Who is the manufacturer of MobileDiagnost wDR 2.2?

Sedecal., Sa. filed the 510(k) submission for MobileDiagnost wDR 2.2 (K191813).

What is the FDA product code for MobileDiagnost wDR 2.2?

IZL. It is classified under 21 CFR 892.1720 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MobileDiagnost wDR 2.2?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like MobileDiagnost wDR 2.2?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MobileDiagnost wDR 2.2

Q: What are the predicate devices for MobileDiagnost wDR 2.2?

MobileDiagnost wDR 2.0 (K141895).

K191813 · Sedecal., Sa. · IZL · Aug 2, 2019 · Radiology

Device Facts

Record ID	K191813
Device Name	MobileDiagnost wDR 2.2
Applicant	Sedecal., Sa.
Product Code	IZL · Radiology
Decision Date	Aug 2, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1720
Device Class	Class 2
Attributes	Pediatric

Intended Use

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.

Device Story

MobileDiagnost wDR 2.2 is a motorized mobile radiographic system; utilizes high voltage generator, X-ray tube, collimator, and wireless portable detectors (SkyPlate E). Operated by qualified doctors or technologists in clinical settings. System captures digital X-ray images; processes them via Eleva Workspot using UNIQUE 2 post-processing software. Features include keyless access, sliding column for improved visibility, and capability for exposure during battery charging or at zero-degree column position. Output is digital radiographic images for clinical diagnostic review. Benefits include improved workflow, enhanced image processing (reduced noise, improved contrast), and flexibility in space-constrained environments.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through non-clinical performance testing, including verification and validation of design features, image quality metrics (MTF, DQE), and compliance with international consensus standards (IEC 60601 series, ISO 14971, ISO 10993-1).

Technological Characteristics

Mobile X-ray system; motorized base; wireless flat-panel detectors (SkyPlate E, CsI scintillator, TFT readout). High voltage generator (20kW/40kW); Rhenium-Tungsten/Molybdenum X-ray tube. Connectivity: DICOM, 1 GBit/s Ethernet, 150 Mbit/s WLAN. Software: Eleva Workspot with UNIQUE 2 processing. Sterilization: N/A (non-invasive). Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 60601-2-28, IEC 62304, IEC 62366, ISO 14971, ISO 10993-1.

Indications for Use

Indicated for diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts in adult and pediatric patients. Can be used with patient sitting, standing, or lying (prone/supine). Contraindicated for mammography.

Regulatory Classification

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.

Predicate Devices

MobileDiagnost wDR 2.0 (K141895)

Reference Devices

Philips Eleva Workspot with SkyPlate Detectors (K141736)
Philips Eleva Workspot with SkyFlow (K153318)
DigitalDiagnost C90 (K182973)

Related Devices

K141895 — MOBILEDIAGNOST WDR · Sedecal., Sa. · Sep 18, 2014
K173018 — MDR17 Mobile Direct Radiographic System · Del Medical, Inc. · Nov 20, 2017
K213568 — DRX-Rise Mobile X-ray System · Carestream Health · Mar 23, 2022
K120062 — DRX-REVOLUTION MOBILE X-RAY SYSTEM · Carestream Health, Inc. · Apr 13, 2012
K241505 — DRX-Revolution Mobile X-ray System · Carestream Health, Inc. · Dec 10, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191813 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) | |----------------------------------------------|---------------------------------------------| |----------------------------------------------|---------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *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 time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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 – 13 Pol. Ind. Río de Janeiro 28110 Algete, Madrid Spain (España) Establishment registration number: 9617251 | | | Contact Person: | Laura Green of Laura Green, LLC 227 East 284th Street Willowick, Ohio 44095 Tel.: (404) 897-5675 Email: 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 | {4}------------------------------------------------ | Reference Device 1: | Trade Name: | Philips Eleva Workspot with SkyPlate Detectors | |---------------------|----------------------------|---------------------------------------------------| | | Manufacturer: | Philips Medical Systems DMC 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 with SkyFlow | | | Manufacturer: | Philips Medical Systems DMC 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 Systems DMC 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 {5}------------------------------------------------ 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) , {6}------------------------------------------------ - 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 {7}------------------------------------------------ marketed and predicate MobileDiagnost wDR 2.0 (K141895- September 18, 2014) do not raise any new questions regarding safety or effectiveness. | Table-1 Comparison of technological characteristics of currently marketed and predicate MobileDiagnost wDR | | | | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2.0 versus the MobileDiagnost wDR 2.2 | | | | | | Predicate Device: MobileDiagnost wDR2.0 (K141895) | MobileDiagnost wDR2.2 (Pending) | Discussion & Conclusion | | Basic Information | | | | | Base Unit Type | Mobile X-ray unit with wireless detector | Same | Identical; thus, demonstrating SE. | | Dimensions: (1 x w x h) In operation max. | 2550 mm x 670 mm x 2125 mm | 2577 mm x 670 mm x 2125 mm | The differences in the dimensions do not impact the safety or effectiveness of the device. Thus, demonstrating SE. | | Dimensions: (1 x w x h) In transport | 1375 mm x 670 mm x1980 mm | 1382 mm x 670 mm x 1960 mm | The differences in the dimensions do not impact the safety or effectiveness of the device. Thus, demonstrating SE. | | Dimensions: Source - floor distance | 550 mm to 2020 mm | 530 mm to 2020 mm | The differences in the dimensions do not impact the safety or effectiveness of the device. Thus, demonstrating SE. | | X ray Tube assembly rotation around telescope arm axis | +/-180° | Same | Identical; thus, demonstrating SE. | | X ray tube assembly around longitudinal tube axis | +90° to -30° | Same | Identical; thus; demonstrating SE. | | Mains Supply | 100 VAC/110 VAC/230 VAC±10% 50 Hz/60 Hz | Same | Identical; thus, demonstrating SE. | | Mode of Releasing Exposure | Releasing Exposure via Hand switch or via Remote Control (Optional) | Same | Identical; thus, demonstrating SE. | | Available Exposure Methods | Free exposure technique on film cassettes or CR systems and wireless portable detectors | Same | Identical; thus, demonstrating SE. | | Detector | | | | | Type | Digital wireless flat detector | Same | Identical; thus, demonstrating SE. | | Detector Models | • SkyPlate Large (Trixell 3543EZ) • Skyplate Small (Trixell 2430EZ) | • SkyPlate Large (Trixell 3543EZ) • Skyplate Small (Trixell 2430EZ) • SkyPlate E large (Trixell 3543DR) | Addition of SkyPlate E detector does not impact the safety or effectiveness of the device. Thus, demonstrating SE | | X-Ray Absorber | CsI Scintillator | Same | Identical; thus, demonstrating SE | | Installation type | Portable | Same | Identical; thus, demonstrating SE | | Readout Mechanism | Thin Film Transistor | Same | Identical; thus, demonstrating SE | | Detector Size | Large: 384 x 460 x 16 mm Small: 328 x 268 x 16 mm | Large: 384 x 460 x 16 mm Small: 328 x 268 x 16 mm SkyPlate E Large: 384.5 x 460.5 x 16 mm | Identical; thus, demonstrating SE | | Maximum X- ray Dose for Linear Response | 50 µGy | Same | Identical; thus, demonstrating SE | | Maximum Usable Dose | 75 µGy | Same | Identical; thus, demonstrating SE | | Image Processing | Eleva Workstation | Same | Identical; thus, demonstrating SE | | Maximum Lifetime Dose | 100 µGy | Same | Identical; thus, demonstrating SE | | Detector Weight | Max 3 kg including .battery | Max 3.1 kg including battery | This difference in the Detector weight has no impact on clinical workflow. Therefore, no impact on safety or effectiveness of the device; 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 the Image Size (X-ray field) does not impact clinical Image Quality. Therefore, no impact on safety or effectiveness of the device; thus, demonstrating SE | | Pixel Size | 148 µm | 160 µm | 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 onthe device; thus, demonstrating SE | | Image matrix size (Number of pixels) | 2330 x 2846 pixels | 2156 x 2662 pixels | 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 or effectiveness of the device; thus, demonstrating SE | | Nyquist Frequency | 3.38 lp/mm | 3.125 lp/mm | This difference in the Nyquist Frequency does not impact clinical Image Quality. Therefore, no impact on safety or effectiveness of the device; thus, demonstrating SE | | Modulation Transfer Function (MTF), typical values | 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 the Modulation Transfer Function does not impact clinical Image Quality. Therefore, no impact on safety or effectiveness of the device; thus, demonstrating SE | | Detective Quantum Efficiency (DQE), typical values | DQE at 2.0 µGy Lp/mm % 0.05 70 1 51 2 42 3 29 3.38 19 (Nyquist) | DQE at 2.0 µGy Lp/mm % 0.05 70 1 51 2 42 3 22 3.125 18 (Nyquist) | This difference in the Detective Quantum Efficiency does not impact clinical Image Quality. Therefore, no impact on safety or effectiveness of the device; thus, demonstrating SE | | ADC Digitisation | 16 Bit | 16 Bit | Identical.; thus, demonstrating SE; | | Signal to Electronic Noise Ratio (SENR) | Min 38 dB - typical: 43 dB (@ 1 µGy) | Min 37 dB - typical: 42.8 dB (@ 1 µGy) | Identical; thus, demonstrating SE | | Data Interface to Workstation | • AP to workspot: 1 GBit/s Ethernet • Detector Ethernet via BUC: 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 Generator E7865X used with 20kW Generator | Same | Identical.; thus, demonstrating SE | | Material | Rhenium-Tungsten, Molybdenum | Same | Identical; thus, demonstrating SE. | | Maximum tube voltage | 150 kVp | Same | Identical; thus, demonstrating SE. | | Nominal focal spot | E7886X 0.7/1.3 E7865X- 0.3/1.0 | Same | Identical; thus, demonstrating SE. | | Anode type | Rotating | Same | Identical; thus, demonstrating SE. | | Nominal anode input power | 20kW, 40kW | Same | Identical; thus, demonstrating SE. | | Generators | | | | | Power Configurations | 20kW and 40kW | Same | Identical.; thus, demonstrating SE | | Column Configuration | Standard Column Short Column (Optional) | Standard Column Sliding 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 Power ON/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 degree column position | No Exposure allowed when the column is at 0 Degree | Exposures are allowed when the column is at 0 Degree | Exposure @ 0 degree column position allows the user to perform examinations in space constraints situations. This difference however does not impact the safety or effectiveness of the device; thus, demonstrating SE | | Exposure during Charging | Exposures are not allowed when the unit is connected to mains (Note: exposure energy is drawn from generator batteries and not from mains) | Exposures are allowed when the unit is connected to mains (Note: exposure energy is drawn from generator batteries and not from mains) | Exposure during charging allows the user to charge the system even during exam preparation. Since, exposure energy is still drawn from generator batteries and not from mains therefore this change does not impact the safety or effectiveness of the device; thus, demonstrating SE | | Collimator | | | | | Operation mode | Manual with light field indicator, multilayer, squared field | Same | Identical; thus, demonstrating SE. | | Shape of the beam | Rectangular | Same | Identical; thus, demonstrating SE. | | Handles on Collimator | Handles are available only to move the Tube head. | Handles can be used to move both Tube head and Collimator | Handles on Collimator provides ease of use to the user. This difference however does not impact the safety or effectiveness of the device; thus, demonstrating SE | | External Connectivity | | | | | DICOM | DICOM compatible | Same | Identical; thus, demonstrating SE. | | Software Platform | | | | | Software | Eleva WorkSpot with SkyFlow | Same | The MobileDiagnost wDR 2.2 and the currently marketed predicate MobileDiagnost wDR 2.0 both use the same software platform, the Philips Eleva Workspot with SkyFlow (K153318). Therefore, there is no impact on the safety and effectiveness of the device | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ | Image Processing Algorithm | UNIQUE | UNIQUE 2 | thus, demonstrating SE. | |----------------------------------|--------|----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | UNIQUE 2 provides improved image processing, reduced noise and improved contrast. Further, UNIQUE 2 is already cleared under K182973 (January 11, 2019) Upgrading to UNIQUE2 does not alter the clinical workflow, hence no impact on the safety or effectiveness of the device; 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: {13}------------------------------------------------ - 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 {14}------------------------------------------------ - 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 {15}------------------------------------------------ | Substantial Equivalence Conclusion: | Family detectors, K141736- July 25, 2014), used in the marketed predicate device MobileDiagnost wDR 2.0 (K141895- September 18, 2014), 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. Non-clinical information is sufficient to support 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 MobileDiagnost wDR 2.2 is substantially equivalent to the currently marketed and predicate MobileDiagnost wDR 2.0 (K141895, September 18, 2014) in terms 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, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601- 1-6, IEC 60601-2-28, IEC 62304, IEC 62366, and ISO 10993-1. The results of these tests demonstrate that the MobileDiagnost wDR 2.2 met the acceptance criteria and is adequate for its intended use. | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|