The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices such as flexible endoscopes and their accessories.

The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor.

The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medical devices. It automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46.6 to 55°C and rinses the load with 0.2-micron filtered water.

Device Description

The enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS) is a medical device processing system used for cleaning and liquid chemically sterilizing immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 3000 Processor, Revital-Ox 2X Concentrate Enzymatic Detergent, S40 Sterilant Concentrate and Max Flow Connectors.

The enspire 3000 Cleaning and LCSPS is an automated, self-contained device for the effective cleaning and liquid chemical sterilization of semi-critical medical devices and their accessories. The devices will not require manual cleaning prior to processing in the enspire 3000 Processor with the exception of duodenoscopes which must be manually cleaned per the manufacturer's instructions for use. In addition, prior to placement in the enspire 3000 processor, the device will undergo a manual leak test and the user will ensure the lumens are not blocked. If the device has internal channels or lumens, Max Flow Connectors are used to facilitate the delivery of detergent, sterilant use-solution and rinse water to internal channels.

Once the device is positioned in the enspire 3000 processor, the unit will create and maintain the conditions necessary for effective cleaning and liquid chemical sterilization of the load. At the beginning of the processing cycle, automated pressure monitoring is performed to confirm the integrity of the flexible endoscope throughout the process. The enspire 3000 processor maintains inflation of the processed device to prevent ingress of fluid during processing and the pressure monitoring is repeated at the end of the processing cycle to ensure that the device is leak tight after cleaning and liquid chemical sterilization. At the end of the processing cycle, the cleaned and liquid chemically sterilized devices are rinsed with 0.2 micron filtered potable water followed by a HEPA-filtered air purge to aid in drying the endoscope. The processor, which is computer controlled and continually monitored, provides documentation of each cycle.

The enspire 3000 processor utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and S40 Sterilant Concentrate for liquid chemical sterilization. S40 Sterilant Concentrate is a single use chemical sterilant concentrate; its active ingredient, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

AI/ML Overview

The provided text is an FDA 510(k) summary for a medical device called the "enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System." This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically for a modification to the existing device (changing materials in the Chemical Delivery System).

As such, the document does not describe a study involving human readers, AI assistance, ground truth labels from experts for diagnostic tasks, or a training set for an AI model. The "device" in question is not an AI/ML algorithm for image analysis or diagnosis. Instead, it's a machine for sterilizing endoscopes.

Therefore, many of the requested points, such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and AI model training details, are not applicable to this type of device and the information provided in the document.

However, I can extract the acceptance criteria and performance related to the modification of this physical device.

Here's the relevant information based on the provided text:

Acceptance Criteria and Device Performance for the Modified Enspire 3000 System

The study described is not for an AI/ML diagnostic device, but rather for a physical medical device (an endoscope reprocessor) that has undergone a material change in one of its components. The acceptance criteria and performance relate to the safety and efficacy of the modified reprocessing system.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Test Description and Acceptance Criteria	Reported Device Performance
Chemical Delivery	The proposed Chemical Delivery System was used in reprocessing cycles to deliver S40 Sterilant Concentrate to the processor to form the use dilution. The delivery of chemistry must be reproducible.	PASS
Material Compatibility	Tensile testing was performed on the proposed material for the Chemical Delivery System unexposed or exposed to the ingredients of S40 Sterilant Concentrate. The materials of construction of the Chemical Delivery System must be compatible with the ingredients of S40 Sterilant Concentrate as demonstrated by no change in tensile testing.	PASS
Rinsing Efficacy	A representative endoscope was exposed to multiple processing cycles and extracted per ISO 10993-12. The device extracts were analyzed to verify chemical residual levels were below the highest acceptable levels.	PASS
Biocompatibility	Based on results of toxicological review per ISO 10993-1, representative endoscopes were exposed to multiple processing cycles and extracted per ISO 10993-12. The device extracts were tested for cytotoxicity per ISO 10993-5 to verify that the device extracts were non-cytotoxic.	PASS

Regarding the other requested information, which is primarily relevant for AI/ML diagnostic devices, it is not found in this document because the device is not an AI/ML system.

Here's why each point is Not Applicable (N/A) in this context:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A: The "test set" here refers to physical tests conducted on the modified device and its components, not a dataset of medical images or patient data. The document mentions "multiple processing cycles" and "representative endoscope" but no specific numeric sample sizes for these qualitative/quantitative tests. Data provenance in terms of country of origin or retrospective/prospective is not relevant for this type of device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A: Ground truth for diagnostic AI models is established by human experts (e.g., radiologists). For this device, "ground truth" is based on established engineering and chemical standards (e.g., ISO standards, acceptable chemical residual levels, non-cytotoxicity). No human experts are described as "establishing ground truth" in the way they would for a diagnostic AI study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: Adjudication methods are used in AI studies where multiple human readers disagree on a diagnosis or annotation. This is a physical device subject to engineering and chemical validation tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A: An MRMC study is relevant for evaluating the impact of AI assistance on human diagnostic performance. This device is an endoscope reprocessor, having no direct interaction with human diagnostic reading.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: "Standalone performance" refers to the accuracy of an AI algorithm in performing a diagnostic task without human intervention. This device performs a physical reprocessing function, not a diagnostic one.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A: As explained in point 3, the "ground truth" for this device's performance relies on engineering specifications, chemical analysis, and biocompatibility standards rather than medical diagnostic ground truth sources like pathology or patient outcomes.
8. The sample size for the training set
- N/A: This device is a physical machine, not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established
- N/A: As this is not an AI/ML model, there is no training set or associated ground truth to establish in that context.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 2, 2024

STERIS Corporation Jennifer Nalepka Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K243433

Trade/Device Name: enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: November 5, 2024 Received: November 5, 2024

Dear Jennifer Nalepka:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katharine Segars -S

Katharine Segars, Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K243433

Device Name

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System

Indications for Use (Describe)

The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, reusable, semicritical, heat sensitive medical devices such as flexible endoscopes and their accessories.

The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medical devices. It automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liguid chemically sterilizes the load during a controlled 6-minute exposure at 46.6 to 55°C and rinses the load with 0.2-micron filtered water.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System K243433

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600

Contact: Jennifer Nalepka Manager, Regulatory Affairs Tel: 440-392-7458 Email: jennifer_nalepka@steris.com

November 27, 2024 Summary Date:

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

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1. Device Name

Trade Name:	enspire 3000 Cleaning and Liquid Chemical SterilantProcessing System
Device Classification:	Class II
Common/usual Name:	Endoscope Cleaner and Reprocessor
Classification Name:	Endoscope and Accessories
Classification Number:	21 CFR 876.1500
Product Code:	FEB

2. Predicate Device

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System, K230930

3. Description of Device

The enspire 3000 processor utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and S40 Sterilant Concentrate for liquid chemical sterilization. S40 Sterilant

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Concentrate is a single use chemical sterilant concentrate; its active ingredient, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

Proposed Modification

The modification being proposed for clearance through this premarket notification is for a change in materials of the Chemical Delivery System (CDS) of the enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS). The CDS is designed to hold the S40 Sterilant Concentrate cup and puncture the start of the liquid chemical sterilization phase of the cycle so that the chemistry can be mixed with water to form the use dilution. The CDS assembly consists of a cup receiver and lid, puncture needle, pneumatic cylinder, and door. The cup receiver and lid are made from acrylonitrile butadiene styrene (ABS) plastic and these parts will be changed to be made from polysulfone (PS).

4. Indications for Use

ട. Technological Characteristic Comparison Tables

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Table 1. Predicate Device Comparison Table
Feature	Proposed DeviceK243433enspire 3000 Cleaning andLiquid Chemical SterilantProcessing System (CLCSPS)	Predicate DeviceK230930enspire 3000 Cleaning andLiquid Chemical SterilantProcessing System (CLCSPS)	Comparison
Intended UseIndications forUse	The enspire™ 3000 SeriesCleaning and Liquid ChemicalSterilant Processing System isintended to effectively provide apressure monitor, clean, provideliquid chemical sterilization, rinse,and air purge validatedimmersible, reusable, semi-critical,heat sensitive medical devicessuch as flexible endoscopes andtheir accessories.The validated cleaning processreplaces cleaning for endoscopesother than duodenoscopes. Manualcleaning of duodenoscopesaccording to the manufacturer'swritten instructions for use isrequired prior to placement in the	The enspire™ 3000 SeriesCleaning and Liquid ChemicalSterilant Processing System isintended to effectively provide apressure monitor, clean, provideliquid chemical sterilization, rinse,and air purge validatedimmersible, reusable, semi-critical,heat sensitive medical devicessuch as flexible endoscopes andtheir accessories.The validated cleaning processreplaces cleaning for endoscopesother than duodenoscopes. Manualcleaning of duodenoscopesaccording to the manufacturer'swritten instructions for use isrequired prior to placement in the	Identical
Feature	Proposed DeviceK243433enspire 3000 Cleaning andLiquid Chemical SterilantProcessing System (CLCSPS)enspire™ 3000 Series Processor.	Predicate DeviceK230930enspire 3000 Cleaning andLiquid Chemical SterilantProcessing System (CLCSPS)enspire™ 3000 Series Processor.	Comparison
OperatingPrinciples /Technology	The enspire™ 3000 SeriesProcessor uses only Revital-Ox 2XConcentrate Enzymatic detergentto clean and S40 SterilantConcentrate to liquid chemicallysterilize medical devices. Itautomatically dilutes the S40Sterilant Concentrateto its use dilution (> 1820 mg/Lperacetic acid), liquid chemicallysterilizes the load during acontrolled 6-minute exposure at46.6 to 55°C and rinses the loadwith 0.2-micron filtered water.Microprocessor controlled unitwith a fixed basin. The processor lid is openedwith hands-free lid operation. Devices with internal lumensare interfaced with theprocessor using connectors,i.e. Max Flow Units Instrument pressuremonitoring performed atbeginning and end of cycle tomonitor endoscope integrity Revital-Ox 2X ConcentrateEnzymatic Detergent isdispensed for the cleaningphase of the processing cycle. Single-use cup of S40Sterilant Concentrate is placedin a specialized compartment;when the processor fills withwater during the LCS phase ofthe processing cycle, it createsthe sterilant use dilution The processor automaticallyrinses the load with 0.2 micronfiltered water after cleaningand LCS phases HEPA-filtered air purge to aidin drying	The enspire™ 3000 SeriesProcessor uses only Revital-Ox 2XConcentrate Enzymatic detergentto clean and S40 SterilantConcentrate to liquid chemicallysterilize medical devices. Itautomatically dilutes the S40Sterilant Concentrateto its use dilution (> 1820 mg/Lperacetic acid), liquid chemicallysterilizes the load during acontrolled 6-minute exposure at46.6 to 55°C and rinses the loadwith 0.2-micron filtered water.Microprocessor controlled unitwith a fixed basin. The processor lid is openedwith hands-free lid operation. Devices with internal lumensare interfaced with theprocessor using connectors,i.e. Max Flow Units Instrument pressuremonitoring performed atbeginning and end of cycle tomonitor endoscope integrity Revital-Ox 2X ConcentrateEnzymatic Detergent isdispensed for the cleaningphase of the processing cycle. Single-use cup of S40Sterilant Concentrate is placedin a specialized compartment;when the processor fills withwater during the LCS phase ofthe processing cycle, it createsthe sterilant use dilution The processor automaticallyrinses the load with 0.2 micronfiltered water after cleaningand LCS phases HEPA-filtered air purge to aidin drying	Identical
Feature	Proposed DeviceK243433enspire 3000 Cleaning andLiquid Chemical SterilantProcessing System (CLCSPS)	Predicate DeviceK230930enspire 3000 Cleaning andLiquid Chemical SterilantProcessing System (CLCSPS)	Comparison
ProcessParameters	Standardized cycle parameterscannot be altered by the operator.The critical process parametersmonitored during processing:Detergent dilution andcleaning timeDetergent dilution temperatureUse dilution contact timeUse dilution temperature	Standardized cycle parameterscannot be altered by the operator.The critical process parametersmonitored during processing:Detergent dilution andcleaning timeDetergent dilution temperatureUse dilution contact timeUse dilution temperature	Identical
ProcessMonitors	The processor monitors andcontrols the detergent and LCSuse dilution phase times.Cycle record documentssuccessful cycle completion oridentifies fault if cycle abortsAlarms if RTDs indicatetemperature out ofspecificationAlarms if pressure switchindicates that high pressurepump is not operatingAlarms if pressure transducerindicates circulation pressure isout of specificationAlarms if internal water filterfailed Filter Integrity Test.Alarms if loss of pressureinside of endoscope indicates aleak	The processor monitors andcontrols the detergent and LCSuse dilution phase times.Cycle record documentssuccessful cycle completion oridentifies fault if cycle abortsAlarms if RTDs indicatetemperature out ofspecificationAlarms if pressure switchindicates that high pressurepump is not operatingAlarms if pressure transducerindicates circulation pressure isout of specificationAlarms if internal water filterfailed Filter Integrity Test.Alarms if loss of pressureinside of endoscope indicates aleak	Identical
DesignFeatures	Unalterable and standardizedProcessing Cycle for cleaningand liquid chemicalsterilizationFilter Integrity Test fordemonstrating 0.2 micronwater filter maintainsfunctionality after replacementor power outageAutomated stand-alone systemwith one reprocessing basinBasin lid features a rotatingspray arm.Intended for use with onlyRevital-Ox 2X Concentrate	Unalterable and standardizedProcessing Cycle for cleaningand liquid chemicalsterilizationFilter Integrity Test fordemonstrating 0.2 micronwater filter maintainsfunctionality after replacementor power outageAutomated stand-alone systemwith one reprocessing basinBasin lid features a rotatingspray arm.Intended for use with onlyRevital-Ox 2X Concentrate	Identical
Feature	Proposed DeviceK243433enspire 3000 Cleaning andLiquid Chemical SterilantProcessing System (CLCSPS)	Predicate DeviceK230930enspire 3000 Cleaning andLiquid Chemical SterilantProcessing System (CLCSPS)	Comparison
	Sterilant Concentrate• Automated delivery ofRevital-Ox 2X ConcentrateEnzymatic Detergent• Automated dilution anddelivery of S40 Sterilant• Processor provides 0.2 micronfiltered water for liquidchemical sterilization andrinsing after LCS phase ofProcessing Cycle• Compressed air for processorduring drain sequence isfiltered through a 0.2 micronmembrane air filter• Includes a bar code scanner;employs touchscreen displayinterface; has USB drive forelectronic cycle download;facilitates use of a web-baseddata management system.• Separate, optional printer	Sterilant Concentrate• Automated delivery ofRevital-Ox 2X ConcentrateEnzymatic Detergent• Automated dilution anddelivery of S40 Sterilant• Processor provides 0.2 micronfiltered water for liquidchemical sterilization andrinsing after LCS phase ofProcessing Cycle• Compressed air for processorduring drain sequence isfiltered through a 0.2 micronmembrane air filter• Includes a bar code scanner;employs touchscreen displayinterface; has USB drive forelectronic cycle download;facilitates use of a web-baseddata management system.• Separate, optional printer
	Cycle Parameters		Comparison
Integrity Test	Performed at beginning and end ofcycle	Performed at beginning and end ofcycle	Identical
Pre-RinsePhase	Pre-filtered water at 40°C	Pre-filtered water at 40°C	Identical
IncomingWater Temp	37 - 45°C	37 - 45°C	Identical
CleaningPhaseTemperature	> 42.2°C	> 42.2°C	Identical
CleaningPhaseExposureTime	2 minutes	2 minutes	Identical
Rinse Phaseafter Cleaning	Pre-filtered water below 55°C	Pre-filtered water below 55°C	Identical
HLD or LCSPhaseTemperatureRange	LCS: 46.6 - 50°C	LCS: 46.6 - 50°C	Identical
HLD or LCSPhaseExposure	6 minutes	6 minutes	Identical
Feature	Proposed DeviceK243433enspire 3000 Cleaning andLiquid Chemical SterilantProcessing System (CLCSPS)	Predicate DeviceK230930enspire 3000 Cleaning andLiquid Chemical SterilantProcessing System (CLCSPS)	Comparison
Time
Rinse Phaseafter HLD orLCS	Hot potable tap water that is pre-filtered then filtered through a 0.2micron bacterial retentive filter	Hot potable tap water that is pre-filtered then filtered through a 0.2micron bacterial retentive filter	Identical
Number ofrinses	2 after Cleaning Phase2 after LCS Phase	2 after Cleaning Phase2 after LCS Phase	Identical
Alcohol Rinse	No	No	Identical
Air Purge	Yes	Yes	Identical
ApproximateCycle Time	38 minutes	38 minutes	Identical
Accessories			Comparison
Detergent	Revital-Ox 2X ConcentrateEnzymatic Detergent	Revital-Ox 2X ConcentrateEnzymatic Detergent	Identical
High LevelDisinfectant	N/A	N/A	Identical
LiquidChemicalSterilant	S40 Sterilant Concentrate	S40 Sterilant Concentrate	Identical
Connectors	Max Flow Connectors	Max Flow Connectors	Identical
ChemicalIndicator	Celerity Chemical Indicator forenspire 3000 Cleaning and LiquidChemical Sterile ProcessingSystem	Celerity Chemical Indicator forenspire 3000 Cleaning and LiquidChemical Sterile ProcessingSystem	Identical
Spore TestStrip	VERIFY Spore Test Strip for S40Sterilant	VERIFY Spore Test Strip for S40Sterilant	Identical
OperatorMaintenance	Periodic replacement of detergent,water filters and air filter. Periodicreplacement of printer tape if usingthe external printer option.Cleaning outside of the unit andbasin drain screen as needed.	Periodic replacement of detergent,water filters and air filter. Periodicreplacement of printer tape if usingthe external printer option.Cleaning outside of the unit andbasin drain screen as needed.	Identical

Table 1 Predicate Device ﺮ ricol ты

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Summary of Non-Clinical Testing 6.

Shown in Table 3 is the new testing that was performed to demonstrate substantial equivalence of the enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System with the proposed modification. There are no proposed modifications associated with Revital-Ox 2X Enzymatic Detergent, S40 Sterilant Concentrate or MaxFlow Connectors.

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Test	Test Description and Acceptance Criteria	Result
Chemical Delivery	The proposed Chemical Delivery System was used in reprocessingcycles to deliver S40 Sterilant Concentrate to the processor toform the use dilution. The delivery of chemistry must bereproducible.	PASS
MaterialCompatibility	Tensile testing was performed on the proposed material for theChemical Delivery System unexposed or exposed to theingredients of S40 Sterilant Concentrate. The materials ofconstruction of the Chemical Delivery System must be compatiblewith the ingredients of S40 Sterilant Concentrate as demonstratedby no change tensile testing.	PASS
Rinsing Efficacy	A representative endoscope was exposed to multiple processingcycles and extracted per ISO 10993-12. The device extracts wereanalyzed to verify chemical residual levels were below the highestacceptable levels.	PASS
Biocompatibility	Based on results of toxicological review per ISO 10993-1,representative endoscopes were exposed to multiple processingcycles and extracted per ISO 10993-12. The device extracts weretested for cytotoxicity per ISO 10993-5 to verify that the deviceextracts were non-cytotoxic.	PASS

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7. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K230930), Class II (21 CFR 876.1500), product code FEB.

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.