(23 days)
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
The DuraDiagnost is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients.
The DuraDiagnost consist of the following components: Tube column with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review.
The provided text describes a 510(k) premarket notification for the Philips DuraDiagnost, an X-ray system. The submission focuses on demonstrating substantial equivalence to a predicate device (DuraDiagnost K141381), rather than proving the performance of a novel AI algorithm. Therefore, many of the requested details, such as acceptance criteria for AI performance metrics, sample sizes for test sets, expert adjudication methods for AI ground truth, MRMC studies, standalone AI performance, and AI training set details, are not applicable to this submission.
The document primarily evaluates the DuraDiagnost against safety and effectiveness standards applicable to X-ray systems and its equivalence to a previous version of the device.
Here's the information that can be extracted, and an explanation of why other requested information is not present:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria for image quality or clinical performance metrics in a readily extractable table format for human or AI performance. Instead, it states that the device meets acceptance criteria by:
- Complying with international and FDA-recognized consensus standards.
- Demonstrating substantial equivalence to its predicate device in terms of design, technology, indications for use, safety, and effectiveness.
The "performance" is reported as compliance with the following standards and internal tests:
| Acceptance Criteria (Demonstrated via) | Reported Device Performance |
|---|---|
| Compliance with Consensus Standards | - AAMI / ANSI ES60601-1: 2005/(R)2012 and . C1:2009/(R)2012 and, A2:2010/(R)2012 (consolidated text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance. (Edition 3.1). |
| - IEC 60601-1-2 (Edition 4.0 2014): Electromagnetic Disturbances | |
| - IEC 60601-1-3 (Edition 2.1 2013): Radiation Protection in Diagnostic X-Ray Equipment | |
| - IEC 60601-2-28 (Edition 2.0 2010-03): X-ray tube assemblies for medical diagnosis | |
| - IEC 60601-2-54 (Edition 1.1 2015): X-Ray Equipment for Radiography and Radioscopy | |
| - IEC 60601-1-6 (Edition 3.1 2013): Usability | |
| - IEC 62304 (Edition 1.1 2015): Medical device software (Software life cycle processes) | |
| - IEC 62366-1 (Edition 1.0 2015): Application of usability engineering to medical devices | |
| - ISO 14971 (Edition 2.0, corrected version, 2007): Application of risk management to medical devices | |
| - CFR 1020.30: Diagnostic x-ray systems and their major components | |
| - CFR 1020.31: Radiographic equipment | |
| - FDA Guidance: "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - September 1, 2016" | |
| - FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - May 11, 2005." | |
| - FDA Guidance: "Guidance for Industry and FDA Staff - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued October 2, 2014 | |
| - FDA Guidance: "Pediatric Information for X-ray Imaging Device Premarket Notifications," issued November 28, 2017 | |
| Verification/Validation Tests (Non-clinical) | - Tests performed with regards to intended use, technical claims, requirement specifications, and risk management results. |
| Substantial Equivalence to Predicate Device (K141381) | - The DuraDiagnost, including its wireless portable detector (SkyPlate E) and fixed RAD detector (Pixium 4343RCE), and the UNIQUE 2 Post Processing software, are found to be substantially equivalent to components and functionalities of legally marketed predicate devices and reference devices. Minor differences in technical characteristics (e.g., image area, image matrix, pixel size, operating system) are stated not to affect safety or effectiveness. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it is a 510(k) submission based on comparison to a predicate device and compliance with general safety and performance standards for X-ray systems, not specific clinical performance studies with AI. The non-clinical verification/validation tests performed would typically use test phantoms or specific equipment testing, not a "test set" of patient data in the way an AI algorithm would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the submission is not for an AI algorithm requiring clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable.
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
This is not applicable. The device is an X-ray system, not an AI-powered diagnostic aide. The document explicitly states: "The DuraDiagnost does not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated..." (Page 15).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device includes image processing software (UNIQUE 2 and SkyFlow), listed as comparable or updated versions of software present in predicate/reference devices, but it is not presented as a standalone AI diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of an AI study. The "ground truth" for this submission refers to the established safety standards and the performance characteristics of the predicate device, against which the new device (DuraDiagnost) is compared. Compliance with engineering standards and performance specifications (e.g., tube voltage, focal spot size, image matrix, pixel size) serves as the "ground truth" for the device's equivalent performance to what is already on the market.
8. The sample size for the training set
This is not applicable. The document does not describe the development or training of a new AI algorithm.
9. How the ground truth for the training set was established
This is not applicable.
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Image /page/0/Picture/0 description: The image shows 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 Healthcare (Suzhou) Co., Ltd. % Ms. Mary Zhu Senior Regulatory Engineer No. 258, Zhong Yuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 REPUBLIC OF CHINA
July 9, 2020
Re: K201640
Trade/Device Name: DuraDiagnost Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: June 1, 2020 Received: June 16, 2020
Dear Ms. Zhu:
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
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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) K201640
Device Name DuraDiagnost
Indications for Use (Describe)
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
| 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) number: K201640
510(k) Summary
SPECIAL 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:Manufacturer: | June 01, 2020Philips Healthcare (Suzhou) Co., Ltd.No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINAEstablishment Registration Number: 30095296302nd manufacturing site:Philips Medical Systems Nederland B.V.Veenpluis 6, 5684PC Best, The NetherlandsEstablishment Registration Number: 3003768277 | |
|---|---|---|
| Contact Person: | Mary ZhuSenior Regulatory EngineerPhone: +86-021-24128746(cell: +86-183-5113-2881)Fax: +86-512-68018677E-mail: Mary.ZHU@philips.com | |
| Device Name:Classification: | DuraDiagnostClassification Name: Stationary X-Ray SystemClassification Regulation: 21CFR §892.1680Classification Panel: RadiologyDevice Class: Class IIPrimary product code: KPR (System, X-Ray, Stationary)Secondary code: MQB(21 CFR 892.1680) | |
| Predicate Device: | Trade Name: DuraDiagnostManufacturer: Philips Healthcare (Suzhou) Co., Ltd.510(k) Clearance: K141381-June 12, 2014Classification Regulation: 21 CFR, Part 892.1680Classification Name: Stationary X-Ray SystemClassification Panel: RadiologyDevice Class: Class IIProduct Code: KPR, MQB | |
| Reference Device 1: | Trade Name: MobileDiagnost WDR 2.2Manufacturer: SEDECAL SA | |
| 510(k) Clearance: | K191813- August 2, 2019 | |
| Classification Regulation: | 21CFR 892.1720 | |
| Classification Name: | Mobile x-ray system | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code | IZL, MQB | |
| Reference Device 2: | Trade Name: | Philips Eleva Workspot withSkyFlow |
| Manufacturer: | Philips Medical SystemsDMC GmbH | |
| 510(k) Clearance: | K153318- December 22, 2015 | |
| Classification Regulation: | 21 CFR 892.1680 | |
| Classification Name: | Stationary X-Ray System | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code | MQB, LLZ | |
| Reference Device 3: | Trade Name: | DigitalDiagnost C90 |
| Manufacturer: | Philips Medical SystemsDMC GmbH | |
| 510(k) Clearance: | K182973- January 11, 2019 | |
| Classification Regulation: | 21CFR 892.1680 | |
| Classification Name: | Stationary X-Ray System | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code | MQB, KPR, LLZ | |
| Device description: | The DuraDiagnost is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients.The DuraDiagnost consist of the following components: Tube column with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review. | |
| Indications for use: | The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the |
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patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
The fundamental scientific technology utilized in the Fundamental scientific technology: DuraDiagnost and the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014) is equivalent with regards to the functionality of the following components: Integrated tube column, patient table with a floating table top, high-voltage generator, dual-focus rotation anode X-Ray tube, manual beam limiting device, digital detector, wall stand and workstation for images post-processing, storage and viewing (See Table 1 comparing the DuraDiagnost to the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014) provided below).
The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the DuraDiagnost when compared to the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014).
The wireless portable detector of the DuraDiagnost is identical to the wireless portable detector (SkyPlate E) of the currently marketed and reference device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019) manufactured by SEDECAL SA. Therefore, both the wireless portable detector (Skyplate E) of the DuraDiagnost and the currently marketed and reference device 1, MobileDiagnost WDR 2.2 employ identical fundamental scientific technology.
The DuraDiagnost and the currently marketed and Reference Device 3, DigitalDiagnost C90 (K182973- January 11, 2019) manufactured by Philips Medical Systems DMC GmbH are provided with identical; fixed RAD detector (Pixium 4343RCE), UNIQUE 2 Post Processing software and embedded Windows 10 operating system. Therefore, DuraDiagnost and the currently marketed and reference
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device 3, DigitalDiagnost C90 employ identical fundamental scientific technology.
| Table 1 | |||
|---|---|---|---|
| Comparison of Technological Characteristics of Currently marketed and Predicate DuraDiagnost versus the DuraDiagnost | |||
| Feature | Predicate Device:DuraDiagnost(K141381) | Device:DuraDiagnost | Comment |
| Basic information | |||
| Product Code | KPR & MQB | Identical | No difference; thus,demonstrating SE. |
| Regulation No. | 21 CFR 892.1680 | Identical | No difference; thus,demonstrating SE. |
| Device Class | II | Identical | No difference; thus,demonstrating SE. |
| ElectricalRequirement | Input voltage: 3- phase,200/208/240/380/400/415/440/480/500Vac;Frequency:50/60Hz;Current:Short term: 112A (withgenerator M-CABINETCXA Pro 50kW), 134A(with generator M-CABINET CXA Pro65kW), 160A (withgenerator M-CABINETCXA Pro80kW);Long term: 10A. | Input voltage: 3- phase,200/208/240/380/400/415/440/480/500Vac;Frequency:50/60Hz;Current:Short term: 112A (withgenerator M-CABINETCXA Pro 50kW), 134A(with generator M-CABINET CXA Pro65kW),Long term: 10A. | Equivalent. TheDuraDiagnost and thecurrently marketed andpredicate DuraDiagnost areboth provided with similarelectrical requirements.Therefore, no impact on thesafety or effectiveness of thedevice. Thus, demonstratingSE. |
| Design characteristic | |||
| X-ray Tube | RO 1750 ROT 360 &SRO 33100 ROT 360 | Identical | No difference; thus,demonstrating SE. |
| Max TubeVoltage | 150kV | Identical | No difference; thus,demonstrating SE. |
| Focal Spot Size | 0.6mm/1.2mm | Identical | No difference; thus,demonstrating SE. |
| Tube Max power | 50KW/100KW(250W equivalent anodeinput power) | Identical | No difference; thus,demonstrating SE. |
| Anode Type | Rotation | Identical | No difference; thus,demonstrating SE. |
| Generator | Philips Healthcare(Suzhou),M-CABINET CXA Pro50kW,M-CABINET CXA Pro65kW,M-CABINET CXA Pro80kW | Philips Healthcare(Suzhou),M-CABINET CXA Pro50kW,M-CABINET CXA Pro65kW, | Equivalent. DuraDiagnostand the currently marketedand predicate DuraDiagnostare both provided with50KW/65KWgenerators. Thus,demonstrating SE. |
| Max Power | 50KW/65KW/80KW | 50KW/65KW | |
| KV range | 40-150 | Identical | No difference; thus,demonstrating SE. |
| Milli ampere sec(mAs) product | 0.4 mAs-600 mAs (withAEC control) | Identical | No difference; thus,demonstrating SE. |
| Collimator | |||
| Operation Mode | Manual collimation | Identical | No difference; thus,demonstrating SE. |
| Shape of Beam | Rectangular | Identical | No difference: thus,demonstrating SE. |
| Detector | |||
| Type | Digital Detector• Fixed RAD Detector• Wireless StaticDetector | Identical | No difference; thus,Demonstrating SE. |
| Fixed RADDetector | Pixium 4343RG | Pixium 4343RCE(Note: this detector isidentical to fixed RADdetector of the currentlymarketed and ReferenceDevice 3, DigitalDiagnostC90 cleared underK182973). | The difference between4343RCE and 4343RG isscintillator material and otherminor differences of imagearea and image matrix ascompared in this table. Thedifferences don't affect thesafety or effectiveness.And the fixed RAD detectorPixium 4343RCE of theDuraDiagnost is identical tothe fixed RAD detector of thecurrently marketed andReference Device 3,DigitalDiagnostC90(K182973- January 11,2019, Philips MedicalSystems DMC).Thus, demonstrating SE |
| Wireless StaticDetector | • SkyPlate Large(Trixell 3543EZ) | • SkyPlate Large (Trixell3543EZ) | The SkyPlate Large Detectorof the DuraDiagnost isidentical to the SkyPlate |
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| ● | SkyPlate E (Trixell3543DR) (Note: thisdetector is identical tothe Skyplate EDetector of thecurrently marketed andreference device 1,MobileDiagnost WDR2.2 cleared underK191813). | Large Detector of thecurrently marketed andPredicate DuraDiagnost(K141381,SkyPlate E is additionallyadded dectector. There areminor differences betweenSkyPlate E and the SkyplateLarge detector of image area,image matrix and pixel size ascompared in this table. Theminor differences don't affectthe safety or effectiveness.And the Skyplate E Detectorof DuraDiagnost is identicalto the Skyplate E Detector ofthe currently marketed andreference device 1,MobileDiagnost WDR 2.2(K191813- August 2, 2019).Thus, demonstrating SE | |||
|---|---|---|---|---|---|
| X-ray ScintillatorMaterial | ● | GdOS (Fixed: Pixium4343RG) | ● | Cesium Iodide (Fixed:Pixium 4343RCE.Pixium 4343RCE isidentical to fixed RADdetector of thecurrently marketed andReference Device 3,DigitalDiagnost C90cleared under K182973) | The fixed RAD detector ofthe DuraDiagnost andcurrently marketed andReference Device 3,DigitalDiagnostC90(K182973- January 11,2019, Philips MedicalSystems DMC) are bothfabricated from identicalCesium Iodide material , thusdemonstrating SE. |
| ● | Cesium Iodide(Wireless: SkyPlateLarge) | ● | Cesium Iodide(Wireless: SkyPlateLarge and SkyPlate E) | The Wireless detector of theDuraDiagnost and thecurrently marketed andpredicate DuraDiagnost areboth fabricated from identicalCesium Iodide material, thusdemonstrating SE. | |
| Image Area | ● | 42.5cm x 42.5cm(Fixed: Pixium4343RG) | ● | 42.03cm x42.54cm(Fixed:Pixium 4343RCE) | The image area of theDuraDiagnost, provided withfixed RAD detector is |
| 34.5cm x 42.1cm(Wireless: SkyPlateLarge) | 34.5cm x42.1cm(Wireless:SkyPlate Large) | identical to the image area ofthe Fixed RAD Detector ofthe currently marketed andReference Device 3,DigitalDiagnostC90(K182973- January 11,2019, Philips MedicalSystems DMC), thusdemonstrating substantialequivalence | |||
| 34.5cm x42.5cm(Wireless:SkyPlate E) | The image area of theproposed DuraDiagnost,provided with wirelessdetector SkyPlate Large isidentical to the wirelessdetector SkyPlate Large of thecurrently marketed andPredicate DuraDiagnost(K141381). Thus,demonstrating SE. | ||||
| The image area of theproposed Wireless DetectorSkyPlate E is identical to theWireless Detector SkyPlate Eof the currently marketed andreference device 1,MobileDiagnost WDR 2.2(K191813- August 2, 2019,Sedecal SA,). thusdemonstrating SE | |||||
| Image Matrix | 2,874 x 2,869 (Fixed:Pixium 4343RG) | 2,874 x 2840 (Fixed:Pixium 4343RCE) | The image matrix of theproposed DuraDiagnostPhilips Medical Systems | ||
| 2330 x 2846(Wireless-SkyPlateLarge) | 2330 x 2846 (Wireless-SkyPlate Large) | DMC, provided with fixedRAD detector is identical tothe image matrix of the |
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| ● | 2156 x 2653 (Wireless-SkyPlate E) | currently marketed andReference Device 3,DigitalDiagnostC90(K182973- January 11,2019,). thus demonstratingsubstantial equivalence. |
|---|---|---|
| The image matrix of theDuraDiagnostprovided with the wirelessSkyPlate Large Detector isidentical to the wirelessSkyPlate Large of thecurrently marketed predicateDevice DuraDiagnost,(K141381). Thusdemonstrating SE. | ||
| The image matrix of theDuraDiagnost provided withwireless detector SkyPlate Eis similar to the currentlymarketed and ReferenceDevice 1, MobileDiagnostWDR 2.2 (K191813- August2, 2019, Sedecal SA).Infinitesimal change in theimage size (X-ray field) doesnot impact clinical ImageQuality. Therefore, they areequivalent and there is noimpact on the safety andeffectiveness of the device;thus demonstrating SE. |
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| Pixel Size | • 148 μm (Fixed: Pixium 4343RG)• 148 μm(Wireless-SkyPlate Large) | • 148 μm (Fixed: Pixium 4343RCE)• 148 μm(Wireless-SkyPlate Large)• 160 μm (Wireless-SkyPlate E) | The pixel size of the proposed DuraDiagnost Philips Medical Systems DMC, provided with fixed RAD detector is identical to the pixel size of the currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019,). thus demonstrating substantial equivalence.The pixel size of the DuraDiagnost provided with the wireless SkyPlate Large Detector is identical to the wireless SkyPlate Large of the currently marketed predicate Device DuraDiagnost, (K141381). Thus demonstrating SE.The pixel size of the DuraDiagnost provided with wireless detector SkyPlate E is identical to the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019, Sedecal SA), thus demonstrating SE. |
|---|---|---|---|
| Analog / Digital (A/D) conversion | 16 bits | Identical | No difference; thus, demonstrating SE. |
| Table | |||
| Table type | Fixed and Height adjustment | Height adjustment | The DuraDiagnost is provided with height adjustment table that is also provided with the currently marketed and predicate |
| Height adjustment | 51.5 cm to 75.0 cm above floor, motorized adjustment | 51.5 cm to 91.5 cm above floor, motorized adjustment | DuraDiagnost. Thus demonstrating SE.The height adjustment of the proposed DuraDiagnost, provided with height adjustable table is identical to the currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019, Philips Medical Systems DMC). thus, demonstrating SE. |
| Tabletop longitudinal travel range | +/- 550mm | Identical | No difference; thus, demonstrating SE. |
| Tabletop Lateral travel | +/- 130mm | Identical | No difference; thus, demonstrating SE. |
| Loading (patient weight) | 210 Kg | Identical | No difference; thus, demonstrating SE. |
| Wall Stand | |||
| Vertical movement range | 1500mm | Identical | No difference; thus, demonstrating SE. |
| Movement mode | Manual | Identical | No difference; thus, demonstrating SE.. |
| Tube Stand | |||
| Type | Floor mounted | Identical | No difference; thus, demonstrating SE. |
| Tube rotation | +/- 120 degree | Identical | No difference; thus, demonstrating SE. |
| Longitudinal movement range | 1400mm | Identical | No difference; thus, demonstrating SE. |
| Source to Image Distance (SID) | |||
| SID | Table: 40-115cm;Wallstand: 110-245cm | Identical | No difference; thus, demonstrating SE. |
| External Connectivity | |||
| DICOM | DICOM compatible | Identical | No difference; thus, demonstrating SE. |
| Software Platform | |||
| Software | Eleva WorkSpot | Identical | No difference; thus, demonstrating SE. |
| SkyFlow Software | No | Yes | The DuraDiagnost includes the SkyFlow software that is also used in the currently marketed and Reference Device 3, Eleva Workspot with SkyFlow, (K153318- December 22, 2015, Philips Medical Systems DMC), thus, demonstrating SE. |
| Image Processing Algorithm | UNIQUE | UNIQUE 2 | UNIQUE 2 image processing algorithm provided with DuraDiagnost was |
| previously cleared with thecurrently marketed andReference Device 3,DigitalDiagnost C90(K182973- January 11, 2019,Philips Medical SystemsDMC).Upgrading to UNIQUE2image processing algorithmdoes not alter the clinicalworkflow, hence no impact onthe safety or effectiveness ofthe device; thus,demonstrating SE | |||
| Operating System | Windows 7 embedded | Windows 10 embeddedIntroduction of operatingsystem Windows 10embedded does not impactclinical image quality.Therefore, there is no impacton the safety andeffectiveness of the device;thus, demonstrating SE. |
DuraDiagnost Premarket Notification- Special 510(k)
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DuraDiagnost Premarket Notification- Special 510(k)
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Based on the information provided above, the DuraDiagnost is considered substantially equivalent to the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014) in terms of fundamental scientific technology.
Summary of Non-Clinical This 510(k) premarket notification contains the technical Performance data: documentation, which demonstrates that the DuraDiagnost is substantially equivalent to the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014). The technical documentation includes nonclinical verification / validation tests. These tests were performed on the DuraDiagnost according to the following international and FDA-recognized consensus standards:
- · International and FDA-recognized consensus standards:
- AAMI / ANSI ES60601-1: 2005/(R)2012 and . C1:2009/(R)2012 and, A2:2010/(R)2012 (consolidated text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance. (Edition 3.1). FDA/CDRH recognition number 19-4.
DuraDiagnost Premarket Notification- Special 510(k) Page 11 of 14
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- IEC 60601-1-2, Medical electrical equipment -● Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Disturbances - Requirements and tests (Edition 4.0 2014). FDA/CDRH recognition number 19-8.
- . IEC 60601-1-3, Medical Electrical Equipment Part 1-3: General Requirements for Basic Safety and Essential Performance-Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment. (Edition 2.1 2013). FDA/CDRH recognition number 12-269.
- IEC60601-2-28 Medical electrical equipment -● Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis, (Edition 2.0 2010-03). FDA/CDRH recognition number 12-204.
- IEC 60601-2-54, Medical Electrical Equipment-. Part 2-54: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy (Edition 1.1 2015). FDA/CDRH recognition number 12-296.
- IEC 60601-1-6, Medical Electrical Equipment ● Part 1-6: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Usability (Edition 3.1 2013). FDA/CDRH recognition number 5-89.
- IEC 62304 Medical device software Software ● life cycle processes (Edition 1.1 2015) FDA/CDRH recognition number 13-79
- IEC 62366-1 Medical devices Part 1: ● Application of usability engineering to medical devices (Edition 1.0 2015). FDA/CDRH recognition number 5-114.
- ISO 14971 Medical devices Application of risk ● management to medical devices (Edition 2.0, corrected version, 2007). FDA/CDRH recognition number 5-40.
- · CFR 1020.30 Diagnostic x-ray systems and their major components.
- · CFR 1020.31 Radiographic equipment.
- · Device specific guidance document, entitled "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - September 1, 2016"
DuraDiagnost Premarket Notification- Special 510(k) Page 12 of 14
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- · FDA's Guidance document entitled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - May 11, 2005."
- · FDA's Guidance document entitled, "Guidance for Industry and FDA Staff - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" ,issued October 2, 2014
- · Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 28, 2017
Non-clinical verification and validation tests have been performed with regards to the intended use, the technical claims, requirement specifications, and the risk management results.
Non-clinical verification and validation test results demonstrate that DuraDiagnost:
- Complies with the aforementioned international . and FDA-recognized consensus standards and FDA guidance documents.
- meets the acceptance criteria and is adequate for ● its intended use.
Therefore, DuraDiagnost is substantially equivalent to the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014) in terms of safety and effectiveness.
Summary of Clinical Data: The DuraDiagnost does not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes:
- . Indication for use;
- Fundamental scientific technology; ●
- Non-clinical performance testing; and
- Safety and effectiveness. .
Furthermore, the SkyPlate E detector and Pixium 4343RCE detector utilizes the same design, technology and Image acquisition workflow compared to the previously Skyplate Large detector and Pixium 4343RG
DuraDiagnost Premarket Notification- Special 510(k) Page 13 of 14
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the marketed and detector used in predicate DuraDiagnost (K141381, June 12, 2014). All technical detector characteristics that potentially have an influence on image quality are assessed and verified according to FDA Guidance for Industry and Food and Drug Administration Staff: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices; issued on September 1, 2016.
Substantial Equivalence The DuraDiagnost is substantially equivalent to the Conclusion: currently marketed and predicate DuraDiagnost (K141381, June 12, 2014) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, substantial equivalence was demonstrated non-clinical performance (verification with and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-1-6, IEC 60601-2-28, IEC 62304, and IEC 62366-1.
The results of these tests demonstrate that DuraDiagnost met the acceptance criteria and is adequate for its intended use.
§ 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.