(135 days)
No
The document does not mention AI, ML, or any related concepts like deep learning, neural networks, or training/test sets for algorithmic development. The software upgrade is described as supporting hardware modifications and a remote interface, not advanced image processing or analysis using AI/ML.
No
The device is described as a radiographic system used for generating diagnostic images by converting X-rays into image signals, which is for diagnosis, not therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the system "uses digital detectors for generating diagnostic images by converting X-rays into image signals," indicating its role in producing images used for diagnosis.
No
The device description explicitly lists multiple hardware components (floor-mounted x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless and fixed detectors, new Bucky Wall Stands, new patient table) in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue samples, etc.
- The MULTIX Impact system is a radiographic system. It uses X-rays to create images of the inside of the human body directly, without taking any samples.
The description clearly states its intended use is for radiographic exposures of the whole body and that it uses digital detectors to convert X-rays into image signals. This is the definition of a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
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.
Product codes
KPR
Device Description
The MULTIX Impact (VA11) 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 and fixed detectors) based on the predicate device, the MULTIX Impact (K182517). The following modifications have been made to the predicate device:
-
- A new 43*43cm wireless detector, Mars1717VS manufactured by iRay
- A new 43*43cm fixed detector, Venu1717X manufactured by iRay 2.
-
- A new Remote Interface used for patient examination management
-
- Upgraded software version from VA10 to VA11 to support hardware modifications and Remote Interface.
- న. New Bucky Wall Stands
-
- New patient table
The new system will be branded as the MULTIX Impact.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-rays
Anatomical Site
skull, chest, abdomen, and extremities
Indicated Patient Age Range
pediatric, adult and bariatric patients
Intended User / Care Setting
hospitals, clinics, and medical practices.
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)
Non-clinical tests were conducted for the MULTIX Impact (VA11) during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.
The risk analysis was completed and risk controls were implemented to mitigate identified hazards. The test results support that all the software specifications have met the acceptance criteria. Verification and validation testing was found acceptable to support the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Siemens Medical Solutions USA, Inc. % Mr. Martin Rajchel Regulatory Affairs Specialist 40 Liberty Boulevard, Mailcode 65-1A MALVERN PA 19355
Re: K193089
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: February 11, 2020 Received: February 12, 2020
Dear Mr. Rajchel:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
March 20, 2020
1
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 medical devices and radiation-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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193089
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 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.
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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510(k) Summary: MULTIX Impact
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
Date Prepared: November 5, 2019
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
Martin Rajchel Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 610-448-6545 martin.rajchel@siemens-healthineers.com
Siemens Medical Solutions USA, Inc.
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3. Subject 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 Impact |
|---|---|
| 510(k) #: | K182517 |
| Clearance Date: | January 11, 2019 |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
5. Device Description
The MULTIX Impact (VA11) 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 and fixed detectors) based on the predicate device, the MULTIX Impact (K182517). The following modifications have been made to the predicate device:
-
- A new 43*43cm wireless detector, Mars1717VS manufactured by iRay
- A new 43*43cm fixed detector, Venu1717X manufactured by iRay 2.
-
- A new Remote Interface used for patient examination management
-
- Upgraded software version from VA10 to VA11 to support hardware modifications and Remote Interface.
- న. New Bucky Wall Stands
-
- New patient table
The new system will be branded as the MULTIX Impact.
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.
The MULTIX Impact uses digital detectors for generating diagnostic images by converting X-
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rays into image signals. The MULTIX Impact is also designed to be u film/screen or Computed Radiography (CR) cassettes.
7. Substantial Equivalence
The MULTIX Impact (VA11) is a modification of the predicate device, the MULTIX Impact, cleared via K182517. The subject device is within the same classification regulation, has the same indications for use, and the same mechanical design as the predicate device. The MULTIX Impact (VA11) 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 (VA11) is substantially equivalent to the commercially available MULTIX Impact (K182517) in terms of the indications for use, design, material, functionality, technology, and energy source. The subject device uses the same or similar components cleared in the MULTIX Impact (e.g. tube, generator, collimator, patient table, Bucky Wall Stand, and imaging system).
The components of the subject device have many of the same technological characteristics as the ones from the predicate device. There are some technological characteristics that differ slightly as shown in the comparison tables below. Verification and validation testing have been successfully completed and test results show that the subject device, MULTIX Impact (VA11) with all its components, is substantially equivalent to the predicate device.
The modifications made to the subject device, MULTIX Impact (VA11), do not affect the intended use of the device nor do they alter its fundamental scientific technology compared to the predicate device, the MULTIX Impact (K182517).
The following tables compare the main performance data of the subject device with the predicate device.
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| | MULTIX Impact
VA11 (Subject) | MULTIX Impact
K182517
(Predicate) | Comparison
Results |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| 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. | 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. | Same |
| | The MULTIX Impact uses
digital detectors for generating
diagnostic images by
converting x-rays into image
signals. | 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 is also
designed to be used with
conventional film/screen or
Computed Radiography (CR)
cassettes. | |
| Table 1: Indications for Use Comparison: | |||
|---|---|---|---|
| -- | -- | -- | ------------------------------------------ |
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| Attribute | MULTIX Impact
VA11 (Subject) | MULTIX Impact
K182517
(Predicate) | Comparison
Results |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SSXI for
RAD
imaging | Trixell Pixium 3543EZH | Trixell Pixium 3543EZH | Same |
| | iRay Mars1717VS
with corresponding tray in
bucky wall stand and patient
table | | Different.
New flat detectors.
Performance testing
and co-existence
testing concluded no
impact on image
quality. |
| | iRay Venu1717X
with corresponding tray in
bucky wall stand | | |
| HMI
(Human
Machine
Interface) | Touch user interface | Touch user interface | Same |
| | Remote Interface supported by
Siemens provided tablet that
meets minimum requirements. | N.A. | Different.
New option.
Performance testing
and co-existence
testing concluded no
impact on safety and
effectiveness. |
| UI (User
Inteface) on
Imaging
System | Color scheme is grey (dark)
Button shape is rounded or
pill-shaped | Color scheme is blue
(dark)
Button shape is
square | Different.
Performance testing
concluded no impact
on safety and
effectiveness. |
| Software
version | VA11 | VA10 | Different.
Improved to support
hardware
modifications and
Remote Interface;
Performance testing
concluded no impact
on safety and
effectiveness. |
| Other minor modifications | | | |
| | MULTIX Impact
VA11 (Subject) | K182517
(Predicate) | Comparison
Results |
| Bucky Wall
Stand
(BWS) | For Pixium 3543 EZH:
BWS with motorized height
adjustment with new functions:
- Option for fixed left or right
direction to load the detector - Option for selectable left or
right direction to load
detector during installation | For Pixium 3543 EZH:
BWS with motorized
height adjustment - Standard
configuration for
fixed left or right
direction to load
detector | Different.
Improved to support
more operational
possibilities.
Performance testing
concluded no impact
on safety and
effectiveness. |
| | For Mars1717VS:
BWS with manual and
motorized height adjustment
with new functions - New tray for Mars1717VS
- Option for fixed left or right
direction to load detector - Option for selectable left or
right direction to load
detector during installation | | Different.
Modification to
support the new
detectors.
Performance is
unchanged. Testing
concluded no impact
on safety and
effectiveness. |
| | For Venu1717X:
BWS with motorized height
adjustment with new functions - New tray for Venu1717X
- Option for fixed left or right
direction to load detector - Option for selectable left or
right direction to load
detector during installation - Additional emergency button
and motion switch | | |
| Patient table | Elevating Patient table in z-axis
for Pixium 3543 EZH | Elevating Patient table in
z-axis for Pixium 3543 | Same |
| MULTIX Impact
VA11 (Subject) | K182517
(Predicate) | Comparison
Results | |
| Fixed and elevating Patient
tables in z-axis for
Mars1717VS: - new tray for new detector | EZH | Different.
Modification to
support the new
detector. Performance
is unchanged. Testing
concluded no impact
on safety and
effectiveness. | |
Table 2: Subject Device Compared to Predicate
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Malvern, PA 19355
USA
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Table 3: Comparison of iRay Flat Detectors to the predicate Trixell Pixium 3543EZh
| Technical
Specifications | iRay Mars1717VS
(wireless)
(Subject) | iRay Venu1717X
(fixed) (Subject) | Trixell Pixium
3543EZH
detector (wireless)
(Predicate) | Comparison
Results |
|-----------------------------|--------------------------------------------|-------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| | 426 mm x 426
mm | 426 mm x 426
mm | 348 mm x 424
mm | Different.
Minor change to
size dimension
only; no impact on
safety and
effectiveness. |
| | 3070 x 3070 pixels | 3070 x 3070
pixels | 2350 x 2866
pixels | Different.
Improved active
area (larger)
larger dimensions;
no impact on
safety and
effectiveness. |
| | 139 µm | 139 µm | 148 um | Different.
Minor change to
pixel size only; no
impact on safety
and effectiveness. |
| Material | Amorphous | Amorphous | Amorphous | Same |
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| | Cesium iodide
(CsI)
16 bit | Cesium iodide
(CsI)
16 bit | Cesium iodide
(CsI)
16 bit | Same |
|---------------------------------------|----------------------------------|----------------------------------|----------------------------------|--------------------------------------------------------------------------------------------|
| Quantum
Efficiency) | DQE @ 1
lp/mm (2 μGy),
65% | DQE @ 1
lp/mm (2 μGy),
65% | DQE @ 1
lp/mm (2 μGy),
51% | Different.
Minor
improvement to
DQE; no impact
on safety and
effectiveness. |
| (Modulations
transfer
function) | MTF @ 1
lp/mm, 64% | MTF @ 1
lp/mm, 64% | MTF @ 1
lp/mm, 63% | Different.
Minor
improvement to
MTF; no impact
on safety and
effectiveness. |
9. Nonclinical Performance Testing
Non-clinical tests were conducted for the MULTIX Impact (VA11) during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.
MULTIX Impact (VA11) 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 60601-2-28:2017; IEC 60601-2-54:2015; 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.
The risk analysis was completed and risk controls were implemented to mitigate identified hazards. The test results support that all the software specifications have met the acceptance criteria. Verification and validation testing was found acceptable to support the claim of substantial equivalence.
General Safety and Effectiveness Concerns 10.
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
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MULTIX Impact (VA11) Radiography X-ray system is continually monitor 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 healthcare professionals familiar with and responsible for the x-ray examinations to be performed.
11. Conclusion as to Substantial Equivalence
The MULTIX Impact (VA11) has the same indications for use as the predicate device, MULTIX Impact. The operating environment and mechanical design are similar. It is Siemens opinion that the MULTIX Impact (VA11) is substantially equivalent to the MULTIX Impact, cleared in K182517 on January 11, 2019.
Verification and validation testing demonstrate that the MULTIX Impact (VA11) performs as intended. The non-clinical test data demonstrate that the MULTIX Impact (VA11) 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 (VA11) 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 and Food and Drug Administration Staff Document issued on July 11, 2016.
- Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017.
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff
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Document issued on: September 1, 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: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff Document issued on: July 28, 2014
- Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food . and Drug Administration Staff Document issued on: August 14, 2013
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