Philips Radiology Smart Assistant

{0}------------------------------------------------ December 13, 2021 Image /page/0/Picture/1 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. Philips Medical Systems DMC GmbH % Connie Pascual Sr. Regulatory Affairs Specialist Roentgenstrasse 24-26 Hamburg, Hamburg 22335 GERMANY Re: K212186 Trade/Device Name: Philips Radiology Smart Assistant Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, JAA Dated: November 12, 2021 Received: November 15, 2021 Dear Connie Pascual: 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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Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K212186 Device Name Philips Radiology Smart Assistant #### Indications for Use (Describe) Philips Radiology Smart Assistant is intended to provide patient positioning feedback using validated 2D X-Ray systems. Philips Radiology Smart Assistant is a software which informs Healthcare Professionals regarding patient positioning quality in accordance with clinical guidelines. Philips Radiology Smart Assistant is not intended for diagnostic purposes. It is not intended to be used as the basis for repeating an image. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | 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. 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. 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The background is white. # 7. 510(k) Summary ### 510(k) Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92. | Date Prepared: | November 12, 2021 | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | Philips Medical Systems DMC GmbH<br>Roentgenstrasse 24-26<br>22335 Hamburg<br>GERMANY<br>Establishment Registration Number: 3003768251 | | Primary Contact Person: | Connie Pascual<br>Regulatory Affairs Manager<br>Phone: +1 (978) 659-2440<br>E-mail: connie.pascual@philips.com | | Secondary Contact Person: | Ann Lebar<br>Phone: +1 (414) 217-6244<br>E-mail: ann.lebar@philips.com | | Device Name: | Philips Radiology Smart Assistant | | Classification: | | | Classification Name: | System, X-Ray, Stationary | | Classification Regulation: | 21 CFR 892.1680 | | Classification Panel: | Radiology | | Device Class: | Class II | | Product code: | KPR, JAA | | Trade Name/Device Name: | Philips Radiology Smart Assistant | | Primary Predicate Device: | | | Manufacturer: | Philips Medical Systems DMC GmbH | | 510(k) Clearance: | K210692 | | Classification Regulation: | 21 CFR Part 892.1680 | | Classification Name: | System, X-Ray, Stationary | | Classification Panel: | Radiology | | Device Class: | Class II | | Product Code: | KPR | | Trade Name/Device Name: | DigitalDiagnost | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white. | Reference Device: | Philips Healthcare Informatics, Inc. | |----------------------------|----------------------------------------| | 510(k) Clearance: | K182926 | | Classification Regulation: | 21 CFR 892.2050 | | Classification Name: | System, Image Processing, Radiological | | Classification Panel: | Radiology | | Device Class: | Class II | | Product Code: | LLZ | | Trade Name/Device Name: | IntelliSpace Radiology | Device description: Philips Radiology Smart Assistant is a software package intended to be used by qualified healthcare professionals. The software is used with general purpose computing hardware for the processing, display of images, and patient positioning feedback within a clinical environment. Philips Radiology Smart Assistant software supports receiving and displaying images from X-ray systems. The system supports receiving, sending, storing, acceptance and displaying of medical images received from the following modality types via DICOM: DX as well as hospital/radiology information systems. Philips Radiology Smart Assistant includes a post-processing patient positioning feedback function for posterior-anterior (PA) chest X-ray images. The patient positioning assessment is intended to provide a qualified healthcare professional with timely feedback on the quality of acquired X-ray images that do not suffice the positioning quality standards of clinical guidelines. The quality check comprises an assessment of the following parameters: - Collimation - Patient Rotation - Patient Inhalation State Indications for Use: Philips Radiology Smart Assistant is intended to provide patient positioning feedback using validated 2D X-Ray systems. Philips Radiology Smart Assistant is a software which informs Healthcare Professionals regarding patient positioning quality in accordance with clinical guidelines. Philips Radiology Smart Assistant is not intended for diagnostic purposes. It is not intended to be used as the basis for repeating an image. Fundamental Scientific Technology: The proposed device, Philips Radiology Smart Assistant, is a software accessory to currently marketed parent predicate device, DigitalDiagnost (K210692). This software is used with general purposed computing hardware for the processing and display of images throughout a clinical environment by healthcare professionals. The Philips Radiology Smart Assistant provides post-processing patient positioning feedback for PA chest X-ray images. At a high level the Philips Radiology Smart Assistant and the parent predicate device (K210692) are based on the following equivalent elements: {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. - Similar Intended Use - Prescription Only - Compatibility with standard radiological images - Processes and displays digital radiographic images The following technological differences exist between the proposed and parent predicate device: - Anatomy of interest is PA chest images only - Patient Positioning Feedback feature - . Not intended to be used on pediatric population #### Summary of technological characteristics: The presented technological differences are considered low risk, providing additional features such as the Patient Positioning Feedback for the purposes of training and education for healthcare professionals. This new functionality has been verified and validated, and does not raise new questions on safety and/or effectiveness. This new features has not changed the intended use and operational principles of the parent predicate device. Therefore, Philips Radiology Smart Assistant is substantially equivalent to the currently marketed parent predicate device, DigitalDiagnost (K210692). Non-clinical performance testing has been performed on the Philips Radiology Smart Summary of Assistant and demonstrates compliance with the following international and FDA-Non-Clinical recognized consensus standards and FDA guidance document: Performance Data: - ' EN ISO 14971:2012 Medical devices – Application of risk management to medical devices - I IEC 82304-1:2016 Health Software – General requirements for product safety - 트 IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices - 트 NEMA-PS 3.1 – PS 3.20 Digital Imaging and Communications in Medicine (DICOM) - I Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical characteristics claims, the requirement specifications and the risk management results. Non-Clinical verification and or validation test results demonstrate that the Philips Radiology Smart Assistant: - Complies with the aforementioned international and FDA-recognized ● consensus standards and FDA guidance document, and - Meets the acceptance criteria and is adequate for its intended use. Therefore, the Philips Radiology Smart Assistant is substantially equivalent to the primary currently marketed and predicate device, DigitalDiagnost (K210692) in terms of safety and effectiveness. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white. Summary of The Philips Radiology Smart Assistant did require a clinical study based upon the following attributes: Clinical Data: - Main Feature Patient Positioning Feedback ● - . Indications for use Clinical performance testing was conducted on previously acquired posteroanterior (PA) chest X-ray images in order to demonstrate the performance of the Philips Radiology Smart Assistant in providing patient positing feedback. The algorithm's assessment as to whether or not an image met quality criteria for aspects of patient positioning quality was compared to the positioning quality assessment of clinicians using standard diagnostic metrics. The results of the clinical performance study support the performance of the Philips Radiology Smart Assistant in identification of patient positioning quality issues. The clinical performance study demonstrates that the Philips Radiology Smart Assistant is safe and effective for the specified intended use. The Philips Radiology Smart Assistant is a software accessary that is substantially Substantial equivalent to its predicate parent device, DigitalDiagnost (K210692), in terms of Equivalence similar intended use and different technological characteristics that do not raise Conclusion: different questions of safety and effectiveness. A clinical performance study was performed to demonstrate the performance of the patient positioning feedback algorithm. Substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC 82304, IEC 62366 and EN ISO 14971. The results of these tests demonstrate that Philips Radiology Smart Assistant met the acceptance criteria and is adequate for the specified intended use.