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

K190081 · STERIS Corporation · NVE · Aug 21, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K190081
• Device Name: RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
• Applicant: STERIS Corporation
• Product Code: NVE · Gastroenterology, Urology
• Decision Date: Aug 21, 2019
• Decision: SESE
• Submission Type: Traditional
• 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

The RAS 12 Rack and RAS 12 Long Rack are accessories for AMSCO 7052HP/7053HP washer/disinfectors. They hold up to 12 robotic-assisted surgery instruments (da Vinci EndoWrist X/Xi, S/Si, Single-Site, and staplers). The device eliminates the need for manual pre-cleaning. The operator loads soiled instruments into the rack and selects the RAS Cycle on the washer/disinfector. The system performs automated spray-washing and lumen flushing using enzymatic cleaner and neutral detergent, followed by a thermal rinse for intermediate-level disinfection and a drying phase. The process is controlled by the washer/disinfector's integrated software, which monitors temperature, time, water volume, chemistry injection, and pump rotation. The output is cleaned, disinfected, and dried instruments ready for steam sterilization. The device is used in hospital sterile processing departments by technicians. It benefits patients by ensuring standardized, validated reprocessing of complex robotic instruments, reducing the risk of residual soil or contamination.

Clinical Evidence

No clinical data. Bench testing only. Simulated use and in-use testing on da Vinci EndoWrist instruments demonstrated cleaning efficacy with protein levels <6.4 µg/cm² and TOC <12 µg/cm². Thermal disinfection validation achieved >6-log reduction of vegetative organisms and >3-log reduction of mycobacterium. Biocompatibility testing confirmed no cytotoxicity of chemical residuals.

Technological Characteristics

Stand-alone pass-through single-chamber washer/disinfector with integrated software. Features in-line self-cleaning filtration. Uses spray arms and lumen flushing. Energy source: electrical. Sterilization: thermal disinfection (194°F/90°C for 1 minute, A0=600). Connectivity: USB port for data download/printing. Software: system-integrated control logic.

Indications for Use

Indicated for the automated cleaning, rinsing, drying, and intermediate level disinfection of reusable da Vinci EndoWrist X/Xi, S/Si, and Single-Site instruments and staplers in a hospital/medical center sterile processing department (SPD).

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

• da Vinci SonicPro Cleaning System (K073112)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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)

[X] 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:

Marcia L. Benedict Senior Director, Regulatory Affairs Tel: [phone] Fax: [phone]

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 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

da Vinci SonicPro Cleaning System: K073112

#### Device Description 3.

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.

#### 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 K190081<br>RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors | Predicate Device<br>da Vinci SonicPro<br>Cleaning System<br>(K073112) | Comparison |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use<br>Indications<br>for Use | The RAS Racks are used in the<br>RAS Cycles of the AMSCO<br>7052HP and 7053HP Single-<br>Chamber Washer/Disinfectors<br>for the effective cleaning,<br>rinsing, drying and<br>intermediate level disinfection<br>of reusable da Vinci<br>EndoWrist® X/Xi, S/Si, and<br>Single-Site instruments and<br>staplers. | The da Vinci SonicPro<br>Cleaning System is intended<br>for the automated cleaning<br>of reusable EndoWrist<br>Instruments and accessories<br>used with the da Vinci and<br>da Vinci S surgical systems.<br>The Cleaning System when<br>used in accordance with its<br>labeling provides an<br>automated cleaning method<br>as part of the re-processing<br>sequence for the EndoWrist<br>Instruments and Accessories. | The intended<br>use is the same;<br>details<br>provided differ.<br>The proposed<br>device<br>specifically<br>names claimed<br>da Vinci<br>EndoWrist<br>device models.<br>The proposed<br>device achieves<br>cleaning<br>without<br>preliminary<br>manual<br>cleaning, while<br>the predicate<br>device requires<br>EndoWrist<br>manual<br>cleaning. |
| 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 effective<br>cleaning of complex lumened<br>da Vinci instruments and<br>staplers. Validated parameters<br>of the RAS cycle, which<br>includes prewash, cleaning<br>stages, rinsing, intermediate | The Cleaning System<br>provides a microprocessor<br>controlled unit with the<br>ability to clean internal and<br>external surfaces of lumened<br>robotic surgical instruments<br>such as the da Vinci<br>EndoWrist instruments.<br>Cleaning follows manual<br>cleaning steps and is<br>accomplished through use of<br>hot water, user-selected<br>detergent, flow, ultrasonic<br>energy, and rinsing | Similar;<br>however<br>The predicate<br>includes use of<br>ultrasonic<br>energy<br>The proposed<br>device includes<br>thermal<br>disinfection<br>and drying,<br>without<br>sonication |
| Feature | Proposed Device K190081<br>RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors | Predicate Device<br>da Vinci SonicPro<br>Cleaning System<br>(K073112) | Comparison |
| | level thermal disinfection, and<br>heated drying, cannot be<br>reduced from the minimum<br>default parameters. | mechanism. | |
| 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<br>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. | The Cleaning System is a<br>stand-alone unit mounted on<br>a movable frame with<br>integrated hardware and<br>software. Provides<br>temperature controlled<br>spray, ultrasonic cleaning,<br>and flushing with user-<br>selected chemistries.<br>Includes pumps, filter,<br>chamber/tank, basket, flush<br>tubes, printer connection. | Similar |
| 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 per the manufacturer's<br>IFU (da Vinci Instrument<br>Reprocessing Manual). When<br>received in the SPD within one<br>hour they are flushed with<br>water and installed in the<br>appropriate RAS Rack<br>according to the detailed<br>instructions provided in its<br>Operator Manual. | Thoroughly clean the outside<br>of the entire instrument or<br>accessory using running<br>water with a clean, soft,<br>nylon bristled brush. Repeat<br>scrubbing as needed. See<br>Reprocessing Instructions<br>PN 550875. Thoroughly<br>rinse. Place in SonicPro<br>instrument basket. Attach<br>the slip luer end of flush<br>tubes to main flush port of<br>each instrument and to<br>quick-connect fittings in<br>tank. | Different<br>instrument prep<br>required, as<br>reflected in<br>intended use<br>statements. |
| 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 at<br>specified volume of 0.74<br>oz. (22 mL)Series of washing stages:<br>> 2-minute Prewash, not | The critical process<br>parameters are:<br>Instrument Cycle (5mm or 8<br>mm): 30 - 45 °C (86 - 113°F)User-selected pH neutral<br>cleaning agent @ 0.5<br>oz/gal - 3.0 oz/gal | Each system<br>has established<br>critical<br>parameters to<br>achieve<br>validated<br>outcomes. The<br>cycles differ. |
| Feature | Proposed Device K190081<br>RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors | Predicate Device<br>da Vinci SonicPro<br>Cleaning System<br>(K073112) | Comparison |
| | 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<br>stage @150°F with<br>Prolystica Ultra<br>Concentrate HP Detergent<br>> 2-minute rinse, not 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 Detergent<br>> 1-minute rinse, not heated<br>• Pump provides continuous<br>circulation through lumens<br>and spray arms at pressure<br>above 45 psi | • 135 W/gal ultrasonic<br>power density<br>• 30 psi minimum flushing<br>pressure<br>Accessory Cycle:<br>• 25 - 45 °C (77 - 113°F)<br>• User-selected pH neutral<br>cleaning agent @ 0.5<br>oz/gal - 3.0 oz/gal<br>• 135 W/gal ultrasonic<br>power density<br>• 30 psi minimum flushing<br>pressure | |
| 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 (90°C)<br>• Time 1 minute<br>• $A_0$ = 600 | No disinfection cycle | Capabilities<br>differ |
| Drying | • Temperature (high =<br>setpoint 220°F)<br>• Default time 20 minutes<br>(adjustable from 2 to 30<br>minutes) | No drying capability | Capabilities<br>differ |
| Record<br>keeping | Provides printout or download<br>capability from USB port or<br>using optional printer | Connection to separate<br>thermal printer | Capabilities<br>differ |
| Water<br>Quality | < 120 ppm hardness | < 200 ppm hardness | Similar |
| Feature | Proposed Device K190081<br>RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors | Predicate Device<br>da Vinci SonicPro<br>Cleaning System<br>(K073112) | Comparison |
| Sonication | No capability | 135 W/gal ultrasonic power<br>density | Capabilities<br>differ |
| Process<br>Monitors: | 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 system<br>provides<br>monitoring<br>suitable to<br>assure critical<br>parameters are<br>met. |
| 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. | Cleaning System injects<br>user-selected cleaning<br>solution at user-selected<br>volume between 0.5 oz/gal –<br>3.0 oz/gal (in increments of<br>0.5 oz.) | Similar;<br>predicate<br>allows volume<br>to be altered |
| 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. | Use only pH-neutral, low-<br>foaming, enzymatic cleaning<br>agents | Proposed<br>device limits<br>options to<br>validated<br>cleaners;<br>predicate<br>cleaner is user-<br>selected |
| Cycle time | Approximately 1 hour and 15 –<br>20 minutes | Approximately 40 minutes<br>Instrument Cycles, 30<br>minutes Accessory Cycle | Predicate<br>cycles are<br>shorter |
| #<br>Instruments | Up to 12 da Vinci instruments<br>and/or staplers/cycle | Up to 10 instruments/cycle | Proposed<br>device can<br>process more |
| Self-<br>Disinfection<br>Cycle | No self-disinfection cycle.<br>A Decon Cycle using AMSCO<br>Liquid Descaler is run once<br>weekly. | No self-disinfection cycle.<br>System Purge Cycle (5 min.<br>cleaning with hot water and<br>ultrasonics followed by hot<br>water and ultrasonic rinse) is<br>performed daily. | Similar |
| Feature | Proposed Device K190081<br>RAS Racks and Cycles in<br>AMSCO® 7052HP/7053HP<br>Single-Chamber<br>Washer/Disinfectors | Predicate Device<br>da Vinci SonicPro<br>Cleaning System<br>(K073112) | Comparison |
| Filters | Each RAS Rack features an<br>in-line, self-cleaning filtration<br>assembly. Operator performs a<br>manual cleaning step weekly. | Includes a 10-micron water<br>filter that is replaced<br>annually or after 200 cycles,<br>whichever comes first | Each provides<br>filtration<br>differently |
| Accessories | Prolystica Ultra Concentrate<br>HP Enzymatic Cleaner and<br>Prolystica Ultra Concentrate<br>HP Neutral Detergent | Thermal printer, Accessory<br>and Instrument Baskets,<br>Flush Tubes, unspecified<br>cleaning agent | Accessories<br>differ |

# 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 Use<br>Testing | Endowrist instruments identified as master devices for<br>their most challenging features were soiled and allowed to<br>dry for at least one hour. They were processed in triplicate<br>trials using the RAS Cycle to the end of the initial rinse<br>(prior to thermal rinse), then examined visually and<br>sampled for quantitation of two soil markers: protein <6.4<br>µg/cm², TOC <12 µg/cm². | PASS |
| In-Use Testing | Clinically used Endowrist instruments were installed in<br>the Rack according to its IFU, the rack was placed in the<br>washer/disinfector, and the RAS Cycle was run to the end<br>of initial rinse (prior to thermal rinse). Instruments were<br>examined visually and sampled for quantitation of two<br>soil markers: protein <6.4 µg/cm², TOC <12 µg/cm². | PASS |
| Rinsing Efficacy<br>and<br>Biocompatibility | Two EndoWrist instruments were processed three (3)<br>consecutive times in full loads using double cleaner<br>concentrations. Rinse water and device extracts were<br>tested for cytotoxicity. Device extracts were analyzed<br>to verify that the chemical residual level is not<br>cytotoxic | PASS |

Table 2. Performance Testing

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| Thermal<br>Disinfection | Achieves greater than 6-log reduction of each organism in<br>a mixed suspension of vegetative organisms, and greater<br>than 3-log reduction of mycobacterium species | PASS |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| W/D Physical<br>Performance | Chemical injection control operates within specifications<br>Temperature control operates within specifications<br>Pump maintains high speed performance as designed<br>Drying is achieved by the RAS Cycle | PASS |
| Human Factors | Typical users were capable of following the written<br>instructions for use to correctly configure and load the<br>RAS Rack and to select the correct cycle of the<br>washer/disinfector. | PASS |
| Electrical Safety<br>Conformance | UL 61010-1 Safety Requirements for Electrical<br>Equipment for Measurement, Control, and Laboratory<br>Use - Part 1: General Requirements, 3rd Edition<br>UL 61010-2-040 Safety Requirements for Electrical<br>Equipment for Measurement, Control, and Laboratory<br>Use - Part 2-040: Particular Requirements for Sterilizers<br>and Washer-Disinfectors Used to Treat Medical<br>Materials, 2nd Edition<br>IEC 61326-1:2012 Electrical equipment for measurement,<br>control and laboratory use – EMC requirements – Part 1:<br>General requirements<br>• conformance to FCC Part 15 | PASS |
| Software<br>Validation | The software that controls the system was validated and<br>determined 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).