Sensis Vibe (VD15)

{0}------------------------------------------------ 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 15, 2023 Siemens Medical Solutions USA Inc. Patricia Jones Regulatory Affairs Professional 40 Liberty Boulevard Malvern, Pennsylvania 19355 Re: K223812 Trade/Device Name: Sensis Vibe (VD15B) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DOK, DSJ, DSK, DRO, DXN, KRB, DOA, FLL, CCK Dated: December 18, 2022 Received: December 20, 2022 Dear Patricia Jones: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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, # Robert T. Kazmierski -S for LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223812 Device Name Sensis Vibe Hemo Sensis Vibe Combo #### Indications for Use (Describe) The Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) recording systems are intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or electrophysiology studies, for cardiac as well as interventional radiology and surgical studies. The system is equipped with modules, enabling various configurations ranging from a standalone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the administrative tools. The device is intended to be used on either or both of the following populations: - 1. Adult and pediatric populations requiring electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias. - 2. Adult and pediatric populations requiring hemodynamic examinations, typically when the patient has a heart or vascular disease resulting in insufficient hemodynamic functionality. | Type of Use (Select one or both, as applicable) | |---------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | <span style="font-size: 10pt;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | 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/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots. # 510(k) Summary: Sensis Vibe Hemo and Sensis Vibe Combo Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65 Malvern, PA 19355 Date Prepared: August 14, 2023 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 Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Reqistration Number: 2240869 #### Manufacturing Site: Siemens AG/Siemens Healthcare GmbH Siemensstr. 1-OR- Rittigfeld 1 FORCHHEIM Bavaria, DE 91301 Establishment Registration Number: 3004977335 #### 2. Contact Person: Ms. Patricia D. Jones Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (678) 575-8832 Email: patricia.jones@siemens-Healthineers.com - 3. Device Name and Classification: Trade Name: Classification Name: Classification Panel: Requlation Number: Device Class: Product Codes: 4. #### Sensis Vibe Hemo (VD15B) Sensis Vibe Combo (VD15B) Programmable diagnostic computer Cardiovascular Diagnostic Devices 21 CFR §870.1425 Class II DQK, DSJ, DSK, DRQ, DXN, KRB, DQA, FLL, CCK - Legally Marketed Primary Predicate Device Trade Name: Sensis Vibe (VC12) 510(k) Clearance K150493 Clearance Date June 30, 2015 Programmable diagnostic computer Classification Name: Classification Panel: Cardiovascular Diagnostic Devices {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern. Requlation Number: Device Class: Product Code: Total Product Life Cycle: 21 CFR §870.1425 Class II DOK All product Recall incidents are considered during the Design Input phase of development to ensure the latest models will not be affected by any of the applicable issues. iLab Polaris-Modality Guidance System K191008 July 02, 2019 Programmable diagnostic computer Cardiovascular Diagnostic Devices 21 CFR §870.1425 Class II DOK DSK, ITX, IYO Datex-Ohmeda S/5 E-PRESTIN Module Family, including E-Prestin, E-Restin, E-PRETN, E-PP, and E-PT/E modules K051217 February 03, 2006 Patient Physiological Monitor (with arrhythmia detector or alarm Cardiovascular Diagnostic Devices 21 CFR §870.1025 Class II MHX # Trade Name: 510(k) Clearance Clearance Date Classification Name: Classification Panel: Regulation Number: Device Class: Product Code: Subsequent Product Code Reference Device Trade Name: Predicate Device 510(k) Clearance Clearance Date Classification Name: Classification Panel: Requlation Number: Device Class: Product Code: #### 5. Device Description: SIEMENS Medical Solutions USA. Inc. intends to market the Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B), a hemodynamic and electrophysiological recording system. This 510(k) submission describes modifications to the previously cleared Primary Predicate Device the Sensis (K150493). Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) is a multi-channel computer-based stationary system for the measurement, display, and printout of bio-physiological events. There are two configurations for this device: Sensis Vibe-Hemo and Sensis Vibe Combo. Hemodynamic and electrophysiologic signals such as intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG) are measured and displayed by the system; several hemodynamic calculations are performed based on the measured values of the input signals. These data can be recorded in real-time and stored on removable media or in a digital DICOM archive. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots. The Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) system is comprised of the following basic hardware components: a small cabinet (video distribution box), front-end electronics, a keyboard with a mouse, and master and slave monitor(s) for real-time presentation of ECG tracings and pressure and ICEG waveforms. The small cabinet (video distribution box) contains power distribution electronics, video drivers, and a separation device for electrical isolation between the small cabinet and the signal input box. The front-end electronics contain modules for the acquisition of invasive blood pressure, ECG, SpO2, CO, and optionally ICEG and NBP, and are normally stalled at the operating table. The following modifications are made to the cleared Predicate Device: Sensis system: - 1) Updated system Software/Hardware from VC12 to VD15B - A. Added a temperature display (measured by third-party temperature probes) with the use of an adapter cable that connects to the HiSiB. - Introduction of Diastolic Hyperemia-Free Ratio (DFRTM) assessment of B. blood flow through single or multiple lesions without inducing hyperemia. - 2) Updated the Indications for Use Statement to include the Subject Device Marketing Name: Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B). - 3) Updated 510(k) Information for Primary Predicate Device # 6. Indications for Use: The Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) recording systems are intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or electrophysiology studies, for cardiac as well as interventional radiology and surgical studies. The system is equipped with modules, enabling various configurations ranging from a standalone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the administrative tools. The device is intended to be used on either or both of the following populations: - 1. Adult and pediatric populations requiring electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias. - 2. Adult and pediatric populations requiring hemodynamic examinations, typically when the patient has a heart or vascular disease resulting in insufficient hemodynamic functionality. #### 7. Substantial Equivalence: Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo The (VD15B) Electrophysiological and Hemodynamic Recording System with software VD15B are {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots arranged in a circular pattern. substantially equivalent to the commercially available Siemens Sensis which was described in premarket notification K150493 which received 510(k) clearance on June 30, 2015. (See Table 1 below): | Predicate Device Name and<br>Manufacturer | 510(k) Number | Clearance<br>Date | Comparable Properties | |----------------------------------------------------------------------------------------------------------------------------------|---------------|-------------------|----------------------------------------------| | <b>Primary Predicate</b><br>Siemens : Sensis<br>Product Code: DQK | K150493 | 06/30/2015 | • Indications for use<br>• All Functionality | | <b>Predicate Device:</b><br>Boston Scientific: iLab Polaris-<br>Modality Guidance System<br>Product Codes: DQK, DSK, IYO,<br>ITX | K191008 | 07/02/2019 | • DFRTM | | <b>Reference Device:</b><br>GE : E-PRESTIN Multi-parameter<br>Hemodynamic Module<br>Product Code: MHX | K051217 | 02/03/2006 | • Temperature | #### Table 1: Predicate Device Comparable Properties for Subject Device Modifications: #### Summary of Technological Characteristics of the Subject Device as Compared 8. with the Predicate Device: Technological differences between the Subject Device and the Predicate Devices are provided in Table 2 below for all modifications. | Modifications | Subject Device<br>Sensis Vibe Hemo (VD15B)<br>and Sensis Vibe Combo<br>(VD15B) | Primary Predicate Device<br>Sensis (VC12)<br>(K150393) | Comparison<br>Results | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | New System<br>Software<br>Changes | 1. Updated system Software<br>from VC12 to VD15B<br>A. Added a temperature<br>display (measured by<br>third-party temperature<br>probes) with the use of<br>an adapter cable that<br>connects to the HiSiB. | System Software Version<br>(VC12)<br>No Temperature display | Comparable:<br>The addition of a<br>temperature display<br>with the use of an<br>adapter cable is a<br>change from the<br>primary predicate<br>device. Testing was<br>performed and test<br>results indicate this<br>feature does not raise<br>any new safety or<br>effectiveness issues. | | | B. Introduction of<br>Diastolic Hyperemia-<br>Free RatioTM (DFRTM)<br>assessment of blood<br>flow through single or<br>multiple lesions<br>without inducing<br>hyperemia. | Predicate Device<br>iLabs Polaris Multi-<br>Modality Guidance<br>System<br>K191008 | Comparable:<br>The algorithm usedto calculate DFRTM<br>has the same<br>measuring points. | | | | Diastolic Hyperemia-Free<br>Ratio (DFRTM) assessment<br>of blood flows through<br>single or multiple lesions<br>without inducing hyperemia. | Testing was<br>performed and test<br>results indicate this<br>feature does not<br>raise any new<br>safety or<br>effectiveness issues. | ### Table 2: Summary of Comparison of Technological Characteristics {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern. | Modifications | Subject Device<br>Sensis Vibe Hemo (VD15B)<br>and Sensis Vibe Combo (VD15B) | Primary Predicate Device<br>Sensis (VC12)<br>(K150393) | Comparison Results | |------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | effectiveness<br>issues. | | IFU Statement | 2. Revised IFU Statement | | Comparable:<br>Same as Primary<br>Predicate Device<br>except for the Name<br>change from "Sensis"<br>to "Sensis Vibe<br>Hemo (VD15B) and<br>Sensis Vibe Combo<br>(VD15B)" Corrected<br>verb usage typos. | | Update 510(k)<br>Information | 3. Update 510(k) Information for Primary Predicate Device is provided in Volume<br>011. | | | The subject devices, the Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B), do not affect the intended use of the device nor does it alter its fundamental scientific technology from the 510(k) cleared predicate device. Non-clinical and bench-testing information supports the new extended functionality of the Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B), which is provided in Volume 020. #### 9. Conformity to Standards and Nonclinical Performance Testing: Siemens claims conformance to a signed statement of conformance to the following performance standards: | Recognition # | Product Area | Title of Standard | Reference Number<br>and Date | Standards<br>Development<br>Organization | |---------------------------------------------------------------------------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------| | 2-258 | Biocompatibility | Biological evaluation of medical<br>devices - Part 1: Evaluation and<br>testing within a risk management<br>process | 10993-1:2018 | ISO | | 5-134 | General I (QS/<br>RM) | Medical devices - Symbols to be<br>used with information to be supplied<br>by the manufacturer - Part 1:<br>General requirements | 15223-1:2021 | ISO | | 14-579 | Sterility | Processing of health care products -<br>Information to be provided by the<br>medical device manufacturer for the<br>processing of medical devices - Part<br>2: Non-critical medical devices. | 17664-2:2021 | ISO | | 15-135 | General I (QS/RM) | Medical devices - Information to be<br>supplied by the manufacturer | 20417:2021 | ISO | | 5-129 | General | Medical devices - Part 1: Application of usability engineering to medical devices | 62366-1 Edition 1.1<br>2020-06<br>CONSOLIDATED<br>VERSION | IEC | | Recognition # | Product Area | Title of Standard | Reference Number<br>and Date | Standards<br>Development<br>Organization | | 13-83 | Software/<br>Informatics | Principles for medical device<br>security - Risk management. | TIR57:2016 | AAMI | | 19-4 | General | Medical electrical equipment - Part<br>1: General requirements for basic<br>safety and essential performance<br>(IEC 60601-1:2005, MOD)<br>[Including Amendment 2 (2021)] | ES60601-<br>1:2005/(R)2012 &<br>A1:2012,<br>C1:2009/(R)2012 &<br>A2:2010/(R)2012<br>(Consolidated Text) | ANSI AAMI | | 19-8 | General | Medical electrical equipment - Part<br>1-2: General requirements for basic<br>safety and essential performance -<br>Collateral standard: Electromagnetic<br>disturbances -- Requirements and<br>tests | 60601-1-2 Edition<br>4.0:2014-02 | IEC | | 5-76 | General | Medical Electrical Equipment - Part<br>1-8: General Requirements for<br>Basic Safety And Essential<br>Performance - Collateral Standard:<br>General Requirements, Tests And<br>Guidance For Alarm Systems In<br>Medical Electrical Equipment And<br>Medical Electrical Systems | 60601-1-8 Edition 2.1<br>2012-11 | IEC | | 12-273 | Radiology | Safety of laser products - Part 1:<br>Equipment classification, and<br>requirements [Including: Technical<br>Corrigendum 1 (2008),<br>Interpretation Sheet 1 (2007),<br>Interpretation Sheet 2 (2007)] | 60825-1:2014<br>(recognized: 2007) | IEC | | 5-104 | General | Graphical symbols for electrical<br>equipment in medical practice | TR 60878 Ed. 3.0<br>b:2015 | IEC | | 13-79 | Software/<br>Informatics | Medical Device Software - Software<br>Life Cycle Processes | 62304 Edition 1.1<br>2015-06 Consolidated<br>Version | IEC | | 3-105 | Cardiovascular | Medical electrical equipment - Part<br>2-25: Particular requirements for the<br>basic safety and essential<br>performance of electrocardiographs | 60601-2-25 Edition<br>2.0 2011-10 | IEC | | 3-115 | Cardiovascular | Medical electrical equipment - Part<br>2-34: Particular requirements for<br>the basic safety including essential<br>performance of invasive blood<br>pressure monitoring equipment | 60601-2-34 Edition<br>3.0 2011-05 | IEC | | 1-140 | Anesthesiology | Medical electrical equipment - Part<br>2-55: Particular requirements for the<br>basic safety and essential<br>performance of respiratory gas<br>monitors | 80601-2-55 Second<br>edition 2018-02 | ISO | | 6-421 | General | Medical electrical equipment - Part<br>2-56: Particular requirements for the<br>basic safety and essential<br>performance of clinical<br>thermometers for body temperature<br>measurement [Including:<br>Amendment 1 (2018)]. | 80601-2-56 Second<br>edition: 2017-03 | ISO | | 1-139 | Anesthesiology | Medical electrical equipment - Part<br>2-61: Particular requirements for<br>basic safety and essential<br>performance of pulse oximeter<br>equipment | 80601-2-61 Second<br>Edition 2017-12<br>(Corrected version<br>2018-02) | ISO | | Recognition # | Product Area | Title of Standard | Reference Number<br>and Date | Standards<br>Development<br>Organization | | 3-123 | Cardiovascular | Medical electrical equipment - Part<br>2-30: Particular requirements for the<br>basic safety and essential<br>performance of automated non-<br>invasive sphygmomanometers | 80601-2-30: Edition<br>2.0 2018-03 | IEC | | 13-38 | Software/Informatics | Application of risk management for<br>IT-networks incorporating medical<br>devices - Part 1: Roles,<br>responsibilities and activities (IEC<br>80001-1:2010) / Endorsement<br>notice | 80001-1 Edition 1.0<br>2010-10 | IEC | | 13-104 | Software/Informatics | Standard for Safety, Software<br>Cybersecurity for Network-<br>Connectable Products, Part 2-1:<br>Particular Requirements for Network<br>Connectable Components of<br>Healthcare and Wellness Systems | 2900-2-1 First Edition<br>2017 | ANSI UL | | 13-96 | Software/Informatics | Standard for Safety, Standard for<br>Software Cybersecurity Network-<br>Connectable Products, Part 1:<br>General Requirements | 2900-1 First Edition<br>2017 | ANSI UL | | 5-125 | General | Medical devices - Application of risk<br>management to medical devices | 14971:2019 | ISO | | Sensis Vibe complied with the following additional standards currently not recognized | | | | | | N/A | N/A | Medical Electrical Equipment:<br>Safety of Multifunction Patient<br>Monitoring Equipment | 80601-2-49:2018 | IEC | | N/A | N/A | Digital Imaging and<br>Communications in Medicine<br>(DICOM) | 12052:2017 | ISO | | N/A | N/A | Medical electrical equipment - Part<br>1: General requirements for basic<br>safety and essential performance | 60601-1:2021 | IEC | | N/A | N/A | Medical electrical equipment - Part<br>1-9: General requirements for basic<br>safety and essential performance -<br>Collateral Standard: Requirements<br>for environmentally conscious<br>design | 60601-1-9:2020 | IEC | | N/A | N/A | Degrees of protection provided by<br>enclosures (IP code). | 60529:2015 | IEC | | N/A | N/A | Systems and software engineering -<br>Systems and software Quality<br>Requirements and Evaluation<br>(SQuaRE) - System and software<br>quality models. | 25010:2011 | ISO IEC | | N/A | N/A | Technical documentation for the<br>assessment of electrical and<br>electronic products with respect to<br>the restriction of hazardous<br>substances | 63000:2016 | IEC | | N/A | N/A | Standard for Safety for Information<br>Technology Equipment - Safety -<br>Part<br>1: General Requirements / national<br>adoption of IEC 60950a-1 with<br>modifications | 60950-1:2014 | ANSI UL | | Recognition # | Product Area | Title of Standard | Reference Number<br>and Date | Standards<br>Development<br>Organization | | | | 60950-1-2011 / Approved 2014-10-<br>14 ANSI. | | | | N/A | N/A | Plastics - Generic identification and<br>marking of plastics products | 11469:2016 | ISO | | N/A | N/A | Medical electrical equipment -<br>Recurrent<br>test and test after repair of medical<br>electrical equipment | 62353:2014 | ISO | {8}------------------------------------------------ Image /page/8/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a cluster of orange dots. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots of varying sizes. The modifications described in this Premarket Notification are supported with verification and validation testing. ### Verification and Validation: Software Documentation for a Major 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. and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) Systems during product development. The bench test study is performed to demonstrate that Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) DFR index is numerically equivalent to iLab Polaris Modality Guidance System's DFR index. In the bench test study, DFR indices obtained from Sensis Vibe Hemo (VD15B), and Sensis Vibe Combo (VD15B) are compared with DFR indices obtained from the bench test study performed and submitted for iLab Polaris-Modality Guidance System (K191008). The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) were tested and found to be safe and effective for intended users, uses, and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual. Customer employees are adequately trained in the use of this equipment. Siemens conforms to the cybersecurity requirementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical {11}------------------------------------------------ Image /page/11/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots in a circular pattern. device to an external recipient. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital. Provided in the Software Section is the required cybersecurity information. ### Summary: Performance tests were conducted to test the functionality of the Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) Systems. These tests have been performed to assess the functionality of the subject device. The results of all conducted testing and clinical assessment were found acceptable and do not raise any new safety or effectiveness issues. ### 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 safely and effectively. 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 practices, and all equipment is subject to final performance testing. ### 11. Conclusion as to Substantial Equivalence: The predicate devices were cleared based on non-clinical supportive information and data. Similar non-clinical test results demonstrate that the Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) Systems acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristics, non-clinical performance data and software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Devices that are currently marketed for the same intended use.