DigitalDiagnost C50
Device Facts
| Record ID | K163410 |
|---|---|
| Device Name | DigitalDiagnost C50 |
| Applicant | Philips Healthcare (Suzhou) Co., Ltd. |
| Product Code | KPR · Radiology |
| Decision Date | Jan 4, 2017 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
Indications for Use
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.
Device Story
Digital radiography system; generates radiographic images of human anatomy. Components: ceiling-suspended X-ray assembly, wall stand, patient table with floating top, high-voltage generator, digital detectors (fixed/wireless), and Eleva workstation. Operated by physicians or technicians in clinical settings. X-ray tube produces radiation; digital detectors capture signals; workstation performs post-processing, storage, and viewing. Images transferred via DICOM network. Supports clinical decision-making through diagnostic imaging. Benefits: provides fast, smooth radiography examinations.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via design features, indications for use, fundamental scientific technology, and non-clinical performance testing (bench testing).
Technological Characteristics
Stationary X-ray system. Components: dual-focus rotating anode X-ray tube, high-voltage generator (50-80kW), manual collimator, digital detectors (GdOS scintillator). Connectivity: DICOM 3.0. Software: Eleva workspot. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 62304, ISO 14971, IEC 62366.
Indications for Use
Indicated for generating radiographic images of human anatomy in patients sitting, standing, or lying (prone/supine). For use by qualified/trained doctors or technicians. Not for mammographic applications.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- DuraDiagnost (K141381)
Reference Devices
- Nexus DR Digital X-ray Imaging System (K161459)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 4, 2017
Philips Healthcare (Suzhou) Co., LTD % Alina Zhou Q&R Director No. 258, Zhong Yuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA
Re: K163410 Trade/Device Name: DigitalDiagnost C50 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: December 01, 2016 Received: December 05, 2016
Dear Alina Zhou:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michal D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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5 Statement of Indication for Use/Intended Use
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known)
K163410
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) | |
|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| <div><span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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## 6 510(k) Summary of Safety and Effectiveness
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## 510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | November 25, 2016 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd.<br>No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024<br>Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA<br>Establishment Registration Number: 3009529630 |
| Contact Person: | Alina Zhou<br>Q&R Director<br>Phone: +86-512-67336582<br>Fax: +86-512-68018677<br>E-mail: Alina.Zhou@philips.com |
| Trade Name: | DigitalDiagnost C50 |
| Common Name: | Digital Radiography System |
| Classification: | |
| Classification Name: | Stationary X-Ray System |
| Classification Regulation: | 21CFR §892.1680 |
| Classification Panel: | Radiology |
| Device Class: | Class II |
| Classification Product Code: | KPR (System, X-Ray, Stationary) |
| Predicate Device : | |
| Trade Name: | DuraDiagnost |
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. |
| 510(k) Clearance: | K141381 (June 12, 2014) |
| Classification Regulation: | 21 CFR, Part 892.1680 |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Device Class: | Class II |
| Product Code: | KPR, MQB |
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| Reference Device : | Trade Name: | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) | |
|--------------------|----------------------------|----------------------------------------------------------------|--|
| | Manufacturer: | Varian Medical Systems | |
| | 510(k) Clearance: | K161459 (September 06, 2016) | |
| | Classification Regulation: | 21CFR §892.1680 | |
| | Classification Name: | Solid State X-Ray Imager (flat panel/digital imager) | |
| | Classification Panel: | Radiology | |
| | Device Class: | Class II | |
| | Product Code: | MQB | |
Device Description The Philips DigitalDiagnost C50 Digital Radiography System (Philips 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 Philips DigitalDiagnost C50 consists 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.
- Indications for The Philips DigitalDiagnost C50 is intended for use in generating Use: radiographic images of human anatomy by a 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.
| Summary of the<br>Technological<br>Characteristics &<br>Fundamental<br>Scientific<br>Technology: | The components of the Philips DigitalDiagnost C50 employ<br>similar basic construction and fundamental scientific technology as<br>provided with the currently marketed and predicate Philips<br>DuraDiagnost (K141381 – 06/12/2014) with regards to the<br>functionality of the following components: integrated tube |
|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | assembly, patient table with a floating table top, high-voltage<br>generator, dual-focus rotation anode X-Ray tube, manual beam<br>limiting device, digital detector, wall stand and workstation for |
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images post-processing, storage and viewing (see the comparison table comparing the Philips DigitalDiagnost C50 to the currently marketed predicate Philips DuraDiagnost 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 Philips DigitalDiagnost C50 when compared to the currently marketed and predicate Philips DuraDiagnost.
The wireless portable detector of the Philips DigitalDiagnost C50 is identical to the wireless portable detector (PaxScan 4336Wv4) of the currently marketed and reference device. Varian Nexus DR™ Digital X-ray Imaging System (K161459, 09/06/ 2016) manufactured by Varian Medical System. Therefore, both the wireless portable detector of the Philips DigitalDiagnost C50 and the wireless portable detector of the reference device, Varian Nexus DR™ Digital X-ray Imaging System employ identical fundamental scientific technology.
The Fixed detector (Model No. 4343RG) of the Philips DigitalDiagnost C50 is identical to the fixed detector (Model No. 4343RG) of the currently marketed and predicate Philips DuraDiagnost and is manufactured by Trixell Company. Therefore, the fixed detector of the Philips DigitalDiagnost C50 and the currently marketed and predicate DuraDiagnost employ identical fundamental scientific technology.
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| Summary of Technological Characteristics of the Philips DigitalDiagnost C50 to<br>the Currently Marketed Predicate Devices | | | |
|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Currently Marketed<br>and Predicate<br>Philips DuraDiagnost<br>(K141381, 06/12/2014) | Proposed<br>Philips<br>DigitalDiagnost C50 | Comment |
| X-ray Tube | RO 1750 ROT 360 &<br>SRO 33100 ROT 360 | RO 1750 ROT 380 &<br>SRO 33100 ROT 380 | Both devices utilize similar<br>x-ray tubes.<br>The specifications of both<br>tubes are exactly the same,<br>including nominal X-ray<br>tube voltage, nominal focal<br>spot values, maximum tube<br>current, maximum anode<br>heat content, total filtration<br>(minimum), maximum and<br>anode heat dissipation.<br>The only minor difference<br>is the tube housing which<br>does not affect the<br>performance of the tube<br>and therefore, there is no<br>impact on the safety and<br>effectiveness of the device.<br>Thus, demonstrating SE. |
| Max Tube<br>Voltage | 150kV | Same | No difference; thus,<br>demonstrating SE. |
| Focal Spot Size | 0.6mm/1.2mm | Same | No difference; thus,<br>demonstrating SE. |
| Tube Maz<br>Power | 50KW/100KW<br>(250W equivalent anode<br>input power) | Same | No difference; thus,<br>demonstrating SE. |
| Anode Type | Rotation | Same | No difference; thus,<br>demonstrating SE. |
| Generator | Philips Healthcare<br>(Suzhou),<br>M-CABINET CXA Pro<br>50kW, M-CABINET<br>CXA Pro 65kW, M-<br>CABINET Pro CXA<br>80kW | Philips Healthcare<br>(Suzhou),<br>M-CABINET CXA Pro<br>50kW,<br>M-CABINET CXA Pro<br>65kW | Equivalent. The Philips<br>DigitalDiagnost C50 is<br>provided with<br>50KW/65KW that is also<br>provided with the currently<br>marketed and predicate<br>Philips DuraDiagnost. |
| Max Power | 50KW/65KW/80KW | 50KW/65KW | Therefore, no impact on the<br>safety and effectiveness of<br>the device. Thus,<br>demonstrating SE. |
| KV range | 40-150 | Same | No difference; thus,<br>demonstrating SE. |
| Milli ampere sec<br>(mAs) product | 0.4 mAs-600 mAs (with<br>AEC control) | Same | No difference; thus,<br>demonstrating SE. |
| Collimator | | | |
| Operation Mode | Manual collimation | Same | No difference; thus,<br>demonstrating SE. |
| Shape of Beam | Rectangular | Same | No difference; thus, demonstrating SE. |
| Detector<br>Type | Digital Detector<br>Fixed: GdOS<br>Wireless: Pixium<br>3543EZ (CSI) | Digital Detector<br>Fixed: GdOS<br>Wireless: PaxScan<br>4336Wv4 (Gdos) | The Fixed Portable<br>Detector of the Philips<br>DigitalDiagnost C50 is<br>identical to the currently<br>marketed and predicate<br>Philips DuraDiagnost.<br>The wireless detector is of<br>the Philips<br>DigitalDiagnost C50 is<br>identical to the Reference<br>Device, Nexus DRTM<br>Digital X-ray Imaging<br>System (K161259,<br>09/062016 - Varian<br>Medical System.)<br>Therefore, there is no<br>impact on the safety and<br>effectiveness of the device;<br>thus, demonstrating SE. |
| X-ray Scintillator<br>Material | GdOS (Fixed)<br>Cesium Iodide (Wireless) | GdOS (Fixed)<br>GdOS (Wireless) | The Fixed Portable<br>Detector of the Philips<br>DigitalDiagnost C50 is<br>identical to the currently<br>marketed and predicate<br>Philips DuraDiagnost.<br>The wireless detector of the<br>Philips DigitalDiagnost<br>C50 is identical to the<br>Reference Device, Nexus<br>DRTM Digital X-ray<br>Imaging System (K161259,<br>09/062016 - Varian<br>Medical System.)<br>Therefore, there is no<br>impact on the safety and<br>effectiveness of the device;<br>thus, demonstrating SE. |
| Image Area | 42.5cm x 42.5cm (Fixed)<br>42.4cm x 34.8cm<br>(wireless) | 42.5cm x 42.5cm<br>(Fixed)<br>42.7 cm x 34.4 cm<br>(wireless) | The image area of the<br>Philips DigitalDiagnost<br>C50, provided with the<br>Fixed Portable Detector, is<br>identical to the currently<br>marketed and predicate<br>Philips DuraDiagnost.<br>The image area of the<br>Philips DigitalDiagnost<br>C50, provided with the<br>wireless detector is |
| | | | |
| | | | Device, Nexus DRTM<br>Digital X-ray Imaging<br>System (K161259,<br>09/062016 - Varian<br>Medical System.)<br>Therefore, there is no<br>impact on the safety and<br>effectiveness of the device;<br>thus, demonstrating SE. |
| Image Matrix | 2874 x 2869 (Fixed)<br>2866 x 2350 (wireless) | 2874 x 2869 (Fixed)<br>3072 x 2476 (wireless) | The image matrix of the<br>Philips DigitalDiagnost<br>C50, provided with the<br>Fixed Portable Detector, is<br>identical to the currently<br>marketed and predicate<br>Philips DuraDiagnost.<br><br>The image matrix of the<br>Philips DigitalDiagnost<br>C50, provided with the<br>wireless detector, is<br>identical to the Reference<br>Device, Nexus DRTM<br>Digital X-ray Imaging<br>System (K161259,<br>09/062016 - Varian<br>Medical System.)<br>Therefore, there is no<br>impact on the safety and<br>effectiveness of the device;<br>thus, demonstrating SE. |
| Analog / Digital<br>(A/D) conversion | 16 bits | Same | No difference; thus,<br>demonstrating SE. |
| Source to Image Distance (SID) | | | |
| SID | Table: 40-115cm;<br>Wallstand: 110-245cm | SID depends on<br>different<br>configurations, because<br>the DigitalDiagnost<br>C50 is a ceiling<br>suspension X-ray<br>system. | The slight difference<br>between the SID of the<br>DigitalDiagnost C50 and<br>the currently marketed and<br>predicate Philips<br>DuraDiagnost does not<br>alter the application usage;<br>as demonstrated through<br>Section 17 bench testing.<br><br>Therefore, there is no<br>impact on the safety and<br>effectiveness of the device;<br>thus, demonstrating SE. |
| External Connectivity | | | |
| DICOM | DICOM 3.0 compatible | Same | No difference; thus,<br>demonstrating SE. |
| Software Platform | | | |
| Software | Eleva workspot | Same | No difference; thus,<br>demonstrating SE. |
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Summary of Non-The DigitalDiagnost C50 complies with the following international Clinical and FDA-recognized consensus standards: Performance Data:
- International and FDA-recognized consensus standards: .
- o 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.
- o IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
- IEC 60601-1-3 Edition 2.1 2013-04, O Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
- IEC 60601-2-28 Edition 2.0 2010-03, O Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis.
- IEC 60601-2-54 Edition 1.0 2009-06, O Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
- IEC 62304 Edition 1.1 2015-06, Medical O device software - software life cycle processes.
- ISO 14971 Second edition 2007-03, O Medical devices - Application of risk management to medical devices.
- IEC 62366 Edition 1.1 2014-01, Medical o devices - Application of usability engineering to medical devices.
- CFR 1020.30 Diagnostic x-ray systems and their major . components.
- CFR 1020.31 Radiographic equipment.
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- 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 guidance document entitled, "Radio Frequency Wireless Technology in Medical Devices - August 14 2013."
- FDA draft guidance document entitled, "Pediatric Information for X-ray Imaging Device Premarket Notifications issued on May 10, 2012."
Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results.
Non-Clinical verification and or validation test results demonstrate that the DigitalDiagnost C50:
- Complies with the aforementioned international and FDA-. recognized consensus standards and device specific guidance document.
- . Meets the acceptance criteria and is adequate for its intended use.
Therefore, the DigitalDiagnost C50 is substantially equivalent to the primary currently marketed and predicate Philips DuraDiagnost (K141381- 06/12/2014) in terms of safety and effectiveness.
The DigitalDiagnost C50 did not require a clinical study since Summary of Clinical Data: substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes:
- Design features;
- Indication for use; ●
- Fundamental scientific technology;
- Non-clinical performance testing; and ●
- Safety and effectiveness. ●
Furthermore, one modification included in this submission is to replace the current wireless detector with an equivalent and already cleared wireless detector by Varian Medical Systems (Varian PaxScan 4336Wv4 of the reference device, Varian Nexus
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DR™ Digital X-ray Imaging System (K161459, cleared on 09/06/2016); therefore a clinical image study is not required.
Substantial The DigitalDiagnost C50 is substantially equivalent to the Equivalence currently marketed and predicate Philips DuraDiagnost (K141381 Conclusion: - 06/12/2014) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Also, the wireless detector provided with the DigitalDiagnost C50 is substantially equivalent to the currently marketed and reference device, Varian Nexus DRTM Digital X-ray Imaging System (K161459, 09/06/2016) with regards to the wireless detector (PaxScan 4336Wv4).
> Additionally, substantial equivalence was demonstrated with nonclinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 62304, IEC 62366 and ISO 14971. The results of these tests demonstrate that the DigitalDiagnost C50 met the acceptance criteria and is adequate for its intended use.
