The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories. High level disinfection is achieved within the 50 -57°C HLD Phase of the Endoscope Processing Cycle (4 minute generation sequence followed by a 6 minute exposure sequence).

Device Description

The Reliance Endoscope Processing System includes the Reliance Endoscope Processor, Reliance DG Dry Germicide, Klenzyme Enzymatic Presoak and Cleaner, and CIP 200 Acid-Based Process and Research Cleaner. The Reliance Endoscope Processor is an electromechanical washer/high level disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor self-decontamination cycles. The processor utilizes a proprietary, single use, dry, germicide package (Reliance DG Dry Germicide) that generates the active ingredient, peracetic acid, upon automatic dilution in water by the processor. In the optional washing phase, washing is provided through the automated delivery of Klenzyme Enzymatic Presoak and Cleaner. CIP 200 Acid-Based Process and Research Cleaner is used in one of the two self-decontamination cycles. The system provides endoscope processing cycles with optional programmable washing phases and a non-optional high level disinfection phase, followed by a rinse phase and an air purge phase. The processor prints a detailed cycle summary. The processor also features two decontamination cycles, D-SHORT and D-LONG, to be used without endoscopes in the processor.

AI/ML Overview

Acceptance Criteria and Device Performance for Reliance® Endoscope Processing System

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the Reliance® Endoscope Processing System, which is designed for washing and high-level disinfection of semi-critical medical devices. The acceptance criteria and device performance are primarily focused on germicidal efficacy, biocompatibility, material compatibility, and processor performance, adhering to FDA guidance documents.

Here's a summary:

Acceptance Criteria Category	Specific Criteria/Test	Acceptance Criteria (from FDA Guidence Documents)	Reported Device Performance (Reliance® Endoscope Processing System)
Germicidal Efficacy (High-Level Disinfection)	Sporicidal Activity (AOAC Sporicidal Activity Test)	Must demonstrate sporicidal activity against relevant spores.	Proven to be sporicidal within 6 minutes of in situ exposure (Bacillus subtilis, Clostridium sporogenes). Confirmatory and supplemental testing successful, including with aged germicide.
	Tuberculocidal Activity (AOAC Tuberculocidal Activity Test)	Must demonstrate tuberculocidal activity against relevant mycobacteria.	Proven to be tuberculocidal within 6 minutes of exposure (Mycobacterium bovis). Potency confirmed with aged germicide. (Additionally, tuberculocidal against Mycobacterium terrae via Ascenzi Quantitative Suspension Test).
	Virucidal Activity (EPA Virucidal Testing DIS/TSS-7)	Must demonstrate virucidal activity against representative viruses.	Proven to reduce viable population of Poliovirus Type 1, Adenovirus Type 5, and Herpes Simplex Virus Type 1 by > 4 log10.
	Bactericidal Activity (AOAC Bactericidal Activity Test)	Must demonstrate bactericidal activity against relevant bacteria.	Proven to be bactericidal within 6 minutes of exposure at worst-case conditions (Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa).
	Fungicidal Activity (AOAC Fungicidal Activity Test)	Must demonstrate fungicidal activity against relevant fungi.	Proven to be fungicidal within 6 minutes of exposure (Trichophyton mentagrophytes).
	Simulated-Use Test (High-Level Disinfection)	Must achieve a significant log reduction of challenge organisms on clinically relevant devices under worst-case conditions.	Reproducibly achieved > 6 log10 reduction of Mycobacterium terrae in triplicate trials within the processor for challenging flexible endoscopes and accessories at minimum recommended dose.
Cleaning Performance	Washing Phase Efficacy	Devices should be visually clean and show significant reduction in extractable protein.	Devices were visually clean and achieved greatly reduced yield of extractable protein (reduced from ≥173 to ≤5 µg/cm2) after shortest possible washing phase, using a combination of eggs, blood, mucin, and serum as soiling agents.
Biocompatibility/Safety	Acute Oral Toxicity (Use Dilution)	Safe handling and minimal toxicity from use dilution.	LD50 = >5000 mg/kg (meaning very low acute oral toxicity).
	Rabbit Eye Irritation	Minimal to non-irritating to eyes.	Minimally irritating.
	Rabbit Skin Irritation	Non-irritating to skin.	Non-irritating.
	Cytotoxicity (of Use Dilution)	Should reach non-cytotoxic levels with minimal dilution.	Dilution Cytotoxicity Score: 1:1 to 1:2 (3 - moderate), 1:4 to 1:16 (2 - mild), 1:20-1:40 (1 - slight), 0 - nontoxic. Use dilution reaches non-cytotoxic levels with minimal dilution.
	Residuals (on Medical Devices)	Residues remaining on devices must be below established limits and non-toxic.	Extracts from processed medical devices demonstrated no toxic residuals remain on devices under worst-case circumstances; worst-case residue levels were far below allowable limits and final rinse water was non-cytotoxic.
Material Compatibility	Effect on Medical Devices/Materials	No deleterious functional effects on medical devices; cosmetic changes should be acceptable and comparable to predicate devices.	No deleterious effects observed on flexible endoscopes and common materials of device construction after 300 processing cycles, other than minor cosmetic changes (e.g., fading markings, bleaching of black anodized aluminum) similar to predicate. No functional changes.
System Performance	Critical Process Parameters (e.g., temperature, germicide detection, boot pressure, water filter integrity)	Parameters must be within required specifications under worst-case conditions.	Each critical parameter was found to be within required specifications under worst-case conditions.
	Rinse Phase Efficacy	Effective removal of high-level disinfection solution.	Effective; evaluations of extracts showed residual levels far below allowable limits and non-cytotoxic.
	Air Purge Phase Efficacy	Ability to remove rinse water from processed devices.	Validated to confirm ability to remove rinse water.
	Filter Integrity Test System Reliability	Reliable detection of filter failure.	Documented to reliably detect filter failure.
	D-LONG Decontamination Cycle Efficacy	Processor can be disinfected after high-level challenge.	Can disinfect the processor after a high-level challenge with P. aeruginosa followed by a 5-day inactive period.
	D-SHORT Decontamination Cycle Efficacy	Can kill bacteria to prevent biofilm formation.	Can kill bacteria that have potential to form biofilm.
Clinical Performance (In-Use Study)	No Organisms Recovered	No organisms should be recovered after processing clinically used devices.	No organisms were recovered after processing in triplicate evaluations. Bioburden before disinfection was as high as 10^8 CFU/device.

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

Clinical In-Use Study: Three flexible endoscopes representing the range of types indicated in the product labeling were used in clinical procedures. Data provenance is a US hospital (retrospective or prospective is not explicitly stated, but "in-use study" strongly implies prospective).
Simulated-Use Test: Performed in "triplicate trials" on "selected clinically relevant flexible endoscopes and their accessories." The exact number of endoscopes or accessories is not specified beyond "selected," but implies at least the number required for triplicate testing.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test sets. The studies referenced are based on recognized microbiological and toxicology standards (AOAC, EPA) and FDA guidance documents.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method. For the in-use studies and simulated-use studies, the reported results are quantitative microbial reductions or absence of organisms. For material compatibility, it refers to "no deleterious effects" and "minor cosmetic changes."

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the device's ability to disinfect rather than human interpretation aided by AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies are standalone performance evaluations of the automated reprocessing system (processor and germicide) without direct human intervention impacting the disinfection efficacy once the cycle is initiated. Human actions primarily involve manual pre-cleaning and loading the device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is primarily microbiological viability (log reduction of specific microorganisms, absence of microorganisms) and chemical/physical property measurements (protein levels, toxicity, material changes, electrical standards conformity).

8. The Sample Size for the Training Set

The document does not refer to a training set in the context of an AI/ML algorithm. This is a medical device (endoscope reprocessing system), not an AI/ML product. Therefore, the concept of a training set as typically understood for machine learning is not applicable here. The development and validation of the system involved extensive laboratory testing (e.g., germicidal efficacy, material compatibility, functional performance) and a clinical in-use study.

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

As stated above, the concept of a training set for an AI/ML algorithm is not applicable to this device. The "ground truth" for the device's performance was established through standardized testing methodologies (e.g., AOAC, EPA methods) and adherence to FDA guidance, which define the expected outcomes for high-level disinfection and safety. For instance, sporicidal activity is proven by demonstrating a reduction in specified spores to required levels, and biocompatibility by demonstrating toxicity profiles below established thresholds.

Summary

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Certification to electromagnetic standards, continued: Non-clinical Tests: Limits and Methods of Processor CISPR 22 (1997) Measurements of Radio Performance, (equivalent to EN 55022:1998) Disturbance Characteristics of continued Information Technology Equipment The Reliance Endoscope Processing System was evaluated in an inuse study in a US hospital. Three flexible endoscopes representing the range of types indicated in the product labeling were used in clinical procedures and processed according to instructions for use. In triplicate Clinical Tests evaluations of each endoscope, no orqanisms were recovered after processing. Bioburden levels on the clinically used endoscopes after manual cleaning and before high level disinfection were determined to be as high as 108 CFU/device. The above data document that the Reliance Endoscope Processing System meets the FDA requirements of the quidance documents: • Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants (2000), and · Guidance on Premarket Notification [510(k)] Submissions for Conclusion Automated Endoscope Washers (1993). Conformity to the requirements of these quidances demonstrates the safety and effectiveness of the Reliance Endoscope Processing System. Based on the results of all testing conducted, this system is as safe and effective as the predicate devices.

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Date	July 5, 2006
Submitter	STERIS Corporation5960 Heisley RoadMentor Ohio 44060 USATelephone: 440-354-2600
Contact	Nancy A. RobinsonDirector, Advanced SterilizationSTERIS Corporation5960 Heisley RoadMentor, OH 44060 USATel.: 440-392-7742Fax: 440-392-8955E-mail: nancy_robinson@steris.com
	Trade name: The Reliance® Endoscope Processing System
	Common name: Automated endoscope reprocessing system
Device Name	The System includes the followingClassification names:Processor: Medical Washer-Disinfector for High Level Disinfection of Medical Devices Germicide: Liquid Chemical Germicide Cleaners: Accessories to the Medical Washer-Disinfector
Legally MarketedDevices to whichSubstantialEquivalence isClaimed	The Reliance Endoscope Processing System is substantiallyequivalent to the following legally marketed Class II medical devices:Reliance Processor:Custom Ultrasonic System 83 Plus, based on similar indications for use, designs, and features Reliance™ DG Dry germicide:STERIS 20™ Sterilant Concentrate, with respect to device design, active ingredient, conditions of use, and chemical monitoring andSterilox Liquid Chemical HLD System, with respect to indications for use (high level disinfectant) and in situ generation of the active ingredient

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	Property ▼	STERISReliance EndoscopeProcessor		Custom UltrasonicsSystem 83 Plus
	Intended Use	Wash and high leveldisinfect up to twomanually pre-cleaned,immersible, reusable,heat-sensitive, semi-critical devices such as GIflexible endoscopes,bronchoscopes and theiraccessories.High level disinfection isachieved within the50 - 57°C HLD Phase ofthe EndoscopeProcessing Cycle(4-minute generationsequence followed by a6-minute exposuresequence).		Clean and high leveldisinfect one or twosubmersible flexibleendoscopes intendedused to treat anddiagnose disorders of thegastrointestinal and/orpulmonary tracts.High level disinfectioncontact conditions varywith the germicide usedin the processor.
Summary oftechnologicalcharacteristics forcomparison topredicate:a) Processor	OperationalPrinciples	Pressure in controlhandle boot driveswashing/disinfecting/rinsesolutions through lumens.Circulation pump spraysexterior surfaces.		Fluid connectors/attachments flowcleaning/disinfecting/rinsesolution through lumens.Immersion system withultrasonic cavitationsduring all phases exceptdisinfection.
		Flow units are requiredonly for endoscopechannels that do not openin the endoscope controlhandle and whenmechanical action isrequired for valveoperation		Adaptors are required toflow solutions throughlumens.
	Cycle Description	Phase	Time	Phase	Time
			Optional:Washing 1(Wash withrinse)	Wash timecan beadjusted tobe between5 and 10minutes	Wash
		Rinse	40 seconds	Rinse	1.5 minutes
	Property ▼	STERISReliance EndoscopeProcessor		Custom UltrasonicsSystem 83 Plus
	Cycle Description,continued	Phase	Time	Phase	Time
		Optional:Washing 2(Wash withrinse)	Wash timecan beadjusted tobe between5 and 10minutes	Not applicable
		Rinse	40 seconds
		Dry GermicideGeneration	4 minutes
		Dry GermicideExposure	6 minutes	ChemicalImmersion	Varies withgermicideused
		Rinse 1	40 seconds	Rinse 1	1 minute
Summary oftechnologicalcharacteristics forcomparison topredicate:a) Processor,continued		Rinse 2	40 seconds	Rinse 2	1.5 minutes
		Air purge	Air purgetime can beadjusted tobe between4 and 30minutes	Air purge	40 seconds
		Alcohol Flush: Productlabeling instructs the user tofollow departmentalprocedures regardingflushing the endoscopechannels with alcohol andstorage of the endoscopebefore use.		Alcohol Flush: Productlabeling indicates that analcohol rinse can beperformed manually by theuser while the device isattached to the processor.
	Critical DesignFeatures	Intended for use withReliance DG Dry Germicideonly		Intended for use withdifferent types of liquidchemical germicides(aldehydes and mostoxidizing germicides)
		Microprocessor controlled		Microprocessor controlled
		Internal componentsconstructed of stainless steeland silicone		Internal componentsconstructed of stainlesssteel

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RELIANCE® ENDOSCOPE PROCESSING SYSTEM

	Property ▼	STERISReliance EndoscopeProcessor	Custom UltrasonicsSystem 83 Plus
	Critical DesignFeatures,continued	Processor provides0.2 micron filtered waterfor washing, disinfectionand rinsing	Water filtration systemexternal to device(customer supplied)
		Automated injection ofwashing solution	Manual injection ofcleaning solution
		Automated generationand delivery of high leveldisinfection solution	High level disinfectantselected and added byoperator
		Air intake for Air Purge isHEPA filtered	No air cleaning option
Summary oftechnologicalcharacteristics forcomparison topredicate:a) Processor,continued	ProcessParameters	Can select the followingendoscope processingcycles:• Disinfect only• Wash and disinfectProcessor also providesthe following self-decontamination cycles:• D-SHORT (must berun every 54 hours)• D-LONG (must berun when D-SHORThas not been run inthe past 54 hours)	Can select the followingendoscope processingcycles:• Wash only• Wash and disinfect• Disinfect only





		Disinfection time notadjustable	Adjustable disinfectiontime to accommodatedifferent HLD solutions.
		Washing and air purgetimes adjustable	Cleaning and air purgetimes adjustable
		Temperature notadjustable	Temperature isadjustable
	Property ▼	STERISReliance EndoscopeProcessor	Custom UltrasonicsSystem 83 Plus
Summary oftechnologicalcharacteristics forcomparison topredicate:a) Processor,continued	ProcessParameters,continued	Washing solutionconcentration not adjustableReliance DG Dry Germicidesolution concentration notadjustable	Cleaning solution is added byoperator (3 oz. Tergal 800)Liquid chemical germicidesolution is adjustable
		Water quality is notadjustable; filtration systemsare provided with processor	Water quality external toprocessor and provided bycustomer
	Process Monitors	Control Handle Boot pressurealarms if pressure too low toprocess, or if too high andcould potentially damagescopes	Pressure monitor cut off at5 psiFlow sensor for air/waterchannel to detectbackpressureAir restrictor allowing forvisual confirmation of flow (airbubbles) through the air/waterchannel.
		Detection of a fresh RelianceDG Dry Germicide containerin every processing cycle	No on-board monitoring forpresence of germicide orgermicide components
		Washing solution levelmonitored; alarm indicateswhen container does nothave sufficient amount tocomplete cycle	Cleaner solution level notmonitored
		Temperature alarms if out ofrange	No temperature monitoringother than heaterthermocouple
		Water filter integrity test	No water filter integrity test
	MaintenanceRequirements	D-SHORT decontaminationcycle required every 54 hoursD-LONG decontaminationcycle required if D-SHORTnot performed within past 54hours.	Daily decontamination ofinternal plumbing usingdisinfectant solution
		Periodic cleaning of debrisscreen and spray arms	Daily cleaning with "Comet"or "Ajax"Cleaning when changingdisinfectant
		Periodic replacement ofwater and air filters	Filters provided by customer

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	Device▶	Reliance DG DryGermicide	STERIS 20	Sterilox LiquidChemical HLDSystem
	General Features: The general features of Reliance DG Dry Germicide and thepredicate germicides are similar in that they are intended to process pre-cleaned, immersible, reusable medical devices. The germicides are supplied in aready to use, single use dose.
	Intended Use:	Dry germicide foruse only in theRelianceEndoscopeProcessor.	Sterilant for useonly in theSYSTEM 1Processor.	High leveldisinfectant for useonly with theSterilox Generator.
Summary oftechnologicalcharacteristicsforcomparison topredicate:b) RelianceDG DryGermicide		Provides high leveldisinfection of up totwo manually pre-cleaned,immersible,reusable, heat-sensitive, semi-critical medicaldevices such asendoscopes andtheir accessories.	Provides sterileprocessing ofmanually pre-cleanedimmersible,reusable, semi-critical and criticaldevices.	Provides for highlevel disinfection ofpre-cleaned,immersible,reusable, heat-sensitive, semi-critical medicaldevices.
	Labeling:	Dry Germicide	Liquid ChemicalSterilant	High LevelDisinfectant
	GermicideExposure Time(min) forintended use(High LevelDisinfection orSterileProcessing)	10(4-minutegenerationsequence followedby a 6-minuteexposuresequence)	12	10
	UseTemperature	50 - 57°C	50 - 56°C	25°C
	Reuse	Single use	Single use	Single use
	Device▶	Reliance DG DryGermicide	STERIS 20	Sterilox LiquidChemical HLDSystem
HumanFactors		Dispensed ready touse.Container openedautomatically bythe processor,limiting userexposure to thegermicide.	Dispensed readyto use.Container openedautomatically bythe processor,limiting userexposure to thegermicide	Dispensed ready touse.
Physical and Chemical Properties: The physical and chemical properties ofReliance DG Dry Germicide and the predicate germicides are similar in that theyare supplied in a single use, ready to use dose in a form that is readily soluble inwater and results in a ~ pH neutral solution
Summary oftechnologicalcharacteristicsforcomparison topredicate:b) RelianceDG DryGermicide,continued	Container	Single-use,2 CompartmentContainer	Single-use,2 CompartmentContainer	Single use.
	Composition,PackagedProduct	Dry/Dry	Dry/Liquid	Liquid
	Appearance	Translucent liquid	Lime green liquid	Colorless liquid
	Odor	Slightly acidic	Slightly acidic	odorless
	pH	7.0 - 8.5	6 - 8	5 – 7
	Solubility inWater	Complete	Complete	Complete
Operational Principles - The operational principles of Reliance DG DryGermicide and the predicate devices are similar in that they result in high leveldisinfection (or sterile processing for STERIS 20) of the intended devices bydirect contact of the germicides with the device surfaces for a specified period oftime and temperature, under dynamic conditions. The active ingredient isgenerated (predicate, Sterilox System) in situ from a ready to use dose ofgermicide
	Softwarecontrolledparameters	Yes	Yes	Yes
	Form	Water andgermicide.	Water andgermicide.	Water andgermicide.
	Contact	Dynamic liquidcontact.	Dynamic liquidcontact.	Dynamic or staticliquid contact.
	Purpose	Provides high leveldisinfection whenused in theRelianceEndoscopeProcessoraccording tolabeling.	Provides liquidchemicalsterilization whenused in theSystem 1according tolabeling.	Provides HighLevel Disinfectionwhen usedaccording tolabeling.
Summary oftechnologicalcharacteristicsforcomparison topredicate:b) RelianceDG DryGermicide,continued	Device▶	Reliance DG DryGermicide	STERIS 20	Sterilox LiquidChemical HLDSystem
	ActiveIngredient	Chemicalgeneration ofperacetic acid fromacetylsalicylic acidand sodiumperborate whencombined withwater in theRelianceEndoscopeProcessor (in situ).	35% peroxyaceticacid diluted to0.2 % for use inthe SYSTEM 1Processor.	Electrolyticgeneration ofactive (mainlyhypochlorous acid)from salinesolution in theSterilox Generator(in situ).
	Mode of Action	It is believed thatperacetic acidexerts itsgermicidal effect byseveralmechanisms:-oxidizing sulfhydraland sulfur bonds inproteins andenzymes,particularly in thecell walls6-hydroxyl radicalsproduced from PAAare bactericidal9-PAA damages theviral capsid andviral nucleicacid10,11	It is believed thatperacetic acidexerts itsgermicidal effectby severalmechanisms:-oxidizingsulfhydral andsulfur bonds inproteins andenzymes,particularly in thecell walls1-hydroxyl radicalsproduced fromPAA arebactericidal2-PAA damages theviral capsid andviral nucleic acid3,4	Attacking thesurface andplasma membraneproteins impairstransport of solutesand the saltbalance ofbacterial cells 12.
	Rinses	Automatic, 0.2micron filteredwater.	Automatic, sterilefiltered water.	Dependent uponuse.
	Microbiology: The microbial efficacy of Reliance DG Dry Germicide and thepredicate devices was demonstrated using standard test methodologies.Potency and simulated use tests for Reliance DG Dry Germicide wereconducted under worst case operating conditions of the Reliance EndoscopeProcessor at or below the minimum effective dose of 9000 mg/L PAA min.Standards tests were modified to minimal operating conditions obtained withinthe Reliance Endoscope Processor. Dacron sutures rather than black waxedsilk suture loops were used in sporicidal activity tests as described13.
	Device▶	Reliance DG DryGermicide	STERIS 20	Sterilox LiquidChemical HLDSystem
Summary oftechnologicalcharacteristicsforcomparison topredicate:b) RelianceDG DryGermicide,continued	SporicidalActivity ofDisinfectantsAOAC OfficialMethod 966.04	Meets efficacyrequirements'.Bacillus subtilisClostridiumsporogenes	Meets efficacyrequirements'.Bacillus subtilisClostridiumsporogenes	Meets efficacyrequirements'.Bacillus subtilisClostridiumsporogenes
	ConfirmatorySporicidalActivity ofDisinfectantsAOAC OfficialMethod 966.04	Meets efficacyrequirements14.Bacillus subtilisClostridiumsporogenes	Meets efficacyrequirements'.Bacillus subtilisClostridiumsporogenes	Meets efficacyrequirements'.Bacillus subtilisClostridiumsporogenes
	FungicidalActivity ofDisinfectantsAOAC OfficialMethod 955.17	Solution isfungicidal.Trichophytonmentagrophytes	Solution isfungicidal.Trichophytonmentagrophytes	Solution isfungicidal.Trichophytonmentagrophytes
	Use-DilutionMethodAOAC, OfficialMethods955.14,955.15, 964.02	Solution isbactericidal.SalmonellacholeraesuisStaphylococcusaureusPseudomonasaeruginosa	Solution isbactericidal.SalmonellacholeraesuisStaphylococcusaureusPseudomonasaeruginosa	Solution isbactericidal.SalmonellacholeraesuisStaphylococcusaureusPseudomonasaeruginosa
	EPA VirucidalTesting(DIS/TSS-7,Nov. 1981)	Process conditionsare virucidal.Herpes simplexType 1Adenovirus Type 5Poliovirus Type 1	Solution isvirucidal.Herpes simplexType 2Poliovirus Type 1Influenza A	Solution is virucidalHerpes simplexType 1Poliovirus Type 2Humanimmunodeficiencyvirus Type I
	TuberculocidalActivity ofDisinfectantsAOAC OfficialMethod 965.12	Solution istuberculocidal.Mycobacteriumbovis	Solution istuberculocidal.Mycobacteriumbovis	Solution istuberculocidal.Mycobacteriumbovis
	TuberculocidalActivityAscenziQuantitativeSuspensionTest	Solution istuberculocidalMycobacteriumterrae	Not performed	Unknown

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1 - 1 - 1 -

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

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

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

11 Maillard et. al., J. Appl Bacteriol (1996) 80:540-5540-5540-5540-

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

. (2000) 83:26) Water SF (1930) 22(17) 10-16:
13 McDonnell et al., J. AOAC International (2000) 83:269-275.

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.. .

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

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RELIANCE® ENDOSCOPE PROCESSING SYSTEM

	Device▶	Reliance DG Dry Germicide	STERIS 20	Sterilox Liquid Chemical HLD System
Summary oftechnologicalcharacteristicsforcomparison topredicate:b) RelianceDG DryGermicide,continued	Simulated-UseTest	Meets efficacyrequirementMycobacteriumterrae	Meets efficacyrequirementBacillus subtilissporesGeobacillusstearothermophilus spores	Meets efficacyrequirementMycobacteriumterrae
	Clinical In-Use	No survivingmicroorganisms onany of theendoscopes oraccessories tested	Not required attime ofsubmission.	No survivingmicroorganisms onthe endoscopestested.
	Toxicology: Toxicology of the Reliance DG Dry Germicide use dilution and itspredicate devices were characterized with acute toxicity tests.
	Rat Acute OralToxicity - UseDilution	LD50 = >5000 mg/kg	LD50 =>10,000mg/kg	LD50 = >5000mg/kg
	Rabbit EyeIrritation	Minimally irritating	Minimallyirritating	Non-irritating
	Rabbit SkinIrritation	Non-irritating	Non-irritating	Non-irritating
	Cytotoxicity	Dilution Cytotoxicity Score 1:1 to 1:2 3 - moderate 1:4 to 1:16 2 - mild 1:201:40 1 - slight0 - nontoxic				Not tested
		Residues: Residues of Reliance DG Dry Germicide and its predicate deviceshave been shown to be effectively reduced to safe levels through chemicalanalysis of medical device extracts.
		ResidueReduction	Automatic withinthe RelianceEndoscopeProcessor,2 x 15 L - 0.2 $\mu$filtered water rinseseffectively reducesgermicide residuesto safe levels.	Automatic withinSYSTEM 1Processor, 4 x 10L sterile filteredwater rinseseffectively reducegermicideresidues to safelevels.	Effectivelyremoved fromdevices by therinses followingdisinfection.
		Reusable Device Compatibility: The medical device compatibility of RelianceDG Dry Germicide and its predicate devices was established through testingwith finished devices or device materials of construction.

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Summary oftechnologicalcharacteristicsforcomparison topredicate:b) RelianceDG DryGermicide,continued	Device▶	Reliance DG	STERIS 20	Sterilox LiquidChemical HLDSystem
	DeviceMaterialCompatibility	Compatible withintended flexibleendoscopes andaccessoriesestablished throughtesting finishedmedical devices.No devicefunctional changes.Some materialsshow cosmeticchanges such asfading of externalmarkings but allremained legible,and bleaching ofblack anodizedaluminum withoutharm to the basematerial.	Compatible withmedical devicesand materials oftheir construction.No devicefunctionalchanges.Some materialsshow cosmeticchanges such asfading of externalmarkings but allremained legible,and bleaching ofblack anodizedaluminum withoutharm to the basematerial.	Does not produceany corrosion orother visibledamage in themajority ofendoscopecomponents.Color changes andthe "tack" of thecoating of the outerendoscopesheaths werenoted on someendoscopes.Corrosion wasnoted on anodizedaluminum.
Chemical Indicator: Chemical monitoring of Reliance DG Dry Germicide and itspredicate device (STERIS 20) is accomplished through a chemical reaction onan indicator pad in the presence of active ingredient.
ChemicalMonitoring	Reliance PI,Process Indicator(separatesubmission).Chemical reactionon indicator pad toproduce colorchange.	STERISPROCESSIndicatorChemical Monitor(K921559).Chemical reactionon indicator pad toproduce colorchange.	Pre-programmedcolorimetric fordirect-reading ofchlorineconcentration.

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	DeviceDescription
• The Reliance Endoscope Processor is an electromechanical washer/highlevel disinfector with a microprocessor-based controller that provides forautomated endoscope processing cycles and processor self-decontaminationcycles.
• The processor utilizes a proprietary, single use, dry, germicide package(Reliance DG Dry Germicide) that generates the active ingredient, peraceticacid, upon automatic dilution in water by the processor.
• In the optional washing phase of the endoscope processing cycle, washing isprovided through the automated delivery of Klenzyme Enzymatic Presoakand Cleaner, a currently marketed product for manual cleaning of medicaldevices.
• CIP 200 Acid-Based Process and Research Cleaner, a currently marketedgeneral cleaning agent, is used in one of the two self-decontamination cyclesprovided by the processor.
The Reliance Endoscope Processing System provides for cycles with thefollowing features:
	• Endoscope Processing Cycle
	⇒ The first part of this cycle is an optional programmable washing phase.This phase consists of a wash that uses Klenzyme, followed by a rinse.The washing phase can be programmed on or off. In the "on" mode, theuser can choose either one or two washing phases per processing cycle,and the wash time can be adjusted to be between 5 and 10 minutes. TheReliance washing phase does not replace manual pre-cleaning bythe user.
	⇒ The second part is a high level disinfection phase that is non-optionaland the parameters cannot be changed by the user. In this phase, theproprietary Reliance DG Dry Germicide components, provided in a singleuse container, are dissolved with water at ~50°C and circulatedthroughout the processor and through device lumens for a 6 minuteexposure time.
	⇒ Following high level disinfection, the Reliance EndoscopeProcessor removes the high level disinfection solutionthrough a rinse phase which is non-optional and theparameters cannot be changed by the user. Theprocessor filters the rinse water (as well as all of thewater used throughout the cycle) through a 0.2 micronbacterial-retentive filter. It also incorporates an automaticinternal integrity check of this filter at the end of eachprocessing cycle. If the integrity check fails, an alarmalerts the user, and the processor does not complete thecycle.
Device Description,continued	⇒ The last step in the processing cycle is an air purgephase using HEPA-filtered air. The air purge helps toremove excess rinse water from the processed devices.The final air purge is preset to run for 4 minutes;additional air purge time may be selected by the operator.⇒ The processor will print a detailed cycle summary at theend of each cycle that includes information such asprocessor number, cycle date, start and stop times, aswell as phase parameters. With an optional bar codereader, the printouts can also include identificationnumbers for the operator, patient, device, doctor andprocedure.
	Decontamination Cycles The processor also features two decontamination cycles that are to be used without endoscopes in the processor:⇒ The first, called D-SHORT , consists of hot water circulating through the processor for 10 minutes, followed by a 10-minute hot air purge. This cycle is to be run every 54 hours.D-SHORT is intended to prevent biofilm from forming.⇒ The second, called D-LONG , consists of a cycle in which CIP 200Acid-Based Process and Research Cleaner is added to hot water. The cleaning solution is then circulated through the processor for 20 minutes; this is followed by three rinses to remove the solution from the processor and a 10-minute hot air purge. D-LONG is to be used on those occasions when the D-SHORT cycle has not been run within the past 54 hours.
Intended Use	The Reliance Endoscope Processing System is intended for washingand high level disinfection of up to two manually pre-cleaned,immersible, reusable, heat-sensitive, semi-critical devices such as GIflexible endoscopes, bronchoscopes and their accessories. High leveldisinfection is achieved within the 50 - 57°C HLD Phase of theEndoscope Processing Cycle (4-minute generation sequence followedby a 6-minute exposure sequence).
Non-clinical Tests:Germicide Efficacy	The Reliance Endoscope Processing System was developed andvalidated in accord with two primary FDA Guidance documents:Content and Format of Premarket Notification [510(k)] Submissions forLiquid Chemical Sterilants/High Level Disinfectant (2000), and Guidance on Premarket Notification [510(k)] Submissions for AutomatedEndoscope Washers (1993). A summary of this testing follows:Reliance DG Dry Germicide Efficacy:Reliance DG Dry Germicide was tested and shown to generate aneffective high level disinfection solution using the standard array ofmicrobiological tests for germicidal efficacy. The testing wasperformed at conditions of use that were worst case with respect togermicide concentration, contact time, circulation, water hardness,temperature and artificial soiling. ⇒ Sporicidal: Reliance DG Dry Germicide was proven to besporicidal as defined by AOAC Sporicidal Activity Test with an insitu exposure time of 6 minutes. Confirmatory testing wascompleted successfully and supplemental confirmatory testing wascompleted in the Reliance Endoscope Processor. Potency wassubsequently confirmed in the processor using Reliance DG DryGermicide containers that were aged beyond the end of its shelflife.⇒ Tuberculocidal; Reliance DG Dry Germicide was proven to betuberculocidal as defined by the AOAC Tuberculocidal Activity Testwith an exposure time of 6 minutes. Potency was subsequentlyconfirmed using Reliance DG Dry Germicide aged beyond the endof its shelf life.⇒ Virucidal: The Reliance Process was proven to reduce the viablepopulation of poliovirus Type 1, adenovirus Type 5, and herpessimplex virus Type 1 by > 4 $log_{10}$ .⇒ Bactericidal: Reliance DG Dry Germicide was proven to bebactericidal as defined by the AOAC Bactericidal Activity Test withan exposure time of 6 minutes at worst case conditions, whetherperformed in situ or in vitro .⇒ Fungicidal: Reliance DG Dry Germicide was proven to befungicidal as defined by the AOAC Fungicidal Activity Test with anexposure time of 6 minutes, whether performed in situ or in vitro .Simulated-Use: Reliance DG Dry Germicide, at the minimumrecommended dose, reproducibly achieved greater than a 6 $log_{10}$reduction of Mycobacterium terrae in triplicate trials within theReliance Endoscope Processor for selected clinically relevantflexible endoscopes and their accessories. The test articlesrepresented the range of most challenging devices, accessories, andprocessing situations.
Non-clinical tests:GermicideBiocompatibility,MaterialCompatibility andStability	• Biocompatibility:The Reliance chemical formulations, as supplied in packaging as well asin use dilutions, can be safely handled and used by customers.Residues that may remain on medical endoscopes and accessories arebelow established residue limits and do not pose a risk to patients.Safety statements in product labeling are appropriate to the potentialrisk.⇒ Reliance DG Dry Germicide, its components, reaction products,and residuals remaining on medical devices were evaluated forbiocompatibility and possible risks to users. Testing included acuteoral and ocular toxicity tests, dermal irritation studies, in vitrobacterial mutation genotoxicity studies, sensitization tests, and invitro cytotoxicity evaluations; literature reviews of raw materialtoxicity data were also performed. Certain components in the single-use container, which under normal use conditions never contact theuser, have the potential for irritation or skin sensitization; thereforeappropriate warnings and instructions are displayed on labeling forthe unusual event of a spill or container breakage.⇒ Use dilution reaches non-cytotoxic levels with minimal dilution.⇒ Biocompatibility testing of extracts from processed medicaldevices demonstrated that no toxic residuals remain on devicesunder worst case circumstances. The test data indicate that theworst case residue levels for the components of maximum potentialrisk are far below the allowable limits. Furthermore, the processorfinal rinse water was found to be non-cytotoxic.
	• Reliance Endoscope Processing System Material Compatibility:The Reliance System was evaluated for its effect on intact medicaldevices, including flexible endoscopes and/or common materials ofdevice construction. After 300 processing cycles, no deleteriouseffects were observed other than minor cosmetic changes similar tothose seen with the predicate device (STERIS 20). No functionalchanges in flexible endoscopes were observed.
	• Reliance DG Dry Germicide Stability:Reliance DG Dry Germicide was tested and found stable for 18 monthsin the unopened moisture-resistant foil pouch at the stated conditions forstorage. Once opened, the containers within each pouch are to be usedwithin 2 weeks, or by the expiration date on the container, whichevercomes first
Non-clinical Tests:ProcessorPerformance	Reliance Endoscope Processor Performance The critical process parameters for the processor (water temperatureand volume, fresh Reliance DG Dry Germicide container detection,boot pressure, delivery of washing solutions and high level disinfectionsolution and water filter integrity testing) were each evaluated inreplicate under worst case conditions and found to be within requiredspecifications.Each processor phase or cycle was separately evaluated anddocumented to be effective under worst case conditions:⇒ Validation of the washing phase of the Endoscope ProcessingCycle documented that after the shortest possible washing phase,devices pre-soiled with a combination of eggs, blood, mucin andserum in saline: 1) were visually clean, and 2) achieved greatlyreduced yield of extractable protein per cm2 device area (assayedto be reduced from ≥173 to ≤ 5 µg/cm2).⇒ Validation of the high level disinfection phase of the EndoscopeProcessing Cycle was performed through a simulated-use study inchallenging clinically relevant endoscopes as described above, aswell as in the in-use study described below.⇒ The rinse phase of the endoscope processing cycle was shown tobe effective. Evaluations of extracts of devices exposed to worstcase conditions in the Endoscope Processing Cycle documentedthat levels of residuals remaining on devices were far belowallowable limits and were not cytotoxic.⇒ The air purge phase was validated to confirm the ability to removerinse water from processed medical devices.⇒ The filter integrity test system of the processor was documentedto reliably detect filter failure.⇒ The two self-decontamination cycles were shown to be effectiveas follows:D-LONG cycle - can disinfect the Reliance Endoscope Processorafter a high level challenge with P. aeruginosa followed by a 5 dayinactive period;D-SHORT cycle - can kill bacteria that have potential to formbiofilm.
Non-clinical Tests:ProcessorPerformance,continued	In addition, the Reliance Endoscope Processor has been certified to thefollowing electrical standards:
	UL 3101-1First Edition (1993)	The Standard for Safety of LaboratoryUse Electrical Equipment
	CAN/CSA C22.2No. 1010.1-92 (1992)	Safety Requirements for ElectricalEquipment for Measurement, Controland Laboratory Use
	CENELECEN 61010-1: 1993 + A2: 1995	Safety Requirements for ElectricalEquipment for Measurements, Controland Laboratory Use Part 1: GeneralRequirements (IEC 61010-1:1990 +A1: 1992, modified +A2:1995)
	IEC 61010-2-045 (2000)	Safety Requirements for ElectricalEquipment for Measurement, Control,and Laboratory Use - Part 2-045:Particular Requirements for WasherDisinfectors Used in Medical,Pharmaceutical, Veterinary andLaboratory Fields
	CENELEC EN 61326 (1998)	Electrical Equipment forMeasurement Control and LaboratoryUse, EMC Requirements Part:General Requirements IncludingAmendments A1:1998; IEC61326:1997 + A1: 1998
	EN 55011 (1998)	Industrial, Scientific and Medical(ISM) Radio-Frequency Equipment -Radio Disturbance Characteristics -Limits and Methods of Measurement
	EN 50082 (1997)	Electromagnetic Compatibility -Generic Immunity Standard - Part 1Residential, Commercial and LightIndustry
	EN 61000	Testing and MeasurementTechniques
	Part 4-2 (1999)	Electrostatic Discharge ImmunityTest, Level 3
	Part 4-3 (1996)	Radiated, Radio-Frequency,Electromagnetic Field Immunity Test(in situ)
	Part 4-4 (1995)	Electrical Fast Transient/BurstImmunity Test, Level 3
	Part 4-5 (1995)	Surge Immunity Test, Level 3
	Part 4-6 (1996)	Conducted RF Immunity Test, Level 2
	Certification to electromagnetic standards, continued:
Non-clinical Tests:ProcessorPerformance,continued	CISPR 22 (1997)(equivalent to EN 55022:1998)	Limits and Methods ofMeasurements of RadioDisturbance Characteristics ofInformation Technology Equipment
Clinical Tests	The Reliance Endoscope Processing System was evaluated in an in-use study in a US hospital. Three flexible endoscopes representing therange of types indicated in the product labeling were used in clinicalprocedures and processed according to instructions for use. In triplicateevaluations of each endoscope, no organisms were recovered afterprocessing. Bioburden levels on the clinically used endoscopes aftermanual cleaning and before high level disinfection were determined to beas high as 105 CFU/device.

and the comments of the comments of

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And Controller Comments of Children

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Image /page/19/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the text "HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

STERIS Corporation c/o Mark A. Heller Wilmer Cutler Pickering Hale and Dorr, LLP The Willard Office Building 1455 Pennsylvania Avenue, N.W. Washington, D.C. 20004

JUL 2 1 2006

Re: K040049

Trade/Device Name: Reliance® Endoscope Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: For Endoscopes Cleaning Germicide Accessories Regulatory Class: Class Il Product Code: NZA Dated: October 31. 2005 Received: October 31, 2005

Dear Mr. Heller:

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.

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

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

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Page 2 -- Mark A. Heller

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electroni product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your dev to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), plea contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

Miriam C. Provost

( Donna-Bea Tillman, Ph.D., M.P.A.
Director Director Office of Device Evaluation Center for Devices and Radiological Health

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Reliance® Endoscope Processing System Revised July 5, 2006

510(k) Section 3.3

Indications for Use

510(k) Number (if known): K040049

Device Name: Reliance® Endoscope Processing System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use × (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost for bBT

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . "n of Anesthesiology, General Hospi con Control. Dental Devices

Number: K040049

Page 1 of 1

(Posted November 13, 2003)

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.