e. NM gantry carrying 2 nuclear detectors and a CT gantry), patient table, power distribution unit (PDU), operator console with two acquisition systems (i.e. NM and CT) and a digital processing system, interconnecting cables and associated accessories.
NM/CT 850 and NM/CT 860 generate NM images and CT-based attenuation correction and anatomical localization data for SPECT imaging. NM/CT 860 also generates diagnostic CT images. The NM images are generated through computer reconstruction of data acquired by a Nal-based dual detector NM system that uses a variety of planar and tomographic acquisition types. The CT images are generated by computer reconstruction of data acquired using the Revolution ACTs CT system.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for the GE Healthcare NM/CT 850 and NM/CT 860 devices, which are SPECT/CT systems. The purpose of this document is to demonstrate "substantial equivalence" to existing predicate devices, rather than establishing de novo acceptance criteria and then proving the device meets them through a study.

Instead, the submission outlines non-clinical testing performed to demonstrate that the modifications to the predicate device (Discovery NM/CT 670) maintain equivalent functionality and performance. The modifications primarily involve replacing the CT subsystem with GE's 8-slice Revolution ACTs, incremental NM image quality enhancement, and the addition of a Smart Console.

Therefore, the information requested in your prompt regarding acceptance criteria and a study to prove they are met in the traditional sense of a new device validation might not be directly applicable or explicitly stated as such in this 510(k) summary. The document emphasizes testing demonstrating equivalence to predicate devices, not setting new benchmarks.

However, I can extract the relevant information about the non-clinical testing conducted to support the claim of substantial equivalence, which serves a similar purpose in the context of this regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of "acceptance criteria" for the entire device in the way one might expect for a novel AI device or a new product with entirely new performance claims. Instead, it describes "performance metrics/claims" that were tested to demonstrate substantial equivalence to predicate devices. The listed performance metrics from the "Summary of Additional Testing: Non-Clinical Testing" section are:

Performance Metric/Claim	Reported Device Performance
System Sensitivity	Successfully verified and substantiated through mathematical and physics analysis.
System Resolution	Successfully verified and substantiated through mathematical and physics analysis.
Lesion Detectability	Evaluated using a Channelized Hotelling Model Observer (CHO) study. The model observer is shown to have significant positive correlations with the rankings of an average human observer.
Potential for Dose / Time Reduction	Demonstrated in phantom testing with a bone scan protocol using the CHO model observer to obtain equivalent AUC/SNR at the reduced dose/time.

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

Test Set Sample Size: The document refers to "a variety of test methods and phantoms" for non-clinical testing. For the lesion detectability and dose/time reduction evaluations, a phantom was used. No information about a "test set" of clinical data (patients/images) is provided, as the testing was non-clinical.
Data Provenance: The data provenance is from non-clinical phantom testing conducted by GE Healthcare. This is not retrospective or prospective clinical data from human subjects. The country of origin of the data is not explicitly stated but is implied to be internal testing at GE Medical Systems Israel or other GE Healthcare facilities.

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

Not applicable in the context of this non-clinical phantom study. The "ground truth" for phantom studies is the known physical properties and configurations of the phantom itself. For the lesion detectability evaluation, while a model observer was correlated with "an average human observer," no specific number or qualifications of human experts establishing ground truth for a clinical test set are mentioned, as no clinical test set was used for this part of the evaluation.

4. Adjudication Method for the Test Set:

Not applicable, as the "test set" comprised phantoms with known configurations, not clinical cases requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "Given the above information and the type and scope of changes, particularly that the NM imaging component is identical to the predicate, and the CT component is virtually identical to the Revolution ACTs reference device, clinical testing is not needed to demonstrate substantial equivalence." This indicates that an MRMC study was not performed.

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

Yes, in essence. The non-clinical testing, particularly the use of the Channelized Hotelling Model Observer (CHO) for lesion detectability and dose/time reduction, represents a form of standalone (algorithm/system-only) performance evaluation using objective metrics on phantom data. The CHO model is an objective performance metric that predicts how well a human observer would perform.

7. The Type of Ground Truth Used:

For the non-clinical testing, the ground truth was based on the known physical properties and configurations of the phantoms used to simulate various imaging conditions and lesions.

8. The Sample Size for the Training Set:

Not applicable. This document describes a 510(k) submission for a SPECT/CT imaging device, not an AI algorithm that requires a "training set" in the machine learning sense. The "Smart Console" mentioned is an enhancement to workflow and accessibility, not an AI feature that would typically be trained on a large dataset for diagnostic output.

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

Not applicable, as there was no explicit "training set" for an AI algorithm described in this submission.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

GE Healthcare GE Medical Systems Israel, Functional Imaging % Mr. George Mashour Senior Regulatory Affairs Leader 4 Havozma Street Tirat Hacarmel 30200 ISRAEL

April 17, 2018

Re: K173816

Trade/Device Name: NM/CT 850, NM/CT 860 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK Dated: March 8, 2018 Received: March 9, 2018

Dear Mr. Mashour:

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 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K173816

Device Name NM/CT 850 NM/CT 860

Indications for Use (Describe)

CT System: Intended specifically for attenuation correction and anatomical localization.

NM/CT 850 does not support standalone CT operation.

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

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K173816

Device Name NM/CT 860

Indications for Use (Describe)

NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT), Imaging modes include single photon, multi-isotope, and multipeak, with data stored in frame/list mode. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has small, water-like droplets or swirls around its perimeter, giving it a dynamic and fluid appearance. The logo is simple, recognizable, and associated with a well-known multinational corporation.

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:	December 14, 2017
Submitter:	GE Medical Systems Israel, Functional Imaging (GE Healthcare)4 Havozma StreetTirat Hacarmel, 30200, Israel
Primary Contact:	George MashourRegulatory Affairs LeaderGE Medical Systems Israel, Functional ImagingTel: +972-4-8563666 ext. 639Fax: +972-4-8577662email: george.mashour@ge.com
Secondary Contacts:	John JaeckleChief Regulatory Affairs EngineerGE HealthcareTel: 262-424-9547email: john.jaeckle@ge.com
Device Trade Name:	NM/CT 850NM/CT 860
Common / UsualName:	Single Photon Emission Computed Tomography (SPECT) & ComputedTomography X-Ray (CT)
Classification Names:	21CFR 892.1200 & 21CFR 892.1750
Product Code:	90 KPS & 90 JAK

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Image /page/6/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The frame has four stylized water droplets or swirls evenly spaced around the circle. The logo is presented in a blue color.

NM/CT 850 and NM/CT 860 are a modification to the predicate Marketed Devices device Discovery NM/CT 670 (K093514). The modification is mainly for replacing the CT subsystem with GE's 8 slice Revolution ACTs (K171013), incremental NM Image Quality (IQ) enhancement and addition of a Smart Console for enhanced workflow and accessibility. All the rest of system remains the same as in Discovery NM/CT 670 (K093514) and has equivalent functionality and performance.

The systems are marketed as NM/CT 860 and NM/CT 850.

Predicate Device(s): Discovery NM/CT 670 (K093514)

Optima NM/CT 640 (K121019) Reference Device

Revolution ACTs (K171013)

Xeleris 4.0 Workstation (K153355)

NM/CT 850 and NM/CT 860 consist of 2 back-to-back gantries (i.e. Device Description: NM gantry carrying 2 nuclear detectors and a CT gantry), patient table, power distribution unit (PDU), operator console with two acquisition systems (i.e. NM and CT) and a digital processing system, interconnecting cables and associated accessories.
NM/CT 850 and NM/CT 860 generate NM images and CT-based attenuation correction and anatomical localization data for SPECT imaging. NM/CT 860 also generates diagnostic CT images. The NM images are generated through computer reconstruction of data acquired by a Nal-based dual detector NM system that uses a variety of planar and tomographic acquisition types. The CT images are generated by computer reconstruction of data acquired using the Revolution ACTs CT system.

The main technological differences between the CT system of the predicate Discovery NM/CT 670 device and that of the proposed NM/CT 850 and NM/CT 860 devices, are as following:

Aspect	Discovery NM/CT 670(K093514)	NM/CT 860NM/CT 850
Rotation Speed	0.8, 1.0, 2.0, 3.0, 4.0 sec	0.98, 1.0, 1.2, 1.5, 2.0, 3.0,4.0 sec.
Available kV	80, 100, 120, 140 kV	80, 100, 120, 140 kV
Tube Current	10-440 mA	10-200 mA (NM/CT 860)10-30 mA (NM/CT 850)
DetectorComposition	16 x 0.625 mm rowswith 4 x 1.25 mm rowson either side	8 x 1.25 mm rows

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has a white border with wave-like designs, giving it a dynamic appearance.

Slices perrotation	16	8
Max BeamWidth	20 cm	10 cm
Bore	70 cm	70 cm
SFOV	50 cm	50 cm

Intended Use:

NM/CT 850

The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography component which is intended specifically for enabling attenuation correction and anatomical localization of SPECT images.

NM/CT 860 Intended Use

The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body and vascular X-ray Computed Tomography applications

Indications for Use: NM/CT 850

The GE NM/CT 850 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy.

· NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). Imaging modes include single photon, multiisotope, and multi peak frame, with data stored frame/list mode.

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Image /page/8/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are white swirls around the letters, and the circle is outlined in white. The logo is simple and recognizable.

imaging-enhancement features include assortment The of collimators, gating by physiological signals, and real-time automatic body contouring.

· CT System: Intended specifically for attenuation correction and anatomical localization.
· NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration, and fusion).

The GE NM/CT 850 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include digital processing of data and images, including display, quality check, transfer, and processing, to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to obtain additional images, imaging planes, analysis results, and uptake quantitation. The system may be used for patients of all ages.

NM/CT 850 does not support standalone CT operation

NM/CT 860

The GE NM/CT 860 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy.

· NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT), Imaging modes include single photon, multiisotope, and multi-peak, with data stored in frame/list mode. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.
· CT System: produces Cross sectional images of the body by

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Image /page/9/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circle. There are decorative flourishes resembling water droplets or stylized leaves surrounding the circle, giving it a distinctive and recognizable appearance.

computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine and Helical acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body and vascular X-Ray Computed Tomography applications

· NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration, and fusion).
The GE NM/CT 860 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include digital processing of data and images, including display, quality check, transfer, and processing, to produce images in a variety of trans-axial and reformatted planes., The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages.
NM/CT 850 and NM/CT 860 employ the same fundamental scientific Technology: technology as the predicate device Discovery NM/CT 670 (K093514) and the reference devices, Optima NM/CT 640 (K121019), Revolution ACTs (K171013) and Xeleris 4.0 Workstation (K153355).
Summary of Non-Clinical Testing: Determination of Substantial NM/CT 850 and NM/CT 860 have completed testing and is in Equivalence: compliance with IEC 60601-1 Ed. 3.1 and its associated collateral and particular standards, 21CFR Subchapter J and the relevant NEMA

The device has successfully completed all design control testing per our quality system. No new hazards were identified and no unexpected test results were obtained. The NM/CT 850 and NM/CT 860 were designed and will be 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:

standards, including XR-25, XR-26, XR-28, PS3.1-3.20 and NU-1

. Risk Analysis
. Required Reviews
. Design Reviews
Software Development Lifecycle .
Testing on unit level (Module verification)
· Integration testing (System verification)

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Image /page/10/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script in the center. There are white swirls around the letters, and a white border around the blue circle. The logo is simple and recognizable, and it is associated with a well-known company.

· Performance testing (Verification)
· Safety testing (Verification)
· Simulated use testing (Validation)

GE believes the NM/CT 850 and NM/CT 860 systems are of comparable type and substantially equivalent to the predicate (i.e. Discovery NM/CT 670) and reference (i.e. Optima NM/CT 640, Revolution ACTs and Xeleris 4.0) devices, and hence is safe and effective for its intended use. The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.

Summary of Additional Testing:

In addition to the verification and validation testing successfully completed as required by GE Healthcare's quality system, additional engineering (i.e. non-clinical testing) was performed to provide the requisite data to substantiate performance, claims, and, ultimately substantial equivalence.

Non-Clinical Testing

The additional engineering performance evaluation testing used a variety of test methods and phantoms appropriate for the performance metric/claim that was to be tested and evaluated. Mathematical and physics analysis were performed to demonstrate that each performance metric/claim was successfully verified and substantiated.

The areas additionally evaluated for the non-clinical testing included system sensitivity, system resolution, lesion detectability and potential for dose / time reduction. The lesion detectability evaluation included use of a Channelized Hotelling Model Observer (CHO) study. The potential for dose/time reduction is demonstrated in phantom testing with a bone scan protocol using the CHO model observer to obtain equivalent AUC/SNR at the reduced dose/time. The model observer is shown to have significant positive correlations with the rankings of an average human observer4.

-Gifford, Howard C., Michael A. King, Daniel J. de Vries, and Edward J. Soares. "Channelized Hotelling and human observer correlation for lesion detection in hepatic SPECT imaging." J. Nucl. Med. vol. 41, no. 3, pp. 514-521, March 2000.

Clinical Testing

Because the changes associated with NM/CT 850 and NM/CT 860 do not change the Indications for Use from the predicate and reference devices, and represent equivalent technological characteristics, this

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Image /page/11/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a white border, and there are four white swirls around the circle. The logo is simple and recognizable, and it is associated with a well-known company.

type of change supports using scientific, established / standardized, engineering/physics-based performance testing, without inclusion of clinical images for determining substantial equivalence.

Given the above information and the type and scope of changes, particularly that the NM imaging component is identical to the predicate, and the CT component is virtually identical to the Revolution ACTs reference device, clinical testing is not needed to demonstrate substantial equivalence.

Based on the conformance to standards, development under GE Conclusion: Healthcare's quality system, the successful verification testing, and the additional engineering testing, GE Healthcare believes that the NM/CT 850 and NM/CT 860 are substantially equivalent to the predicate (i.e. Discovery NM/CT 670) and reference (i.e. Optima NM/CT 640, Revolution ACTs and Xeleris 4.0) devices, and hence is safe and effective for their intended use.

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.