(120 days)
The MULTIX Impact system is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The MULTIX Impact system is not meant for mammography.
The MULTIX Impact uses digital detectors for generating diagnostic images by converting x-rays into image signals. The MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
The MULTIX Impact Radiography X-ray system is a modular system of X-ray components (floor-mounted X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless detectors) similar to the predicate the Multix Fusion Max. This 510(k) submission describes modifications to the predicate device the Multix Fusion Max cleared via K162971. The following modifications have been made to the cleared predicate device and the new system will be branded the MULTIX Impact:
- A new 43x35cm Wireless detector, 3543DR 1.
- A new X-ray tube and a new generator
- An optional 40 line grid with grid suppression algorithm
- Wireless Remote Control Console
- An optional All-in-one PC containing touch screen function
- An optional positioning assistance camera
- Upgrade software to VA10
- Upgrade operator system from Windows XP to Windows 10
The Siemens MULTIX Impact X-ray system is a modification of the predicate device, the Multix Fusion Max (K162971). The submission focuses on demonstrating substantial equivalence rather than presenting an effectiveness study for a new clinical claim. Therefore, the information provided primarily concerns performance testing to confirm that the modifications do not negatively impact safety or effectiveness.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission demonstrating substantial equivalence to a predicate device for an X-ray system, the acceptance criteria are generally focused on demonstrating that various component modifications do not degrade performance below the predicate's established levels, and that the device meets relevant safety and performance standards. Formal "acceptance criteria" for a specific clinical task are not explicitly stated for the device as a whole in the way they would be for a diagnostic AI algorithm. Instead, the comparison is to the predicate and established standards.
| Attribute Tested/Modified | Acceptance Criteria (Implied) | Reported Device Performance | Comparison Results |
|---|---|---|---|
| Indications for Use | "Intended use is the same." | Reworded for simplicity, but maintains same scope. | Same |
| Operating System | "Does not affect safety or effectiveness." | Upgraded from Windows XP to Windows 10. | Meets criteria |
| Suppression algorithm for low line grid | "Does not affect image quality." | Performance testing concluded. | Meets criteria |
| Post-processing software | "Does not affect image quality." | Different parameters (e.g., Contrast, Detail vs. Amplification, Edge Enhancement). Performance testing concluded. | Meets criteria |
| Floor mounted support | "Does not affect safety or effectiveness." | Mechanical (new feature). | Meets criteria |
| X-ray tube assembly | Same or equivalent performance as predicate. | 80 kW, Two-focus. | Same |
| Collimator | Same or equivalent performance as predicate. | Standard collimator (ACSS). | Same |
| Optional digital camera | "Does not affect safety or effectiveness." | Camera on collimator for patient positioning (new feature). | Meets criteria |
| Patient Table | "Does not affect safety or effectiveness." | Improvement of Bucky movement to motorized from manual. | Meets criteria |
| Bucky Wall Stand | Same or equivalent performance as predicate; "Does not affect safety or effectiveness." | Similar to predicate, some models without charging tray. | Meets criteria |
| Touch Interface | Same or equivalent functionality. | Graphical user interface. | Same |
| X-ray generator | Same or equivalent performance. | 55kW, 65kW or 80kW. | Same |
| Operating modes | Same or equivalent functionality. | RAD Single Exposure. | Same |
| Imaging System | "Does not affect safety or effectiveness." | Addition of touch screen function as option. | Meets criteria |
| Display | "Does not affect safety or effectiveness." | Different size ratio (16:9 vs. 4:3). | Meets criteria |
| DICOM 3 Functions | Same or equivalent functionality. | Send, StC, Print, Query/Retrieve, Get Worklist, MPPS. | Same |
| Radiographic Grid | "Does not affect image quality." | Addition of 40-line grid (with suppression algorithm). Performance testing concluded. | Meets criteria |
| Accessory (Wireless Remote Control Console) | "Does not affect safety or effectiveness." | Improvement of wireless function. | Meets criteria |
| New 43x35cm Wireless detector (Trixell Pixium 3543 DR vs. 3543 EZh predicate) | Detectors should exhibit comparable critical specifications (Dimensions, Resolution, Pixel size, Semiconductor Material, Scintillator, Acquisition depth, DQE, MTF). Differences should be "not significant." | Dimensions: 345mm x 426mm (subject) vs. 348mm x 424mm (subject to predicate) and 349mm x 425mm (predicate). Resolution: 2156 x 2662 pixels (subject) vs. 2350 x 2866 pixels and 2356 x 2872 pixels (predicate). Pixel size: 160 µm (subject) vs. 148 µm (predicate). Other: Same for Semiconductor Material, Scintillator, Acquisition depth, DQE (51%), MTF (62-63%). | "Difference not significant" for dimensions, resolution, pixel size. "Same" for other parameters. |
| Compliance with Standards | Conformance to various IEC, ISO, and NEMA standards, notably IEC 60601 series. | Conforms to listed standards (IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-3:2008+A1:2013, IEC 62366-1:2015, ISO 14971:2007, IEC 60601-1-6:2013, IEC 62304:2015, IEC 60601-2-28:2010-03, IEC 60601-2-54:2015-04, NEMA PS 3.1 - 3.20 (2016), ISO 10993-1:2009). | Achieved |
| Software Concerns | "All the software specifications have met the acceptance criteria" and "continued conformance with special controls for medical devices containing software." | Software Documentation for Moderate Level of Concern per FDA Guidance (May 11, 2005) included. Non-clinical tests (integration and functional) conducted. | Achieved |
| Risk Management | Risk control implemented to mitigate identified hazards. | Hazard analysis completed, controls implemented, testing supports. | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
The document describes modifications to an existing X-ray system and its components. The "test set" here refers to the actual physical device and its components undergoing verification and validation testing, rather than a dataset of medical images for a diagnostic algorithm.
- Sample Size for Test Set: Not applicable in the context of a dataset of cases. The testing was performed on the MULTIX Impact system itself and its components.
- Data Provenance: Not applicable in the clinical data sense. The testing is described as "Non-clinical tests... during product development" and "testing for verification and validation." This implies internal testing by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study requiring expert clinical read-outs for ground truth. The "ground truth" for this submission is adherence to technical specifications, performance standards (like DQE, MTF), and safety requirements, which are evaluated by engineering and quality control processes.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of clinical image adjudication for ground truth establishment. Technical performance and safety are verified through engineering tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was performed or is mentioned. This submission is for an X-ray system, not an AI-powered diagnostic device, and it focuses on demonstrating substantial equivalence of modified hardware and software components, not on comparative effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an X-ray system, which is inherently used with human operators. There is no "algorithm only" performance claim. The software modifications are part of the overall X-ray system's functionality.
7. The Type of Ground Truth Used
The "ground truth" for this submission relates to:
- Technical Specifications: Ensuring components meet their specified performance parameters (e.g., DQE, MTF for the detector, power output for the generator).
- Compliance with Standards: Verification that the device adheres to recognized national and international standards (IEC, ISO, NEMA).
- Safety and Effectiveness: Demonstration that modifications do not introduce new safety risks or degrade the overall effectiveness of the predicate device, as evaluated through risk analysis and functional testing.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Denise Adams, RAC Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code: 65-1A MALVERN PA 19355
Re: K182517
Trade/Device Name: MULTIX Impact Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: November 28, 2018 Received: November 29, 2018
Dear Ms. Adams:
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
January 11, 2019
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
MULTIX Impact
Indications for Use (Describe)
The MULTIX Impact system is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pedianc, adult and bariatic patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The MULTIX Impact system is not meant for mammography.
The MULTIX Impact uses digital detectors for generating diagnostic images by converting x-rays into image signals. The MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
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Image /page/3/Picture/1 description: The image shows 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 word "Healthineers" is a cluster of orange dots.
510(k) Summary: MULTIX Impact
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
Date Prepared: September 11, 2018
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
1. General Information
Importer / Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number 2240869
Location of Manufacturing Site
Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road, Shanghai 201318. China Establishment Registration Number 3003202425
Siemens Healthcare GmbH Siemensstrasse 1 Forchheim, Germany 91301 Establishment Registration Number: 3004977335
2. Contact Person
Denise Adams, RAC Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 610-448-6139 adams.denise@siemens-healthineers.com
Siemens Medical Solutions USA, Inc.
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3. Device Name and Classification
| Trade Name: | MULTIX Impact |
|---|---|
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
4. Legally Marketed Predicate Device
| Trade Name: | Multix Fusion Max |
|---|---|
| 510(k) #: | K162971 |
| Clearance Date: | November 22, 2016 |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
5. Device Description
The MULTIX Impact Radiography X-ray system is a modular system of X-ray components (floor-mounted X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless detectors) similar to the predicate the Multix Fusion Max. This 510(k) submission describes modifications to the predicate device the Multix Fusion Max cleared via K162971. The following modifications have been made to the cleared predicate device and the new system will be branded the MULTIX Impact:
- A new 43×35cm Wireless detector, 3543DR 1.
-
- A new X-ray tube and a new generator
-
- An optional 40 line grid with grid suppression algorithm
-
- Wireless Remote Control Console
- ર. An optional All-in-one PC containing touch screen function
- An optional positioning assistance camera 6.
- Upgrade software to VA10 7.
-
- Upgrade operator system from Windows XP to Windows 10
6. Indications for Use
The MULTIX Impact system is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The MULTIX Impact system is not meant for mammography.
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Image /page/5/Picture/1 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 words is a pattern of orange dots.
The MULTIX Impact uses digital detectors for generating diagnostic images by converting Xrays into image signals. The MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
7. Substantial Equivalence
The MULTIX Impact is a modification to the predicate device the Multix Fusion Max cleared via K162971. It is within the same classification with similar indications for use and the same mechanical design as the predicate device. The MULTIX Impact is substantially equivalent to the predicate device and documentation is provided to support a claim of substantial equivalence.
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device
The MULTIX Impact is comparable in indications for use, design, material, functionality, technology, energy source and is substantially equivalent to the commercially available Siemens' Multix Fusion Max. It uses the same or similar components cleared in the Multix Fusion Max (e.g. collimator, patient table, Bucky wall stand).
The components of the subject device have many of the same technological characteristics as the ones from the predicate device. There are several technological characteristics that differ slightly as shown in the comparison tables.
Testing and validation have been successfully completed and test results show that the subject device MULTIX Impact with all of its components are comparable to the predicate device and therefore is substantially equivalent to the predicate device.
The modifications made to the subject device MULTIX Impact do not affect the intended use of the device nor do they alter its fundamental scientific technology from the 510(k) cleared predicate device the Multix Fusion Max.
The following tables compare the main performance data of the subject device with the predicate device to substantiate equivalence.
| Attribute | MULTIX Impact(subject) | Multix Fusion MaxK162971(predicate) | ComparisonResults |
|---|---|---|---|
| Indicationsfor Use | The MULTIX Impact systemis a radiographic system usedin hospitals, clinics, andmedical practices. MULTIXImpact enables radiographicexposures of the whole body | The Multix Fusion Maxsystem is a radiographicsystem used in hospitals,clinics, and medicalpractices. Multix Fusion Maxenables radiographic | Intended use isthe same.Indications foruse have beenreworded to |
Table 1: Indications for Use Comparison
Siemens Medical Solutions USA, Inc.
40 I iberty Boulevard Malvern PA 19355-9998 USA
Tel.: +1-888-826-9702 usa.siemens.com/healthineers
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Image /page/6/Picture/1 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 word "Healthineers" is a series of orange dots that are arranged in a pattern.
| including: skull, chest,abdomen, and extremitiesand may be used onpediatric, adult and bariatricpatients. Exposures may betaken with the patient sitting,standing, or in the proneposition. The MULTIXImpact system is not meantfor mammography.The MULTIX Impact usesdigital detectors forgenerating diagnostic imagesby converting X-rays intoimage signals.The MULTIX Impact is alsodesigned to be used withconventional film/screen orComputed Radiography (CR)cassettes. | exposures of the whole bodyincluding: skull, chest,abdomen, and extremitiesand may be used onpediatric, adult and bariatricpatients. Exposures may betaken with the patient sitting,standing, or in the proneposition. The Multix FusionMax system is not meant formammography.The Multix Fusion Max usesa mobile (wired), or fixed(integrated) or wirelessdigital detector forgenerating diagnostic imagesby converting X-rays intoimage signals.The Multix Fusion is alsodesigned to be used withconventional film/ screen orComputed Radiography (CR)cassettes. | simplify. |
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------- |
40 Liberty Boulevard
Malvern, PA 19355-9998
USA
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Image /page/7/Picture/1 description: The image shows 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 word "Healthineers" are a series of orange dots that are arranged in a pattern.
| Attribute | MULTIX Impact(subject) | Multix Fusion MaxK162971(predicate) | ComparisonResults |
|---|---|---|---|
| OperatingSystem | Windows 10 | Windows XP | New operatingsystem, doesnot affect safetyor effectiveness |
| Suppressionalgorithm forlow line grid | The new 40 low line gridrequires a suppressionalgorithm to suppress lineartifacts | N/A | Performancetestingconcluded doesnot affect imagequality. |
| Post-processingsoftware | -Contrast-Detail-Latitude-Noise-WLShift-WWShift | -Amplification-Edge Enhancement-Harmonization-Noise Reduction-Center Shift-Width Factor | Performancetestingconcluded doesnot affect imagequality. |
| Floormountedsupport | Mechanical | N/A | Does not affectsafety oreffectiveness |
| X-ray tubeassembly | 80 kWTwo-focus | 80 kWTwo-focus | Same |
| Collimator | Standard collimator (ACSS) | Standard collimator(ACSS) | Same |
| Optionalcollimator | Manual collimator | N/A | Does not affectsafety oreffectiveness |
| Optionaldigitalcamera | Camera on collimator to aidin patient positioning | N/A | Does not affectsafety oreffectiveness |
| Attribute | MULTIX Impact(subject) | Multix Fusion MaxK162971(predicate) | ComparisonResults |
| Patient Table | Radiographic tablemotorized with floating tabletop and motorized Buckytray with charging in trayfunction (wireless detector) | Radiographic tablemotorized with floating tabletop and manual Bucky traywith charging in trayfunction (wireless detector) | Improvement ofBuckymovement tomotorized.Does not affectsafety oreffectiveness |
| Radiographic tablemotorized with floating tabletop and motorized Buckytray (wireless detector) | Radiographic tablemotorized with floating tabletop and manual Bucky traywith charging in trayfunction (wireless detector) | Improvement ofBuckymovement tomotorizedwithoutchargingfunction in trayDoes not affectsafety oreffectiveness | |
| Fixed radiographic table withfloating table top and manualBucky tray (portable wirelessdetector) | N/A | Does not affectsafety oreffectiveness | |
| Bucky WallStand | BWS for wireless detectorVertical motorized andcharging in tray | BWS for wireless detectorVertical motorized andcharging in tray | Same |
| BWS for wireless detectorVertical motorized | BWS for wireless detectorVertical motorized andcharging in tray | No chargingtray. Does notaffect safety oreffectiveness | |
| BWS for wireless detectorManual movement in z-axis | N/A | Does not affectsafety oreffectiveness | |
| Attribute | MULTIX Impact(subject) | Multix Fusion MaxK162971(predicate) | ComparisonResults |
| TouchInterface | Graphical user interface | Graphical user interface | Same |
| X-raygenerator | 55kW, 65kW or 80kW | 55kW, 65 kW or 80 kW | Same |
| Operatingmodes | RAD Single Exposure | RAD Single Exposure | Same |
| ImagingSystem | All in one PC basedhigh resolution digitaltouch screen function asoption | Fluorospot Compact PCbasedhigh resolution digital | Addition oftouch screenfunction asoption. Doesnot affect safetyor effectiveness |
| Display | Black & WhiteColorSize Ratio 16:9 | Black & WhiteColorSize Ratio 4:3 | Different sizeratio. Does notaffect safety oreffectiveness |
| DICOM 3Functions | Send, StC, Print,Query/Retrieve, GetWorklist, MPPS | Send, StC, Print,Query/Retrieve, GetWorklist, MPPS | Same |
| RadiographicGrid | 92-line grid(ratio 13:1)40-line grid(ratio 13:1) | 92-line grid(ratio 13:1)85-line grid(ratio 5:1) (optional) | Same ratiowith newaddition of 40-line grid.Performancetestingconcluded thatcombined withsuppressionalgorithm doesnot affect imagequality |
| Accessory | Wireless Remote ControlConsole via bluetooth | Remote Control console | Improvement ofwirelessfunction. Does |
Table 2: Subject Device Compared to the Predicate
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Image /page/8/Picture/1 description: The image shows 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 word "Healthineers" is a series of orange dots that form a curved line.
40 Liberty Boulevard
Malvern, PA 19355-9998
USA
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Image /page/9/Picture/1 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.
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355-9998
USA
Tel.: +1-888-826-9702
usa.siemens.com/healthineers
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Image /page/10/Picture/1 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 word "Healthineers" is a graphic of orange dots.
| Attribute | MULTIX Impact(subject) | Multix Fusion MaxK162971(predicate) | ComparisonResults |
|---|---|---|---|
| not affect safetyor effectiveness |
40 Liberty Boulevard
Malvern, PA 19355-9998
USA
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Image /page/11/Picture/1 description: The image shows 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 graphic of orange dots arranged in a circular pattern.
| Table 3: Comparison of Trixell Pixium 3543 DR to the Predicate Trixell Pixium | ||
|---|---|---|
| 3543 EZh |
| TechnicalSpecifications | Trixell Pixium3543 DRdetector(wireless)(subject) | Trixell Pixium3543 EZhdetector(wireless)(subject) | Trixell Pixium3543 EZhdetector(wireless)(predicate) | ComparisonResults |
|---|---|---|---|---|
| Dimensions | 345 mm x 426 mm | 348 mm x 424 mm | 349 mm x 425 mm | Difference not significant |
| Resolution | 2156 x 2662 pixels | 2350 x 2866 pixels | 2356 x 2872 pixels | Difference not significant |
| Pixel size | 160 $ \mu $ m | 148 $ \mu $ m | 148 $ \mu $ m | Difference not significant/Same |
| SemiconductorMaterial | Amorphous silicon, a-Si | Amorphous silicon, a-Si | Amorphous silicon, a-Si | Same |
| Scintillator | Cesium iodide (CsI) | Cesium iodide (CsI) | Cesium iodide (CsI) | Same |
| Acquisitiondepth | 16 bit | 16 bit | 16 bit | Same |
| DQE (DetectiveQuantumEfficiency) | DQE @ 1 lp/mm (2 $ \mu $ Gy), 51% | DQE @ 1 lp/mm (2 $ \mu $ Gy), 51% | DQE @ 1 lp/mm (2 $ \mu $ Gy), 51% | Same |
| MTF(Modulationstransferfunction) | MTF @ 1 lp/mm,62% | MTF @ 1 lp/mm, 63% | MTF @ 1 lp/mm,63% | Difference not significant/Same |
9. Nonclinical Performance Testing
Non-clinical tests were conducted for the MULTIX Impact during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.
MULTIX Impact conforms to the following standards: IEC 60601-1:2012; IEC 60601-1-2:2014; IEC 60601-1-3:2008+A1:2013; IEC 62366-1:2015; ISO 14971:2007; IEC 60601-1-6:2013; IEC 62304:2015; IEC 60601-2-28:2010-03; IEC 60601-2-54:2015-04; NEMA PS 3.1 - 3.20 (2016) and ISO 10993-1:2009.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted on the MULTIX Impact during product development.
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Image /page/12/Picture/1 description: The image shows 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.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
10. General Safety and Effectiveness Concerns
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition, the MULTIX Impact Radiography X-ray system is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.
Risk management is ensured via a hazard analysis which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed.
11. Conclusion as to Substantial Equivalence
The MULTIX Impact has similar indications for use as the predicate Multix Fusion Max. The operating environment and mechanical design are similar. It is Siemens opinion, that the MULTIX Impact is substantially equivalent to the Multix Fusion Max, cleared in K162971 on November 22, 2016.
Verification and validation testing demonstrates that the MULTIX Impact should perform as intended. The non-clinical test data demonstrate that the MULTIX Impact device performance is comparable to the predicate device that is currently marketed for the same intended use.
In summary, Siemens is of the opinion that the MULTIX Impact does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate device.
12. Guidance documents
The following FDA guidance documents were utilized in the documentation of this Premarket Notification:
- Content of Premarket Submissions 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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.