The Reliance™ Advance Endoscope Processing System is intended for cleaning and high level disinfection of up to two immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.

During the system's standardized Endoscope Processing Cycle, cleaning is achieved within the Cleaning phase, and high level disinfection is achieved within the 50 - 57°C HLD phase (4 minute generation sequence followed by a 6-minute exposure sequence).

Manual cleaning is not required prior to processing in Reliance Advance Endoscope Processing System.

Device Description

The Reliance Advance Endoscope Processing System is an economical, easy-to-use cleaning and high level disinfection system that can clean and high level disinfect up to two immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes and related accessories.

The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, dry peracetic acid generating oxidative chemistry. The Reliance Advance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering the highest level of patient and staff safety. The Reliance Advance Endoscope Processing System is a combination of products that are used to clean and high level disinfect flexible endoscopes and their accessories.

The Reliance Advance Endoscope Processor is an electromechanical . washer/high level disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor selfdecontamination cycles.
. The proprietary enzymatic detergent is dispensed automatically during the Cleaning phase of the cycle to effectively clean endoscope(s) and accessories.
. Reliance DG Dry Germicide is a proprietary, two-part, dry, single-use oxidative chemistry, designed to generate the high level disinfection solution upon automatic dilution in water within the Reliance Endoscope Processor.
. Various accessories are available to accommodate the processing needs of specific endoscopes and endoscopic accessories.
VERIFY Process Indicator for Reliance EPS is available to monitor for the . effective dose of the Reliance DG active ingredient, peracetic acid.
CIP 200 Acid-Based Process and Research Cleaner, a general cleaning agent, is . used in one of the two self-decontamination cycles provided by the processor.

AI/ML Overview

The STERIS Reliance™ Advance Endoscope Processing System is intended for cleaning and high-level disinfection of immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes, and their accessories. Manual cleaning is not required prior to processing.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance testing summaries across several categories, with implicit acceptance criteria that the device achieved the stated outcomes.

Acceptance Criteria Category	Specific Acceptance Criteria (Implicit)	Reported Device Performance
Cleaning Phase Efficacy	Simulated Use: All test articles visually clean; all recovered samples from soiled areas meet established "clean" acceptance levels for protein, carbohydrates, and total organic carbon.	Simulated Use Studies: * Fifteen (15) heat-sensitive flexible endoscopes, dilators, and accessories, soiled with select test soils, were processed. * Performance: "1) all test articles were visually clean, and 2) all samples recovered from previously soiled areas for all test articles met the established acceptance levels defined as 'clean' for protein, carbohydrates, and total organic carbon in validated assays for those components."
	Clinical In-Use: All tested clinically soiled endoscopes visually clean; all meet soil pre-determined "clean" acceptance levels for protein, carbohydrates, and total organic carbon.	Clinical In-Use Studies: * Four types of flexible endoscopes (bronchoscopes, gastroscopes, colonoscopies, duodenoscopes) and their accessories, after clinical use and bedside pre-cleaning, were processed only through the cleaning phase. * Performance: "In triplicate evaluations, each of the tested clinically soiled endoscopes 1) was visually clean, and 2) met the soil pre-determined 'clean' acceptance levels for protein, carbohydrates, and total organic carbon in validated assays."
Enzymatic Detergent Stability	Stable in Bag-in-Box packaging for 12 months under representative storage conditions.	"The proprietary enzymatic detergent has been shown to be stable in its Bag-in-Box packaging through 12 months under representative storage conditions." (Note: ongoing testing for shelf-life extension)
Software Validation	Meet FDA requirements for a Major Level of Concern determination based on FDA Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities dated August 1993.	"All acceptance criteria were met."
Material Compatibility	No deleterious effects (other than minor cosmetic changes) on common materials of endoscope and accessory construction after 300 processing cycles; no functional changes.	Enzymatic Detergent: "After 300 processing cycles, no deleterious effects were observed other than minor cosmetic changes. No functional changes in flexible endoscopes were observed." Reliance DG: "After 300 processing cycles, no deleterious effects were observed other than minor cosmetic changes. No functional changes in flexible endoscopes were observed."
Processor Performance	Critical process parameters (water temperature/volume, DG container detection, boot pressure, water filter integrity, cleaning/HLD solution delivery) within required specifications under worst-case conditions. Each phase effective under worst-case conditions. Self-decontamination cycles effective.	"The critical process parameters for the processor (...) have each been evaluated in replicate under worst case conditions, and found to be within required specifications." "Each processor phase or cycle has been separately evaluated and shown to be effective under worst case conditions." Self-decontamination: D-LONG can disinfect after high-level challenge with Pseudomonas aeruginosa. D-SHORT can kill bacteria that have potential to form biofilm.
Reliance DG Microbial Efficacy	Sporicidal, Tuberculocidal, Virucidal, Bactericidal, Fungicidal: Meet defined AOAC or other criteria within 6 minutes exposure time. Minimum 6 log10 reduction of Mycobacterium terrae in simulated use. No organisms recovered in clinical in-use.	Potency: * Sporicidal: Proven sporicidal (AOAC Sporicidal Activity Test, 6 min exposure), confirmed in processor and in vitro with aged DG. * Tuberculocidal: Proven tuberculocidal (AOAC Tuberculocidal Activity Test, 6 min exposure), confirmed with aged DG. * Virucidal: Poliovirus Type 1, adenovirus Type 5, herpes simplex virus Type 1 reduced by > 4 log10. * Bactericidal: Proven bactericidal (AOAC Bactericidal Activity Test, 6 min exposure) in situ or in vitro. * Fungicidal: Proven fungicidal (AOAC Tuberculocidal Activity Test, 6 min exposure) in situ or in vitro. Simulated-Use: "reproducibly achieved greater than a 6 log10 reduction of Mycobacterium terrae in triplicate trials within the Reliance Endoscope Processor for each selected clinically relevant flexible endoscope and its accessory." In-Use: "In triplicate evaluations of each endoscope, no organisms were recovered after processing." (Bioburden before HLD up to 10^5 CFU/device).
Reliance DG Stability	Stable for 18 months in unopened packaging. Opened containers used within 2 weeks or by expiration.	"Reliance DG has been shown to be stable for 18 months in the unopened moisture-resistant package at the stated conditions for storage. Once opened, the five Reliance DG containers within each package are to be used within two (2) weeks, or by the expiration date on the container, whichever comes first."
Biocompatibility	Chemical formulations and residuals safe for handling and use, below established residue limits, and non-cytotoxic.	"The Reliance chemical formulations, as supplied in packaging as well as in use dilutions, can be safely handled and used by customers. Residues that may remain on medical endoscopes and accessories are below established residue limits and do not pose a risk to patients." Testing: In vitro cytotoxicity, chemical residual analysis, literature reviews of toxicity data for enzymatic detergent components. For Reliance DG: acute oral/ocular toxicity, dermal irritation, in vitro bacterial mutation genotoxicity, sensitization, in vitro cytotoxicity, literature reviews. Performance: "Use dilution reaches non-cytotoxic levels with minimal dilution." "Biocompatibility testing of extracts from processed medical devices demonstrated that no toxic residuals remain on devices under worst case circumstances."
VERIFY Process Indicator	"Change to colorless (complete change)" at or above minimum effective PAA dose of 9000 mg/L PAA; failure to change (incomplete change) below.	Acceptance criteria stated as: "NOT colorless (incomplete change) at end of Reliance Advance Endoscope Processing Cycle using the minimum effective PAA dose of 9000 mg/L PAA min, or in a processing cycle without PAA." This implies the indicator should change color to indicate sufficient PAA, and not change if insufficient. The actual performance against this acceptance criterion is not explicitly stated as "met" or "passed" in the provided text.

2. Sample Sizes and Data Provenance

Cleaning Phase Efficacy (Simulated Use):
- Test Set Sample Size: 15 heat-sensitive flexible endoscopes, dilators, and their accessories.
- Data Provenance: Not explicitly stated, but "simulated use studies" typically imply laboratory-controlled settings, likely in the US (where STERIS Corporation is based). Retrospective (if using existing designs) or prospective (for new device evaluation).
Cleaning Phase Efficacy (Clinical In-Use):
- Test Set Sample Size: Four types of flexible endoscopes (bronchoscopes, gastroscopes, colonoscopies, and duodenoscopes) and their accessories. "In triplicate evaluations" implies 3 runs for each endoscope type.
- Data Provenance: "US hospital." Prospective (actual clinical use).
Reliance DG Microbial Efficacy (Simulated-Use):
- Test Set Sample Size: "each selected clinically relevant flexible endoscope and its accessory," with "triplicate trials." Specific number of endoscopes not detailed beyond "each selected."
- Data Provenance: Not explicitly stated, likely laboratory-based, possibly in the US. Retrospective or prospective.
Reliance DG Microbial Efficacy (In-Use):
- Test Set Sample Size: "Three flexible endoscopes representing the range of types indicated in the product labeling." "In triplicate evaluations of each endoscope."
- Data Provenance: Not explicitly stated, but "clinical procedures" suggests data from a healthcare setting, likely in the US. Prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications for establishing ground truth for cleaning or disinfection efficacy. The "clean" acceptance levels for protein, carbohydrates, and total organic carbon are described as "established" and "pre-determined," implying standards or expert consensus, but details are not provided. Microbial studies refer to AOAC tests, which are standardized protocols rather than expert consensus on individual cases.

4. Adjudication Method for Test Set

Not applicable. The studies described are performance tests against established criteria (e.g., visual cleanliness, chemical residue levels, microbial reduction logs, standardized test protocols like AOAC), not image-based diagnostic studies requiring reader adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study (MRMC for comparing human reader performance with/without AI) is not relevant to the described device, which is an automated endoscope reprocessor, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance

Yes, in essence. The described performance studies (cleaning efficacy, microbial efficacy, processor performance) represent the standalone performance of the device (the Reliance Advance Endoscope Processing System) without human intervention in the core processing steps, beyond loading and initiating the cycle. Manual cleaning is explicitly not required prior to processing, emphasizing its standalone cleaning capability. The human role is minimal during the automated cycle.

7. Type of Ground Truth Used

Cleaning Efficacy:
- Simulated Use: A combination of established acceptance levels for protein, carbohydrates, and total organic carbon (measured by validated assays) and visual cleanliness.
- Clinical In-Use: Similar to simulated use, relying on pre-determined "clean" acceptance levels for chemical residues and visual cleanliness.
Microbial Efficacy:
- Potency (Sporicidal, Tuberculocidal, Virucidal, Bactericidal, Fungicidal): Based on standardized microbiological test protocols (e.g., AOAC tests) which define specific reduction requirements against target microorganisms.
- Simulated-Use & In-Use: Measured microbial reduction logs (e.g., > 6 log10 reduction) and absence of recovered organisms after processing, determined by laboratory culturing methods.
Other tests (Material Compatibility, Stability, Processor Performance): Based on objective measurements, observations, and adherence to predefined engineering or chemical specifications.

8. Sample Size for the Training Set

The document does not describe the development of an AI algorithm or a "training set" in the context of machine learning. The device is an electromechanical system with a microprocessor-based controller and proprietary chemistry, the development of which would involve engineering, chemistry, and microbiology rather than machine learning training data.

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

Not applicable, as there is no mention of a training set for an AI algorithm. The "ground truth" for the device's design and engineering would be based on scientific principles, regulatory standards, and performance testing results.

Summary

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Image /page/0/Picture/1 description: The image shows the word "STERIS" in a bold, sans-serif font. There is a registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal lines that are stacked on top of each other. The lines are not straight, but have a slight wave to them.

JUL 2 6 2013

510(k) Summary For Reliance™ Advance Endoscope Processing System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:

Marcia L. Benedict Senior Director, Regulatory Affairs Telephone: (440) 392-7063 Fax No:

July 26, 2013 Summary Date:

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

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1. Device Name

Trade Name:	Reliance Advance Endoscope Processing System
Common/usual Name:	Automated Endoscope Reprocessor
Classification Name:	21 CFR 876.1500Endoscope Cleaning Germicide Accessories
Device Class:	II
Product Code:	NZA

2. Predicate Device

Reliance Endoscope Processing System (EPS) - K102244 EVOTECH Endoscope Cleaner and Reprocessor (ECR) - K061899

3. Description of Device

The Reliance Advance Endoscope Processor is an electromechanical . washer/high level disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor selfdecontamination cycles.
. The proprietary enzymatic detergent is dispensed automatically during the Cleaning phase of the cycle to effectively clean endoscope(s) and accessories.
. Reliance DG Dry Germicide is a proprietary, two-part, dry, single-use oxidative chemistry, designed to generate the high level disinfection solution upon automatic dilution in water within the Reliance Endoscope Processor.
. Various accessories are available to accommodate the processing needs of specific endoscopes and endoscopic accessories.
VERIFY Process Indicator for Reliance EPS is available to monitor for the . effective dose of the Reliance DG active ingredient, peracetic acid.

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CIP 200 Acid-Based Process and Research Cleaner, a general cleaning agent, is . used in one of the two self-decontamination cycles provided by the processor.
The Reliance Advance Endoscope Processing Cycle can perform endoscope leak testing and integrity monitoring throughout the following standardized cycle:
The first part of this cycle is a standardized, non-optional cleaning phase that consists of a dynamic wash using proprietary enzymatic detergent, followed by a rinse. In this phase, a controlled quantity of the concentrated enzymatic detergent is dispensed into the circulating warm water volume in the processor. forming an effective cleaning solution that is directed through endoscope lumens and onto all device surfaces.
The Reliance cleaning phase can be used in place of manual cleaning by the user. It does not replace the bedside pre-cleaning performed in the procedure room.
The second part is a non-optional high level disinfection phase; its parameters cannot be changed by the user. In this phase, the proprietary Reliance DG components, provided in a single use container, are dissolved with water at ~50℃ to create the peracetic acid disinfection solution that is circulated throughout the processor and through device lumens for a 6 minute exposure time.
=> Following high level disinfection, the Reliance Advance Endoscope Processor removes the germicide use-dilution through a rinse phase which is nonoptional; the parameters cannot be changed by the user. The processor filters the rinse water (as well as all of the water used throughout the cycle) through a 0.2 micron bacterial-retentive filter. There is an automatic internal integrity check of this filter at the end of each processing cycle. If the integrity check fails, an alarm alerts the user, and the processor does not complete the cvcle.
The last step in the processing cycle is an air purge phase using HEPAfiltered air. The air purge helps to remove 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.
At the end of each cycle the processor prints a detailed evcle summary with information such as processor number, date, start and stop times, and phase parameters. With an optional bar code reader, the printouts can also include identification numbers for the operator, patient, device, doctor and procedure.

The processor features two decontamination cycles that are to be used without endoscopes in the processor:

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 cvcle in which CIP 200 Acid-Based Process and Research Cleaner is added to hot water and circulated through the processor for 20 minutes; this is followed by three rinses to

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remove the solution, and a 10-minute hot air purge. D-LONG is used when the D-SHORT cycle has not been run within the past 54 hours.

4. Intended Use

The Reliance Advance Endoscope Processing System is intended for cleaning and high level disinfection of up to two immersible, reusable, heat-sensitive, semicritical devices such as GI flexible endoscopes, bronchoscopes and their accessories.

During the system's Endoscope Processing Cycle, cleaning is achieved within the Cleaning Phase, and high level disinfection is achieved within the 50 - 57°C HLD Phase (4 minute generation sequence followed by a 6 minute exposure sequence).

Manual cleaning is not required prior to processing in Reliance Advance Endoscope Processing System.

Technological Characteristics న.

The Reliance Advance Endoscope Processing System is not significantly different from the predicate Reliance EPS in technology. Technological modifications of the Reliance EPS design for the Reliance Advance Endoscope Processing System are summarized below:

Property▼	Proposed Reliance AdvanceEndoscope Processor	K102244 STERISReliance Endoscope Processor
EndoscopeProcessingCycle	The standardized Endoscope ProcessingCycle (with one or two endoscopes)includes a Cleaning phase and its rinse,which is followed by the HLD phase,final rinses, and air purge.	In the Endoscope Processing Cycle (withone or two endoscopes) the user has theoption to select zero, one or two Washphases of 5 - 10 minutes each includinga rinse, which is followed by the HLDphase, final rinses, and air purge.
EnzymaticDetergentand DoseControl	Peristaltic pump injects a meteredvolume of the proprietary new enzymaticdetergent during the Cleaning phase.A flow meter provides feedback to themicroprocessor to verify that therequired volume of enzymatic detergentwas injected by the peristaltic pump.	Peristaltic pump injects a meteredvolume of Klenzyme during Washphases.

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The Reliance Advance Endoscope Processing System is technologically similar to the EvoTech Endoscope Cleaner and Reprocessor (ECR) predicate, as shown in the comparison table below.

Property ▼	Proposed Reliance AdvanceEndoscope Processor	K061899EvoTech Endoscope Processor
Control	Microprocessor-controlledprogrammable processor monitors andcontrols critical cycle parameters andprovides a printed record upon cyclecompletion.	Microprocessor-controlledprogrammable processor monitors andcontrols critical cycle parameters andprovides a printed record upon cyclecompletion.
Capacity	One or two endoscopes and accessories	One or two endoscopes and accessories
Mechanismfor channelaccess	Uses a pressurized control handle bootsuch that operation is largely connector-less. Flow Units are used for specializeddevice processing needs.	Relies upon multiple tubings andconnectors to provide flow to innerchannels of endoscopes.
EnzymaticDetergent	Requires use of a proprietary enzymaticdetergent for cleaning.	Requires use of a proprietary enzymaticdetergent for cleaning.
Germicide	Requires Reliance DG Dry Germicide.	Requires Cidex OPA.
Monitoring	Requires use of a VERIFY ProcessIndicator for Reliance EPS strip witheach Endoscope Processing Cycle.	Has an on-board concentration monitor.
Rinsing	Devices are rinsed with filtered water.	Devices are rinsed with filtered water.
Leak Test	Automated leak test is selectable.	Automated test assures absence of majorleaks in the endoscope body.
Alcohol flush	Not provided	Selectable in this system
Self-Disinfection	Has capacity to perform self-disinfection.	Has capacity to perform self-disinfection.

6. Description of Safety and Substantial Equivalence

The Reliance Advance Endoscope Processing System has the same intended use for cleaning and high level disinfection of flexible endoscopes as the predicate EvoTech ECR. It is substantially equivalent to the EvoTech ECR with respect to achieving cleaning and high level disinfection of a wide range of flexible endoscopes and accessories.

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7. Performance Testing Summary

Reliance Advance Endoscope Processing System Performance Testing Summary
CleaningPhaseEfficacy	• Cleaning Phase Effectiveness in Simulated Use StudiesReliance Advance EPS has been tested and shown to achieve effective cleaningof soiled flexible endoscopes and their accessories. Testing was performed on adiverse array of OEM endoscopes incorporating the most challenging designfeatures for cleaning, and under worst case simulated use conditions with respectto soil levels, drying, enzymatic detergent concentration, water condition, andcleaning phase exposure time.
	Fifteen (15) heat-sensitive flexible endoscopes, dilators, and their accessorieswere soiled with select test soils at levels appropriate to the intended use of theinstrument. After the worst case Reliance Advance EPS cleaning phase insimulated use, 1) all test articles were visually clean, and 2) all samples recoveredfrom previously soiled areas for all test articles met the established acceptancelevels defined as "clean" for protein, carbohydrates, and total organic carbon invalidated assays for those components.
	• Cleaning Phase Effectiveness in Clinical In-Use StudiesEfficacy of the Reliance Advance EPS Cleaning Phase was evaluated in use in aUS hospital. Four types of flexible endoscopes (bronchoscopes, gastroscopes,colonoscopies, and duodenoscopes) and their accessories as listed in RelianceAdvance EPS labeling were used in clinical procedures, pre-cleaned at thebedside, allowed to dry for 47 – 100 minutes, and then processed through theReliance Advance Endoscope Processing Cycle's Cleaning phase only, accordingto the instructions for use. Cleaning endpoints were evaluated.
	In triplicate evaluations, each of the tested clinically soiled endoscopes 1) wasvisually clean, and 2) met the soil pre-determined "clean" acceptance levels forprotein, carbohydrates, and total organic carbon in validated assays.
EnzymaticDetergentStability	• Enzymatic Detergent Stability:The proprietary enzymatic detergent has been shown to be stable in its Bag-in-Box packaging through 12 months under representative storage conditions. This protocol of testing continues; the shelf life may be extended based on additional data meeting established acceptance criteria.
SoftwareValidation	The Reliance Advance EPS software was developed and validated in accordance with the FDA requirements for a Major Level of Concern determination based on the recommendation in the FDA Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities dated August 1993.All acceptance criteria were met.

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Reliance Advance Endoscope Processing System Performance Testing Summary
MaterialCompatibility	Enzymatic Detergent Material Compatibility
	The proprietary enzymatic detergent was evaluated for its effect on commonmaterials of endoscope and accessory construction. After 300 processing cycles,no deleterious effects were observed other than minor cosmetic changes. Nofunctional changes in flexible endoscopes were observed.
	Reliance DG Material Compatibility:
		The system was previously evaluated for its effect on intact medical devices,including flexible endoscopes and/or common materials of device construction.After 300 processing cycles, no deleterious effects were observed other than minorcosmetic changes. No functional changes in flexible endoscopes were observed.
	specifications.	The critical process parameters for the processor (water temperature and volume,fresh DG container detection, boot pressure, water filter integrity testing, anddelivery of cleaning and high level disinfection solutions) have each beenevaluated in replicate under worst case conditions, and found to be within required
	Each processor phase or cycle has been separately evaluated and shown to beeffective under worst case conditions:
ProcessorPerformance	The standard Cleaning phase using STERIS's proprietary enzymaticîdetergent had no effect on generation of the active from Reliance DG inReliance Advance EPS during the HLD phase of the Endoscope ProcessingCycle.
	The HLD and Rinse phases of the Endoscope Processing Cycle have beenीshown to be effective. The air purge phase effectively removes rinse waterfrom processed devices. The filter integrity test system has been shown toreliably detect filter failure.
	The two self-decontamination cycles were shown to be effective as follows inੀprior studies:
	D-LONG cycle - can disinfect the Reliance Endoscope Processor after a. .high level challenge with Pseudomonas aeruginosa followed by a 5 dayinactive period;
	●	D-SHORT cycle - can kill bacteria that have potential to form biofilm.
Certificationto electricalsafetystandards	ANSI/UL -61010-1, 200	Electrical equipment for measurement, control andlaboratory use Part 1, 200 Edition
	CAN/CSA C22.2 61010-1,2" Ed.	Electrical equipment for measurement, control andlaboratory use Part 1, 2nd Edition
	IEC 61010-1:2001	Safety requirements for electrical equipment formeasurement, control and laboratory use, Part 1:General requirements
	IEC 61010-2-40, 1st Ed.	Safety requirements for electrical equipment formeasurement, control and laboratory use -Part 2-040: Particular requirements for sterilizers andwasher-disinfectors used to treat medical materials
	IEC 61326-1:2005, 136 Ed.	Electrical equipment for measurement, control andlaboratory use, EMC requirements Part 1: Generalrequirements

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Reliance Advance Endoscope Processing System Performance Testing Summary
Reliance DGDryGermicideEfficacy	Reliance DG Dry Germicide Use Solution Microbial Efficacy:
	Potency: Reliance DG has been tested and shown to generate an effective highlevel disinfection solution using the standard array of microbiological tests forgermicidal efficacy. Prior to the current submission, the following testing wasperformed at conditions of use that were worst case with respect to germicideconcentration, contact time, circulation, water hardness, temperature and artificialsoiling.
	⇒ Sporicidal: Reliance DG was proven to be sporicidal as defined by AOACSporicidal Activity Test with exposure time of 6 minutes. Confirmatory testingwas completed successfully and supplemental confirmatory testing wascompleted in the Reliance Endoscope Processor. Potency was subsequentlyconfirmed in the processor and in vitro using Reliance DG containers thatwere aged beyond the end of its shelf life.
	⇒ Tuberculocidal: Reliance DG was proven to be tuberculocidal as defined bythe AOAC Tuberculocidal Activity Test with an exposure time of 6 minutes.Potency was subsequently confirmed using Reliance DG aged beyond theend of its shelf life.
	⇒ Virucidal: The Reliance Process was proven to reduce the viable populationof poliovirus Type 1, adenovirus Type 5, and herpes simplex virus Type 1by > $4 log10$ .
	⇒ Bactericidal: Reliance DG was proven to be bactericidal as defined by theAOAC Bactericidal Activity Test with an exposure time of 6 minutes at worstcase conditions, whether performed in situ or in vitro.
	⇒ Fungicidal: Reliance DG was proven to be tuberculocidal as defined by theAOAC Tuberculocidal Activity Test with an exposure time of 6 minutes,whether performed in situ or in vitro.
	Simulated-Use: Reliance DG, at its minimum recommended concentration,reproducibly achieved greater than a 6 $log^{10}$ reduction of Mycobacterium terrae intriplicate trials within the Reliance Endoscope Processor for each selectedclinically relevant flexible endoscope and its accessory. The test articlesrepresented the range of most challenging devices, accessories, and processingsituations.
	In-Use: Three flexible endoscopes representing the range of types indicated in theproduct labeling were used in clinical procedures and processed according toinstructions for use. In triplicate evaluations of each endoscope, no organismswere recovered after processing. Bioburden levels on the clinically usedendoscopes after manual cleaning and before high level disinfection weredetermined to be as high as 105 CFU/device.
Reliance DG Stability:
Reliance DGStability	Reliance DG has been shown to be stable for 18 months in the unopenedmoisture-resistant package at the stated conditions for storage. Once opened, thefive Reliance DG containers within each package are to be used within two (2)weeks, or by the expiration date on the container, whichever comes first.
Reliance Advance Endoscope Processing System Performance Testing Summary
Bio-compatibility	Biocompatibility:The Reliance chemical formulations, as supplied in packaging as well as in usedilutions, can be safely handled and used by customers. Residues that mayremain on medical endoscopes and accessories are below established residuelimits and do not pose a risk to patients. Safety statements in product labeling areappropriate to the potential risk.
	⇒ Enzymatic detergent components, reaction products, and residuals remainingon medical devices were evaluated for biocompatibility and possible risks tousers including literature reviews of raw material toxicity data. Testingincluded in vitro cytotoxicity evaluations on extracts of processed devices andrinse water, and analysis for chemical residuals.
	⇒ Reliance DG, its components, reaction products, and residuals remaining onmedical devices have previously been evaluated for biocompatibility andpossible risks to users. Testing included acute oral and ocular toxicity tests,dermal irritation studies, in vitro bacterial mutation genotoxicity studies,sensitization tests, and in vitro cytotoxicity evaluations; literature reviews ofraw material toxicity data were also performed. Certain components in thesingle-use DG container, which under normal use conditions never contactthe user, have the potential for irritation or skin sensitization; thereforeappropriate warnings and instructions are displayed on labeling for theunusual event of a spill or container breakage.
	⇒ Use dilution reaches non-cytotoxic levels with minimal dilution.
	⇒ Biocompatibility testing of extracts from processed medical devicesdemonstrated that no toxic residuals remain on devices under worst casecircumstances. The test data indicate that the worst case residue levels forthe components of maximum potential risk are far below the allowable limits,and the processor final rinse water was found to be non-cytotoxic.
	Performanceof VERIFY CIfor RelianceEPS
NOT colorless (incomplete change) at end of Reliance Advance EndoscopeProcessing Cycle using the minimum effective PAA dose of 9000 mg/L PAAmin, or in a processing cycle without PAA

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Conclusion:

The completed nonclinical performance testing has demonstrated that the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate devices.

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

July 26, 2013

STERIS Corporation Ms. Marcia L. Benedict Senior Director, Regulatory Affairs 5960 Heislev Road Mentor OH 44060

Re: K123768

Trade/Device Name: Reliance™ Advance Endoscope Reprocessing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NZA Dated: June 27, 2013 Received: June 28, 2013

Dear Ms. Benedict:

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 - Ms. Benedict

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{11}------------------------------------------------

Indications for Use

510(k) Number (if known): | 23 7 レタ

Device Name:

Reliance™ Advance Endoscope Processing System

Indications For Use:

Manual cleaning is not required prior to processing in Reliance Advance Endoscope Processing System.

Prescription Use (Part 2) CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sreekanth Gutala -S 2013.07.25 14:42:31 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K183768

Page 1 of 1

December 6, 2012

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.