(28 days)
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremittes, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not for mammography.
The MobileDiagnost wDR 2.2 is a motorized mobile radiographic system consisting of a mobile base unit, a user interface consisting of Eleva Workspot combined with flat solid state X-ray detectors used to operate, generate, process and handle digital X- ray images. The MobileDiagnost wDR 2.2 integrates a new wireless portable detector (SkyPlate E). The family of SkyPlate detectors (Large and Small) have already been integrated into the MobileDiagnost wDR 2.0 based on the K141736 pre-market submission.
The provided text describes a 510(k) premarket notification for the MobileDiagnost wDR 2.2, a mobile X-ray system. The focus of the submission is to demonstrate substantial equivalence to a predicate device, the MobileDiagnost wDR 2.0 (K141895), with several modifications. The document does not contain a clinical study to prove the device meets acceptance criteria in terms of diagnostic effectiveness or a "performance study" in the typical sense of evaluating a new diagnostic algorithm's accuracy. Instead, the submission relies on demonstrating substantial equivalence through non-clinical verification and validation tests against established standards.
Therefore, the requested information needs to be framed within this context of demonstrating substantial equivalence, rather than a traditional diagnostic performance study.
Here's the breakdown of the information based on the provided text:
Acceptance Criteria and Device Performance (within the context of Substantial Equivalence)
The acceptance criteria are implicitly defined by the compliance with recognized international and FDA consensus standards and the outcome of the comparison to the predicate device, showing that modifications do not raise new questions of safety or effectiveness. The device performance is assessed against these standards and through direct comparison of technical characteristics to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission relying on technical changes and compliance with standards, the "acceptance criteria" are compliance with these standards and the "reported device performance" is the verification that these standards are met, and that the technical characteristics of the modified device are acceptably equivalent to the predicate.
| Feature Area / Acceptance Criteria | Reported Device Performance (MobileDiagnost wDR 2.2) | Conclusion (vs. Predicate) |
|---|---|---|
| I. Compliance with International and FDA-recognized Consensus Standards & FDA Guidance Documents | Non-clinical verification and validation tests demonstrate compliance with: - IEC 60601-1 (Edition 3.1) - IEC 60601-1-2 (Edition 4.0) - IEC 60601-1-3 (Edition 2.1) - IEC 60601-1-6 (Edition 3.1) - IEC 60601-2-54 (Edition 1.1) - IEC 62304 (Edition 1.0:2006) - IEC 62366 (Edition 1.0 2015) - ISO 14971 (Edition 2.0, 2007) - ISO 10993-1 (Edition 4.0 2009) - IEC 60601-2-28 (Edition 2.0 2010-03) - IEC 62220-1 (Edition 1.0 2015-03) - NEMA PS 3.1 - 3.20 (DICOM) - "Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices" (Sept 1, 2016) - "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) - "Pediatric Information for X-ray Imaging Device Premarket Notifications" (Nov 28, 2017) | Meets acceptance criteria and is adequate for its intended use, demonstrating substantial equivalence. Non-clinical information deemed sufficient to support substantial equivalence. |
| II. Technical Characteristics Equivalence (MobileDiagnost wDR 2.2 vs. MobileDiagnost wDR 2.0) | ||
| Base Unit Type, X-ray Tube rotational capabilities, Mains Supply, Mode of Exposure, Available Exposure Methods, X-ray Absorber, Installation type, Readout Mechanism, Maximum X-ray Dose for Linear Response, Maximum Usable Dose, Maximum Lifetime Dose, Image Processing (Eleva Workstation), ADC Digitisation, Signal to Electronic Noise Ratio (SENR), Data Interface to Workstation, X-ray Tube type, material, maximum voltage, nominal focal spot, anode type, nominal anode input power, Generator configurations, Collimator operation mode, beam shape, External Connectivity (DICOM), Software Platform (Eleva WorkSpot with SkyFlow). | Same/Identical to predicate. | Identical; thus, demonstrating Substantial Equivalence (SE). |
| Dimensions (overall, transport, source-floor distance) | Minor differences in mm measurements. | Differences do not impact safety or effectiveness. Thus, demonstrating SE. |
| Detector Models | Addition of SkyPlate E Large (Trixell 3543DR). Previously cleared SkyPlate Large/Small retained. | Addition of SkyPlate E detector does not impact safety or effectiveness. Thus, demonstrating SE. All technical detector characteristics influencing image quality assessed per FDA guidance. |
| Detector Weight | Max 3.1 kg (vs. Max 3 kg for predicate). | Difference has no impact on clinical workflow, safety, or effectiveness. Thus, demonstrating SE. |
| Image Size (X-ray field) | 345.0 mm x 426.0 mm (vs. 344.8 mm x 421.2 mm for predicate). | Difference does not impact clinical Image Quality, safety, or effectiveness. Thus, demonstrating SE. |
| Pixel Size | 160 µm (vs. 148 µm for predicate). | Difference of 12 µm pixel size does not impact image resolution "to an extent that can impact the clinical image quality," safety or effectiveness. Thus, demonstrating SE. |
| Image matrix size (Number of pixels) | 2156 x 2662 pixels (vs. 2330 x 2846 pixels for predicate). | "Infinitesimal change" and reduction in number of pixels due to 160 µm pixel size does not impact clinical Image Quality, safety, or effectiveness. Thus, demonstrating SE. |
| Nyquist Frequency | 3.125 lp/mm (vs. 3.38 lp/mm for predicate). | Difference does not impact clinical Image Quality, safety, or effectiveness. Thus, demonstrating SE. |
| Modulation Transfer Function (MTF) & Detective Quantum Efficiency (DQE) | Slightly different typical values reported (e.g., MTF at 1 lp/mm: 62% vs. 61%; DQE at 3 lp/mm: 22% vs. 29%). | Differences do not impact clinical Image Quality, safety, or effectiveness. Thus, demonstrating SE. |
| Grids | Addition of new large grids for SkyPlate E. Previously cleared grids retained. | Addition of new grids has no impact on clinical workflow, safety, or effectiveness. Thus, demonstrating SE. |
| Column Configuration | Sliding Column (vs. Standard/Short Column for predicate). | Sliding Column provides better viewing; its introduction does not impact safety or effectiveness. Thus, demonstrating SE. |
| System Power ON/OFF | Keyless user access (vs. Physical Key for predicate). | Keyless user access provides authenticated access; its introduction does not impact safety or effectiveness. Thus, demonstrating SE. |
| Exposure @ zero degree column position | Exposures allowed (vs. No Exposure allowed for predicate). | Allows examinations in space-constrained situations; difference does not impact safety or effectiveness. Thus, demonstrating SE. |
| Exposure during Charging | Exposures allowed (vs. Not allowed for predicate). | Allows charging during exam preparation; exposure energy still drawn from generator batteries, not mains. Does not impact safety or effectiveness. Thus, demonstrating SE. |
| Handles on Collimator | Handles can be used to move both Tube head and Collimator (vs. only Tube head for predicate). | Provides ease of use; difference does not impact safety or effectiveness. Thus, demonstrating SE. |
| Image Processing Algorithm | UNIQUE 2 (vs. UNIQUE for predicate). | UNIQUE 2 provides improved image processing (reduced noise, improved contrast) and was already cleared under K182973. Upgrading does not alter clinical workflow, safety, or effectiveness. Thus, demonstrating SE. |
Study Details (as applicable for a Substantial Equivalence submission based on non-clinical data)
The provided text clearly states: "The MobileDiagnost wDR 2.2 does not require clinical study since substantial equivalence to the primary currently marketed and predicate device MobileDiagnost wDR 2.0 (K141895- September 18, 2014) was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness."
This means there was no "study" in the sense of a clinical trial or a diagnostic performance study to evaluate accuracy, sensitivity, specificity, etc., with human or AI readers. The "study" here refers to the comprehensive non-clinical verification and validation process against relevant standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. No clinical test set of patient data was used for a diagnostic performance evaluation. The "tests" were non-clinical verification and validation tests on the device itself (e.g., electrical safety, electromagnetic compatibility, radiation protection, software validation, usability, risk management).
- Data Provenance: Not applicable. No patient data (retrospective or prospective, from any country) was used for evaluating the device's diagnostic performance for the purpose of this 510(k) submission.
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. There was no diagnostic test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no diagnostic test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. This device is not an AI-assisted diagnostic product but rather an X-ray imaging system with updated components and software functionalities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an X-ray system, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. There was no diagnostic performance study requiring ground truth. Ground truth for the non-clinical tests would be the established scientific/engineering principles, specifications, and regulatory standards.
8. The sample size for the training set
- Not applicable. This device is an X-ray system, not a machine learning model that requires a "training set" in the context of AI. The software (UNIQUE 2) was previously cleared (K182973), indicating its own development and validation, but details of its training are not provided here.
9. How the ground truth for the training set was established
- Not applicable, as there was no training set for the device itself. For the incorporated UNIQUE 2 image processing algorithm, its ground truth establishment (if it involved machine learning) would have been part of its original 510(k) (K182973), but those details are not in this document.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 2, 2019
Sedecal SA % Ms. Laura Green Consultant Laura Green, LLC. 227 East 284th Street WILLOWICK OH 44095
Re: K191813
Trade/Device Name: MobileDiagnost wDR 2.2 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB Dated: July 3, 2019 Received: July 5, 2019
Dear Ms. Green:
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
MobileDiagnost wDR 2.2
Indications for Use (Describe)
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremittes, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not for 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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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510(k) Summary 6.
K191813
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: | July 3, 2019 | |
|---|---|---|
| Manufacturer: | SEDECAL SA | |
| C/ Pelaya, 9 – 13Pol. Ind. Río de Janeiro28110 Algete, MadridSpain (España)Establishment registration number: 9617251 | ||
| Contact Person: | Laura Green of Laura Green, LLC227 East 284th StreetWillowick, Ohio 44095Tel.: (404) 897-5675Email: laurag9@roadrunner.com | |
| Device Name: | MobileDiagnost wDR 2.2 | |
| Classification: | Classification Name | Mobile X-Ray System |
| Classification Regulation: | 21CFR 892.1720 | |
| Classification Panel: | 90-Radiology | |
| Device Class: | Class II | |
| Primary product code: | IZL | |
| Secondary code: | MQB | |
| Predicate Device: | Trade Name: | MobileDiagnost wDR 2.0 |
| Manufacturer: | Sedecal SA | |
| 510(k) Clearance: | K141895-September 18, 2014 | |
| Classification Regulation: | 21CFR 892.1720 | |
| Classification Name: | Mobile X-Ray System | |
| Classification Panel: | 90-Radiology | |
| Device Class: | Class II | |
| Product Code | IZL, MOB |
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| Reference Device 1: | Trade Name: | Philips Eleva Workspot withSkyPlate Detectors |
|---|---|---|
| Manufacturer: | Philips Medical SystemsDMC GmbH | |
| 510(k) Clearance: | K141736- July 25, 2014 | |
| Classification Regulation: | 21CFR 892.1680 | |
| Classification Name: | Stationary X-Ray System | |
| Classification Panel: | 90-Radiology | |
| Device Class: | Class II | |
| Product Code | MQB, LLZ | |
| Reference Device 2: | Trade Name: | Philips Eleva Workspot withSkyFlow |
| Manufacturer: | Philips Medical SystemsDMC GmbH | |
| 510(k) Clearance: | K153318- December 22, 2015 | |
| Classification Regulation: | 21 CFR 892.1680 | |
| Classification Name: | Stationary X-Ray System | |
| Classification Panel: | 90-Radiology | |
| Device Class: | Class II | |
| Product Code | MQB, LLZ | |
| Reference Device 3: | Trade Name: | DigitalDiagnost C90 |
| Manufacturer: | Philips Medical SystemsDMC GmbH | |
| 510(k) Clearance: | K182973- January 11, 2019 | |
| Classification Regulation: | 21CFR 892.1680 | |
| Classification Name: | Stationary X-Ray System | |
| Classification Panel: | 90-Radiology | |
| Device Class: | Class II | |
| Product Code | MQB, KPR, LLZ |
Device description:
The MobileDiagnost wDR 2.2 is a motorized mobile radiographic system consisting of a mobile base unit, a user interface consisting of
MobileDiagnost wDR 2.2 Premarket Notification- Special 510(k) Page 28 of 131
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Indications for use:
Eleva Workspot combined with flat solid state X-ray detectors used to operate, generate, process and handle digital X- ray images. The MobileDiagnost wDR 2.2 integrates a new wireless portable detector (SkyPlate E). The family of SkyPlate detectors (Large and Small) have already been integrated into the MobileDiagnost wDR 2.0 based on the K141736 pre-market submission.
The Indication for Use of the MobileDiagnost wDR 2.2 is identical to that of the currently marketed and predicate device. MobileDiagnost wDR 2.0 (K141895- September 18, 2014) and is as follows:
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not for mammography.
The fundamental scientific technology utilized Fundamental scientific technology: in the MobileDiagnost wDR 2.2 and the marketed currently and predicate MobileDiagnost wDR 2.0 (K141895) is equivalent to high voltage generator, X-ray tube and Collimator. The MobileDiagnost wDR 2.2 is provided with the Wireless portable detectors, Workstation for images post-processing, storage and viewing and image post processing algorithms that are the same as provided in the Reference following Devices that are manufactured by Philips Medical Systems.
- Philips Eleva Workspot with SkyPlate ● Detectors (K141736, July 25, 2014) ,
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- Philips Eleva Workspot with SkyFlow -● (K153318, December 22, 2015),
- Philips DigitalDiagnost C90 - Image ● Post Processing algorithms - UNIQUE 2 (K182973, January 11, 2019)
A comparison of the the technological characteristics of the MobileDiagnost wDR 2.2 the currently marketed and predicate to MobileDiagnost wDR 2.0 is provided below in Table 1.
Modifications to the MobileDiagnost wDR 2.2 include:
- Introduction of SkyPlate E detector and Grids
- · Upgrade to UNIQUE 2 Post Processing software (previously cleared under K182973)
- · Exposure (@ zero degree column position to accommodate imaging in narrow rooms
- · Exposure during Charging to offer use of the device while charging the battery
- · Handles have been added to the Collimator for additional positioning functionality
- · Keyless user access replaces the physical key previously required
The aforementioned modifications have 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.
Note: The outcome of this comparison demonstrates that the minor differences in the technological characteristics between the MobileDiagnost wDR 2.2 and the currently
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marketed and predicate MobileDiagnost wDR 2.0 (K141895- September 18, 2014) do not raise any new questions regarding safety or effectiveness.
| Table-1Comparison of technological characteristics of currently marketed and predicate MobileDiagnost wDR | |||
|---|---|---|---|
| 2.0 versus the MobileDiagnost wDR 2.2 | |||
| Predicate Device:MobileDiagnostwDR2.0(K141895) | MobileDiagnost wDR2.2(Pending) | Discussion & Conclusion | |
| Basic Information | |||
| Base UnitType | Mobile X-ray unit withwireless detector | Same | Identical; thus,demonstrating SE. |
| Dimensions:(1 x w x h)In operationmax. | 2550 mm x 670 mm x2125 mm | 2577 mm x 670 mm x 2125 mm | The differences in thedimensions do not impactthe safety or effectivenessof the device. Thus,demonstrating SE. |
| Dimensions:(1 x w x h)In transport | 1375 mm x 670 mmx1980 mm | 1382 mm x 670 mm x 1960 mm | The differences in thedimensions do not impactthe safety or effectivenessof the device. Thus,demonstrating SE. |
| Dimensions:Source - floordistance | 550 mm to 2020 mm | 530 mm to 2020 mm | The differences in thedimensions do not impactthe safety or effectivenessof the device. Thus,demonstrating SE. |
| X ray Tubeassemblyrotationaroundtelescope armaxis | +/-180° | Same | Identical; thus,demonstrating SE. |
| X ray tubeassemblyaroundlongitudinaltube axis | +90° to -30° | Same | Identical; thus;demonstrating SE. |
| Mains Supply | 100 VAC/110 VAC/230VAC±10%50 Hz/60 Hz | Same | Identical; thus,demonstrating SE. |
| Mode ofReleasingExposure | Releasing Exposure viaHand switch or viaRemote Control(Optional) | Same | Identical; thus,demonstrating SE. |
| AvailableExposureMethods | Free exposure techniqueon film cassettes or CRsystems and wirelessportable detectors | Same | Identical; thus,demonstrating SE. |
| Detector | |||
| Type | Digital wireless flatdetector | Same | Identical; thus,demonstrating SE. |
| DetectorModels | • SkyPlate Large(Trixell 3543EZ)• Skyplate Small(Trixell 2430EZ) | • SkyPlate Large (Trixell3543EZ)• Skyplate Small (Trixell2430EZ)• SkyPlate E large (Trixell3543DR) | Addition of SkyPlate Edetector does not impactthe safety or effectivenessof the device. Thus,demonstrating SE |
| X-RayAbsorber | CsI Scintillator | Same | Identical; thus,demonstrating SE |
| Installationtype | Portable | Same | Identical; thus,demonstrating SE |
| ReadoutMechanism | Thin Film Transistor | Same | Identical; thus,demonstrating SE |
| Detector Size | Large: 384 x 460 x 16mmSmall: 328 x 268 x 16mm | Large: 384 x 460 x 16 mmSmall: 328 x 268 x 16 mmSkyPlate E Large: 384.5 x 460.5x 16 mm | Identical; thus,demonstrating SE |
| Maximum X-ray Dose forLinearResponse | 50 µGy | Same | Identical; thus,demonstrating SE |
| MaximumUsable Dose | 75 µGy | Same | Identical; thus,demonstrating SE |
| ImageProcessing | Eleva Workstation | Same | Identical; thus,demonstrating SE |
| MaximumLifetime Dose | 100 µGy | Same | Identical; thus,demonstrating SE |
| DetectorWeight | Max 3 kg including.battery | Max 3.1 kg including battery | This difference in theDetector weight has noimpact on clinicalworkflow. Therefore, noimpact on safety oreffectiveness of thedevice; thus,demonstrating SE |
| Image Size(X-ray field) | 344.8 mm x 421.2 mm | 345.0 mm x 426.0 mm | This difference in theImage Size (X-ray field)does not impact clinicalImage Quality.Therefore, no impact onsafety or effectiveness ofthe device; thus,demonstrating SE |
| Pixel Size | 148 µm | 160 µm | The difference of 12 µmpixel size does not impactthe image resolution to an |
| extent that can impact theclinical image quality.Therefore, no impact onthe device; thus,demonstrating SE | |||
| Image matrixsize (Numberof pixels) | 2330 x 2846 pixels | 2156 x 2662 pixels | Infinitesimal change in theimage size (X-ray field)and reduction in numberof pixels due to 160 µmpixel size does not impactclinical Image Quality.Therefore, no impact onsafety or effectiveness ofthe device; thus,demonstrating SE |
| NyquistFrequency | 3.38 lp/mm | 3.125 lp/mm | This difference in theNyquist Frequency doesnot impact clinical ImageQuality.Therefore, no impact onsafety or effectiveness ofthe device; thus,demonstrating SE |
| ModulationTransferFunction(MTF), typicalvalues | 1 lp/mm 61%2 lp/mm 30%3 lp/mm 14%3.38 lp/mm 10%(Nyquist) | 1 lp/mm 62%2 lp/mm 34%3 lp/mm 18%3.125 lp/mm 16% (Nyquist) | This difference in theModulation TransferFunction does not impactclinical Image Quality.Therefore, no impact onsafety or effectiveness ofthe device; thus,demonstrating SE |
| DetectiveQuantumEfficiency(DQE), typicalvalues | DQE at 2.0 µGyLp/mm %0.05 701 512 423 293.38 19 (Nyquist) | DQE at 2.0 µGyLp/mm %0.05 701 512 423 223.125 18 (Nyquist) | This difference in theDetective QuantumEfficiency does not impactclinical Image Quality.Therefore, no impact onsafety or effectiveness ofthe device; thus,demonstrating SE |
| ADCDigitisation | 16 Bit | 16 Bit | Identical.; thus,demonstrating SE; |
| Signal toElectronicNoise Ratio(SENR) | Min 38 dB - typical: 43 dB (@ 1 µGy) | Min 37 dB - typical: 42.8 dB (@1 µGy) | Identical; thus,demonstrating SE |
| Data Interfaceto Workstation | • AP toworkspot: 1GBit/s Ethernet• DetectorEthernet viaBUC: 100 | Same | Identical; thus,demonstrating SE |
| Detector to AP: 150 Mbit/s WLAN (gross transfer rate) | |||
| Grids | |||
| Type | Large Grids for SkyPlate Large (468 mm × 476 mm × 25 mm) Small Grid for SkyPlate Small (280 mm × 354 mm × 25 mm) | Large Grids for SkyPlate Large (468 mm × 476 mm × 25 mm) Small Grid for SkyPlate Small (280 mm × 354 mm × 25 mm) Large Grids for SkyPlate E (468 mm × 476 mm × 23 mm) | Addition of new grids for Skyplate E introduction has no impact on clinical workflow. Therefore, no impact on safety or effectiveness of the device; thus, demonstrating SE |
| Design characteristics | |||
| X - Ray Tube | |||
| Tube | E7886X used with 40kW GeneratorE7865X used with 20kW Generator | Same | Identical.; thus, demonstrating SE |
| Material | Rhenium-Tungsten, Molybdenum | Same | Identical; thus, demonstrating SE. |
| Maximumtube voltage | 150 kVp | Same | Identical; thus, demonstrating SE. |
| Nominal focalspot | E7886X0.7/1.3E7865X- 0.3/1.0 | Same | Identical; thus, demonstrating SE. |
| Anode type | Rotating | Same | Identical; thus, demonstrating SE. |
| Nominalanode inputpower | 20kW, 40kW | Same | Identical; thus, demonstrating SE. |
| Generators | |||
| PowerConfigurations | 20kW and 40kW | Same | Identical.; thus, demonstrating SE |
| ColumnConfiguration | Standard ColumnShort Column (Optional) | Standard ColumnSliding Column | Sliding Column provides better viewing while driving the system.Introduction of Sliding column does not impact the safety or effectiveness of the device; thus, demonstrating SE |
| System PowerON/OFF | Using Physical Key | Keyless user access | Keyless user access provides authenticated access to System Power ON.Introduction of Keypad does not impact the safety |
| Exposure @zero degreecolumnposition | No Exposure allowedwhen the column is at 0Degree | Exposures are allowed when thecolumn is at 0 Degree | Exposure @ 0 degreecolumn position allows theuser to performexaminations in spaceconstraints situations. Thisdifference however doesnot impact the safety oreffectiveness of thedevice; thus,demonstrating SE |
| ExposureduringCharging | Exposures are notallowed when the unit isconnected to mains(Note: exposure energyis drawn from generatorbatteries and not frommains) | Exposures are allowed when theunit is connected to mains (Note:exposure energy is drawn fromgenerator batteries and not frommains) | Exposure during chargingallows the user to chargethe system even duringexam preparation. Since,exposure energy is stilldrawn from generatorbatteries and not frommains therefore thischange does not impactthe safety or effectivenessof the device; thus,demonstrating SE |
| Collimator | |||
| Operationmode | Manual with light fieldindicator, multilayer,squared field | Same | Identical; thus,demonstrating SE. |
| Shape of thebeam | Rectangular | Same | Identical; thus,demonstrating SE. |
| Handles onCollimator | Handles are availableonly to move the Tubehead. | Handles can be used to moveboth Tube head and Collimator | Handles on Collimatorprovides ease of use to theuser. This differencehowever does not impactthe safety or effectivenessof the device; thus,demonstrating SE |
| ExternalConnectivity | |||
| DICOM | DICOM compatible | Same | Identical; thus,demonstrating SE. |
| SoftwarePlatform | |||
| Software | Eleva WorkSpot withSkyFlow | Same | The MobileDiagnost wDR2.2 and the currentlymarketed predicateMobileDiagnost wDR 2.0both use the same softwareplatform, the Philips ElevaWorkspot with SkyFlow(K153318). Therefore,there is no impact on thesafety and effectiveness ofthe device |
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| ImageProcessingAlgorithm | UNIQUE | UNIQUE 2 | thus, demonstrating SE. |
|---|---|---|---|
| UNIQUE 2 providesimproved imageprocessing, reduced noiseand improved contrast.Further, UNIQUE 2 isalready cleared underK182973 (January 11,2019)Upgrading to UNIQUE2does not alter the clinicalworkflow, hence noimpact on the safety oreffectiveness of thedevice; thus,demonstrating SE |
Based on the information provided above, the MobileDiagnost considered substantially equivalent to the currently marketed and predicate MobileDiagnost wDR 2.0 (K141895-September 18, 2014) with regards to fundamental scientific technology.
This 510(k) premarket notification contains the technical documentation, which demonstrates that the MobileDiagnost wDR 2.2 is substantially equivalent to the currently marketed and predicate MobileDiagnost wDR 2.0 (K141895-September 18, 2014). The technical documentation includes non-clinical verification / validation tests. These tests were performed on the MobileDiagnost wDR 2.2 according to the following international and FDA-recognized consensus standards:
- IEC 60601-1, Medical Electrical Equipment -. Part 1: General requirements for basic safety and essential performance (Edition 3.1). FDA/CDRH recognition number 19-4.
- IEC 60601-1-2, Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Disturbances - Requirements and tests (Edition 4.0 2014). FDA/CDRH recognition number 19-8.
Summary of Non-Clinical Performance data:
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- IEC 60601-1-3, Medical Electrical Equipment Part 1-3: General Requirements for Basic Safety and Essential Performance-Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment. (Edition 2.1 2013). FDA/CDRH recognition number 12-269.
- IEC 60601-1-6, Medical Electrical Equipment ● Part 1-6: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Usability (Edition 3.1 2013). FDA/CDRH recognition number 5-89.
- IEC 60601-2-54, Medical Electrical Equipment-● Part 2-54: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy (Edition 1.1 2015). FDA/CDRH recognition number 12-296.
- IEC 62304 Medical device software - Software cycle processes (Edition 1.0:2006) life FDA/CDRH recognition number 13-32
- IEC 62366 IEC Application of Usability Engineering to Medical Devices (Edition 1.0 2015). FDA/CDRH recognition number 5-114.
- ISO 14971 Medical devices Application of risk ● management to medical devices (Edition 2.0, version, 2007). FDA/CDRH corrected recognition number 5-40.
- ISO 10993-1 Biological evaluation of medical devices. Part 1: Evaluation and testing within a risk management process (Edition 4.0 2009). FDA/CDRH recognition number 2-220
- IEC60601-2-28 Medical electrical equipment -Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis, (Edition 2.0 2010-03). FDA/CDRH recognition number 12-204
- IEC 62220-1 Medical electrical equipment-● Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging (Edition 1.0 2015-03) FDA/CDRH recognition number 12-289
- NEMA PS 3.1 - 3.20 Digital Imaging And Communications In Medicine (DICOM) Set
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- Guidance for the Submission of 510(k)s for Solid ● State X-Ray Imaging Devices, issued September 1, 2016
- Guidance . for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
- Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 28, 2017
Non-clinical verification and validation tests have been performed with regards to the intended use, the technical claims, requirement specifications, and the risk management results.
Non-clinical verification and validation test results demonstrate that the MobileDiagnost wDR 2.2:
- Complies with the aforementioned international . and FDA-recognized consensus standards and FDA guidance documents.
- meets the acceptance criteria and is adequate for ● its intended use.
Therefore, the MobileDiagnost wDR 2.2 is substantially equivalent to the currently marketed and predicate MobileDiagnost wDR 2.0 (K141895-September 18, 2014)
Summary of Clinical Data: The MobileDiagnost wDR 2.2 does not require clinical study since substantial equivalence to the primary currently marketed and predicate device MobileDiagnost wDR 2.0 (K141895- September 18, 2014) was demonstrated with the following attributes:
- . Indication for use;
- Technological characteristics; ●
- Non-clinical performance testing; and
- Safety and effectiveness. ●
Furthermore, the SkyPlate E detector also has the same design, technology and Image acquisition workflow compared to the previously cleared detector (SkyPlate
MobileDiagnost wDR 2.2 Premarket Notification- Special 510(k) Page 38 of 131
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| Substantial EquivalenceConclusion: | Family detectors, K141736- July 25, 2014), used in themarketed predicate device MobileDiagnost wDR 2.0(K141895- September 18, 2014), except difference in thepixel size. All technical detector characteristics thatpotentially have an influence on image quality areassessed and verified according to FDA Guidance forIndustry and Food and Drug Administration Staff:Guidance for the Submission of 510(k)'s for Solid StateX-ray Imaging Devices; issued on September 1, 2016.Non-clinical information is sufficient to support thesubstantial equivalence as per chapter VII- Non clinicalConsiderations of FDA Guidance for the Submission of510(k)'s for Solid State X-ray Imaging Devices.The MobileDiagnost wDR 2.2 is substantially equivalentto the currently marketed and predicate MobileDiagnostwDR 2.0 (K141895, September 18, 2014) in terms ofdesign features, fundamental scientific technology,indications for use, and safety and effectiveness.Additionally, substantial equivalence was demonstratedwith non-clinical performance (verification andvalidation) tests, which complied with the requirementsspecified in the international and FDA-recognizedconsensus standards, ISO 14971, IEC 60601-1, IEC60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-1-6, IEC 60601-2-28, IEC 62304, IEC 62366, and ISO10993-1.The results of these tests demonstrate that theMobileDiagnost wDR 2.2 met the acceptance criteria andis adequate for its intended use. |
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§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.