(25 days)
The DigitalDiagnost is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
The proposed DigitalDiagnost is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The system is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE. Together with the tube these components form the radiography Image Chain. The additional option of the portable wireless detector i.e. the SkyPlates family can be used for free exposures as well as in the patient support table or in the vertical stand.
The proposed DigitalDiagnost is a modification of the predicate device, DigitalDiagnost C90 (K202564). The modifications include change of colour of the table, stand and ceiling suspension; changes in ceiling suspension, service features and a software update. The changes related to the software updates and service features have been recently cleared in the reference device, CombiDiagnost R90 (K203087).
The provided text describes a 510(k) summary for the Philips Medical Systems DMC GmbH DigitalDiagnost, demonstrating its substantial equivalence to a predicate device. The information details the device, its intended use, and the non-clinical tests performed. It explicitly states that no clinical data was submitted for this 510(k) premarket notification.
Therefore, many of the requested details regarding acceptance criteria for device performance, expert ground truth, MRMC studies, or training/test set specifics cannot be directly extracted from the provided document as they pertain to clinical studies or AI/algorithm performance evaluations, which were not part of this submission. The provided text focuses on demonstrating the substantial equivalence of modifications (e.g., color changes, mechanical button changes, software updates for service features) to an existing cleared device through non-clinical testing.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly met by "Pass" results for the listed non-clinical tests. The reported device performance is that it complies with the requirements for each test.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| System Verification Testing | The system conforms to the system requirements. For service features (Monitoring of key system parameters, Remote Silent Logfile Export, Configurable Philips Remote Server Upload, Additional DICOM Information to Support Performance Bridge, and Migrate Eleva software logging platform from HSDP PF1.0 to HSDP PF2.0 APIs), the protocols are identical to the previously cleared reference device (CombiDiagnost R90 (K203087)), except for the newly introduced 'Monitoring of key system parameters'. | Pass. System verification test activities substantiate that the system conforms to the system requirements. |
| Software Verification Testing | The software conforms to the requirements. (Specific to service features where protocols are identical to the reference device, CombiDiagnost R90 (K203087), except for 'Monitoring of key system parameters'). | Pass. Software verification test activities substantiate that the software conforms to the requirements. |
| Risk Control Measure Verification Testing | The system meets the defined risk control measures. (Identical to Predicate device, DigitalDiagnost C90 (K202564)). | Pass. System meets the defined risk control measures. |
| Image Quality Testing | The tested equipment complies with the applicable Imaging Performance requirements. (Identical to Predicate device, DigitalDiagnost C90 (K202564)). | Pass. Results demonstrate that the tested equipment complies with the applicable Imaging Performance requirements. |
| Usability Engineering | The test complies with the usability requirements. (Identical to Predicate device, DigitalDiagnost C90 (K202564) and in compliance with IEC 60601-1-6 Edition 3.1 2013-10). | Pass. Results demonstrate that the test complies with the usability requirements. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data, as it explicitly states that no clinical data was submitted. The tests conducted were non-clinical verification and validation tests, implying laboratory or engineering testing rather than a clinical study with patient samples. Therefore, information on sample size for a test set (meaning patient data) and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical ground truth was established for a test set in this non-clinical submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was used.
5. 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 reported, as no clinical data or AI assistance feature is mentioned in the context of this 510(k) for the DigitalDiagnost. The changes are related to physical components and underlying software infrastructure, not an AI-based interpretation aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as there is no mention of a standalone algorithm for diagnostic performance. The device is an X-ray system, and the software updates are described as related to service features (logging, remote export, etc.) and not image interpretation algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards against which the device was tested (e.g., system requirements, risk control measures, imaging performance requirements, usability requirements). These are established technical benchmarks, not clinical ground truth derived from expert consensus or pathology.
8. The sample size for the training set
Not applicable, as there is no mention of a training set, which is typically associated with machine learning or AI models. The software updates are for system functionality and service.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model.
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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Medical Systems DMC GmbH % Supriya Dalvi Regulatory Affairs Specialist Roentgenstrasse 24-26 Hamburg, Hamburg 22335 GERMANY
Re: K210692
Trade/Device Name: DigitalDiagnost Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB, LLZ Dated: March 3, 2021 Received: March 8, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
April 2, 2021
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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,
For
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
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Indications for Use
510(k) Number (if known) K210692
Device Name DigitalDiagnost
Indications for Use (Describe)
The DigitalDiagnost is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and 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) |
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510(k) Summary of Safety and Effectiveness
| PreparationDate: | March 3rd 2021 | ||
|---|---|---|---|
| 510(k)Owner: | Philips Medical Systems DMC GmbH | ||
| Roentgenstrasse 24 | |||
| 22335 Hamburg | |||
| GERMANY | |||
| Establishment registration number: 3003768251 | |||
| Contact: | Dr. Supriya A. Dalvi | ||
| Regulatory Operations Specialist | |||
| Phone: +91 9825604544 / +91 8733918445 | |||
| Fax: +49 40 5078-2425 | |||
| E-mail: supriya.dalvi@philips.com | |||
| ProposedDevice | Device Name | DigitalDiagnost | |
| Legal Manufacturer | Philips Medical Systems DMC GmbH | ||
| Classification Name: | Stationary x-ray system | ||
| Classification Regulation: | 21 CFR 892.1680 | ||
| Classification Panel: | 90 - Radiology | ||
| Device Class: | Class II | ||
| Primary Product Code: | KPR | ||
| Secondary Product Codes: | MQB, LLZ | ||
| PredicateDevice | Device Name | DigitalDiagnost C90 (K202564, cleared September30th, 2020) | |
| Legal Manufacturer | Philips Medical Systems DMC GmbH | ||
| Classification Name: | Stationary X-Ray System | ||
| Classification Regulation: | 21 CFR Part 892.1680 | ||
| Classification Panel: | 90 - Radiology | ||
| Device Class: | Class II | ||
| Primary Product Code: | KPR | ||
| Secondary Product Codes: | MQB, LLZ | ||
| ReferenceDevice | Device Name | CombiDiagnost R90 (K203087, cleared 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 |
This 510(k) summary of safety and effectiveness is prepared in accordance with 21 CFR §807.92.
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| Classification Panel: | 90 - Radiology | ||
|---|---|---|---|
| Device Class: | Class II | ||
| Primary Product Code: | JAA | ||
| Secondary Product Codes: | KPR, MQB | ||
| Device Description: | The proposed DigitalDiagnost is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The system is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE. Together with the tube these components form the radiography Image Chain. The additional option of the portable wireless detector i.e. the SkyPlates family can be used for free exposures as well as in the patient support table or in the vertical stand.The proposed DigitalDiagnost is a modification of the predicate device, DigitalDiagnost C90 (K202564). The modifications include change of colour of the table, stand and ceiling suspension; changes in ceiling suspension, service features and a software update. The changes related to the software updates and service features have been recently cleared in the reference device, CombiDiagnost R90 (K203087). | ||
| Indications for Use: | The DigitalDiagnost is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography. | ||
| Fundamental Scientific Technology: | The proposed DigitalDiagnost employs the same basic construction, fundamental scientific technology and workflow as the predicate device, DigitalDiagnost C90 (K202564) with regards to the functionality of all its components. It has the same high voltage generator, X-ray tube, Collimator, detectors, workstation (ELEVA) for images post-processing, storage and viewing.The solid state imaging including the detector for proposed device are same as predicate device (K202564) having the same physical, functional and operational characteristics. Also, other image chain components like X-ray tube and generator, which are used for exposure characteristics and clinical performance evaluation remains same. Hence all the features and characteristics potentially influencing image quality are same as predicate device, in accordance to FDA guidance document 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, dated September 1, 2016'.The changes with respect to the predicate device are mainly to accommodate users with a focused need for core functionality, some of the optional features of the predicate device have been replaced or modified to result in the proposed DigitalDiagnost. These changes do not affect the clinical or functional outcome of the device. The modifications have been evaluated per the ISO 14971 risk assessment. Design control and risk management activities show that all risks are sufficiently mitigated and that the overall residual risks are acceptable. Refer Table 1 below for comparison of the technological characteristics of the proposed device and predicate device, DigitalDiagnost C90 | ||
| Predicate device,DigitalDiagnost C90(K202564) | Proposed device,DigitalDiagnost | ||
| LegalManufacturer | Philips Medical Systems DMC GmbH | Identical | |
| Classification | Class II per 21 CFR 892.1680,Product codes KPR, MQB LLZ | Identical | |
| RegulationName | Stationary X-ray system | Identical | |
| Class | II | Identical | |
| Review Panel | Radiology | Identical | |
| Indicationsfor Use | The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography. | Identical except updated trade name | |
| Principle ofOperation | DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. It is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography. The system consists of several components that can be combined to create a variety of different Xray configurations. | Identical | |
| Components | Height adjustable table (TH2) | Identical except color of table(Change #1) | |
| Single side suspended table (TH-S) | Identical except color of table(Change #1) | ||
| Vertical moveable stand (VM) | Identical except color of VM(Change #1) | ||
| Fixed Vertical Stand (VS) | Identical except color of fixedvertical stand (Change #1) | ||
| Other components like Fixed RAD Detector, Wireless Static Detector, Generator, Tube | Identical | ||
| Digital wireless flat detectorCelling Suspension CSM | IdenticalIdentical except change in color ofCSM (Change #1) | ||
| Collimator | Ralco P 225 ACS DHHS• Motorized automatic | Identical except- no live camera (Change #2) | |
| With light field indicator Live Tube Head Camera for patient positioning support With 2 Lasers (inside the collimator) | |||
| Tube HeadControl | Touch control functionality for tubehead operationThe User interface on Eleva tubehead is touch control. Eleva screendisplay in the examination roomenables the user to use all thecontrol room parameters fromexamination room as well | Mechanical buttons for tube headoperation (Change #3)The User interface on tube headhas mechanical buttons. Only fewfunctions can be used on tube headscreen in the examination roomwith help of these mechanicalbuttons. However, all thefunctionalities can still becontrolled from AWS (Acquisitionworkstation) in the control room | |
| Tube Head -controlhandle | Control handle with flat capacitivesmart-sensor for releasing brakes forthe CSM movement | Control handle with a mechanicalbutton for releasing brakes for theCSM movement (Change #3) | |
| Detectorcalibrationfilter | Integrated in collimator (0.5 mm Cu+ 2 mm Al filter) | External to the collimator (21mmAl filter (Change #4)21mm Al filter used in theproposed device is equivalent tothe 0.5 mm Cu + 2 mm Al filterused in the predicate device. | |
| ServiceFeatures | Monitoring of system parameters isas a part of overall service log | Monitoring of system parametersis a part of overall service log,additionally in the proposeddevice, a provision is made toallow service personnel to extractlogs of defined key systemparameters for offline analysis.(Change #5) | |
| Remote Silent Logfile Export is notpresent | Remote Silent Logfile Export ispresent.Service feature to remotely exportthe log file of a system; Identicalto the feature used in the referencedevice (K203087).(Change #5) | ||
| Configurable Philips Remote ServerUpload is not present | Configurable Philips RemoteServer Upload is present.Service feature where automaticupload of the log file to the PhilipsRemote Server shall beconfigurable via the Service Tool.Identical to the feature used in thereference device (K203087)(Change #5) | ||
| Additional DICOM Information toSupport Performance Bridge is notpresent | Additional DICOM Information toSupport Performance Bridge ispresent. | ||
| Software | Eleva Logging HSDP PF1.0 | Service feature where DICOM data will be used by the PerformanceBridge Data collector tool, which is a customer dashboard for system performance monitoring.Identical to the feature used in the reference device (K203087) (Change #5)Eleva Logging HSDP PF2.0.Service feature involving update of software logging infrastructure.Identical to the feature used in the reference device (K203087) (Change #5) | |
| Software | Eleva Software, Version 41 | Eleva Software, Version 42 (Change #6)Identical to the software used for radiography in the reference device (K203087). | |
| Imageprocessing | Windows 10 Operating systemEleva workstation | IdenticalIdentical | |
| Summary ofNon-Clinicaland ClinicalPerformanceData: | The outcome of this technological characteristics comparison and risk assessment demonstrate that the minor differences in the technological characteristics do not affect the safety or effectiveness of the proposed DigitalDiagnost, when compared to the legally marketed predicate device (K202564).This 510(K) premarket notification includes non-clinical verification and validation tests. Tests were performed on the proposed DigitalDiagnost according to the following FDA recognized standards and guidance documents:ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (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 - Collateral Standard: 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 - Collateral Standard: Radiation protection in diagnostic X-ray equipment (Recognition # 12-269) IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: 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-ray equipment for radiography and radioscopy (Recognition # 12-296) IEC 62304 Edition 1.1 2015-06, Medical device software - Software life cycle processes (Recognition # 13-79) |
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| Tests | Protocol | Test results |
|---|---|---|
| SystemVerificationtesting | Identical to predicate device, DigitalDiagnostC90 (K202564) except for the service featuresin Change # 5 (Monitoring of key systemparameters, Remote Silent Logfile Export,Configurable Philips Remote Server Upload,Additional DICOM Information to SupportPerformance Bridge and Migrate Elevasoftware logging platform from HSDP PF1.0to HSDP PF2.0 APIs). | PassSystem verification testactivities substantiate thatthe system conforms to thesystem requirements |
| Softwareverificationtesting | The protocols for these service features areidentical to the previously cleared referencedevice, CombiDiagnost R90 (K203087)except for the service feature 'Monitoring ofkey system parameters'. The feature'Monitoring of key system parameters' isnewly introduced in the proposed device. | PassSoftware verification testactivities substantiate thatthe software conforms to therequirements |
| Risk controlmeasureverificationtesting | Identical to Predicate device, DigitalDiagnostC90 (K202564) | Pass.System meets the definedrisk control measures |
| Image qualitytesting | Identical to Predicate device, DigitalDiagnostC90 (K202564) | Pass.Results demonstrate that thetested equipment complieswith the applicable ImagingPerformance requirements |
| UsabilityEngineering | Identical to Predicate device, DigitalDiagnostC90 (K202564) and in compliance to the FDAconsensus standards, IEC 60601-1-6 Edition3.1 2013-10 (Recognition number 5-89) | Pass.Results demonstrate that thetest complies with theusability requirements |
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| 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 DigitalDiagnostis substantially equivalent to the manufacturer's legally marketed predicate device(K202564), demonstrating the subject device to be safe and effective. |
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.