(55 days)
MOBILETT Impact is a mobile device intended to visualize anatomical structures of human beings by converting an Xray pattern into a visible image. MOBILETT Impact is not intended for mammography examinations.
MOBILETT Impact is a complete X-ray imaging system on wheels. It contains a single tank high voltage generator with an X-ray tube and collimator attached to the end of a telescopic support arm connected to a swiveling column. The system is a manually driven system, with no motor support for movement. The system includes a digital image acquisition system with an image display and graphical user interface. The digital detector, Max wi-D can be stored in the built-in docking station in the system. In addition, the system can be used with detectors Max mini and Core-L. All three detectors are equipped with rechargeable batteries, which can be charged by external battery chargers. The system can perform X-Ray when it is connected to mains. Exposure can be released by a hand switch or remote control. The included system batteries only power the imaging system if it is not connected to the mains. Besides the detectors and image system, the hardware of the same as for the predicate device SEDECAL SM-V, which was cleared on 11/21/2022 with K222951.
The provided text describes the Siemens MOBILETT Impact, a mobile X-ray system. However, it does not detail acceptance criteria or a study proving the device meets specific performance metrics for image quality or diagnostic accuracy in the way an AI/CADe device would.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SEDECAL SM-V, K222951) and a reference device (MULTIX Impact, K213700) based on regulatory compliance, technological characteristics, and safety.
The summary highlights:
- Regulatory Compliance: Adherence to various IEC, ANSI AAMI, ISO, NEMA, and FDA standards for medical electrical equipment, radiation protection, usability, risk management, software life cycle, and digital imaging.
- Technological Equivalence: Comparison of features like regulation description, product code, indications for use (similar), high voltage generator, X-ray tube, tube voltage/current, collimator, touch screen control, movement (non-motorized), US Performance Standard, and power source (all same as predicate or similar).
- Safety and Effectiveness Concerns: General statements about IFU, safety features (visual/audible warnings), error monitoring, and adherence to recognized industry practices to minimize electrical, mechanical, and radiation hazards.
Regarding the specific information requested in your prompt for an AI/CADe device:
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Table of acceptance criteria and reported device performance: This information is not provided in the document. The document confirms regulatory compliance with various standards, but it doesn't state specific device performance metrics like sensitivity, specificity, or AUC for diagnostic tasks, as would be expected for an AI device.
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Sample size used for the test set and data provenance: This information is not provided. A "Customer Use Test (CUT)" was performed, but no details on sample size, data type, or provenance are given.
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Number of experts used to establish the ground truth for the test set and qualifications: This information is not provided. The CUT involved "gathering feedback on the device's usability in the clinical environment," but it doesn't describe a ground truth establishment process by experts for a diagnostic task.
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Adjudication method for the test set: This information is not provided.
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Multi-reader multi-case (MRMC) comparative effectiveness study: This information is not provided. The device is a mobile X-ray system, not an AI/CADe system designed to improve human reader performance.
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Standalone performance (algorithm only without human-in-the-loop performance): This information is not provided. The device is a hardware system for X-ray imaging, not a standalone algorithm.
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Type of ground truth used: For the "Customer Use Test (CUT)," the "ground truth" implicitly involved qualitative feedback on "system function and performance-related clinical workflow, image quality, ease of use, and overall performance and stability." This is not a quantitative ground truth for a diagnostic task like pathology or outcomes data.
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Sample size for the training set: This information is not provided. There is no mention of a training set as this is a hardware device.
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How the ground truth for the training set was established: This information is not provided.
In summary, the provided FDA 510(k) clearance letter and its associated summary are for a conventional mobile X-ray imaging system, not an AI/CADe product. Therefore, the detailed performance metrics and study design elements typically associated with AI/CADe device validation (e.g., sensitivity, specificity, reader studies, ground truth establishment by experts) are not present in this document. The "study" mentioned is a "Customer Use Test (CUT)" focused on usability and overall system performance in a clinical workflow, rather than a diagnostic performance study.
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July 25, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
Siemens Medical Solutions USA, Inc. % Camila Rodriguez Valentin Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355
Re: K231577
Trade/Device Name: MOBILETT Impact Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: May 31, 2023 Received: May 31, 2023
Dear Camila Rodriguez Valentin:
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
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devices or postmarketing safety reporting (21 CFR 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 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 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
Enclosure
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Indications for Use
510(k) Number (if known) K231577
Device Name MOBILETT Impact
Indications for Use (Describe)
MOBILETT Impact is a mobile device intended to visualize anatomical structures of human beings by converting an Xray pattern into a visible image. MOBILETT Impact is not intended for mammography examinations.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a cluster of orange dots.
| 510(k) Summary: | Mobilett Impact |
|---|---|
| 510(k) Number: | K231577 |
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: May 31, 2023
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR § 807.92.
General Information: 1.
Importer / Distributor:
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869
Location of Manufacturing Site: Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim. Germany Establishment Registration Number: 3004977335
2. Contact Person:
Camila Rodriguez Valentin Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, US camila.rodriguezvalentin@siemens-healthineers.com
Alternate Contact Person:
Martin Rajchel Senior Regulatory Affairs Manager Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, US martin.rajchel @ siemens-healthineers.com
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Image /page/4/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
3. Subject Device Name and Classification:
Trade Name:
MOBILETT Impact
Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
System, X-ray, Mobile Radiology 21 CFR §892.1720 II IZL
4. Legally Marketed Predicate Device:
| Trade Name | SM-V |
|---|---|
| Company | SEDECAL SA |
| 510(k) Number | K222951 |
| Device Classification Name | System, X-ray, Mobile |
| Regulation Number | 21 CFR §892.1720 |
| Review Panel | Radiology |
| Product Code | IZL |
| Device Class | II |
-
- Legally Marketed Reference Device:
| Trade Name | MULTIX Impact |
|---|---|
| Company | Siemens Shanghai MedicalEquipment Ltd. |
| 510(k) Number | K213700 |
| Device Classification Name | Stationary X-Ray System |
| Regulation Number | 21 CFR §892.1680 |
| Review Panel | Radiology |
| Product Code | KPR |
| Device Class | II |
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Image /page/5/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots.
6. Device Description:
MOBILETT Impact is a complete X-ray imaging system on wheels. It contains a single tank high voltage generator with an X-ray tube and collimator attached to the end of a telescopic support arm connected to a swiveling column.
The system is a manually driven system, with no motor support for movement. The system includes a digital image acquisition system with an image display and graphical user interface. The digital detector, Max wi-D can be stored in the built-in docking station in the system. In addition, the system can be used with detectors Max mini and Core-L.
All three detectors are equipped with rechargeable batteries, which can be charged by external battery chargers. The system can perform X-Ray when it is connected to mains. Exposure can be released by a hand switch or remote control. The included system batteries only power the imaging system if it is not connected to the mains.
Besides the detectors and image system, the hardware of the same as for the predicate device SEDECAL SM-V, which was cleared on 11/21/2022 with K222951.
7. Indication for Use:
MOBILETT Impact is a mobile device intended to visualize anatomical structures of human beings by converting an X-ray pattern into a visible image. MOBILETT Impact is not intended for mammography examinations.
8. Technological Characteristics and Substantial Equivalence:
MOBILETT Impact and its predicate device SM-V. K222951, are mobile X-ray systems within the same classification regulation, design, functionality, technology, and energy source. The subject device has similar intended use as the predicate device (SM-V) and components cleared in the predicate device (SM-V) and reference device (MULTIX Impact VA21). Mobilett Impact uses a software of Moderate Level of Concern (LOC) based on the predicate device (SM-V).
While some technical characteristics of the subject device differ slightly from those of the predicate device and reference device, verification and validation testing have demonstrated that the subject device and all its components are substantially equivalent to the predicate device. These variations do not impact the device's intended use or alter its fundamental scientific technology compared to the predicate device or reference device.
MOBILETT Impact is substantially equivalent to the predicate device, SM-V. Tables 8-1 and 8-2 compare the proposed subject device side-by-side with the predicate and reference devices.
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Image /page/6/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
| Feature | Predicate deviceSM-V | Subject deviceMobilett Impact | Comment |
|---|---|---|---|
| RegulationDescription | System, X-Ray, Mobile | System, X-Ray, Mobile | Same |
| RegulationNumber | 892.1720 | 892. 1720 | Same |
| ClassificationProduct Code | IZL | IZL | Same |
| Indications foruse | This is a mobile diagnostic x-ray system intended for useby a qualified/trained doctoror technician on both adultand pediatric subjects fortaking diagnostic radiographicexposures of the skull, spinalcolumn, chest, abdomen,extremities, and other bodyparts. Applications can beperformed with the patientsitting, standing, or lying inthe prone or supine position.Not for mammography. | Mobilett Impact is a mobiledevice intended to visualizeanatomical structures ofhuman beings by convertingan X-ray pattern into a visibleimage. Mobilett Impact is notintended for mammographyexaminations. | Similar |
| Configuration | Mobile X-Ray system withoutdigital flat detector and imagesystem. | Mobile X-Ray system withdigital flat detector and imagesystem. | Different.Digital flatdetector and imagesystem added. |
| High voltagegenerator | 16, 20, 32 KW Monoblockgenerator | 16, 20, 32 KW Monoblockgenerator | Same |
| X-Ray Tube | SEDECAL, type CC01654 | SEDECAL, type CC01654 | Same |
| Tube voltage | 40 kV to 150 kV | 40 kV to 150 kV | Same |
| Tube current | 0.32 mAs to 200 mAs | 0.32 mAs to 200 mAs | Same |
| Collimator | Varex Optica 10 | Varex Optica 10 | Same |
| Touch screencontrol | 19" touch display | 19" touch display | Same |
| Movement | Non-motorized movement | Non-motorized movement | Same |
| US PerformanceStandard | 21 CFR 1020.30 | 21 CFR 1020.30 | Same |
| Power Source | Universal power supply, from100 V~ to 240 V~.1 phase | Universal power supply, from100 V~ to 240 V~.1 phase | Same |
| Imaging software | Not included | Impact Imaging System (IIS) | Different. |
| system added | |||
| Size | 123 x 59 x 191 cm (includingcolumn) /123 x 59 x 126 cm | 123 x 59 x 191 cm (includingcolumn) /123 x 59 x 126 cm | Same |
| Weight | 275 kg | 275 kg | Same |
| Digital detectors | Not included | Trixell Pixium 3543EZh(Max wi-D)Trixell Pixium 2430EZ(Max mini)iRAY Mars 1417VS(Core L) | Different.Digital Flatdetectors havebeen added |
Table 8-1: Comparison of the Subject Device (Mobilett Impact) to the Predicate Device (SM-V)
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Image /page/7/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.
Table 8-2: Comparison of the Subject Device (Mobilett Impact) to the Reference Device (Multix Impact) – Detector and Imaging System
| Feature | Predicate deviceMultix Impact | Subject deviceMobilett Impact | Comment |
|---|---|---|---|
| Detector | - Trixell Pixium 3543 EZh (MAX wi-D)- iRay Mars 1717VS (Core XL)- iRay Venu1717X (Core Static) | - Trixell Pixium 3543EZh (MAX wi-D)- Trixell Pixium 2430EZ (Max Mini)- iRay Mars 1417VS (Core L) | Same.Trixell Pixium 3543 EZh is the sameDifferent.Trixell Pixium 2430 EZ is already used with other Siemens systems (see K221218, K201670, K181229, K173639)Different.iRay Mars 1417VS newly added. |
| Imaging System | Impact Imaging System (IIS) | Impact Imaging System (IIS) | Same |
| Display | With and without touch screen (Options)Ratio 16:9 | With touch screenRatio 4:3 | SimilarMOBILETT Impact is only available with touch screen |
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Image /page/8/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a cluster of orange dots.
9. Summary of Non-Clinical Tests:
The MOBILETT Impact was tested and complied with the voluntary standards listed in the table below:
| Standards DevelopmentOrganization and ReferenceNumber | Title of Standard |
|---|---|
| ANSI AAMI60601-1, 2012 Ed. 3.1 | Medical Electrical Equipment - Part 1: GeneralRequirements for Safety |
| IEC 60601-1-2 2020 Ed 4.1 | Medical Electrical Equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard:Electromagnetic Compatibility -- Requirements and Tests |
| IEC 60601-1-3:Edition 2.1, 2013 | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard:Radiation protection in diagnostic X-ray equipment |
| IEC 60601-2-28, 2017 | Medical electrical equipment - Part 2-28: Particular requirementsfor the basic safety and essential performance of X-ray tubeassemblies for medical diagnosis |
| IEC 60601-2-542018, Edition 1.2 | Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy |
| IEC 60601-1-62013 Ed 3.1 | Medical electrical equipment – Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability |
| IEC 62366-1 2020 Ed 1.1 | Medical devices – Application of usability engineering to medicaldevices |
| ISO 14971: 2019 | Medical devices – application of risk management to medicaldevices |
| IEC 62304 2015, Ed.1.1 | Medical device software - Software life cycle processes |
| IEC 61910-1: 2014, Ed 1.0 | Medical electrical equipment - Radiation dose documentation -Part 1: Radiation dose structured reports for radiography andradioscopy |
| NEMA PS 3.1 - 3.20 2021 | Digital Imaging and Communications in Medicine(DICOM) Set |
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Image /page/9/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a cluster of orange dots arranged in a circular pattern.
The following quality assurance measures were applied to the development of the system:
- · Risk Analysis
- · Requirement Specification Reviews
- · Design Reviews
- · Integration testing (System verification and validation)
10. Summary of Clinical Tests:
A Customer Use Test (CUT) was performed at three hospitals to ensure the acceptance of the design and to gather feedback on the device's usability in the clinical environment.
The focus of the test was:
- System function and performance-related clinical workflow
- Image quality
- Ease of use
- Overall performance and stability
The clinical test results stated that the system's intended use was met. and the clinical need was covered.
11. General Safety and Effectiveness Concerns:
The Instructions for Use (IFU) are included within the device labeling, and the information provided enables the user to operate the device safely and effectively. Several safety features, including visual and audible warnings, are incorporated into the system design. In addition, the device is continually monitored, and if an error occurs, the system functions will be blocked, and an error message will be displayed.
Furthermore, the operators are healthcare professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
12. Conclusion as to Substantial Equivalence:
MOBILETT Impact is substantially equivalent to the predicate device SM-V (technical characteristics and performance with similar indications for use). The operating environment is the same, and the technology differences do not affect safety and effectiveness. Siemens concludes, according to this submission material and the documentation provided, that the MOBILETT Impact is substantially equivalent to the predicate device.
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Image /page/10/Picture/0 description: The image displays the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, while "Healthineers" is written in orange. To the right of the text is a cluster of orange dots of varying sizes.
13. Guidance documents
The following FDA guidance documents were utilized in this Premarket Notification:
Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography Document issued on October 20, 2006
Content of Premarket Submission for Management of Cybersecurity in Medical Devices -Guidance for Industry and Food and Drug Administration Staff Document Issued on October 2, 2014
Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically- Powered Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document issued on July 11, 2016
Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on May 11, 2005
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for MedicalDevices - Guidance for Industry and Food and Drug Administration Staff Document issued on September 14, 2018.
The 510(k) Program: Evaluation Substantial Equivalent in Premarket Notifications 510(k) - Guidance for Industry and Food and Drug Administration Staff Document issued on July 28, 2014.
Pediatric Information for X-ray Imaging Device Premarket Notifications - Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - Guidance for Industry and Food and Drug Administration Staff Document issued on September 1, 2016
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document issue on August 13, 2013
§ 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.