(120 days)
No
The document describes a standard radiographic system with hardware and software upgrades, but there is no mention of AI or ML capabilities for image analysis, processing, or other functions. The "grid suppression algorithm" is a common image processing technique and not indicative of AI/ML.
No
The device is a radiographic system used for generating diagnostic images, not for therapy.
Yes
The "Intended Use / Indications for Use" section states that the device "uses digital detectors for generating diagnostic images".
No
The device description explicitly lists multiple hardware components (X-ray tube, generator, detectors, Bucky wall stand, Bucky table, etc.) and describes modifications to these hardware components. While software is mentioned as being upgraded, the device is clearly a physical X-ray system with associated software, not a software-only device.
Based on the provided information, the MULTIX Impact system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is a "radiographic system used in hospitals, clinics, and medical practices" for generating "diagnostic images by converting x-rays into image signals." This describes an imaging device used for visualizing internal structures of the body.
- Device Description: The device description details components like an X-ray tube, generator, detectors, and a Bucky system. These are all components of a radiographic imaging system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body). IVD devices are specifically designed for such testing.
Therefore, the MULTIX Impact system is a medical 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 pedianc, adult and bariatic patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The MULTIX Impact system is not meant for mammography. The MULTIX Impact uses digital detectors for generating diagnostic images by converting x-rays into image signals. The MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Product codes
KPR
Device Description
The MULTIX Impact Radiography X-ray system is a modular system of X-ray components (floor-mounted X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless detectors) similar to the predicate the Multix Fusion Max. This 510(k) submission describes modifications to the predicate device the Multix Fusion Max cleared via K162971. The following modifications have been made to the cleared predicate device and the new system will be branded the MULTIX Impact:
- A new 43×35cm Wireless detector, 3543DR 1.
-
- A new X-ray tube and a new generator
-
- An optional 40 line grid with grid suppression algorithm
-
- Wireless Remote Control Console
- ર. An optional All-in-one PC containing touch screen function
- An optional positioning assistance camera 6.
- Upgrade software to VA10 7.
-
- Upgrade operator system from Windows XP to Windows 10
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
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
Non-clinical tests were conducted for the MULTIX Impact during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.
Non-clinical tests (integration and functional) were conducted on the MULTIX Impact during product development.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Verification and validation testing demonstrates that the MULTIX Impact should perform as intended. The non-clinical test data demonstrate that the MULTIX Impact device performance is comparable to the predicate device that is currently marketed for the same intended use.
Key Metrics
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Denise Adams, RAC Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code: 65-1A MALVERN PA 19355
Re: K182517
Trade/Device Name: MULTIX Impact Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: November 28, 2018 Received: November 29, 2018
Dear Ms. Adams:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
January 11, 2019
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
MULTIX Impact
Indications for Use (Describe)
The MULTIX Impact system is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pedianc, adult and bariatic patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The MULTIX Impact system is not meant for mammography.
The MULTIX Impact uses digital detectors for generating diagnostic images by converting x-rays into image signals. The MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
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Type of Use (Select one or both, as applicable)
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3
Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots.
510(k) Summary: MULTIX Impact
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
Date Prepared: September 11, 2018
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
1. General Information
Importer / Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number 2240869
Location of Manufacturing Site
Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road, Shanghai 201318. China Establishment Registration Number 3003202425
Siemens Healthcare GmbH Siemensstrasse 1 Forchheim, Germany 91301 Establishment Registration Number: 3004977335
2. Contact Person
Denise Adams, RAC Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 610-448-6139 adams.denise@siemens-healthineers.com
Siemens Medical Solutions USA, Inc.
4
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3. Device Name and Classification
| Trade Name: | MULTIX Impact |
|---|---|
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
4. Legally Marketed Predicate Device
| Trade Name: | Multix Fusion Max |
|---|---|
| 510(k) #: | K162971 |
| Clearance Date: | November 22, 2016 |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
5. Device Description
The MULTIX Impact Radiography X-ray system is a modular system of X-ray components (floor-mounted X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless detectors) similar to the predicate the Multix Fusion Max. This 510(k) submission describes modifications to the predicate device the Multix Fusion Max cleared via K162971. The following modifications have been made to the cleared predicate device and the new system will be branded the MULTIX Impact:
- A new 43×35cm Wireless detector, 3543DR 1.
-
- A new X-ray tube and a new generator
-
- An optional 40 line grid with grid suppression algorithm
-
- Wireless Remote Control Console
- ર. An optional All-in-one PC containing touch screen function
- An optional positioning assistance camera 6.
- Upgrade software to VA10 7.
-
- Upgrade operator system from Windows XP to Windows 10
6. Indications for Use
The MULTIX Impact system is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The MULTIX Impact system is not meant for mammography.
5
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The MULTIX Impact uses digital detectors for generating diagnostic images by converting Xrays into image signals. The MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
7. Substantial Equivalence
The MULTIX Impact is a modification to the predicate device the Multix Fusion Max cleared via K162971. It is within the same classification with similar indications for use and the same mechanical design as the predicate device. The MULTIX Impact is substantially equivalent to the predicate device and documentation is provided to support a claim of substantial equivalence.
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device
The MULTIX Impact is comparable in indications for use, design, material, functionality, technology, energy source and is substantially equivalent to the commercially available Siemens' Multix Fusion Max. It uses the same or similar components cleared in the Multix Fusion Max (e.g. collimator, patient table, Bucky wall stand).
The components of the subject device have many of the same technological characteristics as the ones from the predicate device. There are several technological characteristics that differ slightly as shown in the comparison tables.
Testing and validation have been successfully completed and test results show that the subject device MULTIX Impact with all of its components are comparable to the predicate device and therefore is substantially equivalent to the predicate device.
The modifications made to the subject device MULTIX Impact do not affect the intended use of the device nor do they alter its fundamental scientific technology from the 510(k) cleared predicate device the Multix Fusion Max.
The following tables compare the main performance data of the subject device with the predicate device to substantiate equivalence.
| Attribute | MULTIX Impact
(subject) | Multix Fusion Max
K162971
(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 | The Multix Fusion Max
system is a radiographic
system used in hospitals,
clinics, and medical
practices. Multix Fusion Max
enables radiographic | Intended use is
the same.
Indications for
use have been
reworded to |
Table 1: Indications for Use Comparison
Siemens Medical Solutions USA, Inc.
40 I iberty Boulevard Malvern PA 19355-9998 USA
Tel.: +1-888-826-9702 usa.siemens.com/healthineers
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Image /page/6/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.
| including: skull, chest,
abdomen, and 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. | 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 Fusion
Max system is not meant for
mammography.
The Multix Fusion Max uses
a mobile (wired), or fixed
(integrated) or wireless
digital detector for
generating diagnostic images
by converting X-rays into
image signals.
The Multix Fusion is also
designed to be used with
conventional film/ screen or
Computed Radiography (CR)
cassettes. | simplify. |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------- |
|---|
40 Liberty Boulevard
Malvern, PA 19355-9998
USA
7
Image /page/7/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" are a series of orange dots that are arranged in a pattern.
| Attribute | MULTIX Impact
(subject) | Multix Fusion Max
K162971
(predicate) | Comparison
Results |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
System | Windows 10 | Windows XP | New operating
system, does
not affect safety
or effectiveness |
| Suppression
algorithm for
low line grid | The new 40 low line grid
requires a suppression
algorithm to suppress line
artifacts | N/A | Performance
testing
concluded does
not affect image
quality. |
| Post-
processing
software | -Contrast
-Detail
-Latitude
-Noise
-WLShift
-WWShift | -Amplification
-Edge Enhancement
-Harmonization
-Noise Reduction
-Center Shift
-Width Factor | Performance
testing
concluded does
not affect image
quality. |
| Floor
mounted
support | Mechanical | N/A | Does not affect
safety or
effectiveness |
| X-ray tube
assembly | 80 kW
Two-focus | 80 kW
Two-focus | Same |
| Collimator | Standard collimator (ACSS) | Standard collimator(ACSS) | Same |
| Optional
collimator | Manual collimator | N/A | Does not affect
safety or
effectiveness |
| Optional
digital
camera | Camera on collimator to aid
in patient positioning | N/A | Does not affect
safety or
effectiveness |
| Attribute | MULTIX Impact
(subject) | Multix Fusion Max
K162971
(predicate) | Comparison
Results |
| Patient Table | Radiographic table
motorized with floating table
top and motorized Bucky
tray with charging in tray
function (wireless detector) | Radiographic table
motorized with floating table
top and manual Bucky tray
with charging in tray
function (wireless detector) | Improvement of
Bucky
movement to
motorized.
Does not affect
safety or
effectiveness |
| | Radiographic table
motorized with floating table
top and motorized Bucky
tray (wireless detector) | Radiographic table
motorized with floating table
top and manual Bucky tray
with charging in tray
function (wireless detector) | Improvement of
Bucky
movement to
motorized
without
charging
function in tray
Does not affect
safety or
effectiveness |
| | Fixed radiographic table with
floating table top and manual
Bucky tray (portable wireless
detector) | N/A | Does not affect
safety or
effectiveness |
| Bucky Wall
Stand | BWS for wireless detector
Vertical motorized and
charging in tray | BWS for wireless detector
Vertical motorized and
charging in tray | Same |
| | BWS for wireless detector
Vertical motorized | BWS for wireless detector
Vertical motorized and
charging in tray | No charging
tray. Does not
affect safety or
effectiveness |
| | BWS for wireless detector
Manual movement in z-axis | N/A | Does not affect
safety or
effectiveness |
| Attribute | MULTIX Impact
(subject) | Multix Fusion Max
K162971
(predicate) | Comparison
Results |
| Touch
Interface | Graphical user interface | Graphical user interface | Same |
| X-ray
generator | 55kW, 65kW or 80kW | 55kW, 65 kW or 80 kW | Same |
| Operating
modes | RAD Single Exposure | RAD Single Exposure | Same |
| Imaging
System | All in one PC based
high resolution digital
touch screen function as
option | Fluorospot Compact PC
based
high resolution digital | Addition of
touch screen
function as
option. Does
not affect safety
or effectiveness |
| Display | Black & White
Color
Size Ratio 16:9 | Black & White
Color
Size Ratio 4:3 | Different size
ratio. Does not
affect safety or
effectiveness |
| DICOM 3
Functions | Send, StC, Print,
Query/Retrieve, Get
Worklist, MPPS | Send, StC, Print,
Query/Retrieve, Get
Worklist, MPPS | Same |
| Radiographic
Grid | 92-line grid
(ratio 13:1)
40-line grid
(ratio 13:1) | 92-line grid
(ratio 13:1)
85-line grid
(ratio 5:1) (optional) | Same ratio
with new
addition of 40-
line grid.
Performance
testing
concluded that
combined with
suppression
algorithm does
not affect image
quality |
| Accessory | Wireless Remote Control
Console via bluetooth | Remote Control console | Improvement of
wireless
function. Does |
Table 2: Subject Device Compared to the Predicate
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Image /page/8/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots that form a curved line.
40 Liberty Boulevard
Malvern, PA 19355-9998
USA
9
Image /page/9/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots.
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355-9998
USA
Tel.: +1-888-826-9702
usa.siemens.com/healthineers
10
Image /page/10/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots.
| Attribute | MULTIX Impact
(subject) | Multix Fusion Max
K162971
(predicate) | Comparison
Results |
|-----------|----------------------------|---------------------------------------------|---------------------------------------|
| | | | not affect safety
or effectiveness |
40 Liberty Boulevard
Malvern, PA 19355-9998
USA
11
Image /page/11/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a graphic of orange dots arranged in a circular pattern.
| Table 3: Comparison of Trixell Pixium 3543 DR to the Predicate Trixell Pixium | ||
|---|---|---|
| 3543 EZh |
| Technical
Specifications | Trixell Pixium
3543 DR
detector
(wireless)
(subject) | Trixell Pixium
3543 EZh
detector
(wireless)
(subject) | Trixell Pixium
3543 EZh
detector
(wireless)
(predicate) | Comparison
Results |
|----------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------|
| Dimensions | 345 mm x 426 mm | 348 mm x 424 mm | 349 mm x 425 mm | Difference not significant |
| Resolution | 2156 x 2662 pixels | 2350 x 2866 pixels | 2356 x 2872 pixels | Difference not significant |
| Pixel size | 160 $ \mu $ m | 148 $ \mu $ m | 148 $ \mu $ m | Difference not significant/
Same |
| Semiconductor
Material | Amorphous silicon, a-Si | Amorphous silicon, a-Si | Amorphous silicon, a-Si | Same |
| Scintillator | Cesium iodide (CsI) | Cesium iodide (CsI) | Cesium iodide (CsI) | Same |
| Acquisition
depth | 16 bit | 16 bit | 16 bit | Same |
| DQE (Detective
Quantum
Efficiency) | DQE @ 1 lp/mm (2 $ \mu $ Gy), 51% | DQE @ 1 lp/mm (2 $ \mu $ Gy), 51% | DQE @ 1 lp/mm (2 $ \mu $ Gy), 51% | Same |
| MTF
(Modulations
transfer
function) | MTF @ 1 lp/mm,62% | MTF @ 1 lp/mm, 63% | MTF @ 1 lp/mm,63% | Difference not significant/
Same |
9. Nonclinical Performance Testing
Non-clinical tests were conducted for the MULTIX Impact during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.
MULTIX Impact conforms to the following standards: IEC 60601-1:2012; IEC 60601-1-2:2014; IEC 60601-1-3:2008+A1:2013; IEC 62366-1:2015; ISO 14971:2007; IEC 60601-1-6:2013; IEC 62304:2015; IEC 60601-2-28:2010-03; IEC 60601-2-54:2015-04; NEMA PS 3.1 - 3.20 (2016) and ISO 10993-1:2009.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted on the MULTIX Impact during product development.
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The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
10. General Safety and Effectiveness Concerns
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition, the MULTIX Impact Radiography X-ray system is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.
Risk management is ensured via a hazard analysis which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed.
11. Conclusion as to Substantial Equivalence
The MULTIX Impact has similar indications for use as the predicate Multix Fusion Max. The operating environment and mechanical design are similar. It is Siemens opinion, that the MULTIX Impact is substantially equivalent to the Multix Fusion Max, cleared in K162971 on November 22, 2016.
Verification and validation testing demonstrates that the MULTIX Impact should perform as intended. The non-clinical test data demonstrate that the MULTIX Impact device performance is comparable to the predicate device that is currently marketed for the same intended use.
In summary, Siemens is of the opinion that the MULTIX Impact does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate device.
12. Guidance documents
The following FDA guidance documents were utilized in the documentation of this Premarket Notification:
- Content of Premarket Submissions for Management of Cybersecurity in ● Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014
- Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices Guidance for Industry