The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

Device Description

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (S1 endo) is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant concentrate, interchangeable Processing Trays/Containers, and Quick Connects.

The S1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.

The S1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific S1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

AI/ML Overview

The STERIS Corporation's SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, demonstrates substantial equivalence to its predicate device (K222615) based on non-clinical testing. The device is a liquid chemical sterilization system intended for processing immersible, reusable semi-critical medical devices and their accessories in healthcare facilities. The modifications being reviewed are limited to the use of alternative, drop-in replacement components for the control boards.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Use of new control boards:
New control boards must fit.	Pass (demonstrated by testing)
New control boards must run all cycles.	Pass (demonstrated by testing)
New control boards must run without alarms.	Pass (demonstrated by testing)
Software confirmation test:
Ensure proper software version.	Pass (demonstrated by testing)
Ensure proper operation of cycles.	Pass (demonstrated by testing)
Ensure proper operation of alarms.	Pass (demonstrated by testing)

2. Sample size used for the test set and the data provenance:

The document mentions "non-clinical performance testing" and "the same methods used to verify the original design" but does not specify the exact sample size for the test set (e.g., number of sterilization cycles performed, number of control boards tested).

The data provenance is implicitly from STERIS Corporation's internal testing labs, as they designed and manufactured the device. The testing is retrospective in the sense that it's performed after the modifications were made to confirm functionality against established criteria. No external country of origin is mentioned for the testing data itself; it's generated by the manufacturer for regulatory submission in the U.S.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The testing appears to be objective, verifying technical specifications and operational parameters, rather than requiring expert interpretation for ground truth establishment in the traditional sense of medical image analysis or clinical diagnosis. The "ground truth" here is the expected functional performance of the device and its components.

4. Adjudication method for the test set:

This information is not provided as the nature of the testing (functional verification of control boards and software) would likely involve automated system checks and predefined pass/fail criteria rather than expert adjudication of subjective results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable as the device is a liquid chemical sterilant processing system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable for the same reasons as #5. The device operates as an automated system; there isn't an "algorithm only" performance that would need to be separated from human interaction in the way an AI diagnostic tool might.

7. The type of ground truth used:

The ground truth used for these specific tests (related to new control boards and software) is functional criteria and predefined technical specifications. For example, a control board "fits" if it physically integrates correctly, "runs all cycles" if it successfully initiates and completes the sterilization sequence, and "runs without alarms" if no error states are triggered during operation. The software's "proper version" is a verifiable identifier, and its "proper operation of cycles and alarms" refers to its adherence to programmed logic and responses.

More broadly for the device as a sterilizer, the ultimate ground truth would be microbial efficacy (sterilization) and material compatibility, which are also stated to meet efficacy requirements based on in-vitro testing for its intended use (as described in Table 2).

8. The sample size for the training set:

This information is not applicable. The device is a physical sterilizer with a control system, not a machine learning or AI model that requires a training set. The "training" for such a system would be its design, engineering, and manufacturing processes, along with verification and validation testing.

9. How the ground truth for the training set was established:

This is not applicable as there is no "training set" in the context of an AI/ML model for this device. The ground truth for the device's overall function (sterilization efficacy) is established through standardized microbiological testing methods (e.g., AOAC Official Methods, simulated-use tests, clinical in-use tests as referenced in Table 2) against specific log reduction criteria for various microorganisms. For component performance (like the control boards), the ground truth is established by design specifications and functional requirements.

Summary

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March 28, 2023

STERIS Corporation Jennifer Nalepka Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K230582

Trade/Device Name: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 Regulation Number: 21 CFR 880.6885 Regulation Name: Sterilant, Medical Devices, Liquid Chemical Sterilants/Disinfectants Regulatory Class: Class II Product Code: MED Dated: March 1, 2023 Received: March 2, 2023

Dear Jennifer Nalepka:

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,

Clarence W. Murray III -S

Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K230582

Device Name

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

Indications for Use (Describe)

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

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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510(k) Summary For SYSTEM 1 endo Liquid Chemical Sterilant Processing System Model P6900

K230582

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600

Contact:

Jennifer Nalepka Manager, Regulatory Affairs Phone: (440) 392-7458 Email: jennifer nalepka@steris.com

March 1, 2023 Summary Date:

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

Trade Name:	SYSTEM 1 endo Liquid Chemical Sterilant ProcessingSystem, Model P6900
Device Class:	Class II
Common/Usual Name:	Liquid Chemical Sterilizer
Classification Name:	Sterilant, Medical Devices, Liquid ChemicalSterilants/Disinfectants
Classification Number:	21 CFR 880.6885
Product Code:	MED

2. Predicate Device

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, K222615

3. Description of Device

4. Indications for Use

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.

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The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

5. Technical Characteristic Comparison Table

The S1 endo is the same as the predicate device with the exception of the proposed modification. A comparison between the proposed and predicate devices can be found in Table 1 and Table 2 below.

Table 1. Processor Comparison Table.

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Table 2. S40 Sterilant Concentrate Comparison Table

1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.
2 Clapp et al., Free Rad. Res., (1994) 21:147-167.

² Clapp et al., Free Rad. Res., (1994) 21:147-167.

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³ Maillard et. al., J. Med. Microbiol (1995) 42:415-420.

4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554.
5 McDonnell et al., J. ADAC International (2000) 83:269-276.

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The proposed device has the same intended use as the predicate with the same technological characteristics. The modifications, subject of this submission, are to use control boards that have been slightly modified by using alternative, drop-in replacement components in the manufacture of the devices.

6. Summary of Non-Clinical Testing

Non-clinical performance testing was performed according to the test methodology listed below and is the same methods used to verify the original design. The testing demonstrated that the subject device met the acceptance criteria described in the standard/methodology.

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Test	Criterion	Conclusion
Use of new control boards	New control boards must fit and run all cycles without alarms	Pass
Software confirmation test	Ensure proper version, proper operation of cycles and alarms	Pass

Table 3. Summary of Non-Clinical Testing

7. Conclusion

The conclusions drawn from the non-clinical performance data, the SYSTEM 1 endo Liquid Chemical Sterilant Processing System is as safe, as effective, and performs as well or better than the legally marketed predicate device K222615, Class II (21 CFR 880.6885), product code MED.

Regulation Number and Section

§ 880.6885 Liquid chemical sterilants/high level disinfectants.

(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.

Feature	Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900	Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K222615)	Comparison
IntendedUseIndicationsfor Use	The SYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable semi-critical heat-sensitive medicaldevices and their accessories inhealthcare facilities.The SYSTEM 1 endo Processorautomatically dilutes the S40Sterilant Concentrate to its usedilution (> 1820 mg/L peraceticacid), liquid chemically sterilizesthe load during a controlled 6-minute exposure at 45.5 to 60°C,and rinses the load with 0.2micron filtered water.The SYSTEM 1 endo Processoruses only S40 SterilantConcentrate to liquid chemicallysterilize medical devices.	The SYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable semi-critical heat-sensitive medicaldevices and their accessories inhealthcare facilities.The SYSTEM 1 endo Processorautomatically dilutes the S40Sterilant Concentrate to its usedilution (> 1820 mg/L peraceticacid), liquid chemically sterilizesthe load during a controlled 6-minute exposure at 45.5 to 60°C,and rinses the load with 0.2micron filtered water.The SYSTEM 1 endo Processoruses only S40 SterilantConcentrate to liquid chemicallysterilize medical devices.	Identical
OperatingPrinciples/Technology	A microprocessor controlled unit with interchangeable processing trays/containers. The processor lid opens to reveal the processing chamber in which the load is placed. Devices with internal lumens are interfaced with the processor using connectors, i.e. Quick Connects	A microprocessor controlled unit with interchangeable processing trays/containers. The processor lid opens to reveal the processing chamber in which the load is placed. Devices with internal lumens are interfaced with the processor using connectors, i.e. Quick Connects.	Identical
Feature	Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900	Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K222615)	Comparison
	S40 Sterilant is placed in a specialized compartment and when the processor fills with water, it creates the sterilant use dilution from the single use sterilant cup. The processor monitors and controls the use dilution temperature and contact time. The processor automatically rinses the load with 0.2 micron filtered water to remove sterilant residuals.	S40 Sterilant is placed in a specialized compartment and when the processor fills with water, it creates the sterilant use dilution from the single use sterilant cup. The processor monitors and controls the use dilution temperature and contact time. The processor automatically rinses the load with 0.2 micron filtered water to remove sterilant residuals.
ProcessParameters	Standardized cycle parameters cannot be altered by operator. The critical process parameters are: Use dilution contact time Use dilution temperature Peracetic acid concentration Integrity of the internal water filter (tested by the system)	Standardized cycle parameters cannot be altered by operator. The critical process parameters are: Use dilution contact time Use dilution temperature Peracetic acid concentration Integrity of the internal water filter (tested by the system)	Identical
ProcessMonitors:	Cycle Printout documents successful cycle completion or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic cycle Alarms if pressure transducer indicates internal water filter failed integrity test	Cycle Printout documents successful cycle completion or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic cycle Alarms if pressure transducer indicates internal water filter failed integrity test	Identical
DesignFeatures	Microprocessor controlled unalterable and standardized	Microprocessor controlled unalterable and standardized	Identical
Feature	Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900	Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K222615)	Comparison
	liquid chemical sterilizationand Diagnostic cycles Intended for use only withS40 Sterilant Concentrate Automated dilution anddelivery of S40 Sterilant Processor provides 0.2 micronfiltered water for liquidchemical sterilization andrinsing Make-up air for processorduring drain sequences isfiltered through a 0.2 micronmembrane air filter Includes a barcode scanner;employs touchscreen displayinterface; has USB drive forelectronic cycle download;facilitates use of a web-baseddata management system. Separate, optional printer	liquid chemical sterilizationand Diagnostic cycles Intended for use only withS40 Sterilant Concentrate Automated dilution anddelivery of S40 Sterilant Processor provides 0.2 micronfiltered water for liquidchemical sterilization andrinsing Make-up air for processorduring drain sequences isfiltered through a 0.2 micronmembrane air filter Includes a barcode scanner;employs touchscreen displayinterface; has USB drive forelectronic cycle download;facilitates use of a web-baseddata management system. Separate, optional printer
Cycle Parameters
Incomingwater temp.	$\geq 43°C$	$\geq 43°C$	Identical
Temperatureto startsterilantexposure	$\geq 46°C$	$\geq 46°C$	Identical
Temperaturealarm pointduring LCSexposure	$< 45.5$ or $> 60°C$	$< 45.5$ or $> 60°C$	Identical
Temperaturerange oftypical LCScycle	46 - 55°C	46 - 55°C	Identical
ExposureTime - S40use dilution	6 minutes	6 minutes	Identical
Rinse waterpreparation	Hot potable tap water is pre-filtered is filtered through 0.2 micronbacterial retentive membranefilter	Hot potable tap water is pre-filtered is filtered through 0.2 micronbacterial retentive membranefilter	Identical
Feature	Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900	Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K222615)	Comparison
Number ofrinses	2	2	Identical
Air Purge	Aids in removing excess waterfrom instrument lumens afterrinsing	Aids in removing excess waterfrom instrument lumens afterrinsing	Identical
InternalWater FilterIntegrity Test	Conducted during the Diagnosticcycle	Conducted during the Diagnosticcycle	Identical
ApproximateCycle Time	18 - 20 minutes	18 - 20 minutes	Identical
DiagnosticCycle	Performs 14 tests on processor'ssystems confirming properfunction. Recommended toperform each day of use. After afailed Diagnostic cycle, a liquidchemical sterilization cyclecannot be performed until theproblem is rectified and asuccessful Diagnostic cycle hasbeen completed.	Performs 14 tests on processor'ssystems confirming properfunction. Recommended toperform each day of use. After afailed Diagnostic cycle, a liquidchemical sterilization cyclecannot be performed until theproblem is rectified and asuccessful Diagnostic cycle hasbeen completed.	Identical
Accessories
Sterilant	Uses S40 Sterilant Concentrate	Uses S40 Sterilant Concentrate	Identical
ProcessingTrays andContainers	Uses interchangeable processingtrays/containers• Universal Flex Processing Tray• General Processing Container& Tray• Directed Flow ProcessingContainer & Tray• Flexible Endoscope ProcessingContainer & Tray• Ultrasound Processing Tray	Uses interchangeable processingtrays/containers• Universal Flex Processing Tray• General Processing Container& Tray• Directed Flow ProcessingContainer & Tray• Flexible Endoscope ProcessingContainer & Tray• Ultrasound Processing Tray	Identical
QuickConnects	Uses Quick Connects to attachinstrument lumens to theTray/Container ports	Uses Quick Connects to attachinstrument lumens to theTray/Container ports	Identical
ChemicalIndicator	VERIFY Chemical Indicator forS40 Sterilant is available for usein SYSTEM 1 endo LCSPS	VERIFY Chemical Indicator forS40 Sterilant is available for usein SYSTEM 1 endo LCSPS	Identical
Spore TestStrip	VERIFY Spore Test Strip for S40Sterilant for use in SYSTEM 1endo LCSPS	VERIFY Spore Test Strip for S40Sterilant for use in SYSTEM 1endo LCSPS	Identical
Feature	Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900	Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K222615)	Comparison
OperatorMaintenance	Periodic replacement of waterfilters and air filter.Periodic replacement of printertape, if using the external printeroption.	Periodic replacement of waterfilters and air filter.Periodic replacement of printertape, if using the external printeroption.	Identical

Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K222615)	Comparison
Indications forUse	The SYSTEM 1E Processoruses only S40 SterilantConcentrate to liquid chemicallysterilize medical devices.	The SYSTEM 1E Processoruses only S40 SterilantConcentrate to liquid chemicallysterilize medical devices.	Identical
Germicidalclaim	Liquid Chemical Sterilant	Liquid Chemical Sterilant	Identical
GermicideExposureTime (min) forintended use	6	6	Identical
UseTemperature	45.5-60°C – allowable46-55°C - typicalPotency and simulated useevaluations conducted at <43°C	45.5-60°C – allowable46-55°C - typicalPotency and simulated useevaluations conducted at <43°C	Identical
Reuse	Single use	Single use	Identical
HumanFactors	Dispensed ready to use.Container is opened and dilutedby the processor, thus limitinguser exposure to the activeingredient	Dispensed ready to useContainer is opened and dilutedby the processor, thus limitinguser exposure to the activeingredient	Identical
ActiveIngredient	35% peroxyacetic (peracetic)acid automatically diluted foruse in the SYSTEM 1EProcessor.	35% peroxyacetic (peracetic)acid automatically diluted foruse in the SYSTEM 1EProcessor.	Identical
Mode ofAction	It is believed that peracetic acidexerts its germicidal effect byseveral mechanisms:-oxidizing sulfhydryl and sulfurbonds in proteins and enzymes,particularly in the cell walls 1-hydroxyl radicals producedfrom PAA are bactericidal 2	It is believed that peracetic acidexerts its germicidal effect byseveral mechanisms:-oxidizing sulfhydryl and sulfurbonds in proteins and enzymes,particularly in the cell walls1-hydroxyl radicals produced fromPAA are bactericidal2	Identical
Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K222615)	Comparison
Rinses	-PAA damages the viral capsidand viral nucleic acid3,4.	-PAA damages the viral capsidand viral nucleic acid3,4	Identical
	Automatic, UV-irradiated, dual0.1 micron filtered, potable hotwater.	Automatic, UV-irradiated, dual0.1 micron filtered, potable hotwater.
Microbial Efficacy
SporicidalActivity ofDisinfectantsAOACOfficialMethod 966.04	Meets efficacy requirements5.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacy requirements5.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Identical
ConfirmatorySporicidalActivity ofDisinfectantsAOACOfficialMethod 966.04	Meets efficacy requirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacy requirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Identical
FungicidalActivity ofDisinfectantsAOACOfficialMethod 955.17	Solution is fungicidal.Trichophyton mentagrophytesTesting conducted in vitro	Solution is fungicidal.Trichophyton mentagrophytesTesting conducted in vitro	Identical
Use DilutionMethodAOAC,OfficialMethods955.14, 955.15,964.02	Solution is bactericidal.Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosaTesting conducted in vitro	Solution is bactericidal.Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosa	Identical
EPA ViricidalTesting(DIS/TSS-7,Nov. 1981)	Solution is viricidal.Herpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro	Solution is viricidal.Herpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro	Identical
TuberculocidalActivityAscenziQuantitativeSuspensionTest	Solution is tuberculocidalMycobacterium terraeTesting conducted in vitro	Solution is tuberculocidalMycobacterium terraeTesting conducted in vitro	Identical
Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K222615)	Comparison
Simulated-UseTest	Meets efficacy requirement.$\geq$ 6 log reduction Geobacillusstearothermophilus spores in amanual application	Meets efficacy requirement.$\geq$ 6 log reduction Geobacillusstearothermophilus spores in amanual application	Identical
Clinical In-Use	No surviving microorganismson representative medicaldevices tested	No surviving microorganisms onrepresentative medical devicestested	Identical
Biocompatibility
CytotoxicityDevice Extracts	Two rinses with UV treated,dual 0.1-micron membranefiltered water effectively reducesterilant residues to safe levels.	Two rinses with UV treated, dual0.1-micron membrane filteredwater effectively reduce sterilantresidues to safe levels.	Identical
ResidueReduction	Automatic within the SYSTEM1E Processor:Two rinses with UV treated,dual 0.1-micron membranefiltered water effectively reducesterilant residues to safe levels.	Automatic within the SYSTEM1E Processor:Two rinses with UV treated, dual0.1-micron membrane filteredwater effectively reduce sterilantresidues to safe levels.	Identical
DeviceMaterialCompatibility	Compatible with medicaldevices as established bytesting finished flexibleendoscopes through 300 cyclesand rigid devices through 150cycles.No functional changes haveoccurred to flexible devices.Some materials show cosmeticchanges such as fading of blackanodized aluminum withoutharm to the base material.	Compatible with medicaldevices as established by testingfinished flexible endoscopesthrough 300 cycles and rigiddevices through 150 cycles.No functional changes haveoccurred to flexible devices.Some materials show cosmeticchanges such as fading of blackanodized aluminum withoutharm to the base material.	Identical