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 > 6-log reduction of MS2 virus is delivered to the water.
1. 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 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 is intended for liquid chemical sterilization of cleand, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically diutes 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 a obsolescence of the glue for creating the 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 due to obsolescence of the glue for creating the 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. Table 1 compares the proposed and predicate devices.

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 due to obsolescence of the glue for creating the 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.

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 Ouick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Tables 1 and 2 compare the proposed and predicate devices.

AI/ML Overview

The acceptance criteria and study results for the STERIS systems regarding modifications due to obsolescence of the glue for creating the upper lid seal are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance

The documents describe three similar devices:

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

For all three models, the purpose of the submission is for modifications due to the obsolescence of the glue for creating the upper lid seal. The testing performed confirms the performance of the modified device remains equivalent to the predicate.

Test	Purpose	Acceptance Criteria	Reported Device Performance (Result)
I. Biocompatibility	To ensure new upper lid glue does not cause a cytotoxic response.	The upper lid glue meets the acceptance criteria for cytotoxicity in ISO 10993-5:2009, Annex A Neutral Red Assay in accordance with methods disclosed in K090036.	PASS
II. Material Compatibility	To demonstrate that the new upper lid seal glue remains fully bonded after multiple Liquid Chemical Sterilization and Diagnostic Cycles.	The upper lid seal maintains integrity after multiple Liquid Chemical Sterilization and Diagnostic Cycles in accordance with methods disclosed in K131078.	PASS
III. Performance of Processor	To demonstrate that the upper lid seal with the new glue does not leak during Liquid Chemical Sterilization and Diagnostic Cycles.	Diagnostic Cycles in accordance with methods disclosed in K131078. (Note: The acceptance criteria here state "Diagnostic Cycles in accordance with methods disclosed in K131078" but the purpose clearly indicates testing during both LCS and Diagnostic cycles. The "PASS" result implies it was met for both as intended.)	PASS

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

The documents do not specify a numerical sample size (e.g., number of units, number of cycles) for the non-clinical testing performed. The description refers to "multiple Liquid Chemical Sterilization and Diagnostic Cycles" for material compatibility and performance testing.

The data provenance is from non-clinical bench testing conducted by the manufacturer, STERIS Corporation, based in Mentor, Ohio, USA. The studies are prospective in the sense that they were conducted specifically to evaluate the performance of the modified device.

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

This type of submission (510(k) for a modification of an existing device) and the nature of the tests (biocompatibility, material compatibility, processor performance related to a seal) do not involve human expert interpretation of data like medical imaging. Therefore, no experts in the sense of clinicians establishing ground truth from patient data were involved or reported for these specific non-clinical tests. The ground truth is based on predefined engineering and biological acceptance criteria derived from established standards (ISO 10993-5:2009) and previous FDA clearances (K090036, K131078).

4. Adjudication Method for the Test Set

Not applicable. The tests are objective and deterministic (pass/fail based on physical and biological measurements) rather than subjective clinical assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance with and without AI assistance is being evaluated, which is not the case for a chemical sterilant processing system.

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

Not applicable. This is a physical chemical sterilization system, not a software algorithm that performs diagnostic or analytical functions. The "performance of processor" test demonstrates the functionality of the device itself (including its automated processes), which could be considered a form of standalone performance evaluation for its intended physical function.

7. The Type of Ground Truth Used

The ground truth for these tests is based on:

Standardized biological safety criteria: ISO 10993-5:2009 for cytotoxicity.
Engineering specifications and integrity: Maintaining physical integrity of the seal and preventing leaks during operation, as defined by the device's design and referenced historical predicate device data (K131078).

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device (a sterilant processing system) and its component modification, not an AI/ML algorithm that requires training data sets.

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

Not applicable, as no training set for an AI/ML algorithm was used.

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.

December 10, 2019

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

Re: K192929

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: November 18, 2019 Received: November 19, 2019

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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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.

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192929

Device Name

SYSTEM 1E Liquid Chemical Sterilant Processing System

Indications for Use (Describe)

The SYSTEM 1E Processor uses only $40 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 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)

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."

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192929

Device Name

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800

Indications for Use (Describe)

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192929

Device Name

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

Indications for Use (Describe)

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 shows the logo for STERIS. The word STERIS is in all capital letters and in a serif font. Below the word STERIS is an image of several blue horizontal lines that are curved to resemble waves.

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

December 2, 2019 Summary Date:

Premarket Notification: K192929

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Device Name 1.

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

Predicate Device 2.

SYSTEM 1E Liquid Chemical Sterilant Processing System, K190104

3. Description of Device

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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.

米 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.

ട്. 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.

Feature	Proposed Device	Predicate Device
	SYSTEM 1E Processor	SYSTEM 1E Processor (K190104)
Indicationsfor Use	The SYSTEM 1E Liquid ChemicalSterilant Processing System isintended for liquid chemicalsterilization of cleaned, immersible,and reusable critical and semi-	The SYSTEM 1E Liquid ChemicalSterilant Processing System isintended for liquid chemicalsterilization of cleaned, immersible,and reusable critical and semi-
Feature	Proposed DeviceSYSTEM 1E Processor	Predicate DeviceSYSTEM 1E Processor (K190104)
	critical heat-sensitive medicaldevices in healthcare facilities.	critical heat-sensitive medicaldevices in healthcare facilities.
	The SYSTEM 1E Processor dilutesthe S40 Sterilant Concentrate to itsuse dilution (>1820 mg/L peraceticacid), liquid chemically sterilizes theload during a controlled 6-minuteexposure at 45.5 to 60°C, and rinsesthe load with extensively treated*potable water. After completion of acycle, critical devices should be usedimmediately; semi-critical devicesshould be used immediately or maybe handled and stored in a mannersimilar to that of high leveldisinfected endoscopes. Criticaldevices not used immediately shouldbe processed again before use.	The SYSTEM 1E Processor dilutesthe S40 Sterilant Concentrate to itsuse dilution (>1820 mg/L peraceticacid), liquid chemically sterilizes theload during a controlled 6-minuteexposure at 45.5 to 60°C, and rinsesthe load with extensively treated*potable water. After completion of acycle, critical devices should be usedimmediately; semi-critical devicesshould be used immediately or maybe handled and stored in a mannersimilar to that of high leveldisinfected endoscopes. Criticaldevices not used immediately shouldbe processed again before use.
	The SYSTEM 1E Processor usesonly S40 Sterilant Concentrate toliquid chemically sterilize medicaldevices.	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 orlarger particles/contaminants.• Pre-filter B is a surface filterthat removesparticles/contaminants >0.1 micron.2. UV Irradiation:• During transit through the UVwater treatment chamber, aUV dose sufficient to achievea ≥ 6-log reduction of MS2virus is delivered to the water.3. 0.1-micron filtration:• The water prepared by pre-filtration and UV irradiation	* 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 orlarger particles/contaminants.• Pre-filter B is a surface filterthat removesparticles/contaminants >0.1 micron.2. UV Irradiation:• During transit through the UVwater treatment chamber, aUV dose sufficient to achievea ≥ 6-log reduction of MS2virus is delivered to the water.3. 0.1-micron filtration:• The water prepared by pre-filtration and UV irradiation
Feature	Proposed DeviceSYSTEM 1E Processor	Predicate DeviceSYSTEM 1E Processor (K190104)
	membranes to removebacteria, fungi and protozoa >0.1 micron.	membranes to removebacteria, fungi and protozoa> 0.1 micron.
OperatingPrinciples/Technology	A microprocessor controlled unitwith interchangeable processingtrays/containers. The processor lidopens to reveal the processingchamber in which the load is placed.Devices with internal lumens areinterfaced with the processor usingconnectors. Sterilant Concentrate isplaced in a specialized compartmentand when the processor fills withwater, it creates the sterilant usedilution from the single use sterilantcup. The processor monitors andcontrols the use dilution temperatureand contact time. The processorautomatically rinses the load withextensively treated water to removesterilant residuals.	A microprocessor controlled unitwith interchangeable processingtrays/containers. The processor lidopens to reveal the processingchamber in which the load is placed.Devices with internal lumens areinterfaced with the processor usingconnectors. Sterilant Concentrate isplaced in a specialized compartmentand when the processor fills withwater, it creates the sterilant usedilution from the single use sterilantcup. The processor monitors andcontrols the use dilution temperatureand contact time. The processorautomatically rinses the load withextensively treated water to removesterilant residuals.
ProcessParameters	Standardized cycle parameterscannot be altered by operator. Thecritical process parameters are:● Contact Time● Use Dilution Temperature● Peracetic acid concentration● Bacterial retentive water filterintegrity● UV irradiation	Standardized cycle parameterscannot be altered by operator. Thecritical process parameters are:● Contact Time● Use Dilution Temperature● Peracetic acid concentration● Bacterial retentive water filterintegrity● UV irradiation
ProcessMonitors	● Cycle Printout documentssuccessful cycle completion oridentifies fault if cycle aborts● Alarms if thermocouplesindicate temperature out ofspecification● Alarms if pressure switchindicates that high pressurepump is not operating● Alarms if conductivity probeindicated conductivityspecification not met● Alarms if pressure transducerindicates circulation pressure isout of specification duringDiagnostic cycle	● Cycle Printout documentssuccessful cycle completion oridentifies fault if cycle aborts● Alarms if thermocouplesindicate temperature out ofspecification● Alarms if pressure switchindicates that high pressurepump is not operating● Alarms if conductivity probeindicated conductivityspecification not met● Alarms if pressure transducerindicates circulation pressure isout of specification duringDiagnostic cycle
Feature	Proposed DeviceSYSTEM 1E Processor	Predicate DeviceSYSTEM 1E Processor (K190104)
DesignFeatures	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	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
	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.
Processing Cycle
Incomingwatertemperature	≥ 43°C	≥ 43°C
Temperatureto startexposurephase	≥ 46°C	≥ 46°C
Temperaturealarm pointduring theexposurephase	<45.5 or >60°C	<45.5 or >60°C
Temperaturerange during atypical LiquidChemicalSterilantProcessingCycle	46 - 55°C	46 - 55°C
ExposureTime	6 minutes	6 minutes
Rinse waterpreparation	Hot potable tap water is:pre-filtered	Hot potable tap water is:pre-filtered
Feature	Proposed DeviceSYSTEM 1E Processor	Predicate DeviceSYSTEM 1E Processor (K190104)
	flowed through a UV Light treatment chamber to achieve ≥ a 6-log reduction of virus Filtered through redundant 0.1-micron filter membranes	flowed through a UV Light treatment chamber to achieve ≥ a 6-log reduction of virus Filtered through redundant 0.1-micron filter membranes
Number of rinses	2	2
Air Purge	Aids in removing excess water from instrument lumens after rinsing	Aids in removing excess water from instrument lumens after rinsing
Water Filter Integrity Test	Conducted at the end of every liquid chemical sterilant processing cycle and during the Diagnostic cycle	Conducted at the end of every liquid chemical sterilant processing cycle and during the Diagnostic cycle
Approximate Cycle time	25 minutes	25 minutes
Diagnostic Cycle	Performs 15 tests on processor's systems confirming proper function (same tests as predicate device except for an added UV monitor test). Recommended to perform every 24 hours. After a failed Diagnostic cycle, a liquid chemical sterilant processing cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed.	Performs 15 tests on processor's systems confirming proper function (same tests as predicate device except for an added UV monitor test). Recommended to perform every 24 hours. After a failed Diagnostic cycle, a liquid chemical sterilant processing cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed.
Interchangeable Components
Processing Tray / Containers	Uses interchangeable processing trays/containers Universal Flexible Processing Tray (C1160E) General Processing Container/Tray (C1200) Directed Flow Processing Container/Tray (C1220) Flexible Endoscope Processing Container / Tray (C1140) Ultrasound Processing Tray (C3000XL)	Uses interchangeable processing trays/containers Universal Flexible Processing Tray (C1160E) General Processing Container/Tray (C1200) Directed Flow Processing Container/Tray (C1220) Flexible Endoscope Processing Container / Tray (C1140) Ultrasound Processing Tray (C3000XL)
Accessories
Sterilant Concentrate	Uses S40 Sterilant Concentrate	Uses S40 Sterilant Concentrate
Quick Connects	Uses Quick Connects to adapt instrument lumens to the Tray/Container ports	Uses Quick Connects to adapt instrument lumens to the Tray/Container ports
Chemical Indicator	VERIFY Chemical Indicator for S40 Sterilant (K173428)	VERIFY Chemical Indicator for S40 Sterilant (K173428)
Feature	Proposed DeviceSYSTEM 1E Processor	Predicate DeviceSYSTEM 1E Processor (K190104)
Spore TestStrip	VERIFY Spore Test Strip for S40Sterilant (K180553)	VERIFY Spore Test Strip for S40Sterilant (K180553)
OperatorMaintenanceRequirements	Periodic replacement of printer tape,water filters and air filter	Periodic replacement of printer tape,water filters and air filter

Table 1. Processor Device Comparison Table

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Table 2. S40 Sterilant Concentrate Device Comparison Table

¹ Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.
² Clapp et al., Free Rad. Res., (1994) 21:147-167.

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

4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554.
§ McDomell et al., J. AOAC Interntional (2000) 83:269-276.
§ McDonnell et al., J. AOAC International (2000) 83:269-27

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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.

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Test	Purpose	Acceptance Criteria	Result
Biocompatibility	To ensure new upper lidglue does not cause acytotoxic response.	The upper lid glue meets theacceptance criteria forcytotoxicity in ISO 10993-5:2009, Annex A Neutral RedAssay in accordance withmethods disclosed inK090036.	PASS
MaterialCompatibility	To demonstrate that thenew upper lid seal glueremains fully bondedafter multiple LiquidChemical Sterilizationand Diagnostic Cycles	The upper lid seal maintainsintegrity after multiple LiquidChemical Sterilization andDiagnostic Cycles	PASS
Performance ofProcessor	To demonstrate that theupper lid seal with thenew glue does not leakduring Liquid ChemicalSterilization andDiagnostic Cycles.	Diagnostic Cycles inaccordance with methodsdisclosed in K131078	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 (K190104), 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.

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: December 2, 2019

Premarket Notification: K192929

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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: K173256

3. Description of Device

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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 46 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.

ട്. Technological Characteristic Table

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, ModelP6800	Predicate Device (K173256)SYSTEM 1 endo Processor, ModelP6800
IntendedUseIndicationsfor Use	The SYSTEM 1 endo LiquidChemical Sterilant Processing Systemis intended for liquid chemicalsterilization of cleaned, immersible,and reusable semi-critical medicaldevices and their accessories inhealthcare facilities.The SYSTEM 1 endo Processorautomatically dilutes the S40 SterilantConcentrate to its use dilution (>1820mg/L peracetic acid), liquidchemically sterilizes the load during acontrolled 6-minute exposure at 45.5to 60°C, and rinses the load with 0.2micron filtered water.The SYSTEM 1 endo Processor usesonly S40 Sterilant Concentrate toliquid chemically sterilize medicaldevices.	The SYSTEM 1 endo LiquidChemical Sterilant Processing Systemis intended for liquid chemicalsterilization of cleaned, immersible,and reusable semi-critical medicaldevices and their accessories inhealthcare facilities.The SYSTEM 1 endo Processorautomatically dilutes the S40 SterilantConcentrate to its use dilution (>1820mg/L peracetic acid), liquidchemically sterilizes the load during acontrolled 6-minute exposure at 45.5to 60°C, and rinses the load with 0.2micron filtered water.The SYSTEM 1 endo Processor usesonly S40 Sterilant Concentrate toliquid chemically sterilize medicaldevices.
	Proposed Device	Predicate Device (K173256)
Feature	SYSTEM 1 endo Processor, ModelP6800	SYSTEM 1 endo Processor, ModelP6800
OperatingPrinciples /Technology	A microprocessor controlled unit withinterchangeable processingtrays/containers. The processor lidopens to reveal the processingchamber in which the load is placed.Devices with internal lumens areinterfaced with the processor usingconnectors, i.e. Quick Connects. S40Sterilant is placed in a specializedcompartment and when the processorfills with water, it creates the sterilantuse dilution from the single usesterilant cup. The processor monitorsand controls the use dilutiontemperature and contact time. Theprocessor automatically rinses theload with 0.2 micron filtered water toremove sterilant residuals.	A microprocessor controlled unit withinterchangeable processingtrays/containers. The processor lidopens to reveal the processingchamber in which the load is placed.Devices with internal lumens areinterfaced with the processor usingconnectors, i.e. Quick Connects. S40Sterilant is placed in a specializedcompartment and when the processorfills with water, it creates the sterilantuse dilution from the single usesterilant cup. The processor monitorsand controls the use dilutiontemperature and contact time. Theprocessor automatically rinses theload with 0.2 micron filtered water toremove sterilant residuals.
ProcessParameters	Standardized cycle parameters cannotbe altered by the operator. Thecritical process parameters are:● Use dilution contact time● Use dilution temperature● Peracetic acid concentration● Bacterial retentive water filterintegrity	Standardized cycle parameters cannotbe altered by the operator. Thecritical process parameters are:● Use dilution contact time● Use dilution temperature● Peracetic acid concentration● Bacterial retentive water filterintegrity
ProcessMonitors	● Cycle Printout documentssuccessful cycle completion oridentifies fault if cycle aborts● Alarms if thermocouples indicatetemperature out of specification● Alarms if pressure switchindicates that high pressurepump is not operating● Alarms if conductivity probeindicated conductivityspecification not met● Alarms if pressure transducerindicates circulation pressure isout of specification in Diagnosticcycle● Alarms if pressure transducerindicates internal water filterfailed integrity test	● Cycle Printout documentssuccessful cycle completion oridentifies fault if cycle aborts● Alarms if thermocouples indicatetemperature out of specification● Alarms if pressure switchindicates that high pressurepump is not operating● Alarms if conductivity probeindicated conductivityspecification not met● Alarms if pressure transducerindicates circulation pressure isout of specification in Diagnosticcycle● Alarms if pressure transducerindicates internal water filterfailed integrity test
Feature	Proposed DeviceSYSTEM 1 endo Processor, ModelP6800	Predicate Device (K173256)SYSTEM 1 endo Processor, ModelP6800
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
Cycle Parameters
Incomingwater temp.	≥ 43°C	≥ 43°C
Temperatureto startsterilantexposure	≥ 46°C	≥ 46°C
Temperaturealarm pointduring LCSexposure	< 45.5°C or > 60°C	< 45.5°C or > 60°C
Temperaturerange oftypical LCScycle	46-55°C	46-55°C
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
Number ofrinses	2	2
Air Purge	Aids in removing excess water frominstrument lumens after rinsing	Aids in removing excess water frominstrument lumens after rinsing
Internalwater filterintegrity test	Conducted during the Diagnosticcycle	Conducted during the Diagnosticcycle
Approximatecycle time	18 - 20 minutes	18 - 20 minutes
Feature	Proposed DeviceSYSTEM 1 endo Processor, ModelP6800	Predicate Device (K173256)SYSTEM 1 endo Processor, ModelP6800
DiagnosticCycle	Performs 14 tests on processor'ssystems confirming proper function.Recommended to perform each day ofuse. After a failed Diagnostic cycle aliquid chemical sterilization cyclecannot be performed until theproblem is rectified and a successfulDiagnostic cycle has been completed.	Performs 14 tests on processor'ssystems confirming proper function.Recommended to perform each day ofuse. After a failed Diagnostic cycle aliquid chemical sterilization cyclecannot be performed until theproblem is rectified and a successfulDiagnostic cycle has been completed.
Accessories
Sterilant	Uses S40 Sterilant Concentrate – SeeTable 2	Uses S40 Sterilant Concentrate – SeeTable 2
ProcessingTrays andContainers	Uses interchangeable processingtrays/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 processingtrays/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
QuickConnects	Uses Quick Connects to attachinstrument lumens to theTray/Container ports	Uses Quick Connects to attachinstrument lumens to theTray/Container ports
ChemicalIndicator	VERIFY Chemical Indicator for S40Sterilant (K173428)	VERIFY Chemical Indicator for S40Sterilant (K173428)
Spore TestStrip	VERIFY Spore Test Strip for S40Sterilant (K180553)	VERIFY Spore Test Strip for S40Sterilant (K180553)
OperatorMaintenance	Periodic replacement of printer tape,water filters and air filter	Periodic replacement of printer tape,water filters and air filter

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

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

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

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

9 McDonnell et al., J. AOAC International (2000) 83:269-275

10 McDonnell et al., J. AOAC International (2000) 83:269-275

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

Summary of Non-Clinical Testing 6.

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

Test	Purpose	Acceptance Criteria	Result
Biocompatibility	To ensure new upper lidglue does not cause acytotoxic response.	The upper lid glue meets theacceptance criteria forcytotoxicity in ISO 10993-5:2009, Annex A Neutral RedAssay in accordance withmethods disclosed inK090036.	PASS
MaterialCompatibility	To demonstrate that thenew upper lid seal glueremains fully bondedafter multiple LiquidChemical Sterilizationand Diagnostic Cycles	The upper lid seal maintainsintegrity after multiple LiquidChemical Sterilization andDiagnostic Cycles inaccordance with methodsdisclosed in K131078	PASS
Performance ofProcessor	To demonstrate that theupper lid seal with thenew glue does not leakduring Liquid ChemicalSterilization andDiagnostic Cycles.	Diagnostic Cycles inaccordance with methodsdisclosed in K131078	PASS

Table 3. Performance Testing

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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 (K173256), Class II (21 CFR 880.6885), product code MED.

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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 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

December 2, 2019 Summary Date:

Premarket Notification: K192929

{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. K191343.

3. Description of Device

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.

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 Ouick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Tables 1 and 2 compare the proposed and predicate devices.

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Indications for Use 4.

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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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) 83:269-275

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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.

6. Summary of Non-Clinical Testing

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

Test	Purpose	Acceptance Criteria	Result
Biocompatibility	To ensure new upper lidglue does not cause acytotoxic response.	The upper lid glue meets theacceptance criteria forcytotoxicity in ISO 10993-5:2009, Annex A Neutral RedAssay in accordance withmethods disclosed inK090036.	PASS
Material Compatibility	To demonstrate that thenew upper lid seal glueremains fully bonded aftermultiple Liquid ChemicalSterilization andDiagnostic Cycles	The upper lid seal maintainsintegrity after multiple LiquidChemical Sterilization andDiagnostic Cycles inaccordance with methodsdisclosed in K131078	PASS
Performance of Processor	To demonstrate that theupper lid seal with the newglue does not leak duringLiquid ChemicalSterilization andDiagnostic Cycles.	Diagnostic Cycles inaccordance with methodsdisclosed in K131078	PASS

Table 3. Summarv of verification activities
---------------------------------------------	--	--

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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 (K191343) Class II (21 CFR 880.6885), product code MED.

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(K180432)
Indications forUse	The SYSTEM 1E Processor usesonly S40 Sterilant Concentrate toliquid chemically sterilize medicaldevices.	The SYSTEM 1E Processor usesonly S40 Sterilant Concentrate toliquid chemically sterilize medicaldevices.
	Germicidalclaim	Liquid Chemical Sterilant	Liquid Chemical Sterilant
GermicideExposureTime (min) forintended use	6	6
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
	Reuse	Single use	Single use
HumanFactors	Dispensed ready to use. Container isopened and diluted by the processor,thus limiting user exposure to theactive ingredient	Dispensed ready to useContainer is opened and diluted bythe processor, thus limiting userexposure to the active ingredient
	ActiveIngredient	35% peroxyacetic (peracetic) acidautomatically diluted for use in theSYSTEM 1E Processor.	35% peroxyacetic (peracetic) acidautomatically diluted for use in theSYSTEM 1E Processor.
Mode ofAction		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 produced fromPAA are bactericidal 2	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
	Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K180432)
		-PAA damages the viral capsid andviral nucleic acid3,4.
	Rinses	Automatic, UV-irradiated, dual 0.1micron filtered, potable hot water.	Automatic, UV-irradiated, dual 0.1micron filtered, potable hot water.
	Microbial Efficacy
SporicidalActivity ofDisinfectantsAOACOfficialMethod 966.04	Meets efficacy requirements5.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacy requirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro
ConfirmatorySporicidalActivity ofDisinfectantsAOACOfficialMethod 966.04	Meets efficacy requirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacy requirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro
FungicidalActivity ofDisinfectantsAOACOfficialMethod 955.17	Solution is fungicidal.Trichophyton mentagrophytesTesting conducted in vitro	Solution is fungicidal.Trichophyton mentagrophytesTesting conducted in vitro
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
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
TuberculocidalActivityAscenziQuantitativeSuspensionTest	Solution is tuberculocidalMycobacterium terraeTesting conducted in vitro	Solution is tuberculocidalMycobacterium terraeTesting conducted in vitro
Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K180432)
Simulated-UseTest	Meets efficacy requirement.≥ 6 log reduction Geobacillusstearothermophilus spores in amanual application	Meets efficacy requirement.≥ 6 log reduction Geobacillusstearothermophilus spores in amanual application
Clinical In Use	No surviving microorganisms onrepresentative medical devicestested	No surviving microorganisms onrepresentative medical devicestested
	Biocompatibility
CytotoxicityDevice Extracts	Two rinses with UV treated, dual0.1-micron membrane filtered watereffectively reduce sterilant residuesto safe levels.	Two rinses with UV treated, dual0.1-micron membrane filtered watereffectively reduce sterilant residuesto safe levels.
ResidueReduction	Automatic within the SYSTEM 1EProcessor:Two rinses with UV treated, dual0.1-micron membrane filtered watereffectively reduce sterilant residuesto safe levels.	Automatic within the SYSTEM 1EProcessor:Two rinses with UV treated, dual0.1-micron membrane filtered watereffectively reduce sterilant residuesto safe levels.
DeviceMaterialCompatibility	Compatible with medical devices asestablished by testing finishedflexible endoscopes through 300cycles and rigid devices through 150cycles.No functional changes haveoccurred to flexible devices.Some materials show cosmeticchanges such as fading of blackanodized aluminum without harm tothe base material.	Compatible with medical devices asestablished by testing finishedflexible endoscopes through 300cycles and rigid devices through 150cycles.No functional changes haveoccurred to flexible devices.Some materials show cosmeticchanges such as fading of blackanodized aluminum without harm tothe base material.

Feature	S40 Sterilant Concentratein S1 endo LCSPS	S40 Sterilant Concentratein S1 endo LCSPS (K173256)
Intended Use	The SYSTEM 1E Processor uses onlyS40 Sterilant Concentrate to liquidchemically sterilize medical devices.	The SYSTEM 1E Processor uses onlyS40 Sterilant Concentrate to liquidchemically sterilize medical devices.
Germicidalclaim	Liquid Chemical Sterilant	Liquid Chemical Sterilant
Feature	S40 Sterilant Concentratein S1 endo LCSPS	S40 Sterilant Concentratein S1 endo LCSPS (K173256)
Exposure Time	6 minutes	6 minutes
UseTemperature	45.5-60°C - allowable rangePotency and simulated useevaluations conducted at <43°C	45.5-60°C - allowable rangePotency and simulated use evaluationsconducted at <43°C
Reuse	Single use	Single use
Human Factors	Dispensed ready to use. Container isopened and diluted by the processor,limiting user exposure to the sterilantconcentrate	Dispensed ready to use. Container isopened and diluted by the processor,limiting user exposure to the sterilantconcentrate
ActiveIngredient	35% peroxyacetic (peracetic) acidautomatically diluted for use in theProcessor.	35% peroxyacetic (peracetic) acidautomatically diluted for use in theProcessor.
Mode of Action	It is believed that peracetic acid exertsits germicidal effect by severalmechanisms:	It is believed that peracetic acid exertsits germicidal effect by severalmechanisms:
	-oxidizing sulfhydral and sulfur bondsin proteins and enzymes, particularlyin the cell walls 1	-oxidizing sulfhydral and sulfur bondsin proteins and enzymes, particularlyin the cell walls 5
	-hydroxyl radicals produced fromPAA are bactericidal 2	-hydroxyl radicals produced from PAAare bactericidal 6
	-PAA damages the viral capsid andviral nucleic acid3,4.	-PAA damages the viral capsid andviral nucleic acid7,8.
Rinses	2 automated rinses with prefiltered,0.2 micron membrane filtered,potable hot water.	2 automated rinses with prefiltered, UVirradiated, dual 0.1 micron membranefiltered, potable hot water.
SporicidalActivity ofDisinfectantsAOAC OfficialMethod 966.04	Meets efficacy requirements9.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacy requirements10.Bacillus subtilisClostridium sporogenesTesting conducted in vitro
ConfirmatorySporicidalActivity ofDisinfectants	Meets efficacy requirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacy requirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro
Feature	S40 Sterilant Concentratein S1 endo LCSPS	S40 Sterilant Concentratein S1 endo LCSPS (K173256)
AOAC OfficialMethod 966.04
FungicidalActivity ofDisinfectantsAOAC OfficialMethod 955.17	Solution is fungicidal.Trichophyton mentagrophytesTesting conducted in vitro	Solution is fungicidal.Trichophyton mentagrophytesTesting conducted in vitro
Use DilutionMethod AOAC,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
EPA VirucidalTesting(DIS/TSS-7,Nov. 1981)	Solution is virucidalHerpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro	Solution is virucidalHerpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro
TuberculocidalActivity ofDisinfectantsAOAC OfficialMethod 965.12	Not performed. A quantitativesuspension Tuberculocidal test wasconducted.	Not performed. A quantitativesuspension Tuberculocidal test wasconducted.
TuberculocidalActivityAscenziQuantitativeSuspension Test	Solution is tuberculocidalMycobacterium terraetesting conducted in vitro	Solution is tuberculocidalMycobacterium terraetesting conducted in vitro
Simulated Use	Meets efficacy requirement.> 6 log $_{10}$ reduction Geobacillusstearothermophilus spores in amanual application	Meets efficacy requirement.> 6 log $_{10}$ reduction Geobacillusstearothermophilus spores in a manualapplication
Clinical In Use	No surviving microorganisms onrepresentative medical devices tested	No surviving microorganisms onrepresentative medical devices tested
CytotoxicityDevice Extracts	Two Processor controlled rinses withprefiltered, dual 0.2 micron filteredpotable water effectively reducesterilant residues to non-cytotoxiclevels.	Two Processor controlled rinses withprefiltered, dual 0.2 micron filteredpotable water effectively reducesterilant residues to non-cytotoxiclevels.
ResidueReduction	Two Processor controlled rinses withprefiltered, dual 0.2 micron filteredpotable water effectively reducesterilant residues to safe levels.	Two Processor controlled rinses withprefiltered, dual 0.2 micron filteredpotable water effectively reducesterilant residues to safe levels.
Feature	S40 Sterilant Concentratein S1 endo LCSPS	S40 Sterilant Concentratein S1 endo LCSPS (K173256)
MaterialCompatibility	Compatible with medical devices asestablished by testing finishedmedical devices through 300 cycles.No functional changes occurred todevices. Some materials showcosmetic changes such as fading ofexternal markings (yet all remainedlegible) and bleaching of blackanodized aluminum without harm tothe base material.	Compatible with medical devices asestablished by testing finished medicaldevices through 300 cycles. Nofunctional changes occurred todevices. Some materials showcosmetic changes such as fading ofexternal markings (yet all remainedlegible) and bleaching of blackanodized aluminum without harm tothe base material.

Table 1. Processor Comparison Table
Feature	Proposed DeviceSYSTEM 1 endo Liquid ChemicalSterilant Processing System, ModelP6900	Predicate DeviceSYSTEM 1 endo Liquid ChemicalSterilant Processing System, ModelP6900 (K191343)
	The SYSTEM 1 endo LiquidChemical Sterilant Processing Systemis intended for liquid chemicalsterilization of cleaned, immersible,and reusable semi-critical heat-sensitive medical devices and theiraccessories in healthcare facilities.	The SYSTEM 1 endo LiquidChemical Sterilant Processing Systemis intended for liquid chemicalsterilization of cleaned, immersible,and reusable semi-critical heat-sensitive medical devices and theiraccessories in healthcare facilities.
IntendedUseIndicationsfor Use	The SYSTEM 1 endo Processorautomatically dilutes the S40 SterilantConcentrate to its use dilution (>1820 mg/L peracetic acid), liquidchemically sterilizes the load during acontrolled 6-minute exposure at 45.5to 60°C, and rinses the load with 0.2micron filtered water.The SYSTEM 1 endo Processor usesonly S40 Sterilant Concentrate toliquid chemically sterilize medicaldevices.	The SYSTEM 1 endo Processorautomatically dilutes the S40 SterilantConcentrate to its use dilution (>1820 mg/L peracetic acid), liquidchemically sterilizes the load during acontrolled 6-minute exposure at 45.5to 60°C, and rinses the load with 0.2micron filtered water.The SYSTEM 1 endo Processor usesonly S40 Sterilant Concentrate toliquid chemically sterilize medicaldevices.
Feature	Proposed DeviceSYSTEM 1 endo Liquid ChemicalSterilant Processing System, ModelP6900	Predicate DeviceSYSTEM 1 endo Liquid ChemicalSterilant Processing System, ModelP6900 (K191343)
OperatingPrinciples/Technology	A microprocessor controlled unit with interchangeable processing trays/containers. The processor lid opens to reveal the processing chamber in which the load is placed.	A microprocessor controlled unit with interchangeable processing trays/containers. The processor lid opens to reveal the processing chamber in which the load is placed.
	Devices with internal lumens are interfaced with the processor using connectors, i.e. Quick Connects.	Devices with internal lumens are interfaced with the processor using connectors, i.e. Quick Connects.
	S40 Sterilant is placed in a specialized compartment and when the processor fills with water, it creates the sterilant use dilution from the single use sterilant cup.	S40 Sterilant is placed in a specialized compartment and when the processor fills with water, it creates the sterilant use dilution from the single use sterilant cup.
	The processor monitors and controls the use dilution temperature and contact time. The processor automatically rinses the load with 0.2 micron filtered water to remove sterilant residuals.	The processor monitors and controls the use dilution temperature and contact time. The processor automatically rinses the load with 0.2 micron filtered water to remove sterilant residuals.
ProcessParameters	Standardized cycle parameters cannot be altered by operator. The critical process parameters are: Use dilution contact time Use dilution temperature Peracetic acid concentration Integrity of the internal water filter (tested by the system)	Standardized cycle parameters cannot be altered by operator. The critical process parameters are: Use dilution contact time Use dilution temperature Peracetic acid concentration Integrity of the internal water filter (tested by the system)
Feature	Proposed Device	Predicate Device
ProcessMonitors	SYSTEM 1 endo Liquid ChemicalSterilant Processing System, ModelP6900Cycle Printout documents successful cycle completion 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 in Diagnostic cycle Alarms if pressure transducer indicates internal water filter failed integrity test	SYSTEM 1 endo Liquid ChemicalSterilant Processing System, ModelP6900 (K191343)Cycle Printout documents successful cycle completion 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 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 sterilization and rinsing Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter Includes a barcode scanner; employs touchscreen display interface; has USB drive for electronic cycle download; facilitates use of a web-based data management system. Separate, optional printer	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 sterilization and rinsing Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter Includes a barcode scanner; employs touchscreen display interface; has USB drive for electronic cycle download; facilitates use of a web-based data management system. Separate, optional printer
Cycle Parameters
Incomingwater temp.	≥ 43°C	≥ 43°C
Feature	Proposed DeviceSYSTEM 1 endo Liquid ChemicalSterilant Processing System , ModelP6900	Predicate DeviceSYSTEM 1 endo Liquid ChemicalSterilant Processing System, ModelP6900 (K191343)
Temperatureto startsterilantexposure	$\geq$ 46°C	$\geq$ 46°C
Temperaturealarm pointduring LCSexposure	< 45.5 or > 60°C	< 45.5 or > 60°C
Temperaturerange oftypical LCScycle	46 - 55°C	46 - 55°C
ExposureTime - S40use dilution	6 minutes	6 minutes
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
Number ofrinses	2	2
Air Purge	Aids in removing excess water frominstrument lumens after rinsing	Aids in removing excess water frominstrument lumens after rinsing
InternalWater FilterIntegrityTest	Conducted during the Diagnosticcycle	Conducted during the Diagnosticcycle
Approximate CycleTime	18 - 20 minutes	18 - 20 minutes
DiagnosticCycle	Performs 14 tests on processor'ssystems confirming proper function.Recommended to perform each day ofuse. After a failed Diagnostic cycle, aliquid chemical sterilization cyclecannot be performed until theproblem is rectified and a successfulDiagnostic cycle has been completed.	Performs 14 tests on processor'ssystems confirming proper function.Recommended to perform each day ofuse. After a failed Diagnostic cycle, aliquid chemical sterilization cyclecannot be performed until theproblem is rectified and a successfulDiagnostic cycle has been completed.
Accessories
Sterilant	Uses S40 Sterilant Concentrate - seeTable 2	Uses S40 Sterilant Concentrate - seeTable 2
Feature	Proposed DeviceSYSTEM 1 endo Liquid ChemicalSterilant Processing System , ModelP6900	Predicate DeviceSYSTEM 1 endo Liquid ChemicalSterilant Processing System, ModelP6900 (K191343)
ProcessingTrays andContainers	Uses interchangeable processingtrays/containers	Uses interchangeable processingtrays/containers
	• Universal Flex Processing Tray	• Universal Flex Processing Tray
	• General Processing Container &Tray	• General Processing Container &Tray
	• Directed Flow ProcessingContainer & Tray	• Directed Flow ProcessingContainer & Tray
	• Flexible Endoscope ProcessingContainer & Tray	• Flexible Endoscope ProcessingContainer & Tray
	• Ultrasound Processing Tray	• Ultrasound Processing Tray
QuickConnects	Uses Quick Connects to attachinstrument lumens to theTray/Container ports	Uses Quick Connects to attachinstrument lumens to theTray/Container ports
ChemicalIndicator	VERIFY Chemical Indicator for S40Sterilant (K173428)	VERIFY Chemical Indicator for S40Sterilant (K173428)
Spore TestStrip	VERIFY Spore Test Strip for S40Sterilant (K180553)	VERIFY Spore Test Strip for S40Sterilant (K180553)
Operator	Periodic replacement of water filtersand air filter.	Periodic replacement of water filtersand air filter.
Maintenance	Periodic replacement of printer tape,if using the external printer option.	Periodic replacement of printer tape,if using the external printer option.