(198 days)
Multitom Rax is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients.
The True2scale Body Scan functionality (i.e., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the genetrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan is not intended to be used for interventional purposes.
The Real3D functionality (i.e., cone-beam CT acquisition and reconstruction technique) of the Multitom Rax is intended to be used for 3-D bone imaging of the head, the upper and lower extremities as well as the lumbar spine. Real3D is not intended for imaging of the torso of patients with a Body Mass Index (BMI) exceeding 30 kg/m².
Multitom Rax is not for mammography examinations.
Multitom Rax is a stationary X-ray system for radiography and fluoroscopy. Multitom Rax consists of a floor mounted patient table (option) and ceiling suspended X-ray tube, and a ceiling suspended Solid State X-ray Imager (SSXI). Together with an X-ray generator and a digital imaging system, Multitom Rax provides comprehensive image acquisition modes to support radiographic and fluoroscopic imaging procedures.
With the True2scale Body Scan technology, Multitom Rax performs a continuous scan that moves along the patient's vertical axis with a highly collimated radiation beam along a line trajectory using the system's two telescopic arms. The projections, which are acquired during the scanning process, form the basis for a reconstruction to obtain a 2D representation of the scanned object.
With the Real3D technology, Multitom Rax performs a continuous, circular scan around the patient using the system's two telescopic arms. The projections, which are acquired during the scanning process, form the basis for a reconstruction to obtain a 3D representation of the scanned object.
The Siemens Multitom Rax device's Real3D functionality (cone-beam CT) was evaluated by comparing its technological characteristics and performance to a legally marketed predicate device (Multitom Rax with True2scale Body Scan Option) and a reference device (CurveBeam LineUP).
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in a separate section with numerical targets for each performance metric. Instead, the comparison to the reference device (CurveBeam LineUP) serves as the benchmark to demonstrate performance is at least equivalent or better, especially for the newly added CBCT functionality. The acceptance criteria can be inferred from the comparison table where the subject device's performance is listed against the reference device.
| Feature | Reference Device (CurveBeam LineUP) Performance | Subject Device (Multitom Rax Real3D) Performance | Comment / Implied Acceptance |
|---|---|---|---|
| kVp | 100 - 120 | 60 - 130 | Better for Multitom Rax Real3D (Wider range of kVp, implying flexibility and potentially better image quality for diverse patient types and body regions). |
| Voxel size | 0.3 mm | 0.2 mm - 0.5 mm (depending on chosen reconstruction kernel) | Better for Multitom Rax Real3D (Ability to achieve smaller voxel size, indicating higher spatial resolution). |
| Slice spacing | 0.3 mm | 0.2 mm - 0.5 mm (depending on chosen reconstruction kernel) | Better for Multitom Rax Real3D (Ability to achieve smaller slice spacing). |
| FOV (diameter, height) | Regular: 20 cm x 20 cm (d, h) Extended: 35 cm x 20 cm (d, h) | Real 3D Hi-Res: 15 cm x 15 cm (d, h) Real3D: 23 cm x 23 cm (d, h) | Not directly comparable, but Multitom Rax Real3D has a larger regular FOV. Extended FOV not available for Multitom Rax, but its regular FOV is larger than the reference's regular FOV. This indicates suitability for diverse anatomical regions. |
| Scan time* | 23s or 26s | Real3D Hi-Res: 14s Real3D: 12s or 16s (depending on anatomy) | Better for Multitom Rax Real3D and Real3D Hi-Res (Shorter scan times, reducing patient motion artifacts and patient dose). |
| High-contrast resolution (10% MTF) | 12 lp/cm | Real 3D Hi-Res: up to 25 lp/cm (very sharp kernel) Real 3D: up to 15 lp/cm (sharp kernel) | Better for Multitom Rax Real3D (Significantly higher line pairs per centimeter, indicating superior ability to resolve fine details). |
| Low-contrast detectability | n/a | 20 HU @ 4 mm (smooth kernel) 10 HU @ 8 mm (smooth kernel) | Not reported for CurveBeam LineUP. Justification for adequacy: Intended use is high-contrast bone imaging, so low-contrast detectability is not as critical as for hemorrhage detection. The reported values are therefore considered acceptable for the intended use. |
| Slice Sensitivity Profile / z-axis point spread function | Not directly reported (isotropic voxels assumed) | 0.42 mm ± 0.1 mm (Real3D) 0.31 mm ± 0.1 mm (Real 3D Hi-Res) | Not reported for CurveBeam LineUP. Justification for adequacy: Isotropic resolution for Multitom Rax Real3D is stated, implying consistent resolution in all directions, which is a desirable characteristic. |
| Image noise | n/a | Smooth: 20 ± 15 HU Medium: 60 ± 40 HU Sharp: 100 ± 60 HU Very sharp: 300 ± 150 HU | Not reported for CurveBeam LineUP. Justification for adequacy: Noise depends on dose, object, and reconstruction kernel, making direct comparison difficult. The reported values are considered acceptable for the intended diagnostic quality of high-contrast bone imaging. |
| Uniformity (in-plane) | < 100 HU | < 150 HU | Better for CurveBeam LineUP. Justification for adequacy: Despite being higher, the uniformity of <150 HU is considered acceptable as it allows for standard viewing windowing functions typical for bone imaging (e.g., 2000 HU / 300 HU or 1500 HU / 450HU). |
| CT Number Accuracy | Air: -1000 ± 200 HU Water: 0 ± 150 HU Bone: n/a | Air: -1000 ± 250 HU Water: 0 ± 150 HU Bone: 450 ± 150 HU | Air: Better for CurveBeam LineUp. Water: Equivalent. Bone: Not reported for CurveBeam LineUp. Justification for adequacy: The CT number accuracy for Multitom Rax Real3D, although slightly wider for air, is still within ranges that allow for standard bone viewing windowing functions and is therefore considered adequate for its intended high-contrast bone imaging use. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions an "image quality evaluation of 21 anonymized clinical and phantom data sets."
- Sample size: 21 data sets (comprising clinical and phantom data).
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). It simply mentions "anonymized clinical and phantom data sets."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The image quality evaluation was conducted by "expert US board-certified radiologists."
- Number of experts: Not explicitly stated, but implies a group of experts plural.
- Qualifications of experts: US board-certified radiologists. No specific years of experience are mentioned.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states the image quality evaluation was conducted by experts "showing that presented 3D images are of sufficient diagnostic quality to assess osseous structures including fractures and bone angles." This suggests a consensus or individual assessment against diagnostic quality, rather than a specific algorithmic adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, the document does not describe an MRMC comparative effectiveness study that assesses how much human readers improve with AI vs. without AI assistance. The study described is an image quality evaluation by radiologists, not a comparative effectiveness study involving AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, standalone performance was evaluated through the non-clinical tests and the comparison of technological characteristics against a reference device. These tests assessed the intrinsic image quality metrics (high-contrast resolution, low-contrast detectability, CT number accuracy, uniformity, image noise, etc.) of the Real3D functionality without human intervention in the diagnostic process.
7. The Type of Ground Truth Used
For the non-clinical performance metrics (e.g., resolution, uniformity, CT number accuracy), the ground truth is established through phantom data and standardized measurement techniques. For the "clinical" aspects of the 21 data sets, the ground truth for diagnostic quality assessment was the expert consensus/opinion of US board-certified radiologists who determined if the images were of "sufficient diagnostic quality to assess osseous structures including fractures and bone angles."
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. The descriptions focus on the validation and verification of software and the performance evaluation of the Real3D functionality.
9. How the Ground Truth for the Training Set Was Established
As the document does not provide information on the training set, the method for establishing its ground truth is also not provided.
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November 17, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
Siemens Medical Solutions % Denise Adams Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355
Re: K221281
Trade/Device Name: Multitom Rax Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, JAK Dated: October 18, 2022 Received: October 19, 2022
Dear Denise 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
Zhkke
Laurel Burk, 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) K221281
Device Name Multitom Rax
Indications for Use (Describe)
Multitom Rax is a device intended to visualize anatomical structures by converting an X- ray pattern into a visible image. The system has medical applications ranging from gastrointestinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients.
The True2scale Body Scan functionality (i.e., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the genetrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan is not intended to be used for interventional purposes.
The Real3D functionality (i.e., cone-beam CT acquisition and reconstruction technique) of the Multitom Rax is intended to be used for 3-D bone imaging of the head, the upper and lower extremities as well as the lumbar spine. Real3D is not intended for imaging of the torso of patients with a Body Mass Index (BMI) exceeding 30 kg/m².
Multitom Rax is not for mammography examinations.
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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510(k) Summary: Multitom Rax
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: November 16, 2022
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.
1. General Information:
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:
Denise Adams, RAC Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, US adams.denise@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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-
- Device Name and Classification:
Trade Name: Multitom Rax Classification Name: Image-intensified fluoroscopic x-ray system Classification Panel: Radiology Classification Regulation: 21 CFR §892.1650 Device Class: II Product Code: OWB Secondary Product Code: JAA, JAK
- Device Name and Classification:
4. Legally Marketed Predicate Device:
| Trade Name | Multitom Rax With True2scale Body Scan Option |
|---|---|
| Company | Siemens Medical Solutions USA, Inc. |
| 510(k) Number | K212212 |
| Device Classi-ficationName | Interventional Fluoroscopic X-ray System |
| RegulationNumber | 892.1650 |
| Review Panel | Radiology |
| Product Code | OWB |
| SecondaryProduct Code | JAA |
| Device Class | 2 |
5. Legally Marketed Reference Device:
| Trade Name | LineUP |
|---|---|
| Company | CurveBeam, LLC |
| 510(k) Number | K180727 |
| Device Classi-ficationName | Computed tomography X-ray System |
| RegulationNumber | 892.1750 |
| Review Panel | Radiology |
| Product Code | JAK |
| Device Class | 2 |
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6. Device Description:
Multitom Rax is a stationary X-ray system for radiography and fluoroscopy. Multitom Rax consists of a floor mounted patient table (option) and ceiling suspended X-ray tube, and a ceiling suspended Solid State X-ray Imager (SSXI). Together with an X-ray generator and a digital imaging system, Multitom Rax provides comprehensive image acquisition modes to support radiographic and fluoroscopic imaging procedures.
With the True2scale Body Scan technology, Multitom Rax performs a continuous scan that moves along the patient's vertical axis with a highly collimated radiation beam along a line trajectory using the system's two telescopic arms. The projections, which are acquired during the scanning process, form the basis for a reconstruction to obtain a 2D representation of the scanned object.
With the Real3D technology, Multitom Rax performs a continuous, circular scan around the patient using the system's two telescopic arms. The projections, which are acquired during the scanning process, form the basis for a reconstruction to obtain a 3D representation of the scanned object.
7. Indication for Use:
Multitom Rax is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging fromgastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications.lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients.
The True2scale Body Scan functionality (i.e., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the generation of a geometrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan is not intended to be used for interventional purposes.
The Real3D functionality (i.e., cone-beam CT acquisition and reconstruction technique) of the Multitom Rax is intended to be used for 3D bone imaging of the head, the upper and lower extremities as well as the lumbar spine.
Real3D is not intended for imaging of the torso of patients with a Body Mass Index (BMI) exceeding 30 kg/m².
Multitom Rax is not for mammography examinations.
8. Substantial Equivalence:
The subject device is the same as the predicate device. The software was updated and new CBCT trajectories have been introduced. The Real3D (CBCT) functionality has been tested and does not raise any new concerns of safety and effectiveness. A comparison to a legally marketed CBCT device was done and supports substantial equivalence.
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Image /page/6/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 words is a graphic of orange dots arranged in a circular pattern.
The device remains within the same classification regulation for the same technology as the predicate device with the addition of computed tomography. The system software design was completed in accordance with Siemens Quality Management System Design Controls. The scope of internationally recognized standards compliance remains the same.
- Summary of Technological Characteristics of the Subject Device as Compared with 9. the Predicate Device:
The software of the subject device was updated and new CBCT trajectories have been added.
Comparison of the Subject Device (Multitom Rax) to the PredicateDevice (Multitom Rax With True2scale Body Scan Option)
| Feature | Predicate deviceMultitom Rax WithTrue2scale Body Scan Op-tion | Subject deviceMultitom Rax | Comment |
|---|---|---|---|
| Regulation De- | Image-intensified fluoro- | Image-intensified fluoro- | Same |
| scription | scopic X-ray system | scopic X-ray system | |
| RegulationNumber | 892.1650 | 892.1650 | Same |
| ClassificationProduct Code | OWB | OWB | Same |
| SecondaryProduct Code | JAA | JAA, JAK | New productcode for CBCT |
| Indications foruse | Multitom Rax is a deviceintended to visualize ana-tomical structures by con-verting an X-ray patterninto a visible image. Thesystem has medical appli-cations ranging from gas-trointestinal examinationstocranial, skeletal, thoracicand lung exposures as wellasexaminations of the uro-genital tract. The unit mayalso be used in emergencyapplications, lymphogra-phy, endoscopy, myelog-raphy, venography, ar-thrography, interventionalradiology, digital angi-ography, and digital sub-traction angiography(DSA). The system may be | Multitom Rax is a deviceintended to visualize ana-tomical structures by con-verting an X-ray patterninto a visible image. Thesystem has medical applica-tions ranging from gastroin-testinal examinationsto cra-nial, skeletal, thoracic andlung exposures as well asexaminations of the urogen-ital tract. The unit may alsobe used in emergency appli-cations, lymphography, en-doscopy, myelography, ve-nography, arthrography, in-terventional radiology, digi-tal angiography, and digitalsubtraction angiography(DSA). The system may beused on pediatric, adult, and | Real3D added toIndications forUse |
| used on pediatric, adult,and bariatric patients.The True2scale Body Scanfunctionality (i.e., slot-scanning-based acquisitionand reconstruction tech-nique) of the Multitom Raxis intended to be used forthe generation of a geomet-rically accurate (in scan-ning direction) 2-D repre-sentation of the spine, thelower limbs or the full bodywhich may be used for theassessment of body axesand skeletal alignment. TheTrue2scale Body Scan isnot intended to be used forinterventional purposes.Multitom Rax is not formammography examina-tions. | bariatric patients.The True2scale Body Scanfunctionality (i.e., slot-scanning-based acquisitionand reconstruction tech-nique) of the Multitom Raxis intended to be used forthe generation of a geomet-rically accurate (in scan-ning direction) 2-D repre-sentation of the spine, thelower limbs or the full bodywhich may be used for theassessment of body axesand skeletal alignment. TheTrue2scale Body Scan isnot intended to be used forinterventional purposes.The Real3D functionality(i.e., cone-beam CT acqui-sition and reconstructiontechnique) of the MultitomRax is intended to be usedfor 3D bone imaging of thehead, the upper and lowerextremities as well as thelumbar spine.Real3D is not intended forimaging of the torso of pa-tients with a Body Mass In-dex (BMI) exceeding 30kg/m².Multitom Rax is not formammography examina-tions. | ||
| Scan axis | Horizontal and Vertical | Horizontal and Vertical | Same |
| MechanicalSystem design | Tube and detector bothmove on rails with threetranslational and two rota-tional degrees of freedom.They can move on definedpaths (trajectories) aroundthe patient to acquire theprojections. | Tube and detector both moveon rails with three transla-tional and two rotational de-grees of freedom. They canmove on defined paths (tra-jectories) around the patientto acquire the projections. | Same |
| projections. | |||
| High voltagegenerator | High frequency generator65 or 80 kW | High frequency generator65 or 80 kW | Same |
| X-Ray Tube | Max anode heat capacity820 KHU(Nominal) Focal size: 0.6 /1.0 | Max anode heat capacity820 KHU(Nominal) Focal size: 0.6 /1.0 | Same |
| Image detector | SSXI with Cesium Iodidescintillator | SSXI with Cesium Iodidescintillator | Same |
| Gray scale | 16 bit | 16 bit | Same |
| PatientSupportStructure | Floor mounted patient ta-ble for supine examina-tions. Patient support de-vice for standing patient. | Floor mounted patient tablefor supine examinations.Patient support device forstanding patient. | Same |
| Cone-beam CTfunctionality | N/A | Trajectories for CBCT im-age acquisitionallowing various Source-to-Imager and Source-to-Iso-center Distances parallel toaxis of rotation.The X-ray beam is colli-mated to a rectangular shapematching the 43 cm x 43 cmflat panel detector (with anarrow unexposed margin).For the high-resolutionmode, the beam size is lim-ited to 21 cm x 21 cm.Scans available for upperand lower extremities, head,and lumbar spine.Filtered backprojection-based reconstruction forCBCT, which accounts forthe acquisition geometry.Metal Artifact Reduction forCBCT | Added supportfor CBCT func-tionality |
| Feature | CurveBeam LineUp | Multitom Rax Real3D | Comment |
| kVp | 100 - 120 | 60 - 130 | Better for Multitom Rax Real3D |
| Voxel size | 0.3 mm | 0.2 mm - 0.5 mm (depending on chosen reconstruction kernel) | Better for Multitom Rax Real3D |
| Slice spacing | 0.3 mm | 0.2 mm - 0.5 mm (depending on chosen reconstruction kernel | Better for Multitom Rax Real3D |
| FOV (diameter, height) | Regular:20 cm x 20 cm (d, h)Extended:35 cm x 20 cm (d, h) | Real 3D Hi-Res:15 cm x 15 cm (d, h)Real3D:23 cm x 23 cm (d, h) | Extended FOV not available at Multitom RaxRegular FOV is bigger for Multitom Rax Real3D |
| Scan time* | 23s or 26s | Real3D Hi-Res: 14sReal3D: 12s or 16s (depending on anatomy) | Better for Multitom Rax Real3D and Real3D Hi-Res*Scan time is defined as the duration in which the exposure alarm (buzzer) is ON and X-ray ON light is illuminated |
| High-contrast resolution (10% MTF) | 12 lp/cm | Real 3D Hi-Res:up to 25 lp/cm (very sharp kernel)Real 3D:up to 15 lp/cm (sharp kernel) | Better for Multitom Rax Real3D |
| Low-contrast detectability | n/a | 20 HU @ 4 mm (smooth kernel)10 HU @ 8 mm (smooth kernel) | Not reported for CurveBeam LineUp.Also, the intended use of Real3D is high-contrast bone imaging, therefore the low-contrast detectability is not of as high importance as it would be for hemorrhage detection |
| Slice Sensitivity Profile / z-axis point spread function | The LineUP has a fixed and rigid patient positioning platform that does not incorporate any table motion or indexing (no "table pitch"). The detector panel has a square shape, while the pixels on the panels are square shaped as well. The raw projections are acquired in a single 360° orbit, thus covering the entire Field of View (FOV) height in one rotation. This results in isotropic voxels in the reconstructed volume, hence the same spatial resolution in the z-axis as in the x-y plane. Due to this projection geometry, calculation of a separate z-axis point spread function should not be applicable. | $0.42 \text{ mm } \pm 0.1 \text{ mm}$ (Real3D)$0.31 \text{ mm } \pm 0.1 \text{ mm}$ (Real 3D Hi-Res) | Not reported for CurveBeam LineUp.Isotropic resolution for Multitom Rax Real3D. |
| Image noise | n/a | Smooth: $20 \pm 15 \text{ HU}$Medium: $60 \pm 40 \text{ HU}$Sharp: $100 \pm 60 \text{ HU}$Very sharp: $300 \pm 150 \text{ HU}$ | Not reported for CurveBeam LineUp.Also, as noise depends on both, radiation dose and the imaged object and the used post-processing (reconstruction kernel), a direct comparison of two devices is mostly not feasible. |
| Uniformity (in-plane) | < 100 HU | < 150 HU | Better for CurveBeam LineUpJustification: Intended use of Real3D is high-contrast bone imaging, therefore the in-plane uniformity should at least allow to apply standard viewing windowing functions (typical bone windows are, for instance, 2000 HU / 300 HU (W/C) or 1500 HU/ 450HU (W/C)), which is fulfilled for the CBCT functionality |
| of the Multitom Rax. | |||
| CT NumberAccuracy | Air: $-1000 \pm 200$ HUWater: $0 \pm 150$ HUBone (400 mg CaHA/ccm): n/a | Air:$-1000 \pm 250$ HUWater:$0 \pm 150$ HUBone (400 mg CaHA/ccm):$450 \pm 150$ HU | Air: Better for CurveBeam LineUpWater: equivalentBone: Not reported for CurveBeam LineUp.Justification: Intended use of Real3D is high-contrast bone imaging, therefore the CT number accuracy should allow to apply standard viewing windowing functions (typical bone windows are, for instance, 2000 HU / 300 HU (W/C) or 1500 HU/ 450HU (W/C)) which is fulfilled for the CBCT functionality of the Multitom Rax. |
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Comparison of the CBCT-functionality of the Subject Device (Multito ence Device (LineUP)
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SIEME
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Summary of Non-Clinical Tests: 10.
The Multitom Rax VF11 software design was completed in accordance with Siemens Quality Management System Design Controls and verification and validation testing were successfully conducted. The following performance tests were conducted:
- High-contrast Resolution (MTF) ●
- Low-contrast Detectability
- CT Number Accuracy
- Uniformity ●
- Image Noise (in-plane) ●
- Image Noise (z-direction)
- Slice Sensitivity Profile (SSP) ●
- Noise Power Spectrum (NPS)
- . CTDI measurements/accuracy
The Real3D image output should not be used for quantitative HU-value based diagnoses.
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11. Summary of Tests to comply with International Standards
The device complies with the voluntary standards as listed in the following table:
| Standards DevelopmentOrganizationandReference Number | Title of Standard |
|---|---|
| ANSI AAMI60601-1, 2012 Ed. 3.1 | Medical Electrical Equipment - Part 1: GeneralRequirements for Safety |
| IEC 60601-1-2 2014 Ed 4.0 | Medical Electrical Equipment - Part 1-2: Generalrequire-ments for basic safety and essential performance -Collat-eral Standard: Electromagnetic Compatibility -- Require-ments and Tests |
| IEC 60601-1-3:Edition 2.1, 2013 | Medical electrical equipment - Part 1-3: General require-ments for basic safety and essential performance -Collat-eral Standard: Radiation protection in diagnostic X-rayequipment |
| IEC 60601-2-28, 2017 | Medical electrical equipment - Part 2-28: Particular re-quirements for the basic safety and essential performanceof X-ray tube assemblies for medical diagnosis |
| IEC 60601-2-542018, Edition 1.2 | Medical electrical equipment - Part 2-54: Particular re-quirements for the basic safety and essential performanceof X-ray equipment for radiography and radioscopy |
| IEC 60601-1-62013 Ed 3.1 | Medical electrical equipment – Part 1-6: General require-ments for basic safety and essential performance -Collat-eral standard: Usability |
| IEC 62366-1 2015 Ed 1.0 | Medical devices – Application of usability engineering tomedical devices |
| ISO 14971: 2019 | Medical devices – application of risk management tomedical 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 documen-tation - Part 1: Radiation dose structured reportsfor radi-ography and radioscopy |
| NEMA PS 3.1 - 3.20 2016 | Digital Imaging and Communications in Medicine (DI-COM) Set |
| IEC 60601-2-43: 2017 | Medical electrical equipment - Part 2-43: Particular re-quirements for the safety of X-ray equipment for inter-ventional procedures |
| ISO EN ISO 15223-12017-04 | Medical devices - Symbols to be used with medical de-vice labels, labelling and information to be supplied - Part1: General requirements |
| IEC 62220-1-1:2015 | Medical electrical equipment – Characteristics of digitalX-ray imaging devices – Part 1-1:Determination of the detective quantum efficiency –De-tectors used in radiographic imaging |
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12. Summary of Clinical Tests:
For the subject of this premarket submission, Siemens did a Customer Use Test over the course of three months as well as a dedicated evaluation of the image quality.
The purpose of the Customer Use Test was to proof the effectiveness of the changes between VF10 and VF11, focusing on the performance of the Real3D functionality in terms of workflow and image quality. The analysis of the feedback material stated that the MTR Real3D can be used for CBCT bone imaging of hand, wrist, foot, ankle, knee, and lumbar spine and was vastly improved compared to the predecessor version.
In addition, an image quality evaluation of 21 anonymized clinical and phantom data sets including images of the foot, ankle, knee, hip, lumbar spine, elbow, hand, and head by expert US board-certified radiologists was conducted showing that presented 3D images are of sufficient diagnostic quality to assess osseous structures including fractures and bone angles.
13. 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 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 health care 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.
14. Conclusion as to Substantial Equivalence:
The Multitom Rax that is the subject of this 510(k) is the same as the predicate device. The software was updated and new CBCT trajectories have been introduced, and the Indications for Use have been updated to include language about the Real3D feature. A comparison to a legally marketed CBCT device was done and supports substantial equivalence. Therefore, Siemens concludes the subject device is substantially equivalent to the predicate and the reference device.
15. 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
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Content of Premarket Submission for Management of Cybersed 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 Medical Devices - 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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.