The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system out would also be used by the plysician for staging of tumors, planning, guiding, and monitoring theram on the CE Discovery NMCT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, in inded to produce:

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 Wolle body scanning) and tomographic mode (SPECT, Gated SPECT) The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contractions

CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, nordiac 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 Discovery NM/CT 670 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to produce additional images, imaging planes, and analysis results. The system may be used fors pationts of all ages.

Device Description

The Discovery NM/CT 670 system is a hybrid SPECT-CT system for performing nuclear cardiology medicine studies, CT studies or SPECT-CT hybrid studies wherein the SPECT and CT studies may be registered and displayed in a fused form on processing and review Workstation. The Discovery NM/CT 670 system is intended to allow healthcare facilities to carry out SPECT and CT studies using the same instrument Major parts of the hybrid system include the following parts : new NM Gantry with Dual detector heads , CT Gantry (same as BrightSpeed Elite (BSD16) gantry), new common patient table , Integrated operation Console including BSD16 operation console and NM operation console & BSD16 Power Distribution Unit .

AI/ML Overview

The provided 510(k) summary for the Discovery NM/CT 670 system explicitly states that "The Discovery NM/CT 670 did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor specific details about sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these were not conducted or reported for this submission.

Instead, the submission for the Discovery NM/CT 670 relies on demonstrating substantial equivalence to predicate devices (K022960- INFINIA and K082816- GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM) by showing that it employs the same fundamental scientific technology and complies with voluntary standards.

Here's a breakdown of the available information regarding how the device meets acceptance criteria, based on the provided text:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Verification Activities)

Since no clinical studies were performed, the "acceptance criteria" discussed are related to manufacturing, design, and regulatory compliance rather than clinical performance metrics like sensitivity, specificity, or reader agreement. The "reported device performance" refers to the successful completion of these internal verification and validation activities.

Acceptance Criterion Type	Reported Device Performance/Method
Regulatory Compliance & Standards	The Discovery NM/CT 670 and its applications are designed to comply with voluntary standards as detailed in Sections 9, 11, and 17 of the premarket submission.
Risk Management	Risk Analysis was performed.
Design Control & Verification	Requirements Reviews: Conducted.Design Reviews: Conducted.Testing on unit level (Module verification): Performed.Integration testing (System verification): Performed.Performance testing (Verification): Performed.Safety testing (Verification): Performed.
Final Validation (System Level)	Final acceptance testing (Validation): Performed.
Technical Equivalence to Predicates	The Discovery NM/CT 670 employs the same fundamental scientific technology as its predicate devices. - CT part: Identical to predicate device K082816 (16 slices, BSD16), with a new equivalent patient table (meets NM attenuation requirements or less) and minor software modifications.- NM part: Improved modification of predicate device K022960- Infinia (new NM Gantry with Dual detector heads).

Additional Information Not Applicable or Not Provided in the Document:

Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with expert ground truth was used.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical test set with expert adjudication was used.
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. The device is not an AI-assisted diagnostic tool as understood in the context of MRMC studies for AI, but a hybrid imaging system. No human reader studies with or without AI assistance were conducted or reported.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a medical imaging system, not a standalone algorithm. Its "performance" is assessed through engineering verification and validation against its design specifications and equivalence to predicate devices, not through standalone diagnostic accuracy studies.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the internal verification and validation activities, the "ground truth" would be the engineering specifications and established performance benchmarks of the predicate devices. No clinical outcomes, pathology, or expert consensus ground truth was established from clinical studies.
The sample size for the training set: Not applicable as no machine learning algorithm requiring a training set is discussed or implied to be part of the substantial equivalence determination process for this device's regulatory review. The device is a hardware imaging system with associated software.
How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the K093514 submission specifically states that clinical studies were not required to support substantial equivalence. The device's acceptance relied on demonstrating technical equivalence to predicate devices and adherence to internal quality assurance measures and voluntary standards.

Summary

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K093514

DEC 1 0 2009

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	September, 23, 2009
Submitter:	GE Healthcare, GE Medical Systems Israel, Functional Imaging4 HAYOZMA StTIRAT HACARMEL, 30200, ISRAEL
Primary Contact Person:	Eli WernerRegulatory Affairs LeaderGE Healthcare, GE Medical Systems Israel, Functional Imaging+972-4-8563666+972-4-8577664
Secondary Contact Person:	Laurence BigioQA site managerGE Healthcare, GE Medical Systems Israel, Functional Imaging+972-4-8563666+972-4-8577664
Device: Trade Name:	Discovery NM/CT 670
Common/Usual Name:	Single Photon Emission Computed Tomography (SPECT ) &Computed Tomography X-Ray (CT)
Classification Names:	21CFR 892.1200 & 21CFR 892.1750
Product Code:	90 KPS & 90 JAK
Predicate Device(s):	K022960- INFINIA; K082816- GE BRIGHTSPEED DELIGHTCT SCANNER SYSTEM; K082506- SYMBIA, VERSION 4.0;K052434- HAWKEYE 4 OPTION FOR DUAL-HEADVARIABLE ANGLE GAMMA CAMERA
Device Description:	The Discovery NM/CT 670 system is a hybrid SPECT-CT systemfor performing nuclear cardiology medicine studies, CT studies orSPECT-CT hybrid studies wherein the SPECT and CT studiesmay be registered and displayed in a fused form on processingand review Workstation. The Discovery NM/CT 670 system isintended to allow healthcare facilities to carry out SPECT and CTstudies using the same instrumentMajor parts of the hybrid system include the following parts :new NM Gantry with Dual detector heads , CT Gantry (same as
Intended Use:	BrightSpeed Elite (BSD16) gantry), new common patient table ,Integrated operation Console including BSD16 operation consoleand NM operation console & BSD16 Power Distribution Unit .The GE Discovery NM/CT 670 system is a medical tool intendedfor use by appropriately trained healthcare professionals to aid indetecting, localizing, diagnosing of diseases and organ functionfor the evaluation of diseases, trauma, abnormalities, and

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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. planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce:

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 scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.

CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac 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 Discovery NM/CT 670 system may include signal analysis and display equipment, patient and equipment supports. components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to produce additional images, imaging planes, and analysis results. The system may be used for patients of all ages.

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The Discovery NM/CT 670 employs the same fundamental Technology: scientific technology as its predicate devices the Nuclear Medicine SPECT system (NM) K022960- Infinia and the CT system, BrightSpeed Elite K082816- ; The CT part is an identical CT system to its predicate device K082816, 16 slices, (BSD16) except for new equivalent patient table that share common use with the NM system and minor software modifications. The common table meets attenuation requirements for NM and provides equivalent or less attenuation vs. original CT table. The NM part (NM gantry and dual head NM detectors) are improved modification of the NM predicate device K022960- Infinia.

Determination of Substantial Equivalence:

The Discovery NM/CT 670 and its applications is designed to comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Final acceptance testing (Validation) Performance testing (Verification) Safety testing (Verification)

The Discovery NM/CT 670 did not require clinical studies to support substantial equivalence.

Conclusion:

GE Healthcare considers the Discovery NM/CT 670 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

·Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

DEC 1 0 2009

GE Medical Systems Israel, Functional Imaging . % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

Re: K093514

Trade/Device Name: Discovery NM/CT 670 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS and JAK Dated: November 11, 2009 Received: November 13, 2009

Dear Mr. Devine:

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 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

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Page 2 -

Enclosure

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to prematket 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

K093514

Device Name: Discovery NM/CT 670

Indications for Use:

The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained bealthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ finction of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neirological disorders and cancer. The system out would also be used by the plysician for staging of tumors, planning, guiding, and monitoring theram on the CE Discovery NMCT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, in inded to produce:

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),

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hula Reimer

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number

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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.