(39 days)
Not Found
No
The summary describes a standard X-ray imaging system and its components. There is no mention of AI, ML, or related terms, nor any description of algorithms that would suggest their use for image analysis, processing, or other functions beyond basic digital imaging. The performance testing focuses on hardware and software verification against predicate devices and standards, not on the performance metrics typically associated with AI/ML algorithms (e.g., sensitivity, specificity, AUC).
No
The device is a diagnostic imaging system, designed to visualize anatomical structures using X-ray, not to treat conditions.
Yes
The 'Intended Use / Indications for Use' section explicitly states: "The Multitom Rax is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies." This directly labels it as a diagnostic device.
No
The device description explicitly states it is a "stationary X-ray system" consisting of hardware components like a patient table, X-ray tube, and X-ray imager. While it includes a digital imaging system and software, it is not solely software.
Based on the provided information, the Multitom Rax is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that the Multitom Rax is a diagnostic imaging system that visualizes anatomical structures within the body using X-rays. It does not analyze blood, tissue, or other biological samples.
- The device description focuses on the hardware and software for generating and capturing X-ray images. This is consistent with an in vivo imaging system, not an in vitro diagnostic device.
- The performance studies and predicate devices are related to X-ray imaging systems. The comparisons are made to other radiographic and fluoroscopic devices, not IVD devices.
Therefore, the Multitom Rax is an in vivo diagnostic imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Multitom Rax is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.
The Multitom Rax is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal. thoracic and lung exposures as well as examination of the unit may also be used in lymphography, endoscopy, myelography, pediatrics, arthrography, interventional radiography, digital angiography and digital subtraction angiography (DSA).
The Multitom Rax may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
The Multitom Rax is not for mammography examinations
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA
Device Description
The Multitom Rax is a stationary X-ray system for radiography and fluoroscopy. The Multitom Rax consists of a floor mounted patient table 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 the Multitom Rax provides comprehensive image acquisition modes to support radiographic and fluoroscopic imaging procedures. X-ray tube and SSXI suspension movements are synchronized to provide rotation around a center. Series imaging acquired during the rotation are provided to 3D post-processing workstations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
gastrointestinal, cranial, skeletal, thoracic, lung, urogenital tract, lymphography, endoscopy, myelography, venography, arthrography
Indicated Patient Age Range
pediatrics (examinations), Not Found (specific age range)
Intended User / Care Setting
outpatient and emergency treatment, healthcare professionals
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were performed on the Multitom Rax which demonstrated that the device is safe and effective, performs comparably to the predicate devices, and is substantially equivalent to the predicate devices. Tests included verification/validation testing to internal functional specifications (including software). The Multitom Rax uses the same solid state X-ray imager (SSXI) as the Primary predicate. X-ray geometry and techniques are the same so that clinical image comparisons involving SSXI were not conducted. Documentation provided demonstrates compliance of the new device to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. including results of verification/validation tests to software requirements and software risk hazards. Performance testing confirmed that the Multitom Rax complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment and with relevant voluntary safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically IEC standards listed in the table. Together, the verification/validation activities successfully confirmed device requirements has been fulfilled and that system functionality is consistent with the user needs and intended uses. The Multitom Rax device correctly performs as designed and raises no new questions regarding safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2015
Siemens Medical Solutions USA, Inc. % Mr. Darren Dorman Regulatory Affairs Specialist 40 Liberty Blvd., 65-1A MALVERN PA 19355
Re: K152928
Trade/Device Name: Multitom Rax Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Codes: OWB, JAA Dated: October 5, 2015 Received: October 6, 2015
Dear Mr. Dorman:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oaks
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Multitom Rax
Indications for Use (Describe)
The Multitom Rax is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.
The Multitom Rax is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal. thoracic and lung exposures as well as examination of the unit may also be used in lymphography, endoscopy, myelography, pediatrics, arthrography, interventional radiography, digital angiography and digital subtraction angiography (DSA).
The Multitom Rax may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
The Multitom Rax is not 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 shows the word "SIEMENS" in a sans-serif font. The word is written in all capital letters. The color of the text is a light blue or turquoise color.
510(k) Summary: Multitom Rax
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
October 2, 2015 Date Prepared:
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
Manufacturing Site: SIEMENS AG Sector Healthcare Siemensstraße 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335
2. Contact Person:
Mr. Darren Dorman Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard · Mail Code 65-1A Malvern, PA 19355, USA Phone: +1 610 448-6483 ▪ Fax: +1 610 640-4481 Email: darren.dorman@siemens.com
Alternate Contact Person :
Ms. Patricia D. Jones Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mail code 65-1A Malvern, PA 19355, USA Phone : +1-610-448-6474. Fax : +1-610-640-4481 Email : patricia.d.iones@siemens.com
3. Device Name and Classification:
4
Healthcare
Multitom Rax
| Trade Name: | Multitom Rax |
|---|---|
| Device: | Interventional fluoroscopic X-ray system |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
| Regulation Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | OWB |
| Subsequent Product Code: | JAA |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 892.1650 |
| Device Class | 2 |
| Legally Marketed Predicate Devices: | |
| Primary Predicate: | |
| Trade Name: | AXIOM Luminos dRF |
| 510(k) Number: | K062623 |
| Device: | Interventional Fluoro X-Ray System |
| Regulation Description: | Image-intensified fluoro X-ray System |
| Regulation Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | OWB |
| Subsequent Product Codes: | JAA, OXO |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 892.1650 |
| Device Class | 2 |
| Recall Information: | Z-0326-2009; Z-0327-2009; Z-0717- |
| 2011; Z-1159-2012; Z-1383-2012; Z- | |
| 1848-2013; Z-0016-2014; Z-1845-2014; | |
| Z-0374-2014; Z-0140-2014; Z-1711-2014; | |
| Z-2292-2014; Z-2649-2014 | |
| Secondary Predicate: | |
| Trade Name: | AXIOM Aristos FX Plus |
| 510(k) Number: | K061054 |
| Device: | Solid State X-Ray Imager |
| Regulation Description: | Image-intensified fluoro X-ray System |
| Regulation Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | MQB |
| Submission Type: | Special 510(k) |
| Regulation Number: | 892.1680 |
| Device Class | 2 |
| Recall Information: | Z-0984-03; Z-0163-2009; Z-1959-2011; |
| Z-0860-2012; Z-1583-2015 |
5
5. Device Description:
The Multitom Rax is a stationary X-ray system for radiography and fluoroscopy. The Multitom Rax consists of a floor mounted patient table 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 the Multitom Rax provides comprehensive image acquisition modes to support radiographic and fluoroscopic imaging procedures. X-ray tube and SSXI suspension movements are synchronized to provide rotation around a center. Series imaging acquired during the rotation are provided to 3D post-processing workstations.
6. Indication for Use:
The Multitom Rax is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, anqiography and pediatric examinations.
The Multitom Rax is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The unit may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiography, digital angiography and digital subtraction angiography (DSA).
The Multitom Rax may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
The Multitom Rax is not for mammography examinations.
7. Substantial Equivalence:
The new device Multitom Rax is within the same classification regulation for the same indication for use as the Primary predicate AXIOM Luminos dRF (K062623, cleared 08/22/2007). The mechanical design is compared to the Secondary predicate the AXIOM Aristos FX Plus (K061054, cleared 05/09/2006). Documentation is provided to support a claim of substantial equivalence to these Siemens' predicate devices.
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Devices:
Changes implemented for the subject device include hardware and software changes. The subject device, Multitom Rax, uses the same X-ray generator, the same X-ray tube and the same SSXI with the same digital imaging system and same image processing software as the Primary predicate AXIOM Luminos dRF. The system can be controlled in the room or remotely in the same fashion as the Primary predicate AXIOM Luminos dRF.
6
The mechanical design concept is the same as for the Secondary predicate the AXIOM Aristos FX Plus.
The subject device was changed in reqard to movement flexibility of the suspension arms and increased number of predefined automatic positions of tube and SSXI. Dedicated positions for certain examinations can be stored with the organ programs. When such an organ program is selected the Multitom Rax automatically moves to that position. This feature was also available with the secondary predicate AXIOM Aristos FX Plus.
The software algorithm for this movement has been optimized to find the fastest way to that position. There are hardware and software collision control features in place as well. The scanner offers both automated tube-todetector and detector-to-tube alignment. This feature is called: "RAXalign." Due to the increase in movement speed and the addition of circular movement a more sophisticated collisions software was implemented.
The automatic exposure control processes the data from 5 dose measurement fields instead of 3 compared with the predicate devices. The number of organ programs was increased and additional programs are provided for pediatric applications.
Summary of Non-Clinical Test Data:
Multitom Rax is a new device based on components used with both predicate devices AXIOM Luminos dRF(K062623) and AXIOM Aristos FX Plus (K061054) The Multitom Rax design was completed in accordance with Siemens Quality Management System Design Controls and Engineering, standards compliance, and Verification and Validation testing were successfully conducted. Tests were performed on the Multitom Rax which demonstrated that the device is safe and effective, performs comparably to the predicate devices, and is substantially equivalent to the predicate devices. Tests included verification/validation testing to internal functional specifications (including software). The Multitom Rax uses the same solid state X-ray imager (SSXI) as the Primary predicate. X-ray geometry and techniques are the same so that clinical image comparisons involving SSXI were not conducted. Documentation provided demonstrates compliance of the new device to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. including results of verification/validation tests to software requirements and software risk hazards.
Performance testing confirmed that the Multitom Rax complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment and with relevant voluntary safety standards for Electrical Safety
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and Electromagnetic Compatibility testing, specifically IEC standards listed in the table
below. Together, the verification/validation activities successfully confirmed device requirements has been fulfilled and that system functionality is consistent with the user needs and intended uses. The Multitom Rax device correctly performs as designed and raises no new questions regarding safety or effectiveness. Therefore, when compared to the predicate devices the Multitom Rax supports a determination of substantial equivalence to the predicate devices.
9. Summary of Non-Clinical Tests
The Siemens Multitom Rax complies with the voluntary standards as listed in the following table:
| Development
Organization and
| Reference Number | Title of Standard |
|---|---|
| IEC 60601-1 3rd, 2005 | Medical Electrical Equipment - Part 1: General Requirements |
| for Safety | |
| IEC 60601-1-2 3rd | |
| 2007 | 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: 3rd | |
| 2008 | Medical electrical equipment - Part 1-3: General requirements |
| for basic safety and essential performance - Collateral | |
| Standard: Radiation protection in diagnostic X-ray equipment | |
| IEC 62366, 2007 | Medical devices - Application of usability engineering to |
| medical devices | |
| ISO 14971, 2010 | medical devices - application of risk management to medical |
| devices | |
| IEC 62304 Ed. 1.0, | |
| 2006 | Medical device software - Software life cycle processes |
| IEC 60601-2-28 Ed | |
| 2.0, 2010 | 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, 2009 | Medical electrical equipment - Part 2-54: Particular |
| requirements for the basic | |
| safety and essential performance of X-ray equipment for | |
| radiography and | |
| radioscopy | |
| IEC 61910-1, 2014 | Medical electrical equipment - Radiation dose documentation - |
| Part 1: Radiation dose structured reports for radiography and | |
| radioscopy (IEC 61910-1:2014) | |
| NEMA PS 3.1 - 3.20, | |
| 2011 | Digital Imaging and Communications in Medicine (DICOM) Set |
| IEC 60825-1, 2007 | Safety of laser products - Part 1: Equipment classification, and |
| requirements |
8
| ISO 10993-1. 2009 | Biological evaluation of medical devices -- Part 1: Evaluation
and testing within a risk management process |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-43, 2010 | Medical electrical equipment - Part 2-43: Particular
requirements for the safety of X-ray equipment for
interventional procedures |
10 Summary of Clinical Tests:
For the subject of this premarket submission, Siemens did not do an evaluation of the clinical image quality as required by the "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices." because the subject device uses the same SSXI as the Primary predicate device.
11. 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 Multitom Rax 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.
12. Conclusion as to Substantial Equivalence:
The Multitom Rax is intended for the same indications for use as the Primary predicate AXIOM Luminos dRF. The operating environment is the same and mechanical design the same as the Secondary predicate the AXIOM Aristos FX Plus. Siemens concludes via the documentation provided in this 510(k) submission that the Multitom Rax is substantially equivalent to the AXIOM Luminos dRF (K051133 cleared 06/01/2005) and the AXIOM Aristos FX Plus (K061045 cleared 05/09/2006).