(28 days)
No
The document mentions image processing algorithms but does not explicitly state or imply the use of AI or ML. There is no mention of AI, DNN, or ML in the text, nor are there descriptions of training or test sets typically associated with AI/ML development.
No
The device is used for taking diagnostic radiographic exposures for imaging purposes, not for treating conditions or diseases.
Yes
The device is intended for "taking diagnostic radiographic exposures" and explicitly mentions "Applications can be performed with patient sitting, standing or lying in the prone or supine positions," indicating its use in obtaining images for diagnosis, which is a diagnostic function.
No
The device description explicitly states it 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". This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for taking diagnostic radiographic exposures of various body parts. This is an imaging procedure performed on a patient, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The description details a mobile radiographic system that generates and processes X-ray images. This aligns with medical imaging equipment, not IVD devices.
- Input Imaging Modality: The input modality is X-ray, which is a form of medical imaging, not a method used for analyzing biological samples.
- Anatomical Site: The device is used on various anatomical sites within the patient's body. IVDs analyze samples taken from the body.
IVD devices are designed to examine specimens such as blood, urine, or tissue to provide information for diagnosis, monitoring, or screening. This device is a medical imaging system used to visualize internal structures of the body directly.
N/A
Intended Use / Indications for 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.
Product codes
IZL, MQB
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified/trained doctor or technologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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. ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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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, |
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. |
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