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

K200577 · STERIS Corporation · NVE · Apr 3, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K200577
• Device Name: RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
• Applicant: STERIS Corporation
• Product Code: NVE · Gastroenterology, Urology
• Decision Date: Apr 3, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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 Story

Device consists of specialized racks (RAS 12 Rack, RAS 12 Long Rack) used within AMSCO 7052HP/7053HP Single-Chamber Washer/Disinfectors. System processes up to 12 soiled robotic-assisted surgery instruments per cycle. Operation involves automated spray-washing and lumen flushing using Prolystica Ultra Concentrate HP Enzymatic Cleaner and Neutral Detergent, followed by thermal rinse for intermediate level disinfection and heated drying. Operated by sterile processing department staff. Integrated software controls cycle parameters (temperature, pressure, chemical dosing, timing). Output is cleaned, disinfected, and dried instruments ready for steam sterilization. Benefits include standardized, automated reprocessing of complex robotic instruments, reducing manual cleaning requirements and ensuring consistent disinfection.

Clinical Evidence

No clinical data. Bench testing only; device is identical to the predicate.

Technological Characteristics

Stand-alone pass-through single-chamber washer/disinfector with integrated software. Features in-line self-cleaning filtration assembly. Operates via automated spray arms and lumen flushing at >45 psi. Validated cycle parameters: prewash, enzymatic/detergent wash phases at 122°F/150°F, thermal rinse at 194°F (A₀=600), and heated drying. Uses specific Prolystica chemistries.

Indications for Use

Indicated for cleaning, rinsing, drying, and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers in hospital/medical center sterile processing departments.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (K190081)

Submission Summary (Full Text)

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April 3, 2020

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

Re: K200577

Trade/Device Name: RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the 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: March 4, 2020 Received: March 5, 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For CAPT Elizabeth Claverie, M.S. Assistant Director 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 (if known)

## K200577

## 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)

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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 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: [phone] Fax No: [phone]

Contact:

Jennifer Nalepka Lead Regulatory Affairs Specialist Tel: [phone] Fax: [phone] Email: [e-mail]

Submission Date: March 4, 2020

Premarket Notification Number: K200577

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

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### 1. Device Name

| Trade Name: | RAS 12 Rack, RAS 12 Long Rack<br>RAS Cycle of AMSCO 7052HP Single Chamber<br>Washer/Disinfector and AMSCO 7053HP Single<br>Chamber 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

RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector, K190081

### 3. 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 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.

### 4. Indications for Use

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.

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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<br>RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors<br>(K200577 ) | Predicate Device<br>RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors<br>(K190081) | Comparison |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended<br>Use<br>Indications<br>for Use | The RAS Racks are used in<br>the RAS Cycles of the<br>AMSCO 7052HP and<br>7053HP Single-Chamber<br>Washer/Disinfectors for the<br>effective cleaning, rinsing,<br>drying and intermediate level<br>disinfection of reusable da<br>Vinci EndoWrist® X/Xi,<br>S/Si, and Single-Site<br>instruments and staplers. | The RAS Racks are used in<br>the RAS Cycles of the<br>AMSCO 7052HP and<br>7053HP Single-Chamber<br>Washer/Disinfectors for the<br>effective cleaning, rinsing,<br>drying and intermediate level<br>disinfection of reusable da<br>Vinci EndoWrist® X/Xi,<br>S/Si, and Single-Site<br>instruments and staplers. | Identical |
| Operating<br>Principles<br><br>Technology | The RAS Racks and RAS<br>Cycle of the 7052HP/7053HP<br>SC w/d provide the necessary<br>combination of cleaning<br>agents in hot water with<br>temperature and water<br>pressure control during timed<br>sequences to achieve<br>effective cleaning of complex<br>lumened da Vinci instruments<br>and staplers. Validated<br>parameters of the RAS cycle,<br>which includes prewash,<br>cleaning stages, rinsing,<br>intermediate level thermal<br>disinfection, and heated<br>drying, cannot be reduced<br>from the minimum default<br>parameters. | The RAS Racks and RAS<br>Cycle of the 7052HP/7053HP<br>SC w/d provide the necessary<br>combination of cleaning<br>agents in hot water with<br>temperature and water<br>pressure control during timed<br>sequences to achieve<br>effective cleaning of complex<br>lumened da Vinci instruments<br>and staplers. Validated<br>parameters of the RAS cycle,<br>which includes prewash,<br>cleaning stages, rinsing,<br>intermediate level thermal<br>disinfection, and heated<br>drying, cannot be reduced<br>from the minimum default<br>parameters. | Identical |
| Where<br>Used | Hospital/medical center SPD | Hospital/medical center SPD | Identical |
| Design | The Washer/Disinfector is a<br>stand-alone pass-through<br>design single-chamber unit | The Washer/Disinfector is a<br>stand-alone pass-through<br>design single-chamber unit | Identical |

| Table 1. Technological Characteristics Comparison Table | |
|---------------------------------------------------------|--|
| | |

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| | Proposed Device<br>RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors<br>(K200577 ) | Predicate Device<br>RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors<br>(K190081) | Comparison |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Feature | with integrated software. The<br>RAS Racks position and<br>provide flow to loaded da<br>Vinci items throughout the<br>RAS Cycle while spray arms<br>assure all surfaces are cleaned<br>with validated chemistries,<br>rinsed, thermal disinfected,<br>and dried. | with integrated software. The<br>RAS Racks position and<br>provide flow to loaded da<br>Vinci items throughout the<br>RAS Cycle while spray arms<br>assure all surfaces are cleaned<br>with validated chemistries,<br>rinsed, thermal disinfected,<br>and dried. | Identical |
| Instrument<br>preparation | Reusable EndoWrist® X/Xi,<br>S/Si, and Single-Site<br>instruments and staplers are<br>handled at point of use in the<br>OR, then transferred to the<br>Decontamination Area of the<br>sterile processing department<br>where they are prepared for<br>automated cleaning per the<br>manufacturer's IFU (da Vinci<br>Addendum for Automated<br>Reprocessing Manual). When<br>received in the SPD within<br>one hour they are flushed<br>with water and installed in the<br>appropriate RAS Rack<br>according to the detailed<br>instructions provided in its<br>Operator Manual. | Reusable EndoWrist® X/Xi,<br>S/Si, and Single-Site<br>instruments and staplers are<br>handled at point of use in the<br>OR, then transferred to the<br>Decontamination Area of the<br>sterile processing department<br>where they are prepared for<br>automated cleaning per the<br>manufacturer's IFU (da Vinci<br>Addendum for Automated<br>Reprocessing Manual). When<br>received in the SPD within<br>one hour they are flushed<br>with water and installed in the<br>appropriate RAS Rack<br>according to the detailed<br>instructions provided in its<br>Operator Manual. | |
| Critical<br>Parameters<br>for<br>Cleaning | Minimum critical cycle<br>parameters are provided by<br>default in the RAS Cycle:<br>• Dosing of validated<br>concentrated chemistries<br>at specified volume of<br>0.74 oz. (22 mL)<br>• Series of washing stages:<br>> 2-minute Prewash, not<br>heated<br>> Wash phase 1 - initial 6-<br>minute stage @122°F<br>with Prolystica Ultra<br>Concentrate HP<br>Enzymatic Cleaner<br>followed by 6 minute | Minimum critical cycle<br>parameters are provided by<br>default in the RAS Cycle:<br>• Dosing of validated<br>concentrated chemistries<br>at specified volume of<br>0.74 oz. (22 mL)<br>• Series of washing stages:<br>> 2-minute Prewash, not<br>heated<br>> Wash phase 1 - initial 6-<br>minute stage @122°F<br>with Prolystica Ultra<br>Concentrate HP<br>Enzymatic Cleaner<br>followed by 6 minute | |
| Feature | Proposed Device<br>RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors<br>(K200577) | Predicate Device<br>RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors<br>(K190081) | Comparison |
| | stage @150°F with<br>Prolystica Ultra<br>Concentrate HP<br>Detergent<br>> 2-minute rinse, not<br>heated<br>> Wash phases 3 and 4,<br>each - initial 6-minute<br>stage @122°F with<br>Prolystica Ultra<br>Concentrate HP<br>Enzymatic Cleaner<br>followed by 6-minute<br>stage @150°F with<br>Prolystica Ultra<br>Concentrate HP<br>Detergent<br>> 1-minute rinse, not<br>heated<br>• Pump provides<br>continuous circulation<br>through lumens and spray<br>arms at pressure above 45<br>psi | stage @150°F with<br>Prolystica Ultra<br>Concentrate HP<br>Detergent<br>> 2-minute rinse, not<br>heated<br>> Wash phases 3 and 4,<br>each - initial 6-minute<br>stage @122°F with<br>Prolystica Ultra<br>Concentrate HP<br>Enzymatic Cleaner<br>followed by 6-minute<br>stage @150°F with<br>Prolystica Ultra<br>Concentrate HP<br>Detergent<br>> 1-minute rinse, not<br>heated<br>• Pump provides<br>continuous circulation<br>through lumens and spray<br>arms at pressure above 45<br>psi | |
| Critical<br>Parameters<br>for<br>Thermal<br>Disinfection | Minimum critical cycle<br>parameters are provided by<br>default in the RAS Cycle:<br>• Temperature 194°F<br>(90°C)<br>• Time 1 minute<br>• A₀ = 600 | Minimum critical cycle<br>parameters are provided by<br>default in the RAS Cycle:<br>• Temperature 194°F<br>(90°C)<br>• Time 1 minute<br>• A₀ = 600 | Identical |
| Drying | • Temperature (high =<br>setpoint 220°F)<br>• Default time 20 minutes<br>(adjustable from 2 to 30<br>minutes) | • Temperature (high =<br>setpoint 220°F)<br>• Default time 20 minutes<br>(adjustable from 2 to 30<br>minutes) | Identical |
| Record<br>keeping | Provides printout or<br>download capability from<br>USB port or using optional<br>printer | Provides printout or<br>download capability from<br>USB port or using optional<br>printer | Identical |
| Water<br>Quality | < 120 ppm hardness | < 120 ppm hardness | Identical |
| | Proposed Device | Predicate Device | |
| Feature | RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors<br>(K200577 ) | RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors<br>(K190081) | Comparison |
| Sonication | No capability | No capability | Identical |
| Process<br>Monitors: | Monitors water temperature for each<br>filling of the sump Monitors time of each<br>phase at set point<br>temperature. Monitors water fill<br>volume Monitors volume of<br>cleaner injected Monitors pump rotation | Monitors water temperature for each<br>filling of the sump Monitors time of each<br>phase at set point<br>temperature. Monitors water fill<br>volume Monitors volume of<br>cleaner injected Monitors pump rotation | Identical |
| Cleaner<br>dispensed | Washer/disinfector<br>automatically dispenses the<br>validated volume of<br>concentrated chemistry at<br>specified points in the RAS<br>Cycle. | Washer/disinfector<br>automatically dispenses the<br>validated volume of<br>concentrated chemistry at<br>specified points in the RAS<br>Cycle. | Identical |
| Cleaning<br>chemistries | Uses only Prolystica Ultra<br>Concentrate HP Enzymatic<br>Cleaner and Prolystica Ultra<br>Concentrate HP Neutral<br>Detergent in RAS Cycle. | Uses only Prolystica Ultra<br>Concentrate HP Enzymatic<br>Cleaner and Prolystica Ultra<br>Concentrate HP Neutral<br>Detergent in RAS Cycle. | Identical |
| Cycle time | Approximately 1 hour and 15<br>- 20 minutes | Approximately 1 hour and 15<br>- 20 minutes | Identical |
| #<br>Instruments | Up to 12 da Vinci<br>instruments and/or<br>staplers/cycle | Up to 12 da Vinci<br>instruments and/or<br>staplers/cycle | Identical |
| Self-<br>Disinfection<br>Cycle | No self-disinfection<br>cycle. A Decon Cycle using<br>AMSCO Liquid Descaler<br>is run once weekly. | No self-disinfection<br>cycle. A Decon Cycle using<br>AMSCO Liquid Descaler<br>is run once weekly. | Identical |
| Filters | Each RAS Rack features an<br>in-line, self-cleaning filtration<br>assembly. Operator performs<br>a manual cleaning step<br>weekly. | Each RAS Rack features an<br>in-line, self-cleaning filtration<br>assembly. Operator performs<br>a manual cleaning step<br>weekly. | Identical |
| Accessories | Prolystica Ultra Concentrate<br>HP Enzymatic Cleaner and | Prolystica Ultra Concentrate<br>HP Enzymatic Cleaner and | Identical |
| Feature | Proposed Device<br>RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors<br>(K200577 ) | Predicate Device<br>RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors<br>(K190081) | Comparison |
| | Prolystica Ultra Concentrate<br>HP Neutral Detergent | Prolystica Ultra Concentrate<br>HP Neutral Detergent | |

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### Summary of Non-Clinical Performance Testing 6.

The purpose of this Special 510(k) is to update labeling based on a labeling revision being enacted by Intuitive Surgical to allow for automated cleaning and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers 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 as or better than the legally marketed predicate device (K190081), Class II (21 CFR 876.1500), product code NVE.