CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01

{0}------------------------------------------------ # K100714 APR - 1 2011 # 21. 510(k) SUMMARY - SAFETY AND EFFECTIVENESS # Applicant / Contact: Cedars-Sinai Medical Center Department of Medicine Artificial Intelligence in Medicine Program 8700 Beverly Blvd. Los Angeles, CA 90048 Tel: 310-423-4663 Fax: 310-423-0173 # Preparer / Consultant: Erik Rodriguez Global Regulatory Solutions 2143 Country Place Escondido, CA 92026 (858) 722-3353 erodriguez@grsolutions.us # A. Submitted By: Cedars-Sinai Medical Center Department of Medicine Artificial Intelligence in Medicine Program 8700 Beverly Blvd. Los Angeles, CA 90048 Tel: 310-423-4663 Fax: 310-423-0173 Contact Person: Mr. Geoff Pollard, Project Manager (At Address Above) | B. Device Trade Name: | CSMC Cardiac Suite | |-----------------------|---------------------------------------| | Common Name: | Nuclear Medicine Software Application | | Classification Name: | Emission Computed Tomography System | | Device Class: | 21 CFR 892.1200, Class II | | Product Code: | 90 KPS | March 3, 2010 C. Date prepared: {1}------------------------------------------------ | D. Predicate Device(s): AutoQUANT® Plus and Cedars-Sinai BPGS and | |------------------------------------------------------------------------| | MoCo Software Programs | | Manufacturer | Product Name | 510(k) No. | |-------------------|------------------------------------------|------------| | ADAC Laboratories | AutoQUANT® Plus | K060020 | | GE/SMV America | Cedars-Sinai BPGS/MoCo Software Programs | K010509 | | PRODUCT NAME | 510(k)<br>NUMBER | CLEARANCE<br>DATE | MANUFACTURER | |----------------------------------------------------|------------------|-------------------|-----------------------------------------------------------| | AutoQUANT® Plus | K060020 | January 20, 2006 | ADAC Laboratories<br>540 Alder Dr.<br>Milpitas, CA 95035 | | Cedars-Sinai BPGS<br>and MoCo Software<br>Programs | K010509 | April 27, 2001 | GE/SMV America<br>8380 Darrow Road<br>Twinsburg, OH 44087 | #### E. Intended Use: The CSMC Cardiac Suite is intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. CSMC Cardiac Suite may be used in multiple settings including the hospital, clinic, doctors office, or remotely. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices. #### F. Device Description: The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. Cedars-Sinai Cardiac Suite minimum system requirements include a computer with at least 1GB RAM, 50MB hard disk space for software installation, a display resolution at least 1024x768 with 16-bit color, a network adapter, a mouse (or other pointer device; trackpad, trackball, etc.) and one of the following operating systems: Windows XP Professional. Windows Vista Professional. Windows 7 Professional. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files. CSMC Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and {2}------------------------------------------------ review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies. ### G. Technological Comparison: CSMC CARDIAC SUITE has similar indications for use and overall function and performs in a similar manner with respect to data display and analysis to both predicates listed herein. Cardiac Suite is also equivalent to AutoQUANT Plus, QPS, QGS, QBS, QARG applications (K060020) and MoCo (K010509). # H. Testing: Testing was conducted to demonstrate that each software application functioned as per its specifications. The summary of all verification tests are listed in the table below. Unresolved Anomalies are referenced herein: | Test Description | Date | Build | Pass | Fail | |------------------------------|------------|-------|------|------| | Known Issues | 2010-03-01 | N/A | N/A | 10 | | QPS Verification | 2009-12-24 | 13291 | 1211 | 0 | | QGS Verification | 2009-12-24 | 13250 | 1211 | 0 | | QBS Verification | 2009-12-24 | 13250 | 632 | 0 | | QARG Verification | 2009-12-21 | 13250 | 1161 | 0 | | CSImport<br>Verification | 2009-12-23 | 13291 | 111 | 2 | | MOCO Verification | 2009-12-21 | 13250 | 23 | 0 | | Installation<br>Verification | 2009-12-21 | 13291 | 82 | 0 | | Regression | 2010-03-01 | 13397 | 912 | 0 | | Regression | 2010-02-28 | 13395 | 912 | 0 | | Regression | 2010-02-27 | 13395 | 912 | 0 | | Regression | 2010-02-26 | 13395 | 912 | 0 | | Regression | 2010-02-25 | 13394 | 912 | 0 | #### Summary of Test Results * Regression tests are run nightly; only the last 5 regression tests are listed #### Performance Testing CSMC Cardiac Suite utilizes several algorithms requiring performance testing. With the exception of two new algorithms ("Quality Score" and "RV algorithm") all algorithms operate identically (i.e. produce the same results) as with previous {3}------------------------------------------------ versions of the software (referenced in predicate devices). In order to ensure the algorithms operate identically to predicate devices a set of 16 studies' algorithm results are compared to those of the predicate device. These test results are included in our regression tests. #### Substantially Equivalent/Conclusion CSMC CARDIAC SUITE is is substantially equivalent to AutoQUANT Plus, QPS, QGS, QBS, QARG applications (K060020), MoCo (K010509) previously cleared by FDA. The CSMC Cardiac Suite has similar indications for use and overall function and performs in a similar manner with respect to data display and analysis as the predicate devices AutoQUANT Plus. This updated version of QPS (Quantitative Perfusion SPECT) and QGS (Quantitative Gated SPECT) includes an automatic registration algorithm between SPECT/PET and CT/CTA datasets, an improved contouring algorithm based on a quality score and RV (right ventricle) extraction and analysis. Therefore, this premarket notification has demonstrated substantial equivalence as defined and understood in the Federal Food. Drug. & Cosmetic Act and its amendments. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a single staff entwined by two snakes. #### 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 Mr. Geoff Pollard, Project Manager Cedars-Sinai Medical Center Department of Medicine, Artificial Intelligence in Medicine Program 8700 Beverly Blvd. LOS ANGELES CA 90048 Re: K100714 APR - 1 2011 Trade/Device Name: Cedars-Sinai Cardiac Suite Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed tomography system Regulatory Class: II Product Code: KPS Dated: October 29, 2010 Received: October 29, 2010 Dear Mr. Pollard: 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 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 Parts 801 and 809); medical device reporting (reporting of {5}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally renarketed 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 S 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 {6}------------------------------------------------ # Indications for Use # 510(k) Number (if known): K100714 # Device Name: Cedars-Sinai Cardiac Suite #### Indications for Use: The Cedars-Sinai Cardiac Suite of applications is intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. Cedars-Sinai Cardiac Suite may be used in multiple settings including the hospital, clinic, doctors office, or remotely. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 1 of 1 (Division Sign-Off) Division of Radiological Devices Division of Radiological Davice Evaluation and Safe 510K.