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

The SYSTEM 1E Processor 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 extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.

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

The extensive treatment of EPA potable water consists of:

1. Pre-filtration through two pre-filters:
- · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
- · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron.
1. UV Irradiation:
- · During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
3.0.1 micron filtration:

· The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

Device Description

The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Six Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying the Indications for Use. The current submission is provided to describe the addition of a second supplier for bacterial retentive water filter, referred to in labeling as the MaxPure filter and A and B Pre-filters and to add an alternate resin for the construction of the sterilant capsule.

The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, 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 instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called the "SYSTEM 1E Liquid Chemical Sterilant Processing System." This summary primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data as one might find for a novel device. The modifications described are mainly about alternative suppliers for components and an alternative resin for the sterilant capsule, not changes to the core functionality or claims.

However, I can extract the information related to the acceptance criteria and the type of study that demonstrates the device meets these criteria, based on the provided "Summary of verification activities."

Here's the breakdown:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
The modification does not change the final product release specifications (for MaxPure Filter)	Pass
The modification does not change the final product release specifications (for MaxPure Filter via microbial retention challenge)	Pass
The modification does not change the final product release specifications (for Pre-filter A and B)	Pass
The modification does not change the final product release specifications (for S40 Sterilant Concentrate Acid concentration)	Pass
The container contents are compatible with the container package and labeling (for Capsule Alternate Resin and Supplier)	Pass

Study Details

The provided document describes verification activities rather than a full-fledged clinical study or comparative effectiveness study as would be typical for a device with clinical efficacy claims. The purpose of these activities is to ensure that the modifications (alternate suppliers for filters and sterilant capsule resin) do not negatively impact the device's established safety and effectiveness.

Sample size used for the test set and the data provenance:
- MaxPure Filter alternate supplier: "Accumulation of successful liquid chemical sterilization cycles and diagnostic cycles to represent the filter's 3-months use life." The exact number of cycles or filters tested is not specified.
- MaxPure Filter microbial retention challenge: Similar to above, "following the accumulation of liquid chemical sterilization cycles and diagnostic cycles representing 3 months use." The exact number of filters or challenges is not specified. The test was based on ASTM F838-15, which is a standard in vitro test method.
- Pre-filter A and B alternate supplier: "Accumulation of successful liquid chemical sterilization cycles and diagnostic cycles to represent the filter's 3-month use life." The exact number of cycles or filters tested is not specified.
- S40 Sterilant Concentrate Acid (alternate resin for capsule): "Evaluation of the concentration of peracetic acid over the shelf life." The specific number of samples or duration of testing is not provided.
- Capsule Alternate Resin and Supplier: "Physical evaluation of compatibility of the alternate resin with container contents." The specific number of units or tests is not provided.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a submission to the U.S. FDA, it is presumed to be from studies conducted under applicable U.S. or international standards, likely at the manufacturer's facility or accredited labs. All studies appear to be retrospective for these verification activities, as they are testing components of an already-cleared device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to the type of studies described. These are engineering and microbiological verification tests, not diagnostic studies requiring expert human interpretation for ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable as these are technical verification tests, not studies with human interpretation requiring adjudication.
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. The device is a liquid chemical sterilant processing system, not an AI-powered diagnostic or imaging device used by human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable, as the device is not an algorithm or AI system. Its performance is inherent in its physical and chemical processes.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the filter integrity challenge, the ground truth would be the direct measurement of microbial retention (e.g., log reduction of bacteria) using standard microbiological methods (ASTM F838-15).
- For sterilant concentration, the ground truth is the chemical assay of peracetic acid.
- For material compatibility, the ground truth is physical observation and testing of material integrity and interaction with contents.
- The "type of ground truth" here refers to established physical, chemical, and microbiological standards and measurements, not clinical expert consensus or pathology.
The sample size for the training set:
- This is not applicable, as this device does not use machine learning or AI algorithms that require a "training set."
How the ground truth for the training set was established:
- This is not applicable, as no training set is mentioned or implied for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

April 4, 2018

Steris Corporations Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K180342

Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: March 12, 2018 Received: March 13, 2018

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180342

Device Name

SYSTEM 1E Liquid Chemical Sterilant Processing System

Indications for Use (Describe)

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

The extensive treatment of EPA potable water consists of:

1. Pre-filtration through two pre-filters:
- · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
- · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron.
1. UV Irradiation:
- · During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
3.0.1 micron filtration:

· The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word "STERIS" is written in a serif font in all capital letters. Below the word is an image of several horizontal wavy lines in blue.

510(k) Summary For SYSTEM 1E Liquid Chemical Sterilant Processing System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

Contact: Jennifer Nalepka Senior Regulatory Affairs Specialist Tel: 440-392-7458 Fax: 440-357-9198

March 27, 2018 Summary Date:

Premarket Notification Number: K180342

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

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1. Device Name

Trade Name:	SYSTEM 1E Liquid Chemical SterilantProcessing System
Device Classification:	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 1E Liquid Chemical Sterilant Processing System cleared under K170956

3. Description of Device

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4. Intended Use

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

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

米 The extensive treatment of EPA potable water consists of:
- 1. Pre-filtration through two pre-filters:
  - Pre-filter A is a gross depth filter that removes approximately 2.5 . micron or larger particles/contaminants.
  - Pre-filter B is a surface filter that removes particles/contaminants > . 0.1 micron.
- 1. UV Irradiation:
  - During transit through the UV water treatment chamber, a UV dose . sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
- 1. 0.1 micron filtration:
  - The water prepared by pre-filtration and UV irradiation is filtered ● through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

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5. Description of Technological Similarities and Differences

The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific modification described in this submission. The differences between the proposed and predicate devices are limited to the addition of an alternate supplier for the MaxPure Filter and A and B Pre-filters and to add an alternate resin for the construction of the sterilant capsule. These proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.

Device Comparison Table

Feature	ProposedSYSTEM 1E Processor	K170956SYSTEM 1E Processor	Comparison
Indicationsfor Use	The SYSTEM 1E LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization ofcleaned, immersible, andreusable critical and semi-critical heat-sensitive medicaldevices in healthcarefacilities.The SYSTEM 1E Processordilutes the S40 SterilantConcentrate to its use dilution(>1820 mg/L peracetic acid),liquid chemically sterilizesthe load during a controlled6-minute exposure at 45.5 to60℃, and rinses the load withextensively treated* potablewater. After completion of acycle, critical devices shouldbe used immediately; semi-critical devices should beused immediately or may behandled and stored in amanner similar to that of highlevel disinfected endoscopes.Critical devices not usedimmediately should beprocessed again before use.	The SYSTEM 1E LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization ofcleaned, immersible, andreusable critical and semi-critical heat-sensitive medicaldevices in healthcarefacilities.The SYSTEM 1E Processordilutes the S40 SterilantConcentrate to its use dilution(>1820 mg/L peracetic acid),liquid chemically sterilizesthe load during a controlled6-minute exposure at 45.5 to60℃, and rinses the load withextensively treated* potablewater. After completion of acycle, critical devices shouldbe used immediately; semi-critical devices should beused immediately or may behandled and stored in amanner similar to that of highlevel disinfected endoscopes.Critical devices not usedimmediately should beprocessed again before use.	Identical

Table 6-1. Processor Device Comparison Table
-----------------------------------------------	--	--	--	--	--

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Feature	ProposedSYSTEM 1E Processor	K170956SYSTEM 1E Processor	Comparison
	The SYSTEM 1E Processoruses only S40 SterilantConcentrate to liquidchemically sterilize medicaldevices.	The SYSTEM 1E Processoruses only S40 SterilantConcentrate to liquidchemically sterilize medicaldevices.
	* The extensive treatment ofEPA potable water consistsof:1. Pre-filtration throughtwo pre-filters:• Pre-filter A is a grossdepth filter thatremovesapproximately 2.5micron or largerparticles/contaminants.• Pre-filter B is a surfacefilter that removesparticles/contaminants> 0.1 micron.	* The extensive treatment ofEPA potable water consistsof:1. Pre-filtration throughtwo pre-filters:• Pre-filter A is a grossdepth filter thatremovesapproximately 2.5micron or largerparticles/contaminants.• Pre-filter B is a surfacefilter that removesparticles/contaminants> 0.1 micron.
	2. UV Irradiation:• During transit throughthe UV watertreatment chamber, aUV dose sufficient toachieve a ≥ 6-logreduction of MS2 virusis delivered to thewater.	2. UV Irradiation:• During transit throughthe UV watertreatment chamber, aUV dose sufficient toachieve a ≥ 6-logreduction of MS2 virusis delivered to thewater.
	3. 0.1-micron filtration:• The water prepared bypre-filtration and UVirradiation is filteredthrough redundant,0.1-micron (absoluterated) membranes toremove bacteria, fungiand protozoa > 0.1micron	3. 0.1-micron filtration:• The water prepared bypre-filtration and UVirradiation is filteredthrough redundant,0.1-micron (absoluterated) membranes toremove bacteria, fungiand protozoa > 0.1micron
Feature	ProposedSYSTEM 1E Processor	K170956SYSTEM 1E Processor	Comparison
OperatingPrinciples/Technology	A microprocessor controlled unit with interchangeableprocessing trays/containers.The processor lid opens to reveal the processingchamber in which the load is placed. Devices with internallumens are interfaced with the processor using connectors.Sterilant Concentrate is placed in a specializedcompartment and when the processor fills with water, itcreates the sterilant use dilution from the single usesterilant cup. The processor monitors and controls the usedilution temperature and contact time. The processorautomatically rinses the load with extensively treated waterto remove sterilant residuals.	A microprocessor controlled unit with interchangeableprocessing trays/containers.The processor lid opens to reveal the processingchamber in which the load is placed. Devices with internallumens are interfaced with the processor using connectors.Sterilant Concentrate is placed in a specializedcompartment and when the processor fills with water, itcreates the sterilant use dilution from the single usesterilant cup. The processor monitors and controls the usedilution temperature and contact time. The processorautomatically rinses the load with extensively treated waterto remove sterilant residuals.	Identical
	ProcessParameters	Standardized cycle parameters cannot be alteredby operator. The critical process parameters are:● Contact Time● Use Dilution Temperature● Peracetic acid concentration● Bacterial retentive water filter integrity● UV irradiation	Standardized cycle parameters cannot be alteredby operator. The critical process parameters are:● Contact Time● Use Dilution Temperature● Peracetic acid concentration● Bacterial retentive water filter integrity● UV irradiation	Identical
		ProcessMonitors	● Cycle Printout documents successfulcycle completion or identifies fault if cycleaborts● Alarms if thermocouples indicate temperature outof specification● Alarms if pressure switch indicates thathigh pressure pump is not operating	● Cycle Printout documents successfulcycle completion or identifies fault if cycleaborts● Alarms if thermocouples indicate temperature outof specification● Alarms if pressure switch indicates thathigh pressure pump is not operating	Identical
			Feature	ProposedSYSTEM 1E Processor	K170956SYSTEM 1E Processor	Comparison
			DesignFeatures	probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates 0.1-micron water filter failed integrity test during liquid chemical sterilant processing and Diagnostic cycles. Alarms if UV monitor indicates UV intensity out of specification Microprocessor controlled unalterable and standardized liquid chemical sterilant processing and Diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron filtered, UV treated water for liquid chemical sterilant processing and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2-micron membrane air filter.	probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates 0.1-micron water filter failed integrity test during liquid chemical sterilant processing and Diagnostic cycles. Alarms if UV monitor indicates UV intensity out of specification Microprocessor controlled unalterable and standardized liquid chemical sterilant processing and Diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron filtered, UV treated water for liquid chemical sterilant processing and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2-micron membrane air filter.	Identical
			Processing Cycle
			Incomingwatertemperature	$\geq 43°C$	$\geq 43°C$	Identical
		Temperatureto startexposurephase	$\geq 46°C$	$\geq 46°C$	Identical
	Feature	ProposedSYSTEM 1E Processor	K170956SYSTEM 1E Processor	Comparison
	Temperaturealarm pointduring theexposurephase	<45.5 or >60°C	<45.5 or >60°C	Identical
Temperaturerange duringa typicalLiquidChemicalSterilantProcessingCycle	46 - 55°C	46 - 55°C	Identical
ExposureTime	6 minutes	6 minutes	Identical
Rinse waterpreparation	Hot potable tap water is:• pre-filtered• flowed through a UVLight treatment chamberto achieve ≥ a 6-logreduction of virus• Filtered throughredundant 0.1-micronfilter membranes	Hot potable tap water is:• pre-filtered• flowed through a UVLight treatment chamberto achieve ≥ a 6-logreduction of virus• Filtered throughredundant 0.1-micronfilter membranes	Identical
Number ofrinses	2	2	Identical
Air Purge	Aids in removing excesswater from instrument lumensafter rinsing	Aids in removing excesswater from instrument lumensafter rinsing	Identical
Water FilterIntegrityTest	Conducted at the end of everyliquid chemical sterilantprocessing cycle and duringthe Diagnostic cycle	Conducted at the end of everyliquid chemical sterilantprocessing cycle and duringthe Diagnostic cycle	Identical
ApproximateCycle time	25 minutes	25 minutes	Identical
Feature	ProposedSYSTEM 1E Processor	K170956SYSTEM 1E Processor	Comparison
DiagnosticCycle	Performs 15 tests onprocessor's systemsconfirming proper function(same tests as predicatedevice except for an addedUV monitor test).Recommended to performevery 24 hours. After a failedDiagnostic cycle, a liquidchemical sterilant processingcycle cannot be performeduntil the problem is rectifiedand a successful Diagnosticcycle has been completed.	Performs 15 tests onprocessor's systemsconfirming proper function(same tests as predicatedevice except for an addedUV monitor test).Recommended to performevery 24 hours. After a failedDiagnostic cycle, a liquidchemical sterilant processingcycle cannot be performeduntil the problem is rectifiedand a successful Diagnosticcycle has been completed.	Identical
	ProcessingTray /Containers	Uses interchangeableprocessing trays/containers• Universal FlexibleProcessing Tray (C1160E)• General ProcessingContainer/Tray (C1200)• Directed Flow ProcessingContainer/Tray (C1220)• Flexible EndoscopeProcessing Container / Tray(C1140)• Ultrasound Processing Tray(C3000XL)	Uses interchangeableprocessing trays/containers• Universal FlexibleProcessing Tray (C1160E)• General ProcessingContainer/Tray (C1200)• Directed Flow ProcessingContainer/Tray (C1220)• Flexible EndoscopeProcessing Container / Tray(C1140)• Ultrasound Processing Tray(C3000XL)	Identical
		AccessoriesSterilantConcentrate	Uses S40 SterilantConcentrate	Uses S40 SterilantConcentrate	Identical
			QuickConnects	Uses Quick Connects to adaptinstrument lumens to theTray/Container ports	Uses Quick Connects to adaptinstrument lumens to theTray/Container ports	Identical
		ChemicalIndicator	VERIFY Chemical Indicatorfor the SYSTEM 1EProcessor (K102217)	VERIFY Chemical Indicatorfor the SYSTEM 1EProcessor (K102217)	Identical
		Spore TestStrip	VERIFY Spore Test Strip forS40 Sterilant Concentrate(K100049)	VERIFY Spore Test Strip forS40 Sterilant Concentrate(K100049)	Identical
		OperatorMaintenanceRequirements	Periodic replacement ofprinter tape, water filters andair filter	Periodic replacement ofprinter tape, water filters andair filter	Identical
		Feature	ProposedS40 Sterilant Concentrate	K170956S40 Sterilant Concentrate	Comparison
Indications for Use	S40 Sterilant Concentrate is for use only with the SYSTEM 1E Liquid Chemical Sterilant Processing System	S40 Sterilant Concentrate is for use only with the SYSTEM 1E Liquid Chemical Sterilant Processing System	Identical
Germicidal claim	Liquid Chemical Sterilant	Liquid Chemical Sterilant	Identical
Germicide Exposure Time (min) for intended use	6	6	Identical
Use Temperature	45.5-60°C – allowable46-55°C - typicalPotency and simulated use evaluations conducted at $\le$ 43°C	45.5-60°C – allowable46-55°C - typicalPotency and simulated use evaluations conducted at $\le$ 43°C	Identical
Reuse	Single use	Single use	Identical
Human Factors	Dispensed ready to use.Container is opened and diluted by the processor, thus limiting user exposure to the active ingredient	Dispensed ready to useContainer is opened and diluted by the processor, thus limiting user exposure to the active ingredient	Identical
Active Ingredient	35% peroxyacetic (peracetic) acid automatically diluted for use in the SYSTEM 1E Processor.	35% peroxyacetic (peracetic) acid automatically diluted for use in the SYSTEM 1E Processor.	Identical
Mode of Action	It is believed that peracetic acid exerts its germicidal effect by several mechanisms:-oxidizing sulfhydryl and sulfur bonds in proteins and enzymes, particularly in the cell walls 1-hydroxyl radicals produced from PAA are bactericidal 2-PAA damages the viral capsid and viral nucleic acid3,4	It is believed that peracetic acid exerts its germicidal effect by several mechanisms:-oxidizing sulfhydryl and sulfur bonds in proteins and enzymes, particularly in the cell walls1-hydroxyl radicals produced from PAA are bactericidal2-PAA damages the viral capsid and viral nucleic acid3,4	Identical
Feature	Proposed	K170956	Comparison
	S40 Sterilant Concentrate	S40 Sterilant Concentrate
Rinses	Automatic, UV-irradiated,dual 0.1 micron filtered,potable hot water.	Automatic, UV-irradiated,dual 0.1 micron filtered,potable hot water.	Identical
Microbial Efficacy
SporicidalActivity ofDisinfectantsAOACOfficialMethod 966.04	Meets efficacyrequirements5.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacyrequirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Identical
ConfirmatorySporicidalActivity ofDisinfectantsAOACOfficialMethod 966.04	Meets efficacyrequirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacyrequirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Identical
FungicidalActivity ofDisinfectantsAOACOfficialMethod 955.17	Solution is fungicidal.TrichophytonmentagrophytesTesting conducted in vitro	Solution is fungicidal.TrichophytonmentagrophytesTesting 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 aeruginosaTesting conducted in vitro	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
Simulated-UseTest	Meets efficacy requirement.> 6 log reductionGeobacillus	Meets efficacy requirement.> 6 log reductionGeobacillus	Identical
Feature	Proposed	K170956	Comparison
	S40 Sterilant Concentratestearothermophilus spores in	S40 Sterilant Concentratestearothermophilus spores in
	a manual application	a manual application
Clinical In-Use	No survivingmicroorganisms onrepresentative medicaldevices tested	No survivingmicroorganisms onrepresentative medicaldevices tested	Identical
Biocompatibility
CytotoxicityDeviceExtracts	Two rinses with UV treated,dual 0.1-micron membranefiltered water effectivelyreduce sterilant residues tosafe levels.	Two rinses with UV treated,dual 0.1-micron membranefiltered water effectivelyreduce sterilant residues tosafe levels.	Identical
ResidueReduction	Automatic within theSYSTEM 1E Processor:Two rinses with UV treated,dual 0.1-micron membranefiltered water effectivelyreduce sterilant residues tosafe levels.	Automatic within theSYSTEM 1E Processor:Two rinses with UV treated,dual 0.1-micron membranefiltered water effectivelyreduce sterilant residues tosafe levels.	Identical
DeviceMaterialCompatibility	Compatible with medicaldevices as established bytesting finished flexibleendoscopes through 300cycles and rigid devicesthrough 150 cycles.No functional changes haveoccurred to flexible devices.Some materials showcosmetic changes such asfading of black anodizedaluminum without harm tothe base material.	Compatible with medicaldevices as established bytesting finished flexibleendoscopes through 300cycles and rigid devicesthrough 150 cycles.No functional changes haveoccurred to flexible devices.Some materials showcosmetic changes such asfading of black anodizedaluminum without harm tothe base material.	Identical
ChemicalMonitoring	VERIFY Chemical Indicatorfor the SYSTEM 1EProcessor(K102217)	VERIFY Chemical Indicatorfor the SYSTEM 1EProcessor(K102217)	Identical

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Table 6-2. S40 Sterilant Concentrate Device Comparison Table

No changes have been made to the S40 Sterilant Concentrate

1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.

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

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

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4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554.

5 McDonnell et al., J. AOAC International (2000) 83:269-276.

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Table 6-3 summarizes the verification activity that was performed with its respective acceptance criteria to ensure that this modification does not affect the safety or effectiveness of the SYSTEM 1E Liquid Chemical Sterilant Processing System.

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Test	Verification/ValidationActivity	Acceptance Criteria	Result
MaxPureFilteralternatesupplier	Accumulation of successfulliquid chemical sterilizationcycles and diagnostic cycles torepresent the filter's 3-monthsuse life.	The modification doesnot change the finalproduct releasespecifications	Pass
MaxPureFilteralternatesupplier	Evaluation of filter integrityby microbial retention challengebased on ASTM F838-15following the accumulation ofliquid chemical sterilizationcycles and diagnostic cyclesrepresenting 3 months use.	The modification doesnot change the finalproduct releasespecifications	Pass
Pre-filter Aand Balternatesupplier	Accumulation of successfulliquid chemical sterilizationcycles and diagnostic cycles torepresent the filter's 3-monthuse life.	The modification doesnot change the finalproduct releasespecifications	Pass
S40SterilantConcentrateAcid	Evaluation of the concentrationof peracetic acid over the shelflife.	The modification doesnot change the finalproduct releasespecifications	Pass
CapsuleAlternateResin andSupplier	Physical evaluation ofcompatibility of the alternateresin with container contents.	The container contentsare compatible withthe container packageand labeling	Pass

			Table 6-3. Summary of verification activities.
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6. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as the legally marketed predicate device (K170956), 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.