SnapShot Freeze 2

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. GE Medical Systems, LLC. % Ms. Laura Turner Regulatory Affairs Leader 3000 N. Grandview Blvd. WAUKESHA WI 53188 February 13, 2019 Re: K183161 Trade/Device Name: SnapShot Freeze 2 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, LLZ Dated: November 13, 2018 Received: November 15, 2018 Dear Ms. Turner: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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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 comprehensive regulatory information about medical devices and radiation-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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183161 Device Name SnapShot Freeze 2 Indications for Use (Describe) SnapShot Freeze 2 is designed for use with gated cardiac acquisitions to reduce cardiac induced motion artifacts. 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. 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GE Healthcare 510(k) Premarket Notification Submission for SnapShot Freeze 2 510(k) Summary SnapShot Freeze 2 {4}------------------------------------------------ # GE Healthcare 510(k) Premarket Notification Submission for SnapShot Freeze 2 Image /page/4/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle has a stylized, swirling design around the letters, giving it a dynamic and recognizable appearance. # 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: | 2/4/2019 | Primary Contact: | Laura Turner | |------------------|----------------------------------------------------------------------------|------------------|---------------------------| | Submitter: | GE Medical Systems, LLC<br>3000 North Grandview Blvd<br>Waukesha, WI 53188 | | Regulatory Affairs Leader | | Primary Contact: | Laura Turner | | Phone 262-548-4588 | | | Email: laura.turner@ge.com | | | | Secondary Contacts: | Helen Peng | |---------------------|-----------------------------| | | Regulatory Affairs Director | | | GE Healthcare | | | Tel: 262-424-8222 | | | Email: hong.peng@meg.ge.com | # PRODUCT IDENTIFICTION | Device Name: | SnapShot Freeze 2 | |---------------------------------------------|------------------------------------------------------------------| | Regulation number/<br>Product Code | 21 CFR 892.1750 Computed tomography x-ray system /<br>JAK | | Secondary Regulation<br>number/Product Code | 21 CFR 892.2050 Picture archiving and communications system/ LLZ | | Device Classification | Class II | {5}------------------------------------------------ Image /page/5/Picture/0 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. The circle is surrounded by a series of curved, teardrop-shaped elements, also in blue, that give the impression of motion or energy emanating from the central letters. The logo is simple, recognizable, and associated with a large, multinational corporation. # Predicate Device Information : | Device Name | CardIQ Xpress 2.0 with SnopShot Freeze Option | |------------------------------------|----------------------------------------------------------| | Manufacturer | GE Medical System SCS (d.b.a GE Healthcare) | | 510(k) number | K120910 cleared on June 18, 2012 | | Regulation number<br>/product Code | 21 CFR 892.1750 Computed tomography x-ray system,<br>JAK | #### Device Description SnapShot Freeze 2 (SSF 2) is a post processing software, which can be delivered on general purpose computing platforms. SnapShot Freeze 2 is an automated motion correction algorithm designed for use with gated cardiac acquisitions from GE CT scanners to reduce cardiac induced motion artifacts in the whole heart. It is based on the same fundamental algorithm as the predicate product commercially marketed under the name CardIQ Xpress 2.0 with SnapShot Freeze Option (K120910, AKA SSF 1). Same as its predicate device the SSF 2 algorithm works on multi-phase, gated cardiac CT DICOM compatible image data and produces a new image series in which motion artifact is reduced. The device is marketed as SnapShot Freeze 2 # Intended Use SnapShot Freeze 2 is intended to be used for motion correction of gated cardiac image series # Indications for Use SnapShot Freeze 2 is designed for use with gated cardiac acquisitions to reduce cardiac induced motion artifacts. # Technological Characteristic SSF 2 employs the same fundamentally technology as that of the predicate. The motion correction algorithm fundamentally remains the same, taking the multi-phase temporal enhanced cardiac gated DICOM series, applying motion correction and producing the dramatically motion reduced DICOM dataset. The difference is that the SSF2 extends the motion correction capability to the whole heart beyond the coronary vessels as offered in the predicate. # Comparisons {6}------------------------------------------------ Image /page/6/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. The letters are stylized and connected, and there are swirling shapes around the letters. The logo is simple and recognizable, and it is associated with a large and well-known company. The most notable change in SSF 2 as compared to SSF1 is the ability to extend motion correction capability to the whole heart compared with only coronary vessel motion artifact reduction. This may enable new applications in assessing other structures of the heart that are impacted by motion artifacts. The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device: | Specification/<br>Attribute | Predicate Device<br>CardIQ Xpress 2.0 with SnapShot<br>Freeze Option (K120910) | Proposed Device<br>SnapShot Freeze 2 | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Patient Population | Patients referred for a CT<br>cardiovascular examination | Same | | Contraindications | None | Same | | Platforms | AW workstation, AW Server & CT<br>Console | AW workstation, AW Server, CT<br>Console & other platforms<br>including cloud-based computing<br>and image processing platforms | | Input | 3-phase temporal cardiac image<br>series | Same | | Output | Motion corrected target phase<br>image series | Same | | Motion Correction<br>of coronary vessels | Yes – SSF algorithm is capable of<br>coronary vessel motion correction | Same | | Whole heart motion<br>correction | Not Available | Yes, enchantment to the<br>algorithm demonstrates whole<br>heart motion correction | | Effective Temporal<br>Resolution* | 6x improvement in reducing<br>blurring artifacts of the coronary<br>arteries due to cardiac motion.<br><br>Effective temporal resolution of<br>29 ms for 0.35 sec/rot gantry<br>speed. | 6x improvement in reducing<br>blurring artifacts of the coronary<br>arteries due to cardiac motion.<br><br>Effective temporal resolution of<br>29 ms for 0.35 sec/rot gantry<br>speed.<br><br>Effective temporal resolution of<br>24 ms for 0.28sec/rot gantry. | *As demonstrated in mechanical and mathematical cardiac phantom testing. {7}------------------------------------------------ SnapShot Freeze 2 does not introduce any new risks/hazards, warnings, or limitations. # Determination of Substantial Equivalence Engineering bench testing was performed to support substantial equivalence and the product performance claims. The testing used a commercially available cardiac motion phantom with linear motion of variable velocity for modeling of the coronary vessels and the whole heart. The testing also used a mathematical phantom to demonstrate effective temporal resolution, coronary motion and whole heart motion correction. The combination of both analyses (from physical and mathematical motion phantoms) is intended to provide further confidence in the capabilities and full extent of the Snapshot Freeze 2 whole heart motion correction. A representative clinical sample image set of 60 CT cardiac cases, focused on patient populations with elevated heart rate were assessed by three board certified radiologists using 5point Likert scale. This data is representative of routine clinical imaging from a cardiac acquisition perspective, but intentionally includes data from subjects with elevated heart rates or those with heart rate variability which represent more challenging cases, in which such an algorithm is most likely to be utilized. The assessment demonstrated the diagnostic capability of the motion corrected images by SSF 2. SnapShot Freeze 2 has successfully completed the required design control testing per GE's quality system. No new hazards were identified, and no unexpected test results were obtained. SnapShot Freeze 2 was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The following quality assurance measures have been 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) The testing and results did not raise different questions of safety and effectiveness than associated with predicate device using device-based respiratory gating. The substantial equivalence was also based on software documentation for a "Moderate" level of concern device. # Conclusion: {8}------------------------------------------------ Image /page/8/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 circular shape. The circle is adorned with swirling, wave-like elements, giving it a dynamic and recognizable appearance. The logo is presented in a blue color. Based on the conformance to standards, development under our quality system, and the engineering and clinical testing provided, GE Medical Systems believes that the SnapShot Freeze 2 is as safe and effective, and performs in a substantially equivalent manner to the predicate device CardIQ Xpress 2.0 with SnopShot Freeze Option.