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:

Adult and pediatric populations requiring electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias.
Adult and pediatric populations requiring hemodynamic examinations, typically when the patient has a heart or vascular disease resulting in insufficient hemodynamic functionality.

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.

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.

AI/ML Overview

The Siemens Medical Solutions USA Inc. Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) are electrophysiological and hemodynamic recording systems. The acceptance criteria and the study proving the device meets these criteria are detailed below. It's important to note that the provided document outlines conformity to standards and non-clinical performance testing for specific modifications to an existing cleared device (Sensis K150493) rather than a comprehensive de novo clinical study for the entire system.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
New System Software Changes
Temperature Display	The addition of a temperature display (measured by third-party temperature probes) with the use of an adapter cable connecting to the HiSiB should not raise any new safety or effectiveness issues.	Comparable: "Testing was performed and test results indicate this feature does not raise any new safety or effectiveness issues."
DFR™ Assessment	Introduction of Diastolic Hyperemia-Free Ratio (DFR™) assessment of blood flow through single or multiple lesions without inducing hyperemia. The algorithm used to calculate DFR™ should have the same measuring points as the predicate device (iLabs Polaris Multi-Modality Guidance System K191008).	Comparable: "The algorithm used to calculate DFRTM has the same measuring points." "Testing was performed and test results indicate this feature does not raise any new safety or effectiveness issues." Numerical equivalence to iLab Polaris' DFR index demonstrated via bench testing.
IFU Statement	Revised IFU Statement should be comparable to the Primary Predicate Device (Sensis VC12 K150493) except for the name change and corrected verb usage typos, and should not raise new safety or effectiveness issues.	Comparable: "Same as Primary Predicate Device except for the Name change from 'Sensis' to 'Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B)' Corrected verb usage typos."
Software Conformance	Continued conformance with special controls for medical devices containing software (Major Level of Concern per FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005, and "Off-The-Shelf Software Use in Medical Devices").	Software documentation for a Major Level of Concern was included. Testing results support that all software specifications have met the acceptance criteria.
Risk Management	Risk analysis completed, and risk control implemented to mitigate identified hazards.	Risk analysis was completed, and risk control was implemented to mitigate identified hazards.
Human Factors	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.	The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator’s manual.
Cybersecurity	Conforms to cybersecurity requirements, including 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 device to an external recipient (considering IEC 80001-1:2010).	A cybersecurity statement considering IEC 80001-1:2010 was provided. Required cybersecurity information was included in the Software Section.
Overall Safety & Effectiveness	The device is safe and effective for intended users, uses, and use environments through the design control verification and validation process, and does not raise any new safety or effectiveness issues compared to predicate devices.	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. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new safety or effectiveness issues.

2. Sample Size Used for the Test Set and Data Provenance:

The document primarily describes non-clinical bench testing for the modifications made to the device.

DFR™ Bench Test Study: DFR indices obtained from Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) were compared with DFR indices obtained from a previous bench test study performed and submitted for iLab Polaris-Modality Guidance System (K191008).
Other Testing: General "verification and validation testing," "non-clinical tests," and "software documentation" were performed. No specific sample sizes for clinical data sets are mentioned, as the focus is on a substantial equivalence claim based on modifications and adherence to standards.
Data Provenance: The data provenance for the DFR™ comparison is a prior bench test study. For other aspects, it is internal company testing and validation processes. No mention of country of origin for specific test data is provided. Given it's premarket notification, it's likely internal development and testing data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not specify the number or qualifications of experts used to establish ground truth for this submission, as it relies heavily on bench testing and reference to prior clearances. For the DFR™ comparison, the "ground truth" is essentially the established performance of the legally marketed predicate device (iLab Polaris).

4. Adjudication Method for the Test Set:

Given that the testing described is primarily non-clinical bench testing, there is no mention of an adjudication method (e.g., 2+1, 3+1). Such methods are typically used in clinical studies involving interpretation by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described in this submission. The device is a "programmable diagnostic computer" intended as a "diagnostic and administrative tool," not an AI-assisted diagnostic aid that directly improves human reader performance in interpreting medical images or signals. Its function is to measure, display, and record bio-physiological events and perform calculations like DFR™.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The description of the device and its testing suggests that it functions as a standalone system (algorithm/hardware only) for measuring, displaying, and recording physiological data, and performing calculations like DFR™. The DFR™ bench test compared the device's output numerically to that of a predicate device, indicating a standalone performance evaluation of this specific function.

7. The Type of Ground Truth Used:

For the DFR™ assessment modification, the ground truth relied upon was the numerical output and algorithm of a legally marketed predicate device (iLab Polaris-Modality Guidance System). For other aspects (temperature display, software, etc.), the "ground truth" is adherence to established engineering specifications, safety standards, and performance benchmarks as determined by internal verification and validation processes. There is no mention of pathology or outcomes data as ground truth for this submission.

8. The Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. The submission focuses on modifications to an existing device, which implies that core algorithms have likely been developed and validated previously. The new DFR™ functionality appears to be a direct implementation of an existing, cleared algorithm from a predicate device, rather than a novel AI model requiring a new training set.

9. How the Ground Truth for the Training Set Was Established:

As no specific training set is mentioned for the modifications, the document does not describe how ground truth for any training set was established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, 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

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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

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Indications for Use

510(k) Number (if known) K223812

Device Name Sensis Vibe Hemo Sensis Vibe Combo

Indications for Use (Describe)

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.
1. 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)
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/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

1. Device Name and Classification: Trade Name:
  Classification Name: Classification Panel: Requlation Number: Device Class: Product Codes:

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

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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:

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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.
1. Updated the Indications for Use Statement to include the Subject Device Marketing Name: Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B).
1. Updated 510(k) Information for Primary Predicate Device

6. Indications for Use:

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.
1. 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

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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 andManufacturer	510(k) Number	ClearanceDate	Comparable Properties
Primary PredicateSiemens : SensisProduct Code: DQK	K150493	06/30/2015	• Indications for use• All Functionality
Predicate Device:Boston Scientific: iLab Polaris-Modality Guidance SystemProduct Codes: DQK, DSK, IYO,ITX	K191008	07/02/2019	• DFRTM
Reference Device:GE : E-PRESTIN Multi-parameterHemodynamic ModuleProduct 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 DeviceSensis Vibe Hemo (VD15B)and Sensis Vibe Combo(VD15B)	Primary Predicate DeviceSensis (VC12)(K150393)	ComparisonResults
New SystemSoftwareChanges	1. Updated system Softwarefrom VC12 to VD15BA. Added a temperaturedisplay (measured bythird-party temperatureprobes) with the use ofan adapter cable thatconnects to the HiSiB.	System Software Version(VC12)No Temperature display	Comparable:The addition of atemperature displaywith the use of anadapter cable is achange from theprimary predicatedevice. Testing wasperformed and testresults indicate thisfeature does not raiseany new safety oreffectiveness issues.
	B. Introduction ofDiastolic Hyperemia-Free RatioTM (DFRTM)assessment of bloodflow through single ormultiple lesionswithout inducinghyperemia.	Predicate DeviceiLabs Polaris Multi-Modality GuidanceSystemK191008	Comparable:The algorithm usedto calculate DFRTMhas the samemeasuring points.
		Diastolic Hyperemia-FreeRatio (DFRTM) assessmentof blood flows throughsingle or multiple lesionswithout inducing hyperemia.	Testing wasperformed and testresults indicate thisfeature does notraise any newsafety oreffectiveness issues.

Table 2: Summary of Comparison of Technological Characteristics

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Modifications	Subject DeviceSensis Vibe Hemo (VD15B)and Sensis Vibe Combo (VD15B)	Comparison Results
		effectivenessissues.
IFU Statement	2. Revised IFU Statement	Comparable:Same as PrimaryPredicate Deviceexcept for the Namechange from "Sensis"to "Sensis VibeHemo (VD15B) andSensis Vibe Combo(VD15B)" Correctedverb usage typos.
Update 510(k)Information	3. Update 510(k) Information for Primary Predicate Device is provided in Volume011.

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 Numberand Date	StandardsDevelopmentOrganization
2-258	Biocompatibility	Biological evaluation of medicaldevices - Part 1: Evaluation andtesting within a risk managementprocess	10993-1:2018	ISO
5-134	General I (QS/RM)	Medical devices - Symbols to beused with information to be suppliedby the manufacturer - Part 1:General requirements	15223-1:2021	ISO
14-579	Sterility	Processing of health care products -Information to be provided by themedical device manufacturer for theprocessing of medical devices - Part2: Non-critical medical devices.	17664-2:2021	ISO
15-135	General I (QS/RM)	Medical devices - Information to besupplied by the manufacturer	20417:2021	ISO
5-129	General	Medical devices - Part 1: Application of usability engineering to medical devices	62366-1 Edition 1.12020-06CONSOLIDATEDVERSION	IEC
Recognition #	Product Area	Title of Standard	Reference Numberand Date	StandardsDevelopmentOrganization
13-83	Software/Informatics	Principles for medical devicesecurity - Risk management.	TIR57:2016	AAMI
19-4	General	Medical electrical equipment - Part1: General requirements for basicsafety and essential performance(IEC 60601-1:2005, MOD)[Including Amendment 2 (2021)]	ES60601-1:2005/(R)2012 &A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012(Consolidated Text)	ANSI AAMI
19-8	General	Medical electrical equipment - Part1-2: General requirements for basicsafety and essential performance -Collateral standard: Electromagneticdisturbances -- Requirements andtests	60601-1-2 Edition4.0:2014-02	IEC
5-76	General	Medical Electrical Equipment - Part1-8: General Requirements forBasic Safety And EssentialPerformance - Collateral Standard:General Requirements, Tests AndGuidance For Alarm Systems InMedical Electrical Equipment AndMedical Electrical Systems	60601-1-8 Edition 2.12012-11	IEC
12-273	Radiology	Safety of laser products - Part 1:Equipment classification, andrequirements [Including: TechnicalCorrigendum 1 (2008),Interpretation Sheet 1 (2007),Interpretation Sheet 2 (2007)]	60825-1:2014(recognized: 2007)	IEC
5-104	General	Graphical symbols for electricalequipment in medical practice	TR 60878 Ed. 3.0b:2015	IEC
13-79	Software/Informatics	Medical Device Software - SoftwareLife Cycle Processes	62304 Edition 1.12015-06 ConsolidatedVersion	IEC
3-105	Cardiovascular	Medical electrical equipment - Part2-25: Particular requirements for thebasic safety and essentialperformance of electrocardiographs	60601-2-25 Edition2.0 2011-10	IEC
3-115	Cardiovascular	Medical electrical equipment - Part2-34: Particular requirements forthe basic safety including essentialperformance of invasive bloodpressure monitoring equipment	60601-2-34 Edition3.0 2011-05	IEC
1-140	Anesthesiology	Medical electrical equipment - Part2-55: Particular requirements for thebasic safety and essentialperformance of respiratory gasmonitors	80601-2-55 Secondedition 2018-02	ISO
6-421	General	Medical electrical equipment - Part2-56: Particular requirements for thebasic safety and essentialperformance of clinicalthermometers for body temperaturemeasurement [Including:Amendment 1 (2018)].	80601-2-56 Secondedition: 2017-03	ISO
1-139	Anesthesiology	Medical electrical equipment - Part2-61: Particular requirements forbasic safety and essentialperformance of pulse oximeterequipment	80601-2-61 SecondEdition 2017-12(Corrected version2018-02)	ISO
Recognition #	Product Area	Title of Standard	Reference Numberand Date	StandardsDevelopmentOrganization
3-123	Cardiovascular	Medical electrical equipment - Part2-30: Particular requirements for thebasic safety and essentialperformance of automated non-invasive sphygmomanometers	80601-2-30: Edition2.0 2018-03	IEC
13-38	Software/Informatics	Application of risk management forIT-networks incorporating medicaldevices - Part 1: Roles,responsibilities and activities (IEC80001-1:2010) / Endorsementnotice	80001-1 Edition 1.02010-10	IEC
13-104	Software/Informatics	Standard for Safety, SoftwareCybersecurity for Network-Connectable Products, Part 2-1:Particular Requirements for NetworkConnectable Components ofHealthcare and Wellness Systems	2900-2-1 First Edition2017	ANSI UL
13-96	Software/Informatics	Standard for Safety, Standard forSoftware Cybersecurity Network-Connectable Products, Part 1:General Requirements	2900-1 First Edition2017	ANSI UL
5-125	General	Medical devices - Application of riskmanagement to medical devices	14971:2019	ISO
Sensis Vibe complied with the following additional standards currently not recognized
N/A	N/A	Medical Electrical Equipment:Safety of Multifunction PatientMonitoring Equipment	80601-2-49:2018	IEC
N/A	N/A	Digital Imaging andCommunications in Medicine(DICOM)	12052:2017	ISO
N/A	N/A	Medical electrical equipment - Part1: General requirements for basicsafety and essential performance	60601-1:2021	IEC
N/A	N/A	Medical electrical equipment - Part1-9: General requirements for basicsafety and essential performance -Collateral Standard: Requirementsfor environmentally consciousdesign	60601-1-9:2020	IEC
N/A	N/A	Degrees of protection provided byenclosures (IP code).	60529:2015	IEC
N/A	N/A	Systems and software engineering -Systems and software QualityRequirements and Evaluation(SQuaRE) - System and softwarequality models.	25010:2011	ISO IEC
N/A	N/A	Technical documentation for theassessment of electrical andelectronic products with respect tothe restriction of hazardoussubstances	63000:2016	IEC
N/A	N/A	Standard for Safety for InformationTechnology Equipment - Safety -Part1: General Requirements / nationaladoption of IEC 60950a-1 withmodifications	60950-1:2014	ANSI UL
Recognition #	Product Area	Title of Standard	Reference Numberand Date	StandardsDevelopmentOrganization
		60950-1-2011 / Approved 2014-10-14 ANSI.
N/A	N/A	Plastics - Generic identification andmarking of plastics products	11469:2016	ISO
N/A	N/A	Medical electrical equipment -Recurrenttest and test after repair of medicalelectrical equipment	62353:2014	ISO

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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.

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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

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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.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).