(27 days)
No
The document describes a standard radiographic system with hardware and software updates, but there is no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
The device is described as a radiographic system used for generating diagnostic images by converting X-rays into image signals, which is for diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section states that the device is used for "generating diagnostic images by converting X-rays into image signals." This indicates its role in creating images that are used for diagnosis.
No
The device description explicitly states it is a "modular system of X-ray components (floor-mounted x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless detector)" and mentions hardware modifications (a new elevating table). While it includes upgraded software, it is clearly a hardware system with accompanying software, not a software-only device.
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, etc.
- The MULTIX Impact E is a radiographic system. It uses X-rays to create images of the inside of the body without taking any samples.
The description clearly states its purpose is for "radiographic exposures of the whole body" and uses "digital detectors for generating diagnostic images by converting X-rays into image signals." This is the definition of an imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MULTIX Impact E is a radiographic system used in hospitals, clinics, and medical practices.
MULTIX Impact E enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and obese patients. Exposures may be taken with the patient sitting, or in the prone position.
MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact E is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. MULTIX Impact E is not intended for mammography.
Product codes
KPR, MQB
Device Description
The MULTIX Impact E Radiography X-ray system is a modular system of X-ray components (floormounted x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless detector) based on the predicate device, the MULTIX Impact E (VB10) (K220919). The following modifications have been made to the predicate device:
-
- A new elevating table (option)
- Upgraded software version to VB20 to support hardware modifications. 2)
The modified system will be branded as the MULTIX Impact E.
Mentions image processing
MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, chest, abdomen, and extremities and whole body.
Indicated Patient Age Range
pediatric, adult and obese patients.
Intended User / Care Setting
Used in hospitals, clinics, and medical practices. Operators are 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)
Non-clinical tests (integration and functional) were conducted on the MULTIX Impact E during product development. The test results support that all the software specifications have met the acceptance criteria. Verification and validation testing were found acceptable to support the claim of substantial equivalence.
Verification and validation testing demonstrate that the MULTIX Impact E performs as intended. The non-clinical test data demonstrate that the MULTIX Impact E device performance is comparable to the predicate device that is currently marketed for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
November 29, 2023
Siemens Medical Solutions % Camila Rodriguez Valentin Regulatory Affairs Professional 40 Liberty Boulevard MALVERN, PA 19355
Re: K233532
Trade/Device Name: MULTIX Impact E Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR, MQB Dated: November 2, 2023 Received: November 2, 2023
Dear Camila Rodriguez Valentin:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233532
Device Name MULTIX Impact E
Indications for Use (Describe)
MULTIX Impact E is a radiographic system used in hospitals, clinics, and medical practices.
MULTIX Impact E enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and obese patients. Exposures may be taken with the patient sitting, or in the prone position.
MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact E is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. MULTIX Impact E is not intended for mammography.
| 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 displays 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 cluster of orange dots arranged in a circular pattern.
| 510(k) Summary: | MULTIX Impact E |
|---|---|
| 510(k) Number: | K233532 |
| Company: | Siemens Medical Solutions USA, Inc. |
| 40 Liberty Boulevard | |
| Malvern, PA 19355 | |
| Date Prepared: | October 30, 2023 |
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 Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road Shanghai, 201318, China Establishment Registration Number: 3003202425
Contract Manufacturing Site:
Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335
2. Contact Person:
Camila Rodriguez Valentin Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, US camila.rodriguezvalentin@siemens-healthineers.com
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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
3. Subject Device Name and Classification:
| Trade Name: | MULTIX Impact E |
|---|---|
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
| Secondary Product Code: | MQB |
Legally Marketed Predicate Device: 4.
| Trade Name | MULTIX Impact E |
|---|---|
| Company | Siemens Medical Solutions USA |
| 510(k) Number | K220919 |
| Device Classification Name | Stationary X-Ray System |
| Regulation Number | 21 CFR §892.1680 |
| Review Panel | Radiology |
| Device Class | Class II |
| Product Code | KPR |
| Secondary Product Code: | MQB |
5. Legally Marketed Reference Device:
| Trade Name | MULTIX Impact |
|---|---|
| Company | Siemens Medical Solutions |
| 510(k) Number | USA K213700 |
| Device Classification Name | Stationary X-Ray System |
| Regulation Number | 21 CFR §892.1680 |
| Review Panel | Radiology |
| Device Class | Class II |
| Product Code | KPR |
| Secondary Product Code: | MQB |
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6. Device Description:
The MULTIX Impact E Radiography X-ray system is a modular system of X-ray components (floormounted x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless detector) based on the predicate device, the MULTIX Impact E (VB10) (K220919). The following modifications have been made to the predicate device:
-
- A new elevating table (option)
- Upgraded software version to VB20 to support hardware modifications. 2)
The modified system will be branded as the MULTIX Impact E.
7. Indication for Use:
MULTIX Impact E is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact E enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and obese patients. Exposures may be taken with the patient sitting, standing, or in the prone position.
MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact E is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
MULTIX Impact E is not intended for mammography.
8. Technological Characteristics and Substantial Equivalence:
The MULTIX Impact E is substantially equivalent to the commercially available MULTIX Impact E (VB10) (K220919) in terms of the intended use, design, biocompatibility material, functionality, technology, and energy source. The subject device uses the same or similar components cleared in the MULTIX Impact E (VB10) (e.g. detector, BWS and imaging system etc.).
The components of the subject device have many of the same technological characteristics as those in the predicate device. Some technological characteristics that differ slightly are shown in the comparison tables below. Verification and validation testing have been successfully completed and test results show that the subject device, MULTIX Impact E with all its components, is substantially equivalent to the predicate device.
The modifications made to the subject device, MULTIX Impact E, 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 E (VB10) (K220919).
Tables 8-1 and 8-2 compare the main performance data of the subject device with the predicate device and reference device.
Malvern, PA 19355
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Table 8-1: Comparison of the Subject Device (MULTIX Impact E) to the Predicate e (MULTIX Impact E VB10)
| Attribute | MULTIX Impact E
(Subject) | MULTIX Impact VB10
K220919
(Predicate) | Comparison
Results |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | MULTIX Impact E is a
radiographic system used in
hospitals, clinics, and medical
practices.
MULTIX Impact E enables
radiographic exposures of the whole
body including: skull, chest,
abdomen, and extremities and may
be used on pediatric, adult and
obese patients. Exposures may be
taken with the patient sitting,
standing, or in the prone position.
MULTIX Impact E uses digital
detectors for generating diagnostic
images by converting X- rays into
image signals. MULTIX Impact E
is also designed to be used with
conventional film/screen or
Computed Radiography (CR)
cassettes.
MULTIX Impact E is not intended
for mammography | MULTIX Impact E is a
radiographic system used in
hospitals, clinics, and medical
practices.
MULTIX Impact E enables
radiographic exposures of the
whole body including: skull,
chest, abdomen, and
extremities and may be used on
pediatric, adult and obese
patients. Exposures may be
taken with the patient sitting,
standing, or in the prone
position.
MULTIX Impact E uses digital
detectors for generating
diagnostic images by
converting X- rays into image
signals. MULTIX Impact E is
also designed to be used with
conventional film/screen or
Computed Radiography (CR)
cassettes.
MULTIX Impact E is not
intended for mammography | Same |
| Attribute | MULTIX Impact E
(Subject) | MULTIX Impact E VB10
K220919
(Predicate) | Comparison Results |
| Detector | Wireless detector: Mars1717VS | Wireless detector:
Mars1717VS | Same |
| Tube Stand
(TS) | Integrated fully manual TS
- Manual tube tilting
- Manual longitudinal
movement - Manual tube lifting | Integrated fully manual TS
- Manual tube tilting
- Manual longitudinal
movement - Manual tube lifting | Same |
| Attribute | MULTIX Impact E
(Subject) | MULTIX Impact E VB10
K220919
(Predicate) | Comparison Results |
| | Independent fully manual TS - Manual tube tilting
- Manual longitudinal
movement - Manual tube lifting
- Movement range: 33 ~ 180 cm | Integrated fully manual TS
- Manual tube tilting
- Manual longitudinal
movement - Manual tube lifting
- Movement range: 50 ~ 185
cm | Similar
The movement range
has been increased,
Verification and
Validation testing
concluded no impact on
safety and effectiveness. |
| X-ray Tube | RAY-12S_3 tube with following
key performance:
-Heat capacity of anode: 170KJ
(230kHU)
-Input Power with Ref.300W:
54KW
-Anode rotary frequency: 50/60
Hz (3000/3600 rpm) | RAY-12S_3 tube with
following key performance:
-Heat capacity of anode: 170KJ
(230kHU)
-Input Power with Ref.300W:
54KW
-Anode rotary frequency: 50/60
Hz (3000/3600 rpm) | Same |
| Collimator | Manual collimator with
feedback following information
to system:
-Blade positions
-Cu filter status | Manual collimator with
feedback following information
to system:
-Blade positions
-Cu filter status | Same |
| Generator | 50KW high frequency X-ray
Generator with line voltage 3-
phase, 380V / 400V / 440V
(50/60Hz), 480 V (60Hz) | 50KW high frequency X-ray
Generator with line voltage 3-
phase, 380V / 400V / 440V
(50/60Hz), 480 V (60Hz) | Same |
| | 40KW high frequency X-ray
Generator with line voltage 1-
phase, 208-230V/(50/60Hz) | 40KW high frequency X-ray
Generator with line voltage 1-
phase, 208-230V/(50/60Hz) | Same |
| Automatic
Exposure
Control
(AEC) | 3 fields AEC chamber with
analog interface to system | 3 fields AEC chamber with
analog interface to system | Same |
| Patient
Table | Fixed table with integrated rail
mounting tube stand | Fixed table with integrated rail
mounting tube stand | Same |
| Attribute | MULTIX Impact E
(Subject) | MULTIX Impact E VB10
K220919
(Predicate) | Comparison Results |
| | Elevating table (option) with
independent rail mounting tube
stand | N.A. | Different
An elevating table
(option) increases the
clinical flexibility and
versatility of the system
enabling easy patient
access and transfer.
Verification and
Validation testing
concluded no impact on
safety and effectiveness. |
| Human
Machine
Interface
(HMI) | Tube-side control module
(TCM) with following
functions:
-SID display
-Tube angle display
-Release brakes | Tube-side control module
(TCM) with following
functions:
-SID display
-Tube angle display
-Release brakes | Same |
| | Touch User Interface module
(TUI)
-Rotation vertical axis (RVA)
button is added in TUI Software | Touch User Interface module
(TUI)
-N.A. | Similar
TUI software is updated
for introducing the
independent rail.
Verification and
Validation testing
concluded no impact on
safety and effectiveness. |
| UI (User
Interface)
on
Imaging
System | Siemens UI concept | Siemens UI concept | Same |
| Software
version | VB20 | VB10 | Different
Updated to support all
hardware modifications.
Verification and
Validation testing
concluded no impact on
safety and effectiveness. |
| Technical
Specifications | MULTIX Impact E
(Subject) | MULTIX Impact VA21
K213700
(Reference) | Comparison Results |
| Elevating Table | Motorized elevating table
with manual movement
bucky for beam centering | Motorized elevating table with
motorized movement bucky for
beam centering | Different.
Function reduced for
lower cost and low-end
market. Verification and
Validation testing
concluded no impact on
safety and effectiveness. |
| | Adjustable height: from 52
to 96 cm | Adjustable height: from 51.5 to
90 cm | |
| | No tracking between tube
stand and bucky | Automatic tube tracking (table
mode) | |
| | High weight capacity: 300
kg | High weight capacity: 300 kg | |
| | With Emergency stop | With Emergency stop | Same |
| | Option: Non-table | Option: Non-table | |
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T
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Table 8-2: Comparison of the Subject Device (MULTIX Impact E) New Features to Reference Device (MULTIX Impact VA21)
Summary of Non-Clinical Tests: 9.
The subject device was tested and complied with the voluntary standards listed in the table below:
Table 9: Non-clinical performance testing
| Standards Development
Organization and Reference
| Number | Title of Standard |
|---|---|
| ANSI AAMI ES60601- | |
| 1:2005/(R)2012 & A1:2012 | |
| C1:2009/(R)2012 & | |
| A2:2010/(R)2012 (Cons. Text) | |
| [Incl. AMD2:2021] | Medical electrical equipment - Part 1: General requirements for |
| basic safety and essential performance (IEC 60601-1:2005 MOD) | |
| [Including Amendment 2 (2021)] | |
| IEC 60601-1-2 2020 Ed 4.1 | Medical Electrical Equipment - Part 1-2: General requirements for |
| basic safety and essential performance - Collateral Standard: | |
| Electromagnetic Compatibility -- Requirements and Tests |
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| 60601-1-3 Edition 2.2 2021-01
CONSOLIDATED VERSION | Medical electrical equipment - Part 1-3: General requirements for
basic safety and essential performance - Collateral Standard:
Radiation protection in diagnostic X-ray equipment |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-28, 2017 | 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 Edition 2.0
2022-09 | Medical electrical equipment - Part 2-54: Particular requirements
for the basic safety and essential performance of X-ray equipment
for radiography and radioscopy |
| IEC 60601-1-6 Edition 3.2
2020-07 CONSOLIDATED
VERSION | Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard:
Usability |
| IEC 62366-1 2020 Ed 1.1 | Medical devices - Application of usability engineering to medical
devices |
| ISO 14971: 2019 | Medical devices - application of risk management to medical
devices |
| IEC 62304 2015, Ed.1.1 | Medical device software - Software life cycle processes |
| IEC TR 60601-4-2 Edition1.0
2016-05 | Medical electrical equipment - Part 4-2: Guidance and
interpretation - Electromagnetic immunity: performance of
medical electrical equipment and medical electrical systems |
| NEMA PS 3.1 - 3.20 2021e | Digital Imaging and Communications in Medicine (DICOM) Set |
| ISO EN ISO 10993-1 Fifth
edition 2018 | Biological evaluation of medical devices - Part1: Evaluation and
testing within a risk management process |
Software Documentation level is Basic Documentation Level per FDA's Guidance Document Content of Premarket Submissions for Device Software Functions, issued on June 14, 2023, 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 E 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 were 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 MULTIX Impact E Radiography X-ray system is continually monitored and if an error occurs the system functions will be
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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, mechanical, 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 E has the same indications for use as the predicate device, MULTIX Impact E (VB10) (K220919). The operating environment is same and mechanical design is similar.
Verification and validation testing demonstrate that the MULTIX Impact E performs as intended. The non-clinical test data demonstrate that the MULTIX Impact E device performance is comparable to the predicate device that is currently marketed for the same intended use.
In summary, Siemens concludes that the MULTIX Impact E does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device, MULTIX Impact E (VB10) (K220919).
12. Guidance documents
The following FDA guidance documents were utilized in this Premarket Notification:
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff Document issued on: September 27, 2023
- Electromagnetic Compatibility(EMC) of Medical Devices Guidance for Industry and Food and ● Drug Administration Staff Document issued on June 6, 2022.
- . 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 Document issued on: September 1, 2016
- Content of Premarket Submissions for Device Software Functions Guidance for Industry and ● Food and Drug Administration Staff Document issued on: June 14, 2023
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Image /page/12/Picture/0 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 text is a cluster of orange dots of varying sizes.
- 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