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

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 X/Xi and S/Si Endowrist® instruments, with limited prior manual pre-cleaning, are loaded into the appropriate RAS Rack according to the provided instructions for use. The rack is placed in the AMSCO 7052HP or 7053HP 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 is related to a 510(k) premarket notification for STERIS RAS 12 Rack / RAS 12 Long Rack, used in a washer-disinfector for surgical instruments. This is a medical device, specifically an accessory for automated cleaning and disinfection.

The request asks for details about "acceptance criteria and the study that proves the device meets the acceptance criteria," with a focus on an AI/Machine Learning context. However, the provided document does not describe an AI/Machine Learning device or any study involving AI performance.

Instead, it details the substantial equivalence of a physical medical device (racks for a washer-disinfector) to a legally marketed predicate device. The "performance testing" mentioned is non-clinical and relates to the cleaning and disinfection efficacy of the washer-disinfector system for surgical instruments, not an AI model's diagnostic accuracy or similar metrics.

Therefore, most of the requested information, which is specific to AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect size for human reader improvement with AI), is not present in this document.

The document states:

"The purpose of this Special 510(k) is to update labeling consistent with a labeling revision being enacted by Intuitive Surgical to allow for automated cleaning and intermediate level disinfection of reusable da Vinci X/Xi and S/Si EndoWrist® instruments in the RAS Racks and RAS Cycles of the AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors. The RAS Racks and associated RAS Cycles were not altered in anyway."
"Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well or better than the legally marketed predicate device (K200577), Class II (21 CFR 876.1500), product code NVE."

This indicates that the "study" is a non-clinical performance test to establish cleaning and disinfection efficacy, likely involving standards for residual protein, blood, or other contaminants, rather than diagnostic accuracy.

Given the provided text, I cannot answer the questions specific to AI/ML performance studies because the document does not pertain to an AI/ML device.

I can, however, extract information about the device characteristics and the basis for its clearance as presented in the document, which primarily relies on substantial equivalence to a predicate device and non-clinical performance data for cleaning/disinfection.

What I can infer from the document regarding the device and its assessment:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in a typical table format with quantitative performance metrics for a diagnostic device. Instead, it relies on demonstrating that the proposed device has "identical" or "similar" technological characteristics and performs "as well or better" than its predicate device through non-clinical performance testing related to cleaning, rinsing, disinfection, and drying efficacy.
The "performance" referred to is the successful demonstration of effective cleaning and intermediate level disinfection of specific surgical instruments (da Vinci® X/Xi and S/Si EndoWrist® instruments) when processed in the RAS Racks within the specified washer-disinfector cycles. This would involve meeting established benchmarks for sterility or cleanliness, though the specific criteria (e.g., maximum allowable protein residue) are not detailed in this summary. The table provided is a "Technological Characteristics Comparison Table" comparing the proposed device to the predicate, not a performance table against specific acceptance criteria.

2. Sample sized used for the test set and the data provenance:

Not applicable/mentioned for an AI/ML context. Likely involves a set number of contaminated instruments to be processed and tested, but specific "sample sizes" (e.g., number of instruments, number of cycles) are not detailed in this summary.
Data provenance (country of origin, retrospective/prospective) is not relevant to this type of device assessment and is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. "Ground truth" in this context would be laboratory testing results for cleanliness/disinfection, not expert clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is for AI/ML diagnostic studies.

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 document does not describe an AI-assisted diagnostic device.

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

Not applicable. This is a physical device used for cleaning/disinfection.

7. The type of ground truth used:

For the non-clinical performance testing referenced, the "ground truth" would be established via laboratory assays measuring the reduction of biological contaminants (e.g., protein, hemoglobin) or microbial load on the instruments after processing. This is a direct measurement of the device's efficacy in cleaning and disinfection, not an expert consensus or outcomes data in the clinical sense.

8. The sample size for the training set:

Not applicable. This is for AI/ML devices.

9. How the ground truth for the training set was established:

Not applicable. This is for AI/ML devices.

In summary, the provided document does not contain information relevant to an AI/ML device study or its performance criteria. It describes a 510(k) clearance for a non-AI medical device based on substantial equivalence and non-clinical performance testing for cleaning and disinfection efficacy.

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 seal of the Department of Health & Human Services. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 1, 2020

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

Re: K203199

Trade/Device Name: RAS 12 Rack / RAS 12 Long Rack, used in 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: October 28, 2020 Received: October 29, 2020

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 (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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 CAPT Elizabeth Claverie-Williams, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality 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 (if known)

K203199

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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

510(k) Summary For RAS Racks 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:

Jennifer Nalepka Lead Regulatory Affairs Specialist Tel: 440-392-7458 Fax: 440-357-9198 Email: jennifer_nalepka@steris.com

Submission Date: November 16, 2020

Premarket Notification Number: K203199

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 Rack, used in RASCycle of AMSCO 7052HP / 7053HP SingleChamber Washer-Disinfector
Device Class:	Class II
	Endoscope cleaning accessory
Common/usual Name:	Endoscope washer, cleaner, automated
Classification Name:	21 CFR 876.1500
Classification Number:	NVE
Product Code:

2. Predicate Device

RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector, K200577

3. Device Description

4. Indications for Use

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disinfection and drying of reusable da Vinci® X/Xi and S/Si EndoWrist® instruments.

ട. Technological Characteristics Comparison Table

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

Table 1. Technological Characteristics Comparison Table

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6. Summary of Non-Clinical Performance Testing

The purpose of this Special 510(k) is to update labeling consistent with a labeling revision being enacted by Intuitive Surgical to allow for automated cleaning and intermediate level disinfection of reusable da Vinci X/Xi and S/Si EndoWrist® instruments in the RAS Racks and RAS Cycles of the AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors. The RAS Racks and associated RAS Cycles were not altered in anyway.

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 or better than the legally marketed predicate device (K200577), Class II (21 CFR 876.1500), product code NVE.

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.

Feature	Proposed DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K203199)	Predicate DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K200577)	Comparison
IntendedUseIndicationsfor Use	The RAS Racks are used inthe RAS Cycle of theAMSCO 7052HP Single-Chamber Washer/Disinfectorand the AMSCO 7053HPSingle-ChamberWasher/Disinfector for theeffective cleaning, rinsing,intermediate leveldisinfection and drying ofreusable da Vinci® X/Xi andS/Si EndoWrist®instruments.	The RAS Racks are used inthe RAS Cycles of theAMSCO 7052HP and7053HP Single-ChamberWasher/Disinfectors for theeffective cleaning, rinsing,drying and intermediate leveldisinfection of reusable daVinci EndoWrist® X/Xi,S/Si, and Single-Siteinstruments and staplers.	Identical exceptfor removal ofSingle-Site andStaplerinstruments andre-ordering ofwording tomoreaccuratelyidentify theintended daVinci devices.
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 achieveeffective cleaning of complexlumened da Vinciinstruments. Validatedparameters of the RAS cycle,which includes prewash,cleaning stages, rinsing,intermediate level thermaldisinfection, and heateddrying, cannot be reducedfrom the minimum defaultparameters.	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 achieveeffective cleaning of complexlumened da Vinci instrumentsand staplers. Validatedparameters of the RAS cycle,which includes prewash,cleaning stages, rinsing,intermediate level thermaldisinfection, and heateddrying, cannot be reducedfrom the minimum defaultparameters.	Identical exceptfor the removalof Single-Siteand Staplerinstruments.
Feature	Proposed DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K203199)	Predicate DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K200577)	Comparison
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 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.	Identical
Instrumentpreparation	Reusable EndoWrist® X/Xi,S/Si instruments are handledat point of use in the OR, thentransferred to theDecontamination Area of thesterile processing departmentwhere they are prepared forautomated cleaning andinstalled in the appropriateRAS Rack according to thedetailed instructions providedin its Operator Manual.	Reusable EndoWrist® X/Xi,S/Si, and Single-Siteinstruments and staplers arehandled at point of use in theOR, then transferred to theDecontamination Area of thesterile processing departmentwhere they are prepared forautomated cleaning per the daVinci Addendum forAutomated ReprocessingManual) and installed in theappropriate RAS Rackaccording to the detailedinstructions provided in itsOperator Manual.	Similar;removedSingle-Site andStaplerinstrumentprocessinginstructions.Incorporatedthe manual pre-cleaning stepsfrom da VinciAddendumAutomatedReprocessingManual.
CriticalParametersforCleaning	Minimum critical cycleparameters are provided bydefault in the RAS Cycle:Dosing of validated●concentrated chemistriesat specified volume of0.74 oz. (22 mL)Series of washing stages:●> 2-minute Prewash, notheated> Wash phase 1 - initial 6-minute stage @122°Fwith Prolystica UltraConcentrate HP	Minimum critical cycleparameters are provided bydefault in the RAS Cycle:Dosing of validated●concentrated chemistriesat specified volume of0.74 oz. (22 mL)Series of washing stages:●> 2-minute Prewash, notheated> Wash phase 1 - initial 6-minute stage @ 122°Fwith Prolystica UltraConcentrate HP	Identical
Feature	Proposed DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K203199)	Predicate DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K200577)	Comparison
	Enzymatic Cleanerfollowed by 6-minutestage @150°F withProlystica UltraConcentrate HPDetergent> 2-minute rinse, notheated> Wash phases 3 and 4,each - initial 6-minutestage @122°F withProlystica UltraConcentrate HPEnzymatic Cleanerfollowed by 6-minutestage @150°F withProlystica UltraConcentrate HPDetergent> 1-minute rinse, notheatedPump providescontinuous circulationthrough lumens and sprayarms at pressure above 45psi	Enzymatic Cleanerfollowed by 6-minutestage @150°F withProlystica UltraConcentrate HPDetergent> 2-minute rinse, notheated> Wash phases 3 and 4,each - initial 6-minutestage @122°F withProlystica UltraConcentrate HPEnzymatic Cleanerfollowed by 6-minutestage @150°F withProlystica UltraConcentrate HPDetergent> 1-minute rinse, notheatedPump providescontinuous circulationthrough lumens and sprayarms at pressure above 45psi
CriticalParametersforThermalDisinfection	Minimum critical cycleparameters are provided bydefault in the RAS Cycle:● Temperature 194°F(90°C)● Time 1 minute● A₀ = 600	Minimum critical cycleparameters are provided bydefault in the RAS Cycle:● Temperature 194°F(90°C)● Time 1 minute● A₀ = 600	Identical
Drying	● Temperature (high =setpoint 220°F)● Default time 20 minutes(adjustable from 2 to 30minutes)	● Temperature (high =setpoint 220°F)● Default time 20 minutes(adjustable from 2 to 30minutes)	Identical
Recordkeeping	Provides printout ordownload capability fromUSB port or using optionalprinter	Provides printout ordownload capability fromUSB port or using optionalprinter	Identical
WaterQuality	< 120 ppm hardness	< 120 ppm hardness	Identical
Feature	Proposed DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K203199)	Predicate DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K200577)	Comparison
Sonication	No capability	No capability	Identical
ProcessMonitors:	Monitors watertemperature for eachfilling of the sump Monitors time of eachphase at set pointtemperature. Monitors water fillvolume Monitors volume ofcleaner injected Monitors pump rotation	Monitors watertemperature for eachfilling of the sump Monitors time of eachphase at set pointtemperature. Monitors water fillvolume Monitors volume ofcleaner injected Monitors pump rotation	Identical
Cleanerdispensed	Washer/disinfectorautomatically dispenses thevalidated volume ofconcentrated chemistry atspecified points in the RASCycle.	Washer/disinfectorautomatically dispenses thevalidated volume ofconcentrated chemistry atspecified points in the RASCycle.	Identical
Cleaningchemistries	Uses only Prolystica UltraConcentrate HP EnzymaticCleaner and Prolystica UltraConcentrate HP NeutralDetergent in RAS Cycle.	Uses only Prolystica UltraConcentrate HP EnzymaticCleaner and Prolystica UltraConcentrate HP NeutralDetergent in RAS Cycle.	Identical
Cycle time	Approximately 1 hour and 15- 20 minutes	Approximately 1 hour and 15- 20 minutes	Identical
#Instruments	Up to 12 da Vinciinstruments/cycle	Up to 12 da Vinciinstruments and/orstaplers/cycle	Identicalexcept for theremoval ofSingle-Site andStaplerinstruments
Self-DisinfectionCycle	No self-disinfectioncycle. A Decon Cycle usingAMSCO Liquid Descaleris run once weekly.	No self-disinfectioncycle. A Decon Cycle usingAMSCO Liquid Descaleris run once weekly.	Identical
Filters	Each RAS Rack features anin-line, self-cleaning filtrationassembly. Operator performs	Each RAS Rack features anin-line, self-cleaning filtrationassembly. Operator performs	Identical
Feature	Proposed DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K203199)	Predicate DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K200577)	Comparison
	a manual cleaning stepweekly.	a manual cleaning stepweekly.
Accessories	Prolystica Ultra ConcentrateHP Enzymatic Cleaner andProlystica Ultra ConcentrateHP Neutral Detergent	Prolystica Ultra ConcentrateHP Enzymatic Cleaner andProlystica Ultra ConcentrateHP Neutral Detergent	Identical