AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector

• K Number: K222543
• Device Name: AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
• Manufacturer: Steris
• Date Cleared: 2022-08-25 ( 3 days)
• Product Code: NVE FLE MLR PEC
• Regulation Number: 876.1500

Intended Use

The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1): The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. The V-PRO s2 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues. 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, intermediate level disinfection and drying of reusable da Vinci® X/Xi and S/Si EndoWrist® instruments.

Device Description

The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products. The V-PRO Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer. It has the following pre-programmed cycles (the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle and the Fast Non Lumen Cycle). The V-PRO Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities. The V-PRO s2 Sterilizer executes four sterilization cycles (the Lumen, Non Lumen, Flexible Cycles and Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing. 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.

Predicate Devices

K211500, K190103, K190917, K203199

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard sterilization and washing equipment with pre-programmed cycles. There is no mention of AI, ML, or any adaptive or learning capabilities.

Therapeutic

No
The devices described are sterilizers and washing/disinfecting units for medical instruments, intended to prepare reusable medical devices for use, not to treat patients or address medical conditions.

Diagnostic

No
The provided text describes devices (sterilizers and racks) used for cleaning, disinfecting, and sterilizing medical devices, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components like steam sterilizers, vaporized hydrogen peroxide sterilizers, and racks for washer-disinfectors. While software is mentioned in performance studies, it is integral to the operation of these physical devices, not a standalone software product.

IVD (In Vitro Diagnostic)

Based on the provided text, none of the described devices are IVDs (In Vitro Diagnostics).

Here's why:

• IVDs are used to examine specimens from the human body. The intended use and device descriptions clearly state that these devices are used for sterilizing or cleaning medical devices and instruments. They are not used to analyze biological samples for diagnostic purposes.
• The focus is on sterilization and cleaning processes. The text describes cycles, temperatures, pressures, and the types of materials being processed (heat and moisture-stable materials, medical devices, surgical instruments). This aligns with sterilization and cleaning equipment, not diagnostic tests.

Therefore, these devices fall under the category of medical device sterilization and cleaning equipment, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):
The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.
The V-PRO s2 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.
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, intermediate level disinfection and drying of reusable da Vinci® X/Xi and S/Si EndoWrist® instruments.

Product codes (comma separated list FDA assigned to the subject device)

FLE, PEC, MLR, NVE

Device Description

The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products.

The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.

The sterilizers are generally operated by technicians in a central service or sterile processing department of healthcare facilities. Sterilizers may also be located in a surgical suite to allow for Immediate Use Steam Sterilization (IUSS) for instances where an instrument is needed immediately for a procedure (e.g. after an instrument has been dropped and there is no replacement readily available). Standard practices for use of sterilizers in health care facilities are provided by various organizations (e.g. ANSI/AAMI ST79).

The ALUS is used with the AMSCO 600 Steam Sterilizer's existing transfer carriages and loading carts. It consists of a conveyor system which attaches to the load and/or unload ends of the steam sterilizer. It has a series of barcode labels which correspond to pre-programmed cycles and an optional scanner which when fitted to the system will communicate to the sterilizer which cycle to initiate.
The V-PRO Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer. It has the following pre-programmed cycles (the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle and the Fast Non Lumen Cycle). The V-PRO Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.

The V-PRO Sterilizers uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The four preprogrammed cycles all use a conditioning phase, a sterilize phase and an aeration phase. Packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.
The V-PRO s2 Sterilizer executes four sterilization cycles (the Lumen, Non Lumen, Flexible Cycles and Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing.

The V-PRO s2 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities and utilizes VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The preprogrammed cycles all use a conditioning phase, a sterilize phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.
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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

technicians in a central service or sterile processing department of healthcare facilities. Sterilizers may also be located in a surgical suite
Healthcare Facilities
Healthcare Facilities
Hospital/medical center SPD

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

AMSCO 600 Steam Sterilizer: Non-clinical tests were performed.
Test: 1/2 Cycle sterility assurance Test. Criterion: All biological indicators must show no growth after a 1/2 Cycle exposure with a worst-case load. Conclusion: Pass.
Test: Software confirmation test. Criterion: Ensure proper version, proper operation of cycles and alarms. Conclusion: Pass.

V-PRO maX 2 Low Temperature Sterilization System: Non-clinical performance test was performed according to the test methodology listed and is the same methods used to verify the original design.
Test: 1/2 Cycle sterility assurance Test. Criterion: All biological indicators must show no growth after a 1/2 Cycle exposure with a worst-case load. Conclusion: Pass.
Test: Software confirmation test. Criterion: Ensure proper version, proper operation of cycles and alarms. Conclusion: Pass.

V-PRO s2 Low Temperature Sterilization System: Non-clinical performance test was performed according to the test methodology listed and is the same methods used to verify the original design.
Test: 1/2 Cycle sterility assurance Test. Criterion: All biological indicators must show no growth after a 1/2 Cycle exposure with a worst-case load. Conclusion: Pass.
Test: Software confirmation test. Criterion: Ensure proper version, proper operation of cycles and alarms. Conclusion: Pass.

RAS Racks and RAS Cycle in AMSCO® 7052HP / 7053HP Single Chamber Washer/Disinfectors: Non-clinical performance test was performed according to the test methodology listed and is the same methods used to verify the original design. The testing demonstrated that the subject device met the acceptance criteria described in the standard/methodology.
Test: Critical parameters test. Criterion: Compare the cycle data of RAS cycle between refurbished and new Kodiak controllers to confirm the cleaning efficiency. Conclusion: Pass.
Test: Software confirmation test. Criterion: Ensure proper version, proper parameters are in the cycles for proper operation of cycles. Conclusion: Pass.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K211500, K190103, K190917, K203199

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.

August 25, 2022

Anthony Piotrkowski Director, Regulatory Affairs Steris Inc. 5960 Heislev Rd Mentor, Ohio 44060

Re: K222543

Trade/Device Name: AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector Regulation Number: 21 CFR 880.6880; 21 CFR 880.6860; 21 CFR 876.1500 Regulation Name: Steam Sterilizer; Ethylene Oxide Gas Sterilizer; Endoscope And Accessories Regulatory Class: Class II Product Code: FLE,PEC, MLR, NVE Dated: August 19, 2022 Received: August 22, 2022

Dear Anthony Piotrkowski:

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.

1

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 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 medical devices and radiation-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.

Clarence W. Murray III, Ph.D. 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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Indications for Use

510(k) Number (if known)

K222543

Device Name

AMSCO 600 Steam Sterilizer

Indications for Use (Describe)

The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):

| Cycles | Sterilize
Temperature | Sterilize Time | Dry Time | Maximum Recommended Load |
|-----------------|--------------------------|----------------|------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 2 for
recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg)
each and Fabric Packs. Refer to
Table 2 for recommended
quantities. |
| Prevac | 270°F (132°C) | 10 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3
kg) each . Refer to Table 2 for
recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg)
each. Refer to Table 2 for
recommended quantities. |
| Prevac-
IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Immediate use - single
unwrapped tray |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg)
each. Refer to Table 2 for
recommended quantities. |
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3.5 minutes | 1 minute | Bowie-Dick Test Pack, DART |
| Leak
Test | N/A | N/A | N/A | N/A |

Table 1. AMSCO 600 Steam Sterilizer factory-validated sterilization cvcles and cvcle values

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Table 2 AMSCO 600 Steam Sterilizer full load per sterilizer s
Sterilizer Size	Wrapped Instrument Trays	Fabric Packs
26" x 26" x 39"	9	12
26" x 26" x 51"	12	16
26" x 26" x 63"	15	20

ize

The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.

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

• Prescription Use (Part 21 CFR 801 Subpart D)

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K222543

Device Name

V-PRO maX 2 Low Temperature Sterilization Systems

Indications for Use (Describe)

The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle and Fast Non Lumen Cycle.

The Non Lumen Cycle can sterilize:

t Non-lumened instruments including non-luments, non-lumened rigid, semi-rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of two instrument travs for a total weight of 50 lbs (22.7 kg).

The Fast Non Lumen Cycle can sterilize:

*Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).

The Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.* The flexible endoscopes may contain either:

• · A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length
• Or two lumens with:
  • One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
  • And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length

• The validation studies were conducted with two flexible endoscopes, each packaged into a tray with sillicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. ** The flexible endoscope may contain either:

• · A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length

• Or two lumens with:

  • One lumen that is > 1 mm ID and ≤ 990 mm in length

• And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.

f The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).

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The Lumen Cycle can sterilize:

f Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

• Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length
• Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length
• · Dual channeled devices with stainless lumens that are > 0.77 mm ID and 1.2 mm ID and Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

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6

Indications for Use

510(k) Number (if known) K222543

Device Name

V-PRO® s2 Low Temperature Sterilization System

Indications for Use (Describe)

The V-PRO s2 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: t

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).

The V-PRO s2 Sterilizer Fast Cycle can sterilize: t

Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

• · Single or dual channeled devices with stainless steel lumens that are

• 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (~16-9/64") in length

• ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length

· Triple channeled devices with stainless steel lumens that are either:

• ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length
• ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length
• or
• ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.

• Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).

The V-PRO s2 Sterilizer Flexible Cycle can sterilize: @

One surgical flexible endoscope (such as those used in ENT. Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

• · The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length
• · Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions
• ≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length
• ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
• ≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21-5/16") in length

@ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second

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tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 1bs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.

The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^

Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

• · Single or dual channeled devices with stainless steel lumens that are
• ≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length
• ≥ 1.8 mm (~5/64) ID x ≤ 542 mm (~21-5/16") in length
• · Triple channeled devices with stainless steel lumens that are either:
• ≥ 1.2 mm (~3/64") ID and Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K222543

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

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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9

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510(k) Summary For AMSCO 600 Steam Sterilizer

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact: Tony Piotrkowski Director, Regulatory Affairs

Telephone: [phone] Fax No: [phone] e-mail: [e-mail]

Summary Date: August 24, 2022

Premarket Notification Number: K222543

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

10

1. Device Name

Trade Name:	AMSCO 600 Steam Sterilizer
Device Class:	Class II
Common/usual Name:	Steam Sterilizer
Classification Name:	Sterilizer, Steam
Classification Number:	21 CFR 880.6880
Product Code:	FLE, PEC

2. Predicate Device

K211500 AMSCO 600 Steam Sterilizer

3. Description of Device

The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products.

The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.

The sterilizers are generally operated by technicians in a central service or sterile processing department of healthcare facilities. Sterilizers may also be located in a surgical suite to allow for Immediate Use Steam Sterilization (IUSS) for instances where an instrument is needed immediately for a procedure (e.g. after an instrument has been dropped and there is no replacement readily available). Standard practices for use of sterilizers in health care facilities are provided by various organizations (e.g. ANSI/AAMI ST79).

The ALUS is used with the AMSCO 600 Steam Sterilizer's existing transfer carriages and loading carts. It consists of a conveyor system which attaches to the load and/or unload ends of the steam sterilizer. It has a series of barcode labels which correspond to pre-programmed cycles and an optional scanner which when fitted to the system will communicate to the sterilizer which cycle to initiate.

11

4. Intended Use/Indications for Use

The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture- stable materials used in healthcare facilities and are equipped with the following factory- programmed cycles:

| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Maximum Recommended Load |
|-----------------|--------------------------|-------------------|------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 2
for recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays, maximum
weight 25 lbs. (11.3 kg) each and Fabric
Packs. Refer to Table 2 for
recommended quantities. |
| Prevac | 270°F (132°C) | 10 minutes | 30 minutes | Double wrapped instrument trays, maximum
weight 25 lbs. (11.3 kg) each. Refer to Table
2 for recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays, maximum
weight 25 lbs. (11.3 kg) each. Refer to Table 2
for recommended quantities. |
| Prevac-
IUSS | 270°F (132°C) | 4 minutes | 1 minute | Immediate use - single
unwrapped tray |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays, maximum
weight 25 lbs. (11.3 kg) each. Refer to Table 2
for recommended quantities. |
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3.5 minutes | 1 minute | Bowie-Dick Test Pack, DART |
| Leak Test | N/A | N/A | N/A | N/A |

AMSCO 600 Steam Sterilizer factory-validated sterilization cycles and cycle values

AMSCO 600 Steam Sterilizer full load per sterilizer size

| Sterilizer Size | Wrapped Instrument
Trays | Fabric Packs |
|-----------------|-----------------------------|--------------|
| 26" x 26" x 39" | 9 | 12 |
| 26" x 26" x 51" | 12 | 16 |
| 26" x 26" x 63" | 15 | 20 |

The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.

Technological Characteristics Comparison Table

12

STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification to AMSCO 600 Steam Sterilizer

| Feature | AMSCO 600 Steam Sterilizer
(Modified Device) | AMSCO 600 Steam Sterilizer
(Predicate Device/K211500) | Comparison |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Intended Use | The AMSCO 600 Steam Sterilizer is
designed for sterilization of heat and
moisture-stable materials used in healthcare
facilities. | The AMSCO 600 Steam Sterilizer is
designed for sterilization of heat and
moisture-stable materials used in healthcare
facilities. | Same |
| Critical Process
Parameters | Time Chamber Temperature Pressure | Time Chamber Temperature Pressure | Same |
| Control | Embedded Controller | Embedded Controller | Same control but
using
refurbished/slightly
modified boards |
| SAL | 10-6 | 10-6 | Same |
| Sterilant | Saturated Steam | Saturated Steam | Same |
| Utilities | Steam, Water, Electricity, Air | Steam, Water, Electricity, Air | Same |
| Chamber
Material | 316L Stainless Steel | 316L Stainless Steel | Same |
| Nominal
Chamber Size | 26" w x 26" h x 39" d 26" w x 26" h x 51" d 26" w x 26" h x 63" d | 26" w x 26" h x 39" d 26" w x 26" h x 51" d 26" w x 26" h x 63" d | Same |
| Door | 304L Stainless Steel
26" x 26" Power vertical sliding | 304L Stainless Steel
26" x 26" Power vertical sliding | Same |
| Chamber
Pressure Rating | 45 psig, 300°F | 45 psig, 300°F | Same |
| Door Seal | Steam activated door seal | Steam activated door seal | Same |
| External Process
Monitors | Electronic Control Printer | Electronic Control Printer | Same |
| Accessories | BI, CI, Pouches, Trays, Wraps, Tape,
Containers, Shelves, Loading Equipment,
automated loading system | BI, CI, Pouches, Trays, Wraps, Tape,
Containers, Shelves, Loading Equipment,
automated loading system | Same |
| Test Cycles | Warm Up, Leak Test, DART (Bowie Dick)
Test | Warm Up, Leak Test, DART (Bowie Dick)
Test | Same |
| Internal Process
Monitors | Temperature
-Dual element RTD located in chamber drain

• RTD located in the jacket drain
• RTD located in heat exchanger | Temperature
  -Dual element RTD located in chamber drain
• RTD located in the jacket drain
• RTD located in heat exchanger | Same |
  | | Pressure
  -Pressure transducer in chamber | Pressure
  -Pressure transducer in chamber | |
  | Performance | Meets ANSI/AAMI ST8:2013 | Meets ANSI/AAMI ST8:2013 | Same |
  | Cycles | 270F, Prevac, 4' Full fabric pack 270F, Prevac, 4' Full tray 270F, Prevac, 4' One fabric pack 270F, Prevac, 4' IUSS 275F, Prevac, 3' Full fabric 250F, Gravity, 30' Full tray 270F, Prevac, 10' Full tray | 270F, Prevac, 4' Full fabric pack 270F, Prevac, 4' Full tray 270F, Prevac, 4' One fabric pack 270F, Prevac, 4' IUSS 275F, Prevac, 3' Full fabric 250F, Gravity, 30' Full tray 270F, Prevac, 10' Full tray | Same |
  | Full Loads | 39": 9, 25-lb double wrapped trays or
  12, fabric packs 51": 12, 25-lb double wrapped trays or
  16, fabric packs 63": 15, 25-lb double wrapped trays or
  20, fabric packs | 39": 9, 25-lb double wrapped trays or
  12, fabric packs 51": 12, 25-lb double wrapped trays or
  16, fabric packs 63": 15, 25-lb double wrapped trays or 20,
  fabric packs | Same |

13

The proposed device has the same intended use as the predicate with the same technological characteristics. The modifications, subject of this submission, are to use refurbished control boards and control boards that have been slightly modified by using alternative, drop-in replacement components in the manufacture of the devices. Note that refurbishing for the purposes of the process covered by this submission consists of clearing the memory and uploading the most recent software.

Summary of Nonclinical Tests ട്.

The AMSCO 600 Steam Sterilizer has the same intended use and technological characteristics that do not raise different questions of safety and effectiveness as compared to the predicate device. Testing to assess and demonstrate substantial equivalence to the predicate is summarized below.

Test	Criterion	Conclusion
1/2 Cycle sterility
assurance Test	All biological indicators must show no growth after a 1/2
Cycle exposure with a worst-case load.	Pass
Software
confirmation test	Ensure proper version, proper operation of cycles and
alarms	Pass

6. Conclusion

Based on the intended uses, 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 K211500, Class II (21 CFR 880.6860), product code FLE and the use of refurbished/ slightly modified boards has no impact on the device performance.

14

STERIS®

510(k) Summary For V-PRO® maX 2 Low Temperature Sterilization System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Tel: [phone] Fax: [phone] Email:

[e-mail]

Submission Date: August 24, 2022

Premarket Notification Number: K222543

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

15

1. Device Name

Trade Name:	V-PRO® maX 2 Low Temperature Sterilization System
Device Class:	Class II
Common/usual Name:	Vapor Phase Hydrogen Peroxide Sterilizer
Classification Name:	Sterilizer, Ethylene Oxide Gas
Classification Number:	21 CFR 880.6860
Product Code:	MLR

2. Predicate Device

K190103, V-PRO maX and maX 2 V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems.

3. Description of Device

The V-PRO Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer. It has the following pre-programmed cycles (the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle and the Fast Non Lumen Cycle). The V-PRO Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.

The V-PRO Sterilizers uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The four preprogrammed cycles all use a conditioning phase, a sterilize phase and an aeration phase. Packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.

4. Intended Use / Indications for Use

The maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle and the Fast Non Lumen Cycle.

The Non Lumen Cycle can sterilize: †

Non-lumened instruments including non-lumened general medical instruments, nonlumened rigid, semi-rigid and flexible endoscopes.

16

STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification to V-PRO maX 2 Low Temperature Sterilization System

: The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

The Fast Non Lumen Cycle can sterilize: *

Non-lumened instruments including non-lumened general medical instruments, nonlumened rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).

The Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT,

Urology and Surgical Care) and bronchoscopes in either of the two configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain either:

• A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length
• Or two lumens with:
• One lumen that is ≥ 1 mm ID and ≤ 990 mm in length

■ And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length

• The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. ** The flexible endoscope may contain either:

• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length

• Or two lumens with:
• One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
• = And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.

†† The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).

The Lumen Cycle can sterilize: †

Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

· Single channeled devices with a stainless lumen that is > 0.77 mm ID and 1.8 mm ID and 2.8 mm ID and 0.77 mm (~1/32") internal diameter (ID) and 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or

≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length

-lumened instruments including non-lumened general medical instruments, nonlumened rigid, semi-rigid and flexible endoscopes.

: Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).

The Flexible Cycle can sterilize: ®

One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

· The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm ID and 1.0 mm (~3/64") ID and 1.8 mm (~5/64) ID x ≤ 542 mm (~21-5/16") in length

• Triple channeled devices with stainless steel lumens that are either:

22

STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification to V-PRO s2 Low Temperature Sterilization System

≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length

≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length

or

≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length

^ Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg).

Technological Characteristics Comparison Table

| Feature | V-PRO s2 Low Temperature Sterlization
System
(Modified Device) | V-PRO s2 Low Temperature Sterlization
System
(Predicate Device K190917) | Comparison |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Indications
for Use | See completed indications for use below. No changes are being proposed to the
device's intended use or indications for use | No changes are being proposed to the
device's intended use or indications for use | Identical |
| Process
Parameters | The critical process parameters are:
• Time
• Chamber Temperature
• Vaporizer Temperature
• Chamber Pressure Prior to Injection
• Sterilant Injection Weight | The critical process parameters are:
• Time
• Chamber Temperature
• Vaporizer Temperature
• Chamber Pressure Prior to Injection
• Sterilant Injection Weight | Identical |
| Software/
Firmware
Controlled | Control system consists of a microcomputer
control board and peripheral function circuit
boards, located within the control housing.
A memory backup system maintains cycle
settings and current cycle information.
The software allows user selection of either
the Lumen, Non Lumen, Flexible or Fast
pre-programmed cycle. | Control system consists of a microcomputer
control board and peripheral function circuit
boards, located within the control housing.
A memory backup system maintains cycle
settings and current cycle information.
The software allows user selection of either
the Lumen, Non Lumen, Flexible or Fast
pre-programmed cycle. | Same control
but using
refurbished/
slightly modifed
boards |
| Total Cycle
Time | Lumen Cycle - 60 minutes
Non Lumen Cycle - 28 minutes
Flexible Cycle - 38 minutes
Fast Cycle - 19 minutes | Lumen Cycle - 60 minutes
Non Lumen Cycle - 28 minutes
Flexible Cycle - 38 minutes
Fast Cycle - 19 minutes | Identical |
| Sterilant | VAPROX HC Sterilant (59% Hydrogen
Peroxide). | VAPROX HC Sterilant (59% Hydrogen
Peroxide). | Identical |
| Accessories | Accessories include:
• Self-contained biological indicator
• Biological indicator challenge pack
• Fast Acting Biological Indicator
• Chemical indicator
• Trays & Tray Accessories
• Pouches
• Tape | Accessories include:
• Self-contained biological indicator
• Biological indicator challenge pack
• Fast Acting Biological Indicator
• Chemical indicator
• Trays & Tray Accessories
• Pouches
• Tape | Identical |

6. Summary of Non-Clinical Testing

Non-clinical performance test was performed according to the test methodology listed below and is the same methods used to verify the original design. The testing demonstrated that the subject device met the acceptance criteria described in the standard/methodology.

23

Test	Criterion	Conclusion
1 1/2 Cycle sterility
assurance Test	All biological indicators must show no growth after a 1/2
Cycle exposure with a worst-case load.	Pass
Software
confirmation test	Ensure proper version, proper operation of cycles and
alarms	Pass

7. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the V-PRO s2 Low Temperature Sterilization System is as safe, as effective and performs as well as or better than the legally marketed predicate device K190917, Class II (21 CFR 880.6860), product code MLR and the use of refurbished/slightly modified boards has no impact on the device performance.

24

STERIS®

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: [phone] Fax No: [phone]

Anthony Piotrkowski Contact: Director, Regulatory Affairs Tel: [phone] Fax: [phone] Email: [e-mail]

Submission Date: August 24, 2022

Premarket Notification Number: K222543

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

25

1. Device Name

| Trade Name: | RAS 12 Rack, RAS 12 Long Rack RAS Cycle of
AMSCO 7052HP Single Chamber Washer/Disinfector
and AMSCO 7053HP Single 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, K203199.

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 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.

4. Indications for Use

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.

5. Technological Characteristics Comparison Table

A comparison of technical characteristics between the proposed and predicate devices is summarized below.

26

STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification to RAS Racks and Cycles in AMSCO® 7052HP/7053HP Single-Chamber Washer/Disinfectors

Technological Characteristics Comparison Table

Technological Characteristics Comparison Table
Feature	Proposed Device
RAS Racks and Cycles in AMSCO®
7052HP/7053HP Single-Chamber
Washer/Disinfectors	Predicate Device
RAS Racks and Cycles in AMSCO®
7052HP/7053HP Single-Chamber
Washer/Disinfectors (K203199)	Comparison
Indications
for Use	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.	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.	Identical
Operating
Principles
/
Technology	The RAS Racks and RAS Cycle of the
7052HP/7053HP SC w/d provide the
necessary combination of cleaning agents
in hot water with temperature and water
pressure control during timed sequences to
achieve effective cleaning of complex
lumened da Vinci instruments. Validated
parameters of the RAS cycle, which
includes prewash, cleaning stages, rinsing,
intermediate level thermal disinfection,
and heated drying, cannot be reduced from
the minimum default parameters.	The RAS Racks and RAS Cycle of the
7052HP/7053HP SC w/d provide the
necessary combination of cleaning agents
in hot water with temperature and water
pressure control during timed sequences to
achieve effective cleaning of complex
lumened da Vinci instruments. Validated
parameters of the RAS cycle, which
includes prewash, cleaning stages, rinsing,
intermediate level thermal disinfection.
and heated drying, cannot be reduced from
the minimum default parameters.	Identical
Control	Embedded Controller	Embedded Controller	Same control
but using
refurbished/
slightly
modified
boards
Where Used	Hospital/medical center SPD	Hospital/medical center SPD	Identical
Design	The Washer/Disinfector is a stand-alone
pass-through design single-chamber unit
with integrated software. The RAS Racks
position and provide flow to loaded da
Vinci items throughout the RAS Cycle
while spray arms assure all surfaces are
cleaned with validated chemistries, rinsed,
thermal disinfected, and dried.	The Washer/Disinfector is a stand-alone
pass-through design single-chamber unit
with integrated software. The RAS Racks
position and provide flow to loaded da
Vinci items throughout the RAS Cycle
while spray arms assure all surfaces are
cleaned with validated chemistries, rinsed,
thermal disinfected, and dried.	Identical
Instrument
preparation	Reusable EndoWrist® X/Xi, S/Si
instruments are handled at point of use in
the OR, then transferred to the
Decontamination Area of the sterile
processing department where they are
prepared for automated cleaning and
installed in the appropriate RAS Rack
according to the detailed instructions
provided in its Operator Manual.	Reusable EndoWrist® X/Xi, S/Si
instruments are handled at point of use in
the OR, then transferred to the
Decontamination Area of the sterile
processing department where they are
prepared for automated cleaning and
installed in the appropriate RAS Rack
according to the detailed instructions
provided in its Operator Manual.	Identical
Feature	Proposed Device
RAS Racks and Cycles in AMSCO®
7052HP/7053HP Single-Chamber
Washer/Disinfectors	Predicate Device
RAS Racks and Cycles in AMSCO®
7052HP/7053HP Single-Chamber
Washer/Disinfectors (K203199)	Comparison
Critical
Parameters
for Cleaning	Minimum critical cycle parameters are
provided by default in the RAS Cycle:
Dosing of validated concentrated
chemistries at specified volume of
0.74 oz. (22 mL) Series of washing stages:
➤ 2-minute Prewash, not heated
➤ Wash phase 1 - initial 6-minute stage
@122°F with Prolystica Ultra
Concentrate HP Enzymatic Cleaner
followed by 6-minute stage @150°F
with Prolystica Ultra Concentrate HP
Detergent ➤ 2-minute rinse, not heated ➤ Wash phases 3 and 4, each - initial 6-
minute stage @122°F with Prolystica
Ultra Concentrate HP Enzymatic
Cleaner followed by 6-minute stage
@150°F with Prolystica Ultra
Concentrate HP Detergent ➤ 1-minute rinse, not heated Pump provides continuous circulation
through lumens and spray arms at
pressure above 45 psi	Minimum critical cycle parameters are
provided by default in the RAS Cycle:
Dosing of validated concentrated
chemistries at specified volume of
0.74 oz. (22 mL) Series of washing stages:
➤ 2-minute Prewash, not heated
➤ Wash phase 1 - initial 6-minute stage
@122°F with Prolystica Ultra
Concentrate HP Enzymatic Cleaner
followed by 6-minute stage @150°F
with Prolystica Ultra Concentrate HP
Detergent ➤ 2-minute rinse, not heated ➤ Wash phases 3 and 4, each - initial 6-
minute stage @122°F with Prolystica
Ultra Concentrate HP Enzymatic
Cleaner followed by 6-minute stage
@150°F with Prolystica Ultra
Concentrate HP Detergent ➤ 1-minute rinse, not heated Pump provides continuous circulation
through lumens and spray arms at
pressure above 45 psi	Identical
Critical
Parameters
for Thermal
Disinfection	Minimum critical cycle parameters are
provided by default in the RAS Cycle: Temperature 194°F (90°C) Time 1 minute A0 = 600	Minimum critical cycle parameters are
provided by default 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 30 minutes)	Temperature (high = setpoint 220°F) Default time 20 minutes (adjustable
from 2 to 30 minutes)	Identical
Record
keeping	Provides printout or download capability
from USB port or using optional printer	Provides printout or download capability
from USB port or using optional printer	Identical
Water
Quality