(30 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 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.
Based on the provided text, the device in question, the Philips DigitalDiagnost C50, is a stationary x-ray system cleared through a 510(k) premarket notification. The document does not describe acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/algorithm-driven diagnostic aid.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Philips DuraDiagnost K141381) and a reference device for the wireless detector (Varian Nexus DR™ Digital X-ray Imaging System K161459).
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets acceptance criteria related to AI/algorithm performance, a multi-reader multi-case study, standalone algorithm performance, or the ground truth establishment for a training set. The device is a traditional x-ray system, not an AI-powered diagnostic tool as suggested by some of the detailed questions.
However, I can extract information regarding overall device compliance and performance from the text as it relates to demonstrating substantial equivalence for an X-ray system:
Acceptance Criteria and Device Performance for the Philips DigitalDiagnost C50
The provided text on the Philips DigitalDiagnost C50's 510(k) submission does not include acceptance criteria and a study in the context of an AI-driven diagnostic device. Instead, it focuses on demonstrating substantial equivalence to predicate and reference devices for a stationary X-ray system. The "acceptance criteria" mentioned refer to the device meeting the requirements set forth by international and FDA-recognized consensus standards and device-specific guidance documents, as well as the successful completion of non-clinical verification and validation tests.
1. Table of Acceptance Criteria and Reported Device Performance (as related to Substantial Equivalence and Safety/Effectiveness):
The document details a comparison of technological characteristics between the proposed device (DigitalDiagnost C50) and its predicate (Philips DuraDiagnost) and reference device (Varian Nexus DR™ Digital X-ray Imaging System for the wireless detector). The "acceptance criteria" here are implicitly that the proposed device's characteristics are either identical or that any minor differences do not affect the safety or effectiveness, thus demonstrating substantial equivalence (SE).
| Feature | Acceptance Criteria (based on Predicate/Reference Device Equivalence) | Reported Device Performance (Philips DigitalDiagnost C50) |
|---|---|---|
| X-ray Tube | Similar x-ray tubes, with identical specifications for nominal X-ray tube voltage, nominal focal spot values, maximum tube current, maximum anode heat content, total filtration, maximum and anode heat dissipation. Minor difference in tube housing should not affect performance, safety, and effectiveness. | Uses RO 1750 ROT 380 & SRO 33100 ROT 380, which are similar and have the same specifications as the predicate's tubes (RO 1750 ROT 360 & SRO 33100 ROT 360). The minor tube housing difference has no impact on safety and effectiveness, demonstrating SE. |
| Max Tube Voltage | Same as predicate (150kV). | Same (150kV). No difference; demonstrating SE. |
| Focal Spot Size | Same as predicate (0.6mm/1.2mm). | Same (0.6mm/1.2mm). No difference; demonstrating SE. |
| Tube Max Power | Same as predicate (50KW/100KW, 250W equivalent anode input power). | Same (50KW/100KW, 250W equivalent anode input power). No difference; demonstrating SE. |
| Anode Type | Same as predicate (Rotation). | Same (Rotation). No difference; demonstrating SE. |
| Generator | Equivalent to predicate (M-CABINET CXA Pro 50kW, M-CABINET CXA Pro 65kW, M-CABINET Pro CXA 80kW, particularly 50kW/65kW). Minor difference in max power (80kW not included) should not affect safety and effectiveness. | Uses M-CABINET CXA Pro 50kW, M-CABINET CXA Pro 65kW. Max Power 50KW/65KW. These are equivalent to the predicate's available generators, with no impact on safety and effectiveness, demonstrating SE. |
| kV range | Same as predicate (40-150). | Same (40-150). No difference; demonstrating SE. |
| Milliampere second (mAs) product | Same as predicate (0.4 mAs-600 mAs with AEC control). | Same (0.4 mAs-600 mAs with AEC control). No difference; demonstrating SE. |
| Collimator Operation Mode | Same as predicate (Manual collimation). | Same (Manual collimation). No difference; demonstrating SE. |
| Shape of Beam | Same as predicate (Rectangular). | Same (Rectangular). No difference; demonstrating SE. |
| Detector Type | Fixed: Identical to predicate (GdOS). Wireless: Identical to reference device (PaxScan 4336Wv4 in Varian Nexus DR™ Digital X-ray Imaging System). No impact on safety and effectiveness. | Fixed: GdOS (identical to predicate). Wireless: PaxScan 4336Wv4 (GdOS), identical to the reference device. No impact on safety and effectiveness, demonstrating SE. |
| X-ray Scintillator Material | Fixed: Identical to predicate (GdOS). Wireless: Identical to reference device (GdOS) which replaces the predicate's Cesium Iodide. No impact on safety and effectiveness. | Fixed: GdOS (identical to predicate). Wireless: GdOS (identical to the reference device). No impact on safety and effectiveness, demonstrating SE. |
| Image Area | Fixed: Identical to predicate (42.5cm x 42.5cm). Wireless: Functionally equivalent/identical to reference device (42.7 cm x 34.4 cm vs. reference 42.4cm x 34.8cm). Minor differences should not impact safety and effectiveness. | Fixed: 42.5cm x 42.5cm (identical to predicate). Wireless: 42.7 cm x 34.4 cm (functionally equivalent to reference device's 42.4cm x 34.8cm). No impact on safety and effectiveness, demonstrating SE. |
| Image Matrix | Fixed: Identical to predicate (2874 x 2869). Wireless: Functionally equivalent/identical to reference device (3072 x 2476 vs. reference 2866 x 2350). Minor differences should not impact safety and effectiveness. | Fixed: 2874 x 2869 (identical to predicate). Wireless: 3072 x 2476 (functionally equivalent to reference device's 2866 x 2350). No impact on safety and effectiveness, demonstrating SE. |
| Analog / Digital (A/D) conversion | Same as predicate (16 bits). | Same (16 bits). No difference; demonstrating SE. |
| Source to Image Distance (SID) | Minor differences are acceptable as long as they do not alter application usage and are supported by bench testing results. | SID depends on configurations (ceiling suspension system). Slight difference compared to predicate (Table: 40-115cm; Wallstand: 110-245cm) but bench testing (Section 17) proved no alteration to application usage; thus, no impact on safety and effectiveness, demonstrating SE. |
| External Connectivity | Same as predicate (DICOM 3.0 compatible). | Same (DICOM 3.0 compatible). No difference; demonstrating SE. |
| Software Platform | Same as predicate (Eleva workspot). | Same (Eleva workspot). No difference; demonstrating SE. |
| Compliance with Standards | Complies with specified international and FDA-recognized consensus standards and device-specific guidance documents (e.g., 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, CFR 1020.30, CFR 1020.31, FDA guidance documents). | Compliance confirmed through non-clinical verification and validation tests. The device "Meets the acceptance criteria and is adequate for its intended use" based on these tests. |
2. Sample Size and Data Provenance for Test Set (for an AI/Algorithm):
- Not applicable. The submission is for a traditional X-ray system, not an AI/algorithm-driven diagnostic device. The performance data relies on comparing the technical specifications and non-clinical bench testing against established standards and predicate devices.
3. Number of Experts and Qualifications to Establish Ground Truth (for an AI/Algorithm):
- Not applicable. See point 2.
4. Adjudication Method for Test Set (for an AI/Algorithm):
- Not applicable. See point 2.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. The document explicitly states: "The DigitalDiagnost C50 did not require a clinical study since 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." There is no mention of an MRMC study or an effect size for human readers with or without AI assistance.
6. Standalone Algorithm Performance:
- Not applicable. The device is an X-ray system, not a standalone algorithm.
7. Type of Ground Truth Used (for an AI/Algorithm):
- Not applicable. For this X-ray system, "ground truth" for performance is established through adherence to recognized standards, technical specifications, and successful non-clinical performance (bench) testing, demonstrating that the images generated are of appropriate quality and the system functions safely and effectively as intended.
8. Sample Size for the Training Set (for an AI/Algorithm):
- Not applicable. See point 2.
9. How the Ground Truth for the Training Set Was Established (for an AI/Algorithm):
- Not applicable. See point 2.
In summary, the Philips DigitalDiagnost C50 is a conventional X-ray system whose acceptance criteria are fundamentally tied to demonstrating substantial equivalence to legally marketed predicate devices through comprehensive non-clinical performance (verification and validation) tests and adherence to established international and FDA-recognized consensus standards. The document does not describe the evaluation of an AI or algorithm.
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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)
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINAEstablishment Registration Number: 3009529630 |
| Contact Person: | Alina ZhouQ&R DirectorPhone: +86-512-67336582Fax: +86-512-68018677E-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 theTechnologicalCharacteristics &FundamentalScientificTechnology: | The components of the Philips DigitalDiagnost C50 employsimilar basic construction and fundamental scientific technology asprovided with the currently marketed and predicate PhilipsDuraDiagnost (K141381 – 06/12/2014) with regards to thefunctionality of the following components: integrated tube |
|---|---|
| assembly, patient table with a floating table top, high-voltagegenerator, dual-focus rotation anode X-Ray tube, manual beamlimiting 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 tothe Currently Marketed Predicate Devices | |||
|---|---|---|---|
| Feature | Currently Marketedand PredicatePhilips DuraDiagnost(K141381, 06/12/2014) | ProposedPhilipsDigitalDiagnost C50 | Comment |
| X-ray Tube | RO 1750 ROT 360 &SRO 33100 ROT 360 | RO 1750 ROT 380 &SRO 33100 ROT 380 | Both devices utilize similarx-ray tubes.The specifications of bothtubes are exactly the same,including nominal X-raytube voltage, nominal focalspot values, maximum tubecurrent, maximum anodeheat content, total filtration(minimum), maximum andanode heat dissipation.The only minor differenceis the tube housing whichdoes not affect theperformance of the tubeand therefore, there is noimpact on the safety andeffectiveness of the device.Thus, demonstrating SE. |
| Max TubeVoltage | 150kV | Same | No difference; thus,demonstrating SE. |
| Focal Spot Size | 0.6mm/1.2mm | Same | No difference; thus,demonstrating SE. |
| Tube MazPower | 50KW/100KW(250W equivalent anodeinput power) | Same | No difference; thus,demonstrating SE. |
| Anode Type | Rotation | Same | No difference; thus,demonstrating SE. |
| Generator | Philips Healthcare(Suzhou),M-CABINET CXA Pro50kW, M-CABINETCXA Pro 65kW, M-CABINET Pro CXA80kW | Philips Healthcare(Suzhou),M-CABINET CXA Pro50kW,M-CABINET CXA Pro65kW | Equivalent. The PhilipsDigitalDiagnost C50 isprovided with50KW/65KW that is alsoprovided with the currentlymarketed and predicatePhilips DuraDiagnost. |
| Max Power | 50KW/65KW/80KW | 50KW/65KW | Therefore, no impact on thesafety and effectiveness ofthe device. Thus,demonstrating SE. |
| KV range | 40-150 | Same | No difference; thus,demonstrating SE. |
| Milli ampere sec(mAs) product | 0.4 mAs-600 mAs (withAEC control) | Same | No difference; thus,demonstrating SE. |
| Collimator | |||
| Operation Mode | Manual collimation | Same | No difference; thus,demonstrating SE. |
| Shape of Beam | Rectangular | Same | No difference; thus, demonstrating SE. |
| DetectorType | Digital DetectorFixed: GdOSWireless: Pixium3543EZ (CSI) | Digital DetectorFixed: GdOSWireless: PaxScan4336Wv4 (Gdos) | The Fixed PortableDetector of the PhilipsDigitalDiagnost C50 isidentical to the currentlymarketed and predicatePhilips DuraDiagnost.The wireless detector is ofthe PhilipsDigitalDiagnost C50 isidentical to the ReferenceDevice, Nexus DRTMDigital X-ray ImagingSystem (K161259,09/062016 - VarianMedical System.)Therefore, there is noimpact on the safety andeffectiveness of the device;thus, demonstrating SE. |
| X-ray ScintillatorMaterial | GdOS (Fixed)Cesium Iodide (Wireless) | GdOS (Fixed)GdOS (Wireless) | The Fixed PortableDetector of the PhilipsDigitalDiagnost C50 isidentical to the currentlymarketed and predicatePhilips DuraDiagnost.The wireless detector of thePhilips DigitalDiagnostC50 is identical to theReference Device, NexusDRTM Digital X-rayImaging System (K161259,09/062016 - VarianMedical System.)Therefore, there is noimpact on the safety andeffectiveness of the device;thus, demonstrating SE. |
| Image Area | 42.5cm x 42.5cm (Fixed)42.4cm x 34.8cm(wireless) | 42.5cm x 42.5cm(Fixed)42.7 cm x 34.4 cm(wireless) | The image area of thePhilips DigitalDiagnostC50, provided with theFixed Portable Detector, isidentical to the currentlymarketed and predicatePhilips DuraDiagnost.The image area of thePhilips DigitalDiagnostC50, provided with thewireless detector is |
| Device, Nexus DRTMDigital X-ray ImagingSystem (K161259,09/062016 - VarianMedical System.)Therefore, there is noimpact on the safety andeffectiveness of the device;thus, demonstrating SE. | |||
| Image Matrix | 2874 x 2869 (Fixed)2866 x 2350 (wireless) | 2874 x 2869 (Fixed)3072 x 2476 (wireless) | The image matrix of thePhilips DigitalDiagnostC50, provided with theFixed Portable Detector, isidentical to the currentlymarketed and predicatePhilips DuraDiagnost.The image matrix of thePhilips DigitalDiagnostC50, provided with thewireless detector, isidentical to the ReferenceDevice, Nexus DRTMDigital X-ray ImagingSystem (K161259,09/062016 - VarianMedical System.)Therefore, there is noimpact on the safety andeffectiveness of the device;thus, demonstrating SE. |
| Analog / Digital(A/D) conversion | 16 bits | Same | No difference; thus,demonstrating SE. |
| Source to Image Distance (SID) | |||
| SID | Table: 40-115cm;Wallstand: 110-245cm | SID depends ondifferentconfigurations, becausethe DigitalDiagnostC50 is a ceilingsuspension X-raysystem. | The slight differencebetween the SID of theDigitalDiagnost C50 andthe currently marketed andpredicate PhilipsDuraDiagnost does notalter the application usage;as demonstrated throughSection 17 bench testing.Therefore, there is noimpact on the safety andeffectiveness of the device;thus, demonstrating SE. |
| External Connectivity | |||
| DICOM | DICOM 3.0 compatible | Same | No difference; thus,demonstrating SE. |
| Software Platform | |||
| Software | Eleva workspot | Same | No difference; thus,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.
§ 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.