(90 days)
The Radiography 7000 M is intended for diagnostic procedures on both adult and pediatric patients who are unable to be transferred to the stationary X-ray system. It enables radiographic imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions. The system allows for applications in different positions, such as sitting, standing, and lying in either a prone or supine position. However, it should be noted that the system is not suitable for mammography applications.
The Radiography 7000 M digital mobile will be a new motorized mobile x-ray system that will employ integrated wireless flat panel detectors of two different sizes (large and small) to obtain digital images in mobile environments; the system will also be able to utilize CR or traditional film cassettes in a back-up scenario. The system will primarily use wireless technology for image acquisition and the transmission of images to archive systems like PACS, as well as for the retrieval of patient and exam information from the radiology information system (RIS) or hospital information system (HIS). The system is available in the following configurations: with 20 kW X-ray generator, with 40 kW X-ray generator. The Radiography 7000 M system is an integrated system consisting of the following subsystems: Base Unit (Sedecal Mobile X-ray system SM-IV, cleared under K232185 August 21, 2023), SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories, Eleva WorkSpot 43.0.
The provided text describes the acceptance criteria and the study conducted for the Philips Radiography 7000 M, a mobile X-ray system. The document is a 510(k) summary of safety and effectiveness, and primarily demonstrates substantial equivalence to a predicate device.
Here's an analysis based on the provided information, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a detailed table of specific quantitative acceptance criteria alongside corresponding quantitative device performance metrics for features like image quality (e.g., resolution, SNR) beyond stating compliance with general standards. Instead, it provides a summary that all tests passed, indicating that the device met its acceptance criteria. This is common in 510(k) summaries where detailed test reports are typically provided separately to the FDA.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| System Verification Testing | Conformance to system requirements | Pass |
| Software Verification Testing | Conformance to software requirements | Pass |
| Risk Control | Meeting defined risk control measures | Pass |
| Cybersecurity | Compliance with cybersecurity requirements (e.g., asset ID, risk assessment, mitigation) | Pass |
| Image Quality | Compliance with 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' and image quality test results showing no adverse impact from changes. | Image quality testing performed and compliant. No adverse impact from changes. MTF and DQE values are similar to the predicate device. |
| Electrical Safety & Performance | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-2-28, IEC 62220-1-3 | All relevant IEC standards passed. |
| Usability | Compliance with IEC 60601-1-6, IEC 62366-1 | All relevant IEC standards passed. |
| Software Life Cycle | Compliance with IEC 62304, Guidance for Content of Premarket Submissions for Device Software Functions | All relevant standards and guidance passed. |
| Wireless Technology | Compliance with Guidance for Radio Frequency Wireless Technology in Medical Devices, FCC Rules and Regulations CFR 47, Part 15, Subpart B | All relevant guidance and rules passed. |
| Pediatric Information | Compliance with Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications | All relevant guidance passed. |
| Biological Evaluation | Compliance with ISO 10993-1 | All relevant ISO standards passed. |
| Risk Management | Compliance with ISO 14971 | All relevant ISO standards passed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set sample size" in terms of patient data or clinical images. The testing conducted is primarily non-clinical performance testing and bench testing for compliance with various recognized standards (e.g., electrical safety, software validation, cybersecurity). The data provenance is implied to be from laboratory settings during these non-clinical tests. There is no mention of patient data being used for validating the device's performance in this specific 510(k) submission.
"There is no clinical data submitted in this 510(k) Premarket notification."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical data or clinical "test set" was used (as stated in point 2), there is no information about experts establishing ground truth for such a set. The document focuses on showing substantial equivalence through engineering and regulatory compliance, not clinical performance evaluation with human readers.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring ground truth adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
No MRMC study was done, nor is AI assistance a stated feature of this specific device's submission. The device is a mobile X-ray system, not an AI-powered diagnostic tool. The submission focuses on the safety and effectiveness of the hardware and integrated software for image acquisition, primarily demonstrating equivalence to a predicate device.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a medical device for X-ray imaging, inherently involving a human operator (technologist or physician) to acquire and interpret images. There's no "algorithm only" performance reported in the context of an AI-driven diagnostic algorithm.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" is established by the specified requirements and standards themselves. For example, for electrical safety, the ground truth is adherence to the voltage limits defined in IEC 60601-1. For image quality, it's compliance with established metrics and guidelines from guidance documents. There is no ground truth based on expert consensus, pathology, or outcomes data mentioned, as no clinical study data was submitted.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device requiring a training set, the concept of a training set sample size does not apply here. The device's functionality is based on established physics and engineering principles, not statistical learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 14, 2024
Philips Medical Systems DMC GmbH % Shalin Dave Head of Regulatory Affairs DXR Röntgenstraße 24 Hamburg, 22335 GERMANY
Re: K233678
Trade/Device Name: Radiography 7000 M Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: November 8, 2023 Received: November 16, 2023
Dear Shalin Dave:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K233678
Device Name
Radiography 7000 M
Indications for Use (Describe)
The Radiography 7000 M is intended for diagnostic procedures on both adult and pediatric patients who are unable to be transferred to the stationary X-ray system. It enables radiographic imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions. The system allows for applications in different positions, such as sitting, standing, and lying in either a prone or supine position. However, it should be noted that the system is not suitable for mammography applications.
| 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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PHILIPS
Page 1 of 18
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness is prepared in accordance with 21 CFR §807.92.
| Preparation Date: | November 14th , 2023 |
|---|---|
| 510(k) Owner: | Philips Medical Systems DMC GmbHRöntgenstrasse 2422335 Hamburg GERMANYEstablishment registration number: 3003768251 |
| Primary Contact: | Shalin DaveHead of Regulatory Affairs DXRPhone: +31 (6) 4253260E-mail: shalin.dave@philips.com |
| Secondary Contact: | Ming XiaoRegulatory Affairs ManagerPhone: +49(40) 34971-2306E-mail: ming.xiao@philips.com |
| Proposed Device | |
| Device Name | Radiography 7000 M |
| Legal Manufacturer | Philips Medical Systems DMC GmbHRöntgenstrasse 2422335 HamburgGERMANY |
| Classification Name: | Mobile x-ray system |
| Classification Regulation: | 892.1720 |
| Classification Panel: | 90 - Radiology |
| Device Class: | Class II |
| Product Code: | IZL |
| Predicate Device | |
| Device Name | MobileDiagnost wDR 2.2 |
| Legal Manufacturer | Philips Medical Systems DMC GmbHRöntgenstrasse 2422335 HamburgGERMANY |
| Classification Name: | Mobile x-ray system |
| Classification Regulation: | 892.1720 |
| Classification Panel: | 90 - Radiology |
| Device Class: | Class II |
| Product Code: | IZL, MQB |
| Reference Device # 1 | |
| Device Name | SM-IV |
| Legal Manufacturer | SEDECAL SA |
Philips Medical Systems DMC GmbH
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C/ Pelava, 9 – 13, Pol. Ind. Río de Janeiro22335 Hamburg 28110 Algete, Madrid España (Spain) Tel.- +34 91 6280544 Fax.- +34 91 6280574 Mobile x-ray system 892.1720 90 – Radiology Class II IZL
Device Description:
Classification Name:
Classification Panel:
Device Class:
Product Code:
Classification Regulation:
The Radiography 7000 M digital mobile will be a new motorized mobile x-ray system that will employ integrated wireless flat panel detectors of two different sizes (large and small) to obtain digital images in mobile environments; the system will also be able to utilize CR or traditional film cassettes in a back-up scenario. The system will primarily use wireless technology for image acquisition and the transmission of images to archive systems like PACS, as well as for the retrieval of patient and exam information from the radiology information system (RIS) or hospital information system (HIS).
The system is available in the following configurations.
- with 20 kW X-ray generator
- with 40 kW X-ray generator
The Radiography 7000 M system is an integrated system consisting of the following subsystems:
- Base Unit ( Sedecal Mobile X-ray system SM-IV, cleared under K232185 August 21, 2023)
- · SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories
- Eleva WorkSpot 43.0
The "Radiography 7000M" complies with the requirements specified in FDA's device specific guidance document entitled, "Guidance for the submission of 510(k) for solid state X-ray Imaging Device – September 1, 2016." Compliance with Sections I through VI, VIII and IX, which includes Table of contents, Scope, Purpose, Description, Regulatory Requirements, Non-Clinical Considerations, Labeling and Quality Assurance Program, of the FDA guidance document for the detectors is demonstrated in this submission.
Indications for Use:
The Radiography 7000 M is intended for diagnostic procedures on both adult and pediatric patients who are unable to be transferred to the stationary X-ray system. It enables radiographic imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions. The system allows for applications in different positions, such as sitting, standing, and lying in either a prone or supine position. However, it should be noted that the system is not suitable for mammography applications.
Fundamental Scientific Technology
The proposed Radiography 7000 M is substantially equivalent to the manufacturer's legally marketed devices:
. Predicate Device: MobileDiagnost wDR 2.2 (K191813 - August 2, 2019), Philips Medical
Systems DMC
A detailed comparison of the proposed and predicate device (K191813) is provided in Table 1.
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| Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnostwDR 2.2 versus the proposed Radiography 7000 M | ||||
|---|---|---|---|---|
| Predicate Device:MobileDiagnostwDR 2.2 (K191813, SEdate on August 2, 2019) | Proposed Device:Radiography 7000 M(K233678) | Discussion & Conclusion | ||
| Clinical characteristics | ||||
| Intended use | The MobileDiagnostwDR is suitable for allroutine radiographicexams, includingspecialty areas such asintensive care, trauma,operating room, orpediatric work.Standard radiographyprocedures are, forexample:- X-ray examinations ofthe skeleton includingskull, chest, spine,pelvis, upperextremities, lowerextremities, etc.- X-ray examinations ofthe lung- X-ray examinations ofsoft tissue such asabdomen | The Radiography 7000M is intended fordiagnostic procedureson both adult andpediatricpatients who areunable to betransferred to thestationary X-raysystem. It enablesradiographic imagingof various body parts,including the skull,chest, spine,shoulders, pelvis,extremities, abdomen,and other bodyregions. The systemallows for applicationsin differentpositions, such assitting, standing, andlying in either a proneor supine position.However, it should benoted that the systemis not suitable formammographyapplications. | No difference incharacteristics betweenproducts.Conclusion: Same | |
| Site of the body | Whole Body | Whole Body | No difference incharacteristics betweenproducts.Conclusion: Same | |
| Population | Any type of patient | Any type of patient | No difference incharacteristics betweenproducts.Conclusion: Same | |
| Basic Information | ||||
| Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnostWDR 2.2 versus the proposed Radiography 7000 M | ||||
| Predicate Device:MobileDiagnostWDR 2.2 (K191813, SEdate on August 2, 2019) | Proposed Device:Radiography 7000 M(K233678) | Discussion & Conclusion | ||
| Design | Image: MobileDiagnost WDR 2.2 | Image: Radiography 7000 M | This difference does notimpact the safety oreffectivenessof the device; Hencedemonstrating SubstantialEquivalence. | |
| Configuration | Battery OperatedMobile | Battery OperatedMobile | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Battery | Lead Acid | lithium-ion (Li-ion)with advanced batterymanagement system | Li-Ion battery-basedsolution brings smartbatterymanagement/monitoringsystem with fast charging.No impact on clinicalneeds and safety of thedevice; Hencedemonstrating substantialequivalence. | |
| Weight | 580kg | 450 kg (992 lb) | This difference does notimpact the safety oreffectiveness of thedevice; Hencedemonstrating SubstantialEquivalence. | |
| Dimensions: (I x w x h)In operation max. | 2577 mm x 670 mm x2125 mm | 2670 mm x 540 mm x2220 mm | The differences in thedimensions do not impactthe safety or effectivenessof the device. Hencedemonstrating SubstantialEquivalence. | |
| Dimensions: (I x w x h)In transport | 1382 mm x 670 mm x1960 mm | 1340 mm x 540 mm x1285 mm | The differences in thedimensions do not impactthe safety or effectivenessof the device. Hencedemonstrating SubstantialEquivalence. | |
| Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnostwDR 2.2 versus the proposed Radiography 7000 M | ||||
| Predicate Device:MobileDiagnostwDR 2.2 (K191813, SEdate on August 2, 2019) | Proposed Device:Radiography 7000 M(K233678) | Discussion & Conclusion | ||
| Dimensions: Source -floor distance | 530 mm to 2020 mm | 530 mm to 2020 mm | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Tube Head Display | Not Available | Available with touchscreen - 8.4" | This difference does notimpact the safety oreffectivenessof the device; Hencedemonstrating SubstantialEquivalence. | |
| Head-assemblymovements | Friction basedmovements | Electromagneticbrakes foromnidirectionalHead assemblymovement handlewith capacitive touchtechnology based | This difference does notimpact the safety oreffectivenessof the device; Hencedemonstrating SubstantialEquivalence. | |
| Monitor (MainScreen) | Non DICOM Touch(single) screen - 17" | DICOM Multi-touchmain screen - 21.5" | This difference does notimpact the safety oreffectivenessof the device; Hencedemonstrating SubstantialEquivalence. | |
| Status LightIndicator | NA (Not Available) | Status Light Indicatoron column assembly toindicate system readyfor exposure | This difference does notimpact the safety oreffectivenessof the device; Hencedemonstrating SubstantialEquivalence. | |
| Smart Power ON / Login | keypad based | Smart on/off usingRFID | This difference does notimpact the safety oreffectivenessof the device; Hencedemonstrating SubstantialEquivalence. | |
| X ray Tube assemblyrotation aroundtelescope arm axis | +/-180° | ±180° | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnostwDR 2.2 versus the proposed Radiography 7000 M | ||||
| Predicate Device:MobileDiagnostwDR 2.2 (K191813, SEdate on August 2, 2019) | Proposed Device:Radiography 7000 M(K233678) | Discussion & Conclusion | ||
| X ray tube assemblyaround longitudinaltube axis | +90° to -30° | 110°120° (+90° to -30°) | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Mains Supply | 100 VAC/110 VAC/230VAC±10%50 Hz/60 Hz | 100 – 240V (+/- 10%included in the range)50 Hz/60 Hz | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Mode of ReleasingExposure | Releasing Exposure viaHand switch or viaRemote Control(Optional) | Releasing Exposure viaHand switch or viaRemote Control(Optional) | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Available ExposureMethods | Free exposuretechnique on filmcassettes or CR systemsand wirelessportable detectors | Free exposuretechnique on filmcassettes or CRsystems and wirelessportable detectors | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Dead-man handle | Dead-man handlebased on micro switchmechanism | Dead-man handle withCapacitive touchtechnology | This difference does notimpact the safety oreffectivenessof the device; Hencedemonstrating SubstantialEquivalence. | |
| Collision detection | From front | From front andpartially from side | This difference does notimpact the safety oreffectivenessof the device; Hencedemonstrating SubstantialEquivalence. | |
| Detector | ||||
| Type | Digital wireless flatdetector | Digital wireless flatdetector | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnostWDR 2.2 versus the proposed Radiography 7000 M | ||||
| Predicate Device:MobileDiagnostWDR 2.2 (K191813, SEdate on August 2, 2019) | Proposed Device:Radiography 7000 M(K233678) | Discussion & Conclusion | ||
| Detector Models | SkyPlate Large (Trixell3543EZ 1.2)Skyplate Small (Trixell2430EZ 1.2)SkyPlate E large (Trixell3543DR) | SkyPlate Large (Trixell3543EZ 1.3)Skyplate Small (Trixell2430EZ 1.3)SkyPlate E large (Trixell3543DR) | The difference in thesubject device isadditional protectionprovided for liquid anddust ingression. Thisdifference does notimpact the safety oreffectiveness of thedevice. Hencedemonstrating SubstantialEquivalence. | |
| Detector Size | Large: 384 x 460 x 15mmSmall: 328 x 268 x 15mmSkyPlate E Large: 384.5x 460.5 x 15 mm | Large: 386 x 460 x 16mmSmall: 328 x 269 x 16mmSkyPlate E Large: 384 x460.5 x 15 mm | Length and width of theplastic body increased tosupport bigger sealinglayersThis difference does notimpact the safety oreffectiveness of thedevice. Hencedemonstrating SubstantialEquivalence. | |
| On/off connector unit | Image: Current module EZ1.2 | Image: On/off connector unit | Side view (Cut), improvedsealing:- Additional screw hole onthe opposite side forhomogenious fixationover the whole area- Bigger screw head type tobetter cover the holes.- New fixation screws areself-locking.This difference does notimpact the safety oreffectiveness of thedevice. Hencedemonstrating SubstantialEquivalence. | |
| X-Ray Absorber | Csl Scintillator | Csl Scintillator | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnostWDR 2.2 versus the proposed Radiography 7000 M | ||||
| Predicate Device:MobileDiagnostWDR 2.2 (K191813, SEdate on August 2, 2019) | Proposed Device:Radiography 7000 M(K233678) | Discussion & Conclusion | ||
| Installation type | Portable | Portable | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Readout Mechanism | Thin Film Transistor | Thin Film Transistor | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Maximum X- ray DoseforLinear Response | 50 µGy | 50 µGy | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Maximum Usable Dose | 75 µGy | 75 µGy | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Image Processing | Eleva Workstation | Eleva Workspot | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Maximum LifetimeDose | 100 μGy | 100 μGy | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Detector Weight | Max 3.1 kg includingbattery | Max 3.1 kg includingbattery | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnostwDR 2.2 versus the proposed Radiography 7000 M | ||||
| Predicate Device:MobileDiagnostwDR 2.2 (K191813, SEdate on August 2, 2019) | Proposed Device:Radiography 7000 M(K233678) | Discussion & Conclusion | ||
| Image Size (X-ray field) | 345.0 mm x 426.0 mm | 345.0 mm x 426.0 mm | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Pixel Size | 160 μm | 160 μm | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| lmage matrix size(Number of pixels) | 2156 x 2653 pixels | 2156 x 2653 pixels | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Nyquist Frequency | 3.38 lp/mm3.125 lp/mm | 3.38 lp/mm3.125 lp/mm | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Modulation TransferFunction (MTF), typicalvalues | SkyPlate (543EZ &2430EZ)0.5 lp/mm 81%1 lp/mm 63%1.5 lp/mm 47%2.0 lp/mm 35%2.5 lp/mm 26%3.0 lp/mm 19%(Nyquist)SkyPlate E (3543DR)0.5 lp/mm 80%1 lp/mm 62%1.5 lp/mm 47%2.0 lp/mm 34%2.5 lp/mm 25%3.0 lp/mm 18%(Nyquist) | SkyPlate (543EZ &2430EZ)0.5 lp/mm 81%1 lp/mm 63%1.5 lp/mm 47%2.0 lp/mm 35%2.5 lp/mm 26%3.0 lp/mm 19%(Nyquist)SkyPlate E (3543DR)0.5 lp/mm 80%1 lp/mm 62%1.5 lp/mm 47%2.0 lp/mm 34%2.5 lp/mm 25%3.0 lp/mm 18%(Nyquist) | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnostwDR 2.2 versus the proposed Radiography 7000 M | ||||
| Predicate Device:MobileDiagnostwDR 2.2 (K191813, SEdate on August 2, 2019) | Proposed Device:Radiography 7000 M(K233678) | Discussion & Conclusion | ||
| Detective QuantumEfficiency (DQE), typicalvalues | DQE at 2.0 µGy Lp/mm%0.05 701 512 423 223.125 18 (Nyquist) | DQE at 2.0 µGy Lp/mm%0.05 701 512 423 22(Nyquist) | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| ADCDigitization | 16 Bit | 16 Bit | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Signal to ElectronicNoise Ratio(SENR) | Min 37 dB - typical:42.8 dB (@ 1 µGy) | Min 38 dB - typical: 44dB (@ 1 μGy)Min 37 dB - typical:42.8 dB (@ 1 µGy) | Similar; No impact tosafety or effectiveness ofthe device; Hencedemonstrating SubstantialEquivalence | |
| Data Interface toWorkstation | AP to workspot: 1GBit/s EthernetDetector Ethernet viaBUC: 100Mbit/s EthernetDetector to AP: 150Mbit/s WLAN (grosstransfer rate) | AP to workspot: 1GBit/s EthernetDetector Ethernet viaBUC: 100Mbit/s EthernetDetector to AP viaWLAN (Aruba 303WAP):5GHz - 867 Mbps2.4GHz - 300 Mbps | This difference does notimpact the safety oreffectiveness of thedevice. Hencedemonstrating SubstantialEquivalence. | |
| Grids | ||||
| Type | Large Grids for SkyPlateLarge(468 mm x 476 mm x25mm)Small Grid for SkyPlateSmall(mm x 354 mm x 25 mm)Large Grids for SkyPlateE(468 mm x 476 mm x 23mm) | Large Grids forSkyPlate Large(468 mm x 476mm x 25 mm)Small Grid for SkyPlateSmall(280 mm x 354mm x 25 mm)Large Grids forSkyPlate E(468 mm x 476mmx 25 mm) | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Design characteristicsX - Ray Tube | ||||
| Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnostwDR 2.2 versus the proposed Radiography 7000 M | ||||
| Predicate Device:MobileDiagnostwDR 2.2 (K191813, SEdate on August 2, 2019) | Proposed Device:Radiography 7000 M(K233678) | Discussion & Conclusion | ||
| Tube | E7886X used with 40kWGeneratorE7865X used with 20kWGenerator | XRR-3331 - 0.6/1.2 | Single tube configurationto address both adult andpediatric clinical use case.Hence no impact onclinical needs and safetyof the device; Hencedemonstrating substantialequivalence. | |
| Material | Rhenium-Tungsten,Molybdenum | Rhenium-Tungstenfaced Molybdenum | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Maximum tube voltage | 150 kVp | 150 kVp | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Nominal focal spot | E7886X- 0.7/1.3E7865X- 0.3/1.0 | XRR-3331 - 0.6/1.2 | Single tube configurationto address both adult andpediatric clinical use case.Hence no impact onclinical needs and safetyof the device; Hencedemonstrating substantialequivalence. | |
| Anode type | Rotating | Rotating | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Nominalanode input power | 20kW, 40kW | 20kW, 40kW | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Generators | ||||
| Power Configurations | 20kW and 40kW | 20kW and 40kW | No differences incharacteristics between | |
| Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnostwDR 2.2 versus the proposed Radiography 7000 M | ||||
| Predicate Device:MobileDiagnostwDR 2.2 (K191813, SEdate on August 2, 2019) | Proposed Device:Radiography 7000 M(K233678) | Discussion & Conclusion | ||
| subject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | ||||
| Column Configuration | Standard ColumnSliding Column | Standard ColumnSliding Column | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Exposure @ zerodegree column position | Exposures are allowedwhen the column is at 0Degree | Exposures are allowedwhen the column is at0 Degree | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Exposure duringCharging | Exposures are allowedwhen the unit isconnected to mains(Note: exposure energyis drawn fromgenerator batteries andnot from mains) | Exposures are allowedwhen the unit isconnected to mains(Note: Exposureenergy is drawn fromsuper caps which arepowered by batteryand not from mains.) | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Collimator | ||||
| Operation mode | Manual with light fieldindicator, multilayer,squared field | Manual Collimatorwith front and rearside knobs | External ConnectivityThis difference does notimpact safety oreffectiveness of thedevice; Hencedemonstrating SubstantialEquivalence | |
| Collimator | Collimator with manualfilter selection and noshutter positiontracking | Collimator withmotorized filters andmanual shutterposition tracking | This change will result inautomatic Softwarecalculation of DAP withoutadditional hardwareDAP device requirements.This difference does notimpact the safety oreffectiveness of thedevice. Hencedemonstrating SubstantialEquivalence. | |
| Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnostWDR 2.2 versus the proposed Radiography 7000 M | ||||
| Predicate Device:MobileDiagnostWDR 2.2 (K191813, SEdate on August 2, 2019) | Proposed Device:Radiography 7000 M(K233678) | Discussion & Conclusion | ||
| Shape of the beam | Rectangular | Rectangular | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| Handles on Collimator | Handles can be used tomove both Tube headand Collimator | Handles can be used tomove both Tube headand Collimator | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| External Connectivity | DICOM | DICOM compatible | DICOM compatible | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. |
| Software Platform | Application Software | Eleva Workspot Inc 41with SkyFlow | Eleva Workspot Inc 43with SkyFlow | Subject device softwareloaded with additionalFeatures. This differencedoes not impact the safetyor effectiveness of thedevice. Hencedemonstrating SubstantialEquivalence. |
| Image ProcessingAlgorithm | UNIQUE 2 | UNIQUE 2 | No differences incharacteristics betweensubject and predicatedevice; Hencedemonstrating SubstantialEquivalence. | |
| PC | Intel® Core™ i5 basedPC | Intel® Core™ i7 basedPC, with SSD for betterperformance Placeholder for 5G module | This difference does notimpact the safety oreffectiveness of thedevice. Hencedemonstrating SubstantialEquivalence. | |
| DAP | Hardware DAP support | E-DAP (Software DAP)and Hardware DAP | This difference does notimpact the safety oreffectiveness of thedevice. Hence | |
| Table 1: Comparison of the design feature of the currently marketed and predicate MobileDiagnost wDR 2.2 versus the proposed Radiography 7000 M | ||||
| Predicate Device:MobileDiagnostwDR 2.2 (K191813, SEdate on August 2, 2019) | Proposed Device:Radiography 7000 M(K233678) | Discussion & Conclusion | ||
| Indications For Use(IFU) | Intended for use by aqualified/trained doctoror technologist on bothadult and pediatricpatients for takingdiagnostic radiographicexposures for the skull,spinal column, chest,abdomen, extremities,and other body parts.Applications can beperformed with patientsitting, standing, orlying in the prone orsupinepositions.Not for mammography. | The Radiography 7000M is intended fordiagnostic procedureson both adult andpediatricpatients who areunable to betransferred to thestationary X-raysystem. It enablesradiographic imagingof various body parts,including the skull,chest, spine,shoulders, pelvis,extremities, abdomen,and other bodyregions. The systemallows for applicationsin different positions,such as sitting,standing, and lying ineither a prone orsupine position.However, it should benoted that the systemis not suitable formammographyapplications. | effectiveness of thedevice. Hencedemonstrating SubstantialEquivalence.The wording: "patientswho are unable to betransferred to thestationary X-ray system"has been newly addedinto proposed deviceRadiography 7000 MIndication for Usecompared to thepredicate deviceMobileDiagnost wDR2.2. because bothproposed deviceRadiography 7000 M andpredicate deviceMobileDiagnost wDR 2.2will be operated onpatient that cannot betransferred to Fixed X-raysystem. This aims toenhance user clarity anduser understanding. Thismodification does notalter the operationalsimilarity betweenproposed deviceRadiography 7000 M andits predicate deviceMobileDiagnost wDR 2.2,both capable of operatingon non-transferrablepatients.The inclusion of"shoulders" and "pelvis"in the documentationsignifies additional clarityon its capabilities, but it isessential to note that | |
| Predicate Device:MobileDiagnostwDR 2.2 (K191813, SEdate on August 2, 2019) | Proposed Device:Radiography 7000 M(K233678) | Discussion & Conclusion | ||
| examples, not limitations.The device can be appliedto various body partsbeyond those explicitlymentioned. | ||||
| Conclusion:Based on the informationand comparisonpresented above, it can beconcluded that theIndications For Use of theproposed deviceRadiography 7000 M issubstantially equivalent tothe Indications For Use ofthe currently marketedand predicate deviceMobileDiagnost wDR 2.2. |
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The outcome of this comparison demonstrates that the modifications do not affect the safety or effectiveness of the proposed Radiography 7000 M when compared to the currently marketed and predicate MobileDiagnost wDR 2.2 (K191813 - August 2, 2019).
Summary of Non-Clinical and Clinical Performance Data:
This 510(K) premarket notification includes non-clinical performance testing.
Tests were performed on the proposed Radiography 7000 M according to the following FDA recognized standards and guidance documents: The verification and validation methods and acceptance criteria) used to evaluate the proposed Radiography 7000 M are the same as those used for the predicate device (K191813) and follow International and FDA recognized consensus standards and guidance documents applicable to this device type:
- . IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Recognition # 19-49)
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Recognition # 19-36)
- . IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (Recognition # 12-336)
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- . IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Recognition # 5-132)
- . IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, Medical device software - Software life cycle processes (Recognition # 13-79)
- . IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, Medical devices - Part 1: Application of usability engineering to medical devices (Recognition # 5-129)
- . IEC 60601-2-54 Edition 2.0 2022-09, Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Recognition # 12-348)
- . IEC 60601-2-28 Edition 3.0 2017-06: Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis Recognition # 12-309
- . ISO 14971:2019, Medical devices - Application of risk management to medical devices(Edition 3.0) Recognition # 5-125
- . ISO 10993-1, Fifth edition 2018-08, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (Recognition # 2-258)
- . IEC 62220-1-3:2008 Edition 1.0 2008-06, Medical electrical equipment - Characteristics of digital Xray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging (Recognition # 12-214)
- . IEC 60601-1-9:2007/AMD2:2020 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design.
- NEMA PS 3.1 - 3.20 Digital Imaging And Communications In Medicine (DICOM) Set
- . Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, issued September 1, 2016
- Guidance for Content of Premarket Submissions for Device Software Functions, Issued on June 14, 2023.
- Guidance for Radio Frequency Wireless Technology in Medical Devices, issued on: August 14, 2013
- FCC Rules and Regulations CFR 47, Part 15, Subpart B (10-1-21 Edition)
- . Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 2017
- Guidance for Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions issued on September 27, 2023
The proposed device complies with the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K191813). Also, other image chain components like X-ray tube and generator, which are used for exposure characteristics and clinical performance evaluation remain the same. Hence, all the features and characteristics potentially influencing image quality of the proposed are in accordance with FDA guidance document 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, dated September 1, 2016'. Additionally, Image quality testing has been performed on the proposed device for the changes that are affecting the image quality.
The proposed device complies with the Guidance for Content of Premarket Submissions for Device Software Functions, Issued on June 14, 2023. The changes to the proposed device do not alter the intended use or the fundamental scientific technology when compared to the predicate device (K191813). The software for the
Philips Medical Systems DMC GmbH
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General Management: Dr. Florian Kuhn (Chair), Dieto Ropers, Registered Office: Hamburg, Register Court Hamburg, 66 HRB 77 839, Tax No.: 22/27/250/0688, VAT No.: DE813038453, Bank Details: AG, Hamburg, SWFT-BC: DRESDEF200, BAN: DE82200800000651928300
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proposed device has the Enhanced documentation level. The software verification testing has been conducted as per the documentation level.
The proposed device complies with the Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 2017. The changes made to the proposed device do not affect the pediatric application. The indication for use of the proposed device is the same as the predicate device (K191813).
The proposed device complies with Guidance for Radio Frequency Wireless Technology in Medical Devices, issued August 14, 2013 and FCC Rules and Regulations CFR 47, Part 15, Subpart B (10-1-21 Edition). The verification testing has been conducted for the safety and efficacy of the wireless components.
The proposed device complies with the Guidance for Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions issued on September 27, 2023. A set of cybersecurity controls to assure proposed device's cybersecurity and maintain medical device functionality and safety are in place. Cybersecurity plan and risk document are prepared to assess the proposed device for the following:
- Identification of assets, threats, and vulnerabilities;
- . Assessment of the impact of threats and vulnerabilities on device functionality and end users/patients;
- Assessment of the likelihood of a threat and of a vulnerability being exploited;
- Determination of risk levels and suitable mitigation strategies;
- . Assessment of residual risk.
Refer Table 2 for the non-clinical testing that were performed on the proposed device. Test results demonstrate that the proposed Radiography 7000 M meets acceptance criteria and is adequate for its intended use. Risk assessment activities show that the risks are sufficiently mitigated.
General Management: Dr. Florian Kuhn (Chair), Dieto Ropers, Registered Office: Hamburg, Register Court Hamburg, 66 HRB 77 839, Tax No.: 22/27/250/00688, VAT No.: DE813038453, Bank Details: AG, Hamburg, SWIFT-BC: DRESDEFF200, BAN: DE82200800000651928300
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Table 2 Testing Summary for the changes on the proposed device
| Tests | Test results |
|---|---|
| System Verification testing | PassSystem verification test activities substantiate that the systemconforms to the system requirements |
| Software verification testing | PassSoftware verification test activities substantiate that the softwareconforms to the requirements |
| Risk control | PassSystem meets the defined risk control measures |
| Cyber Security | PassResults demonstrate that thetest complies with theCybersecurity requirements |
There is no clinical data submitted in this 510(k) Premarket notification.
Substantial Equivalence Conclusion:
The proposed device, Radiography 7000 M is substantially equivalent to the currently marketed and predicate device, (K191813) in terms of the design features, technological characteristics, indications for use, and safety and effectiveness.
Additionally, substantial equivalence was demonstrated with non-clinical performance tests and testing as per FDA-recognized consensus standards. The test results demonstrate that the device conforms to its specifications and is safe and effective 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.