Carestream DRX-1 System with DRX Core Detectors

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January 16, 2019 Carestream Health, Inc. % Ms. Carolyn Wagner Director Regulatory Affairs, Clearance & Surveil. 150 Verona Street ROCHESTER NY 14608 Re: K183474 Trade/Device Name: Carestream DRX-1 System with DRX Core Detectors Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: December 14, 2017 Received: December 17, 2018 Dear Ms. Wagner: 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. 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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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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, 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}------------------------------------------------ ## Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries. {3}------------------------------------------------ # Carestream ### "K183474 510(k) Summary" | 510(k) Owner Name:<br>510(k) Owner Address: | Carestream Health, Inc.<br>150 Verona Street<br>Rochester, New York 14608 | |-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Owner Phone:<br>510(k) Owner Fax: | 585-627-6588<br>585-627-8802 | | Contact Person & Info: | Carolyn L Wagner<br>Director Regulatory Affairs, Clearance & Surveillence<br>Carolyn.wagner@carestream.com<br>585-627-6588 | | Date Summary Prepared: | January 15, 2019 | | Device Trade Name:<br>Device Common Name:<br>Classification Name: | Carestream DRX-1 System with DRX Core Detectors<br>Flat Panel Digital Imager<br>Stationary x-ray system | | Device Class:<br>Device Code:<br>Regulation Number: | Class II<br>MQB<br>21 CFR 892.1680 | | Predicate Device: | Carestream DRX-1 System with DRX Plus 3543<br>Detectors<br>Manufactured by: Carestream Health, Inc.<br>510(k) No.: K150766 (June 24, 2015)<br>Classification Regulation: 21 CFR 892.1680<br>Classification Name: Stationary x-ray system<br>Primary Product Code: MQB | #### Device Description: Carestream Health, Inc. is submitting this Special 510(k) premarket notification for a modification to the cleared Carestream DRX-1 System with DRX Plus 3543 Detectors (K150766). The product will be marketed as the Carestream DRX-1 System with DRX Core Detectors. Consistent with the original system, the Carestream DRX-1 System with DRX Core 3543 Detectors are flat panel digital imagers utilizing a stationary digital radiography (DR) x-ray system. {4}------------------------------------------------ #### Indications for Use "The device is intended to capture for display radiographic images of human anatomy including both pediatric and adult patients. The device is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. Excluded from the indications for use are mammography, fluoroscopy, and angiography applications." The Indications for Use for the subject device is the same as for the predicate device and the intended use remains unchanged. Any variation in features or technical specifications have been identified and addressed through testing (described below) to support a substantial equivalence determination. #### Intended Use The intended use for this device, as determined by descriptions and the proposed labeling contained in this submission, is similar to the Indications for Use statement provided above. We believe that the Carestream DRX-1 System with DRX Core Detectors and the predicate device have the same intended use. #### Comparison of Technological Characteristics: Based upon information provided within this submission. we believe that the Carestream DRX-1 System with DRX Core Detectors is substantially equivalent to the legally marketed Carestream DRX-1 System with the DRX Plus 3543 Detectors (predicate device) (K150766). Both the currently marketed DRX Plus 3543 Detectors and the new DRX Core Detectors are used in combination with the image processing software (Eclipse II: K180809) and user interface resident on the DRX-1 System Console component of the Carestream DRX-1 System. The system is used to directly capture conventional projected x-rays to generate digital images. regardless of which detector is being used. An image can be displayed on a preview monitor for viewing with any of the detectors. The system can transmit diagnostic images through a digital network for diagnostic viewing and printing regardless of which detector is used. The Carestream DRX Core 3543C, DRX Core 4343C and DRX Core 4343FC Detectors (investigational devices) are similar to the FDA cleared DRX Plus 3543 Detector (predicate device) except for the scintillator (new supplier change for the CSI scintillator) and same or larger size, with all other aspects of the design remaining the same. Based upon information provided within this submission, we believe that the Carestream DRX-1 System with DRX Core Detectors is substantially equivalent to the legally marketed Carestream DRX-1 System with DRX Plus 3543 Detectors (K150766). #### Discussion of Testing #### Bench Testing The performance characteristics and operation / usability of the Carestream DRX-1 System with DRX Core Detectors were evaluated in non-clinical (bench) testing. These studies have {5}------------------------------------------------ demonstrated the intended workflow, related performance, overall function, shipping performance, verification and validation of requirements for intended use, and reliability of the system including both software and hardware requirements. Non-clinical test results have demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device. In addition to the bench testing described above, the performance of the Carestream DRX-1 System with DRX Core 3543C Detector (investigational) was evaluated against the predicate device in a phantom imaging study. The purpose of this study was to compare the image quality between the investigational and predicate devices using anthropomorphic phantoms. Because detector performance was well characterized by laboratory data, the following information was not necessary to demonstrate substantial equivalence but provides additional support that the device works as intended: A set of anthropomorphic phantoms (adult and pediatric) were used to perform paired acquisitions using the investigational and predicate devices. Thirty image pairs were obtained using a DRX-Evolution stationary x-ray system. The Beam Detect feature was used in half of the acquisitions for both predicate and investigational detectors. Due to intrinsic differences in the efficiencies of the scintillator materials, the GOS (predicate) panel was operated at 30% higher exposure than the CsI panel to facilitate an appropriate image quality comparison. The improved imaging performance of the CsI panel was verified based on a comparison of DQE and MTF to the predicate. Exam types included adult and pediatric chest, shoulder, clavicle, upper and lower extremities. and adult skull. The exams were acquired according to the phantom imaging protocol developed for this study. Three expert observers (former radiographic technologists with extensive experience in resolving image quality related service issues) evaluated images in a blinded pairwise study on a PACS system. Image quality attributes of detail contrast, sharpness and noise were evaluated using a 5 point preference scale. Any artifacts present in the resultant images were evaluated as part of the image comparison and no unique artifacts associated with either detector were evident. Dust or debris was observed in several exams on both the predicate and investigational images suggesting that dirt or contamination was under or on the phantom during acquisition. Since it was common in images from both detectors, such artifacts were deemed inconsequential. #### Conclusion The average preference for all image quality attributes (detail contrast, sharpness and noise) demonstrates that the image quality of the investigational device (exposed with 30% less exposure) is the same as that of the predicate device. The two-sample equivalence tests confirm that the beam detect mode has no effect on preference. #### Summary The statistical test results and graphical summaries generated by the phantom study results demonstrate that the DRX Core 3543C Detector (investigational device) delivers images that are equivalent in quality when compared with images obtained using the commercially available DRX Plus 3543 Detector (predicate device). {6}------------------------------------------------ Results of the Phantom Reader Study indicated that the image quality of the modified Carestream DRX-1 System with DRX Core 3543C Detector is statistically equivalent to or better than that of the DRX Plus 3543 Detector (predicate device). #### IEC Consensus Standards and FDA Guidance Documents The Carestream DRX-1 System with 3543C Core Detector was tested and found compliant to the following consensus standards: IEC 60601-1: Medical electrical equipment—Part 1: General requirements for basic safety and essential performance IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Reguirements and tests IEC 62321: Electrotechnical products – Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenvls, polybrominated diphenyl ethers) The following FDA Guidance Documents were followed in preparation of this 510(k) submission: "Guidance for the Submission of 510(k)s for Solid State Imaging Devices" "Pediatric Information for X-ray Imaging Device Premarket Notifications"