Who is the manufacturer of MULTIX Impact E?

Siemens Medical Solutions USA, Inc. filed the 510(k) submission for MULTIX Impact E (K220919).

What is the FDA product code for MULTIX Impact E?

KPR. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MULTIX Impact E?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MULTIX Impact E?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MULTIX Impact E

K220919 · Siemens Medical Solutions USA, Inc. · KPR · May 17, 2022 · Radiology

Device Facts

Record ID	K220919
Device Name	MULTIX Impact E
Applicant	Siemens Medical Solutions USA, Inc.
Product Code	KPR · Radiology
Decision Date	May 17, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1680
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

Modular stationary X-ray system; floor-mounted tube, bucky wall stand, bucky table, generator, wireless digital detector. Inputs: X-ray radiation attenuated by patient anatomy. Transformation: X-rays converted to digital image signals via detector; system manages exposure parameters via generator and collimator. Outputs: Diagnostic radiographic images. Used in hospitals/clinics by healthcare professionals. Tube-side control module (TCM) and touch user interface (TUI) allow operator to manage SID, tube angle, and brakes. System provides visual/audible warnings and blocks functions upon error detection. Benefits: Enables diagnostic imaging for wide range of patient sizes and body parts; supports conventional film/screen or CR cassettes.

Clinical Evidence

Bench testing only. No clinical data presented. Verification and validation testing confirmed performance comparable to predicate device.

Technological Characteristics

Stationary X-ray system; floor-mounted tube, manual collimator, high-frequency generator (40kW/50kW), wireless digital detector (Mars1717VS). Standards: ANSI AAMI ES60601-1, IEC 60601-1-3, IEC 60601-1-2, IEC 62366-1, ISO 14971, IEC 60601-1-6, IEC 62304, IEC 60601-2-28, IEC 60601-2-54, NEMA PS 3.1-3.20, ISO 10993-1. Software: Moderate level of concern.

Indications for Use

Indicated for radiographic imaging of the whole body (skull, chest, abdomen, extremities) in pediatric, adult, and obese patients. Used in hospitals, clinics, and medical practices. Not for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

MULTIX Impact (K203345)

Related Devices

K162971 — Multix Fusion Max · Siemens Medical Solutions USA, Inc. · Nov 22, 2016
K201670 — YSIO X.pree · Siemens Medical Solutions USA, Inc. · Oct 21, 2020
K142049 — MULTIX FUSION VA30 & VA40 · Siemens Medical Solutions USA, Inc. · Dec 18, 2014
K233532 — MULTIX Impact E · Siemens Medical Solutions · Nov 29, 2023
K182517 — MULTIX Impact · Siemens Medi Cal Solutions, Inc. · Jan 11, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For 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 {2}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 K220919 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 {4}------------------------------------------------ Image /page/4/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 words is a graphic of orange dots arranged in a circular pattern. # 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) - 4) Fixed patient table - Tube-side control module (TCM) ર) - 6) 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ Image /page/6/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. To the right of the word "Healthineers" is a graphic of orange dots. | Attribute | MULTIX Impact E VB10 (Subject) | MULTIX Impact VA20 K203345 (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 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. MULTIX Impact is not intended for mammography. MULTIX Impact uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. | Same | | Attribute | MULTIX Impact E VB10 (Subject) | MULTIX Impact VA20 K203345 (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 | Independent semi-motorized TS - Manual tube tilting - Manual longitudinal movement - Motorized tube lifting | Different. New tube modified from motorized to manual for lower cost. Verification and Validation testing concluded no impact on safety and effectiveness. | | X-ray Tube | RAY-12 3S 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-14S 3F tube with following key performance: -Heat capacity of anode: 260KJ (350kHU) -Input Power with Ref.300W: 78KW -Anode rotary frequency: 150/180 Hz(~ 8500 to 10800 rpm) | Different. Performance reduced for lower cost and low- end market. Verification and Validation testing concluded no impact on safety and effectiveness. | | Collimator | Manual collimator with feedback following information to system: -Blade positions -Cu filter status | Manual collimator without any feedback information to system | Different. Function improved to support more operational possibilities. Verification and Validation testing concluded no impact on safety and effectiveness. | | Generator | 50KW high frequency X-ray Generator with line voltage 3- phase, 380V / 400V / 440V (50/60Hz), 480 V (60Hz) | 55KW/65KW/80KW high frequency X-ray Generator with line voltage 3-phase, 380V / 400V / 440V (50/60Hz), 480 V (60Hz) | Different. Configuration reduced for lower cost and low- end market. Verification and Validation testing concluded no impact on safety and effectiveness. | | | 40KW high frequency X-ray Generator with line voltage 1- phase, 208-230V /(50/60Hz) | N.A. | Different. Modified to support more operational possibilities. | | Attribute | MULTIX Impact E VB10 (Subject) | MULTIX Impact VA20 K203345 (Predicate) | Comparison Results | | | | | Verification and Validation testing concluded no impact on safety and effectiveness. | | Automatic Exposure Control (AEC) | 3 fields AEC chamber with analog interface to system | 5 fields AEC module with CAN interface to system | Different. Modified for lower cost and low-end market. Verification and Validation testing concluded no impact on safety and effectiveness. | | Patient Table | Fixed table with integrated rail mounting tube stand | Fixed table without rail | Different. Modified for lower cost and low-end market. 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 | N.A. | Different. Modified to support more operational possibilities. Verification and Validation testing concluded no impact on safety and effectiveness. | | | Touch User Interface module (TUI) | Touch User Interface module (TUI) | Same | | | N.A. | Remote Interface supported by Siemens provided tablet that meets minimum requirements. | Different. Function reduced for lower cost and low-end market. Verification and Validation testing concluded no impact on safety and effectiveness. | | UI (User Interface) on Imaging System | Siemens UI concept | Siemens UI concept | Same | | Attribute | MULTIX Impact E VB10 (Subject) | MULTIX Impact VA20 K203345 (Predicate) | Comparison Results | | Software version | VB10 | VA20 | Different Updated to support all hardware modifications. Verification and Validation testing concluded no impact on safety and effectiveness. | # Table 1: Indications for Use Comparison: {7}------------------------------------------------ Image /page/7/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. To the right of the words is a graphic of orange dots. # Table 2: Subject Device Compared to Predicate Tel.: +1-888-826-9702 usa.siemens.com/healthineers {8}------------------------------------------------ Image /page/8/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 words is a graphic of orange dots arranged in a circular pattern. 40 Liberty Boulevard Malvern, PA 19355 USA Tel.: +1-888-826-9702 usa.siemens.com/healthineers {9}------------------------------------------------ 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 {10}------------------------------------------------ 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 {11}------------------------------------------------ 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