(26 days)
The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
The proposed DigitalDiagnost C90 is same as the 510(K) approved predicate (K182973) as mentioned below. It is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The proposed DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE, together with the tube these components form the radiography Image Chain. The proposed DigitalDiagnost C90 introduces a new wireless portable detector, pixium 3543DR i.e. SkyPlate E (cleared in reference device 510(K) K191813) and their relevant grids, in addition to the family of SkyPlate detectors (pixium 3543EZ i.e. Large and pixium 2430EZ i.e. Small) that are already integrated in the currently marketed (predicate) DigitalDiagnost C90 (K182973).
The Philips DigitalDiagnost C90 is a stationary x-ray system, and the submission K202564 introduces the SkyPlate E detector and its relevant grids as a modification to the previously cleared DigitalDiagnost C90 (K182973). The acceptance criteria and the study proving the device meets these criteria are primarily based on demonstrating substantial equivalence to the predicate device through non-clinical performance testing. No clinical study was performed.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Philips DigitalDiagnost C90, specifically regarding the addition of the SkyPlate E detector, are based on demonstrating equivalence or non-inferiority to the predicate device (DigitalDiagnost C90 with existing SkyPlate detectors) in key technological characteristics and the maintenance of clinical image quality, safety, and effectiveness. The reported device performance indicates that the new SkyPlate E detector either meets or is equivalent to the performance of the existing detectors, or that any differences do not negatively impact clinical image quality or safety.
| Feature | PREDICATE Device Performance (DigitalDiagnost C90 with SkyPlate Small & Large) | PROPOSED Device Performance (DigitalDiagnost C90 with SkyPlate E) | Acceptance Criteria (Implicit from "Discussion & Conclusion") | Reported Device Performance (Discussion & Conclusion) |
|---|---|---|---|---|
| Detector Type | Digital wireless flat detector | Digital wireless flat detector | Same | Equivalent; No impact to safety and effectiveness. |
| Detector Models | SkyPlate Large (3543EZ), SkyPlate Small (2430EZ) | SkyPlate Large (3543EZ), SkyPlate Small (2430EZ), SkyPlate E (3543DR) | Addition of SkyPlate E does not affect clinical workflow or image quality. | Addition of SkyPlate E detector does not affect the clinical workflow or clinical image quality so there is no impact to the safety and effectiveness of the device. |
| X-Ray Absorber | CsI Scintillator | CsI Scintillator | Same | Equivalent; No impact to safety and effectiveness. |
| Installation Type | Portable | Portable | Same | Equivalent; No impact to safety and effectiveness. |
| Readout Mechanism | Thin Film Transistor | Thin Film Transistor | Same | Equivalent; No impact to safety and effectiveness. |
| Detector Size | SkyPlate Small: 328mm x 268mm x 16mmSkyPlate Large: 384mm x 460mm x 16mm | SkyPlate Small: SameSkyPlate Large: SameSkyPlate E: 384.5mm x 460.5mm x 16.0mm | Equivalent size does not affect clinical workflow or image quality. | Equivalent size does not affect the clinical workflow or clinical image quality so there is no impact to the safety and effectiveness of the device. |
| Max X-ray Dose for Linear Response | 50 μGy | 50 μGy | Same | Equivalent; No impact to safety and effectiveness. |
| Maximum Usable Dose | SkyPlate Small: 75 μGySkyPlate Large: 75 μGy | SkyPlate Small: SameSkyPlate Large: SameSkyPlate E: 80 μGy | Equivalent or better. | Equivalent or better; No impact to safety and effectiveness of the device. |
| Maximum Lifetime Dose | 100 Gy | 100 Gy | Same | Equivalent; No impact to safety and effectiveness. |
| Detector Weight | SkyPlate Small: 1.6 Kg (incl. battery)SkyPlate Large: 2.8 Kg (incl. battery) | SkyPlate Small: SameSkyPlate Large: SameSkyPlate E: 3.1 Kg (incl. battery) | No impact on clinical workflow. | It has no impact on clinical workflow. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. |
| Image Size (X-ray field) | SkyPlate Small: 284x222mmSkyPlate Large: 344.8mm x 421.2mm | SkyPlate Small: SameSkyPlate Large: SameSkyPlate E: 345mm x 426mm | Difference does not impact clinical Image Quality. | This difference in the Image Size (X-ray field) does not impact clinical Image Quality. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. |
| Pixel Size | SkyPlate Small & Large: 148 μm | SkyPlate Small & Large: SameSkyPlate E: 160 μm | Difference of 12 μm does not impact image resolution to affect clinical image quality. | The difference of 12 μm pixel size does not impact the image resolution to an extent that can impact the clinical image quality. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. |
| Image Matrix Size (Number of pixels) | SkyPlate Small: 1500 X 1920SkyPlate Large: 2330 x 2846 | SkyPlate Small: SameSkyPlate Large: SameSkyPlate E: 2156 x 2662 | Infinitesimal change and reduction does not impact clinical Image Quality. | Infinitesimal change in the image size (X-ray field) and reduction in number of pixels due to 160 μm pixel size does not impact clinical Image Quality. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. |
| Nyquist Frequency | SkyPlate Small & Large: 3.38 lp/mm | SkyPlate Small & Large: SameSkyPlate E: 3.125 lp/mm | Difference does not impact clinical Image Quality. | This difference in the Nyquist Frequency does not impact clinical Image Quality. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. |
| Modulation Transfer Function (MTF) | SkyPlate Small & Large (e.g., 1 lp/mm 61%, 3.38 lp/mm 10%) | SkyPlate Small & Large: SameSkyPlate E (e.g., 1 lp/mm 62%, 3.125 lp/mm 16%) | Difference does not impact clinical Image Quality. | This difference in the Modulation Transfer Function does not impact clinical Image Quality. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. |
| Detective Quantum Efficiency (DQE) | SkyPlate Small & Large (e.g., 0 lp/mm 70%, 3.38 lp/mm 19%) | SkyPlate Small & Large: SameSkyPlate E (e.g., 0 lp/mm 70%, 3.125 lp/mm 18%) | Difference does not impact clinical Image Quality. | This difference in the Detective Quantum Efficiency does not impact clinical Image Quality. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. |
| ADC Digitisation | 16 Bit | 16 Bit | Same | Equivalent; No impact to safety and effectiveness. |
| Signal to Electronic Noise Ratio (SENR) | SkyPlate Small & Large: Min 38 dB – typical: 43 dB (@ 1 μGy) | SkyPlate Small & Large: SameSkyPlate E: Min 37 dB - typical: 42.8 dB (@ 1 μGy) | Equivalent. | Equivalent; No impact to safety and effectiveness. |
| Data Interface to Workstation | AP to workspot: 1 GBit/s Ethernet, etc. | Same | Same | Equivalent; No impact to safety and effectiveness. |
| Grids | Large Grids for SkyPlate Large, Small Grid for SkyPlate Small | Large Grids for SkyPlate Large: SameSmall Grid for SkyPlate Small: SameLarge Grids for SkyPlate E | Addition of new grids does not impact clinical workflow. | Addition of new grids for SkyPlate E introduction has no impact on clinical workflow. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. |
| Indications for Use | Acquire, process, store, display, export digital radiographic images, suitable for routine radiography. | Same | Same | Equivalent; No impact to safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "The proposed DigitalDiagnost C90 did not require clinical study since substantial equivalence to the 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."
Therefore, there was no clinical test set with human subject data used for this specific 510(k) submission. The evaluation was based on non-clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test set was used for this submission. The ground truth, in this context, was established through adherence to recognized standards and technical measurements, not expert clinical assessment of a dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for an x-ray system with a new detector, not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an AI algorithm. The performance evaluation was for the imaging system itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission was established through:
- Adherence to international and FDA-recognized consensus standards: This includes technical specifications and performance metrics outlined in standards like IEC 60601 series, IEC 62220-1, and IEC 62304.
- Results of non-standard performance tests: These tests are designed to verify specific technical aspects of the device and confirm its functionality and safety. The report mentions "System Verification Test," "Image Quality Test," and "Human Factors and Usability Engineering Test."
- Comparison to the predicate device: The core of the substantial equivalence claim relies on demonstrating that the new detector either performs the same as, or does not negatively impact the performance of, the previously cleared predicate device based on its technical specifications.
8. The sample size for the training set
Not applicable, as this is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI algorithm.
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September 30, 2020
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Philips Medical Systems DMC GmbH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114
Re: K202564
Trade/Device Name: DigitalDiagnost C90 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, KPR, LLZ Dated: September 2, 2020 Received: September 4, 2020
Dear Prithul Bom:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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5. Statement of Indication for Use/Intended Use
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
Indications for Use
| 510(k) Number (if known) | K202564 |
|---|---|
| Device Name | DigitalDiagnost C90 |
| Indications for Use (Describe) |
The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The
DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care,
trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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K202564
6. 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: | September 23, 2020 |
|---|---|
| Manufacturer: | Philips Medical Systems DMC GmbHRöntgenstraße 2422335 Hamburg, GERMANYEstablishment registration number: 3003768251 |
| Contact Person: | Ming XiaoRegulatory Affairs ManagerPhone: +49 40 34971-2306Fax: +49 40 5078-2147E-mail: ming.xiao@philips.com |
| Device Name: | DigitalDiagnost C90 |
| Classification: | |
| Trade Name: DigitalDiagnost C90 | |
| Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) | |
| Classification Regulation: 21CFR 892.1680 | |
| Regulation Description: Stationary x-ray system | |
| Classification Panel: 90 -- Radiology | |
| Device Class: Class II | |
| Classification Product Code: MQB, KPR, LLZ | |
| Predicate Device: | |
| Trade Name: DigitalDiagnost C90 | |
| Manufacturer: Philips Medical Systems DMC GmbH | |
| 510(k) Clearance: K182973- January 11, 2019 | |
| Classification Regulation: 21CFR 892.1680 | |
| Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) | |
| Classification Panel: 90 - Radiology | |
| Device Class: Class II | |
| Product Code: MQB, KPR, LLZ | |
| Reference Device for SkyPlate E Detector: | |
| Trade Name : MobileDiagnost wDR 2.2 | |
| Manufacturer: Sedecal S.A | |
| 510(K) Clearance: K191813- August 2, 2019 | |
| Classification Regulation: | 21CFR 892.1720 |
| Classification Name: | Mobile X-ray Systems |
| Classification Panel: | 90- Radiology |
| Device Class: | Class II |
| Product Code: | IZL, MQB |
DigitalDiagnost C90 Premarket Notification – Special 510(k)
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| DeviceDescription | The proposed DigitalDiagnost C90 is same as the 510(K) approved predicate(K182973) as mentioned below | Predicate Device: | Proposed Device: | Discussion & Conclusion | |
|---|---|---|---|---|---|
| It is a high-end digital radiography system consisting of a height adjustable patientsupport table and a ceiling suspension consisting of a tube including a control handleused to acquire images with a flat panel fixed RAD detector. Additionally, differentvertical stands for the radiography examinations are available. The ceiling suspensioncan be moved in longitudinal and lateral directions and additionally the tube can betilted and rotated as well. The proposed DigitalDiagnost C90 is configured with aPhilips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE,together with the tube these components form the radiography Image Chain.The proposed DigitalDiagnost C90 introduces a new wireless portable detector,pixium 3543DR i.e. SkyPlate E (cleared in reference device 510(K) K191813) andtheir relevant grids, in addition to the family of SkyPlate detectors (pixium 3543EZi.e. Large and pixium 2430EZ i.e. Small) that are already integrated in the currentlymarketed (predicate) DigitalDiagnost C90 (K182973). | DigitalDiagnostC90 (K182973-January 11,2019) | DigitalDiagnostC90 (K202564) | |||
| Indications forUse/IntendedUse: | The Indication for Use of the proposed DigitalDiagnost C90 is identical to that of thecurrently marketed and predicate device, DigtalDiagnost C90 (K182973- January 11,2019) and is as follows: | Table Features | |||
| The DigitalDiagnost C90 is intended to acquire, process, store, display and exportdigital radiographic images. The DigitalDiagnost C90 is suitable for all routineradiography examinations, including specialist areas like intensive care, trauma orpediatric work, excluding fluoroscopy, angiography and mammography. | Height adjustable table (TH-2) | ||||
| FundamentalScientificTechnology: | The proposed DigitalDiagnost C90 employs the same basic construction andfundamental scientific technology as the currently marketed predicate DigtalDiagnostC90 (K182973, January 11, 2019), with regards to the functionality of all itscomponents | ||||
| The proposed DigitalDiagnost C90 employs the same cleared features as predicateDigitalDiagnost C90 as follows | |||||
| fixed RAD detector (Pixium 4343RCE, K170113, February 9, 2017), wireless detectors (SkyPlate Detector, cleared by Eleva Workspot forDigitalDiagnost, K141736, July 25, 2014), image chain acquisition-station and workflow (Eleva Workspot withSkyFlow, K153318, December 22, 2015). | |||||
| Heightadjustment | 51.5 cm to 91.5cm above floor,motorizedadjustment | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Tableweight | 335 kg | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Max. patientweight | • Static load center:375 kg• Dynamic loadcenter: 318 kg• Dynamic load offcenter: 210 kg | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Table topType | Floating table topof sandwichdesign withGetalit overlay | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Table topDimension | 240 cm x 75 cm | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Table toptravel | • longitudinal: ±56cm• transverse: ±12.8cm,electromagneticbrakes | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Single side suspended table (TH-S) | |||||
| Heightadjustment | 51 cm to 91 cmmotorizedadjustment | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Tableweight | 214 kg | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Max. patientweight | • table top center:225kg• end of table top:135kg | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Table topType | Floating table topof sandwichdesign withKevlar overlay,flat top | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Table topDimension | 260 cm x 75 cm | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Thickness oftable top | 4.7 cm | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Table toptravel | • longitudinal: ±20cm, hydraulicbrakes• transverse: ±20cm, hydraulicbrakes | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Patientcoveragewith fixedRADdetector | • longitudinal: 208cm• Transversal: 83cm | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Celling Suspension CSM | |||||
| Type | Four-partaluminumtelescopic columnwith springcounter balancedholder for X-raytube assembly;adaptable toindividual roomheights | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Ceilingheight atsourceimagedistance 110cm | 2.83 to 3.21 m | Same | Equivalent; No impact to thesafety and effectiveness of thedevice. | ||
| Movement | 3.26 m to 3.41m | Same | Equivalent; No impact to thesafety and effectiveness of thedevice. | ||
| Transversetravel | 1.49 m to 3.21 m | Same | Equivalent; No impact to thesafety and effectiveness of thedevice. | ||
| Verticaltravel | 1.65 m | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| X-ray tubeassemblyrotation | • around verticalaxis: 360° (±180°)with lock positionevery 45°• around horizontalaxis: ±115°, lock | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| positions 0° and | |||||
| ±90° | |||||
| Length ofrails | 4.3 m | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Collimator | • Ralco P 225 ACSDHHS• Motorizedautomaticcollimation• Manual overrulepossible• With light fieldindicator• With 2 Lasers andCamera | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Vertical Stand | |||||
| Vertical moveable stand (VM) | |||||
| Hardware | Counterbalancedrugged columnfor motorizedverticalmovement of thedetector unit | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Verticaltravel | 35 cm to 185 cm | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Horizontaltravel | • Motorized: 3.475m• with extensionrails, motorized:5.5 m | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Swivelingrange | 0° to 90° (right orleft orientatedexecution) | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Lock-inpositions | manual or every15° | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Fixed Vertical Stand (VS) | |||||
| Hardware | Counterbalancedrugged columnfor motorized andmanual verticalmovement of thedetector | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Verticaltravel | 30 cm to 180 cm | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Installation | Floor and wallattachment orfloor only | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Fixed RADDetector | pixium 4343RCE | Same | Equivalent; No impact tosafety and effectiveness of thedevice | ||
| WirelessStaticDetector | • SkyPlate Small(pixium 2430EZ)• SkyPlate Large(pixium 3543EZ) | • SkyPlate Large(pixium 3543EZ)• SkyPlate Small(pixium 2430EZ)• SkyPlate E(pixium 3543DR) | AdditionofSkyPlateEdetector does not affect theclinical workflow or clinicalimage quality so there is noimpact tothe safety andeffectiveness of the device. | ||
| Generator | High-voltagegenerator 65kWor 80kW | Same | Equivalent; No impacttosafety and effectiveness of thedevice. | ||
| Tube | High power X-rayTube, PhilipsSRO 33100 | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| SkyFlow | Yes | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| ElevaWorkspot | Yes | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| SkyPlateDetectorSharing | Yes | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| AutomaticImagestitching | Yes | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Detectors | |||||
| Type | Digital wirelessflat detector | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| DetectorModels | • SkyPlate Large(pixium 3543EZ)• SkyPlate Small(pixium 2430EZ) | • SkyPlate Large(pixium 3543EZ)• SkyPlate Small(pixium 2430EZ) | AdditionofSkyPlateEdetector does not affect theclinical workflow or clinicalimage quality so there is noimpact to the safety andeffectiveness of the device. | ||
| • SkyPlate E(pixium 3543DR) | impact to the safety andeffectiveness of the device. | ||||
| X-RayAbsorber | CsI Scintillator | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Installationtype | Portable | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| ReadoutMechanism | Thin FilmTransistor | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| DetectorSize | • SkyPlate Small:328mm x 268mmx 16 mm• SkyPlate Large:384mm x 460mmx 16 mm | • SkyPlate Small:Same• SkyPlate Large:same• SkyPlate E: 384.5mm x 460.5 mm x16.0 mm | Equivalent size does not affectthe clinical workflow orclinical image quality so thereis no impact to the safety andeffectiveness of the device. | ||
| MaximumX-ray Dosefor LinearResponse | $50 \mu Gy$ | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| MaximumUsable Dose | • SkyPlate Small:$75 \mu Gy$• SkyPlate Large:$75 \mu Gy$ | • SkyPlate Small:Same• SkyPlate Large:Same• SkyPlate E: $80 \mu Gy$ | Equivalent or better; Noimpact to safety andeffectiveness of the device. | ||
| ImageProcessing | ElevaWorkstation | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| MaximumLifetimeDose | 100 Gy | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| DetectorWeight | • SkyPlate Small:1.6 Kg includingbattery• SkyPlate Large:2.8 kg includingbattery | • SkyPlate Small:Same• SkyPlate Largedetector: same• SkyPlate E: 3.1kg includingbattery | It has no impact on clinicalworkflow. Therefore, noimpact on safety andeffectiveness of the device;thus, demonstrating SE | ||
| Image Size(X-ray field) | • SkyPlate Small:284X222mmm• SkyPlate Large:344.8 mm x 421.2 mm | • SkyPlate Small:Same• SkyPlate Large:Same• SkyPlate Edetector: 345 mmx 426 mm | This difference in the ImageSize (X-ray field) does notimpact clinical Image Quality.Therefore, no impact on safetyand effectiveness of thedevice; thus, demonstratingSE | ||
| Pixel Size | • SkyPlate Small &Large: 148 μm | • SkyPlate Small &Large: Same• SkyPlate E: 160μm | The difference of 12 μm pixelsize does not impact the imageresolution to an extent that canimpact the clinical imagequality. Therefore, no impacton safety and effectiveness ofthe device; thus,demonstrating SE | ||
| Imagematrix size(Number ofpixels) | •SkyPlate Small:1500 X 1920Pixels•SkyPlate Large:2330 x 2846pixels | • SkyPlate Small:same• SkyPlate Large:same• SkyPlate E: 2156x 2662 pixels | Infinitesimal change in theimage size (X-ray field) andreduction in number of pixelsdue to 160 μm pixel size doesnot impact clinical ImageQuality. Therefore, no impacton safety and effectiveness ofthe device; thus,demonstrating SE | ||
| NyquistFrequency | • SkyPlate Small &large: 3.38 lp/mm | • SkyPlate Small &large: Same• SkyPlate E: 3.125lp/mm | This difference in the NyquistFrequency does not impactclinical Image Quality.Therefore, no impact on safetyand effectiveness of thedevice; thus, demonstratingSE | ||
| ModulationTransferFunction(MTF),typicalvalues | • SkyPlate Small &Large1 lp/mm 61%2 lp/mm 30%3 lp/mm 14%3.38 lp/mm 10%(Nyquist) | • SkyPlate Small &large: Same• SkyPlate E:1 lp/mm 62%2 lp/mm 34%3 lp/mm 18%3.125 lp/mm 16%(Nyquist) | This difference in theModulation Transfer Functiondoes not impact clinical ImageQuality.Therefore, no impact on safetyand effectiveness of thedevice; thus, demonstratingSE | ||
| DetectiveQuantumEfficiency(DQE), | • SkyPlate Small &large:DQE at 2.0 μGy | • SkyPlate Small &large: Same• SkyPlate E: DQEat 2.0 μGy | This difference in theDetective Quantum Efficiencydoes not impact clinical ImageQuality. | ||
| typicalvalues | Lp/mm | % | Lp/mm | % | Therefore, no impact on safetyand effectiveness of thedevice; thus, demonstratingSE |
| 0 | 70 | 0 | 70 | ||
| 1 | 51 | 1 | 51 | ||
| 2 | 42 | 2 | 42 | ||
| 3 | 29 | 3 | 22 | ||
| 3.38(Nyquist) | 19 | 3.125(Nyquist) | 18 | ||
| ADCDigitisation | 16 Bit | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Signal toElectronicNoise Ratio(SENR) | • SkyPlate Small &Large:Min 38 dB –typical: 43 dB (@1 μGy) | • SkyPlate Small &large: Same• SkyPlate E: Min37 dB - typical:42.8 dB (@ 1μGy) | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| DataInterface toWorkstation | • AP to workspot:1 GBit/sEthernet• DetectorEthernet viaBUC: 100Mbit/s Ethernet• Detector to AP:150 Mbit/sWLAN (grosstransfer rate) | Same | Equivalent; No impact tosafety and effectiveness of thedevice. | ||
| Grids | |||||
| Type | • Large Grids forSkyPlate Large(468 mm × 476mm × 25 mm)• Small Grid forSkyPlate Small(280 mm × 354mm × 25 mm) | • Large Grids forSkyPlate Large:Same• Small Grid forSkyPlate Small:Same• Large Grids forSkyPlate E(468 mm × 476mm × 25 mm) | Addition of new grids forSkyPlate E introduction hasno impact on clinicalworkflow.Therefore, no impact on safetyand effectiveness of thedevice; thus, demonstratingSE | ||
| Indicationsfor Use | TheDigitalDiagnostC90 is intended toacquire, process,store, display andexport digital | Same | Equivalent; No impact tosafety and effectiveness of thedevice. |
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Only modification to the proposed is the introduction of SkyPlate E Detector and their relevant grids (Reference device, K191813- August 2, 2019). The additional SkyPlate E detector that has been integrated in the proposed DigitalDiagnost C90, has equivalent design, technology and Image acquisition workflow compared to the previously cleared detector (SkyPlate Family detectors), used in the marketed predicate device DigtalDiagnost C90 (K182973, January 11, 2019), except difference in the pixel size. 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. Further the Non-clinical information sufficiently supports the substantial equivalence as per chapter VII- Non clinical Considerations of FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.
The aforementioned modifications have also been evaluated in safety risk assessment report. The risks associated with these changes are considered in the risk management report and risk management activities show that all risks are sufficiently mitigated and that the overall residual risks are acceptable. The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the proposed DigitalDiagnost C90 when compared to the currently marketed and predicate DigitalDiagnost C90.
Summary of technological characteristics:
The proposed DigitalDiagnost C90 has same design, indications for use, fundamental scientific technology and similar technological characteristics as the marketed predicate device, DigitalDiagnost C90. Both devices are equivalent with respect to table features, Ceiling suspension CSM, Vertical stand feature. Both uses the same fixed RAD detector, Image chain acquisition station and workflow and Wireless detectors of SkyPlate family. The only modification in the proposed DigitalDiagnost C90 is the introduction of the SkyPlate E detector and its relevant grid. The modifications do not affect the clinical work flow or the clinical image quality demonstrating that the proposed DigitalDiagnost C90 is substantially equivalent to marketed predicate device, DigitalDiagnost C90 (K182973).
Table below provides comparison of the proposed DigitalDiagnost C90 with the predicate (marketed) DigitalDiagnost C90. It also includes the comparison of the SkyPlate E detector with the SkyPlate detector provided with the currently marketed and predicate DigitalDiagnost C90.
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DigitalDiagnost C90 Premarket Notification – Special 510(k)
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| radiographic | ||
|---|---|---|
| images. The | ||
| DigitalDiagnost | ||
| C90 is suitable for | ||
| all routine | ||
| radiography | ||
| examinations, | ||
| including | ||
| specialist areas | ||
| like intensive | ||
| care, trauma or | ||
| pediatric work, | ||
| excluding | ||
| fluoroscopy, | ||
| angiography and | ||
| mammography | ||
Summary of Non-Clinical Performance Data:
This 510(k) premarket notification contains the technical documentation, which demonstrates that the proposed DigitalDiagnost C90 is substantially equivalent to the currently marketed predicate DigitalDiagnost C90 (K182973, January 11, 2019). The technical documentation includes non-clinical verification / validation tests. These tests have been performed on the proposed DigitalDiagnost C90 according to the following international and FDA-recognized consensus standards, as well as additional non-standard performance tests.
IEC 60601-1, Medical electrical equipment. General requirements for safety. . Collateral standard. Safety requirements for medical electrical systems
IEC 60601-1-2, Medical electrical equipment. General requirements for basic ● safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
. IEC 60601-1-3. Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-2-54, Medical electrical equipment. Particular requirements for the ● basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC 62220-1, Medical electrical equipment. Characteristics of digital X-ray ● imaging devices. Determination of the detective quantum efficiency
IEC 62304, Medical device software. Software life-cycle processes .
IEC 60601-1-6. General requirements for basic safety and essential ● performance - Collateral standard: Usability
ISO 14971, Medical devices. Application of risk management to medical ● devices
Additional non-standard performance tests have been performed to demonstrate the safety and effectiveness:
- System Verification Test ●
- . Image Quality Test
- . Human Factors and Usability Engineering Test
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Non-Clinical performance testing confirmed the proposed DigitalDiagnost C90:
- Complies with the aforementioned international and FDA-recognized consensus standards.
- Meets the acceptance criteria of the non-standard performance tests and is adequate for its intended use.
The results of testing support that the proposed DigitalDiagnost C90 is substantially equivalent to the currently marketed and predicate device DigtalDiagnost C90 (K182973, January 11, 2019) in terms of safety and effectiveness.
The proposed DigitalDiagnost C90 did not require clinical study since substantial Summary of Clinical Data: equivalence to the 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.
Substantial The proposed DigitalDiagnost C90 is substantially equivalent to the currently Equivalence marketed predicate device DigtalDiagnost C90 (K182973, January 11, 2019) in terms Conclusion: of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC 62304, IEC 62366 and ISO 14971. The results of these tests demonstrate that proposed DigitalDiagnost C90 met the acceptance criteria and is adequate for this 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.