Discovery NM/CT 670 CZT

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 22, 2016 GE Healthcare GE Medical Systems Israel. Functional Imaging % Mr. George Mashour Regulatory Affairs Leader 4 Hayozma Street Tirat Hacarmel, 30200 ISRAEL Re: K153402 Trade/Device Name: Discovery NM/CT 670 CZT Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK Dated: November 22, 2015 Received: November 24, 2015 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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael 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 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. 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Indications for Use Statement Discovery NM/CT 670 CZT {3}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | | |-----------------------------------------|--| | Food and Drug Administration | | ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. | 510(k) Number (if known) | | |--------------------------|--| |--------------------------|--| K153402 Device Name ## Discovery NM/CT 670 CZT ### Indications for Use (Describe) The GE Discovery NM/CT 670 CZT system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, diagnosing of diseases and 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, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 CZT system, combining a CZT-based, high energy and spatial resolution, Nuclear Medicine (NM) system and a Computed Tomography (CT) system, 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 framellist mode single-photon imaging-enhancement features include, gating by physiological signals, and real-time automatic body contouring. · CT System: Cross sectional images ofthe 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 CZT 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 obtain additional 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) | |-------------------------------------------------| |-------------------------------------------------| | IZJ Prescription Use (Part 21 CFR 801 Subpart D) | DOver-The-Counter Use (21 CFR 801 Subpart C) | |--------------------------------------------------|----------------------------------------------| |--------------------------------------------------|----------------------------------------------| ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ 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." {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a circular border. The logo is colored in a bright blue hue, with the letters and border standing out against a white background. 510(k) Summary Discovery NM/CT 670 CZT {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. Surrounding the circle are decorative, wave-like elements, also in white, which give the impression of motion or energy. # 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: | November 22, 2015 | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems Israel, Functional Imaging (GE Healthcare<br>4 Hayozma Street<br>Tirat Hacarmel, 30200, Israel | | Primary Contact: | George Mashour<br>Regulatory Affairs Leader<br>GE Medical Systems Israel, Functional Imaging<br>Tel: +972-4-8563666 ext. 639<br>Fax: +972-4-8577662<br>email: george.mashour@ge.com | | Secondary Contacts: | John Jaeckle<br>Chief Regulatory Affairs Strategist<br>GE Healthcare<br>Tel: 262-424-9547<br>email: john.jaeckle@ge.com<br>Efrat Hartog-David<br>Regulatory Affairs Manager<br>Tel: +972-4-8563666 ext. 805<br>Fax: +972-4-8577662<br>email: efrat.hartog-david@ge.com | | Device Trade Name: | Discovery NM/CT 670 CZT | | Common / Usual<br>Name: | Single Photon Emission Computed Tomography (SPECT ) &<br>Computed Tomography X-Ray (CT) | | Classification<br>Names: | 21CFR 892.1200 & 21CFR 892.1750 | | Product Code: | 90 KPS & 90 JAK | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and there are decorative swirls or flourishes around the outer edge of the circle. The logo is presented in a blue color scheme. - Marketed Devices Discovery NM/CT 670 CZT is a modification to the Discovery NM/CT 670 (K093514) that replaced the NM Nal-based detectors with CZTbased detectors. The detectors are built of the exact same CZT modules that are used in Discovery NM 750b (K102231). The only difference is the number of modules from which the detectors are comprised. All system parts that are not related to the CZT-based detectors remain the same as in Discovery NM/CT 670 (K093514) and have the same functionality and performance. - Discovery NM/CT 670 (K093514) Predicate Device(s): - Reference Device Discovery NM 750b (K102231). - Discovery NM/CT 670 CZT is a SPECT-CT system consisting of two Device Description: back-to-back gantries (i.e. an 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), interconnecting cables and associated accessories.. The system generates NM images, CT images and enables CTbased attenuation correction and anatomical localization of SPECT images. The NM images are generated through computer reconstruction of data acquired by a CZT-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 a commercially available GE Optima CT 540 system. - The GE Discovery NM/CT 670 CZT system is intended for general Intended Use: 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, cardiac and vascular X-ray Computed Tomography applications. - The GE Discovery NM/CT 670 CZT system is a medical tool intended Indications for Use: for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and 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/CT 670 CZT system, combining a CZT-based, high energy and spatial resolution, Nuclear Medicine (NM) system and a Computed Tomography (CT) system, is {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The frame has decorative swirls or flourishes around the letters, giving it a classic and recognizable appearance. The color of the logo is a light blue. 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 imagingenhancement features include, 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 CZT 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 obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages. - Discovery NM/CT 670 CZT employs the same fundamental scientific Technology: technology as the predicate device and the Discovery NM 750b (K102231) reference device for the CZT-based detectors. #### Summarv of Non-Clinical Testing: Determination of Substantial Discovery NM/CT 670 CZT has completed testing and is in Equivalence: compliance with IEC 60601-1 Ed. 3 and its associated collateral and particular standards, 21CFR Subchapter J, and NEMA XR-25. > The device has successfully completed all design control testing per our quality system. No new hazards were identified and no {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a circular shape. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance. The color of the logo is a light blue. unexpected test results were obtained. The Discovery NM/CT 670 CZT was 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: - . Risk Analysis - . Required Reviews - . Design Reviews - Software Development Lifecycle - . Testing on unit level (Module verification) - Integration testing (System verification) - . Performance testing (Verification) - . Safety testing (Verification) - Simulated use testing (Validation) GE believes Discovery NM/CT 670 CZT system is of comparable type and substantially equivalent to Discovery NM/CT 670. 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) and clinical performance 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 energy resolution. count rate linearity, uniformity and, system resolution and lesion detectability. The lesion detectability evaluation included a model observer study. # Clinical Testing A clinical study using an investigational Discovery NM/CT 670 CZT and the predicate Discovery NM/CT 670 was performed to {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has a swirling design, resembling water droplets or stylized leaves. The logo is colored in a light blue hue. demonstrate the clinical/diagnostic quality by means of sample images and evaluations of them. The sample images were obtained in clinical settings using various clinical protocols for different anatomical procedures. This clinical study was used to obtain the images that were evaluated by 2 nuclear medicine physicians, on a 5-point Likert scale, and then to produce the clinical report included in this 510k The sample images were collected from 19 subjects at one site in Israel with the approval of appropriate ethics committee and in accordance with Israel's Ministry Health's regulation of such clinical investigations. The study was designed and performed run in accordance with applicable GE Healthcare quality system procedures. The images were evaluated for image quality and image resolution by 2 experienced and qualified Nuclear Medicine physicians using a 5 point Likert scale. The result of the evaluations showed that the average overall image quality (IQ, resolution) of the images from the Discovery NM/CT 670 CZT were rated slightly higher than the images from the Nal predicate device. Additionally, the average overall image quality (IQ, resolution) results for Discovery NM/CT 670 CZT images that were created using the first 75% of the counts of the original image (equivalent to acquiring for 75% of the original time -or- acquiring with a 75% lower injected dose for the original time) were found to be equivalent to the average overall image quality results from the predicate device image produced with 100% of its counts. Based on the conformance to standards, development under GE Conclusion: Healthcare's quality system, the successful verification testing, additional engineering testing, and the clinical evaluation, GE Healthcare believes that the Discovery NM/CT 670 CZT is substantially equivalent to the predicate device Discovery NM/CT 670 (K093514), and hence is safe and effective for its intended use.