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 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 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% 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 a modifications for the obsolescence of the support material in the pre-filters.

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 a modifications for the obsolescence of the support material in the pre-filters.

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 Ouick 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 liguid chemical sterilization system, utilizing peracetic acid to process totally immersible semicritical 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 a modifications for the obsolescence of the support material in the pre-filters.

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 Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a Liquid Chemical Sterilant Processing System. The submission is to describe a modification for the obsolescence of the support material in the pre-filters. The device is a "SYSTEM 1E Liquid Chemical Sterilant Processing System" (P6500), and "SYSTEM 1 endo Liquid Chemical Sterilant Processing System" (P6800, P6900).

The acceptance criteria and study that proves the device meets the acceptance criteria are as follows:

1. A table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria	Reported Device Performance (Result)
Performance testing with replacement pre-filters	The modification does not affect the performance of the device.	Pass

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

The document states "new testing was performed to evaluate the modified device". However, it does not specify the sample size used for the performance testing with replacement pre-filters nor the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The performance testing is described for a chemical sterilant system, not an AI/diagnostic imaging device that would typically involve expert ground truth establishment.

4. Adjudication method for the test set:

This information is not applicable to the type of device and testing described. The "Pass" result indicates that the device met the pre-defined performance criteria without the need for human adjudication in the context of this specific regulatory submission.

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

This information is not applicable. The device is a liquid chemical sterilant processing system, not an AI-assisted diagnostic imaging device.

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

This information is not applicable. The device is a liquid chemical sterilant processing system, not an AI/algorithm-based device. The "Performance testing with replacement pre-filters" is a standalone test of the device's physical components.

7. The type of ground truth used:

For the performance testing of the replacement pre-filters, the "ground truth" would be the measured performance of the device against established functional and safety specifications. This is inherent in the "Performance testing" result and implies that either design specifications or predefined performance metrics (e.g., filtration efficiency, fluid flow, sterilant concentration maintenance, temperature control) were met. The document indicates that the modification "does not affect the performance of the device," implying a comparison to the performance of the original device.

For the predicate device, the provided tables (Table 1 and Table 2 details the performance of the S40 Sterilant Concentrate) describe various efficacy tests and the organisms used, which serve as the "ground truth" for germicidal claims:

Sporicidal Activity: Bacillus subtilis, Clostridium sporogenes (in vitro)
Fungicidal Activity: Trichophyton mentagrophytes (in vitro)
Bactericidal Activity: Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa (in vitro)
Viricidal Activity: Herpes simplex Type 1, Adenovirus Type 5, Poliovirus Type 1 (in vitro)
Tuberculocidal Activity: Mycobacterium terrae (in vitro)
Simulated-Use Test: Geobacillus stearothermophilus spores in a manual application (result: >= 6 log reduction)
Clinical In-Use: No surviving microorganisms on representative medical devices tested.

8. The sample size for the training set:

This information is not applicable for this device, as it is not an AI/machine learning device that would require a training set.

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

This information is not applicable for this device.

Summary

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

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

October 3, 2023

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

Re: K232914

Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: September 19, 2023 Received: September 19, 2023

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

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

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

Sincerely,

Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K232914

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."

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

Indications for Use

510(k) Number (if known) K232914

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)	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."

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

Indications for Use

510(k) Number (if known)

K232914

Device Name

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

Indications for Use (Describe)

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% 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."

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for STERIS. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue.

510(k) Summary For K232914 SYSTEM 1E Liquid Chemical Sterilant Processing System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600

Contact: Jennifer Nalepka Manager, Regulatory Affairs Tel: 440-392-7458

October 2, 2023 Summary Date:

Premarket Notification: K232914

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

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

2. Predicate Device

SYSTEM 1E Liquid Chemical Sterilant Processing System, K222615

3. Description of Device

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

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.

5. 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.

Feature	ProposedSYSTEM 1E Processor	Predicate (K222615)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-sensitive	The SYSTEM 1E LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable criticaland semi-critical heat-sensitive	Identical
Feature	Proposed	Predicate (K222615)	Comparison
	SYSTEM 1E Processor	SYSTEM 1E Processor
	medical devices in healthcarefacilities.	medical devices in healthcarefacilities.
	The SYSTEM 1E Processor	The SYSTEM 1E Processor
	dilutes the S40 Sterilant	dilutes the S40 Sterilant
	Concentrate to its use dilution	Concentrate to its use dilution
	(>1820 mg/L peracetic acid),	(>1820 mg/L peracetic acid),
	liquid chemically sterilizes the	liquid chemically sterilizes the
	load during a controlled 6-minute	load during a controlled 6-minute
	exposure at 45.5 to 60°C, and	exposure at 45.5 to 60°C, and
	rinses the load with extensively	rinses the load with extensively
	treated* potable water. After	treated* potable water. After
	completion of a cycle, critical	completion of a cycle, critical
	devices should be used	devices should be used
	immediately; semi-critical	immediately; semi-critical
	devices should be used	devices should be used
	immediately or may be handledand stored in a manner similar to	immediately or may be handledand stored in a manner similar to
	that of high level disinfected	that of high level disinfected
	endoscopes. Critical devices not	endoscopes. Critical devices not
	used immediately should be	used immediately should be
	processed again before use.	processed again before use.
	The SYSTEM 1E Processor uses	The SYSTEM 1E Processor uses
	only S40 Sterilant Concentrate to	only S40 Sterilant Concentrate to
	liquid chemically sterilize medicaldevices.	liquid chemically sterilize medicaldevices.

	* The extensive treatment of EPA	* The extensive treatment of EPA
	potable water consists of:	potable water consists of:
	1. Pre-filtration through twopre-filters:	1. Pre-filtration through two pre-filters:
	• Pre-filter A is a gross	• Pre-filter A is a gross depth
	depth filter that removes	filter that removes
	approximately 2.5 micron	approximately 2.5 micron or
	or larger	larger
	particles/contaminants.	particles/contaminants.
	• Pre-filter B is a surface	• Pre-filter B is a surface filter
	filter that removesparticles/contaminants >	filter that removes
	0.1 micron.	particles/contaminants >0.1 micron.2. UV Irradiation:
	2. UV Irradiation:	• During transit through the
	• During transit through the	UV water treatment
	UV water treatment	chamber, a UV dose
	chamber, a UV dose	sufficient to achieve a > 6-
	sufficient to achieve a > 6-	log reduction of MS2 virus is
	log reduction of MS2 virus is
Feature	ProposedSYSTEM 1E Processor	Predicate (K222615)SYSTEM 1E Processor	Comparison
OperatingPrinciples/Technology	delivered to the water.3. 0.1 micron filtration:• The water prepared bypre-filtration and UVirradiation is filtered throughredundant, 0.1-micron(absolute rated) membranesto remove bacteria, fungi andprotozoa > 0.1 micron.	delivered to the water.3. 0.1 micron filtration:• The water prepared by pre-filtration and UV irradiationis filtered through redundant,0.1-micron (absolute rated)membranes to removebacteria, fungi and protozoa> 0.1 micron.	Identical
	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.
	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 documentssuccessful cycle completionor identifies fault if cycleaborts• Alarms if thermocouplesindicate temperature out ofspecification		• Cycle Printout documentssuccessful cycle completionor identifies fault if cycleaborts• Alarms if thermocouplesindicate temperature out ofspecification	Identical
				Feature		Proposed		Predicate (K222615)	Comparison
						SYSTEM 1E Processor		SYSTEM 1E Processor
						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		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	$\geq 43°C$		$\geq 43°C$	Identical
Temperatureto startexposure	$\geq 46°C$	$\geq 46°C$	Identical
Feature	ProposedSYSTEM 1E Processor	Predicate (K222615)SYSTEM 1E Processor	Comparison
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 and theproposed filters have anew support material.• 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	Similar -function andbiocompatibilityof pre-filter isunchanged.
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 has	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 has	Identical
Feature	ProposedSYSTEM 1E Processor	Predicate (K222615)SYSTEM 1E Processor	Comparison
Interchangeable Components
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

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

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

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

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

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

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
Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K211607)	Comparison
Reuse	Single use	Single use	Identical
HumanFactors	Dispensed ready to use.Container is opened and dilutedby the processor, thus limitinguser exposure to the activeingredient	Dispensed ready to useContainer is opened and dilutedby the processor, thus limitinguser exposure to the activeingredient	Identical
ActiveIngredient	35% peroxyacetic (peracetic)acid automatically diluted foruse in the SYSTEM 1EProcessor.	35% peroxyacetic (peracetic)acid automatically diluted foruse in the SYSTEM 1EProcessor.	Identical
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 walls1-hydroxyl radicals producedfrom PAA are bactericidal 2-PAA damages the viral capsidand viral nucleic acid3,4	It is believed that peracetic acidexerts its germicidal effect byseveral mechanisms:-oxidizing sulfhydryl and sulfurbonds in proteins and enzymes.particularly in the cell walls1-hydroxyl radicals produced fromPAA are bactericidal2-PAA damages the viral capsidand viral nucleic acid3,4	Identical
Rinses	Automatic, UV-irradiated, dual0.1 micron filtered, potable hotwater.	Automatic, UV-irradiated, dual0.1 micron filtered, potable hotwater.	Identical
	Microbial Efficacy
SporicidalActivity ofDisinfectantsAOACOfficialMethod 966.04	Meets efficacy requirements5.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacy requirements5.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Identical
ConfirmatorySporicidalActivity ofDisinfectantsAOACOfficialMethod 966.04	Meets efficacy requirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Meets efficacy requirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro	Identical
FungicidalActivity ofDisinfectants	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
AOACOfficialMethod 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 150	Compatible with medicaldevices as established by testingfinished flexible endoscopesthrough 300 cycles and rigiddevices through 150 cycles.	Identical
Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K211607)	Comparison
	cycles.No functional changes haveoccurred to flexible devices.Some materials show cosmeticchanges such as fading of blackanodized aluminum withoutharm to the base material.	No functional changes haveoccurred to flexible devices.Some materials show cosmeticchanges such as fading of blackanodized aluminum withoutharm to the base material.

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

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

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.

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

{16}------------------------------------------------

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

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.

Table 3. Summary of verification activities.

Test	Acceptance Criteria	Result
Performance testing withreplacement pre-filters	The modification does not affect theperformance of the device.	Pass

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 (K222615), Class II (21 CFR 880.6885), product code MED.

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

Image /page/17/Picture/1 description: The image shows the STERIS logo. The word "STERIS" is written in a serif font in all caps. A registered trademark symbol is to the right of the word. Below the word is a graphic of several horizontal wavy lines in blue.

510(k) Summary For K232914 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600

Contact:

Jennifer Nalepka Manager, Regulatory Affairs Tel: 440-392-7458

Summary Date: October 2, 2023

Premarket Notification: K232914

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

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, K222615

3. Description of Device

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

4. Indications for 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.

ട്. 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. Since there are no technological differences between the proposed and predicate devices, there are no new concerns of safety and effectiveness.

Table 1. Processor Comparison Table

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

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

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

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

{22}------------------------------------------------

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

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

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

Table 2. S40 Sterilant Concentrate Comparison Table

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

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.

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

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 Predicate Device Proposed Device S40 Sterilant Concentrate Comparison Feature S40 Sterilant Concentrate (K211607) Official Method 955.17 Use Dilution Solution is bactericidal. Solution is bactericidal. Method AOAC. Salmonella choleraesuis Salmonella choleraesuis Official Staphylococcus aureus Staphylococcus aureus Identical Methods Pseudomonas aeruginosa Pseudomonas aeruginosa 955.14. 955.15. Testing conducted in vitro Testing conducted in vitro 964.02 Solution is viricidal. Solution is viricidal. EPA Viricidal Herpes simplex Type 1 Herpes simplex Type 1 Testing Adenovirus Type 5 Adenovirus Type 5 Identical (DIS/TSS-7, Poliovirus Type 1 Poliovirus Type 1 Nov. 1981) Testing conducted in vitro Testing conducted in vitro Tuberculocidal Solution is tuberculocidal Solution is tuberculocidal Activity Ascenzi Mycobacterium terrae Mycobacterium terrae Identical Ouantitative Testing conducted in vitro Testing conducted in vitro Suspension Test Meets efficacy requirement. Meets efficacy requirement. Simulated-Use > 6 log reduction Geobacillus > 6 log reduction Geobacillus Identical Test stearothermophilus spores in a stearothermophilus spores in a manual application manual application No surviving microorganisms No surviving microorganisms on Clinical Inon representative medical representative medical devices Identical Use devices tested tested Biocompatibility Two rinses with UV treated, Two rinses with UV treated, dual

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

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

Feature	Proposed DeviceS40 Sterilant Concentrate	Predicate DeviceS40 Sterilant Concentrate(K211607)	Comparison
	No functional changes haveoccurred to flexible devices.	No functional changes haveoccurred 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.

6. Summary of Non-Clinical Testing

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

Table 3. Summary of verification activities

Test	Acceptance Criteria	Result
Performance testing withreplacement prefilters	The modification does not affect theperformance of the device.	Pass

7. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs at least as well as or better than the legally marketed predicate device (K222615), Class II (21 CFR 880.6885), product code MED.

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

Image /page/27/Picture/1 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a serif font, with the "R" having a registered trademark symbol next to it. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water or sound waves.

510(k) Summary For K232914 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600

Contact:

Jennifer Nalepka Manager, Regulatory Affairs Tel: 440-392-7458

October 2, 2023 Summary Date:

Premarket Notification: K232914

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

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

2. Predicate Device

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, K222615

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 Quick 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.

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

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.

ನ. 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. Since there are no technological differences between the proposed and predicate devices, there are no new concerns of safety and effectiveness.

Table 1. Processor Comparison Table

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

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

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

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

STERIS SPECIAL 510(k) PREMARKET NOTIFICATION 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

Table 2. S40 Sterilant Concentrate Comparison Table

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

STERIS SPECIAL 510(k) PREMARKET NOTIFICATION 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

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.

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

STERIS SPECIAL 510(k) PREMARKET NOTIFICATION 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

{36}------------------------------------------------

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 prefilters	The modification does not affect theperformance of the device.	Pass

Table 3. Summary of verification activities

7. Conclusion

Regulation Number and Section

§ 880.6885 Liquid chemical sterilants/high level disinfectants.

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

Feature	Proposed DeviceSYSTEM 1 endo Processor,Model P6800	Predicate DeviceSYSTEM 1 endo Processor,Model P6800(K222615)	Comparison
IntendedUseIndicationsfor Use	The SYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization ofcleaned, immersible, andreusable semi-critical medicaldevices and their accessories inhealthcare facilities.The SYSTEM 1 endo Processorautomatically dilutes the S40Sterilant Concentrate to its usedilution (>1820 mg/L peraceticacid), liquid chemicallysterilizes the load during acontrolled 6-minute exposure at45.5 to 60°C, and rinses the loadwith 0.2 micron filtered water.The SYSTEM 1 endo Processoruses only S40 Sterilant	The SYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable semi-critical 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 Processoruses only S40 Sterilant	Identical
Feature	Proposed DeviceSYSTEM 1 endo Processor,Model P6800	Predicate DeviceSYSTEM 1 endo Processor,Model P6800(K222615)	Comparison
	Concentrate to liquid chemicallysterilize medical devices.	Concentrate to liquid chemicallysterilize medical devices.
OperatingPrinciples /Technology	A microprocessor controlledunit with interchangeableprocessing trays/containers.The processor lid opens toreveal the processing chamberin which the load is placed.Devices with internal lumensare interfaced with the processorusing connectors, i.e. QuickConnects. 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 theprocessing chamber in which theload is placed. Devices withinternal lumens are interfacedwith the processor usingconnectors, i.e. Quick Connects.S40 Sterilant is placed in aspecialized compartment andwhen the processor fills withwater, it creates the sterilant usedilution from the single usesterilant cup. The processormonitors and controls the usedilution temperature and contacttime. The processorautomatically rinses the loadwith 0.2 micron filtered water toremove sterilant residuals.	Identical
ProcessParameters	Standardized cycle parameterscannot be altered by theoperator. The critical processparameters are:● Use dilution contact time● Use dilution temperature● Peracetic acidconcentration● Bacterial retentive waterfilter integrity	Standardized cycle parameterscannot be altered by theoperator. The critical processparameters are:● Use dilution contact time● Use dilution temperature● Peracetic acid concentration● Bacterial retentive waterfilter integrity	Identical
ProcessMonitors	● Cycle Printout documentssuccessful cyclecompletion or identifiesfault if cycle aborts● Alarms if thermocouplesindicate temperature out ofspecification	● Cycle Printout documentssuccessful cycle completionor identifies fault if cycleaborts● Alarms if thermocouplesindicate temperature out ofspecification	Identical
Feature	Proposed DeviceSYSTEM 1 endo Processor,Model P6800	Predicate DeviceSYSTEM 1 endo Processor,Model P6800(K222615)	Comparison
	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	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 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			Comparison
Incomingwater temp.	$\geq$ 43°C	$\geq$ 43°C	Identical
Temperatureto startsterilantexposure	$\geq$ 46°C	$\geq$ 46°C	Identical
Temperaturealarm point	< 45.5°C or > 60°C	< 45.5°C or > 60°C	Identical
Feature	Proposed DeviceSYSTEM 1 endo Processor,Model P6800	Predicate DeviceSYSTEM 1 endo Processor,Model P6800(K222615)	Comparison
during LCSexposure
Temperaturerange oftypical LCScycle	46-55°C	46-55°C	Identical
Rinse waterpreparation	Hot potable wateris pre-filtered and the proposed filters have a new support material.is filtered through 0.2 micron bacterial retentive filter	Hot potable wateris pre-filteredis filtered through 0.2 micron bacterial retentive filter	Similar -function andbiocompatibilityof pre-filter isunchanged.
Number ofrinses	2	2	Identical
Air Purge	Aids in removing excess waterfrom instrument lumens afterrinsing	Aids in removing excess waterfrom instrument lumens afterrinsing	Identical
Internalwater filterintegrity test	Conducted during theDiagnostic cycle	Conducted during the Diagnosticcycle	Identical
Approximatecycle time	18 - 20 minutes	18 - 20 minutes	Identical
DiagnosticCycle	Performs 14 tests on processor'ssystems confirming properfunction.Recommended to perform eachday of use. After a failedDiagnostic cycle a liquidchemical sterilization cyclecannot be performed until theproblem is rectified and asuccessful Diagnostic cycle hasbeen completed.	Performs 14 tests on processor'ssystems confirming properfunction.Recommended to perform eachday of use. After a failedDiagnostic cycle a liquidchemical sterilization cyclecannot be performed until theproblem is rectified and asuccessful Diagnostic cycle hasbeen completed.	Identical
Accessories			Comparison
Sterilant	Uses S40 Sterilant Concentrate– See Table 2	Uses S40 Sterilant Concentrate –See Table 2	Identical
ProcessingTrays andContainers	Uses interchangeable processingtrays/containers	Uses interchangeable processingtrays/containers	Identical
Feature	Proposed DeviceSYSTEM 1 endo Processor,Model P6800	Predicate DeviceSYSTEM 1 endo Processor,Model P6800(K222615)	Comparison
	Universal Flexible Processing Tray General Processing Container and Tray Directed Flow Processing Container and Tray Flexible Endoscope Processing Container and Tray Ultrasound Processing Tray	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	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 inSYSTEM 1 endo LCSPS	VERIFY Spore Test Strip forS40 Sterilant for use inSYSTEM 1 endo LCSPS	Identical
OperatorMaintenance	Periodic replacement of printertape, water filters and air filter	Periodic replacement of printertape, water filters and air filter	Identical