The RAS Racks are used in the RAS Cycles of AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors for the effective cleaning, rinsing, drying and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers.

Device Description

The RAS Racks are designed to enable the mechanical cleaning, rinsing, and disinfection of up to twelve (12) robotic-assisted surgery instruments in a compatible washer-disinfector. Twelve soiled da Vinci Endowrist X/Xi, S/Si, or Single-Site instruments and staplers, without prior manual cleaning, are loaded into the appropriate RAS Rack according to the provided instructions for use. The rack is placed in the AMSCO 7052HP or 7053L Single-Chamber Washer/Disinfector, and the RAS Cycle is selected.

The RAS Cycle performs automated cleaning through a validated series of spraywashing, lumen flushing steps that use Prolystica Ultra Concentrate HP Enzymatic Cleaner alternately with Prolystica Ultra Concentrate HP Neutral Detergent in temperature-controlled solutions. When the series of automated prewash and washing stages are complete, a one-minute rinse occurs. Next the RAS Cycle completes a thermal rinse to achieve intermediate level disinfection of the load before drying it. Upon RAS Cycle completion, the devices are ready to be prepared and packed for steam sterilization.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (RAS-12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO® 7052HP/7053HP Single Chamber Washer/Disinfector) and its performance testing. However, the information is primarily focused on the cleaning, rinsing, drying, and intermediate level disinfection capabilities of the device for reusable surgical instruments, rather than an AI/ML powered medical device.

Therefore, many of the typical acceptance criteria and study components related to AI/ML device performance (such as sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable or not provided in this document.

The document discusses performance criteria for the washer-disinfector and its accessories, which are mechanical and chemical efficacy tests.

Here's an attempt to extract the relevant information based on the provided text, and point out where information typically associated with AI/ML device studies is absent:

Device Studied: RAS-12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO® 7052HP/7053HP Single Chamber Washer/Disinfector

Purpose of the Study: To demonstrate the substantial equivalence of the subject device to a legally marketed predicate device (da Vinci SonicPro Cleaning System: K073112) for the cleaning, rinsing, drying, and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Simulated Use Testing	Endowrist instruments identified as master devices for their most challenging features were soiled and allowed to dry for at least one hour. They were processed in triplicate trials using the RAS Cycle to the end of the initial rinse (prior to thermal rinse), then examined visually and sampled for quantitation of two soil markers: protein <6.4 µg/cm², TOC <12 µg/cm².	PASS
In-Use Testing	Clinically used Endowrist instruments were installed in the Rack according to its IFU, the rack was placed in the washer/disinfector, and the RAS Cycle was run to the end of initial rinse (prior to thermal rinse). Instruments were examined visually and sampled for quantitation of two soil markers: protein <6.4 µg/cm², TOC <12 µg/cm².	PASS
Rinsing Efficacy and Biocompatibility	Two EndoWrist instruments were processed three (3) consecutive times in full loads using double cleaner concentrations. Rinse water and device extracts were tested for cytotoxicity. Device extracts were analyzed to verify that the chemical residual level is not cytotoxic.	PASS
Thermal Disinfection	Achieves greater than 6-log reduction of each organism in a mixed suspension of vegetative organisms, and greater than 3-log reduction of mycobacterium species.	PASS
W/D Physical Performance	Chemical injection control operates within specifications. Temperature control operates within specifications. Pump maintains high speed performance as designed. Drying is achieved by the RAS Cycle.	PASS
Human Factors	Typical users were capable of following the written instructions for use to correctly configure and load the RAS Rack and to select the correct cycle of the washer/disinfector.	PASS
Electrical Safety Conformance	Conformance to UL 61010-1, UL 61010-2-040, IEC 61326-1:2012, and FCC Part 15.	PASS
Software Validation	The software that controls the system was validated and determined to operate effectively and as designed.	PASS

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

Sample Size:
- Simulated Use Testing: "triplicate trials" of Endowrist instruments. The exact number of instruments per trial is not specified, but it's implied to be multiple (up to 12 instruments can be processed per cycle, as per "Technological Characteristics Comparison Table").
- In-Use Testing: "Clinically used Endowrist instruments" were tested. The specific number of instruments is not quantified.
- Rinsing Efficacy and Biocompatibility: "Two EndoWrist instruments" processed "three (3) consecutive times."
- Thermal Disinfection: Not explicitly stated regarding the number of instruments, but refers to log reduction of organisms.
Data Provenance: Not explicitly stated (e.g., country of origin). The testing described as "Simulated Use Testing" and "In-Use Testing" suggests a mix of laboratory efficacy testing and, for "In-Use Testing," potentially real-world clinical usage scenarios, but it's not specified if these were retrospective or prospective studies in a clinical setting. Given this is a 510(k) for a washer-disinfector, the "in-use" testing likely refers to instruments soiled from clinical use rather than a full prospective clinical trial.

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

Not Applicable: This study is evaluating the mechanical and chemical cleaning and disinfection efficacy of a device, not interpreting medical images or data that would require a ground truth established by medical experts (like radiologists). The ground truth is objective cleanliness/disinfection metrics (e.g., protein/TOC levels, log reduction of organisms) determined by laboratory assays. The "Human Factors" test involves typical users, but not "experts" establishing a ground truth.

4. Adjudication Method for the Test Set

Not Applicable: Given the nature of the tests (objective measurements of cleanliness, disinfection, and functional performance), there is no mention or need for an adjudication method for human interpretation.

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

Not Applicable: This is not an AI/ML powered medical device, therefore MRMC studies are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This is not an AI/ML powered medical device. The tests, particularly "Simulated Use Testing" and "In-Use Testing," represent the "standalone" performance of the washer-disinfector system itself in achieving cleaning and disinfection.

7. The Type of Ground Truth Used

Objective Laboratory Measurements:
- Cleaning Efficacy: Quantitation of soil markers (protein <6.4 µg/cm², TOC <12 µg/cm²) based on laboratory analysis. Visual examination was also used.
- Disinfection Efficacy: Log reduction of specified vegetative organisms and mycobacterium species based on microbiological testing.
- Biocompatibility: Cytotoxicity testing of device extracts and verification of chemical residual levels.
- Physical Performance: Measurements against internal specifications (e.g., chemical injection control, temperature control, pump performance, drying).
- Human Factors: Observation of user capability to follow instructions.
- Safety/Software: Conformance to established safety standards and internal software validation.

8. The Sample Size for the Training Set

Not Applicable: This is not an AI/ML device that requires a "training set" in the context of machine learning.

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

Not Applicable: As above, this is not an AI/ML device.

Summary

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August 21, 2019

STERIS Corporation Marcia Benedict Senior Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060

Re: K190081

Trade/Device Name: RAS-12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO® 7052HP/7053HP Single Chamber Washer/Disinfector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NVE Dated: July 19, 2019 Received: July 22, 2019

Dear Marcia 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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-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-regulatoryassistance/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,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number ( known)

K190081

Device Name

RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO® 7052HP / 7053HP Single Chamber Washer-Disinfector

Indications for Use (Describe)

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

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

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Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all caps and in a serif font. Below the word STERIS is an image of several horizontal wavy lines that are blue.

510(k) Summary For RAS 12 Rack, Ras 12 Long Rack and RAS Cycle in AMSCO® 7052HP / 7053HP Single Chamber Washer-Disinfectors

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 Tel: 440-392-7063 Fax: 440-357-9198

July 19, 2019 Submission Date:

Premarket Notification Number: K190081

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

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Device Name 1.

Trade Name:	RAS 12 Rack, RAS 12 Long RackRAS Cycle of AMSCO 7052HP Single ChamberWasher/Disinfector and AMSCO 7053HP SingleChamber Washer/Disinfector
Device Class:	Class II
Common/usual Name:	Endoscope cleaning accessory
Classification Name:	Endoscope washer, cleaner, automated
Classification Number:	21 CFR 876.1500
Product Code:	NVE

2. Predicate Device

da Vinci SonicPro Cleaning System: K073112

Device Description 3.

4. Indications for Use

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5. Technological Characteristics Comparison Table

A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.

Feature	Proposed Device K190081RAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors	Predicate Deviceda Vinci SonicProCleaning System(K073112)	Comparison
IntendedUseIndicationsfor Use	The RAS Racks are used in theRAS Cycles of the AMSCO7052HP and 7053HP Single-Chamber Washer/Disinfectorsfor the effective cleaning,rinsing, drying andintermediate level disinfectionof reusable da VinciEndoWrist® X/Xi, S/Si, andSingle-Site instruments andstaplers.	The da Vinci SonicProCleaning System is intendedfor the automated cleaningof reusable EndoWristInstruments and accessoriesused with the da Vinci andda Vinci S surgical systems.The Cleaning System whenused in accordance with itslabeling provides anautomated cleaning methodas part of the re-processingsequence for the EndoWristInstruments and Accessories.	The intendeduse is the same;detailsprovided differ.The proposeddevicespecificallynames claimedda VinciEndoWristdevice models.The proposeddevice achievescleaningwithoutpreliminarymanualcleaning, whilethe predicatedevice requiresEndoWristmanualcleaning.
OperatingPrinciples/Technology	The RAS Racks and RASCycle of the 7052HP/7053HPSC w/d provide the necessarycombination of cleaningagents in hot water withtemperature and waterpressure control during timedsequences to achieve effectivecleaning of complex lumenedda Vinci instruments andstaplers. Validated parametersof the RAS cycle, whichincludes prewash, cleaningstages, rinsing, intermediate	The Cleaning Systemprovides a microprocessorcontrolled unit with theability to clean internal andexternal surfaces of lumenedrobotic surgical instrumentssuch as the da VinciEndoWrist instruments.Cleaning follows manualcleaning steps and isaccomplished through use ofhot water, user-selecteddetergent, flow, ultrasonicenergy, and rinsing	Similar;howeverThe predicateincludes use ofultrasonicenergyThe proposeddevice includesthermaldisinfectionand drying,withoutsonication
Feature	Proposed Device K190081RAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors	Predicate Deviceda Vinci SonicProCleaning System(K073112)	Comparison
	level thermal disinfection, andheated drying, cannot bereduced from the minimumdefault parameters.	mechanism.
WhereUsed	Hospital/medical center SPD	Hospital/medical center SPD	Identical
Design	The Washer/Disinfector is astand-alone pass-throughdesign single-chamber unitwith integrated software. TheRAS Racks position andprovide flow to loaded daVinci items throughout theRAS Cycle while spray armsassure all surfaces are cleanedwith validated chemistries,rinsed, thermal disinfected,and dried.	The Cleaning System is astand-alone unit mounted ona movable frame withintegrated hardware andsoftware. Providestemperature controlledspray, ultrasonic cleaning,and flushing with user-selected chemistries.Includes pumps, filter,chamber/tank, basket, flushtubes, printer connection.	Similar
Instrumentpreparation	Reusable EndoWrist X/Xi,S/Si, and Single-Siteinstruments and staplers arehandled at point of use in theOR per the manufacturer'sIFU (da Vinci InstrumentReprocessing Manual). Whenreceived in the SPD within onehour they are flushed withwater and installed in theappropriate RAS Rackaccording to the detailedinstructions provided in itsOperator Manual.	Thoroughly clean the outsideof the entire instrument oraccessory using runningwater with a clean, soft,nylon bristled brush. Repeatscrubbing as needed. SeeReprocessing InstructionsPN 550875. Thoroughlyrinse. Place in SonicProinstrument basket. Attachthe slip luer end of flushtubes to main flush port ofeach instrument and toquick-connect fittings intank.	Differentinstrument preprequired, asreflected inintended usestatements.
CriticalParametersforCleaning	Minimum critical cycleparameters are provided bydefault in the RAS Cycle:Dosing of validatedconcentrated chemistries atspecified volume of 0.74oz. (22 mL)Series of washing stages:> 2-minute Prewash, not	The critical processparameters are:Instrument Cycle (5mm or 8mm): 30 - 45 °C (86 - 113°F)User-selected pH neutralcleaning agent @ 0.5oz/gal - 3.0 oz/gal	Each systemhas establishedcriticalparameters toachievevalidatedoutcomes. Thecycles differ.
Feature	Proposed Device K190081RAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors	Predicate Deviceda Vinci SonicProCleaning System(K073112)	Comparison
	heated> Wash phase 1 - initial 6-minute stage @122°Fwith Prolystica UltraConcentrate HPEnzymatic Cleanerfollowed by 6-minutestage @150°F withProlystica UltraConcentrate HP Detergent> 2-minute rinse, not heated> Wash phases 3 and 4,each - initial 6-minutestage @122°F withProlystica UltraConcentrate HPEnzymatic Cleanerfollowed by 6-minutestage @150°F withProlystica UltraConcentrate HP Detergent> 1-minute rinse, not heated• Pump provides continuouscirculation through lumensand spray arms at pressureabove 45 psi	• 135 W/gal ultrasonicpower density• 30 psi minimum flushingpressureAccessory Cycle:• 25 - 45 °C (77 - 113°F)• User-selected pH neutralcleaning agent @ 0.5oz/gal - 3.0 oz/gal• 135 W/gal ultrasonicpower density• 30 psi minimum flushingpressure
CriticalParametersforThermalDisinfection	Minimum critical cycleparameters are provided bydefault in the RAS Cycle:• Temperature 194°F (90°C)• Time 1 minute• $A_0$ = 600	No disinfection cycle	Capabilitiesdiffer
Drying	• Temperature (high =setpoint 220°F)• Default time 20 minutes(adjustable from 2 to 30minutes)	No drying capability	Capabilitiesdiffer
Recordkeeping	Provides printout or downloadcapability from USB port orusing optional printer	Connection to separatethermal printer	Capabilitiesdiffer
WaterQuality	< 120 ppm hardness	< 200 ppm hardness	Similar
Feature	Proposed Device K190081RAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors	Predicate Deviceda Vinci SonicProCleaning System(K073112)	Comparison
Sonication	No capability	135 W/gal ultrasonic powerdensity	Capabilitiesdiffer
ProcessMonitors:	Monitors water temperature for each filling of the sump Monitors time of each phase at set point temperature. Monitors water fill volume Monitors volume of cleaner injected Monitors pump rotation	Monitors water temperature for each filling of the tank Monitors pressure to ensure it remains above 30 psi Monitors power drawn by ultrasonics Senses flow of cleaning solution at proper pressure for dose	Each systemprovidesmonitoringsuitable toassure criticalparameters aremet.
Cleanerdispensed	Washer/disinfectorautomatically dispenses thevalidated volume ofconcentrated chemistry atspecified points in the RASCycle.	Cleaning System injectsuser-selected cleaningsolution at user-selectedvolume between 0.5 oz/gal –3.0 oz/gal (in increments of0.5 oz.)	Similar;predicateallows volumeto be altered
Cleaningchemistries	Uses only Prolystica UltraConcentrate HP EnzymaticCleaner and Prolystica UltraConcentrate HP NeutralDetergent in RAS Cycle.	Use only pH-neutral, low-foaming, enzymatic cleaningagents	Proposeddevice limitsoptions tovalidatedcleaners;predicatecleaner is user-selected
Cycle time	Approximately 1 hour and 15 –20 minutes	Approximately 40 minutesInstrument Cycles, 30minutes Accessory Cycle	Predicatecycles areshorter
#Instruments	Up to 12 da Vinci instrumentsand/or staplers/cycle	Up to 10 instruments/cycle	Proposeddevice canprocess more
Self-DisinfectionCycle	No self-disinfection cycle.A Decon Cycle using AMSCOLiquid Descaler is run onceweekly.	No self-disinfection cycle.System Purge Cycle (5 min.cleaning with hot water andultrasonics followed by hotwater and ultrasonic rinse) isperformed daily.	Similar
Feature	Proposed Device K190081RAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors	Predicate Deviceda Vinci SonicProCleaning System(K073112)	Comparison
Filters	Each RAS Rack features anin-line, self-cleaning filtrationassembly. Operator performs amanual cleaning step weekly.	Includes a 10-micron waterfilter that is replacedannually or after 200 cycles,whichever comes first	Each providesfiltrationdifferently
Accessories	Prolystica Ultra ConcentrateHP Enzymatic Cleaner andProlystica Ultra ConcentrateHP Neutral Detergent	Thermal printer, Accessoryand Instrument Baskets,Flush Tubes, unspecifiedcleaning agent	Accessoriesdiffer

Table 1. Technological Characteristics Comparison Table

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6. Summary of Non-Clinical Performance Testing

Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 2. The RAS Racks and RAS Cycle of the AMSCO 7052HP / 7053HP Single-Chamber Washer/Disinfectors met the established performance criteria.

Test	Acceptance Criteria	Result
Simulated UseTesting	Endowrist instruments identified as master devices fortheir most challenging features were soiled and allowed todry for at least one hour. They were processed in triplicatetrials using the RAS Cycle to the end of the initial rinse(prior to thermal rinse), then examined visually andsampled for quantitation of two soil markers: protein <6.4µg/cm², TOC <12 µg/cm².	PASS
In-Use Testing	Clinically used Endowrist instruments were installed inthe Rack according to its IFU, the rack was placed in thewasher/disinfector, and the RAS Cycle was run to the endof initial rinse (prior to thermal rinse). Instruments wereexamined visually and sampled for quantitation of twosoil markers: protein <6.4 µg/cm², TOC <12 µg/cm².	PASS
Rinsing EfficacyandBiocompatibility	Two EndoWrist instruments were processed three (3)consecutive times in full loads using double cleanerconcentrations. Rinse water and device extracts weretested for cytotoxicity. Device extracts were analyzedto verify that the chemical residual level is notcytotoxic	PASS

Table 2. Performance Testing

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ThermalDisinfection	Achieves greater than 6-log reduction of each organism ina mixed suspension of vegetative organisms, and greaterthan 3-log reduction of mycobacterium species	PASS
W/D PhysicalPerformance	Chemical injection control operates within specificationsTemperature control operates within specificationsPump maintains high speed performance as designedDrying is achieved by the RAS Cycle	PASS
Human Factors	Typical users were capable of following the writteninstructions for use to correctly configure and load theRAS Rack and to select the correct cycle of thewasher/disinfector.	PASS
Electrical SafetyConformance	UL 61010-1 Safety Requirements for ElectricalEquipment for Measurement, Control, and LaboratoryUse - Part 1: General Requirements, 3rd EditionUL 61010-2-040 Safety Requirements for ElectricalEquipment for Measurement, Control, and LaboratoryUse - Part 2-040: Particular Requirements for Sterilizersand Washer-Disinfectors Used to Treat MedicalMaterials, 2nd EditionIEC 61326-1:2012 Electrical equipment for measurement,control and laboratory use – EMC requirements – Part 1:General requirements• conformance to FCC Part 15	PASS
SoftwareValidation	The software that controls the system was validated anddetermined to operate effectively and as designed.	PASS

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 (K073112).

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.