The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities.

The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.

The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

The extensive treatment of EPA potable water consists of:

1. Pre-filtration through two pre-filters:
- · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
- · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron.
1. UV Irradiation:
- · During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > or equal to 6-log reduction of MS2 virus is delivered to the water.
3.0.1 micron filtration:
- · The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria. fungi and protozoa > 0.1 micron.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800 is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution(> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is intended for liquid chemical sterilization of cleaned, immersible, and reusable sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

Device Description

The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The current submission is provided to describe modifications for:

. Obsolescence and replacement of interface board and connector
Obsolescence and replacement of silicone tubing ●
S40 Sterilant Concentrate design modification ●

The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800 is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe modifications for:

Obsolescence and replacement of silicone tubing
S40 Sterilant Concentrate design modification .

The SYSTEM 1 endo Processor is an automated. self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe modifications for:

Obsolescence and replacement of silicone tubing
S40 Sterilant Concentrate design modification

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.

AI/ML Overview

This document is a 510(k) Premarket Notification from STERIS Corporation to the FDA regarding several Liquid Chemical Sterilant Processing Systems. It's important to understand that this document describes a sterilization device, not an AI/ML-driven diagnostic or image analysis device. Therefore, many of the requested criteria related to AI/ML performance (e.g., sample size for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, ground truth for training data) are not applicable to this type of medical device submission.

The acceptance criteria provided are for the functional and physical performance of a chemical sterilant processing system and its associated sterilant, not for an AI model's diagnostic accuracy.

Here's a breakdown of the requested information based on the provided document:

Device Description and Purpose:

The devices are the "SYSTEM 1E Liquid Chemical Sterilant Processing System," "SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800," and "SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900," along with the "S40 Sterilant Concentrate." These systems are intended for liquid chemical sterilization of cleaned, immersible, and reusable heat-sensitive medical devices (critical and semi-critical) in healthcare facilities. They utilize peracetic acid as the sterilant.

The submission is specifically for modifications to existing cleared devices (predicate K210737), primarily involving:

Obsolescence and replacement of interface board and connector (for SYSTEM 1E)
Obsolescence and replacement of silicone tubing (for all models)
S40 Sterilant Concentrate design modification (for all models)

1. Table of Acceptance Criteria and Reported Device Performance

The tables below synthesize the acceptance criteria and the results as presented in the "Summary of verification activities" (Table 3 in each section of the document).

For SYSTEM 1E Liquid Chemical Sterilant Processing System (Page 15, Table 3)

Change	Test	Acceptance Criteria	Result
Obsolescence and replacement of interface board and connector	Functional testing	The modification does not affect the operation of the device.	Pass
	Reliability testing	The modification does not affect the operation of the device.	Pass
	EMC/EMI and electrical safety	The device must meet UL 61010-1:2010 Third Edition and UL 61010-2-040:2015-7-07	Pass
Obsolescence and replacement of silicone tubing	Functional testing	The modification does not affect the operation of the device.	Pass
	Form and fit	The replacement must fit within the device.	Pass
	Physical properties	The replacement must be equivalent to the current tubing.	Pass
S40 Sterilant Concentrate design modification	Stability of sterilant	The design modification does not affect the stability of the sterilant.	Pass
	Delivery of sterilant	The design modification does not affect delivery of the sterilant.	Pass

For SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800 (Page 25, Table 3)

Change	Test	Acceptance Criteria	Result
Obsolescence and replacement of silicone tubing	Functional testing	The modification does not affect the operation of the device.	Pass
	Form and fit	The replacement must fit within the device.	Pass
	Physical properties	The replacement must be equivalent to the current tubing.	Pass
S40 Sterilant Concentrate design modification	Stability of sterilant	The design modification does not affect the stability of the sterilant.	Pass
	Delivery of sterilant	The design modification does not affect delivery of the sterilant.	Pass

For SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (Page 36, Table 3)

Change	Test	Acceptance Criteria	Result
Obsolescence and replacement of silicone tubing	Functional testing	The modification does not affect the operation of the device.	Pass
	Form and fit	The replacement must fit within the device.	Pass
	Physical properties	The replacement must be equivalent to the current tubing.	Pass
S40 Sterilant Concentrate design modification	Stability of sterilant	The design modification does not affect the stability of the sterilant.	Pass
	Delivery of sterilant	The design modification does not affect delivery of the sterilant.	Pass

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

The document does not specify exact sample sizes (e.g., number of units tested, number of cycles performed) for the functional, reliability, EMC/EMI, form and fit, physical properties, stability, or delivery tests. It simply states "Functional testing," "Reliability testing," etc., and confirms the Pass result.

Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned as these were laboratory-based engineering and performance tests for a sterilization device, not clinical data for an AI/ML diagnostic.

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

This criterion is not applicable. The "ground truth" for this device relates to its ability to function as a sterilizer and its components meeting engineering specifications. This is established through predefined performance requirements (e.g., UL standards for electrical safety, physical property equivalence, stability of sterilant), not through expert consensus on medical images or diagnoses. Validation would be performed by engineers and quality control personnel according to established test protocols.

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

This criterion is not applicable. Adjudication methods like 2+1 are used for resolving disagreements among human readers or between AI and human reads in diagnostic studies. For a sterilization device, test results are typically objective (e.g., does it pass/fail a function test, does it meet a physical specification).

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

This criterion is not applicable. This is not an AI-assisted diagnostic device. No human readers or interpretations are involved in its primary function, which is sterilization.

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

This criterion is not applicable. This is not an algorithm, but a physical medical device.

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

The "ground truth" in this context refers to the engineering and performance specifications for the device and its components. These include:

Predefined functional requirements (e.g., device operation, sterilant delivery).
Compliance with recognized electrical safety and electromagnetic compatibility (EMC/EMI) standards (e.g., UL 61010-1, UL 61010-2-040).
Physical properties matching existing components.
Chemical stability of the sterilant.

For the basic germicidal efficacy of the sterilant mentioned in the predicate device comparison (Tables 2 on pages 11-13, 22-23, and 32-34), the ground truth for microbial efficacy (e.g., "Meets efficacy requirements," "Solution is bactericidal") would be established through laboratory microbiological testing (e.g., AOAC Official Methods, EPA Viricidal Testing), which involves culturing specific microorganisms and observing their reduction or elimination after exposure to the sterilant. This is not an AI/ML-related ground truth.

8. The sample size for the training set

This criterion is not applicable. This is not an AI/ML device; there is no "training set."

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

This criterion is not applicable. There is no AI/ML training set for this device. Ground truth for its performance is established through adherence to physical and chemical engineering specifications and established microbiological testing protocols.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 7, 2021

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

Re: K211607

Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: September 1, 2021 Received: September 2, 2021

Dear Jennifer Nalepka:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For 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)

K211607

Device Name

SYSTEM 1E Liquid Chemical Sterilant Processing System

Indications for Use (Describe)

The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

The extensive treatment of EPA potable water consists of:

1. Pre-filtration through two pre-filters:
- · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
- · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron.
1. UV Irradiation:
- · During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > or equal to 6-log reduction of MS2 virus is delivered to the water.
3.0.1 micron filtration:
- · The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria. fungi and protozoa > 0.1 micron.

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.

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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:

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Indications for Use

510(k) Number (if known)

K211607

Device Name

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800

Indications for Use (Describe)

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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."

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

Indications for Use

510(k) Number (if known)

K211607

Device Name

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

Indications for Use (Describe)

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

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."

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Image /page/5/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is written in a serif font in all capital letters. Below the word is a graphic of several horizontal wavy lines in blue, resembling water waves. The registered trademark symbol is located to the right of the word STERIS.

510(k) Summary For SYSTEM 1E Liquid Chemical Sterilant Processing System

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

Jennifer Nalepka Contact: Lead Regulatory Affairs Specialist Tel: 440-392-7458 Fax: 440-357-9198

Summary Date: September 1, 2021

Premarket Notification Number: K211607

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1. Device Name

Trade Name:	SYSTEM 1E Liquid Chemical Sterilant ProcessingSystem
Device Classification:	Class II
Common/usual Name:	Liquid Chemical Sterilizer
Classification Name:	Sterilant, Medical devices, Liquid ChemicalSterilants/Disinfectants
Classification Number:	21 CFR 880.6885
Product Code:	MED

2. Predicate Device

SYSTEM 1E Liquid Chemical Sterilant Processing System, K210737

3. Description of Device

. Obsolescence and replacement of interface board and connector
Obsolescence and replacement of silicone tubing ●
S40 Sterilant Concentrate design modification ●

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4. Indications for Use

The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semicritical heat-sensitive medical devices in healthcare facilities.

The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

- The extensive treatment of EPA potable water consists of:
  - 1. Pre-filtration through two pre-filters:
    - Pre-filter A is a gross depth filter that removes approximately 2.5 . micron or larger particles/contaminants.
    - Pre-filter B is a surface filter that removes particles/contaminants > . 0.1 micron.
  - 1. UV Irradiation:
    - During transit through the UV water treatment chamber, a UV dose . sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
  - 1. 0.1 micron filtration:
    - The water prepared by pre-filtration and UV irradiation is filtered . through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

ട. Technological Characteristic Comparison Table

The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device; the specific modifications described in this submission are for a firmware update and obsolescence to components.

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Table 1. Processor Device Comparison Table
Feature	ProposedSYSTEM 1E Processor	Predicate (K210737)SYSTEM 1E Processor	Comparison
Indications forUse	The SYSTEM 1E LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable criticaland semi-critical heat-sensitivemedical devices in healthcarefacilities.	The SYSTEM 1E LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable criticaland semi-critical heat-sensitivemedical devices in healthcarefacilities.	Identical
	The SYSTEM 1E Processordilutes the S40 SterilantConcentrate to its use dilution(>1820 mg/L peracetic acid),liquid chemically sterilizes theload during a controlled 6-minute exposure at 45.5 to 60°C,and rinses the load withextensively treated* potablewater. After completion of acycle, critical devices should beused immediately; semi-criticaldevices should be usedimmediately or may be handledand stored in a manner similar tothat of high level disinfectedendoscopes. Critical devices notused immediately should beprocessed again before use.	The SYSTEM 1E Processordilutes the S40 SterilantConcentrate to its use dilution(>1820 mg/L peracetic acid),liquid chemically sterilizes theload during a controlled 6-minute exposure at 45.5 to 60°C,and rinses the load withextensively treated* potablewater. After completion of acycle, critical devices should beused immediately; semi-criticaldevices should be usedimmediately or may be handledand stored in a manner similar tothat of high level disinfectedendoscopes. Critical devices notused immediately should beprocessed again before use.
	The SYSTEM 1E Processor usesonly S40 Sterilant Concentrate toliquid chemically sterilizemedical devices.	The SYSTEM 1E Processor usesonly S40 Sterilant Concentrate toliquid chemically sterilizemedical devices.
	* The extensive treatment ofEPA potable water consists of:1. Pre-filtration through twopre-filters:• Pre-filter A is a grossdepth filter that removesapproximately 2.5 micronor largerparticles/contaminants.• Pre-filter B is a surfacefilter that removesparticles/contaminants >0.1 micron.	* The extensive treatment ofEPA potable water consists of:1. Pre-filtration through two pre-filters:• Pre-filter A is a gross depthfilter that removesapproximately 2.5 micronor largerparticles/contaminants.• Pre-filter B is a surfacefilter that removesparticles/contaminants > 0.1 micron.
Feature	ProposedSYSTEM 1E Processor	Predicate (K210737)SYSTEM 1E Processor	Comparison
	• During transit through theUV water treatmentchamber, a UV dosesufficient to achieve a ≥6-log reduction of MS2virus is delivered to thewater.3. 0.1 micron filtration:• The water prepared bypre-filtration and UVirradiation is filteredthrough redundant, 0.1-micron (absolute rated)	• During transit through theUV water treatmentchamber, a UV dosesufficient to achieve a ≥ 6-log reduction of MS2 virusis delivered to the water.3. 0.1 micron filtration:• The water prepared by pre-filtration and UV irradiationis filtered throughredundant, 0.1-micron(absolute rated) membranesto remove bacteria, fungi
	membranes to removebacteria, fungi andprotozoa > 0.1 micron.	and protozoa > 0.1 micron.
OperatingPrinciples/Technology	A microprocessor controlled unitwith interchangeable processingtrays/containers. The processorlid opens to reveal theprocessing chamber in which theload is placed. Devices withinternal lumens are interfacedwith the processor usingconnectors. SterilantConcentrate is placed in aspecialized compartment andwhen the processor fills withwater, it creates the sterilant usedilution from the single usesterilant cup. The processormonitors and controls the usedilution temperature and contacttime. The processorautomatically rinses the loadwith extensively treated water toremove sterilant residuals.	A microprocessor controlled unitwith interchangeable processingtrays/containers. The processorlid opens to reveal theprocessing chamber in which theload is placed. Devices withinternal lumens are interfacedwith the processor usingconnectors. SterilantConcentrate is placed in aspecialized compartment andwhen the processor fills withwater, it creates the sterilant usedilution from the single usesterilant cup. The processormonitors and controls the usedilution temperature and contacttime. The processorautomatically rinses the loadwith extensively treated water toremove sterilant residuals.	Identical
ProcessParameters	Standardized cycle parameterscannot be altered by operator.The critical process parametersare:• Contact Time• Use Dilution Temperature• Peracetic acid concentration• Bacterial retentive water• filter integrity• UV irradiation	Standardized cycle parameterscannot be altered by operator.The critical process parametersare:• Contact Time• Use Dilution Temperature• Peracetic acid concentration• Bacterial retentive water• filter integrity• UV irradiation	Identical
ProcessMonitors	• Cycle Printout documentssuccessful cycle completion	• Cycle Printout documentssuccessful cycle completion	Identical
Feature	ProposedSYSTEM 1E Processor	Predicate (K210737)SYSTEM 1E Processor	Comparison
	or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates 0.1-micron water filter failed integrity test during liquid chemical sterilant processing and Diagnostic cycles. Alarms if UV monitor indicates UV intensity out of specification	or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates 0.1-micron water filter failed integrity test during liquid chemical sterilant processing and Diagnostic cycles. Alarms if UV monitor indicates UV intensity out of specification
DesignFeatures	Microprocessor controlled unalterable and standardized liquid chemical sterilant processing and Diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron filtered, UV treated water for liquid chemical sterilant processing and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2-micron membrane air filter.	Microprocessor controlled unalterable and standardized liquid chemical sterilant processing and Diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron filtered, UV treated water for liquid chemical sterilant processing and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2-micron membrane air filter.	Identical
Processing Cycle			Comparison
Incoming watertemperature	≥ 43°C	≥ 43°C	Identical
Feature	ProposedSYSTEM 1E Processor	Predicate (K210737)SYSTEM 1E Processor	Comparison
Temperature tostart exposurephase	$\geq$ 46°C	$\geq$ 46°C	Identical
Temperaturealarm pointduring theexposure phase	<45.5 or >60°C	<45.5 or >60°C	Identical
Temperaturerange during atypical LiquidChemicalSterilantProcessingCycle	46 - 55°C	46 - 55°C	Identical
ExposureTime	6 minutes	6 minutes	Identical
Rinse waterpreparation	Hot potable tap water is:• pre-filtered• flowed through a UV Lighttreatment chamber toachieve $\geq$ a 6-log reductionof virus• Filtered through redundant0.1-micron filtermembranes	Hot potable tap water is:• pre-filtered• flowed through a UV Lighttreatment chamber toachieve $\geq$ a 6-log reductionof virus• Filtered through redundant0.1-micron filtermembranes	Identical
Number ofrinses	2	2	Identical
Air Purge	Aids in removing excess waterfrom instrument lumens afterrinsing	Aids in removing excess waterfrom instrument lumens afterrinsing	Identical
Water FilterIntegrity Test	Conducted at the end of everyliquid chemical sterilantprocessing cycle and during theDiagnostic cycle	Conducted at the end of everyliquid chemical sterilantprocessing cycle and during theDiagnostic cycle	Identical
ApproximateCycle time	25 minutes	25 minutes	Identical
DiagnosticCycle	Performs 15 tests on processor'ssystems confirming properfunction (same tests as predicatedevice except for an added UVmonitor test). Recommended toperform every 24 hours. After afailed Diagnostic cycle, a liquidchemical sterilant processingcycle cannot be performed untilthe problem is rectified and asuccessful Diagnostic cycle hasbeen completed.	Performs 15 tests on processor'ssystems confirming properfunction (same tests as predicatedevice except for an added UVmonitor test). Recommended toperform every 24 hours. After afailed Diagnostic cycle, a liquidchemical sterilant processingcycle cannot be performed untilthe problem is rectified and asuccessful Diagnostic cycle hasbeen completed.	Identical
Interchangeable Components
Feature	ProposedSYSTEM 1E Processor	Predicate (K210737)SYSTEM 1E Processor	Comparison
ProcessingTray /Containers	Uses interchangeable processingtrays/containers• Universal Flexible ProcessingTray (C1160E)• General ProcessingContainer/Tray (C1200)• Directed Flow ProcessingContainer/Tray (C1220)• Flexible EndoscopeProcessing Container / Tray(C1140)• Ultrasound Processing Tray(C3000XL)	Uses interchangeable processingtrays/containers• Universal Flexible ProcessingTray (C1160E)• General ProcessingContainer/Tray (C1200)• Directed Flow ProcessingContainer/Tray (C1220)• Flexible EndoscopeProcessing Container / Tray(C1140)• Ultrasound Processing Tray(C3000XL)	Identical
	Accessories
SterilantConcentrate	Uses S40 Sterilant Concentrate	Uses S40 Sterilant Concentrate	Identical
QuickConnects	Uses Quick Connects to adaptinstrument lumens to theTray/Container ports	Uses Quick Connects to adaptinstrument lumens to theTray/Container ports	Identical
ChemicalIndicator	VERIFY Chemical Indicator forthe S40 Sterilant Concentrate	VERIFY Chemical Indicator forthe S40 Sterilant Concentrate	Identical
Spore TestStrip	VERIFY Spore Test Strip forS40 Sterilant Concentrate	VERIFY Spore Test Strip forS40 Sterilant Concentrate	Identical
OperatorMaintenanceRequirements	Periodic replacement of printertape, water filters and air filter	Periodic replacement of printertape, water filters and air filter	Identical

Table 1. Processor Device Comparison Table

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{10}------------------------------------------------

{11}------------------------------------------------

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

Table 2. S40 Sterilant Concentrate Device Comparison Table

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1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.

2 Clapp et al., Free Rad. Res., (1994) 21:147-167.

3 Maillard et. al., J. Med. Microbiol (1995) 42:415-420.

4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554.

5 McDonnell et al., J. AOAC International (2000) 83:269-276.

{14}------------------------------------------------

{15}------------------------------------------------

The proposed device and its predicate have identical intended use and technological characteristics. New testing was performed to evaluate the modified device and the results are summarized in Table 3.

Summary of Non-Clinical Testing 6.

Shown in Table 3 is the new testing that was performed to evaluate the modified device.

Change	Test	Acceptance Criteria	Result
Obsolescence andreplacement ofinterface board andconnector	Functional testing	The modification does not affectthe operation of the device.	Pass
	Reliability testing	The modification does not affectthe operation of the device.	Pass
	EMC/EMI andelectrical safety	The device must meet UL61010-1:2010 Third Edition andUL 61010-2-040:2015-7-07	Pass
Obsolescence andreplacement ofsilicone tubing	Functional testing	The modification does not affectthe operation of the device	Pass
	Form and fit	The replacement must fit withinthe device	Pass
	Physical properties	The replacement must beequivalent to the current tubing	Pass
S40 SterilantConcentrate designmodification	Stability of sterilant	The design modification does notaffect the stability of thesterilant.	Pass
	Delivery of sterilant	The design modification does notaffect delivery of the sterilant.	Pass

Table 3. Summary of verification activities.

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 or better than the legally marketed predicate device (K210737), Class II (21 CFR 880.6885), product code MED.

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Image /page/16/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is in large, bold, black letters. Below the word is a graphic of several blue horizontal wavy lines stacked on top of each other.

510(k) Summary For SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800

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

Contact:

Jennifer Nalepka Lead Regulatory Affairs Specialist Tel: 440-392-7458 Fax: 440-357-9198

Summary Date: September 1, 2021

Premarket Notification Number: K211607

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

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

1. Device Name

Trade Name:	SYSTEM 1 endo Liquid Chemical SterilantProcessing System, Model P6800
Device Class:	Class 2
Common/usual Name:	Liquid Chemical Sterilizer
Classification Name:	Sterilant, Medical devices, Liquid ChemicalSterilants/Disinfectants
Classification Number:	21 CFR 880.6885
Product Code:	MED

2. Predicate Device

SYSTEM 1endo Liquid Chemical Sterilant Processing System, Model P6800, K210737

3. Description of Device

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe modifications for:

Obsolescence and replacement of silicone tubing
S40 Sterilant Concentrate design modification .

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required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Table 1 compares the proposed and predicate devices.

Intended Use 4.

The SYSTEM 1 endo Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 55°C, and rinses the load with 0.2 micron filtered potable water.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

5. Description of Technological Similarities and Differences

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is identical to the predicate device. A comparison between the proposed and predicate devices is included in Table 1 and Table 2. Since there are no technological differences between the proposed and predicate devices, there are no new concerns of safety and effectiveness.

Feature	Proposed DeviceSYSTEM 1 endo Processor,Model P6800	Predicate Device (K210737)SYSTEM 1 endo Processor,Model P6800	Comparison
Intended UseIndicationsfor Use	The SYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable semi-critical medical devices and theiraccessories in healthcarefacilities.The SYSTEM 1 endo Processorautomatically dilutes the S40Sterilant Concentrate to its usedilution (>1820 mg/L peraceticacid), liquid chemically sterilizesthe load during a controlled 6-minute exposure at 45.5 to 60°C,and rinses the load with 0.2micron filtered water.	The SYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable semi-critical medical devices and theiraccessories in healthcarefacilities.The SYSTEM 1 endo Processorautomatically dilutes the S40Sterilant Concentrate to its usedilution (>1820 mg/L peraceticacid), liquid chemically sterilizesthe load during a controlled 6-minute exposure at 45.5 to 60°C,and rinses the load with 0.2micron filtered water.	Identical
Feature	Proposed DeviceSYSTEM 1 endo Processor,Model P6800	Predicate Device (K210737)SYSTEM 1 endo Processor,Model P6800	Comparison
	The SYSTEM 1 endo Processoruses only S40 SterilantConcentrate to liquid chemicallysterilize medical devices.	The SYSTEM 1 endo Processoruses only S40 SterilantConcentrate to liquid chemicallysterilize medical devices.
OperatingPrinciples /Technology	A microprocessor controlled unitwith interchangeable processingtrays/containers. The processorlid opens to reveal the processingchamber in which the load isplaced. Devices with internallumens are interfaced with theprocessor using connectors, i.e.Quick Connects. S40 Sterilant isplaced in a specializedcompartment and when theprocessor fills with water, itcreates the sterilant use dilutionfrom the single use sterilant cup.The processor monitors andcontrols the use dilutiontemperature and contact time.The processor automaticallyrinses the load with 0.2 micronfiltered water to remove sterilantresiduals.	A microprocessor controlled unitwith interchangeable processingtrays/containers. The processorlid opens to reveal the processingchamber in which the load isplaced. Devices with internallumens are interfaced with theprocessor using connectors, i.e.Quick Connects. S40 Sterilant isplaced in a specializedcompartment and when theprocessor fills with water, itcreates the sterilant use dilutionfrom the single use sterilant cup.The processor monitors andcontrols the use dilutiontemperature and contact time.The processor automaticallyrinses the load with 0.2 micron	Identical
ProcessParameters	Standardized cycle parameterscannot be altered by the operator.The critical process parametersare:• Use dilution contact time• Use dilution temperature• Peracetic acid concentration• Bacterial retentive waterfilter integrity	Standardized cycle parameterscannot be altered by the operator.The critical process parametersare:• Use dilution contact time• Use dilution temperature• Peracetic acid concentration• Bacterial retentive waterfilter integrity	Identical
ProcessMonitors	• Cycle Printout documentssuccessful cycle completionor identifies fault if cycleaborts• Alarms if thermocouplesindicate temperature out ofspecification• Alarms if pressure switchindicates that high pressurepump is not operating	• Cycle Printout documentssuccessful cycle completionor identifies fault if cycleaborts• Alarms if thermocouplesindicate temperature out ofspecification• Alarms if pressure switchindicates that high pressurepump is not operating	Identical
Feature	Proposed DeviceSYSTEM 1 endo Processor,Model P6800	Predicate Device (K210737)SYSTEM 1 endo Processor,Model P6800	Comparison
	Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic cycle Alarms if pressure transducer indicates internal water filter failed integrity test	Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic cycle Alarms if pressure transducer indicates internal water filter failed integrity test
DesignFeatures	Microprocessor controlled unalterable and standardized liquid chemical sterilization and Diagnostic cycles Intended for use only with S40 Sterilant Concentrate Automated dilution and delivery of S40 Sterilant Processor provides 0.2 micron filtered water for liquid chemical sterilant process and rinsing Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane filter	Microprocessor controlled unalterable and standardized liquid chemical sterilization and Diagnostic cycles Intended for use only with S40 Sterilant Concentrate Automated dilution and delivery of S40 Sterilant Processor provides 0.2 micron filtered water for liquid chemical sterilant process and rinsing Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane filter	Identical
Cycle Parameters
Incomingwater temp.	≥ 43°C	≥ 43°C	Identical
Temperatureto startsterilantexposure	≥ 46°C	≥ 46°C	Identical
Temperaturealarm pointduring LCSexposure	< 45.5°C or > 60°C	< 45.5°C or > 60°C	Identical
Temperaturerange oftypical LCScycle	46-55°C	46-55°C	Identical
Feature	Proposed DeviceSYSTEM 1 endo Processor,Model P6800	Predicate Device (K210737)SYSTEM 1 endo Processor,Model P6800	Comparison
Rinse waterpreparation	Hot potable water• is pre-filtered• is filtered through 0.2 micron bacterial retentive filter	Hot potable water• is pre-filtered• is filtered through 0.2 micron bacterial retentive filter	Identical
Number ofrinses	2	2	Identical
Air Purge	Aids in removing excess waterfrom instrument lumens afterrinsing	Aids in removing excess waterfrom instrument lumens afterrinsing	Identical
Internal waterfilter integritytest	Conducted during the Diagnosticcycle	Conducted during the Diagnosticcycle	Identical
Approximatecycle time	18 – 20 minutes	18 – 20 minutes	Identical
DiagnosticCycle	Performs 14 tests on processor'ssystems confirming properfunction.Recommended to perform eachday of use. After a failedDiagnostic cycle a liquidchemical sterilization cyclecannot be performed until theproblem is rectified and asuccessful Diagnostic cycle hasbeen completed.	Performs 14 tests on processor'ssystems confirming properfunction.Recommended to perform eachday of use. After a failedDiagnostic cycle a liquidchemical sterilization cyclecannot be performed until theproblem is rectified and asuccessful Diagnostic cycle hasbeen completed.	Identical
Accessories
Sterilant	Uses S40 Sterilant Concentrate –See Table 2	Uses S40 Sterilant Concentrate –See Table 2	Identical
ProcessingTrays andContainers	Uses interchangeable processingtrays/containers• Universal FlexibleProcessing Tray• General ProcessingContainer and Tray• Directed Flow ProcessingContainer and Tray• Flexible EndoscopeProcessing Container andTray• Ultrasound Processing Tray	Uses interchangeable processingtrays/containers• Universal FlexibleProcessing Tray• General ProcessingContainer and Tray• Directed Flow ProcessingContainer and Tray• Flexible EndoscopeProcessing Container andTray• Ultrasound Processing Tray	Identical
Feature	Proposed DeviceSYSTEM 1 endo Processor,Model P6800	Predicate Device (K210737)SYSTEM 1 endo Processor,Model P6800	Comparison
QuickConnects	Uses Quick Connects to attachinstrument lumens to theTray/Container ports	Uses Quick Connects to attachinstrument lumens to theTray/Container ports	Identical
ChemicalIndicator	VERIFY Chemical Indicator forS40 Sterilant is available for usein SYSTEM 1 endo LCSPS	VERIFY Chemical Indicator forS40 Sterilant is available for usein SYSTEM 1 endo LCSPS	Identical
Spore TestStrip	VERIFY Spore Test Strip forS40 Sterilant for use in SYSTEM1 endo LCSPS	VERIFY Spore Test Strip for S40Sterilant for use in SYSTEM 1endo LCSPS	Identical
OperatorMaintenance	Periodic replacement of printertape, water filters and air filter	Periodic replacement of printertape, water filters and air filter	Identical

Table 1. Processor Comparison Table

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Table 2. S40 Sterilant Concentrate Comparison Table

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1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.

2 Clapp et al., Free Rad. Res., (1994) 21:147-167.

3 Maillard et. al., J. Med. Microbiol (1995) 42:415-420.

4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554.

5 McDonnell et al., J. AOAC International (2000) 83:269-276.

{24}------------------------------------------------

6. Description of Safety and Substantial Equivalence

{25}------------------------------------------------

The SYSTEM endo Liquid Chemical Sterilant Processing System is the same as the predicate device as identified in Tables 1 and 2.

The proposed device and its predicate have identical intended use and technological characteristics. Testing was performed to evaluate the modifications and demonstrate substantial equivalence to the predicate as summarized in Table 3.

Change	Test	Acceptance Criteria	Result
Obsolescence andreplacement ofsilicone tubing	Functional testing	The modification does notaffect the operation of thedevice	Pass
	Form and fit	The replacement must fitwithin the device	Pass
	Physical properties	The replacement must beequivalent to the currenttubing	Pass
S40 SterilantConcentrate designmodification	Stability of sterilant	The design modificationdoes not affect the stabilityof the sterilant.	Pass
	Delivery of sterilant	The design modificationdoes not affect delivery ofthe sterilant.	Pass

Table 3. Performance Testing

7. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs at least as well or better than the legally marketed predicate device (K210737), Class II (21 CFR 880.6885), product code MED.

{26}------------------------------------------------

Image /page/26/Picture/0 description: The image contains the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol (®) in the upper right corner. Below the word "STERIS" is a graphic of several horizontal, wavy lines in a light blue color. The lines are stacked on top of each other, creating a visual effect of water waves.

510(k) Summary For SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

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

Jennifer Nalepka Contact: Lead Regulatory Affairs Specialist Tel: 440-392-7458 Fax: 440-357-9198

Summary Date: September 1, 2021

Premarket Notification Number: K211607

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

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

1. Device Name

Trade Name:	SYSTEM 1 endo Liquid Chemical SterilantProcessing System, Model P6900
Device Class:	Class 2
Common/usual Name:	Liquid Chemical Sterilizer
Classification Name:	Sterilant, Medical devices, Liquid ChemicalSterilants/Disinfectants
Classification Number:	21 CFR 880.6885
Product Code:	MED

2. Predicate Device

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, K210737.

3. Description of Device

Obsolescence and replacement of silicone tubing
S40 Sterilant Concentrate design modification

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

4. Indications for Use

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heatsensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

5. Technological Characteristic Comparison Table

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System (LCSPS) is the same as the predicate device; the submission is for modifications to the SYSTEM 1 endo LCSPS software. A comparison between the proposed and predicate devices can be found in Table 1 and Table 2 below.

Table 1. Processor Comparison Table

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{30}------------------------------------------------

{31}------------------------------------------------

{32}------------------------------------------------

Table 2. S40 Sterilant Concentrate Comparison Table

{33}------------------------------------------------

1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.

2 Clapp et al., Free Rad. Res., (1994) 21:147-167.

3 Maillard et. al., J. Med. Microbiol (1995) 42:415-420.

4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554.
5 McDonnell et al., J. Appl Bacteriol (1996) 83:269-276.

{34}------------------------------------------------

Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K210737)	Comparison
ActivityAscenziQuantitativeSuspensionTest	Mycobacterium terraeTesting conducted in vitro	Mycobacterium terraeTesting conducted in vitro	Identical
Simulated-UseTest	Meets efficacy requirement.> 6 log reduction Geobacillusstearothermophilus spores in amanual application	Meets efficacy requirement.> 6 log reduction Geobacillusstearothermophilus spores in amanual application	Identical
Clinical In-Use	No surviving microorganismson representative medicaldevices tested	No surviving microorganisms onrepresentative medical devicestested	Identical
Biocompatibility
CytotoxicityDevice Extracts	Two rinses with UV treated,dual 0.1-micron membranefiltered water effectively reducesterilant residues to safe levels.	Two rinses with UV treated, dual0.1-micron membrane filteredwater effectively reduce sterilantresidues to safe levels.	Identical
ResidueReduction	Automatic within the SYSTEM1E Processor:Two rinses with UV treated,dual 0.1-micron membranefiltered water effectively reducesterilant residues to safe levels.	Automatic within the SYSTEM1E Processor:Two rinses with UV treated, dual0.1-micron membrane filteredwater effectively reduce sterilantresidues to safe levels.	Identical
DeviceMaterialCompatibility	Compatible with medicaldevices as established bytesting finished flexibleendoscopes through 300 cyclesand rigid devices through 150cycles.No functional changes haveoccurred to flexible devices.Some materials show cosmeticchanges such as fading of blackanodized aluminum withoutharm to the base material.	Compatible with medicaldevices as established by testingfinished flexible endoscopesthrough 300 cycles and rigiddevices through 150 cycles.No functional changes haveoccurred to flexible devices.Some materials show cosmeticchanges such as fading of blackanodized aluminum withoutharm to the base material.	Identical

6. Description of Safety and Substantial Equivalence

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is the same as the predicate device described in this submission and identified in Tables 1 and 2.

{35}------------------------------------------------

Change	Test	Acceptance Criteria	Result
Obsolescence andreplacement ofsilicone tubing	Functional testing	The modification does not affectthe operation of the device	Pass
	Form and fit	The replacement must fit withinthe device	Pass
	Physical properties	The replacement must beequivalent to the current tubing	Pass
S40 SterilantConcentrate designmodification	Stability of sterilant	The design modification doesnot affect the stability of thesterilant.	Pass
	Delivery of sterilant	The design modification doesnot affect delivery of thesterilant.	Pass

Table 3. Summary of verification activities

7. Conclusion

Regulation Number and Section

§ 880.6885 Liquid chemical sterilants/high level disinfectants.

(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.

Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K210737)	Comparison
Indications forUse	The SYSTEM 1E Processoruses only S40 SterilantConcentrate to liquid chemicallysterilize medical devices.	The SYSTEM 1E Processoruses only S40 SterilantConcentrate to liquid chemicallysterilize medical devices.	Identical
Germicidalclaim	Liquid Chemical Sterilant	Liquid Chemical Sterilant	Identical
GermicideExposureTime (min) forintended use	6	6	Identical
UseTemperature	45.5-60°C – allowable46-55°C - typicalPotency and simulated useevaluations conducted at <43°C	45.5-60°C – allowable46-55°C - typicalPotency and simulated useevaluations conducted at <43°C	Identical
Reuse	Single use	Single use	Identical
HumanFactors	Dispensed ready to use.Container is opened and dilutedby the processor, thus limitinguser exposure to the activeingredient	Dispensed ready to useContainer is opened and dilutedby the processor, thus limitinguser exposure to the activeingredient	Identical
ActiveIngredient	35% peroxyacetic (peracetic)acid automatically diluted foruse in the SYSTEM 1EProcessor.	35% peroxyacetic (peracetic)acid automatically diluted foruse in the SYSTEM 1EProcessor.	Identical
Feature	Proposed Device S40 Sterilant Concentrate	Predicate Device S40 Sterilant Concentrate (K210737)	Comparison
Mode of Action	It is believed that peracetic acidexerts its germicidal effect byseveral mechanisms:-oxidizing sulfhydryl and sulfurbonds in proteins and enzymes,particularly in the cell walls 1-hydroxyl radicals producedfrom PAA are bactericidal 2-PAA damages the viral capsidand viral nucleic acid3,4.	It is believed that peracetic acidexerts its germicidal effect byseveral mechanisms:-oxidizing sulfhydryl and sulfurbonds in proteins and enzymes,particularly in the cell walls1-hydroxyl radicals produced fromPAA are bactericidal2-PAA damages the viral capsidand viral nucleic acid3,4	Identical
Rinses	Automatic, UV-irradiated, dual0.1 micron filtered, potable hotwater.	Automatic, UV-irradiated, dual0.1 micron filtered, potable hotwater.	Identical
Microbial Efficacy
SporicidalActivity ofDisinfectantsAOACOfficialMethod 966.04	Meets efficacy requirements5.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacy requirements5.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Identical
ConfirmatorySporicidalActivity ofDisinfectantsAOACOfficialMethod 966.04	Meets efficacy requirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacy requirements 6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Identical
FungicidalActivity ofDisinfectantsAOACOfficialMethod 955.17	Solution is fungicidal.Trichophyton mentagrophytesTesting conducted in vitro	Solution is fungicidal.Trichophyton mentagrophytesTesting conducted in vitro	Identical
Use DilutionMethodAOAC,OfficialMethods955.14, 955.15,964.02	Solution is bactericidal.Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosaTesting conducted in vitro	Solution is bactericidal.Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosaTesting conducted in vitro	Identical
Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K210737)	Comparison
EPA ViricidalTesting(DIS/TSS-7,Nov. 1981)	Solution is viricidal.Herpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro	Solution is viricidal.Herpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro	Identical
TuberculocidalActivityAscenziQuantitativeSuspensionTest	Solution is tuberculocidalMycobacterium terraeTesting conducted in vitro	Solution is tuberculocidalMycobacterium terraeTesting conducted in vitro	Identical
Simulated-UseTest	Meets efficacy requirement.> 6 log reduction Geobacillusstearothermophilus spores in amanual application	Meets efficacy requirement.> 6 log reduction Geobacillusstearothermophilus spores in amanual application	Identical
Clinical In-Use	No surviving microorganismson representative medicaldevices tested	No surviving microorganisms onrepresentative medical devicestested	Identical
Biocompatibility
CytotoxicityDevice Extracts	Two rinses with UV treated,dual 0.1-micron membranefiltered water effectively reducesterilant residues to safe levels.	Two rinses with UV treated, dual0.1-micron membrane filteredwater effectively reduce sterilantresidues to safe levels.	Identical
ResidueReduction	Automatic within the SYSTEM1E Processor:Two rinses with UV treated,dual 0.1-micron membranefiltered water effectively reducesterilant residues to safe levels.	Automatic within the SYSTEM1E Processor:Two rinses with UV treated, dual0.1-micron membrane filteredwater effectively reduce sterilantresidues to safe levels.	Identical
DeviceMaterialCompatibility	Compatible with medicaldevices as established bytesting finished flexibleendoscopes through 300 cyclesand rigid devices through 150cycles.No functional changes haveoccurred to flexible devices.Some materials show cosmeticchanges such as fading of blackanodized aluminum withoutharm to the base material.	Compatible with medicaldevices as established by testingfinished flexible endoscopesthrough 300 cycles and rigiddevices through 150 cycles.No functional changes haveoccurred to flexible devices.Some materials show cosmeticchanges such as fading of blackanodized aluminum withoutharm to the base material.	Identical

Feature	Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900	Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K210737)	Comparison
IntendedUseIndicationsfor Use	The SYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable semi-critical heat-sensitive medicaldevices and their accessories inhealthcare facilities.The SYSTEM 1 endo Processorautomatically dilutes the S40Sterilant Concentrate to its usedilution (> 1820 mg/L peraceticacid), liquid chemically sterilizesthe load during a controlled 6-minute exposure at 45.5 to 60°C,and rinses the load with 0.2micron filtered water.The SYSTEM 1 endo Processoruses only S40 Sterilant	The SYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable semi-critical heat-sensitive medicaldevices and their accessories inhealthcare facilities.The SYSTEM 1 endo Processorautomatically dilutes the S40Sterilant Concentrate to its usedilution (> 1820 mg/L peraceticacid), liquid chemically sterilizesthe load during a controlled 6-minute exposure at 45.5 to 60°C,and rinses the load with 0.2micron filtered water.The SYSTEM 1 endo Processoruses only S40 Sterilant	Identical
Feature	Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900	Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K210737)	Comparison
	Concentrate to liquid chemicallysterilize medical devices.	Concentrate to liquid chemicallysterilize medical devices.
OperatingPrinciples/Technology	A microprocessor controlled• unit with interchangeableprocessing trays/containers.The processor lid opens toreveal the processingchamber in which the load isplaced.Devices with internal lumens• are interfaced with theprocessor using connectors,i.e. Quick Connects.S40 Sterilant is placed in a• specialized compartment andwhen the processor fills withwater, it creates the sterilantuse dilution from the singleuse sterilant cup.The processor monitors and• controls the use dilutiontemperature and contact time.The processor automaticallyrinses the load with 0.2micron filtered water toremove sterilant residuals.	A microprocessor controlled• unit with interchangeableprocessing trays/containers.The processor lid opens toreveal the processingchamber in which the load isplaced.Devices with internal lumens• are interfaced with theprocessor using connectors,i.e. Quick Connects.S40 Sterilant is placed in a• specialized compartment andwhen the processor fills withwater, it creates the sterilantuse dilution from the singleuse sterilant cup.The processor monitors and• controls the use dilutiontemperature and contact time.The processor automaticallyrinses the load with 0.2micron filtered water toremove sterilant residuals.	Identical
ProcessParameters	Standardized cycle parameterscannot be altered by operator. Thecritical process parameters are:• Use dilution contact time• Use dilution temperature• Peracetic acid concentration• Integrity of the internal waterfilter (tested by the system)	Standardized cycle parameterscannot be altered by operator. Thecritical process parameters are:• Use dilution contact time• Use dilution temperature• Peracetic acid concentration• Integrity of the internal waterfilter (tested by the system)	Identical
ProcessMonitors:	• Cycle Printout documentssuccessful cycle completionor identifies fault if cycleaborts• Alarms if thermocouplesindicate temperature out ofspecification• Alarms if pressure switchindicates that high pressure	• Cycle Printout documentssuccessful cycle completionor identifies fault if cycleaborts• Alarms if thermocouplesindicate temperature out ofspecification• Alarms if pressure switchindicates that high pressure	Identical
Feature	Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900	Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K210737)	Comparison
DesignFeatures	• Alarms if conductivity probeindicated conductivityspecification not met• Alarms if pressure transducerindicates circulation pressureis out of specification inDiagnostic cycle• Alarms if pressure transducerindicates internal water filterfailed integrity test• Microprocessor controlledunalterable and standardizedliquid chemical sterilizationand Diagnostic cycles• Intended for use only withS40 Sterilant Concentrate• Automated dilution anddelivery of S40 Sterilant• Processor provides 0.2 micronfiltered water for liquidchemical sterilization andrinsing• Make-up air for processorduring drain sequences isfiltered through a 0.2 micronmembrane air filter• Includes a barcode scanner;employs touchscreen displayinterface; has USB drive forelectronic cycle download;facilitates use of a web-baseddata management system.• Separate, optional printer	• Alarms if conductivity probeindicated conductivityspecification not met• Alarms if pressure transducerindicates circulation pressureis out of specification inDiagnostic cycle• Alarms if pressure transducerindicates internal water filterfailed integrity test• Microprocessor controlledunalterable and standardizedliquid chemical sterilizationand Diagnostic cycles• Intended for use only withS40 Sterilant Concentrate• Automated dilution anddelivery of S40 Sterilant• Processor provides 0.2 micronfiltered water for liquidchemical sterilization andrinsing• Make-up air for processorduring drain sequences isfiltered through a 0.2 micronmembrane air filter• Includes a barcode scanner;employs touchscreen displayinterface; has USB drive forelectronic cycle download;facilitates use of a web-baseddata management system.• Separate, optional printer	Identical
Cycle Parameters
Incomingwater temp.	≥ 43°C	≥ 43°C	Identical
Temperatureto startsterilantexposure	≥ 46°C	≥ 46°C	Identical
Temperaturealarm pointduring LCSexposure	< 45.5 or > 60°C	< 45.5 or > 60°C	Identical
Temperature	46 - 55°C	46 - 55°C	Identical
Feature	Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900	Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K210737)	Comparison
range oftypical LCScycle
ExposureTime - S40use dilution	6 minutes	6 minutes	Identical
Rinse waterpreparation	Hot potable tap water• is pre-filtered• is filtered through 0.2 micronbacterial retentive membranefilter	Hot potable tap water• is pre-filtered• is filtered through 0.2 micronbacterial retentive membranefilter	Identical
Number ofrinses	2	2	Identical
Air Purge	Aids in removing excess waterfrom instrument lumens afterrinsing	Aids in removing excess waterfrom instrument lumens afterrinsing	Identical
InternalWater FilterIntegrity Test	Conducted during the Diagnosticcycle	Conducted during the Diagnosticcycle	Identical
ApproximateCycle Time	18 - 20 minutes	18 - 20 minutes	Identical
DiagnosticCycle	Performs 14 tests on processor'ssystems confirming properfunction. Recommended toperform each day of use. After afailed Diagnostic cycle, a liquidchemical sterilization cyclecannot be performed until theproblem is rectified and asuccessful Diagnostic cycle hasbeen completed.	Performs 14 tests on processor'ssystems confirming properfunction. Recommended toperform each day of use. After afailed Diagnostic cycle, a liquidchemical sterilization cyclecannot be performed until theproblem is rectified and asuccessful Diagnostic cycle hasbeen completed.	Identical
Accessories
Sterilant	Uses S40 Sterilant Concentrate	Uses S40 Sterilant Concentrate	Identical
ProcessingTrays andContainers	Uses interchangeable processingtrays/containers• Universal Flex Processing Tray• General Processing Container& Tray• Directed Flow ProcessingContainer & Tray• Flexible Endoscope ProcessingContainer & Tray• Ultrasound Processing Tray	Uses interchangeable processingtrays/containers• Universal Flex Processing Tray• General Processing Container& Tray• Directed Flow ProcessingContainer & Tray• Flexible Endoscope ProcessingContainer & Tray• Ultrasound Processing Tray	Identical
Quick	Uses Quick Connects to attach	Uses Quick Connects to attach	Identical
Feature	Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900	Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K210737)	Comparison
	Tray/Container ports	Tray/Container ports
ChemicalIndicator	VERIFY Chemical Indicator forS40 Sterilant is available for usein SYSTEM 1 endo LCSPS	VERIFY Chemical Indicator forS40 Sterilant is available for usein SYSTEM 1 endo LCSPS	Identical
	Spore TestStrip	VERIFY Spore Test Strip for S40Sterilant for use in SYSTEM 1endo LCSPS	VERIFY Spore Test Strip for S40Sterilant for use in SYSTEM 1endo LCSPS
OperatorMaintenance		Periodic replacement of waterfilters and air filter.Periodic replacement of printertape, if using the external printeroption.	Periodic replacement of waterfilters and air filter.Periodic replacement of printertape, if using the external printeroption.