(55 days)
No
The summary describes a standard mobile X-ray system with digital image acquisition. There is no mention of AI, ML, or advanced image processing beyond basic visualization. The performance studies focus on usability and clinical workflow, not algorithmic performance metrics.
No
The device is described as an X-ray imaging system used to visualize anatomical structures, which is for diagnosis and imaging, not therapy.
Yes.
The intended use describes that the device is intended to visualize anatomical structures, which is a key step in disease diagnosis.
No
The device description clearly outlines a complete X-ray imaging system with significant hardware components including a generator, X-ray tube, collimator, support arm, digital image acquisition system, and detectors. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The MOBILETT Impact is an X-ray imaging system. It visualizes anatomical structures within the human body by converting an X-ray pattern into a visible image. This is an in vivo (within the living body) process.
- Intended Use: The intended use clearly states it's for visualizing anatomical structures of human beings, not for testing biological samples.
Therefore, based on its function and intended use, the MOBILETT Impact is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
IZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
anatomical structures of human beings (skull, spinal column, chest, abdomen, extremities, and other body parts)
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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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
1
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
2
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 Medical |
| Equipment 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 device
SM-V | Subject device
Mobilett Impact | Comment |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Regulation
Description | System, X-Ray, Mobile | System, X-Ray, Mobile | Same |
| Regulation
Number | 892.1720 | 892. 1720 | Same |
| Classification
Product Code | IZL | IZL | Same |
| Indications for
use | This is a mobile diagnostic x-
ray system intended for use
by a qualified/trained doctor
or technician on both adult
and pediatric subjects for
taking diagnostic radiographic
exposures of the skull, spinal
column, chest, abdomen,
extremities, and other body
parts. Applications can be
performed with the patient
sitting, standing, or lying in
the prone or supine position.
Not for mammography. | 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. | Similar |
| Configuration | Mobile X-Ray system without
digital flat detector and image
system. | Mobile X-Ray system with
digital flat detector and image
system. | Different.
Digital flat
detector and image
system added. |
| High voltage
generator | 16, 20, 32 KW Monoblock
generator | 16, 20, 32 KW Monoblock
generator | 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 screen
control | 19" touch display | 19" touch display | Same |
| Movement | Non-motorized movement | Non-motorized movement | Same |
| US Performance
Standard | 21 CFR 1020.30 | 21 CFR 1020.30 | Same |
| Power Source | Universal power supply, from
100 V~ to 240 V~.
1 phase | Universal power supply, from
100 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 (including
column) /
123 x 59 x 126 cm | 123 x 59 x 191 cm (including
column) /
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 Flat
detectors have
been 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 device
Multix Impact | Subject device
Mobilett 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 same
Different.
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 screen
Ratio 4:3 | Similar
MOBILETT 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 Development
Organization and Reference
| Number | Title of Standard |
|---|---|
| ANSI AAMI | |
| 60601-1, 2012 Ed. 3.1 | Medical Electrical Equipment - Part 1: General |
| Requirements for Safety | |
| IEC 60601-1-2 2020 Ed 4.1 | Medical Electrical Equipment - Part 1-2: General requirements for |
| basic 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 for |
| basic 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 requirements |
| for the basic safety and essential performance of X-ray tube | |
| assemblies for medical diagnosis | |
| IEC 60601-2-54 | |
| 2018, Edition 1.2 | Medical electrical equipment - Part 2-54: Particular requirements |
| for the basic safety and essential performance of X-ray equipment | |
| for radiography and radioscopy | |
| IEC 60601-1-6 | |
| 2013 Ed 3.1 | Medical electrical equipment – Part 1-6: General requirements for |
| basic safety and essential performance - Collateral standard: | |
| Usability | |
| IEC 62366-1 2020 Ed 1.1 | Medical devices – Application of usability engineering to medical |
| devices | |
| ISO 14971: 2019 | Medical devices – application of risk management to medical |
| devices | |
| 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 and | |
| radioscopy | |
| 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