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.

2. 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 is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

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.

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 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. Seven 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 a proprietary component of S40 Sterilant Concentrate.

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 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.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System 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 current submission is provided to describe the addition of a second supplier for of a proprietary component of S40 Sterilant Concentrate.

The SYSTEM 1 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 SYSTEM 1 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 SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for the SYSTEM 1E Liquid Chemical Sterilant Processing System (K190104) and the SYSTEM 1 endo Liquid Chemical Sterilant Processing System (K190104). This submission describes modifications to the S40 Sterilant Concentrate used with these systems, specifically the addition of a second supplier for a proprietary component of the concentrate.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (K180342 for SYSTEM 1E and K173256 for SYSTEM 1 endo). As such, the studies described are verification tests for the modified component of the sterilant rather than a full stand-alone performance study of the entire device.

Here's the breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For S40 Sterilant Concentrate with alternate source of a proprietary component:

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility of S40 Sterilant Concentrate with alternate source of a proprietary component	Medical devices shall be non-cytotoxic after exposure to S40 Sterilant Concentrate containing the alternate source of a proprietary component	Pass
Stability of S40 Sterilant Concentrate with alternate source of a proprietary component	S40 Sterilant Concentrate shall meet acceptance criteria after 6-months of storage.	Pass

Study Details:

The document clearly states that "New testing was performed to evaluate the modified device," specifically referring to the change in the supplier for a component of the S40 Sterilant Concentrate. The provided tables are comparison tables with predicate devices, indicating that the overall system performance (effectiveness as a sterilant) for the proposed device is considered "identical" to the predicate devices which had already demonstrated efficacy through extensive testing. The new testing is therefore focused on verifying that the change in sterilant component supplier does not negatively impact the established performance.

For the Biocompatibility and Stability Tests (Table 3 on pages 16 and 28):

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the biocompatibility or stability tests regarding the alternate component.
- Data Provenance: The studies were "new testing" performed to evaluate the modified device, implying prospective testing for this specific change. The country of origin for the data is not specified, but the submission is to the US FDA, so it's likely part of US-based regulatory activities.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as these are laboratory-based physical/chemical/biological tests rather than expert interpretation of medical images or clinical data.
Adjudication method for the test set:
- Not applicable; these are objective laboratory tests with pre-defined pass/fail criteria.
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:
- Not applicable. This device is a liquid chemical sterilizer, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device for sterilization, not an algorithm. The "standalone" performance is implied by the "Pass" results of the biocompatibility and stability tests of the sterilant itself. The overall sterilization efficacy of the SYSTEM 1E and SYSTEM 1 endo Processors using S40 Sterilant is established through prior predicate device clearances and the underlying efficacy claims of the sterilant (e.g., sporicidal, fungicidal, bactericidal, virucidal, tuberculocidal activity, and simulated-use tests, summarised in the comparison tables as "Meets efficacy requirements").
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the new tests: The ground truth is laboratory-determined objective measurements against pre-defined regulatory and performance standards for biocompatibility (non-cytotoxicity) and chemical stability.
- For the overall device's sterilization efficacy (as implied by the identical comparison with predicate devices): This would have been established through a combination of in vitro microbiological assays (e.g., AOAC methods for sporicidal, fungicidal, bactericidal activity), in vitro virucidal testing (EPA method), simulated-use tests, and clinical in-use studies. The references to specific methods (e.g., AOAC Official Method 966.04) indicate standardized laboratory protocols are the ground truth.
The sample size for the training set:
- Not applicable in the context of this 510(k) submission, as it's not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

March 22, 2019

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

Re: K190104

Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo 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 5, 2019 Received: March 6, 2019

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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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.

Clarence W. Murray lii III -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) K190104

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.

2. 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 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)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Indications for Use

510(k) Number (if known) K190104

Device Name

SYSTEM 1 endo Liquid Chemical Sterilant Processing System

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)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is written in a serif font in black. Below the word is a graphic of several horizontal wavy lines in blue. The registered trademark symbol is in the upper right corner of the logo.

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

Summary Date: March 5, 2019

Premarket Notification Number: K190104

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

Predicate Device 2.

SYSTEM 1E Liquid Chemical Sterilant Processing System, K180342

3. Description of Device

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Indications for Use 4.

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. Technological Characteristic Comparison Table

The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device; the specific modification described in this submission is for an alternate supplier for a component of S40 Sterilant Concentrate. The differences between the proposed and predicate devices are limited to the addition of an alternate supplier for a proprietary component of S40 Sterilant Concentrate.

There were no changes to the SYSTEM 1E Processor.

Feature	Proposed DeviceSYSTEM 1E Processor	Predicate DeviceSYSTEM 1E Processor(K180432)	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°C, 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 Processoruses only S40 Sterilant	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°C, 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 Processoruses only S40 Sterilant	Identical
	Concentrate to liquidchemically sterilize medical	Concentrate to liquidchemically sterilize medical
Feature	Proposed DeviceSYSTEM 1E Processor	Predicate DeviceSYSTEM 1E Processor(K180432)	Comparison
	devices.	devices.
	* 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 virus	* 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 virus
	is delivered to the	is delivered to the
	water.	water.
	3.0.1-micron	3.0.1-micron
	filtration:	filtration:
	• The water prepared by	• The water prepared by
	pre-filtration and UVirradiation is filtered	pre-filtration and UVirradiation is filtered
	through redundant,	through redundant,
	0.1-micron (absolute	0.1-micron (absolute
	rated) membranes to	rated) membranes to
	remove bacteria, fungi	remove bacteria, fungi
	and protozoa > 0.1	and protozoa > 0.1
	micron.	micron.
Feature	Proposed DeviceSYSTEM 1E Processor	Predicate DeviceSYSTEM 1E Processor(K180432)	Comparison
OperatingPrinciples/Technology	A microprocessor controlledunit with interchangeableprocessing trays/containers.The processor lid opens toreveal the processingchamber in which the load isplaced. Devices with internallumens are interfaced with theprocessor using connectors.Sterilant Concentrate isplaced in a specializedcompartment and when theprocessor fills with water, itcreates the sterilant usedilution from the single usesterilant cup. The processormonitors and controls the usedilution temperature andcontact time. The processorautomatically rinses the loadwith extensively treated waterto remove sterilant residuals.	A microprocessor controlledunit with interchangeableprocessing trays/containers.The processor lid opens toreveal the processingchamber in which the load isplaced. Devices with internallumens are interfaced with theprocessor using connectors.Sterilant Concentrate isplaced in a specializedcompartment and when theprocessor fills with water, itcreates the sterilant usedilution from the single usesterilant cup. The processormonitors and controls the usedilution temperature andcontact time. The processorautomatically rinses the loadwith extensively treated waterto remove sterilant residuals.	Identical
ProcessParameters	Standardized cycleparameters cannot be alteredby operator. The criticalprocess parameters are:• Contact Time• Use Dilution• Temperature• Peracetic acidconcentration• Bacterial retentive waterfilter integrity• UV irradiation	Standardized cycleparameters cannot be alteredby operator. The criticalprocess parameters are:• Contact Time• Use Dilution• Temperature• Peracetic acidconcentration• Bacterial retentive waterfilter integrity• UV irradiation	Identical
ProcessMonitors	• Cycle Printoutdocuments successfulcycle completion oridentifies fault if cycleaborts• Alarms if thermocouplesindicate temperature outof specification• Alarms if pressureswitch indicates thathigh pressure pump isnot operating	• Cycle Printoutdocuments successfulcycle completion oridentifies fault if cycleaborts• Alarms if thermocouplesindicate temperature outof specification• Alarms if pressureswitch indicates thathigh pressure pump isnot operating	Identical
Feature	Proposed DeviceSYSTEM 1E Processor	Predicate DeviceSYSTEM 1E Processor(K180432)	Comparison
	Alarms if conductivity 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	Alarms if conductivity 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
DesignFeatures	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.	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 startexposure	$\geq 46°C$	$\geq 46°C$	Identical
Feature	Proposed DeviceSYSTEM 1E Processor	Predicate DeviceSYSTEM 1E Processor(K180432)	Comparison
phase
Temperaturealarm pointduring theexposurephase	<45.5 or >60°C	<45.5 or >60°C	Identical
Temperaturerange during atypical LiquidChemicalSterilantProcessingCycle	46 - 55°C	46 - 55°C	Identical
ExposureTime	6 minutes	6 minutes	Identical
Rinse waterpreparation	Hot potable tap water is:pre-filteredflowed through a UVLight treatment chamberto achieve ≥ a 6-logreduction of virusFiltered throughredundant 0.1-micronfilter membranes	Hot potable tap water is:pre-filteredflowed through a UVLight treatment chamberto achieve ≥ a 6-logreduction of virusFiltered 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 FilterIntegrity Test	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	Proposed DeviceSYSTEM 1E Processor	Predicate DeviceSYSTEM 1E Processor(K180432)	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
Interchangeable Components
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
Accessories
SterilantConcentrate	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	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K180432)	Comparison
Indications forUse	S40 Sterilant Concentrate isfor use only with theSYSTEM 1E LiquidChemical SterilantProcessing System	S40 Sterilant Concentrate isfor use only with theSYSTEM 1E LiquidChemical SterilantProcessing System	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 anddiluted by the processor,thus limiting user exposureto the active ingredient	Dispensed ready to useContainer is opened anddiluted by the processor,thus limiting user exposureto the active ingredient	Identical
ActiveIngredient	35% peroxyacetic (peracetic)acid automatically dilutedfor use in the SYSTEM 1EProcessor.	35% peroxyacetic (peracetic)acid automatically dilutedfor use in the SYSTEM 1EProcessor.	Identical
Mode ofAction	It is believed that peraceticacid exerts its germicidaleffect by severalmechanisms:-oxidizing sulfhydryl andsulfur bonds in proteins andenzymes, particularly in thecell walls 1-hydroxyl radicals producedfrom PAA are bactericidal 2-PAA damages the viralcapsid and viral nucleicacid3,4.	It is believed that peraceticacid exerts its germicidaleffect by severalmechanisms:-oxidizing sulfhydryl andsulfur bonds in proteins andenzymes, particularly in thecell walls1-hydroxyl radicals producedfrom PAA are bactericidal2-PAA damages the viralcapsid and viral nucleicacid3,4	Identical
Rinses	Automatic, UV-irradiated,dual 0.1 micron filtered	Automatic, UV-irradiated,dual 0.1 micron filtered	Identical
Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K180432)	Comparison
potable hot water.
Microbial EfficacySporicidalActivity 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 reductionGeobacillusstearothermophilus spores ina manual application	Meets efficacy requirement.> 6 log reductionGeobacillusstearothermophilus spores ina manual application	Identical
							Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K180432)	Comparison
							Clinical In-Use	No survivingmicroorganisms onrepresentative medicaldevices tested	No survivingmicroorganisms onrepresentative medicaldevices tested	Identical
	Biocompatibility
CytotoxicityDevice Extracts	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 S40 Sterilant (K173428)	VERIFY Chemical Indicatorfor the SYSTEM 1EProcessor (K102217)	K173428included useof the CI(with namechange) in theSYSTEM 1endoLCSPS.Notechnologicalcharacteristicschanged.

Table 1. Processor Device Comparison Table

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Table 2. S40 Sterilant Concentrate Device Comparison Table

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.

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

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

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The proposed device and its predicate have identical intended use and technological characteristics. New testing was performed to evaluate the modified device and the results are summarized in Table 3.

Test	Acceptance Criteria	Result
Biocompatibility of S40Sterilant Concentratewith alternate source of aproprietary component	Medical devices shall be non-cytotoxicafter exposure to S40 SterilantConcentrate containing the alternatesource of a proprietary component	Pass
Stability of S40 SterilantConcentrate withalternate source of aproprietary component	S40 Sterilant Concentrate shall meetacceptance criteria after 6-months ofstorage.	Pass

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

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 or better than the legally marketed predicate device (K180342).

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Image /page/17/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is written in a serif font in all caps. Below the word is an image of several horizontal wavy lines stacked on top of each other. The lines are blue.

510(k) Summary For SYSTEM 1 endo 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 5, 2019 Summary Date:

Premarket Notification Number: K190104

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1. Device Name

Trade Name:	SYSTEM 1 endo Liquid Chemical SterilanProcessing System
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, K173256. Reference Device: SYSTEM 1 endo Liquid Chemical Sterilant Processing System (Model 6900), K182827

3. Description of Device

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required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Table 1 compares the proposed and predicate devices.

Indications for Use 4.

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

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

ട. Technological Characteristic Comparison Table

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is the same as the predicate device; the specific modification described in this submission is for an alternate supplier for a component of S40 Sterilant Concentrate. The differences between the proposed and predicate devices are limited to the addition of an alternate supplier for of a proprietary component of S40 Sterilant Concentrate.

The similarities and differences between the proposed and predicate devices are identified in Table 1 and Table 2 below.

Feature	Proposed DeviceSYSTEM 1 endo Processor	Predicate DeviceSYSTEM 1 endo Processor(K173256)	Comparison
IntendedUseIndicationsfor Use	The SYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization ofcleaned, immersible, andreusable semi-critical heat-sensitive medical devices andtheir accessories in healthcarefacilities.	The SYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization ofcleaned, immersible, andreusable semi-critical heat-sensitive medical devices andtheir accessories in healthcarefacilities.	Identical
	The SYSTEM 1 endoProcessor automatically dilutesthe S40 Sterilant Concentrateto its use dilution (> 1820	The SYSTEM 1 endoProcessor automaticallydilutes the S40 SterilantConcentrate to its use dilution
Feature	Proposed DeviceSYSTEM 1 endo Processor	Predicate DeviceSYSTEM 1 endo Processor(K173256)	Comparison
	mg/L peracetic acid), liquidchemically sterilizes the loadduring a controlled 6-minuteexposure at 45.5 to 60°C, andrinses the load with 0.2 micronfiltered water.The SYSTEM 1 endo	(> 1820 mg/L peracetic acid),liquid chemically sterilizesthe load during a controlled6-minute exposure at 45.5 to60°C, and rinses the load with0.2 micron filtered water.The SYSTEM 1 endo
	Processor uses only S40Sterilant Concentrate to liquidchemically sterilize medicaldevices.	Processor uses only S40Sterilant Concentrate to liquidchemically sterilize medicaldevices.
OperatingPrinciples/Technology	A microprocessor controlledunit with interchangeableprocessing trays/containers.The processor lid opens toreveal the processing chamberin which the load is placed.Devices with internal lumensare interfaced with theprocessor using connectors,i.e. Quick Connects.S40 Sterilant is placed in aspecialized compartment andwhen the processor fills withwater, it creates the sterilantuse dilution from the singleuse sterilant cup.The processor monitors andcontrols the use dilutiontemperature and contact time.The processor automaticallyrinses the load with 0.2 micronfiltered water to removesterilant residuals.	A microprocessor controlledunit with interchangeableprocessing trays/containers.The processor lid opens toreveal the processingchamber in which the load isplaced.Devices with internal lumensare interfaced with theprocessor using connectors,i.e. Quick Connects.S40 Sterilant is placed in aspecialized compartment andwhen the processor fills withwater, it creates the sterilantuse dilution from the singleuse sterilant cup.The processor monitors andcontrols the use dilutiontemperature and contact time.The processor automaticallyrinses the load withextensively treated filteredwater to remove sterilantresiduals.	Identical
ProcessParameters	Standardized cycle parameterscannot be altered by operator.The critical process parametersare:• Use dilution contact time• Use dilution temperature• Peracetic acidconcentration	Standardized cycleparameters cannot be alteredby operator. The criticalprocess parameters are:• Use dilution contact time• Use dilution temperature• Peracetic acidconcentration	Identical
Feature	Proposed DeviceSYSTEM 1 endo Processor	Predicate DeviceSYSTEM 1 endo Processor(K173256)	Comparison
	• Integrity of the internalwater filter (tested by thesystem)	• Integrity of the internalwater filter (tested by thesystem)
ProcessMonitors:	• Cycle Printout documentssuccessful cyclecompletion or identifiesfault if cycle aborts• Alarms if thermocouplesindicate temperature out ofspecification• Alarms if pressure switchindicates that high pressurepump is not operating• Alarms if conductivityprobe indicatedconductivity specificationnot met• Alarms if pressuretransducer indicatescirculation pressure is outof specification inDiagnostic cycle• Alarms if pressuretransducer indicatesinternal water filter failedintegrity test	• Cycle Printout documentssuccessful cyclecompletion or identifiesfault if cycle aborts• Alarms if thermocouplesindicate temperature outof specification• Alarms if pressure switchindicates that highpressure pump is notoperating• Alarms if conductivityprobe indicatedconductivity specificationnot met• Alarms if pressuretransducer indicatescirculation pressure is outof specification inDiagnostic cycle• Alarms if pressuretransducer indicatesinternal water filter failedintegrity test	IdenticalIn theReferenceDevice,K182827,cycle recordsare electronic
DesignFeatures	• Microprocessor controlledunalterable andstandardized liquidchemical sterilization andDiagnostic cycles• Intended for use only withS40 Sterilant Concentrate• Automated dilution anddelivery of S40 Sterilant• Processor provides 0.2micron filtered water forliquid chemicalsterilization and rinsing	• Microprocessor controlled unalterable and standardized liquid chemical sterilization and Diagnostic cycles • Intended for use only with S40 Sterilant Concentrate • Automated dilution and delivery of S40 Sterilant • Processor provides 0.2 micron filtered water for liquid chemical sterilization and rinsing	IdenticalAdditionaldesignfeatures arepart of theReferenceDevice inK182827:Thereferencedevice usesan updatedcontroller
Feature	Proposed DeviceSYSTEM 1 endo Processor	Predicate DeviceSYSTEM 1 endo Processor(K173256)	Comparison
	Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter Has no barcode scanner, employs a membrane touch panel interface and small display, has no USB drive. Includes an onboard printer for cycle information	Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter Has no barcode scanner, employs a membrane touch panel interface and small display, has no USB drive. Includes an onboard printer for cycle information	and its respective software for identical processing parameters.The proposed device uses an updated touchscreen display, has a barcode reader and USB drive for electronic cycle records, and facilitates use of a web-based data mgmt system.Use of printer is optional.
Cycle Parameters			Comparison
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 water	Hot potable tap water	Hot potable tap water	Identical
Feature	Proposed DeviceSYSTEM 1 endo Processor	Predicate DeviceSYSTEM 1 endo Processor(K173256)	Comparison
preparation	is pre-filtered is filtered through 0.2 micron bacterial retentive membrane filter	is pre-filtered is filtered through 0.2 micron bacterial retentive membrane filter
Number ofrinses	2	2	Identical
Air Purge	Aids in removing excess waterfrom instrument lumens afterrinsing	Aids in removing excesswater from instrument lumensafter rinsing	Identical
InternalWater FilterIntegrityTest	Conducted during theDiagnostic cycle	Conducted during theDiagnostic cycle	Identical
ApproximateCycle Time	18 - 20 minutes	18 - 20 minutes	Identical
DiagnosticCycle	Performs 14 tests onprocessor's systemsconfirming proper function.Recommended to performeach day of use. After a failedDiagnostic cycle, a liquidchemical sterilization cyclecannot be performed until theproblem is rectified and asuccessful Diagnostic cyclehas been completed.	Performs 14 tests onprocessor's systemsconfirming proper function.Recommended to performeach day of use. After a failedDiagnostic cycle, a liquidchemical sterilization cyclecannot be performed until theproblem is rectified and asuccessful Diagnostic cyclehas been completed.	Identical
Accessories
Sterilant	Uses S40 Sterilant Concentrate- see Table 2	Uses S40 SterilantConcentrate - see Table 2	Identical
ProcessingTrays andContainers	Uses interchangeableprocessing trays/containers Universal Flex Processing Tray General Processing Container & Tray Directed Flow Processing Container & Tray Flexible Endoscope Processing Container & Tray Ultrasound Processing Tray	Uses interchangeableprocessing trays/containers Universal Flex Processing Tray General Processing Container & Tray Directed Flow Processing Container & Tray Flexible Endoscope Processing Container & Tray Ultrasound Processing Tray	Identical
QuickConnects	Uses Quick Connects to attachinstrument lumens to the	Uses Quick Connects toattach instrument lumens to	Identical
Feature	Proposed DeviceSYSTEM 1 endo Processor	Predicate DeviceSYSTEM 1 endo Processor(K173256)	Comparison
	Tray/Container ports	the Tray/Container ports
ChemicalIndicator	VERIFY Chemical Indicatorfor S40 Sterilant is availablefor use in SYSTEM 1 endoLCSPS	VERIFY Chemical Indicatorfor S40 Sterilant is availablefor use in SYSTEM 1 endoLCSPS	Identical
Spore TestStrip	VERIFY Spore Test Strip forS40 Sterilant for use inSYSTEM 1 endo LCSPS	VERIFY Spore Test Strip forS40 Sterilant for use inSYSTEM 1 endo LCSPS	Identical
OperatorMaintenance	Periodic replacement of waterfilters and air filter.Periodic replacement ofprinter tape.	Periodic replacement of waterfilters and air filter.Periodic replacement ofprinter tape.	IdenticalIn ReferenceDeviceK182827, theprinter is anexternaloption.

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

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

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

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5 McDonnell et al., J. AOAC International (2000) 83:269-275

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Test	Acceptance Criteria	Result
Biocompatibility of S40Sterilant Concentrate withalternate source of aproprietary component	Medical devices shall be non-cytotoxicafter exposure to S40 SterilantConcentrate containing the alternatesource of a proprietary component	Pass
Stability of S40 SterilantConcentrate withalternate source of aproprietary component	S40 Sterilant Concentrate shall meetacceptance criteria after 6-months ofstorage.	Pass

Table 3. Summary of Verification Testing

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 or better than the legally marketed predicate device (K173256).

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	S40 Sterilant Concentratein S1 endo LCSPS	S40 Sterilant Concentratein S1 endo LCSPS(K173256)	Comparison
Intended Use	For use in S1E or S1 endoLCSPS	For use in S1E or S1 endoLCSPS	Identical
Germicidalclaim	Liquid Chemical Sterilant	Liquid Chemical Sterilant	Identical
ExposureTime	6 minutes	6 minutes	Identical
UseTemperature	45.5 - 60°C - allowable rangePotency and simulated useevaluations conducted at ≤43°C	45.5 - 60°C - allowable rangePotency and simulated useevaluations conducted at ≤43°C	Identical
Reuse	Single use	Single use	Identical
HumanFactors	Ready to use. Container isopened and diluted by theprocessor, limiting userexposure to the sterilantconcentrate	Ready to use. Container isopened and diluted by theprocessor, limiting userexposure to the sterilantconcentrate	Identical
ActiveIngredient	35% peroxyacetic (peracetic)acid automatically diluted foruse in the Processor	35% peroxyacetic (peracetic)acid automatically diluted foruse in the Processor	Identical
Mode ofAction	It is believed that peraceticacid exerts its germicidaleffect by severalmechanisms:-oxidizing sulfhydral andsulfur bonds in proteins andenzymes, particularly in thecell walls 1-hydroxyl radicals producedfrom PAA are bactericidal 2-PAA damages the viralcapsid and viral nucleicacid3,4	It is believed that peraceticacid exerts its germicidaleffect by severalmechanisms:-oxidizing sulfhydral andsulfur bonds in proteins andenzymes, particularly in thecell walls1-hydroxyl radicals producedfrom PAA are bactericidal2-PAA damages the viralcapsid and viral nucleicacid3.4	Identical
	Rinses	2 equivalent automated rinseswith pre-filtered, dual 0.2micron membrane filtered,potable hot water	2 equivalent automated rinseswith pre-filtered, dual 0.2micron membrane filtered,potable hot water
Feature	S40 Sterilant Concentratein S1 endo LCSPS	S40 Sterilant Concentratein S1 endo LCSPS(K173256)	Comparison
SporicidalActivity ofDisinfectantsAOACOfficialMethod966.04	Meets efficacy requirements5Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacy requirements5Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Identical
ConfirmatorySporicidalActivity ofDisinfectantsAOACOfficialMethod966.04	Meets efficacy requirements5Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacy requirements5Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Identical
FungicidalActivity ofDisinfectantsAOACOfficialMethod955.17	Solution is fungicidalTrichophytonmentagrophytesTesting conducted in vitro	Solution is fungicidalTrichophyton mentagrophytesTesting conducted in vitro	Identical
Use DilutionMethodAOAC,OfficialMethods955.14,955.15, 964.02	Solution is bactericidalSalmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosaTesting conducted in vitro	Solution is bactericidalSalmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosaTesting conducted in vitro	Identical
EPA VirucidalTesting(DIS/TSS-7,Nov. 1981)	Solution is virucidalHerpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro	Solution is virucidalHerpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro	Identical
TuberculocidalActivity ofDisinfectantsAOACOfficialMethod965.12	Not performed; a quantitativesuspension Tuberculocidaltest was conducted	Not performed; a quantitativesuspension Tuberculocidaltest was conducted	Identical
Feature	S40 Sterilant Concentratein S1 endo LCSPS	S40 Sterilant Concentratein S1 endo LCSPS(K173256)	Comparison
TuberculocidalActivityAscenziQuantitativeSuspensionTest	Solution is tuberculocidalMycobacterium terraetesting conducted in vitro	Solution is tuberculocidalMycobacterium terraetesting conducted in vitro	Identical
Simulated Use	Meets efficacy requirement.>= 6 log10 reductionGeobacillusstearothermophilus spores ina manual application.	Meets efficacy requirement.> 6 log10 reductionGeobacillusstearothermophilus spores ina manual application.	Identical
Clinical In Use	No surviving microorganismson representative medicaldevices tested in S1 endoLCSPS	No surviving microorganismson representative medicaldevices tested in S1 endoLCSPS	Identical
CytotoxicityDeviceExtracts	Two Processor controlledrinses with pre-filtered, dual0.2 micron filtered potablewater effectively reducesterilant residues to non-cytotoxic levels.	Two Processor controlledrinses with pre-filtered, dual0.2 micron filtered potablewater effectively reducesterilant residues to non-cytotoxic levels.	Identical
ResidueReduction	Two Processor controlledrinses with pre-filtered, dual0.2 micron filtered potablewater effectively reducesterilant residues to safelevels.	Two Processor controlledrinses with pre-filtered, dual0.2 micron filtered potablewater effectively reducesterilant residues to safelevels.	Identical
MaterialCompatibility	Compatible with medicaldevices as established bytesting finished medicaldevices through 300 cycles.No functional changesoccurred to devices. Somematerials show cosmeticchanges such as fading ofexternal markings (yet allremained legible) andbleaching of black anodizedaluminum without harm tothe base material.	Compatible with medicaldevices as established bytesting finished medicaldevices through 300 cycles.No functional changesoccurred to devices. Somematerials show cosmeticchanges such as fading ofexternal markings (yet allremained legible) andbleaching of black anodizedaluminum without harm tothe base material.	Identical