(45 days)
The MobileDiagnost M50 is a mobile radiographic system used for general X-ray imaging. This system can be used for taking x-ray images of patients who can't be moved to a fixed system. Applications include examinations of chest, upper and lower extremities, spinal column, skull radiography and abdominal cavities. MobileDiagnost M50 is not suitable for Mammography.
The MobileDiagnost M50 is a digital mobile X-ray system, used to perform X-ray examinations in different locations of a hospital, particularly for the patient who cannot be transferred to a fixed X-ray room. The MobileDiagnost M50 allows the user to take X-rays on a digital wireless detector and the image can then be viewed on the Eleva Workspot. The MobileDiagnost M50 consists of a mobile base unit and a user interface combined with a flat solid state X-ray detector. It is used by the operator to generate, process and handle digital X-ray images.
The provided text is a 510(k) summary for the Philips MobileDiagnost M50. It does not describe a study involving an AI/Machine Learning device, but rather a mobile x-ray system. The basis of the submission is demonstrating substantial equivalence to a predicate device through non-clinical performance testing and technical comparisons, rather than a clinical effectiveness study of an AI algorithm improving human performance.
Therefore, many of the requested criteria related to AI/ML device studies (such as MRMC studies, ground truth establishment, sample sizes for training/test sets for AI, expert consensus, etc.) are not applicable to this document.
However, I can extract information regarding the device's technical specifications and the non-clinical tests performed to demonstrate safety and effectiveness, which serve as its "acceptance criteria" and "proof" in the context of this 510(k) submission for substantial equivalence.
Here's a breakdown of the requested information based on the provided document, with explanations for what is not applicable:
Device: MobileDiagnost M50 (Mobile X-ray System)
1. Table of Acceptance Criteria and Reported Device Performance
In the context of this 510(k), acceptance criteria are primarily compliance with recognized standards and demonstration of comparable performance to the predicate device through technical specifications and non-clinical testing. The "reported device performance" is the MobileDiagnost M50's specifications and its compliance with the standards.
| Acceptance Criteria (General) | Reported Device Performance (MobileDiagnost M50) | Discussion (from document) |
|---|---|---|
| Compliance with International & FDA Standards | Complies with: ISO 14971, IEC 60601-1, -1-2, -1-3, -1-6, IEC 60601-2-54, IEC 62304, IEC 62366, ISO 10993-1, ISO 13485, CFR 1020.30, CFR 1020.31, FDA Guidance Documents. | Non-clinical verification and validation test results demonstrate that the MobileDiagnost M50 complies with these standards and meets the acceptance criteria for its intended use. This is the primary "proof" of meeting safety and effectiveness for a device of this type seeking 510(k) clearance via substantial equivalence. |
| Technical Equivalence to Predicate (MobileDiagnost wDR 2.0 - K141895) | Demonstrated through direct comparison of specifications. Examples: | The document provides a detailed table comparing features. For minor differences (e.g., dimensions, mono bloc rotation, mains supply, max kVp, nominal anode input power, mAs range), the justification provided is that "The minor differences... do not impact the safety or effectiveness of the device. Thus, demonstrating SE." For cases where the MobileDiagnost M50 uses a different component (e.g., detector scintillator, X-ray tube type, image matrix size, pixel size, image resolution), the justification leans on the fact that these components are either functionally equivalent OR are identical to those in other referenced/cleared devices (e.g., Varian PaxScan 4336Wv4 detector from K161459), thereby inheriting their demonstrated safety and effectiveness and not impacting that of the MobileDiagnost M50 differently. |
| - Base Unit Type | Mobile X-ray unit with wireless detector | Same as predicate. No difference. |
| - Dimensions | LxWxH: Operations 1836x618x2293mm; Transport 1371x618x1500mm | Minor differences from predicate, deemed not to impact safety/effectiveness. |
| - Detector Type | Digital wireless flat detector | Same as predicate. |
| - Scintillator | Gadox | Different from predicate (Cesium Iodide) but uses same wireless detector (PaxScan 4336Wv4) as a cleared reference device (K161459), thus no impact on safety/effectiveness. |
| - Detector Size (Large) | 14" x 17" | Same as predicate. |
| - Image Matrix Size (Large) | 2476 x 3072 pixels | Different from predicate (2330x2846 pixels) but uses same wireless detector as cleared reference device (K161459), thus no impact on safety/effectiveness. |
| - Pixel Size | 139 µm | Different from predicate (148 µm) but uses same wireless detector as cleared reference device (K161459), thus no impact on safety/effectiveness. |
| - Image Resolution | 3.6 lp/mm | Different from predicate (3.38 lp/mm) but uses same wireless detector as cleared reference device (K161459), thus no impact on safety/effectiveness. |
| - X-Ray Tube Type | X22 (Predicate: TOSHIBA E7886X) | Operates in the same manner as predicate's tube; no impact to safety/effectiveness. |
| - Maximum Tube Voltage | 130 kVp (Predicate: 150 kVp) | Minor difference, deemed not to impact safety/effectiveness. |
| - mAs Range | 0.1 mAs - 110 mAs (Predicate: 0.1 mAs - 500 mAs) | Difference noted, but justified as "required detector dose can be achieved for all clinical examinations for the MobileDiagnost M50. Therefore, there is no impact on the safety and effectiveness of the device." |
| - Software Platform | Philips Eleva Workspot | Same as predicate; therefore no impact on safety/effectiveness. |
| Adequacy for Intended Use | Demonstrated via non-clinical verification and validation tests. | "Non-clinical verification and validation test results demonstrate that the MobileDiagnost M50… Meets the acceptance criteria and is adequate for its intended use." |
2. Sample size used for the test set and the data provenance
- Not Applicable: This is a submission for an X-ray system, not an AI/ML device that requires a "test set" of images for AI performance evaluation. The "testing" referred to is non-clinical verification and validation against engineering specifications and regulatory standards. The documentation does not detail specific sample sizes of patients/images for performance testing, as it's not a clinical efficacy study.
- Data Provenance: Not applicable in the context of image data for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: No "ground truth" establishment by experts on a test set of images is mentioned as this is not an AI/ML device. The "ground truth" for this device's performance is compliance with established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No clinical 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
- Not Applicable: This is a mobile X-ray hardware system, not an AI assistance tool. No MRMC study was performed or required. The document explicitly states: "The MobileDiagnost M50 did not require a clinical study since substantial equivalence to the currently marketed and predicate MobileDiagnost wDR 2.0 was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing including validation; and Safety and effectiveness."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an algorithm/AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable: No clinical ground truth was established from patient data. The "ground truth" for clearance is the device's adherence to technical performance specifications and safety standards as demonstrated through non-clinical testing.
8. The sample size for the training set
- Not Applicable: This is not an AI/ML device. No training set for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable: This is not an AI/ML device. No training set or ground truth for it.
Summary of Acceptance/Proof for this Device:
The "acceptance criteria" for the Philips MobileDiagnost M50, as presented in this 510(k) summary, revolve around:
- Compliance with recognized electrical, radiation safety, usability, and quality management standards. This is demonstrated through non-clinical verification and validation tests.
- Demonstration of "substantial equivalence" to a legally marketed predicate device (MobileDiagnost wDR 2.0 - K141895). This is proven by showing that any differences in design features or fundamental scientific technology do not impact the safety or effectiveness of the device. Where components differ (e.g., the detector's scintillator), justification is provided by referencing other predicate/cleared devices that use the same component and have already demonstrated safety and effectiveness (e.g., Varian PaxScan 4336Wv4 detector, K161459).
The "study that proves the device meets the acceptance criteria" is the comprehensive set of non-clinical verification and validation tests performed to ensure compliance with the listed international and FDA-recognized consensus standards and internal design requirements. The results of these tests are stated to have demonstrated that the device "met the acceptance criteria and is adequate for its intended use."
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November 16, 2017
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Philips India Limited % Nidhi Bathwal Regulatory Operations Specialist Plot No. B-79, MIDC, Phase II, Chakan, Taluka-Khed. Village - Savardari Pune, Maharashtra 410501 INDIA
Re: K173187
Trade/Device Name: MobileDiagnost M50 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MOB Dated: October 18, 2017 Received: October 19, 2017
Dear Nidhi Bathwal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Odlo
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
MobileDiagnost M50
Indications for Use (Describe)
The MobileDiagnost M50 is a mobile radiographic system used for general X-ray imaging. This system can be used for taking x-ray images of patients who can't be moved to a fixed system. Applications include examinations of chest, upper and lower extremities, spinal column, skull radiography and abdominal cavities. MobileDiagnost M50 is not suitable 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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7. 510(k) Summary
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | September 29, 2017 | ||
|---|---|---|---|
| Manufacturer: | Philips India LimitedPlot No. B-79, MIDC, Phase-II, ChakanTaluka - khed, Village - SavardariDistrict: PuneMaharashtra 410501IndiaEstablishment Registration Number: 3010685285 | ||
| Primary ContactPerson: | Nidhi BathwalTitle: Regulatory Operations SpecialistPhone: 91-206635 7814E-mail: nidhi.bathwal@philips.com | ||
| SecondaryContact Person | Karthik HoskereTitle: Regulatory Operations SpecialistPhone: 91-206635 7814E-mail: karthik.hoskere@philips.com | ||
| Device Name: | MobileDiagnost M50 | ||
| 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 Product Code: | MOB |
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| PrimaryPredicate Device: | Trade Name: | MobileDiagnost wDR 2.0 |
|---|---|---|
| Manufacturer: | SEDECAL SA | |
| 510(k) Clearance: | K141895 (September 18, 2014) | |
| Classification Regulation: | 21 CFR, Part 892.1720 | |
| Classification Name: | Mobile X-Ray System | |
| Classification Panel: | 90 - Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | IZL | |
| Secondary Product Code: | MQB | |
| Reference Device: | Trade Name: | Nexus DR™ Digital X-ray ImagingSystem (with PaxScan 4336Wv4) |
| Manufacturer: | Varian Medical Systems | |
| 510(k) Clearance: | K161459 (September 6, 2016) | |
| Classification Regulation: | 21 CFR 892.1680 | |
| Classification Name: | Stationary X-ray system | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | MQB | |
| Reference Device: | Trade Name: | Eleva Workspot with SkyFlow |
| Manufacturer: | Philips Medical Systems | |
| 510(k) Clearance: | K153318 (December 22, 2015) | |
| Classification Regulation: | 21 CFR 892.1680 | |
| Classification Name: | Solid State X-ray Imager (FlatPanel/Digital Imager) | |
| Classification Panel: | 90 - Radiology | |
| Device Class: | Class II | |
| Product Code: | MQB | |
| Secondary Product Code: | LLZ |
Device Description:
The MobileDiagnost M50 is a digital mobile X-ray system, used to perform X-ray examinations in different locations of a hospital,
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particularly for the patient who cannot be transferred to a fixed X-ray room. The MobileDiagnost M50 allows the user to take X-rays on a digital wireless detector and the image can then be viewed on the Eleva Workspot.
The MobileDiagnost M50 consists of a mobile base unit and a user interface combined with a flat solid state X-ray detector. It is used by the operator to generate, process and handle digital X-ray images.
The MobileDiagnost M50 is a mobile radiographic system used for Indications for general X-ray imaging. This system can be used for taking x-ray images Use: of patients who can't be moved to a fixed system. Applications include examinations of chest, upper and lower extremities, spinal column, skull radiography and abdominal cavities. MobileDiagnost M50 is not suitable for Mammography.
Fundamental The MobileDiagnost M50 employs the same basic construction and Scientific fundamental scientific technology as the currently marketed and predicate Technology: MobileDiagnost wDR 2.0 (K141895), with regards to the functionality of the following components: high-voltage generator, dual-focus rotation anode X-Ray tube, manual beam limiting device, digital wireless detector, and workstation for post-processing, storage and viewing images (see the comparison table comparing the MobileDiagnost M50 to the currently marketed and predicate MobileDiagnost wDR 2.0 provided below).
The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the MobileDiagnost M50 when compared to the currently marketed and predicate MobileDiagnost wDR 2.0.
The wireless portable detector of the MobileDiagnost M50 is identical to the wireless portable detector (PaxScan 4336Wv4) of the currently marketed and reference device, Varian Nexus DRTM Digital X-ray Imaging System manufactured by Varian Medical System (K161459, cleared Sept 6, 2016). Therefore, both the wireless portable detector of the MobileDiagnost M50 and the wireless portable detector of the reference device, Varian Nexus DR"M Digital X-ray Imaging System employ identical fundamental scientific technology.
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| Summary of Technological Characteristics of the MobileDiagnost M50 to theCurrently Marketed and Predicate Device | |||
|---|---|---|---|
| Feature | Currently Marketed andPredicateMobileDiagnost wDR2.0(K141895) | ProposedMobileDiagnostM50 | Discussion |
| Basic Information | |||
| Base UnitType | Mobile X-ray unit withwireless detector | Same | No difference; thus,demonstrating SE. |
| Dimensions:(l x w x h)In operationmax. | 2550 mm x 670 mm x2125 mm | 1836 mm x 618 mm2293 mm | The minor differences inthe dimensions do notimpact the safety oreffectiveness of thedevice. Thus,demonstrating SE. |
| Dimensions:(l x w x h)In transport | 1375 mm x 670 mm x1980 mm | 1371 mm x 618 mmx 1500 mm | The minor differences inthe dimensions do notimpact the safety oreffectiveness of thedevice. Thus,demonstrating SE. |
| Dimensions:Source -floor distance | 550 mm to 2020 mm | 416 mm to 2056mm | The minor differences inthe dimensions do notimpact the safety oreffectiveness of thedevice. Thus,demonstrating SE. |
| Mono blocrotationaround armaxis | +/-180° | Same | No difference; thus,demonstrating SE. |
| Mono blocrotationaround itsaxis | +90° to -30° | +102° to -49° | The minor differences inthe rotation around theaxis do not impact thesafety or effectiveness ofthe device. Thus,demonstrating SE. |
| MainsSupply | 100 VAC/110 VAC/230VAC±10%50 Hz/60 Hz | 98-120VAC/ 195-240VAC,50 Hz /60 Hz | The minor differences inthe mains supply do notimpact the safety oreffectiveness of thedevice. Thus,demonstrating SE. |
| Mode ofReleasingExposure | Releasing Exposure viaHand switch or viaRemote Control(Optional) | Same | No difference; thus,demonstrating SE. |
| Availableexposuremethods | Free exposure techniqueon film cassettes or CRsystems | Same | No difference; thus,demonstrating SE. |
| Detector | |||
| Type | Digital wireless flatdetector | Same | No difference; thus,demonstrating SE. |
| Scintillator | Cesium Iodide | Gadox | The proposedMobileDiagnost M50uses the same wirelessdetector as in the |
| Detector size | Large detector:14" x 17"Small detector:12" x 10" | Same: Largedetector: 14" x 17" | reference device: NexusDR™ Digital X-rayImaging System (withPaxScan 4336Wv4)(K161459), thereforethere is no impact onsafety and effectiveness.Thus, demonstrating SE.No difference; thus,demonstrating SE. |
| Active area | Large detector:13.6" x 16.6"Small detector:8.7" x 11.2" | Large detector:13.4" x 16.7" | The proposedMobileDiagnost M50uses the same wirelessdetector as in thereference device: NexusDR™ Digital X-rayImaging System (withPaxScan 4336Wv4)(K161459), thereforethere is no impact onsafety and effectiveness.Thus, demonstrating SE. |
| Image matrixsize | Large detector:2330 x 2846 pixelsSmall detector:1500 x 1920 pixels | Large detector:2476 x 3072 pixels | The proposedMobileDiagnost M50uses the same wirelessdetector as in thereference device: NexusDR™ Digital X-rayImaging System (withPaxScan 4336Wv4)(K161459), thereforethere is no impact onsafety and effectiveness.Thus, demonstrating SE. |
| Pixel size | 148 µm | 139 µm | The proposedMobileDiagnost M50uses the same wirelessdetector as in thereference device: NexusDR™ Digital X-rayImaging System (withPaxScan 4336Wv4)(K161459), thereforethere is no impact onsafety and effectiveness.Thus, demonstrating SE. |
| Analog /Digital (A/D)conversion | 16 bits | Same | No difference; thus,demonstrating SE. |
| Imageresolution | 3.38 lp/mm | 3.6 lp/mm | The proposedMobileDiagnost M50uses the same wirelessdetector as in thereference device: NexusDR™ Digital X-rayImaging System (withPaxScan 4336Wv4)(K161459), thereforethere is no impact onsafety and effectiveness.Thus, demonstrating SE. |
| Design Characteristics | |||
| X- Ray Tube | |||
| Type | TOSHIBA E7886X | X22 | The proposedMobileDiagnost M50 X-ray tube operates in thesame manner, thereforethere is no impact tosafety and effectiveness.Thus, demonstrating SE. |
| Material | Rhenium-Tungsten,Molybdenum | Same | No difference; thus,demonstrating SE. |
| Maximumtube voltage | 150 kVp | 130 kVp | The minor differences inthe maximum tubevoltage does not impactsafety or effectiveness ofthe device. Thus,demonstrating SE. |
| Nominalfocal spot | 0.7/1.3 | 0.8 /1.3 | The minor difference inthe focal spot size doesnot impact safety oreffectiveness of thedevice. Thus,demonstrating SE. |
| Anode type | Rotating | Same | No difference; thus,demonstrating SE. |
| Nominalanode inputpower | 20kW, 40kW | 16kW, 32kW | The difference in thenominal anode inputpower does not impactsafety or effectiveness ofthe device. Thus,demonstrating SE. |
| Generator | |||
| Power | 20kW, 40kW | 16kW, 32kW | The minor difference inthe power does notimpact the safety oreffectiveness of thedevice. Thus,demonstrating SE. |
| Type | High frequency | Same | No difference; thus,demonstrating SE. |
| kV range | 40 - 150 kV (1kV steps) | 40 - 125 kV (1kVsteps) | The minor difference inthe maximum tubevoltage does not impactthe safety oreffectiveness of thedevice. Thus,demonstrating SE. |
| Milli amperesec(mAs) range | 0.1 mAs - 500 mAs | 0.1 mAs - 110 mAs | The difference in themAs range does notimpact the safety oreffectiveness of thedevice because therequired detector dosecan be achieved for allclinical examinations forthe MobileDiagnostM50. Therefore, there isno impact on the safetyand effectiveness of thedevice; thus,demonstrating SE. |
| Collimator | |||
| Operationmode | Manual with light fieldindicator, multilayer,squared field | Same | No difference; thus,demonstrating SE. |
| Shape of thebeam | Rectangular | Same | No difference; thus,demonstrating SE. |
| External Connectivity | |||
| DICOM | DICOM compatible | Same | No difference; thus,demonstrating SE. |
| Software Platform | |||
| Software | Philips Eleva Workspot | Same | The proposedMobileDiagnost M50and the currentlymarketed and predicatePhilips MobileDiagnostwDR 2.0 both use thesame software platform,the Philips ElevaWorkspot with SkyFlow(K153318). Therefore,there is no impact on thesafety and effectivenessof the device; thus,demonstrating SE. |
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Based on the information provided above, the MobileDiagnost M50 is considered substantially equivalent to the currently marketed and predicate MobileDiagnost wDR 2.0 (K141895, September 18, 2014) in terms of fundamental scientific technology.
| Summary of Non-ClinicalPerformanceData: | The MobileDiagnost M50 complies with the following Internationaland FDA-recognized consensus standards: ISO 14971, Application of risk management to medical devices IEC 60601-1, Medical Electrical Equipment – Part 1: Generalrequirements for basic safety and essential performance. IEC 60601-1-2, Medical electrical equipment – Part 1-2: Generalrequirements for basic safety and essential performance –Collateral Standard: Electromagnetic Compatibility –Requirements and tests IEC 60601-1-3, Medical Electrical Equipment Part 1-3: GeneralRequirements for Basic Safety and Essential Performance.-Collateral Standard: Radiation Protection in Diagnostic X-RayEquipment. IEC 60601-1-6, Medical Electrical Equipment Part 1-6: GeneralRequirements for Basic Safety and Essential Performance-Collateral Standard: Usability IEC 60601-2-54, Medical Electrical Equipment- Part 2-54:Particular Requirements for the Basic Safety and EssentialPerformance of X-Ray Equipment for Radiography andRadioscopy |
|---|---|
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- IEC 62304, Medical Device Software Software Life Cycle ● Processes.
- IEC 62366, Medical devices - Application of Usability Engineering to Medical Devices.
- ISO 10993-1, Biological Evaluation of Medical Devices. ● Evaluation and Testing within a Risk Management Process
- ISO 13485, Quality management for medical devices
- CFR 1020.30 Diagnostic x-ray systems and their major components.
- CFR 1020.31 Radiographic equipment. ●
- Guidance Document, entitled "Guidance for the ● FDA Submission of 510(k)'s for Solid State X-ray Imaging Devices" issued September 1, 2016
- FDA Guidance Document entitled, "Guidance for the Content of ● Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005
- FDA Draft Guidance Document entitled, "Pediatric Information ● for X-ray Imaging Device Premarket Notifications" issued May 10, 2012
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 M50:
- . Complies with the aforementioned international and FDArecognized consensus standards and FDA guidance documents.
- . Meets the acceptance criteria and is adequate for its intended use.
Therefore, the MobileDiagnost M50 is substantially equivalent to the currently marketed and predicate MobileDiagnost wDR 2.0 (K141895, September 18, 2014) in terms of safety and effectiveness.
Summary of Clinical Data:
The MobileDiagnost M50 did not require a clinical study since substantial equivalence to the currently marketed and predicate MobileDiagnost wDR 2.0 was demonstrated with the following attributes:
- Design features;
- Indication for use;
- Fundamental scientific technology; ●
- Non-clinical performance testing including validation; and ●
- Safety and effectiveness. ●
Furthermore, the MobileDiagnost M50 employs an already cleared wireless detector by Varian Medical Systems (Varian PaxScan 4336Wv4 of the reference device, Varian Nexus DRTM Digital X-ray Imaging
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System - K161459, cleared on 09/06/2016); therefore a clinical image study is not required.
Substantial The MobileDiagnost M50 is substantially equivalent to the currently marketed and predicate MobileDiagnost wDR 2.0 (K141895, September Equivalence Conclusion: 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 62304, IEC 62366, and ISO 10993-1.
The results of these tests demonstrate that the MobileDiagnost M50 met the acceptance criteria and is adequate for its intended use.
§ 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.