(48 days)
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.
The MULTIX Impact E 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 detector) based on the predicate device, the MULTIX Impact (K203345). The following modifications have been made to the predicate device:
- A new X-ray Tube Assembly
- A new Collimator
- A new Generator
- Fixed patient table
- Tube-side control module (TCM)
- Upgraded software version to VB10 to support hardware modifications
The modified system will be branded as the MULTIX Impact E.
This document describes modifications to an existing X-ray system, the MULTIX Impact E, and asserts its substantial equivalence to a predicate device, the MULTIX Impact (K203345).
Here's the breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly equivalence in safety and effectiveness to the predicate device, despite modifications. The performance is assessed through verification and validation testing of the modified components to ensure they do not negatively impact safety and effectiveness and perform as intended.
| Attribute | Predicate Device (MULTIX Impact VA20, K203345) Performance | Subject Device (MULTIX Impact E VB10) Performance | Comparison Results / Acceptance Criterion (Implicit) |
|---|---|---|---|
| Indications for Use | Radiographic system for whole body (skull, chest, abdomen, extremities) on pediatric, adult, bariatric patients, standing, sitting, or prone. Uses digital detectors, film/screen, or CR cassettes. Not for mammography. | Radiographic system for whole body (skull, chest, abdomen, extremities) on pediatric, adult, obese patients, standing, sitting, or prone. Uses digital detectors, film/screen, or CR cassettes. Not for mammography. | Same (Meets implied acceptance criterion of retaining same indications for use) |
| Detector | Wireless detector: Mars1717VS | Wireless detector: Mars1717VS | Same (Meets implied acceptance criterion of retaining same detector technology) |
| Tube Stand (TS) | Independent semi-motorized TS (Manual tilt, manual longitudinal, motorized lift) | Integrated fully manual TS (Manual tilt, manual longitudinal, manual lift) | Different. Performance reduced for lower cost. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
| X-ray Tube | RAY-14S 3F tube (Anode heat: 260KJ; Input Power: 78KW; Anode rotary freq: ~8500-10800 rpm) | RAY-12 3S tube (Anode heat: 170KJ; Input Power: 54KW; Anode rotary freq: 3000/3600 rpm) | Different. Performance reduced for lower cost and low-end market. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
| Collimator | Manual collimator without feedback to system | Manual collimator with feedback (Blade positions, Cu filter status) to system | Different. Function improved to support more operational possibilities. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness and potentially improving functionality) |
| Generator | 55KW/65KW/80KW high frequency X-ray Generator (3-phase, 380-480V) | 50KW high frequency X-ray Generator (3-phase, 380-480V); Additionally: 40KW high frequency X-ray Generator (1-phase, 208-230V) | Different. Configuration reduced for 3-phase, and a new 1-phase option added. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
| Automatic Exposure Control (AEC) | 5 fields AEC module with CAN interface to system | 3 fields AEC chamber with analog interface to system | Different. Modified for lower cost and low-end market. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
| Patient Table | Fixed table without rail | Fixed table with integrated rail mounting tube stand | Different. Modified for lower cost and low-end market. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
| Human Machine Interface (HMI) | Touch User Interface module (TUI); Remote Interface supported by Siemens tablet. | Tube-side control module (TCM) with SID, tube angle display, brake release; Touch User Interface module (TUI). | Different. TCM added, Remote Interface (tablet) removed. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
| UI (User Interface) on Imaging System | Siemens UI concept | Siemens UI concept | Same (Meets implied acceptance criterion of retaining same user interface concept) |
| Software version | VA20 | VB10 | Different. Updated to support hardware modifications. Verification and Validation testing concluded no impact on safety and effectiveness. (Meets implied acceptance criterion of not negatively impacting safety/effectiveness despite change) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document extensively refers to "verification and validation testing" without specifying a distinct "test set" in terms of patient data or image data. The testing appears to be focused on hardware and software performance/functionality testing of the new components and the integrated system. There are no mentions of patient images or clinical data as a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The provided document does not describe a clinical study involving experts establishing ground truth for a diagnostic test set. The testing described is technical verification and validation of the device's components and system functionality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a diagnostic test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an X-ray system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a diagnostic test set. For the verification and validation described, the "ground truth" would be the engineering specifications, performance standards (e.g., IEC, ANSI, NEMA), and safety requirements that the new/modified components and the integrated system are assessed against.
8. The sample size for the training set
Not applicable. This is not a machine learning model requiring a training set. The software mentioned is system control software, validated through standard software development lifecycle processes.
9. How the ground truth for the training set was established
Not applicable.
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U.S. FOOD & DRUG
ADMINISTRATION
Siemens Medical Solutions USA, Inc. % Denise Adams Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355
Re: K220919
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: March 28, 2022 Received: March 30, 2022
Dear Denise Adams:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/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
May 17, 2022
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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
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological Imaging and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220919
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, 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.
| 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 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.
510(k) Summary: MULTIX Impact E
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: May 16, 2022
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 Malvern, PA 19355 Establishment Registration Number: 2240869
Manufacturer
Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road Shanghai, 201318, China Establishment Registration Number: 3003202425
Contract Manufacturer
Siemens Healthcare GmbH Siemensstrasse 1 Forchheim, Germany 91301 Establishment Registration Number: 3004977335
2. Contact Person
Denise Adams Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 610-448-6545 adams.denise@siemens-healthineers.com
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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 |
4. Legally Marketed Predicate Device
| Trade Name: | MULTIX Impact (VA20) |
|---|---|
| 510(k) #: | K203345 |
| Clearance Date: | March 20, 2020 |
| 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 E 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 detector) based on the predicate device, the MULTIX Impact (K203345). The following modifications have been made to the predicate device:
- A new X-ray Tube Assembly 1)
- A new Collimator 2)
- A new Generator 3)
-
- Fixed patient table
- Tube-side control module (TCM) ર)
-
- Upgraded software version to VB10 to support hardware modifications
The modified system will be branded as the MULTIX Impact E.
6. 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.
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Image /page/5/Picture/0 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 text is a series of orange dots arranged in a circular pattern.
7. Substantial Equivalence
The MULTIX Impact E is a modification of the predicate device, the MULTIX Impact (VA20), cleared via K203345. The subject device is within the same classification regulation, has the similar indications for use, and the similar mechanical design as the predicate device. The MULTIX Impact E 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 E is substantially equivalent to the commercially available MULTIX Impact (K203345) 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.g. detector, BWS and imaging system).
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 (K203345).
The following tables compare the main performance data of the subject device with the predicate device.
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| Attribute | MULTIX Impact EVB10(Subject) | MULTIX Impact VA20K203345(Predicate) | ComparisonResults |
|---|---|---|---|
| Indicationsfor Use | MULTIX Impact E is aradiographic system usedin hospitals, clinics, andmedical practices.MULTIX Impact Eenables radiographicexposures of the wholebody including: skull,chest, abdomen, andextremities and may beused on pediatric, adultand obese patients.Exposures may be takenwith the patient sitting,standing, or in the proneposition.MULTIX Impact E usesdigital detectors forgenerating diagnosticimages by converting X-rays into image signals.MULTIX Impact E isalso designed to be usedwith conventionalfilm/screen or ComputedRadiography (CR)cassettes.MULTIX Impact E is notintended formammography. | MULTIX Impact is aradiographic system used inhospitals, clinics, and medicalpractices.MULTIX Impact enablesradiographic exposures of thewhole body including: skull,chest, abdomen, andextremities and may be used onpediatric, adult and bariatricpatients. Exposures may betaken with the patient sitting,standing, or in the proneposition. MULTIX Impact isnot intended formammography.MULTIX Impact uses digitaldetectors for generatingdiagnostic images byconverting X- rays into imagesignals. MULTIX Impact isalso designed to be used withconventional film/screen orComputed Radiography (CR)cassettes. | Same |
| Attribute | MULTIX Impact EVB10(Subject) | MULTIX Impact VA20K203345(Predicate) | Comparison Results |
| Detector | Wireless detector: Mars1717VS | Wireless detector:Mars1717VS | Same |
| Tube Stand(TS) | Integrated fully manual TS- Manual tube tilting- Manual longitudinalmovement- Manual tube lifting | Independent semi-motorized TS- Manual tube tilting- Manual longitudinalmovement- Motorized tube lifting | Different.New tube modified frommotorized to manual forlower cost. Verificationand Validation testingconcluded no impact onsafety and effectiveness. |
| X-ray Tube | RAY-12 3S tube withfollowing key performance:-Heat capacity of anode: 170KJ(230kHU)-Input Power with Ref.300W:54KW-Anode rotary frequency: 50/60Hz (3000/3600 rpm) | RAY-14S 3F tube withfollowing key performance:-Heat capacity of anode: 260KJ(350kHU)-Input Power with Ref.300W:78KW-Anode rotary frequency:150/180 Hz(~ 8500 to 10800rpm) | Different.Performance reducedfor lower cost and low-end market. Verificationand Validation testingconcluded no impact onsafety and effectiveness. |
| Collimator | Manual collimator withfeedback following informationto system:-Blade positions-Cu filter status | Manual collimator without anyfeedback information to system | Different.Function improved tosupport moreoperational possibilities.Verification andValidation testingconcluded no impact onsafety and effectiveness. |
| Generator | 50KW high frequency X-rayGenerator with line voltage 3-phase, 380V / 400V / 440V(50/60Hz), 480 V (60Hz) | 55KW/65KW/80KW highfrequency X-ray Generator withline voltage 3-phase, 380V /400V / 440V (50/60Hz), 480 V(60Hz) | Different.Configuration reducedfor lower cost and low-end market.Verification andValidation testingconcluded no impact onsafety and effectiveness. |
| 40KW high frequency X-rayGenerator with line voltage 1-phase, 208-230V/(50/60Hz) | N.A. | Different.Modified to supportmore operationalpossibilities. | |
| Attribute | MULTIX Impact EVB10(Subject) | MULTIX Impact VA20K203345(Predicate) | Comparison Results |
| Verification andValidation testingconcluded no impact onsafety and effectiveness. | |||
| AutomaticExposureControl(AEC) | 3 fields AEC chamber withanalog interface to system | 5 fields AEC module with CANinterface to system | Different.Modified for lower costand low-end market.Verification andValidation testingconcluded no impact onsafety and effectiveness. |
| Patient Table | Fixed table with integrated railmounting tube stand | Fixed table without rail | Different.Modified for lower costand low-end market.Verification andValidation testingconcluded no impact onsafety and effectiveness. |
| HumanMachineInterface(HMI) | Tube-side control module(TCM) with followingfunctions:-SID display-Tube angle display-Release brakes | N.A. | Different.Modified to supportmore operationalpossibilities.Verification andValidation testingconcluded no impact onsafety and effectiveness. |
| Touch User Interface module(TUI) | Touch User Interface module(TUI) | Same | |
| N.A. | Remote Interface supported bySiemens provided tablet thatmeets minimum requirements. | Different.Function reduced forlower cost and low-endmarket. Verification andValidation testingconcluded no impact onsafety and effectiveness. | |
| UI (UserInterface) onImagingSystem | Siemens UI concept | Siemens UI concept | Same |
| Attribute | MULTIX Impact EVB10(Subject) | MULTIX Impact VA20K203345(Predicate) | Comparison Results |
| Softwareversion | VB10 | VA20 | DifferentUpdated to support allhardware modifications.Verification andValidation testingconcluded no impact onsafety and effectiveness. |
Table 1: Indications for Use Comparison:
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Table 2: Subject Device Compared to Predicate
Tel.: +1-888-826-9702
usa.siemens.com/healthineers
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40 Liberty Boulevard
Malvern, PA 19355
USA
Tel.: +1-888-826-9702
usa.siemens.com/healthineers
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Image /page/9/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots.
9. Nonclinical Performance Testing
Non-clinical tests were conducted for the MULTIX Impact E during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.
MULTIX Impact E conforms to the following standards: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012; IEC 60601-1-3:2013; IEC 60601-1-2:2014; IEC 62366-1:2015; ISO 14971:2019; IEC 60601-1-6:2013; IEC 62304:2015; IEC 60601-2-28:2017; IEC 60601-2-54:2018; NEMA PS 3.1-3.20 (2016) and ISO 10993-1:2018.
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 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.
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 E 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.
40 Liberty Boulevard
Malvern, PA 19355
USA
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Image /page/10/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
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 E has the similar indications for use as the predicate device, MULTIX Impact (K203345). 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 (K203345).
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 Industrv 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 Document issued on: September 1, 2016
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Image /page/11/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a cluster of orange dots.
- 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
§ 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.