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.

AI/ML Overview

The provided text describes premarket notifications (510(k) summaries) for several sterilization and washer-disinfector systems, focusing on modifications to the control boards (using refurbished or slightly modified boards). It does not describe an AI/ML-based medical device. Therefore, the information required to answer the prompt regarding acceptance criteria and study proving device meets criteria (which typically applies to AI/ML device performance, ground truth establishment, expert review, MRMC studies, etc.) is largely not present in the provided document.

The document discusses acceptance criteria and study conclusions in the context of validating sterilization efficacy and proper operation of mechanical systems, not AI performance.

Therefore, for aspects related to AI/ML device performance (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, etc.), the answer will be "N/A" (Not Applicable) or "Not relevant" because the document does not pertain to such a device.

Here's an attempt to extract relevant information wherever possible, and indicate N/A where the information is not provided or not relevant to the type of device described:

Device Category: Sterilization and Washer-Disinfector Systems (Mechanical/Chemical Medical Devices)

1. Table of acceptance criteria and the reported device performance:

Since this document describes multiple devices, I'll consolidate the general nature of the tests and criteria. The performance is consistently reported as "Pass" for all listed tests, indicating they met the defined acceptance criteria.

Device/System	Test	Acceptance Criterion	Reported Performance
AMSCO 600 Steam Sterilizer	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
V-PRO maX 2 Low Temperature Sterilization System	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
V-PRO s2 Low Temperature Sterilization System	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
RAS Racks & RAS Cycle (Washer/Disinfectors)	Critical parameters test	Compare the cycle data of RAS cycle between refurbished and new Kodiak controllers to confirm the cleaning efficiency.	Pass
	Software confirmation test	Ensure proper version, proper parameters are in the cycles for proper operation of cycles.	Pass

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

Sample Size for Test Set: Specific numerical sample sizes for the "tests" listed (e.g., how many 1/2 cycle sterility tests were performed, on how many units, or specific amounts of biological indicators) are not detailed in this summary. The validation studies mentioned for different load configurations (e.g., "two instrument trays", "one pouched instrument tray", "two flexible endoscopes") relate to the type of load tested for sterilization efficacy, not the statistical sample size of individual tests.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. These are typically controlled laboratory validation studies rather than clinical data collection.

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

Not relevant. The "ground truth" for these devices, which are sterilizers/disinfectors, is typically established through microbiology (proving sterility/disinfection) and engineering evaluations (confirming operational parameters and software functionality), not through human expert interpretation of images or other data for diagnostic purposes. The "ground truth" is typically defined by the absence of microbial growth on biological indicators or the achievement of specified physical parameters (time, temperature, pressure).

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

Not relevant. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human experts are making subjective assessments that need to be reconciled (e.g., image interpretation). This document describes validation of mechanical systems and biological efficacy.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, not done. MRMC studies are specific to evaluating the clinical impact of AI models on human reader performance, typically in diagnostic imaging. This document is about sterilizers and washer-disinfectors, which are not AI-assisted diagnostic tools.

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

Not relevant. This question is formulated for an AI/ML algorithm. The "performance" of these devices is their ability to independently execute sterilization/disinfection cycles according to defined parameters and standards. The "software confirmation test" listed in the table is the closest equivalent, verifying the algorithm's (software's) proper operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Biological/Physical Performance Ground Truth: For the sterility assurance tests, the ground truth is established by microbiological culture results (absence of growth on biological indicators) coupled with physical parameter monitoring (time, temperature, pressure). For the cleaning efficiency tests, the ground truth would similarly be based on pre-defined levels of contamination removal as verified by analytical methods, and the adherence to critical cycle parameters. This is not derived from expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be.

8. The sample size for the training set:

Not applicable. These devices are not AI/ML systems that undergo a "training" phase with a dataset in the conventional sense. The "training" for these systems would be the engineering design, development, and iterative testing/refinement of the hardware and embedded software.

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

Not applicable. As above, there is no "training set" in the context of an AI/ML model for these devices. The "ground truth" for the development of these systems would be the established scientific principles of sterilization/disinfection and adherence to relevant industry standards (e.g., ANSI/AAMI ST79 for steam sterilization, or specific standards for low-temperature sterilization and washer-disinfectors).

Summary

{0}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K222543

Device Name

AMSCO 600 Steam Sterilizer

Indications for Use (Describe)

Cycles	SterilizeTemperature	Sterilize Time	Dry Time	Maximum Recommended Load
Prevac	270°F (132°C)	4 minutes	20 minutes	Fabric Packs. Refer to Table 2 forrecommended 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 toTable 2 for recommendedquantities.
Prevac	270°F (132°C)	10 minutes	30 minutes	Double wrapped instrument trays,maximum weight 25 lbs. (11.3kg) each . Refer to Table 2 forrecommended 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 forrecommended quantities.
Prevac-IUSS	270°F (132°C)	4 minutes	1 minutes	Immediate use - singleunwrapped 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 forrecommended 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
LeakTest	N/A	N/A	N/A	N/A

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

{3}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

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:

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).

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).

{5}------------------------------------------------

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 < 527 mm in length
· Triple channeled devices with stainless lumens that are either:

1.2 mm ID and < 275 mm in length

≥ 1.8 mm ID and ≤ 310 mm in length

≥ 2.8 mm ID and ≤ 317 mm in length

Validation testing for all lumen sizes was conducted using a maximum of 20 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 two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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

{7}------------------------------------------------

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 < 275 mm (~10-53/64") in length
≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length

≥ 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 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 Ibs (5.0 kg).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{8}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue.

510(k) Summary For AMSCO 600 Steam Sterilizer

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact: Tony Piotrkowski Director, Regulatory Affairs

Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: Tony_Piotrkowski@steris.com

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	SterilizeTemperature	SterilizeTime	Dry Time	Maximum Recommended Load
Prevac	270°F (132°C)	4 minutes	20 minutes	Fabric Packs. Refer to Table 2for recommended quantities.
Prevac	270°F (132°C)	4 minutes	30 minutes	Double wrapped instrument trays, maximumweight 25 lbs. (11.3 kg) each and FabricPacks. Refer to Table 2 forrecommended quantities.
Prevac	270°F (132°C)	10 minutes	30 minutes	Double wrapped instrument trays, maximumweight 25 lbs. (11.3 kg) each. Refer to Table2 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, maximumweight 25 lbs. (11.3 kg) each. Refer to Table 2for recommended quantities.
Prevac-IUSS	270°F (132°C)	4 minutes	1 minute	Immediate use - singleunwrapped tray
Gravity	250°F (121°C)	30 minutes	30 minutes	Double wrapped instrument trays, maximumweight 25 lbs. (11.3 kg) each. Refer to Table 2for 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 InstrumentTrays	Fabric Packs
26" x 26" x 39"	9	12
26" x 26" x 51"	12	16
26" x 26" x 63"	15	20

Technological Characteristics Comparison Table

{12}------------------------------------------------

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

{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 sterilityassurance Test	All biological indicators must show no growth after a 1/2Cycle exposure with a worst-case load.	Pass
Softwareconfirmation test	Ensure proper version, proper operation of cycles andalarms	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: (440) 354-2600 Fax No: (440) 357-9198

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Tel: 440-392-7437 Fax: 440-357-9198 Email:

tony_piotrkowski@steris.com

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.

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:

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).

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 < 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 ≤ 527 mm in length

· Triple channeled devices with stainless lumens that are either:

≥ 1.2 mm ID and ≤ 275 mm in length

1.8 mm ID and < 310 mm in length

2.8 mm ID and < 317 mm in length

Validation testing for all lumen sizes was conducted using a maximum of 20 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 two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).

{17}------------------------------------------------

5. Technological Characteristics

The proposed and predicate devices are identical in all technological characteristics including but not limited to: fundamental scientific technology, composition, mechanism of action, components and accessories. No physical changes were made to the devices for this modification other than the chip modifications described herein.

Technological Characteristics Comparison Table
Feature	V-PRO maX 2Low TemperatureSterilization System (Proposed)	V-PRO1, 1-Plus, maX and maX 2Low Temperature SterilizationSystem (Predicate – K190103)	Comparison
Intended Use	The maX 2 Low TemperatureSterilization System using VAPROX HCSterilant is intended for use in theterminal sterilization of properly prepared(cleaned, rinsed and dried) medicaldevices in Healthcare Facilities. Thepreprogrammed sterilization cyclesoperate at low pressure and temperature,suitable for processing medical deviceswithout leaving toxic residues	The maX 2 Low TemperatureSterilization System using VAPROX HCSterilant is intended for use in theterminal sterilization of properlyprepared (cleaned, rinsed and dried)medical devices in Healthcare Facilities.The preprogrammed sterilization cyclesoperate at low pressure and temperature,suitable for processing medical deviceswithout leaving toxic residues	Same
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 toInjection• Sterilant Injection Weight	Same
Software/FirmwareControlled	Control system consists of a proprietarymicrocomputer control board andperipheral function circuit boards, locatedwithin the control housing. A memorybackup system maintains user settings andcalibration data indefinitely. Up to 300cycle data files can be stored for review ordownloading by the user.The software allows user selection of thepre- programmed cycle.	Control system consists of a proprietarymicrocomputer control board andperipheral function circuit boards, locatedwithin the control housing. A memorybackup system maintains user settings andcalibration data indefinitely. Up to 300cycle data files can be storedfor review or downloading by the user.The software allows user selection of thepre- programmed cycles.	Same control but usingrefurbished/slightlymodified boards
Sterilant	VAPROX HC Sterilant (59% HydrogenPeroxide).	VAPROX HC Sterilant (59% HydrogenPeroxide).	Same
Accessories	Accessories were submitted underseparate, individual, concurrent 510(k)sand cover the following:• Self-contained biological indicator• Biological indicator challenge pack• Fast Acting Biological Indicator• Chemical indicator• Trays & Tray Accessories• Pouches	Accessories were submitted underseparate, individual, concurrent 510(k)sand cover the following:• Self-contained biological indicator• Biological indicator challenge pack• Fast Acting Biological Indicator• Chemical indicator• Trays & Tray Accessories• Pouches	Same

Technological Characteristics Comparison Table

{18}------------------------------------------------

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

Note that refurbishing for the purposes of the process covered by this submission consists of clearing the memory and uploading the most recent software and may also include replacement of minor components of the board.

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.

Test	Criterion	Conclusion
1 1/2 Cycle sterilityassurance Test	All biological indicators must show no growth after a 1/2Cycle exposure with a worst-case load.	Pass
Softwareconfirmation test	Ensure proper version, proper operation of cycles andalarms	Pass

7. Conclusions

Based on the intended use, technological characteristics and non-clinical performance data, the V-PRO maX 2 Low Temperature Sterilization System is as safe, as effective and performs as well as or better than the legally marketed predicate device K190103. Class II (21 CFR 880.6860), product code MLR and the use of refurbished/slightly modified boards has no impact on the device performance.

{19}------------------------------------------------

STERIS®

510(k) Summary For V-PRO® s2 Low Temperature Sterilization System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Tel: 440-392-7437 Fax: 440-357-9198 Email: tony_piotrkowski@steris.com

August 24, 2022 Submission Date:

Premarket Notification Number: K222543

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

{20}------------------------------------------------

2. Device Name

Trade Name:	V-PRO® s2 Low Temperature Sterilization Systems
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

3. Predicate Device

K190917, V-PRO® s2 and V-PRO 60 Low Temperature Predicate: Sterilization Systems

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 in the manufacture of the devices consists of clearing the memory and uploading the most recent software and may also include replacement of minor components of the board.

4. Description of Device

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.

ട. Intended Use / Indications for Use

The V-PRO s2 Low Temperature Sterilization System using VAPROX® HC Sterilant are 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.

{21}------------------------------------------------

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

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

The 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 instrument tray for a total weight of 25 lbs (11.3 kg).

The Fast Cycle can sterilize: 1

Medical devices (including single, dual and triple channeled rigid and semi-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

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

The Lumen Cycle can sterilize: ^

Medical devices (including single, dual and triple channeled rigid and semi-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:

{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

≥ 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 SterlizationSystem(Modified Device)	V-PRO s2 Low Temperature SterlizationSystem(Predicate Device K190917)	Comparison
Indicationsfor Use	See completed indications for use below. No changes are being proposed to thedevice's intended use or indications for use	No changes are being proposed to thedevice's intended use or indications for use	Identical
ProcessParameters	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/FirmwareControlled	Control system consists of a microcomputercontrol board and peripheral function circuitboards, located within the control housing.A memory backup system maintains cyclesettings and current cycle information.The software allows user selection of eitherthe Lumen, Non Lumen, Flexible or Fastpre-programmed cycle.	Control system consists of a microcomputercontrol board and peripheral function circuitboards, located within the control housing.A memory backup system maintains cyclesettings and current cycle information.The software allows user selection of eitherthe Lumen, Non Lumen, Flexible or Fastpre-programmed cycle.	Same controlbut usingrefurbished/slightly modifedboards
Total CycleTime	Lumen Cycle - 60 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 38 minutesFast Cycle - 19 minutes	Lumen Cycle - 60 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 38 minutesFast Cycle - 19 minutes	Identical
Sterilant	VAPROX HC Sterilant (59% HydrogenPeroxide).	VAPROX HC Sterilant (59% HydrogenPeroxide).	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

{23}------------------------------------------------

Test	Criterion	Conclusion
1 1/2 Cycle sterilityassurance Test	All biological indicators must show no growth after a 1/2Cycle exposure with a worst-case load.	Pass
Softwareconfirmation test	Ensure proper version, proper operation of cycles andalarms	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: (440) 354-2600 Fax No: (440) 357-9198

Anthony Piotrkowski Contact: Director, Regulatory Affairs Tel: 440-392-7437 Fax: 440-357-9198 Email: tony_piotrkowski@steris.com

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 ofAMSCO 7052HP Single Chamber Washer/Disinfectorand AMSCO 7053HP Single ChamberWasher/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

{27}------------------------------------------------

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

{28}------------------------------------------------

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

6. Summary of Non-Clinical Performance Testing

Test	Criterion	Conclusion
Criticalparameters test	Compare the cycle data of RAS cycle between refurbished andnew Kodiak controllers to confirm the cleaning efficiency	Pass
Softwareconfirmation test	Ensure proper version, proper parameters are in the cyclesfor proper operation of cycles	Pass

{29}------------------------------------------------

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 (K203199), Class II (21 CFR 876.1500), product code NVE and the use of refurbished/slightly modified boards has no impact on the device performance.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Feature	AMSCO 600 Steam Sterilizer(Modified Device)	AMSCO 600 Steam Sterilizer(Predicate Device/K211500)	Comparison
Intended Use	The AMSCO 600 Steam Sterilizer isdesigned for sterilization of heat andmoisture-stable materials used in healthcarefacilities.	The AMSCO 600 Steam Sterilizer isdesigned for sterilization of heat andmoisture-stable materials used in healthcarefacilities.	Same
Critical ProcessParameters	Time Chamber Temperature Pressure	Time Chamber Temperature Pressure	Same
Control	Embedded Controller	Embedded Controller	Same control butusingrefurbished/slightlymodified boards
SAL	10-6	10-6	Same
Sterilant	Saturated Steam	Saturated Steam	Same
Utilities	Steam, Water, Electricity, Air	Steam, Water, Electricity, Air	Same
ChamberMaterial	316L Stainless Steel	316L Stainless Steel	Same
NominalChamber 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 Steel26" x 26" Power vertical sliding	304L Stainless Steel26" x 26" Power vertical sliding	Same
ChamberPressure Rating	45 psig, 300°F	45 psig, 300°F	Same
Door Seal	Steam activated door seal	Steam activated door seal	Same
External ProcessMonitors	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 ProcessMonitors	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 or12, fabric packs 51": 12, 25-lb double wrapped trays or16, fabric packs 63": 15, 25-lb double wrapped trays or20, fabric packs	39": 9, 25-lb double wrapped trays or12, fabric packs 51": 12, 25-lb double wrapped trays or16, fabric packs 63": 15, 25-lb double wrapped trays or 20,fabric packs	Same

Technological Characteristics Comparison Table
Feature	Proposed DeviceRAS Racks and Cycles in AMSCO®7052HP/7053HP Single-ChamberWasher/Disinfectors	Predicate DeviceRAS Racks and Cycles in AMSCO®7052HP/7053HP Single-ChamberWasher/Disinfectors (K203199)	Comparison
Indicationsfor Use	The RAS Racks are used in the RAS Cycleof the AMSCO 7052HP Single-ChamberWasher/Disinfector and the AMSCO7053HP Single-ChamberWasher/Disinfector for the effectivecleaning, rinsing, intermediate leveldisinfection and drying of reusable daVinci® X/Xi and S/Si EndoWrist®instruments.	The RAS Racks are used in the RAS Cycleof the AMSCO 7052HP Single-ChamberWasher/Disinfector and the AMSCO7053HP Single-ChamberWasher/Disinfector for the effectivecleaning, rinsing, intermediate leveldisinfection and drying of reusable daVinci® X/Xi and S/Si EndoWrist®instruments.	Identical
OperatingPrinciples/Technology	The RAS Racks and RAS Cycle of the7052HP/7053HP SC w/d provide thenecessary combination of cleaning agentsin hot water with temperature and waterpressure control during timed sequences toachieve effective cleaning of complexlumened da Vinci instruments. Validatedparameters of the RAS cycle, whichincludes prewash, cleaning stages, rinsing,intermediate level thermal disinfection,and heated drying, cannot be reduced fromthe minimum default parameters.	The RAS Racks and RAS Cycle of the7052HP/7053HP SC w/d provide thenecessary combination of cleaning agentsin hot water with temperature and waterpressure control during timed sequences toachieve effective cleaning of complexlumened da Vinci instruments. Validatedparameters of the RAS cycle, whichincludes prewash, cleaning stages, rinsing,intermediate level thermal disinfection.and heated drying, cannot be reduced fromthe minimum default parameters.	Identical
Control	Embedded Controller	Embedded Controller	Same controlbut usingrefurbished/slightlymodifiedboards
Where Used	Hospital/medical center SPD	Hospital/medical center SPD	Identical
Design	The Washer/Disinfector is a stand-alonepass-through design single-chamber unitwith integrated software. The RAS Racksposition and provide flow to loaded daVinci items throughout the RAS Cyclewhile spray arms assure all surfaces arecleaned with validated chemistries, rinsed,thermal disinfected, and dried.	The Washer/Disinfector is a stand-alonepass-through design single-chamber unitwith integrated software. The RAS Racksposition and provide flow to loaded daVinci items throughout the RAS Cyclewhile spray arms assure all surfaces arecleaned with validated chemistries, rinsed,thermal disinfected, and dried.	Identical
Instrumentpreparation	Reusable EndoWrist® X/Xi, S/Siinstruments are handled at point of use inthe OR, then transferred to theDecontamination Area of the sterileprocessing department where they areprepared for automated cleaning andinstalled in the appropriate RAS Rackaccording to the detailed instructionsprovided in its Operator Manual.	Reusable EndoWrist® X/Xi, S/Siinstruments are handled at point of use inthe OR, then transferred to theDecontamination Area of the sterileprocessing department where they areprepared for automated cleaning andinstalled in the appropriate RAS Rackaccording to the detailed instructionsprovided in its Operator Manual.	Identical
Feature	Proposed DeviceRAS Racks and Cycles in AMSCO®7052HP/7053HP Single-ChamberWasher/Disinfectors	Predicate DeviceRAS Racks and Cycles in AMSCO®7052HP/7053HP Single-ChamberWasher/Disinfectors (K203199)	Comparison
CriticalParametersfor Cleaning	Minimum critical cycle parameters areprovided by default in the RAS Cycle:Dosing of validated concentratedchemistries at specified volume of0.74 oz. (22 mL) Series of washing stages:➤ 2-minute Prewash, not heated➤ Wash phase 1 - initial 6-minute stage@122°F with Prolystica UltraConcentrate HP Enzymatic Cleanerfollowed by 6-minute stage @150°Fwith Prolystica Ultra Concentrate HPDetergent ➤ 2-minute rinse, not heated ➤ Wash phases 3 and 4, each - initial 6-minute stage @122°F with ProlysticaUltra Concentrate HP EnzymaticCleaner followed by 6-minute stage@150°F with Prolystica UltraConcentrate HP Detergent ➤ 1-minute rinse, not heated Pump provides continuous circulationthrough lumens and spray arms atpressure above 45 psi	Minimum critical cycle parameters areprovided by default in the RAS Cycle:Dosing of validated concentratedchemistries at specified volume of0.74 oz. (22 mL) Series of washing stages:➤ 2-minute Prewash, not heated➤ Wash phase 1 - initial 6-minute stage@122°F with Prolystica UltraConcentrate HP Enzymatic Cleanerfollowed by 6-minute stage @150°Fwith Prolystica Ultra Concentrate HPDetergent ➤ 2-minute rinse, not heated ➤ Wash phases 3 and 4, each - initial 6-minute stage @122°F with ProlysticaUltra Concentrate HP EnzymaticCleaner followed by 6-minute stage@150°F with Prolystica UltraConcentrate HP Detergent ➤ 1-minute rinse, not heated Pump provides continuous circulationthrough lumens and spray arms atpressure above 45 psi	Identical
CriticalParametersfor ThermalDisinfection	Minimum critical cycle parameters areprovided by default in the RAS Cycle: Temperature 194°F (90°C) Time 1 minute A0 = 600	Minimum critical cycle parameters areprovided 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 (adjustablefrom 2 to 30 minutes)	Temperature (high = setpoint 220°F) Default time 20 minutes (adjustablefrom 2 to 30 minutes)	Identical
Recordkeeping	Provides printout or download capabilityfrom USB port or using optional printer	Provides printout or download capabilityfrom USB port or using optional printer	Identical
WaterQuality	< 120 ppm hardness	< 120 ppm hardness	Identical
Sonication	No capability	No capability	Identical
ProcessMonitors:	Monitors water temperature for eachfilling of the sump Monitors time of each phase at setpoint temperature. Monitors water fill volume Monitors volume of cleaner injected Monitors pump rotation	Monitors water temperature for eachfilling of the sump Monitors time of each phase at setpoint temperature. Monitors water fill volume Monitors volume of cleaner injected Monitors pump rotation	Identical
Cleanerdispensed	Washer/disinfector automaticallydispenses the validated volume ofconcentrated chemistry at specified pointsin the RAS Cycle.	Washer/disinfector automaticallydispenses the validated volume ofconcentrated chemistry at specified pointsin the RAS Cycle.	Identical
Feature	Proposed DeviceRAS Racks and Cycles in AMSCO®7052HP/7053HP Single-ChamberWasher/Disinfectors	Predicate DeviceRAS Racks and Cycles in AMSCO®7052HP/7053HP Single-ChamberWasher/Disinfectors (K203199)	Comparison
Cleaningchemistries	Uses only Prolystica Ultra Concentrate HPEnzymatic Cleaner and Prolystica UltraConcentrate HP Neutral Detergent in RASCycle.	Uses only Prolystica Ultra Concentrate HPEnzymatic Cleaner and Prolystica UltraConcentrate HP Neutral Detergent in RASCycle.	Identical
Cycle time	Approximately 1 hour and 15 - 20 minutes	Approximately 1 hour and 15 - 20 minutes	Identical
Number ofInstruments	Up to 12 da Vinci instruments/cycle	Up to 12 da Vinci instruments/cycle	Identical
Self-DisinfectionCycle	● No self-disinfection cycle.● A Decon Cycle using AMSCO LiquidDescaler is run once weekly.	● No self-disinfection cycle.● A Decon Cycle using AMSCO LiquidDescaler is run once weekly.	Identical
Filters	Each RAS Rack features an in-line, self-cleaning filtration assembly. Operatorperforms a manual cleaning step weekly.	Each RAS Rack features an in-line, self-cleaning filtration assembly. Operatorperforms a manual cleaning step weekly.	Identical
Accessories	Prolystica Ultra Concentrate HPEnzymatic Cleaner and Prolystica UltraConcentrate HP Neutral Detergent	Prolystica Ultra Concentrate HPEnzymatic Cleaner and Prolystica UltraConcentrate HP Neutral Detergent	Identical