(123 days)
No
The summary mentions "digital processing of data and images" and "computer reconstruction," but does not explicitly mention AI or ML. The performance studies mention a "Channelized Hotelling Model Observer (CHO) study," which is a type of computational model used in image quality assessment, but this is not necessarily indicative of AI/ML in the device's core functionality for image generation or analysis.
No
The document consistently describes the device as 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," and notes its use for "staging of tumors; and planning, guiding, and monitoring therapy." It does not mention the device delivering therapy or treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "medical tool intended for use... to aid in detecting, localizing, diagnosing of diseases". This directly aligns with the definition of a diagnostic device.
No
The device description explicitly states that the system consists of physical components like gantries, a patient table, a power distribution unit, and an operator console, in addition to digital processing. This indicates it is a hardware and software system, not software-only.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description of the GE NM/CT 850 and 860 systems clearly indicates they are imaging devices that acquire data from the patient's body using nuclear medicine and computed tomography techniques. They do not analyze biological samples like blood, urine, or tissue in a laboratory setting.
- The intended use describes imaging and diagnosis based on in-vivo data. The text focuses on detecting radioisotope tracer uptake in the patient's body, producing cross-sectional images, and combining these for functional and anatomical mapping. This is all done within the living patient.
The device is a medical imaging system used for in-vivo diagnosis and assessment, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
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.
Product codes (comma separated list FDA assigned to the subject device)
KPS, JAK
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.
Mentions image processing
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 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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
NM System: Single Photon Emission Computed Tomography (SPECT), Gated SPECT, Whole body SPECT, Planar mode (Static, Multi-gated, Dynamic and Whole body). Imaging modes include single photon, multi peak frame, multi-isotope, and multipeak.
CT System: X-Ray Computed Tomography (CT), Axial, Cine and Helical acquisitions.
Anatomical Site
Head, whole body.
Indicated Patient Age Range
patients of all ages.
Intended User / Care Setting
appropriately trained healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 observer.
Clinical Testing: Not needed as changes do not change Indications for Use from predicate and reference devices and are equivalent technological characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Discovery NM/CT 670 (K093514)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Optima NM/CT 640 (K121019), Revolution ACTs (K171013), Xeleris 4.0 Workstation (K153355)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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);
1
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)
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.
| 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)
Device Name NM/CT 860
Indications for Use (Describe)
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
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.
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.
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 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 Street | |
| Tirat Hacarmel, 30200, Israel | |
| Primary Contact: | George Mashour |
| Regulatory Affairs Leader | |
| GE Medical Systems Israel, Functional Imaging | |
| Tel: +972-4-8563666 ext. 639 | |
| Fax: +972-4-8577662 | |
| email: george.mashour@ge.com | |
| Secondary Contacts: | John Jaeckle |
| Chief Regulatory Affairs Engineer | |
| GE Healthcare | |
| Tel: 262-424-9547 | |
| email: john.jaeckle@ge.com | |
| Device Trade Name: | NM/CT 850 |
| NM/CT 860 | |
| 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 |
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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 860
NM/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) |
| Detector
Composition | 16 x 0.625 mm rows
with 4 x 1.25 mm rows
on 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 per
| rotation | 16 | 8 |
|---|---|---|
| Max Beam | ||
| Width | 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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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.