(29 days)
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.
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.
I am sorry, but the provided text does not contain the acceptance criteria or a study proving that the device meets acceptance criteria. The document is an FDA 510(k) premarket notification for a medical device (STERIS RAS 12 Rack and RAS Cycle), which states that the proposed device is substantially equivalent to a legally marketed predicate device (K190081).
The document details the device's intended use, technological characteristics, and compares it to the predicate device. However, it explicitly states in "Summary of Non-Clinical Performance Testing" that "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... The RAS Racks and associated RAS Cycles were not altered in anyway." This implies that the performance testing was likely conducted for the predicate device (K190081) and is referenced, but the details of such a study are not present in this document.
Therefore, I cannot extract the requested information such as a table of acceptance criteria and reported performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, type of ground truth, or training set details.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: (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: 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 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
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 DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K200577 ) | Predicate DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K190081) | Comparison |
|---|---|---|---|
| IntendedUseIndicationsfor Use | 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. | 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 |
| OperatingPrinciplesTechnology | 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. | 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 |
| WhereUsed | Hospital/medical center SPD | Hospital/medical center SPD | Identical |
| Design | The Washer/Disinfector is astand-alone pass-throughdesign single-chamber unit | The Washer/Disinfector is astand-alone pass-throughdesign single-chamber unit | Identical |
| Table 1. Technological Characteristics Comparison Table | |
|---|---|
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| Proposed DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K200577 ) | Predicate DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K190081) | Comparison | |
|---|---|---|---|
| Feature | with 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. | with 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, 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 themanufacturer's IFU (da VinciAddendum for AutomatedReprocessing Manual). Whenreceived in the SPD withinone hour they are flushedwith water and installed in theappropriate RAS Rackaccording to the detailedinstructions provided in itsOperator 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 themanufacturer's IFU (da VinciAddendum for AutomatedReprocessing Manual). Whenreceived in the SPD withinone hour they are flushedwith water and installed in theappropriate RAS Rackaccording to the detailedinstructions provided in itsOperator Manual. | |
| CriticalParametersforCleaning | Minimum critical cycleparameters are provided bydefault in the RAS Cycle:• Dosing of validatedconcentrated 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 HPEnzymatic Cleanerfollowed by 6 minute | Minimum critical cycleparameters are provided bydefault in the RAS Cycle:• Dosing of validatedconcentrated 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 HPEnzymatic Cleanerfollowed by 6 minute | |
| Feature | Proposed DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K200577) | Predicate DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K190081) | Comparison |
| stage @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, notheated• Pump providescontinuous circulationthrough lumens and sprayarms at pressure above 45psi | stage @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, notheated• Pump 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 |
| Proposed Device | Predicate Device | ||
| Feature | RAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K200577 ) | RAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K190081) | Comparison |
| Sonication | No capability | No capability | Identical |
| ProcessMonitors: | Monitors water temperature for eachfilling of the sump Monitors time of eachphase at set pointtemperature. Monitors water fillvolume Monitors volume ofcleaner injected Monitors pump rotation | Monitors water temperature 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 and/orstaplers/cycle | Up to 12 da Vinciinstruments and/orstaplers/cycle | Identical |
| 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 performsa manual cleaning stepweekly. | Each RAS Rack features anin-line, self-cleaning filtrationassembly. Operator performsa manual cleaning stepweekly. | Identical |
| Accessories | Prolystica Ultra ConcentrateHP Enzymatic Cleaner and | Prolystica Ultra ConcentrateHP Enzymatic Cleaner and | Identical |
| Feature | Proposed DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K200577 ) | Predicate DeviceRAS Racks and Cycles inAMSCO® 7052HP/7053HPSingle-ChamberWasher/Disinfectors(K190081) | Comparison |
| Prolystica Ultra ConcentrateHP Neutral Detergent | Prolystica Ultra ConcentrateHP 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.
§ 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.