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 compressor ●
Obsolescence and replacement of upper lid seal ●

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 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 compressor ●
Obsolescence and replacement of upper lid seal ●

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 the modifications for:

Obsolescence and replacement of compressor
Obsolescence and replacement of upper lid seal ●

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

The provided document describes the STERIS SYSTEM 1E, SYSTEM 1 endo Model P6800, and SYSTEM 1 endo Model P6900 Liquid Chemical Sterilant Processing Systems. This submission is for modifications related to the obsolescence and replacement of a compressor and an upper lid seal. The document asserts that these modified devices are substantially equivalent to their predicate device (K211607).

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Performance testing with replacement compressor	The modification does not affect the performance of the device.	Pass
Performance testing with replacement upper lid seal	The modification does not affect the performance of the device.	Pass
Material Compatibility of upper lid seal	The upper lid seal maintains integrity after multiple Liquid Chemical Sterilization and Diagnostic Cycles in accordance with methods disclosed in K131078.	Pass
Biocompatibility of upper lid seal	The upper lid seal meets the acceptance criteria for cytotoxicity in ISO 10993-5, Annex A in accordance with methods disclosed in K090036.	Pass

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size for the non-clinical testing performed. It refers to "multiple Liquid Chemical Sterilization and Diagnostic Cycles" for the material compatibility test but does not quantify "multiple". Similarly, for performance testing, it simply states "the modification does not affect the performance," without detailing the number of test cycles or units involved.

The provenance of the data is not explicitly stated beyond being "non-clinical testing" conducted by STERIS Corporation for their updated devices. It is an internal company study for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish ground truth for this non-clinical testing. The acceptance criteria for performance are based on the device maintaining its original performance and the specific technical standards for material compatibility and biocompatibility (ISO 10993-5, K131078, K090036). These are objective measurements rather than expert interpretations.

4. Adjudication Method for the Test Set:

An adjudication method (e.g., 2+1, 3+1) is not applicable or mentioned as the testing is non-clinical performance and material characterization, yielding objective "Pass/Fail" results against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is a liquid chemical sterilant processing system, not an AI-assisted diagnostic or imaging tool involving human interpretation. Therefore, there's no "effect size of how much human readers improve with AI vs without AI assistance" to report.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance study, in the context of AI, was not performed, nor is it applicable. The device is an automated chemical sterilization system; its performance is independently measured against specified physical and chemical parameters, not an algorithm's output. The "algorithm" here refers to the system's software controlling the sterilization cycle. The testing verifies the system's ability to maintain these controlled conditions.

7. Type of Ground Truth Used:

The ground truth for the non-clinical testing is based on objective measurements and adherence to established industry standards and previous regulatory clearances.

Performance: The device must continue to function as intended, not being adversely affected by component changes.
Material Compatibility: Integrity after multiple cycles, referencing K131078.
Biocompatibility: Cytotoxicity evaluation per ISO 10993-5, Annex A, referencing K090036.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable here as this is not a machine learning or artificial intelligence device. The device's operation is deterministic based on its hardware and programmed cycles, not learned from data.

9. How the Ground Truth for the Training Set Was Established:

As there is no training set for this type of device, this question is not applicable.

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 28, 2022

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

Re: K222615

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 Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: August 29, 2022 Received: August 30, 2022

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 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, PhD 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)

K222615

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.

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."

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Indications for Use

510(k) Number (if known)

K222615

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)

K222615

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.

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."

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Image /page/5/Picture/0 description: The image contains the STERIS logo. The word "STERIS" is in a bold, serif font at the top of the image, with a registered trademark symbol to the right. Below the word is a graphic of several horizontal, wavy lines in a blue color.

K222615 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: August 29, 2022

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

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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, K211607

3. Description of Device

Obsolescence and replacement of compressor ●
Obsolescence and replacement of upper lid seal ●

The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed

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

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.

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 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 > 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.

న్. Technological Characteristic Comparison Table

The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device with the exception of the proposed modification. A comparison between the proposed and predicate devices is included in Table 1 and Table 2.

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Feature	ProposedSYSTEM 1E Processor	Predicate (K211607)SYSTEM 1E Processor	Comparison
Indicationsfor Use	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 Processordilutes the S40 SterilantConcentrate to its use dilution(>1820 mg/L peracetic acid),liquid chemically sterilizes theload during a controlled 6-minuteexposure at 45.5 to 60°C, andrinses the load with extensivelytreated* potable water. Aftercompletion of a cycle, criticaldevices should be usedimmediately; 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 sterilize medicaldevices.* The extensive treatment of EPApotable 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 >	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 Processordilutes the S40 SterilantConcentrate to its use dilution(>1820 mg/L peracetic acid),liquid chemically sterilizes theload during a controlled 6-minuteexposure at 45.5 to 60°C, andrinses the load with extensivelytreated* potable water. Aftercompletion of a cycle, criticaldevices should be usedimmediately; 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 sterilize medicaldevices.* The extensive treatment of EPApotable water consists of:1. Pre-filtration through two pre-filters:• Pre-filter A is a gross depthfilter that removesapproximately 2.5 micron orlargerparticles/contaminants.• Pre-filter B is a surface filterthat removesparticles/contaminants >	Identical
Feature	ProposedSYSTEM 1E Processor	Predicate (K211607)SYSTEM 1E Processor	Comparison
	2. UV Irradiation:• During transit through theUV water treatmentchamber, a UV dosesufficient to achieve a ≥ 6-log reduction of MS2 virus isdelivered to the water.3. 0.1 micron filtration:• The water prepared bypre-filtration and UVirradiation is filtered through	2. UV Irradiation:• During transit through theUV water treatmentchamber, a UV dosesufficient to achieve a ≥ 6-log reduction of MS2 virus isdelivered to the water.3. 0.1 micron filtration:• The water prepared by pre-filtration and UV irradiationis filtered through redundant,
	redundant, 0.1-micron(absolute rated) membranesto remove bacteria, fungi andprotozoa > 0.1 micron.	0.1-micron (absolute rated)membranes to removebacteria, fungi and protozoa> 0.1 micron.
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.Sterilant Concentrate is placed ina specialized 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 load withextensively treated water toremove sterilant residuals.	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.Sterilant Concentrate is placed ina specialized 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 load withextensively 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 waterfilter integrity• UV irradiation	Standardized cycle parameterscannot be altered by operator.The critical process parametersare:• Contact Time• Use Dilution Temperature• Peracetic acid concentration• Bacterial retentive waterfilter integrity• UV irradiation	Identical
ProcessMonitors	• Cycle Printout documents• successful cycle completionor identifies fault if cycle	• Cycle Printout documents• successful cycle completionor identifies fault if cycle	Identical
Feature	ProposedSYSTEM 1E Processor	Predicate (K211607)SYSTEM 1E Processor	Comparison
	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	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
Incomingwatertemperature	≥ 43°C	≥ 43°C	Identical
Temperatureto start	≥ 46°C	≥ 46°C	Identical
Feature	ProposedSYSTEM 1E Processor	Predicate (K211607)SYSTEM 1E Processor	Comparison
exposurephase
Temperaturealarm pointduring theexposurephase	<45.5 or >60°C	<45.5 or >60°C	Identical
Temperaturerange duringa typicalLiquidChemicalSterilantProcessingCycle	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 ≥ a 6-log reductionof virus• Filtered through redundant0.1-micron filter membranes	Hot potable tap water is:• pre-filtered• flowed through a UV Lighttreatment chamber toachieve ≥ a 6-log reductionof virus• Filtered through redundant0.1-micron filter membranes	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 FilterIntegrityTest	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 (K211607)SYSTEM 1E Processor	Comparison
ProcessingTray /Containers	Uses interchangeable processingtrays/containers• Universal Flexible ProcessingTray (C1160E)• General ProcessingContainer/Tray (C1200)• Directed Flow ProcessingContainer/Tray (C1220)• Flexible Endoscope ProcessingContainer / Tray (C1140)• Ultrasound Processing Tray(C3000XL)	Uses interchangeable processingtrays/containers• Universal Flexible ProcessingTray (C1160E)• General ProcessingContainer/Tray (C1200)• Directed Flow ProcessingContainer/Tray (C1220)• Flexible Endoscope ProcessingContainer / 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 for S40Sterilant Concentrate	VERIFY Spore Test Strip for S40Sterilant 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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{12}------------------------------------------------

Table 2. S40 Sterilant Concentrate Device Comparison Table

Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K211607)	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
Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K211607)	Comparison
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
Mode ofAction	It is believed that peracetic acidexerts its germicidal effect byseveral mechanisms:-oxidizing sulfhydryl and sulfur	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 requirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Identical
FungicidalActivity ofDisinfectantsAOACOfficial	Solution is fungicidal.Trichophyton mentagrophytesTesting conducted in vitro	Solution is fungicidal.Trichophyton mentagrophytesTesting conducted in vitro	Identical
Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K211607)	Comparison
Method 955.17
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
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 have	Compatible with medicaldevices as established by testingfinished flexible endoscopesthrough 300 cycles and rigiddevices through 150 cycles.No functional changes haveoccurred to flexible devices	Identical
Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K211607)	Comparison
	occurred to flexible devices.Some materials show cosmeticchanges such as fading of blackanodized aluminum withoutharm to the base material.	Some materials show cosmeticchanges such as fading of blackanodized aluminum withoutharm to the base material.

{13}------------------------------------------------

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.
§ McDonnell et al., J. Appl Bacteriol (1996) 80:540-554.
§ M

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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.

Test	Acceptance Criteria	Result
Performance testing withreplacement compressor	The modification does not affect theperformance of the device.	Pass
Performance testing withreplacement upper lid seal	The modification does not affect theperformance of the device.	Pass
Material Compatibility ofupper lid seal	The upper lid seal maintains integrity aftermultiple Liquid Chemical Sterilization andDiagnostic Cycles in accordance with methodsdisclosed in K131078.	Pass
Biocompatibility of upperlid seal	The upper lid seal meets the acceptance criteriafor cytotoxicity in ISO 10993-5, Annex A inaccordance with methods disclosed inK090036.	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 as or better than the legally marketed predicate device (K211607), 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 all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue.

K222615 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: August 29, 2022

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

Device Name 1.

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, K211607

Description of Device 3.

Obsolescence and replacement of compressor ●
Obsolescence and replacement of upper lid seal ●

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4. Intended Use

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 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. Description of Technological Similarities and Differences

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is identical to the predicate device with the exception of the proposed modification. A comparison between the proposed and predicate devices is included in Table 1 and Table 2.

Feature	Proposed DeviceSYSTEM 1 endo Processor,Model P6800	Predicate Device (K211607)SYSTEM 1 endo Processor,Model P6800	Comparison
IntendedUseIndicationsfor 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
	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 micronfiltered water to remove sterilantresiduals.	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 (K211607)SYSTEM 1 endo Processor,Model P6800	Comparison
Feature	Proposed DeviceSYSTEM 1 endo Processor,Model P6800	Predicate Device (K211607)SYSTEM 1 endo Processor,Model P6800	Comparison
DesignFeatures	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
	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.	$\ge$ 43°C	$\ge$ 43°C	Identical
Temperatureto startsterilantexposure	$\ge$ 46°C	$\ge$ 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
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 water from instrument lumens after rinsing	Aids in removing excess water from instrument lumens after rinsing	Identical
Internalwater filterintegrity test	Conducted during the Diagnostic cycle	Conducted during the Diagnostic cycle	Identical
Approximatecycle time	18 - 20 minutes	18 - 20 minutes	Identical
DiagnosticCycle	Performs 14 tests on processor's systems confirming proper function.Recommended to perform each day of use. After a failed Diagnostic cycle a liquid chemical sterilization cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed.	Performs 14 tests on processor's systems confirming proper function.Recommended to perform each day of use. After a failed Diagnostic cycle a liquid chemical sterilization cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed.	Identical
Accessories
Sterilant	Uses S40 Sterilant Concentrate – See Table 2	Uses S40 Sterilant Concentrate – See Table 2	Identical
ProcessingTrays andContainers	Uses interchangeable processing trays/containers• Universal Flexible Processing Tray• General Processing Container and Tray• Directed Flow Processing Container and Tray• Flexible Endoscope Processing Container and Tray• Ultrasound Processing Tray	Uses interchangeable processing trays/containers• Universal Flexible Processing Tray• General Processing Container and Tray• Directed Flow Processing Container and Tray• Flexible Endoscope Processing Container and Tray• Ultrasound Processing Tray	Identical
Feature	Proposed DeviceSYSTEM 1 endo Processor,Model P6800	Predicate Device (K211607)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 SYSTEMl 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

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

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}------------------------------------------------

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6. Description of Non-Clinical Testing

The SYSTEM endo Liquid Chemical Sterilant Processing testing was performed to evaluate the modifications and demonstrate the device meet the acceptance criteria that is summarized in Table 3.

Test	Acceptance Criteria	Result
Performance testing withreplacement compressor	The modification does not affect theperformance of the device.	Pass
Performance testing withreplacement upper lidseal	The modification does not affect theperformance of the device.	Pass
Material Compatibility ofupper lid seal	The upper lid seal maintains integrityafter multiple Liquid ChemicalSterilization and Diagnostic Cycles inaccordance with methods disclosed inK131078.	Pass
Biocompatibility ofupper lid seal	The upper lid seal meets the acceptancecriteria for cytotoxicity in ISO 10993-5,Annex A in accordance with methodsdisclosed in K090036.	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 as well as or better than the legally marketed predicate device (K211607), Class II (21 CFR 880.6885), product code MED.

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

Image /page/26/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a large, bold, sans-serif font. Below the word is a graphic of several horizontal, wavy lines in blue. The lines are stacked on top of each other, creating a visual effect of water waves.

K222615 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

Contact:

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

August 29, 2022 Summary Date:

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

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

1. Device Name

Trade Name:	SYSTEM 1 endo Liquid Chemical SterilanProcessing 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, K211607.

3. Description of Device

Obsolescence and replacement of compressor
Obsolescence and replacement of upper lid seal ●

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.

{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 with the exception of the proposed modification. 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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{31}------------------------------------------------

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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. AOAC International (2000) 83:269-276.

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

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

6. Description of Non-Clinical Testing

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 testing was performed to evaluate the modified device and the results met the acceptance criteria that are summarized in Table 3.

Test	Acceptance Criteria	Result
Performance testing withreplacement compressor	The modification does not affect theperformance of the device.	Pass
Performance testing withreplacement upper lid seal	The modification does not affect theperformance of the device.	Pass
Material Compatibility ofupper lid seal	The upper lid seal maintains integrity aftermultiple Liquid Chemical Sterilization andDiagnostic Cycles in accordance withmethods disclosed in K131078.	Pass
Biocompatibility of upperlid seal	The upper lid seal meets the acceptancecriteria for cytotoxicity in ISO 10993-5,Annex A in accordance with methodsdisclosed in K090036.	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.