(14 days)
ProxiDiagnost N90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
The ProxiDiagnost N90 is a multi-functional general Radiography/ Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
The ProxiDiagnost N90 is a nearby controlled fluoroscopy system in combination with high-end digital radiography system consisting of a floor-mounted tilt adjustable patient support table and a scan unit consisting of a tube and a flat panel dynamic detector, Pixium FE4343F, for the fluoroscopy examinations. The tabletop can be moved by a motor in the lateral and longitudinal direction and can be tilted by -85° to +90° degrees. The scan unit tilts with the table and can be moved in the longitudinal and lateral direction, relative to the table and to the patient. The system is suitable for routine X-ray examinations and fluoroscopy examinations on patients in standing, seated or lying positions. The ProxiDiagnost N90 retrieves images by means of a Cesium Iodide flat panel detector.
Philips fluoroscopy systems (standard configuration) consist of the Basic unit ("geometry" or "table unit"), Workstation Eleva Workspot (with integrated generator control, hand switch, keyboard, mouse, touch screen and PC), dual screen-monitor, Spot film device (digital camera or flat panel detector), Fixed Detector (Fluoroscopy), X-ray Generator for R/F applications, X-ray tube assembly. The optional components like wireless portable detectors small and large, Bucky tray for wireless portable detectors (SkyPlate) detector, Ceiling Suspension, Fixed Vertical stand, Ceiling Suspension for monitors, monitor trolley, Remote control for R/F (Radiography-fluoroscopy) viewer, accessories for “Stitching Stand", are also available.
The Eleva software of the proposed ProxiDiagnost N90 is based on a workstation i.e., Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operator to preset examination data and to generate, process and handle digital x-ray images. The Eleva Software system is decomposed into software components. These components are clustered in three component collections like the image handling focused Back-end (BE), the acquisition focused Front-end (FE) and Image Processing (IP). The Eleva software is intended to acquire, process, store, display and export digital fluoroscopy and radiographic images.
The ProxiDiagnost N90 uses the same workflow from the currently marketed and predicate device, ProxiDiagnost N90 (K173433) with only the following modifications:
- Inclusion of Extended reviewing options (like the optional reference monitor & remote control),
- Inclusion of some image processing features
- Updates to Operating system and Eleva application Software to include state-of-art operating system and incorporate the changes
- Replacement of the ceiling suspension with that of reference device, DigitalDiagnost C90 (K202564)
- Updates to improve serviceability
- Option for upgradability of Predicate device (K173433) to include the above changes
The provided text is a 510(k) summary for the Philips ProxiDiagnost N90, an X-ray system. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria through an AI/human comparative effectiveness study or a standalone algorithm performance study.
The document does not describe acceptance criteria for an AI algorithm or a study proving an AI algorithm meets those criteria. Instead, it outlines the changes from a predicate device (K173433) and refers to the performance of other reference devices (K203087 and K202564) as justification for the modifications. The "acceptance criteria" discussed are in the context of device safety and effectiveness testing for a conventional medical device (X-ray system), aligning with recognized standards and guidance documents (e.g., IEC 60601 series, ISO 14971).
Therefore, I cannot provide the requested information regarding AI acceptance criteria and performance study details from the given text.
However, I can extract information about the overall device acceptance criteria and testing methodology as described for this X-ray system:
Overall Device Acceptance Criteria (Implied by Testing):
The acceptance criteria for the ProxiDiagnost N90 are implicitly demonstrated through adherence to various international standards and FDA guidance documents related to X-ray systems, electrical safety, electromagnetic compatibility, radiation protection, usability, software lifecycle processes, risk management, and biological evaluation. The testing performed is aimed at ensuring the device's safety and effectiveness compared to its predicate and reference devices, despite the noted modifications.
Study Proving the Device Meets Acceptance Criteria (as described in the document):
The "study" described is a series of non-clinical performance tests and verifications rather than a comparative clinical study with human readers or standalone AI performance.
Information Extracted from the Document (to the extent possible given the context):
-
A table of acceptance criteria and the reported device performance:
The document does not present a table of specific quantitative performance acceptance criteria for an AI algorithm or human reading performance. Instead, it states that "Tests were performed on the proposed ProxiDiagnost N90 according to the following FDA recognized standards and guidance documents." The reported "performance" is that these tests support the device being "safe and effective" and "substantially equivalent" to the predicate.
Acceptance Criterion Category (Implied) Reported Device Performance/Verification Method General Safety & Performance - Compliance with ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).- Compliance with IEC 60601-1-2 Edition 4.0 2014-02 (Electromagnetic disturbances - Requirements and tests).- Compliance with IEC 60601-1-3 Edition 2.1 2013-04 (Radiation protection in diagnostic X-ray equipment).- Compliance with IEC 60601-1-6 Edition 3.1 2013-10 (Usability).- Compliance with IEC 60601-2-54 Edition 1.1 2015-04 (Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy).- Compliance with ANSI AAMI ISO 14971: 2007/(R)2010 (Medical devices-Application of risk management to medical devices).- Compliance with ISO 10993-1, Fifth edition 2018-08 (Biological evaluation of medical devices).- System and software verification testing was performed for all modifications to demonstrate safety and effectiveness. New Features Performance - Extended Reviewing Options: System Verification for Bluetooth remote control and additional reference monitor (test protocol identical to CombiDiagnost R90 K203087).- Image Processing Features: - Digital Subtraction Angiography: Sub-system (Eleva software) & System Verification (test protocol identical to CombiDiagnost R90 K203087). - Predefined annotations: Sub-system (Eleva software) & System Verification (test protocol identical to CombiDiagnost R90 K203087). - Bone Suppression: Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564). - UNIQUE 2 (radiography): Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564). - Intuitive User Interface for Processing Parameters: Sub-system Verification (Eleva software) (test protocol identical to DigitalDiagnost C90 K202564). - Deviation and Target Exposure Indices: Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564). - Update of optional Skyflow feature: Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564). - Access to and Export of Original Image Data: System Verification. - Improved OBSA: Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564). - View Selection for Changed X-Ray Generation Data Sets: Sub-system Verification (Eleva software) (test protocol identical to DigitalDiagnost C90 K202564). - Avoid Ghosting in Verification Images of Portable Detectors: System Verification (test protocol identical to DigitalDiagnost C90 K202564).- Software Updates: - Operating system upgrade to Microsoft Windows 10: Sub-system (Eleva software) & System Verification (test protocol identical to CombiDiagnost R90 K203087). - Upgrade of Eleva Application software to increment 42: All relevant software functions tested at system and subsystem level (referencing tests for change #1, 2, 4 and 5).- Ceiling Suspension & Service Features: - Tube head control: System Verification (test protocol identical to DigitalDiagnost C90 K202564). - Collimator: System Verification (test protocol identical to DigitalDiagnost C90 K202564). - Monitoring and Firmware Updates for Field Service: System Verification (test protocol identical to CombiDiagnost R90 K203087). - Remote access for the field service Engineer: Sub-system Verification (Eleva software). - Service Diagnostic: System Verification (test protocol identical to CombiDiagnost R90 K203087 & DigitalDiagnost C90 K202564). - Hardware upgrades (Alpha drive Upgradeability): System Verification (test protocol identical to DigitalDiagnost C90 K202564). Upgradeability of Predicate Device All relevant Software functions are tested at system and subsystem level (referencing tests for change #1, 2, 3 and 5 a,b,c). -
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of number of patient cases or images. The testing appears to be primarily system-level, software-level, and component-level verification, rather than evaluation on a diagnostic image dataset.
- Data Provenance: The document explicitly states "There is no clinical data submitted in this 510(k) premarket notification." Therefore, there is no information on country of origin or retrospective/prospective nature of data for clinical evaluation, as none was performed.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No clinical data or expert-established ground truth for diagnostic image interpretation was used or provided in this 510(k) submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical image evaluation requiring adjudication was described.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was performed or described. This submission is for an X-ray system, not an AI-powered diagnostic algorithm requiring such a study for its clearance.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No standalone algorithm performance study was performed or described, as this submission is for an X-ray system, not a standalone AI diagnostic algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used in this 510(k) submission, as it explicitly states "There is no clinical data submitted." The testing relies on engineering and regulatory compliance standards.
-
The sample size for the training set:
Not applicable. The document describes an X-ray imaging system, not an AI model that would require a training set.
-
How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI model discussed.
{0}------------------------------------------------
September 21, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Philips Medical Systems DMC GmbH % Supriya Dalvi Regulatory Operations Specialist Roentgenstrasse 24-26 Hamburg, Hamburg 22335 GERMANY
Re: K212837
Trade/Device Name: ProxiDiagnost N90 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, KPR Dated: September 3, 2021 Received: September 7, 2021
Dear Supriya Dalvi:
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. 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
{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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Laurel M. Burk-S. The date of the signature is 2021.09.21, and the time is 14:29:22 -04'00'.
Thalia T. 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) K212837
Device Name
ProxiDiagnost N90
Indications for Use (Describe)
ProxiDiagnost N90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary of Safety and Effectiveness
K212837
This 510(k) summary of safety and effectiveness is prepared in accordance with 21 CFR §807.92.
| PreparationDate: | September 3rd 2021 | |
|---|---|---|
| 510(k)Owner: | Philips Medical Systems DMC GmbHRoentgenstrasse 2422335 HamburgGERMANYEstablishment registration number: 3003768251 | |
| Contact: | Dr. Supriya A. DalviRegulatory Operations SpecialistPhone: +91 9825604544 / +91 8733918445Fax: +49 40 5078-2425E-mail: supriya.dalvi@philips.com | |
| ProposedDevice | Device Name | ProxiDiagnost N90 |
| Legal Manufacturer | Philips Medical Systems DMC GmbH | |
| Classification Name: | Image-intensified fluoroscopic x-ray System | |
| Classification Regulation: | 21 CFR Part 892.1650 | |
| Classification Panel: | 90 – Radiology | |
| Device Class: | Class II | |
| Product Code: | JAA; KPR | |
| PredicateDevice | Device Name | ProxiDiagnost N90 (K173433, February 5, 2018) |
| Legal Manufacturer | Philips Medical Systems DMC GmbH | |
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21 CFR Part 892.1650 | |
| Classification Panel: | 90 – Radiology | |
| Device Class: | Class II | |
| Product Code: | OWB; JAA | |
| ReferenceDevice # 1 | Device Name | CombiDiagnost R90 (K203087, December 3rd, 2020) |
| Legal Manufacturer | Philips Medical Systems DMC GmbH | |
| Classification Name: | Image-intensified fluoroscopic x-ray System | |
| Classification Regulation: | 21 CFR Part 892.1650 | |
| Classification Panel: | 90 – Radiology | |
| Device Class: | Class II | |
| Product Code: | JAA, KPR, MQB | |
| ReferenceDevice # 2 | Device NameLegal ManufacturerClassification Name:Classification Regulation:Classification Panel:Device Class:Product Code: | DigitalDiagnost C90 (K202564, September 30th, 2020)Philips Medical Systems DMC GmbHStationary x-ray system21 CFR 892.168090 – RadiologyClass IIKPR, MQB, LLZ |
| DeviceDescription: | The ProxiDiagnost N90 is a multi-functional general Radiography/ Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, includingspecialist areas like angiography or pediatric work, excluding mammography.The ProxiDiagnost N90 is a nearby controlled fluoroscopy system in combination withhigh-end digital radiography system consisting of a floor-mounted tilt adjustablepatient support table and a scan unit consisting of a tube and a flat panel dynamicdetector, Pixium FE4343F, for the fluoroscopy examinations. The tabletop can bemoved by a motor in the lateral and longitudinal direction and can be tilted by -85° to+90° degrees. The scan unit tilts with the table and can be moved in the longitudinaland lateral direction, relative to the table and to the patient. The system is suitable forroutine X-ray examinations and fluoroscopy examinations on patients in standing,seated or lying positions. The ProxiDiagnost N90 retrieves images by means of aCesium Iodide flat panel detector.Philips fluoroscopy systems (standard configuration) consist of the Basic unit("geometry" or "table unit"), Workstation Eleva Workspot (with integrated generatorcontrol, hand switch, keyboard, mouse, touch screen and PC), dual screen-monitor,Spot film device (digital camera or flat panel detector), Fixed Detector (Fluoroscopy),X-ray Generator for R/F applications, X-ray tube assembly. The optional componentslike wireless portable detectors small and large, Bucky tray for wireless portabledetectors (SkyPlate) detector, Ceiling Suspension, Fixed Vertical stand, CeilingSuspension for monitors, monitor trolley, Remote control for R/F (Radiography-fluoroscopy) viewer, accessories for “Stitching Stand", are also available.The Eleva software of the proposed ProxiDiagnost N90 is based on a workstation i.e.,Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operatorto preset examination data and to generate, process and handle digital x-ray images.The Eleva Software system is decomposed into software components. Thesecomponents are clustered in three component collections like the image handlingfocused Back-end (BE), the acquisition focused Front-end (FE) and Image Processing(IP). The Eleva software is intended to acquire, process, store, display and exportdigital fluoroscopy and radiographic images.The ProxiDiagnost N90 uses the same workflow from the currently marketed andpredicate device, ProxiDiagnost N90 (K173433) with only the followingmodifications:- Inclusion of Extended reviewing options (like the optional reference monitor &remote control),- Inclusion of some image processing features |
{4}------------------------------------------------
{5}------------------------------------------------
| Indicationsfor Use: | Updates to Operating system and Eleva application Software to include state-of--art operating system and incorporate the changesReplacement of the ceiling suspension with that of reference device,-DigitalDiagnost C90 (K202564)Updates to improve serviceability-Option for upgradability of Predicate device (K173433) to include the above-changesProxiDiagnost N90 is a multi-functional general R/F system. It is suitable for all routineradiography and fluoroscopy exams, including specialist areas like angiography orpediatric work, excluding mammography. | ||
|---|---|---|---|
| FundamentalScientificTechnology: | The proposed ProxiDiagnost N90 employs the same basic construction, fundamentalscientific technology and workflow as the predicate device, ProxiDiagnost N90(K173433,) with regards to the functionality of all its components. It has the same highvoltage generator, X-ray tube, Collimator, detectors, workstation (ELEVA) for imagespost-processing, storage and viewing.The changes with respect to the predicate are mainly with the incorporation of thefeatures that are already cleared on the reference devices; CombiDiagnost R90(K203087) & DigitalDiagnost C90 (K202564). These changes are evaluated throughISO 14971 risk analysis procedures. These changes are addressed by the system andsoftware verification testing of the proposed device. The test results support that theproposed ProxiDiagnost N90 is safe and effective. Refer Table 1 below for comparisonof the technological characteristics of the proposed device and predicate device,ProxiDiagnost N90 (K173433)Table 1: Comparison of the Technological Characteristics of the proposed device andpredicate device, ProxiDiagnost N90 (K173433) | ||
| Predicate device,ProxiDiagnost N90 (K173433) | Proposed device,ProxiDiagnost N90 | ||
| LegalManufacturer | Philips Medical Systems DMCGmbH | Identical | |
| Classification | Class II per 21 CFR Part892.1650, Primary Product code:OWBSecondary Product code: JAA | Class II per 21 CFR Part 892.1650,Primary Product code: JAASecondary Product code: KPRThe proposed device is notinterventional X-ray system | |
| RegulationName | Stationary x-ray system | Identical | |
| Class | II | Identical | |
| Review Panel | Radiology | Identical | |
| Indications forUse | ProxiDiagnost N90 is a multi-functional general R/F system. Itis suitable for all routineradiography and fluoroscopyexams, including specialist areaslike angiography or pediatricwork, excludingmammography. | Identical | |
| Principle ofOperation | ProxiDiagnost N90 systems areintended for the medicalapplication procedures forfluoroscopy and Radiography.ProxiDiagnost N90 systems allowradiography (with optional 2ndTube on Ceiling suspension) andfluoroscopy on a patient in supine,seated or standing position,depending on the specificindication. Depending on thespecific indication, X-rayprocedures vary in patientpositioning and the modificationof radiographic parameters | Identical | |
| Table features | Identical | ||
| Generator | Identical | ||
| Components | Tube | Identical | |
| Fixed Detector (Fluoroscopy) | Identical | ||
| Collimator (Fluoroscopy) | Identical | ||
| Grid | Identical | ||
| System Control | Identical | ||
| Extendedreviewingoptions | Bluetooth remote control | Infrared remote control for ImageNavigationIt is identical to the referencedevice, CombiDiagnost R90(K203087) | |
| Optional Reference monitor notavailable | Additional monitor for referenceimage support is available. It isidentical to the reference device,CombiDiagnost R90 (K203087) | ||
| Imageprocessingfunctionality | Optional DSA (Digital SubtractionAngiography) feature not available | Digital Subtraction Angiographyfunctionality is available and usedfor angiography and providesinteractive viewing operations on avascular run, so that the vascularanatomy becomes visible.It is identical to that on the referencedevice, CombiDiagnost R90(K203087) | |
| Predefined annotations integratedinto the dynamic viewer notavailable | This feature enables the user toassign annotation to the image with | ||
| the help of set of predefinedannotations.It is identical to that on thereference device, CombiDiagnostR90 (K203087) | |||
| Optional Bone Suppression featurenot available | Bone Suppression is a availablewhich is a post-processingapplication intended to generate asecondary digital radiographicimage of the chest.It is identical to that on thereference device, DigitalDiagnostC90 (K202564) | ||
| Dynamic UNIQUE(Fluoroscopy only) UNIQUE (radiographymodality) | Dynamic UNIQUE(fluoroscopy modality only)-no change UNIQUE 2 (radiographymodality only)- It is animproved ability for globalcontrast enhancement and amore sophisticated noisesuppression. It is identical tothat on the reference device,DigitalDiagnost C90(K202564) | ||
| Less intuitive user interface andparameter names used in UNIQUEnot self-explanatory. | An intuitive way of modifying theavailable parameters is introducedon the Eleva user interface.It is identical to that on thereference device, DigitalDiagnostC90 (K202564). | ||
| Deviation and Target ExposureIndices not available | Deviation Index (DI) is availablewhich quantifies the deviation ofthe Exposure Index (EI_s) from theTarget Exposure Index (EI_T). Thisfeature is used by the clinical userto identify whether a certain imagehas been correctly exposed.It is identical to that on thereference device, DigitalDiagnostC90 (K202564). | ||
| Optional SkyFlow function (grid-like image contrast forexaminations) is activated only forchest AP/PA imaging. | Optional Skyflow is extended toimaging of other anatomies withSkyplate detector.It is identical to that on thereference device, DigitalDiagnostC90 (K202564) | ||
| Access to and Export of OriginalImage Data not available | Access to and Export of OriginalImage Data is available. Thisfeature enables the access anexport of original image data (cleanraw images without anymodification) on the system. | ||
| One Button Stores All (OBSA)Content and performanceImprovement intended to savemultiple active information /changes made by the user by clickof a single button | It is identical to that on thereference device, DigitalDiagnostC90 (K202564)OBSA additionally used by systemfor sending logfile (Alert files) tocentral data base (RSN, e.g.,RADAR or M2M server) frequentlyby single button click. | ||
| View Selection for Changed X-Ray Generation Data Sets areenabled for change a data set onlyfor current examination or theexaminations that are using thisdata set. | These data sets can be additionallyapplied to subset of allexaminations too that are using thisdata set. This feature is mainly usedby the Philips clinical educationSpecialist.It is identical to that on thereference device, DigitalDiagnostC90 (K202564). | ||
| Avoid Ghosting in VerificationImages of Portable Detectorsfeature not available | The feature for avoiding Ghostingin Verification Images of PortableDetectors is available. It enables thesystem to display verificationimages on wireless (SkyPlate)detector without ghosting artifacts.It is identical to that on thereference device, DigitalDiagnostC90 (K202564). | ||
| Software | Windows 7 Operating System | Windows 10 operating system.The upgrade to Window 10 is a partof routine software upgrade doneby Microsoft.It is identical to that on thereference device, CombiDiagnostR90 (K203087) | |
| Philips Dynamic Eleva ImageChain | Identical | ||
| Image acquisition - ElevaWorkspot (Increment 39) | Eleva Workspot (Increment 42)The Eleva software is upgraded toincorporate the new features.It is identical to that on thereference device, CombiDiagnostR90 (K203087) | ||
| CeilingSuspension(optional) forRadiographyexaminationsonly) | Dimensions & ComponentsTube Head control• Foil buttons for tube headoperation• The monochrome text displayon the Tube Control Handle• The central break releaseswitch on the control handle for | Identical• The User interface on Eleva tubehead is touch control.• 12" color graphics display withtouch control functionality fortube head operation.• Control handle with flatcapacitive sensor for releasing | |
| ServiceFeatures | the ceiling suspensionmovement | brakes for the ceiling suspensionmovementIt is identical to that on thereference device, DigitalDiagnostC90 (K202564) | |
| Collimator• Ralco P 225 ACS DHHS• Motorized automatic collimation• Manual overrule possible• With light field indicator• Two lasers (external to thecollimator) | • Ralco P 225 ACS DHHS• Motorized automatic collimation• Manual overrule possible• With light field indicator• Live Camera (optional) on tubehead for patient positioning support• With 2 Lasers (inside thecollimator) | ||
| • Detector Calibration with a Filterintegrated into the Collimator | |||
| • Detector Calibration with a Filterexternal to the Collimator | |||
| Remote access for Firmwareupdates for the dynamic detector isavailable to perform firmwareupdates of the detector.It is identical to that on thereference device, CombiDiagnostR90 (K203087) | |||
| Remote access for Firmwareupdates for the dynamic detectornot available | |||
| Additional provision is made in theproposed device to allow servicepersonnel to extract logs of definedkey system parameters for offlineanalysis too.It is identical to that on thereference device, CombiDiagnostR90 (K203087) | |||
| Monitoring of system keyparameters is available | |||
| Additional provision is made in theproposed device for collection ofDICOM information by thePerformance Bridge Data collectorfor logs generation.It is identical to that on thereference device, CombiDiagnostR90 (K203087) | |||
| Performance Bridge is available | |||
| Provision is made for remotelyexporting the log files for offlineanalysis of the service engineersIt is identical to that on thereference device, CombiDiagnostR90 (K203087) | |||
| Remote Silent Logfile Export isnot available | |||
| Automatic upload of the log file isconfigured to the Philips Remoteservice Server.It is identical to that on thereference device, CombiDiagnostR90 (K203087) | |||
| Configurable Philips RemoteServer Upload not available | |||
| SAN pulse diagram is used for | SAN pulses introduced for | ||
| monitoring SAN pulses during an | monitoring with the dynamic | ||
| image acquisition with the staticdetectors. | detector in addition to the staticdetectorsIt is identical to that on thereference device, CombiDiagnostR90 (K203087) | ||
| Diagnostic for Detectors -Communication quality indicatoris not available | Diagnostic for Detectors featureenables the collection of diagnosticinformation from static(radiography) detectorcommunication logs for monitoringand logging purposeIt is identical to that on thereference device, DigitalDiagnostC90 (K202564). | ||
| Indication for Rough DetectorHandling on Eleva UI IncludingHistory is not available | Indication for Rough DetectorHandling feature providesinformation/ feedback to the user incase of rough handling of thewireless (SkyPlate detectors)handling on the Eleva user interfaceIt is identical to that on thereference device, DigitalDiagnostC90 (K202564). | ||
| No option for Alpha driveUpgradeability, Serviceability &Spare parts | Alpha drive Upgradeability,Serviceability & Spare parts featureprovides the option of alphamovement on the system and therelevant serviceability and spareparts introductionIt is identical to that on thereference device, DigitalDiagnostC90 (K202564). | ||
| The outcome of this technological characteristics comparison and risk assessmentdemonstrate that the minor differences in the technological characteristics do not affectthe safety or effectiveness of the proposed ProxiDiagnost N90, when compared to thelegally marketed predicate device (K173433). This thus demonstrates the substantialequivalence of the proposed device with the predicate device (K173433). | |||
| Summary ofNon-Clinicaland ClinicalPerformanceData: | This 510(K) premarket notification includes non-clinical performance testing.Tests were performed on the proposed ProxiDiagnost N90 according to the followingFDA recognized standards and guidance documents:• ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, Medical electricalequipment - Part 1: General requirements for basic safety and essentialperformance (Recognition #19-4)• IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance - CollateralStandard: Electromagnetic disturbances - Requirements and tests (Recognition#19-8)• IEC 60601-1-3 Edition 2.1 2013-04, Medical electrical equipment - Part 1-3:General requirements for basic safety and essential performance - CollateralStandard: Radiation protection in diagnostic X-ray equipment (Recognition # 12-260) |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
| • | IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment - Part 1-6:General Requirements For Basic Safety And Essential Performance - CollateralStandard: Usability (Recognition # 5-89) |
|---|---|
| • | IEC 60601-2-54 Edition 1.1 2015-04, Medical electrical equipment - Part 2-54:Particular requirements for the basic safety and essential performance of X-rayequipment for radiography and radioscopy (Recognition # 12-296) |
| • | IEC 62304 Edition 1.1 2015-06, Medical device software - Software life cycleprocesses (Recognition # 13-79) |
| • | ANSI AAMI ISO 14971: 2007/(R)2010, Medical devices-Application of riskmanagement to medical devices (Recognition # 5-40) |
| • | ISO 10993-1, Fifth edition 2018-08, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process (Recognition # 2-258) |
| • | Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices,issued September 1, 2016 |
| • | Guidance for the Content of Premarket Submissions for Software Contained inMedical Devices, issued May 11, 2005 |
| • | Guidance for Pediatric Information for X-ray Imaging Device PremarketNotifications, issued November 2017 |
| • | Guidance for Radio Frequency Wireless Technology in Medical Devices, issuedAugust 14, 2013 |
| • | Guidance for Management of Cybersecurity in Medical Devices, issued October2, 2014 |
{12}------------------------------------------------
| 2e. Intuitive User Interfacefor Processing Parameters | Sub-system Verification (Eleva software) | ||
|---|---|---|---|
| 2f. Deviation and TargetExposure Indices | Sub-system Verification (Elevasoftware)System Verification | ||
| 2g. Update of optionalSkyflow feature | Sub-system Verification (Elevasoftware)System Verification | ||
| 2h. Access to and Export ofOriginal Image Data | System Verification | ||
| 2i. Improved OBSA (onebutton store all) for Contentand performanceImprovement | Sub-system Verification (Elevasoftware)System Verification | ||
| 2j. View Selection forChanged X-Ray GenerationData Sets | Sub-system Verification (Elevasoftware) | ||
| 2k. Avoid Ghosting inVerification Images ofPortable Detectors | System Verification | ||
| 3a. Operating system upgradeto state of art operatingsystem i.e. MicrosoftWindows 10 | Sub-system Verification (Elevasoftware)System Verification | Test protocol identical to referencedevice, CombiDiagnost R90(K203087) | |
| 3b. Upgrade of ElevaApplication software toincrement 42 to accommodatesoftware changes for all therelevant changes (Change #1,2, 4, 5) | All the relevant Softwarefunctions are tested at systemand subsystem level. (Refertesting for change # 1, 2, 4 and5) | ||
| 4a. Tube head control | System Verification | Test protocol identical to referencedevice, DigitalDiagnost C90(K202564) | |
| 4b. Collimator | System Verification | Test protocol identical to referencedevice, DigitalDiagnost C90(K202564) | |
| 5a. Monitoring andFirmware Updates for FieldService | System Verification | Test protocol identical to referencedevice, CombiDiagnost R90(K203087) | |
| 5b. Remote access for thefield service Engineer | Sub-system Verification (Elevasoftware) | ||
| 5c. Service Diagnostic | System Verification | Test protocol identical to referencedevice, CombiDiagnost R90(K203087) & DigitalDiagnost C90(K202564) | |
| 5d. Hardware upgrades | System Verification | Test protocol identical to referencedevice, DigitalDiagnost C90(K202564) | |
| 6. Option for upgradebility ofPredicate device | All the relevant Software functions are tested at system andsubsystem level. (Refer testing for change # 1, 2, 3 and 5 a,b,c) | ||
| There is no clinical data submitted in this 510(k) premarket notification. | |||
| SubstantialEquivalenceConclusion: | The comparison of intended use, design features, technological characteristics, non-clinical performance data, and safety testing demonstrates the proposed ProxiDiagnostN90 is substantially equivalent to the predicate device (K173433), demonstrating theproposed device to be safe and effective. |
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.