DISCOVERY MODEL NM/CT 670

{0}------------------------------------------------ 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 Imaging<br>4 HAYOZMA St<br>TIRAT HACARMEL, 30200, ISRAEL | | Primary Contact Person: | Eli Werner<br>Regulatory Affairs Leader<br>GE Healthcare, GE Medical Systems Israel, Functional Imaging<br>+972-4-8563666<br>+972-4-8577664 | | Secondary Contact Person: | Laurence Bigio<br>QA site manager<br>GE Healthcare, GE Medical Systems Israel, Functional Imaging<br>+972-4-8563666<br>+972-4-8577664 | | Device: Trade Name: | Discovery NM/CT 670 | | Common/Usual Name: | Single Photon Emission Computed Tomography (SPECT ) &<br>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 DELIGHT<br>CT SCANNER SYSTEM; K082506- SYMBIA, VERSION 4.0;<br>K052434- HAWKEYE 4 OPTION FOR DUAL-HEAD<br>VARIABLE ANGLE GAMMA CAMERA | | Device Description: | The Discovery NM/CT 670 system is a hybrid SPECT-CT system<br>for performing nuclear cardiology medicine studies, CT studies or<br>SPECT-CT hybrid studies wherein the SPECT and CT studies<br>may be registered and displayed in a fused form on processing<br>and review Workstation. The Discovery NM/CT 670 system is<br>intended to allow healthcare facilities to carry out SPECT and CT<br>studies using the same instrument<br>Major parts of the hybrid system include the following parts :<br>new NM Gantry with Dual detector heads , CT Gantry (same as | | Intended Use: | BrightSpeed Elite (BSD16) gantry), new common patient table ,<br>Integrated operation Console including BSD16 operation console<br>and NM operation console & BSD16 Power Distribution Unit .<br>The GE Discovery NM/CT 670 system is a medical tool intended<br>for use by appropriately trained healthcare professionals to aid in<br>detecting, localizing, diagnosing of diseases and organ function<br>for the evaluation of diseases, trauma, abnormalities, and | DOC0660252 . ﺃ ; {1}------------------------------------------------ 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. DOC0660252 23 {2}------------------------------------------------ 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) #### DOC0660252 24 {3}------------------------------------------------ ### 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 {4}------------------------------------------------ #### 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 {5}------------------------------------------------ 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 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. 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) 20 Hula Reimer (Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number DOC0660252 : ',