SYSTEM 1.5 STERILE PROCESSING SYSTEM by STERIS Corporation

The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heatsensitive 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 6minute exposure at 46 to 55℃, and rinses the load with extensively treated* potable water. The processed load should be used immediately.

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 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants.
  - · Pre-filter 2 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:

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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.

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 SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following the 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 system, and then through two 0.1 micron 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 IE Processor. The active ingredient in S40, peracetic acid, is combined with inert ingredients 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 ensure thorough circulation of the sterilant solution and rinses.

AI/ML Overview

The acceptance criteria and study proving the device meets these criteria are detailed below, based on the provided text for the SYSTEM 1E Liquid Chemical Sterilant Processing System.

Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (SYSTEM 1E Processor)	Reported Device Performance (S40 Sterilant Concentrate)
Indications for Use (Sterilization Efficacy)	Liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices.	S40 Sterilant Concentrate achieves liquid chemical sterilization within a controlled 6-minute exposure at 46 to 55°C.
Exposure Time (Germicide)	6 minutes	6 minutes (for liquid chemical sterilant claim)
Use Temperature	Allowable: 45.5-60°C; Typical: 46-55°C	Potency and simulated use evaluations conducted at <43°C (indicating the sterilant remains effective even below the typical operating range to ensure robustness). Operating temperature range 46-55°C.
Incoming Water Temperature	≥43°C	Meets ≥43°C
Temperature to start sterilant exposure	≥46°C	Meets ≥46°C
Sterilant Concentration	≥1820 mg/L peracetic acid (after dilution)	Achieved automatically by the processor.
Rinsing Effectiveness (Sterilant Residue Reduction)	Two rinses with UV-treated, dual 0.1 micron membrane filtered water effectively reduce sterilant residues to safe levels; no surviving microorganisms on representative medical devices tested. (Biocompatibility/Cytotoxicity test)	Effectively reduces sterilant residues to safe levels. No surviving microorganisms on representative medical devices tested (Clinical In-Use). Cytotoxicity Device Extracts: Two rinses with UV treated, dual 0.1 micron membrane filtered water effectively reduces sterilant residues to safe levels.
Water Filter Integrity	Dual membrane, 0.1 micron water filter integrity (monitored and alarmed if failed).	Monitored during every liquid chemical sterilization cycle and Diagnostic cycle; alarms if failed.
UV Irradiation Effectiveness (Water Treatment)	UV dose sufficient to achieve a > 6-log reduction of MS2 virus for rinse water.	Achieved for water pre-filtration and UV irradiation; alarms if UV monitor indicates UV intensity out of specification.
Sporicidal Activity	Meets efficacy requirements for Bacillus subtilis and Clostridium sporogenes (≥ 6 log10 reduction of Geobacillus stearothermophilus spores in simulated-use test).	Demonstrated in vitro (AOAC Official Method 966.04) and via simulated-use test (≥ 6 log10 reduction Geobacillus stearothermophilus spores). Meets efficacy requirements.
Fungicidal Activity	Solution is fungicidal for Trichophyton mentagrophytes.	Solution is fungicidal. Trichophyton mentagrophytes (in vitro).
Bactericidal Activity	Solution is bactericidal for Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa.	Solution is bactericidal. Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa (in vitro).
Virucidal Activity	Solution is virucidal for Herpes simplex Type 1, Adenovirus Type 5, Poliovirus Type 1.	Solution is virucidal. Herpes simplex Type 1, Adenovirus Type 5, Poliovirus Type 1 (in vitro).
Tuberculocidal Activity	Solution is tuberculocidal for Mycobacterium terrae (quantitative suspension test).	Solution is tuberculocidal. Mycobacterium terrae (in vitro).
Device Material Compatibility (Endurance)	Compatible with medical devices (flexible endoscopes through 300 cycles, rigid devices through 150 cycles) without functional changes.	Flexible endoscopes compatible through 300 cycles, rigid devices through 150 cycles. No functional changes occurred to flexible devices. Cosmetic changes (fading of black anodized aluminum) noted without harm to base material.
Approximate Cycle Time	~25 minutes	25 minutes
Diagnostic Cycle	Performs 15 tests on processor's systems; recommended every 24 hours. Prevents liquid chemical sterilization cycle after failure until rectified.	Performs 15 tests on processor's systems confirming proper function (same as predicate with added UV monitor test). Recommended to perform every 24 hours. Prevents liquid chemical sterilization processing cycle after failure.

Study Details

The provided document describes the STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System and its sterilant, S40 Sterilant Concentrate. The evaluation is a substantial equivalence determination based on comparison to predicate devices, supported by non-clinical and clinical tests.

Sample Size used for the test set and the data provenance:
- Simulated-Use Test: The document mentions "Simulated-Use Test Meets efficacy requirement. ≥ 6 log10 reduction Geobacillus stearothermophilus spores." However, the exact sample size (number of devices, test runs) for these simulated-use tests is not explicitly stated.
- Clinical In-Use: "No surviving microorganisms on representative medical devices tested." The number of "representative medical devices" is not specified.
- Device Material Compatibility: Tested "finished flexible endoscopes through 300 cycles and rigid devices through 150 cycles." This implies a sample size of at least one flexible endoscope and one rigid device, subjected to these cycle counts.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given STERIS Corporation is based in Mentor, OH, USA, and the submission is to the FDA, it is highly likely the studies were conducted in the USA. The studies are prospective in nature, as they are specifically conducted to demonstrate the efficacy and safety of the new device for regulatory clearance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For sterilization efficacy studies, the "ground truth" is typically established by laboratory methods (e.g., enumeration of surviving microorganisms after exposure to sterilant) which are objectively measurable, rather than through expert consensus. Experts would be involved in designing and executing these studies and interpreting results, but not necessarily "establishing ground truth" in the sense of consensus on an image or clinical finding.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretations (e.g., radiology image readings). This type of method is not applicable to the objective microbial inactivation or material compatibility tests described for this sterilant system.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with or without AI assistance, which is irrelevant for a device that performs automated sterilization. The studies here are focused on the device's intrinsic ability to achieve sterilization and material compatibility.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done. The entire premise of the document describes the performance of the SYSTEM 1E Processor and S40 Sterilant Concentrate as a fully automated system for liquid chemical sterilization (an "algorithm only" in the context of device function). The efficacy claims (sporiciadal, fungicidal, virucidal, bactericidal, tuberculocidal, simulated-use, clinical in-use, material compatibility) are all based on the device's performance without human intervention in the sterilization process itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used for efficacy claims is based on microbiological assays (e.g., colony-forming unit counts for log reduction) and physicochemical measurements (e.g., temperature, concentration, filter integrity, visual inspection for material changes/damage).
- Specifically:
  - Sterilization Efficacy: Direct measurement of microbial inactivation (log reduction) for various microorganisms (Bacillus subtilis, Clostridium sporogenes, Geobacillus stearothermophilus, Trichophyton mentagrophytes, Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa, Herpes simplex Type 1, Adenovirus Type 5, Poliovirus Type 1, Mycobacterium terrae). This is a direct, objective method.
  - Residue Reduction/Biocompatibility: Likely analytical measurements of residual chemicals and cytotoxicity tests.
  - Material Compatibility: Visual and functional inspection of devices after multiple cycles.
The sample size for the training set:
- Training sets are primarily associated with machine learning or AI algorithm development. Since this device is an automated chemical sterilizer, there is no "training set" in the context of AI. The development process would involve iterative design, testing, and refinement, but not in the sense of a machine learning training set.
How the ground truth for the training set was established:
- As there is no AI "training set," this question is not applicable. The underlying scientific principles and performance parameters for chemical sterilization are established through decades of microbiology and engineering research, which guide the design and testing of such devices.

Summary

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Appendix 2

APR - 5 2010

Revised 510(k) Summary

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

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Contact:

Peter A. Burke, Ph. D. Senior Vice President and Chief Technology Officer Tel: 440-392-7787 Fax: 440-392-8978

Summary Date: April 1, 2010

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
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

STERIS SYSTEM 1 PROCESSOR and STERIS 20 STERILANT, K875280, cleared September 13, 1988.

Sterilox Liquid Chemical High Level Disinfection System, K013280, cleared September 18, 2002

Description of Device 3.

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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 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 46 to 55°C, and rinses the load with extensively treated* potable water. The processed load should be used immediately.

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 1 is a gross depth filter that removes approximately 5 micron . or larger particles/contaminants.
  - Pre-filter 2 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.

Description of Safety and Substantial Equivalence ડ.

The SYSTEM 1E Processor and S40 Sterilant Concentrate are substantially equivalent in function and intended use to the STERIS SYSTEM 1 and STERIS 20 Sterilant and Sterilox Liquid Chemical High Level Disinfection System.

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Device Comparison Table

Feature	SYSTEM 1E Processor	SYSTEM 1 Processor(K875280)
Indications for Use	The SYSTEM 1E Liquid ChemicalSterilant Processing System is intendedfor liquid chemical sterilization ofcleaned, immersible, and reusablecritical and semi-critical heat-sensitivemedical devices in healthcare facilities.The SYSTEM 1E Processorautomatically dilutes the S40 SterilantConcentration to its use dilution (≥1820mg/L peracetic acid) and liquidchemically sterilizes the load during acontrolled 6-minute exposure at 46 to55°C and rinses the load withextensively treated potable water. Theprocessed load should be usedimmediately.The SYSTEM 1E Processor uses onlyS40 Sterilant Concentrate to liquidchemically sterilize medical devices.	The SYSTEM 1 is a liquid chemicalsterilization system used for the rapidliquid chemical sterilization of cleanreusable immersible medical devicessuch as flexible and rigid endoscopes,and other medical and dental devicesin hospitals, medical, surgical anddental clinics/offices.
OperatingPrinciples/Technology	A microprocessor controlled unit with interchangeable processingtrays/containers. The processor lid opens to reveal the processing chamber inwhich the load is placed. Devices with internal lumens are interfaced with theprocessor using connectors. Sterilant is placed in a specialized compartment andwhen the processor fills with water, it creates the sterilant use dilution from thesingle use sterilant cup. The processor monitors and controls the use dilutiontemperature and contact time. The processor automatically rinses the load withextensively treated potable water to remove sterilant residuals.
Process Parameters	Standardized cycle parameters cannotbe altered by operator. The criticalprocess parameters are:● Contact Time● Use Dilution Temperature● Peracetic acid concentration● Dual membrane, 0.1 micron waterfilter integrity● UV irradiation	Standardized cycle parameters cannotbe altered by operator. The criticalprocess parameters are:● Contact Time● Use Dilution Temperature● Peracetic acid concentration● 0.2 micron water filter integrity
Feature	SYSTEM 1E Processor	SYSTEM 1 Processor(K875280)
Process Monitors:	Cycle Printout documents successful cycle completion or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates dual membrane 0.1 micron water filter failed integrity test during liquid chemical sterilization processing and Diagnostic cycles Alarms if UV monitor indicates UV intensity out of specification	Cycle Printout documents successful cycle completion or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates sterile water filter failed integrity test during Diagnostic cycle
Design Features	Microprocessor controlled unalterable and standardized liquid chemical sterilization and diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron membrane filtered, UV treated water for liquid chemical sterilization 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 sterilization and diagnostic cycles Intended for use with STERIS 20 Sterilant Concentrate only. Processor provides 0.2 micron filtered water for liquid chemical sterilization 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.
Liquid Chemical Sterilization Cycle
Incoming watertemperature	$\geq 43°C$	$\geq 42°C$
Temperature tostart sterilantexposure	$\geq 46°C$	$\geq 50°C$
Temperature alarmpoint during thesterilant exposure	<45.5 or >60°C	<50 or >60°C
Feature	SYSTEM 1E Processor	SYSTEM 1 Processor(K875280)
Temperature range during a typicalLiquid Chemical Sterilization Cycle	46 - 55°C	50 - 55°C
Sterilant Exposure Time	6 minutes	12 minutes
Rinse water preparation	Hot potable tap water is:• pre-filtered• flown through a UV Light treatment chamber to achieve ≥ a 6-log reduction of MS2 virus• Filtered through redundant 0.1 micron filter membranes	Hot potable tap water is:• pre-filtered• Filtered through 0.2 micron filter membrane
Number of rinses	2	4
Air Purge	Aids in removing excess water from instrument lumens after rinsing
Water Filter Integrity Test	Conducted at the end of every liquid chemical sterilization s cycle and during the Diagnostic cycle	Conducted during the Diagnostic cycle only
Approximate Cycle time	25 minutes	30 minutes
Diagnostic Cycle	Performs 15 tests on processor's systems confirming proper function (same tests as predicate device except for an added UV monitor test). Recommended to perform every 24 hours. After a failed Diagnostic cycle a liquid chemical sterilization processing cycle can not be performed until the problem is rectified and a successful Diagnostic cycle has been completed.	Performs 14 tests on processor's systems confirming proper function. Recommended to perform every 24 hours. After a failed Diagnostic cycle a liquid chemical sterilization processing cycle can not be performed until the problem is rectified and a successful Diagnostic cycle has been completed.
Accessories
Sterilant	Uses S40 Sterilant Concentrate (see Table 5-2 for predicate comparison)	Uses STERIS 20 Sterilant
Processing Tray/Containers	Uses interchangeable processing trays/containers
Quick Connects	Uses Quick Connects to adapt instrument lumens to the Tray/Container ports
Operator Maintenance Requirements	Periodic replacement of printer tape, water filters and air filter

Table 5-1. Processor Device Comparison Table

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Feature	S40 SterilantConcentrate	STERIS 20STERILANT(K875280)	Sterilox LiquidChemical HLD System(013280)
Indications for Use	S40 SterilantConcentrate is for useonly with the SYSTEMIE Liquid ChemicalSterilant ProcessingSystem	STERIS 20 SterilantConcentrate is for useonly in the SYSTEM 1Sterile ProcessingSystem	Sterilox is for usewith manual orautomated endoscopereprocessingprotocols
Germicidal claim	Liquid ChemicalSterilant	Liquid ChemicalSterilant	High Level Disinfectant
GermicideExposure Time(min) for intendeduse	6	12	10
Use Temperature	45.5-60°C - allowable46-55°C - typicalPotency and simulateduse evaluationsconducted at <43°C	50 - 60°C - allowable50 - 55°C - typical	25°C
Reuse	Single use	Single use	Single use
Human Factors	Dispensed ready to use.Container is opened anddiluted by theprocessor, thus limitinguser exposure to theactive ingredient	Dispensed ready to useContainer is opened anddiluted by theprocessor, thus limitinguser exposure to theactive ingredient	Dispensed ready to use.
Active Ingredient	35% peroxyacetic(peracetic) acidautomatically dilutedfor use in the SYSTEM1E Processor.	35% peroxyacetic(peracetic) acidautomatically dilutedfor use in the SYSTEM1 Processor.	Electrolytic generationof the active (mainlyhypochlorous acid)from saline solution inthe Sterilox Generator(in situ).

Table 5-2. Sterilant Device Comparison Table
Feature	S40 SterilantConcentrate	STERIS 20STERILANT(K875280)	Sterilox LiquidChemical HLD System(013280)
Mode of Action	It is believed thatperacetic acid exerts itsgermicidal effect byseveral mechanisms:-oxidizing sulfhydraland sulfur bonds inproteins and enzymes,particularly in the cellwalls1-hydroxyl radicalsproduced from PAA arebactericidal2-PAA damages the viralcapsid and viral nucleicacid3,4.	It is believed thatperacetic acid exerts itsgermicidal effect byseveral mechanisms:-oxidizing sulfhydraland sulfur bonds inproteins and enzymes,particularly in the cellwalls1-hydroxyl radicalsproduced from PAA arebactericidal2-PAA damages the viralcapsid and viral nucleicacid3,4	Attacks surface andplasma membraneproteins impairingtransport of solutes andthe salt balance ofbacterial cells5.
Rinses	Automatic, UV-irradiated, dual 0.1micron filtered, potablehot water.	Automatic, 0.2 micronfiltered potable hotwater.	Dependent upon use.
Sporicidal Activityof DisinfectantsAOAC OfficialMethod 966.04	Meets efficacyrequirements6.Bacillus subtilisClostridium sporogenesTesting conducted invitro	Meets efficacyrequirements6.Bacillus subtilisClostridium sporogenesTesting conducted insitu	Meets efficacyrequirements6.Bacillus subtilisClostridium sporogenesTesting conducted invitro
ConfirmatorySporicidal Activityof DisinfectantsAOAC OfficialMethod 966.04	Meets efficacyrequirements6.Bacillus subtilisClostridium sporogenesTesting conducted invitro	Meets efficacyrequirements6.Bacillus subtilisClostridium sporogenesTesting conducted insitu	Meets efficacyrequirements6.Bacillus subtilisClostridium sporogenesTesting conducted invitro
Fungicidal Activityof DisinfectantsAOAC OfficialMethod 955.17	Solution is fungicidal.TrichophytonmentagrophytesTesting conducted invitro	Solution is fungicidal.TrichophytonmentagrophytesTesting conducted insitu	Solution is fungicidal.TrichophytonmentagrophytesTesting conducted invitro
Feature	S40 SterilantConcentrate	STERIS 20STERILANT(K875280)	Sterilox LiquidChemical HLD System(013280)
Use DilutionMethod AOAC,Official Methods955.14, 955.15,964.02	Solution is bactericidal.SalmonellacholeraesuisStaphylococcus aureusPseudomonasaeruginosaTesting conducted invitro	Solution is bactericidal.SalmonellacholeraesuisStaphylococcus aureusPseudomonasaeruginosaTesting conducted insitu	Solution is bactericidal.SalmonellacholeraesuisStaphylococcus aureusPseudomonasaeruginosaTesting conducted invitro
EPA VirucidalTesting (DIS/TSS-7, Nov. 1981)	Solution is virucidal.Herpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted invitro	Solution is virucidal.Herpes simplex Type 2Poliovirus Type 1Influenza ATesting conducted insitu	Solution is virucidal.Herpes simplex Type 1Poliovirus Type 2Humanimmunodeficiciencyvirus Type ITesting conducted invitro
TuberculocidalActivity ofDisinfectantsAOAC OfficialMethod 965.12	Not performed. Aquantitative suspensionTuberculocidal test wasconducted.	Solution istuberculocidal.Mycobacterium bovisTesting conducted insitu	Solution istuberculocidal.Mycobacterium bovisTesting conducted invitro
TuberculocidalActivity AscenziQuantitativeSuspension Test	Solution istuberculocidalMycobacterium terraeTesting conducted invitro	Not performed. TheAOAC TuberculocidalActivity ofDisinfectants wasconducted.	Not performed. TheAOAC TuberculocidalActivity ofDisinfectants wasconducted.
Simulated-Use Test	Meets efficacyrequirement.$≥ 6 log10$ reductionGeobacillusstearothermophilusspores	Meets efficacyrequirement.$≥ 6 log10$ reductionBacillus subtilus spores	Meets efficacyrequirement$≥ 6 log10$ reduction ofMycobacterium terrae
Clinical In-Use	No survivingmicroorganisms onrepresentative medicaldevices tested	Not required at time ofsubmission.	No survivingmicroorganisms on theendoscopes tested.
Biocompatibility
Cytotoxicity DeviceExtracts	Two rinses with UVtreated, dual 0.1 micronmembrane filteredwater effectivelyreduces sterilantresidues to safe levels.	Not performed	Not performed
Residue Reduction	Automatic within the	Automatic within	Effectively removed
Feature	S40 SterilantConcentrate	STERIS 20STERILANT(K875280)	Sterilox LiquidChemical HLD System(013280)
Device MaterialCompatibility	SYSTEM 1E Processor:Two rinses with UVtreated, dual 0.1 micronmembrane filteredwater effectivelyreduces sterilantresidues to safe levels.	SYSTEM 1 Processor:Four 0.2 micron filteredwater rinses effectivelyreduce sterilant residuesto safe levels.	from devices by therinses followingdisinfection.
	Compatible withmedical devices asestablished by testingfinished flexibleendoscopes through 300cycles and rigid devicesthrough 150 cycles.No functional changeshave occurred toflexible devices.Some materials showcosmetic changes suchas fading of blackanodized aluminumwithout harm to thebase material.	Compatible withmedical devices andtheir materials ofconstruction, asestablished by testingmaterials and finishedmedical devices through100 - 300 cycles.No device functionalchanges.Some materials showcosmetic changes suchas fading of externalmarkings but allremained legible, andbleaching of blackanodized aluminumwithout harm to thebase material.	Device components andmaterials weresubjected to continuousimmersion for unstatedtime periods.Does not produce anycorrosion or othervisible damage in themajority of endoscopecomponents.Color changes and the"tack" of the coating ofthe outer endoscopesheaths were noted onsome endoscopes.Corrosion was noted onanodized aluminum.

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・

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.

S Pieterson et al., Water SA (1996) 22(1); 43-48.

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

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Conclusion -

Based on the non-clinical and clinical tests described above, the SYSTEM 1E Dased on the non ontenteate demonstrate demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.

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Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR - 5 2010

Dr. Peter A. Burke Senior Vice President STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

Re: K090036

Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System Regulation Number: 21CFR 880.6885 Regulation Name: Liquid Chemical Sterilants / High Level Disinfectants Regulatory Class: II Product Code: MED Dated: March 16, 2010 Received: March 17, 2010

Dear Dr. Burke:

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.

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Page 2- Dr. Burke

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Cintron D. Ruiz

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. 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): K090036

SYSTEM 1E Liquid Chemical Sterilant Processing System Device Name:

Indications for 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 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants.
  - · Pre-filter 2 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:

{{ D In

.
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. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


	Jfi)
	on of Anesthesiology, General Hospital
	Infection Control, Dental Devices
510(k) Number:	K090036

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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.