The Xenex LightStrike™+ is a pulsed, broad-spectrum, high-intensity, germicidal UV light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces, free from visual soiling, after manual cleaning and disinfection practices. LightStrike+ is intended for use in unoccupied operating rooms, hospital rooms, and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices. The system is for over-the-counter (OTC) use.

Device Description

LightStrike+ is a system that emits UV germicidal light to reduce the microbial load present on non-porous, non-critical medical device surfaces in healthcare environments, after manual cleaning and disinfection practices. Designed for microbial reduction cycles, the system will achieve the labeled log reductions through the utilization of Xenon lamp technology for the generation of UV germicidal light in the system's intended use environments. It is designed to be moved to targeted locations within a facility. The graphical user interface allows operators (trained cleaning staff) to select preprogrammed rooms and their associated protocols for cycle execution. The system is for use in unoccupied areas and includes design and redundant safety features to help prevent accidental exposure to the UV light.

AI/ML Overview

The LightStrike+ is a whole room microbial reduction device that uses pulsed UV light to reduce microbial load on non-porous, non-critical medical device surfaces after manual cleaning and disinfection. The device is intended for use in unoccupied healthcare environments as an adjunct to existing cleaning practices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is primarily assessed through its ability to achieve a sufficient microbial reduction and its safety. The acceptance criteria are largely derived from the "Special Controls" and the outcomes of the "Performance Testing - Bench" section.

Acceptance Criteria (from Special Controls/Performance Testing)	Reported Device Performance
Microbial Log Reduction: Demonstrate microbial log reduction commensurate with the intended level, using the most resistant microorganism.	"The device has been appropriately evaluated for performance on the bench, demonstrating that is capable to achieve a microbial reduction of 2-log.""The LightStrike+ device demonstrated 2-log average reduction in simulated use testing using worst-case microorganisms."Specific tests included: Optimized Kill Curve testing (determining dosage for 2-log reduction), Simulated-use tests (demonstrating 2-log reduction across inoculated surfaces with most UV resistant organism).
Simulated Use Testing: Evaluate device performance under simulated worst-case use conditions (e.g., soiling, room objects and surfaces, distances).	"Simulated-use tests were provided, demonstrating microbial reduction on medical device surfaces, using the determined most UV resistant organism, achieving an average of 2-log reduction across all inoculated surfaces." (Implies worst-case conditions were incorporated in the "simulated use" methodology, as it's the primary test for confirming the 2-log reduction in a realistic setting).
In-use testing: Evaluate device performance under real-world use conditions. (iii)	Not explicitly stated as completed or presented. The document mentions "In-use testing must evaluate device performance under real-world use conditions," but the "Performance Testing - Bench" section primarily focuses on what appear to be laboratory-based simulations ("simulated-use tests"). The "Benefit/Risk Conclusion" specifically states: "The magnitude of the clinical benefit (i.e., transmission reduction) has not been established based on the non-clinical testing provided by the sponsor. Data was robust for 2-log average reduction on medical device surfaces, in the simulated environment." This strongly suggests a full real-world "in-use" study demonstrating human health outcomes was not part of this submission for determining clearance. This is a notable gap in reported data for this specific criterion.
Photobiological Safety: Demonstrate the photobiological safety of any lamps or lamp systems.	"Photobiological safety of lamps and lamp system test were provided, to evaluate the safety of the lamp that emits UV light when the robot is in use, conducted using a new lamp, because the light intensity is at its maximum when the lamp is new and that represents the worst-case scenario, per IEC 62471 'Photobiological Safety of Lamps and Lamp Systems.'""Photobiological safety of lamps and lamp system met IEC 62471 criteria."
Safety Features: Evaluate safety features intended to prevent exposure and ensure that device operation can only occur in an unoccupied environment.	Device description details: "Tethered Motion Detection Cone" (detects motion, terminates cycle), "Remote Status/Stop Cone" (indicates in use, allows termination), "Door Placard" (warning sign). The system is designed to "automatically stop when the cycle time countdown expires." Operation only occurs "if the room is unoccupied." These design features fulfill the safety requirement.
Material Compatibility: Characterize the long-term material compatibility of the microbiocidal agent on clinically relevant surfaces and/or devices.	"Accelerated UV materials damage test were provided, to evaluate the impact of regular exposure to LightStrike+ with metallic and non-metallic materials commonly present in healthcare environments, including materials commonly used as medical device enclosures.""Materials damage testing results met ISO 4582. ASTM D256-10. and ASTM A370-22 requirements."
Biocompatibility/Chemical Byproducts: Demonstrate safe residual levels of chemicals on medical devices surfaces and/or gaseous byproducts in air.	"Testing was conducted to demonstrate that the operation of LightStrike+ generates Ozone at concentration levels that are below the maximum acceptable level of ozone in medical devices, according to 21 CFR 801.415.""Additionally, test results demonstrate that the levels of toxic chemicals (other than ozone) generated during the use of LightStrike+... are either below the safe exposure limit or will dissipate to safe levels when a user enters the room after the completion of the cycle.""Specifically, the concentrations of Carbon monoxide (CO), Carbon dioxide (CO2), Nitric oxide (NO) and Nitrogen dioxide (NO2) are well below the safe exposure limits, per 29 CFR 1910.1000.""Ozone generation levels were below 21 CFR 801.415 acceptance levels of toxic chemicals were below 29 CFR 1910.1000 acceptance levels."
Software Verification, Validation, and Hazard Analysis: for any software components.	"Adequate cybersecurity and software functionality were demonstrated according to FDA guidance 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices'.""The effectiveness of the software security controls is determined through a threat model - risk assessment." "Xenex controls deployment of software updates as per change control and procedures within the Software Development Plan."
EMC & Electrical Safety: Demonstrate electromagnetic compatibility (EMC) and electrical safety of the device.	"The LightStrike+ electrical safety is in conformance with IEC 60601-1-6. and the electromagnetic compatibility (EMC) is in accordance with IEC 60601-1-2."
Labeling: Include specific warnings, instructions, and material compatibility information.	"The labeling consists of a user manual, instructions for use, and packaging labels. The instructions for use include the indications for use, including the time to achieve a 2-log reduction; a description of the device, contraindications, warnings, precautions, including a door placard with caution signs advising 'DO NOT ENTER' to be affixed on entry ways of rooms/areas, warns of possible UV exposure during operation and warns of risk group 3 UV light generated by device; and instructions for the safe use of the device." "Labeling for this device is in accordance with the special controls listed below."

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

The document does not explicitly state a single dedicated "test set sample size" in the context of typical AI/ML model evaluation (i.e., a dataset held out for final performance assessment). The testing described is primarily bench-top, laboratory-simulated performance testing rather than a clinical study evaluating diagnostic accuracy or similar AI outcomes.

Microbial Reduction Testing: The "simulated-use tests" involved "all inoculated surfaces" to achieve the 2-log reduction. The specific number of surfaces, microorganisms, and replicates is not provided.
Safety Testing (Ozone, Chemicals, Photobiological): These involved specific test setups and measurements compliant with relevant standards (e.g., 21 CFR 801.415, 29 CFR 1910.1000, IEC 62471). The sample size here refers to the number of tests performed or measurements taken, which is not detailed.
Material Compatibility: "metallic and non-metallic materials commonly present in healthcare environments" were tested. The exact number or types of materials is not specified.

Data Provenance:

Given the nature of the tests (bench studies, simulated use, compliance with US and international standards), the data provenance is likely laboratory-generated data from Xenex's own testing facilities or accredited third-party labs.
The data is retrospective in the sense that the studies were completed to support the De Novo application. There's no mention of prospective clinical trial data in human patients or real-world "in-use" data to assess patient outcomes or infection rates.
Country of Origin: The sponsor is Xenex Disinfection Services, Inc., located in San Antonio, TX, USA. It's highly probable the testing was conducted in the USA or by labs commissioned by the US-based company.

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

This information is not applicable in the traditional sense for this device. Ground truth, in this context, is established by:

Quantitative measurements: Log reduction achieved, chemical concentration levels, light intensity measurements, material degradation measurements.
Compliance with established standards: IEC, ASTM, CFR regulations.
Biological assay results: Live/dead microbial counts from inoculated surfaces.

The "experts" involved would be the scientists, microbiologists, engineers, and clinical staff who designed, executed, and interpreted these bench-top studies and ensured compliance with the relevant standards. Their specific number or qualifications are not detailed, but their expertise is implied by the successful completion and acceptance of the studies by the FDA. There is no human diagnostic interpretation involved that would require a panel of experts for ground truth establishment.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies where human readers or multiple reviewers establish a ground truth for subjective interpretations (e.g., medical image diagnosis). For the LightStrike+, ground truth is based on objective, repeatable scientific measurements and compliance with quantitative thresholds defined by regulations and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed.

MRMC studies are relevant for evaluating the impact of AI on human performance in diagnostic tasks (e.g., radiologists reading images with or without AI assistance).
The LightStrike+ is a disinfection device, not a diagnostic AI tool. Its effectiveness is measured by microbial reduction.
The submission explicitly states: "The magnitude of the clinical benefit (i.e., transmission reduction) has not been established based on the non-clinical testing provided by the sponsor." This confirms the absence of studies evaluating its impact on human infection rates when used in a real-world setting.

Effect Size: Since no MRMC study was done, there is no effect size reported for human readers improving with AI vs. without AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in spirit. The performance tests described (e.g., "simulated-use tests demonstrating microbial reduction") represent the device's standalone performance in achieving microbial reduction. This is an "algorithm only" or "device only" performance in that it measures the physical effect of the UV light on microorganisms under controlled conditions, without human intervention in the disinfection process itself beyond setup and activation. The device is designed to operate autonomously in an unoccupied room.

7. The Type of Ground Truth Used

The ground truth for the LightStrike+ device's performance is established by:

Quantitative Microbial Reduction: Direct measurement of viable microbial colonies before and after device operation on inoculated surfaces, yielding a calculated log reduction. This is a scientific and laboratory-based ground truth.
Compliance with Regulatory Standards: For safety aspects (ozone, toxic chemicals, photobiological safety, electrical safety, EMC), the ground truth is defined by specific quantitative limits set forth in regulations (e.g., 21 CFR 801.415, 29 CFR 1910.1000) and international standards (e.g., IEC 62471, IEC 60601-1-6, IEC 60601-1-2).
Material Integrity: Adherence to material degradation standards (ISO 4582, ASTM D256-10, ASTM A370-22).

This is primarily a laboratory-based, direct measurement, and standards-compliance ground truth, rather than clinical outcomes or expert consensus on subjective data.

8. The Sample Size for the Training Set

The concept of a "training set" in the context of artificial intelligence/machine learning is not directly applicable here. The LightStrike+ is a physical medical device that emits UV light, not an AI model that learns from a dataset.

While it has "Software" components, these appear to be primarily for control, user interface, and safety features (e.g., "room guide," "cycle execution," "motion detection," "wireless communications") rather than data-driven learning or prediction for its primary function of microbial reduction.
The "training" of the device is analogous to its engineering design and optimization to achieve the desired UV output and safety features.

Therefore, there is no "training set" in the common AI/ML sense.

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

As there is no AI/ML training set, this question is not applicable. The "ground truth" for the device's design and optimization would be the physical and biological principles of UV light inactivation of microorganisms, safety standards, and engineering specifications. This is established through established scientific methods, engineering principles, and iterative design/testing, rather than data labeling for machine learning.

Summary

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DE NOVO CLASSIFICATION REQUEST FOR LIGHTSTRIKE+

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Whole room microbial reduction device. A whole room microbial reduction device is a medical device to be used to reduce microbial load on medical device surfaces following cleaning and disinfection.

NEW REGULATION NUMBER: 21 CFR 880.6510

CLASSIFICATION: Class II

PRODUCT CODE: QXJ

BACKGROUND

DEVICE NAME: LightStrike+

SUBMISSION NUMBER: DEN230007

DATE DE NOVO RECEIVED: February 01, 2023

SPONSOR INFORMATION:

Xenex Disinfection Services, Inc. 1074 Arion Circle\ Suite 116 San Antonio, TX 78216 USA

INDICATIONS FOR USE

LIMITATIONS

Limitations on device use are provided in the Instructions for Use Manual:

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Warnings and Precautions

. do not use the device for microbial reduction of the critical or semi-critical surfaces of medical devices.
do not use the device for microbial reduction of food or water. .
do not use the device for microbial reduction of a human or animal body or . corresponding bodily fluids.
. not indicated for use in occupied rooms, areas, and spaces.
follow unit setup and positioning instructions. .

PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS. PRECAUTIONS AND CONTRAINDICATIONS

DEVICE DESCRIPTION

Image /page/1/Figure/9 description: The image shows a LightStrike+ robot with several labeled parts. The robot has a dome and xenon lamp on top, a user interface, and a handle. The robot also has an appliance inlet and cable retainer at the bottom, as well as a tethered motion detection cone, remote status/stop cone, and door placard.

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System Component	Function Summary
Robot	Generates UV light for whole room microbial reduction
Xenon Lamp	Xenon gas lamp that emits germicidal UV at wavelengths from 240to 315nm when pulsed by the robot. The lamp is stored inside of therobot and rises to deliver the UV light
User Interface	Includes a room guide to allow the user to select the room whereLightStrike+ will be used
	Cycle times are preprogrammed for each room and downloaded tothe robot over wireless communications
	When a room is selected, the microbial reduction cycle will start oncethe physical button above the user interface screen is pressed and therobot senses the operator has exited the room
	The microbial reduction cycle will automatically stop when the cycletime countdown expires
Tethered MotionDetection Cone	Safety feature to help prevent inadvertent UV exposure to anyoneentering the room while a cycle is active
	Placed inside the room/area where LightStrike+ will be used, facingthe entry door
	Detects motion from the entry door to a room during a cycle andsignals the robot to terminate the microbial reduction cycle whenmotion is sensed
Remote Status/StopCone	Feature to help prevent users from entering an area during a microbialreduction cycle. The cone serves as an indicator that LightStrike+ isin use within a room/area.
	Located outside the entrance of the room where LightStrike+ is in use
	Includes a feature to allow the user to terminate a cycle from outsidethe room
	Provides a visual countdown to indicate how much time is remainingin an ongoing microbial reduction cycle
	Provides warning to indicate that an individual should not enter theroom during an ongoing cycle
	Once countdown expires, it provides a visual cue that it is safe toenter the room
Handle	Used to wheel and position the robot in the area where LightStrike+will be used
	Can be pulled/pushed from both sides
Door Placard	Warning sign that adheres to the door exterior to indicate thatLightStrike+ is being used in the Room/Area

SUMMARY OF BENCH STUDIES

REPROCESSING, STERILITY AND SHELF-LIFE

The LightStrike+ does not require reprocessing and sterility. The LightStrike+ does not have a labeled shelf life; device performance is not adversely affected by aging or

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storage. Built-in design features monitor when the lamp is nearing the end of its usable life and prevent use of the device at that point.

BIOCOMPATIBILITY

The LightStrike+ uses a Xenon gas flash lamp to produce pulsed broad-spectrum germicidal UV light that reduces microbial load on non-porous, non-critical medical device surfaces in the whole room, for a period of time, after the room has been manual cleaned and disinfected. The operation occurs only if the room is unoccupied.

Testing was conducted to demonstrate that the operation of LightStrike+ generates Ozone at concentration levels that are below the maximum acceptable level of ozone in medical devices, according to 21 CFR 801.415, and is without an appreciable risk of deleterious effects. Additionally, test results demonstrate that the levels of toxic chemicals (other than ozone) generated during the use of LightStrike+ that would be safe for users/patients following the completion of the UV microbial reduction cycle are either below the safe exposure limit or will dissipate to safe levels when a user enters the room after the completion of the cycle.

Specifically, the concentrations of Carbon monoxide (CO), Carbon dioxide (CO2), Nitric oxide (NO) and Nitrogen dioxide (NO2) are well below the safe exposure limits, per 29 CFR 1910.1000, after the use of the LightStrike+ device. Test results demonstrate that there is a very low probability for the generation of toxic levels of Hydroxyl radical. singlet oxygen, and superoxide anion radicals by the LightStrike+ device in an indoor healthcare environment due to the low energy of the photons compared to the required Bond Dissociation Energy and the lack of high levels of pollutants. This is also clear from the low concentration of gases such as Ozone. NO. and NO2 which are generated from the secondary interaction of these species with other molecules. The small amount of the generated radicals will also decay to safe levels because of the extremely low halflife and high reactivity of the species before a user enters the room after a disinfection cycle.

SOFTWARE

The LightStrike+ Software System is a collection software that executes on the Brazos physical device and cloud-based platforms. The Software System includes both off-theshelf software and software that is developed and maintained by Xenex. The Software System is composed of the Microbial Reduction Management System (MRMS). Device Interface, and Firmware Software Items. The MRMS Software Item runs on cloud-based platforms. The Device Interface and Firmware Software Items run on the LightStrike+ physical device.

The interfaces between the top-level Software Items are indicated in Figure 1. MRMS and the Device Interface communicate remotely through two TCP/IP based protocols. HTTPS and MOTT. The Device Interface and the Firmware communicate through a RS232 link using a custom communication protocol and over TCP/IP sockets. In addition

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to the interfaces between Software Items in Figure 1, each Software Item includes some form of interface. The LightStrike+ Software System includes two distinct user types, Device Users and MRMS Users. Device Users are those users that are authorized to use the LightStrike+ physical device and interact with the Device Interface and Firmware Software Items. MRMS Users are those authorized to access the user interfaces of the MRMS Software Item. Adequate cybersecurity and software functionality were demonstrated according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

The LightStrike+ controls the integrity of the software by limiting access to trusted users and ensuring trusted content through software controls as defined within the Cybersecurity System, according to FDA guidance document titled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (https://www.fda.gov/media/86174/download). The effectiveness of the software security controls is determined through a threat model - risk assessment. Xenex controls deployment of software updates as per change control and procedures within the Software Development Plan. All potential firmware and software updates are reviewed against the most recent versions of the SRS.

ELECTROMAGNETIC COMPATIBILITY & ELECTRICAL SAFETY

The LightStrike+ electrical safety is in conformance with IEC 60601-1-6. and the electromagnetic compatibility (EMC) is in accordance with IEC 60601-1-2.

PERFORMANCE TESTING - BENCH

The sponsor conducted the following performance tests to support that the device can achieve its intended use:

. Optimized Kill Curve testing were provided, determining the dosage required for LightStrike+ to achieve a 2-log reduction of select bacterial organisms.
. Bacteriostasis of Intended In-use Surfaces were provided to verify potential inherent bacteriostatic properties of surfaces intended for future In-use testing.
. Recovery validation testing were provided to verify expected effectiveness of microbial recovery methods used to verify microbial reduction system results in a simulated use environment.
Simulated-use tests were provided, demonstrating microbial reduction on medical . device surfaces, using the determined most UV resistant organism, achieving an average of 2-log reduction across all inoculated surfaces.
. Accelerated UV materials damage test were provided, to evaluate the impact of regular exposure to LightStrike+ with metallic and non-metallic materials commonly present in healthcare environments, including materials commonly used as medical device enclosures.
. Ozone tests were provided, to ensure that LightStrike+ users are safe, notwithstanding the very low concentration of ozone that is produced by the device as a byproduct of UV-C light emission (to which the user could be exposed), per 21 CFR 801.415 "Maximum acceptable level of ozone". The levels

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of toxic chemicals (other than ozone) generated during the use of LightStrike+ that would be safe for users/patients following the completion of the UV microbial reduction cycle were also tested, per 29 CFR 1910.1000.

Photobiological safety of lamps and lamp system test were provided, to evaluate . the safety of the lamp that emits UV light when the robot is in use, conducted using a new lamp, because the light intensity is at its maximum when the lamp is new and that represents the worst-case scenario, per IEC 62471 "Photobiological Safety of Lamps and Lamp Systems.
The device has been appropriately evaluated for performance on the bench. demonstrating that is capable to achieve a microbial reduction of 2-log. Materials damage testing results met ISO 4582. ASTM D256-10. and ASTM A370-22 requirements. Ozone generation levels were below 21 CFR 801.415 acceptance levels of toxic chemicals were below 29 CFR 1910.1000 acceptance levels. Photobiological safety of lamps and lamp system met IEC 62471 criteria.

LABELING

The labeling consists of a user manual, instructions for use, and packaging labels. The instructions for use include the indications for use, including the time to achieve a 2-log reduction; a description of the device, contraindications, warnings, precautions, including a door placard with caution signs advising "DO NOT ENTER" to be affixed on entry ways of rooms/areas, warns of possible UV exposure during operation and warns of risk group 3 UV light generated by device; and instructions for the safe use of the device.

Labeling for this device is in accordance with the special controls listed below.

RISKS TO HEALTH

The table below identifies the risks to health that may be associated with use of a whole room microbial reduction device and the measures necessary to mitigate these risks.

Risks to Health	Mitigation Measures
Exposure to microbiocidal agent,leading to skin and eye damage	Non-clinical performance testingBiocompatibility evaluationSoftware verification, validation, and hazard analysisLabeling
Respiratory mucous membrane irritationand pulmonary edema due to chemicalexposure	Non-clinical performance testingBiocompatibility evaluation
Patient cross-contamination due todevice failure leading to inadequatemicrobial reduction	Non-clinical performance testingLabelingSoftware verification, validation, and hazard analysis
Electrical shock	Electrical safety testingNon-clinical performance testing

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Risks to Health	Mitigation Measures
Interference with other devices	LabelingElectromagnetic compatibility testingElectrical safety testingWireless coexistence testingLabeling

SPECIAL CONTROLS

In combination with the general controls of the FD&C Act, the whole room microbial reduction device is subject to the following special controls:

Non-clinical performance testing must demonstrate that the device performs as (1) intended under anticipated conditions of use. The following performance characteristics must be tested:
- (i) Performance testing must demonstrate microbial log reduction of the demonstrated most resistant microorganism on medical device surfaces commensurate with the intended level of microbial reduction.
- (ii) Simulated use testing must evaluate device performance under simulated worstcase use conditions (e.g., soiling, room objects and surfaces, distances).
- In-use testing must evaluate device performance under real-world use conditions. (iii)
- (iv) Performance testing must demonstrate the photobiological safety of any lamps or lamp systems.
- Performance testing must evaluate safety features intended to prevent exposure (v) and ensure that device operation can only occur in an unoccupied environment: and
- Performance testing must characterize the long-term material compatibility of the (vi) microbiocidal agent on clinically relevant surfaces and/or devices.
(2) Biocompatibility testing must demonstrate safe residual levels of chemicals on medical devices surfaces and/or gaseous byproducts in air.
Software verification, validation, and hazard analysis must be performed for any (3) software components.
Performance data must demonstrate the electromagnetic compatibility (EMC) and (4) electrical safety of the device.
Labeling must include: (5)
- Warnings and instructions to ensure the device is operated in an unoccupied (i) environment.
- (ii) Setup and positioning instructions; and
- (iii) Information regarding material compatibility.

BENEFIT-RISK DETERMINATION

Risks:

The risks of the device are based on nonclinical laboratory (bench) studies described above.

Subject device is to be used in an unoccupied room. The only risk of injury is skin and eve damage resulting from exposure to dangerous light source, respiratory issues from exposure to

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ozone, electrical shock and interference with other devices are mitigated with the performance testing, warnings, precautions, and special controls. Risk of device failure leading to microbial growth, increasing the risk of patient-to-patient cross contamination and study limitations, are mitigated with the performance testing, labeling, special controls, and the use as adjunct to manual cleaning and disinfection only.

Benefits:

The probable benefits of the device are based on nonclinical laboratory (bench) studies described above.

The LightStrike+ device demonstrated 2-log average reduction in simulated use testing using worst-case microorganisms. The device will be used as an adjunct to existing manual cleaning practices. LightStrike+ provides additional microbial reduction after manual cleaning and disinfection, strengthening the risk reduction of transmitting pathogens from one patient to the next, or between health care providers and patients. The magnitude of the clinical benefit (i.e., transmission reduction) has not been established based on the non-clinical testing provided by the sponsor. Data was robust for 2-log average reduction on medical device surfaces, in the simulated environment.

Patient Perspectives

This submission did not include specific information on patient perspectives for this device.

Benefit/Risk Conclusion

Based on the performance testing provided (in particular, log reduction test, in a simulated-use test, optimized kill curve determination test, bacteriostasis test, microbial recovering test, biocompatibility test, material degradation test, ozone test, photobiological safety of lamps and lamp systems tests, and labeling), the sponsor has adequately supported that the subject device is a UV-C light microbial reduction device adjunctive to manual cleaning. This feature will provide an additional microbial reduction to surfaces that were previous cleaned and disinfected, helping to prevent cross contamination among patients and healthcare staff.

In conclusion, given the testing provided above, for the following indication statement:

The Xenex LightStrike™+ is a pulsed. broad-spectrum. high-intensity, germicidal UV light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces. free from visual soiling, after manual cleaning and disinfection practices. LightStrike+ is intended for use in unoccupied operating rooms, hospital rooms, and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices. The system is for over-the-counter (OTC) use.

The probable benefits outweigh the probable risks for the LightStrike+. The device provides benefits and the risks can be mitigated using general controls and the identified special controls.

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CONCLUSION

The De Novo request for the LightStrike+ is granted and the device is classified as follows:

Product Code: QXJ Device Type: Whole room microbial reduction device Regulation Number: 21 CFR 880.6510 Class: II

Regulation Number and Section

N/A