The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in 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, planning, guiding, and monitoring therapy.

The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield 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.

The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.

Device Description

The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for 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 main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table. Remote Control Unit and NM operation console. The Discovery NM 630 is a subsystem of its predicate device Discovery NM/CT 670 (K093514).

The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield 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 multiisotope/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.

The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories.

AI/ML Overview

This submission states that no clinical studies were required as the device is deemed substantially equivalent to a predicate device. Therefore, there is no performance data or acceptance criteria related to clinical efficacy. The substantial equivalence is based on the device being a "stand-alone nuclear medicine functionality/components of its predicate device," meaning it does not introduce new safety risks or intended uses and performs comparably to similar devices already on the market.

Here's a breakdown of the requested information, adapted to reflect that no clinical study was performed:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit)	Reported Device Performance	Comments
Safety	No new safety risks introduced compared to predicate device.	Device does not introduce new safety risks.	This is an assertion based on the device being a subset of the predicate's functionality.
Effectiveness/Performance	Performs as well as or better than similar devices currently on the market.	Performs as well or better than similar devices currently on the market.	This is an assertion based on the device employing the same fundamental scientific technology as the NM subsystem of its predicate device.
Intended Use	No new intended uses introduced compared to predicate device.	Device does not introduce new intended uses.	This aligns with the device being a subset of the predicate.
Technological Equivalence	Employs the same fundamental scientific technology as the NM subsystem of its predicate device.	Employs the same fundamental scientific technology as the NM subsystem of its predicate device.	This is the core argument for substantial equivalence.
Compliance with Standards	Complies with voluntary standards as detailed in Sections 9, 11, and 17 of the premarket submission.	Designed to comply with voluntary standards (Sections 9, 11, 17 of submission).	No specific performance metrics or results from these compliance tests are provided in the summary.
Quality System Adherence	Developed in accordance with GE's Quality System, including risk analysis, design reviews, and various levels of testing.	Developed in accordance with GE's Quality System, and subject to: 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).	These are internal quality assurance measures; specific results are not provided in the summary.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. No clinical test set was used to establish performance.
Data Provenance: Not applicable. No clinical data was used for a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth was established by experts for a test set, as no clinical studies were performed.

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

Not applicable. No adjudication methods were mentioned as no clinical studies were performed.

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. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is a SPECT imaging system, not an AI-enabled diagnostic tool requiring human-in-the-loop performance evaluation.

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

No. The device is a SPECT imaging system, not an algorithm, so a standalone performance study in the context of an algorithm's diagnostic accuracy was not performed. The "standalone functionality" mentioned refers to the device being a complete nuclear medicine system in itself, distinct from a CT component.

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

Not applicable. No clinical ground truth was established, as no clinical studies were performed. The "ground truth" for this submission focuses on demonstrating substantial equivalence to a predicate device through technical and functional comparisons, not clinical performance metrics.

8. The sample size for the training set

Not applicable. The device is a SPECT imaging system, not an AI/ML algorithm that requires a training set of data.

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

Not applicable. The device is a SPECT imaging system, not an AI/ML algorithm that requires a training set with established ground truth.

Summary of the Study (or lack thereof):

The GE Discovery NM 630 did not require clinical studies to support substantial equivalence. The argument for substantial equivalence is based on the device being a subset of its predicate device (Discovery NM/CT 670, K093514), specifically encompassing the "stand-alone nuclear medicine functionality/components." The primary reasoning is that the Discovery NM 630 employs the "same fundamental scientific technology" as the NM subsystem of the predicate device. Therefore, it is asserted that the device does not introduce new safety risks or intended uses and performs as well as or better than similar devices already on the market. Non-clinical tests were conducted which included risk analysis, requirements reviews, design reviews, unit-level testing, integration testing, final acceptance testing, performance testing, and safety testing, all in accordance with GE's Quality System and voluntary standards. No clinical data, patient samples, or expert evaluations for diagnostic accuracy were used as part of this 510(k) submission to demonstrate performance, as it relied on technological equivalence to a legally marketed predicate.

Summary

{0}------------------------------------------------

K111445

JUN - 3 2011

Page 1 of 3

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	[April 12, 2011]
Submitter:	GE Healthcare, GE Medical Systems Israel, Functional Imaging
	4 HAYOZMA St
	TIRAT HACARMEL, 30200, ISRAEL
Primary Contact Person:	Tal Bresler-Stramer
	Regulatory Affairs Leader
	GE Healthcare, GE Medical Systems Israel, Functional Imaging
	(972) 4-8563666
	(972) 4-8577664
Secondary Contact Person:	John Jaeckle
	Regulatory Affairs Manager, MI&CT
	GE Healthcare,
	262-424-9547
Device:Trade Name:	Discovery NM 630
Common/Usual Name:	Single Photon Emission Computed Tomography (SPECT )
Classification Names:	21CFR 829.1200
Product Code:	KPS
Predicate Device(s):	Discovery NM/CT 670 (K093514)
Device Description:	The Discovery NM 630 is an all-purpose dual detector nuclear
	imaging system intended for 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 main components of the Discovery
	NM 630 system are: NM Gantry with Dual detector heads, patient
	table. Remote Control Unit and NM operation console. The
	Discovery NM 630 is a subsystem of its predicate device
	Discovery NM/CT 670 (K093514).
Indications for Use:	The GE Discovery NM 630 system is a medical tool intended for
	use by appropriately trained healthcare professionals to aid in
	detecting, localizing, diagnosing of diseases and in 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, planning, guiding, and monitoring therapy.

{1}------------------------------------------------

Page 2 of 3

Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters and the inner part of the circle are black, while the outer part of the circle is white.

GE Healthcare 510(k) Premarket Notification Submission

The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield 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 multiisotope/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.

The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white.

GE Healthcare 510(k) Premarket Notification Submission

Technology: The Discovery NM 630 is a subset of its predicate device the NM/CT hybrid system Discovery NM/CT 670 (K093514). The Discovery NM 630 employs the same fundamental scientific technology as the NM subsystem of its predicate device the NM/CT hybrid system Discovery NM/CT 670 (K093514).

Summary of Non-Clinical Tests: Determination of Substantial Equivalence:

The Discovery NM 630 and its applications are designed to comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. It was developed in accordance with GE's Quality System. 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 630 did not require clinical studies to support substantial equivalence. The Discovery NM 630 is the stand-alone nuclear medicine Conclusion: functionality/components of its predicate device. It does not introduce and new safety risks, or intended uses. It performs as well or better than similar devices currently on the market and conforms to the recognized standards for NM. GE Healthcare considers the Discovery NM 630 to be as safe, as effective, and is

substantially equivalent to the predicate device.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.

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

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

JUN - 3 2011

Re: K111445

Trade/Device Name: Discovery NM 630 Regulation Number: 21 CFR §892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: May 20, 2011 Received: May 24, 2011

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuarice 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, Parts 801 and 809); medical device reporting (reporting of

{4}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5.10(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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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.

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/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use Form

510(k) Number (if known):

Device Name: Discovery NM 630

Indications for Use:

The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, diagnosing of diseases and in 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, planning, guiding, and monitoring therapy.

The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Spatil

Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111445

Page 1 of 1

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.