(17 days)
The DigitalDiagnost C50 system 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 DigitalDiagnost C50 Digital Radiography System (DigitalDiagnost C50) is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients. The DigitalDiagnost C50 consist of the following components: ceiling suspension with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and an 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.
Here's a breakdown of the acceptance criteria and study information for the DigitalDiagnost C50, based on the provided text.
1. Table of Acceptance Criteria & Reported Device Performance:
| Feature | Acceptance Criteria (Predicate) | Reported Device Performance (DigitalDiagnost C50) | Comment on Equivalence |
|---|---|---|---|
| Basic information | |||
| Product Code | KPR | Identical (KPR) | No difference; thus, demonstrating SE. |
| Regulation No. | 21 CFR 892.1680 | Identical (21 CFR 892.1680) | No difference; thus, demonstrating SE. |
| Device Class | II | Identical (Class II) | No difference; thus, demonstrating SE. |
| Electrical Requirement | Input voltage: 3-phase, 200/208/240/380/400/415/440/480/500Vac; Frequency:50/60Hz; Current: Short term: 112A (with generator M-CABINET CXA 50kW), 134A (M-CABINET CXA 65kW); Long term: 10A. | Identical | No difference; thus, demonstrating SE. |
| Design characteristic | |||
| X-ray Tube | RO 1750 ROT 380 & SRO 33100 ROT 380 | Identical | No difference; thus, demonstrating SE. |
| Max Tube Voltage | 150 kV | 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 anode input power) | Identical | No difference; thus, demonstrating SE. |
| Anode Type | Rotation | Identical | No difference; thus, demonstrating SE. |
| Generator | Philips Healthcare (Suzhou), M-CABINET CXA Pro 50kW, M-CABINET CXA Pro 65kW | Identical | No difference; thus, demonstrating SE. |
| Max Power | 50KW/65KW | Identical | No difference; thus, demonstrating SE. |
| KV range | 40-150 | Identical | No difference; thus, demonstrating SE. |
| Milli ampere sec (mAs) product | 0.4 mAs-600 mAs (with AEC 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 Static Detector | Identical | No difference; thus, demonstrating SE. |
| Fixed RAD Detector | Pixium 4343RG | Pixium 4343RCE (identical to predicate DigitalDiagnost C90 K182973) | The difference between 4343RCE and 4343RG is scintillator material and other minor differences of image area and image matrix. The differences don't affect the safety or effectiveness. Thus, demonstrating SE. |
| Wireless Static Detector | Varian PaxScan4336W | SkyPlate E (Trixell 3543DR) (identical to reference MobileDiagnost WDR 2.2 K191813) | The Skyplate E Detector is identical to the Skyplate E Detector of the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019). Thus, demonstrating SE. |
| X-ray Scintillator Material (Fixed) | GdOS (Fixed: Pixium 4343RG) | Cesium Iodide (Fixed: Pixium 4343RCE) | The fixed RAD detector of the proposed DigitalDiagnost C50 and currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019, Philips Medical Systems DMC) are both fabricated from identical Cesium Iodide material, thus demonstrating SE. |
| X-ray Scintillator Material (Wireless) | GdOS (Wireless Varian PaxScan4336W) | Cesium Iodide (Wireless SkyPlate E) | The Wireless Detector of the proposed DigitalDiagnost C50 and the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019) are both fabricated from identical Cesium Iodide material, thus demonstrating SE. |
| Image Area (Fixed) | 42.5cm x 42.5cm (Fixed: Pixium 4343RG) | 42.03cm x 42.54cm (Fixed: Pixium 4343RCE) | The image area of the DigitalDiagnost C50, provided with fixed RAD detector is identical to the image area of the Fixed RAD Detector of the currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019, Philips Medical Systems DMC), thus demonstrating substantial equivalence. |
| Image Area (Wireless) | 42.7 cm x 34.4 cm (Wireless: Varian PaxScan4336W) | 34.5 cm x 42.5cm (Wireless: SkyPlate E) | The image area of the proposed Wireless Detector SkyPlate E is identical to the Wireless Detector SkyPlate E of the currently marketed and reference device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019, Sedecal SA). thus demonstrating SE. |
| Image Matrix (Fixed) | 2,874 x 2,869 (Fixed: Pixium 4343RG) | 2,874 x 2840 (Fixed: Pixium 4343RCE) | The image matrix of the proposed DigitalDiagnost C50, provided with fixed RAD detector is similar to the image matrix of the currently marketed and Reference Device 3, DigitalDiagnost C90. Thus demonstrating substantial equivalence. Infinitesimal change in the image size (X-ray field) does not impact clinical Image Quality. Therefore, they are equivalent and there is no impact on the safety and effectiveness of the device; thus, demonstrating SE. |
| Image Matrix (Wireless) | 3,072 x 2,476 (Wireless: Varian PaxScan4336W) | 2,156 x 2,653 (Wireless-SkyPlate E) | The image matrix of the proposed DigtialDiagnost C50 provided with wireless detector SkyPlate E is similar to the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2. Infinitesimal change in the image size (X-ray field) does not impact clinical Image Quality. Therefore, they are equivalent and there is no impact on the safety and effectiveness of the device; thus, demonstrating SE. |
| Pixel Size (Fixed) | 148 μm (Fixed: Pixium 4343RG) | 148 μm (Fixed: Pixium 4343RCE) | The pixel size of the proposed DigtialDiagnost C50 provided with fixed RAD detector is identical to the pixel size of the currently marketed and Reference Device 3, DigitalDiagnost C90. Thus demonstrating substantial equivalence. |
| Pixel Size (Wireless) | 139 μm (Wireless: Varian PaxScan4336W) | 160 μm (Wireless-SkyPlate E) | The pixel size of the proposed DigtialDiagnost C50 provided with wireless detector SkyPlate E is identical to the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2. Thus demonstrating SE. |
| Analog / Digital (A/D) conversion | 16 bits | Identical | No difference; thus, demonstrating SE. |
| Table | |||
| Table type | Fixed and Height adjustment | Identical | No difference; thus, demonstrating SE. |
| Height adjustment | 51.5 cm to 91.5 cm above floor, motorized adjustment | Identical | No difference; 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 | Ceiling suspension | Identical | No difference; thus, demonstrating SE. |
| Tube rotation | +/- 135 degree | Identical | No difference; thus, demonstrating SE. |
| Longitudinal movement range | 1500 mm | Identical | No difference; thus, demonstrating SE. |
| Source to Image Distance (SID) | |||
| SID | SID depends on different configurations, because the DigitalDiagnost C50 is a ceiling suspension X-ray system. | Identical | No difference; thus, demonstrating SE. |
| External Connectivity | |||
| DICOM | DICOM 3.0 compatible | Identical | No difference; thus, demonstrating SE. |
| Software Platform | |||
| Software | Eleva WorkSpot | Identical | No difference; thus, demonstrating SE. |
| SkyFlow Software | No | Yes | The proposed Digital Diagnost C50 includes the SkyFlow software used in the currently marketed and reference device 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 DigitalDiagnost C50 was previously cleared with the currently marketed and Reference Device 3, DigitalDiagnost C90 (K182973- January 11, 2019, Philips Medical Systems DMC). Upgrading to UNIQUE2 image processing algorithm does not alter the clinical workflow, hence no impact on the safety or effectiveness of the device; thus, demonstrating SE. |
| Operating System | Windows 7 embedded | Windows 10 embedded | Introduction of operating system Windows 10 embedded does not impact clinical image quality. Therefore, there is no impact on the safety and effectiveness of the device; thus, demonstrating SE. |
Study Proving Acceptance Criteria:
The document states that a non-clinical verification/validation study was performed. The basis for substantial equivalence is that the DigitalDiagnost C50 is considered equivalent to the predicate DigitalDiagnost C50 (K163410) based on:
- Identical Indications for Use.
- Fundamental scientific technology (including largely identical components or components identical to other cleared reference devices).
- Non-clinical performance testing (demonstrating compliance with standards).
- Safety and effectiveness (as supported by the non-clinical testing).
The non-clinical verification and validation tests demonstrated that the DigitalDiagnost C50:
- 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.
2. Sample size used for the test set and the data provenance:
The document explicitly states: "The DigitalDiagnost C50 does not require clinical study..." and "Summary of Clinical Data: Based on the information provided above, the DigitalDiagnost C50 is considered substantially equivalent to the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017) in terms of fundamental scientific technology."
Therefore, there appears to be no clinical test set, sample size, or specific data provenance for a clinical study as part of this 510(k) submission. The evaluation relies on non-clinical performance data and equivalence to predicate/reference devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since no clinical study with a test set was performed, this information is not applicable and not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Since no clinical study with a test set was performed, this information is not applicable and not provided in the document.
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 comparative effectiveness study was mentioned. The device described, DigitalDiagnost C50, is an X-ray system, not an AI-assisted diagnostic device. Therefore, this information is not applicable and not provided in the document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The DigitalDiagnost C50 is an X-ray imaging system. There is no mention of a standalone algorithm-only performance study, as it's not a standalone diagnostic algorithm. Therefore, this information is not applicable and not provided in the document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical verification and validation tests, the "acceptance criteria" were derived from international and FDA-recognized consensus standards and FDA guidance documents (listed on pages 11-12). These standards themselves implicitly define the "ground truth" or acceptable performance ranges for device characteristics, image quality, electrical safety, radiation protection, software lifecycle, usability, and risk management. No other forms of expert consensus, pathology, or outcomes data are mentioned for establishing ground truth for the device's technical specifications.
8. The sample size for the training set:
Since no clinical study or AI algorithm training is described for this device, this information is not applicable and not provided in the document.
9. How the ground truth for the training set was established:
Since no clinical study or AI algorithm training is described for this device, this information is not applicable and not provided in the document.
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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., Lit. % Claire Zhang Advanced Regulatory Engineer No. 258, ZhongYuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA
Re: K201725
Trade/Device Name: DigitalDiagnost C50 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: June 8, 2020 Received: June 23, 2020
Dear Claire Zhang:
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
July 10, 2020
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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) K201725
Device Name DigitalDiagnost C50
Indications for Use (Describe)
The DigitalDiagnost C50 system 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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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: | June 08, 2020 | |
|---|---|---|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd.No. 258, Zhong Yuan Road, Suzhou Industrial Park, 215024Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINAEstablishment Registration Number: 3009529630 | |
| Contact Person: | Claire ZhangAdvanced Regulatory EngineerPhone: +86-021-24128746 (cell: +86-133-8217-7838)Fax: +86-512-68018677E-mail: Claire.Zhang_1@philips.com | |
| Device Name: | DigitalDiagnost C50 | |
| Classification: | Classification NameClassification Regulation:Classification Panel:Device Class:Product code: | Stationary X-Ray System21CFR §892.1680RadiologyClass IIKPR (System, X-Ray, Stationary) |
| Predicate Device: | Trade Name:Manufacturer:510(k) Clearance:Classification Regulation:Classification Name:Classification Panel:Device Class:Product Code | DigitalDiagnost C50Philips Healthcare (Suzhou) Co.,Ltd.K163410-January 4, 201721 CFR, Part 892.1680Stationary X-Ray SystemRadiologyClass IIKPR |
| Reference Device 1: | Trade Name:Manufacturer:510(k) Clearance:Classification Regulation:Classification Name:Classification Panel:Device Class:Product Code | MobileDiagnost WDR 2.2SEDECAL SAK191813- August 2, 201921CFR 892.1720Mobile x-ray systemRadiologyClass IIIZL, 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 DigitalDiagnost C50 Digital Radiography System(DigitalDiagnost C50) is a flexible digital radiography (DR)system that is designed to provide fast and smoothradiography examinations of sitting, standing or lyingpatients.The DigitalDiagnost C50 consist of the followingcomponents: ceiling suspension with X-ray assembly, wallstand with detector carrier, patient table with detector carrierand floating table top, high voltage generator, and anacquisition and reviewing workstation for post-processing,storage and viewing of images. Images may be transferred viaa DICOM network for printing, storage and detailed review. | |
| Indications for use: | The DigitalDiagnost C50 is intended for use in generatingradiographic images of human anatomy by qualified/traineddoctor or technician. Applications can be performed with thepatient sitting, standing, or lying in the prone or supineposition. This device is not intended for mammographicapplications. | |
| Fundamental scientifictechnology: | The fundamental scientific technology utilized in theDigitalDiagnost C50 and the currently marketed and |
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predicate DigitalDiagnost C50 (K163410, January 4, 2017) is equivalent with regards to the functionality of the following components: integrated tube assembly, 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 postprocessing, storage and viewing (See Table 1 comparing the DigitalDiagnost C50 to the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017) 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 DigitalDiagnost C50 when compared to the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017).
The wireless portable detector of the DigitalDiagnost C50 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 DigitalDiagnost C50 and the currently marketed and reference device 1, MobileDiagnost WDR 2.2 employ identical fundamental scientific technology.
The DigitalDiagnost C50 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, embedded Windows 10 operating system. Therefore, DigitalDiagnost C50 and the currently marketed and reference device 3, DigitalDiagnost C90 employ identical fundamental scientific technology in fixed RAD detector (Pixium 4343RCE), UNIQUE 2 Post Processing software, embedded Windows 10 operating system.
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| Table 1Comparison of Technological Characteristics of Currently marketed and Predicate DigitalDiagnost C50versus the DigitalDiagnost C50 | |||
|---|---|---|---|
| Feature | Predicate Device:DigitalDiagnost C50(K163410, January 4, 2017) | Device:DigitalDiagnost C50 | Comment |
| Basic information | |||
| Product Code | KPR | 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-CABINETCXA50kW), 134A (M-CABINETCXA 65kW);Long term: 10A. | Identical | No difference; thus,demonstrating SE. |
| Design characteristic | |||
| X-ray Tube | RO 1750 ROT 380 & SRO33100 ROT 380 | Identical | No difference; thus,demonstrating SE. |
| Max TubeVoltage | 150 kV | Identical | No difference; thus,demonstrating SE. |
| Focal Spot Size | 0.6mm/1.2mm | Identical | No difference: thus.demonstrating SE. |
| Tube Maxpower | 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 | Identical | No difference; thus,demonstrating SE. |
| Max Power | 50KW/65KW | Identical | No difference; thus,demonstrating SE. |
| 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 | Identical | No difference; thus,Demonstrating SE. |
| Fixed RAD Detector | |||
| Wireless Static Detector | |||
| 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 theDigitalDiagnost C50 isidentical to the fixed RADdetector of the currentlymarketed and ReferenceDevice 3, DigitalDiagnostC90(K182973- January 11,2019, Philips Medical SystemsDMC).Thus, demonstrating SE |
| Wireless StaticDetector | Varian PaxScan4336W | SkyPlate E (Trixell3543DR)(Note: this detector isidentical to the Skyplate EDetector of the currentlymarketed and referencedevice 1, MobileDiagnostWDR 2.2 cleared underK191813). | The Skyplate E Detector of theproposed DigitalDiagnost C50is identical to the Skyplate EDetector of the currentlymarketed and ReferenceDevice 1, MobileDiagnostWDR 2.2 (K191813- August 2,2019).Thus, demonstrating SE |
| X-rayScintillatorMaterial | GdOS (Fixed: Pixium4343RG) | Cesium Iodide (Fixed:Pixium 4343RCE. )Note: Pixium4343RCE is identicalto fixed RAD detectorof the currentlymarketed andReference Device 3,DigitalDiagnost C90cleared underK182973. | The fixed RAD detector of theproposed DigitalDiagnost C50and currently marketed andReference Device 3,DigitalDiagnostC90(K182973- January 11,2019, Philips Medical SystemsDMC) are both fabricatedfrom identical Cesium Iodidematerial , thus demonstratingSE. |
| GdOS(Wireless VarianPaxScan4336W) | Cesium Iodide(Wireless SkyPlate E) | The Wireless Detector of theproposed DigitalDiagnost C50and the currently marketed andReference Device 1,MobileDiagnost WDR 2.2(K191813- August 2, 2019) areboth fabricated from identicalCesium Iodide material, thusdemonstrating SE. | |
| Image Area | 42.5cm x 42.5cm(Fixed: Pixium 4343RG)42.7 cm x 34.4 cm(Wireless: VarianPaxScan4336W) | 42.03cm x 42.54cm(Fixed: Pixium4343RCE)34.5 cm x 42.5cm(Wireless: SkyPlate E) | The image area of theDigitalDiagnost C50,provided with fixed RADdetector is identical to theimage area of the Fixed RADDetector of the currentlymarketed and ReferenceDevice 3, DigitalDiagnostC90(K182973- January 11,2019, Philips Medical SystemsDMC), thus demonstratingsubstantial equivalenceThe image area of the proposedWireless Detector SkyPlate Eis identical to the WirelessDetector SkyPlate E of thecurrently 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)3,072 x 2,476(Wireless: VarianPaxScan4336W) | 2,874 x 2840(Fixed: Pixium4343RCE)2,156 x 2,653(Wireless-SkyPlate E) | The image matrix of theproposed DigitalDiagnostC50, provided with fixed RADdetector is similar to the imagematrix of the currentlymarketed and ReferenceDevice 3, DigitalDiagnostC90(K182973- January 11,2019, Philips Medical SystemsDMC). thus demonstratingsubstantial equivalenceThe image matrix of theproposed DigtialDiagnost C50provided with wireless detectorSkyPlate E is similar to thecurrently marketed andReference Device 1,MobileDiagnost WDR 2.2(K191813- August 2, 2019,Sedecal SA). Infinitesimalchange in the image size (X-ray field) does not impactclinical Image Quality.Therefore, they are equivalentand there is no impact on thesafety and effectiveness of thedevice; thus, demonstratingSE. |
| Pixel Size | |||
| 148 μm (Fixed: Pixium 4343RG)139 μm (Wireless: Varian PaxScan4336W) | • 148 μm (Fixed: Pixium 4343RCE)• 160 μm (Wireless-SkyPlate E) | The pixel size of the proposed DigtialDiagnost C50 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 proposed DigtialDiagnost C50 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 | Identical | No difference; thus, demonstrating SE. |
| Height adjustment | 51.5 cm to 91.5 cm above floor, motorized adjustment | Identical | No difference; 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 | Ceiling suspension | Identical | No difference; thus, demonstrating SE. |
| Tube rotation | +/- 135 degree | Identical | No difference; thus, demonstrating SE. |
| Longitudinal movement range | 1500 mm | Identical | No difference; thus, demonstrating SE. |
| Source to Image Distance (SID) | |||
| SID | SID depends on different configurations, because | Identical | No difference; thus, demonstrating SE. |
| the DigitalDiagnost C50 is a ceiling suspension X-ray system. | |||
| External Connectivity | |||
| DICOM | DICOM 3.0 compatible | Identical | No difference; thus, demonstrating SE. |
| Software Platform | |||
| Software | Eleva WorkSpot | Identical | No difference; thus, demonstrating SE. |
| SkyFlowSoftware | No | Yes | The proposed Digital Diagnost C50 includes the SkyFlow software used in the currently marketed and reference device Eleva Workspot with SkyFlow, (K153318- December 22, 2015, Philips Medical Systems DMC), thus, demonstrating SE. |
| ImageProcessingAlgorithm | UNIQUE | UNIQUE 2 | UNIQUE 2 image processing algorithm provided with DigitalDiagnost C50 was previously cleared with the currently marketed and Reference Device 3, DigitalDiagnost C90 (K182973- January 11, 2019, Philips Medical Systems DMC). Upgrading to UNIQUE2 image processing algorithm does not alter the clinical workflow, hence no impact on the safety or effectiveness of the device; thus, demonstrating SE |
| OperatingSystem | Windows 7 embedded | Windows 10 embedded | Introduction of operating system Windows 10 embedded does not impact clinical image quality.Therefore, there is no impact on the safety and effectiveness of the device; thus, demonstrating SE. |
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Based on the information provided above, the DigitalDiagnost C50 is considered substantially equivalent to the currently marketed and predicate DigitalDiagnost C50 ( K163410, January 4, 2017) in terms of fundamental scientific technology.
Summary of Non-Clinical Performance data:
This 510(k) premarket notification contains the technical documentation。 which demonstrates that the DigitalDiagnost C50 is substantially equivalent to the currently marketed and predicate DigitalDiagnost C50 ( K163410, January 4, 2017). The technical documentation includes non-clinical verification / validation tests. These tests were performed on the DigitalDiagnost C50 according to the following international and FDArecognized consensus standards:
- · International and FDA-recognized consensus standards:
- . AAMI / ANSI ES60601-1: 2005/(R)2012 and C1:2009/(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.
- 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
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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"
- · 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 DigitalDiagnost C50 :
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- 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, DigitalDiagnost is substantially C50 equivalent to the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017) in terms of safety and effectiveness.
The DigitalDiagnost C50 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 also has similar design, technology and Image acquisition workflow compared to the previously Pixium 4343RG and Varian PaxScan4336W detector used in the marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017). 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.
The DigitalDiagnost C50 is substantially equivalent to Substantial Equivalence Conclusion: the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017) 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 Page 11 of 12
Summary of Clinical Data:
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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 of these these detests demonstrate that DigitalDiagnost C50 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.