Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes an automated, computer-controlled sterilization system with specific physical processes (filtration, UV, chemical sterilization). There is no mention of AI, ML, or any learning or adaptive capabilities. The modifications described relate to a change in glue for a seal.

Therapeutic

No
The device is a sterilizer for medical devices, not a therapeutic device used to treat or diagnose patients.

Diagnostic

No

Explanation: The document explicitly states the device is a "Liquid Chemical Sterilant Processing System" intended for sterilization of medical devices. While it mentions "Diagnostic Cycles" in the context of performance testing of a glue modification, the device's primary and stated purpose is sterilization, not diagnosis. The "Diagnostic Cycles" referred to are likely internal testing procedures for the machine itself, not for diagnosing patient conditions or analyzing biological samples.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical processing system including a processor, sterilant concentrate, trays, and quick connects, indicating it is a hardware device with integrated software control.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states that the system is for the liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices. This is a process for disinfecting and sterilizing medical instruments, not for performing tests on biological samples or providing diagnostic information.
Device Description: The device description details a system that uses a chemical sterilant (peracetic acid) and treated water to process medical devices. It describes the mechanical and chemical processes involved in sterilization and rinsing. There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic results.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Providing information for diagnosis, monitoring, or treatment decisions
- Using reagents designed for in vitro testing

The device's function is to prepare medical instruments for safe use by sterilizing them, which is a crucial step in infection control within healthcare facilities. This falls under the category of medical device processing, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.
2. 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.
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 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.

Product codes (comma separated list FDA assigned to the subject device)

MED

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.

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

SYSTEM 1E Liquid Chemical Sterilant Processing System:
Non-clinical testing was performed to evaluate the modified device.
Tests performed: Biocompatibility, Material Compatibility, Performance of Processor.
Results: All tests passed.

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800:
Non-clinical testing was performed to evaluate the modifications to the subject device.
Tests performed: Biocompatibility, Material Compatibility, Performance of Processor.
Results: All tests passed.

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900:
Non-clinical testing was performed to evaluate the modifications to the subject device.
Tests performed: Biocompatibility, Material Compatibility, Performance of Processor.
Results: All tests passed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K190104, K173256, K191343

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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

2

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 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 $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.

3

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 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.

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

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 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.

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."

5

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

6

Device Name 1.

| Trade Name: | SYSTEM 1E Liquid Chemical Sterilant Processing
System |
|------------------------|-------------------------------------------------------------------------|
| Device Classification: | Class II |
| Common/usual Name: | Liquid Chemical Sterilizer |
| Classification Name: | Sterilant, Medical devices, Liquid Chemical
Sterilants/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

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.

7

4. Indications for Use

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

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

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

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)
Indications
for Use	The SYSTEM 1E Liquid Chemical
Sterilant Processing System is
intended for liquid chemical
sterilization of cleaned, immersible,
and reusable critical and semi-	The SYSTEM 1E Liquid Chemical
Sterilant Processing System is
intended for liquid chemical
sterilization of cleaned, immersible,
and reusable critical and semi-
Feature	Proposed Device
SYSTEM 1E Processor	Predicate Device
SYSTEM 1E Processor (K190104)
	critical heat-sensitive medical
devices in healthcare facilities.	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 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 SYSTEM 1E Processor uses
only S40 Sterilant Concentrate to
liquid chemically sterilize medical
devices.
	* The extensive treatment of EPA
potable water consists of:

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.
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.
0.1-micron filtration:
• The water prepared by pre-
filtration and UV irradiation | * The extensive treatment of EPA
potable water consists of:
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.
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.
0.1-micron filtration:
• The water prepared by pre-
filtration and UV irradiation |
| Feature | Proposed Device
SYSTEM 1E Processor | Predicate Device
SYSTEM 1E Processor (K190104) |
| | membranes to remove
bacteria, fungi and protozoa >
0.1 micron. | membranes to remove
bacteria, fungi and protozoa

0.1 micron. |
| Operating
Principles/
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.
Devices with internal lumens are
interfaced with the processor using
connectors. Sterilant Concentrate 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
extensively treated water to remove
sterilant residuals. | 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. Sterilant Concentrate 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
extensively treated water to remove
sterilant residuals. |
| Process
Parameters | Standardized cycle parameters
cannot be altered by operator. The
critical process parameters are:
● Contact Time
● Use Dilution Temperature
● Peracetic acid concentration
● Bacterial retentive water filter
integrity
● UV irradiation | Standardized cycle parameters
cannot be altered by operator. The
critical process parameters are:
● Contact Time
● Use Dilution Temperature
● Peracetic acid concentration
● Bacterial retentive water filter
integrity
● UV irradiation |
| Process
Monitors | ● 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 during
Diagnostic cycle | ● 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 during
Diagnostic cycle |
| Feature | Proposed Device
SYSTEM 1E Processor | Predicate Device
SYSTEM 1E Processor (K190104) |
| Design
Features | 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 | | |
| Incoming
water
temperature | ≥ 43°C | ≥ 43°C |
| Temperature
to start
exposure
phase | ≥ 46°C | ≥ 46°C |
| Temperature
alarm point
during the
exposure
phase | 60°C | 60°C |
| Temperature
range during a
typical Liquid
Chemical
Sterilant
Processing
Cycle | 46 - 55°C | 46 - 55°C |
| Exposure
Time | 6 minutes | 6 minutes |
| Rinse water
preparation | Hot potable tap water is:
pre-filtered | Hot potable tap water is:
pre-filtered |
| Feature | Proposed Device
SYSTEM 1E Processor | Predicate Device
SYSTEM 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 Device
SYSTEM 1E Processor | Predicate Device
SYSTEM 1E Processor (K190104) |
| Spore Test
Strip | VERIFY Spore Test Strip for S40
Sterilant (K180553) | VERIFY Spore Test Strip for S40
Sterilant (K180553) |
| Operator
Maintenance
Requirements | 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

8

9

10

11

12

| Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K180432) | |
|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The SYSTEM 1E Processor uses
only S40 Sterilant Concentrate to
liquid chemically sterilize medical
devices. | The SYSTEM 1E Processor uses
only S40 Sterilant Concentrate to
liquid chemically sterilize medical
devices. | |
| | Germicidal
claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant |
| Germicide
Exposure
Time (min) for
intended use | 6 | 6 | |
| Use
Temperature | 45.5-60°C – allowable
46-55°C - typical
Potency and simulated use
evaluations conducted at ≤43°C | 45.5-60°C – allowable
46-55°C - typical
Potency and simulated use
evaluations conducted at ≤43°C | |
| | Reuse | Single use | Single use |
| Human
Factors | Dispensed ready to use. Container is
opened and diluted by the processor,
thus limiting user exposure to the
active ingredient | Dispensed ready to use
Container is opened and diluted by
the processor, thus limiting user
exposure to the active ingredient | |
| | Active
Ingredient | 35% peroxyacetic (peracetic) acid
automatically diluted for use in the
SYSTEM 1E Processor. | 35% peroxyacetic (peracetic) acid
automatically diluted for use in the
SYSTEM 1E Processor. |
| Mode of
Action | | It is believed that peracetic acid
exerts its germicidal effect by
several mechanisms:
-oxidizing sulfhydryl and sulfur
bonds in proteins and enzymes,
particularly in the cell walls 1
-hydroxyl radicals produced from
PAA are bactericidal 2 | It is believed that peracetic acid
exerts its germicidal effect by
several mechanisms:
-oxidizing sulfhydryl and sulfur
bonds in proteins and enzymes,
particularly in the cell walls1
-hydroxyl radicals produced from
PAA are bactericidal2 |
| | Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K180432) |
| | | -PAA damages the viral capsid and
viral nucleic acid3,4. | |
| | Rinses | Automatic, UV-irradiated, dual 0.1
micron filtered, potable hot water. | Automatic, UV-irradiated, dual 0.1
micron filtered, potable hot water. |
| | Microbial Efficacy | | |
| Sporicidal
Activity of
Disinfectants
AOAC
Official
Method 966.04 | Meets efficacy requirements5.
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Meets efficacy requirements6.
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | |
| Confirmatory
Sporicidal
Activity of
Disinfectants
AOAC
Official
Method 966.04 | Meets efficacy requirements6.
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Meets efficacy requirements6.
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | |
| Fungicidal
Activity of
Disinfectants
AOAC
Official
Method 955.17 | Solution is fungicidal.
Trichophyton mentagrophytes
Testing conducted in vitro | Solution is fungicidal.
Trichophyton mentagrophytes
Testing conducted in vitro | |
| Use Dilution
Method
AOAC,
Official
Methods
955.14, 955.15,
964.02 | Solution is bactericidal.
Salmonella choleraesuis
Staphylococcus aureus
Pseudomonas aeruginosa
Testing conducted in vitro | Solution is bactericidal.
Salmonella choleraesuis
Staphylococcus aureus
Pseudomonas aeruginosa
Testing conducted in vitro | |
| EPA Viricidal
Testing
(DIS/TSS-7,
Nov. 1981) | Solution is viricidal.
Herpes simplex Type 1
Adenovirus Type 5
Poliovirus Type 1
Testing conducted in vitro | Solution is viricidal.
Herpes simplex Type 1
Adenovirus Type 5
Poliovirus Type 1
Testing conducted in vitro | |
| Tuberculocidal
Activity
Ascenzi
Quantitative
Suspension
Test | Solution is tuberculocidal
Mycobacterium terrae
Testing conducted in vitro | Solution is tuberculocidal
Mycobacterium terrae
Testing conducted in vitro | |
| Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K180432) | |
| Simulated-Use
Test | Meets efficacy requirement.
≥ 6 log reduction Geobacillus
stearothermophilus spores in a
manual application | Meets efficacy requirement.
≥ 6 log reduction Geobacillus
stearothermophilus spores in a
manual application | |
| Clinical In Use | No surviving microorganisms on
representative medical devices
tested | No surviving microorganisms on
representative medical devices
tested | |
| | Biocompatibility | | |
| Cytotoxicity
Device Extracts | Two rinses with UV treated, dual
0.1-micron membrane filtered water
effectively reduce sterilant residues
to safe levels. | Two rinses with UV treated, dual
0.1-micron membrane filtered water
effectively reduce sterilant residues
to safe levels. | |
| Residue
Reduction | Automatic within the SYSTEM 1E
Processor:
Two rinses with UV treated, dual
0.1-micron membrane filtered water
effectively reduce sterilant residues
to safe levels. | Automatic within the SYSTEM 1E
Processor:
Two rinses with UV treated, dual
0.1-micron membrane filtered water
effectively reduce sterilant residues
to safe levels. | |
| Device
Material
Compatibility | Compatible with medical devices as
established by testing finished
flexible endoscopes through 300
cycles and rigid devices through 150
cycles.
No functional changes have
occurred to flexible devices.
Some materials show cosmetic
changes such as fading of black
anodized aluminum without harm to
the base material. | Compatible with medical devices as
established by testing finished
flexible endoscopes through 300
cycles and rigid devices through 150
cycles.
No functional changes have
occurred to flexible devices.
Some materials show cosmetic
changes such as fading of black
anodized aluminum without harm to
the base material. | |

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.

13

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

14

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.

15

Test	Purpose	Acceptance Criteria	Result
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
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	PASS
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	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.

16

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

17

Device Name 1.

| Trade Name: | SYSTEM 1 endo Liquid Chemical Sterilant
Processing System, Model P6800 |
|------------------------|---------------------------------------------------------------------------|
| Device Class: | Class 2 |
| 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 1endo Liquid Chemical Sterilant Processing System: K173256

3. Description of Device

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

18

4. Intended Use

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 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 Device
SYSTEM 1 endo Processor, Model
P6800 | Predicate Device (K173256)
SYSTEM 1 endo Processor, Model
P6800 |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use
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 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 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. |
| | Proposed Device | Predicate Device (K173256) |
| Feature | SYSTEM 1 endo Processor, Model
P6800 | SYSTEM 1 endo Processor, Model
P6800 |
| Operating
Principles /
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.
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. 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. | 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. 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. |
| Process
Parameters | Standardized cycle parameters cannot
be altered by the operator. The
critical process parameters are:
● Use dilution contact time
● Use dilution temperature
● Peracetic acid concentration
● Bacterial retentive water filter
integrity | Standardized cycle parameters cannot
be altered by the operator. The
critical process parameters are:
● Use dilution contact time
● Use dilution temperature
● Peracetic acid concentration
● Bacterial retentive water filter
integrity |
| Process
Monitors | ● 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 | ● 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 |
| Feature | Proposed Device
SYSTEM 1 endo Processor, Model
P6800 | Predicate Device (K173256)
SYSTEM 1 endo Processor, Model
P6800 |
| Design
Features | 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 | | |
| Incoming
water temp. | ≥ 43°C | ≥ 43°C |
| Temperature
to start
sterilant
exposure | ≥ 46°C | ≥ 46°C |
| Temperature
alarm point
during LCS
exposure | 60°C | 60°C |
| Temperature
range of
typical LCS
cycle | 46-55°C | 46-55°C |
| Rinse water
preparation | 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 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 |
| Internal
water filter
integrity test | Conducted during the Diagnostic
cycle | Conducted during the Diagnostic
cycle |
| Approximate
cycle time | 18 - 20 minutes | 18 - 20 minutes |
| Feature | Proposed Device
SYSTEM 1 endo Processor, Model
P6800 | Predicate Device (K173256)
SYSTEM 1 endo Processor, Model
P6800 |
| Diagnostic
Cycle | Performs 14 tests on processor's
systems confirming proper function.

Recommended to perform each day of
use. After a failed Diagnostic cycle a
liquid chemical sterilization cycle
cannot be performed until the
problem is rectified and a successful
Diagnostic cycle has been completed. | Performs 14 tests on processor's
systems confirming proper function.

Recommended to perform each day of
use. After a failed Diagnostic cycle a
liquid chemical sterilization cycle
cannot be performed until the
problem is rectified and a successful
Diagnostic cycle has been completed. |
| Accessories | | |
| Sterilant | Uses S40 Sterilant Concentrate – See
Table 2 | Uses S40 Sterilant Concentrate – See
Table 2 |
| Processing
Trays and
Containers | Uses interchangeable processing
trays/containers Universal Flexible Processing Tray General Processing Container and Tray Directed Flow Processing Container and Tray Flexible Endoscope Processing Container and Tray Ultrasound Processing Tray | Uses interchangeable processing
trays/containers Universal Flexible Processing Tray General Processing Container and Tray Directed Flow Processing Container and Tray Flexible Endoscope Processing Container and Tray Ultrasound Processing Tray |
| Quick
Connects | Uses Quick Connects to attach
instrument lumens to the
Tray/Container ports | Uses Quick Connects to attach
instrument lumens to the
Tray/Container ports |
| Chemical
Indicator | VERIFY Chemical Indicator for S40
Sterilant (K173428) | VERIFY Chemical Indicator for S40
Sterilant (K173428) |
| Spore Test
Strip | VERIFY Spore Test Strip for S40
Sterilant (K180553) | VERIFY Spore Test Strip for S40
Sterilant (K180553) |
| Operator
Maintenance | 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

19

20

21

Table 2. S40 Sterilant Concentrate Comparison Table

| Feature | S40 Sterilant Concentrate
in S1 endo LCSPS | S40 Sterilant Concentrate
in S1 endo LCSPS (K173256) |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The SYSTEM 1E Processor uses only
S40 Sterilant Concentrate to liquid
chemically sterilize medical devices. | The SYSTEM 1E Processor uses only
S40 Sterilant Concentrate to liquid
chemically sterilize medical devices. |
| Germicidal
claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant |
| Feature | S40 Sterilant Concentrate
in S1 endo LCSPS | S40 Sterilant Concentrate
in S1 endo LCSPS (K173256) |
| Exposure Time | 6 minutes | 6 minutes |
| Use
Temperature | 45.5-60°C - allowable range
Potency and simulated use
evaluations conducted at Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Meets efficacy requirements10.
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro |
| Confirmatory
Sporicidal
Activity of
Disinfectants | Meets efficacy requirements6.
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Meets efficacy requirements6.
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro |
| Feature | S40 Sterilant Concentrate
in S1 endo LCSPS | S40 Sterilant Concentrate
in S1 endo LCSPS (K173256) |
| AOAC Official
Method 966.04 | | |
| Fungicidal
Activity of
Disinfectants
AOAC Official
Method 955.17 | Solution is fungicidal.
Trichophyton mentagrophytes
Testing conducted in vitro | Solution is fungicidal.
Trichophyton mentagrophytes
Testing conducted in vitro |
| Use Dilution
Method AOAC,
Official
Methods
955.14, 955.15,
964.02 | Solution is bactericidal.
Salmonella choleraesuis
Staphylococcus aureus
Pseudomonas aeruginosa
Testing conducted in vitro | Solution is bactericidal.
Salmonella choleraesuis
Staphylococcus aureus
Pseudomonas aeruginosa
Testing conducted in vitro |
| EPA Virucidal
Testing
(DIS/TSS-7,
Nov. 1981) | Solution is virucidal
Herpes simplex Type 1
Adenovirus Type 5
Poliovirus Type 1
Testing conducted in vitro | Solution is virucidal
Herpes simplex Type 1
Adenovirus Type 5
Poliovirus Type 1
Testing conducted in vitro |
| Tuberculocidal
Activity of
Disinfectants
AOAC Official
Method 965.12 | Not performed. A quantitative
suspension Tuberculocidal test was
conducted. | Not performed. A quantitative
suspension Tuberculocidal test was
conducted. |
| Tuberculocidal
Activity
Ascenzi
Quantitative
Suspension Test | Solution is tuberculocidal
Mycobacterium terrae
testing conducted in vitro | Solution is tuberculocidal
Mycobacterium terrae
testing conducted in vitro |
| Simulated Use | Meets efficacy requirement.

6 log ${10}$ reduction Geobacillus
stearothermophilus spores in a
manual application | Meets efficacy requirement.
6 log ${10}$ reduction Geobacillus
stearothermophilus spores in a manual
application |
| Clinical In Use | No surviving microorganisms on
representative medical devices tested | No surviving microorganisms on
representative medical devices tested |
| Cytotoxicity
Device Extracts | Two Processor controlled rinses with
prefiltered, dual 0.2 micron filtered
potable water effectively reduce
sterilant residues to non-cytotoxic
levels. | Two Processor controlled rinses with
prefiltered, dual 0.2 micron filtered
potable water effectively reduce
sterilant residues to non-cytotoxic
levels. |
| Residue
Reduction | Two Processor controlled rinses with
prefiltered, dual 0.2 micron filtered
potable water effectively reduce
sterilant residues to safe levels. | Two Processor controlled rinses with
prefiltered, dual 0.2 micron filtered
potable water effectively reduce
sterilant residues to safe levels. |
| Feature | S40 Sterilant Concentrate
in S1 endo LCSPS | S40 Sterilant Concentrate
in S1 endo LCSPS (K173256) |
| Material
Compatibility | Compatible with medical devices as
established by testing finished
medical devices through 300 cycles.
No functional changes occurred to
devices. Some materials show
cosmetic changes such as fading of
external markings (yet all remained
legible) and bleaching of black
anodized aluminum without harm to
the base material. | Compatible with medical devices as
established by testing finished medical
devices through 300 cycles. No
functional changes occurred to
devices. Some materials show
cosmetic changes such as fading of
external markings (yet all remained
legible) and bleaching of black
anodized aluminum without harm to
the base material. |

22

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

23

24

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 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
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
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	PASS

Table 3. Performance Testing

25

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.

26

Image /page/26/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a large, bold, sans-serif font. Below the word is a graphic of several horizontal, wavy lines in 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 Sterilant
Processing System, Model P6900 |
|------------------------|---------------------------------------------------------------------------|
| Device Class: | Class 2 |
| 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. K191343.

3. Description of Device

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 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. Tables 1 and 2 compare the proposed and predicate devices.

28

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
Feature	Proposed Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System, Model
P6900	Predicate Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System, Model
P6900 (K191343)
	The SYSTEM 1 endo Liquid
Chemical Sterilant Processing System
is intended for liquid chemical
sterilization of cleaned, immersible,
and reusable semi-critical heat-
sensitive medical devices and their
accessories in healthcare facilities.	The SYSTEM 1 endo Liquid
Chemical Sterilant Processing System
is intended for liquid chemical
sterilization of cleaned, immersible,
and reusable semi-critical heat-
sensitive medical devices and their
accessories in healthcare facilities.
Intended
Use
Indications
for Use	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 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. |
| Feature | Proposed Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System, Model
P6900 | Predicate Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System, Model
P6900 (K191343) |
| Operating
Principles
/
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. |
| Process
Parameters | 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 |
| Process
Monitors | SYSTEM 1 endo Liquid Chemical
Sterilant Processing System, Model
P6900
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 | SYSTEM 1 endo Liquid Chemical
Sterilant Processing System, Model
P6900 (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 |
| Design
Features | 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 | | |
| Incoming
water temp. | ≥ 43°C | ≥ 43°C |
| Feature | Proposed Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System , Model
P6900 | Predicate Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System, Model
P6900 (K191343) |
| Temperature
to start
sterilant
exposure | $\geq$ 46°C | $\geq$ 46°C |
| Temperature
alarm point
during LCS
exposure | 60°C | 60°C |
| Temperature
range of
typical LCS
cycle | 46 - 55°C | 46 - 55°C |
| Exposure
Time - S40
use dilution | 6 minutes | 6 minutes |
| Rinse water
preparation | Hot potable tap water
• is pre-filtered
• is filtered through 0.2 micron
bacterial retentive membrane
filter | Hot potable tap water
• is pre-filtered
• is filtered through 0.2 micron
bacterial retentive membrane
filter |
| 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 |
| Internal
Water Filter
Integrity
Test | Conducted during the Diagnostic
cycle | Conducted during the Diagnostic
cycle |
| Approximat
e Cycle
Time | 18 - 20 minutes | 18 - 20 minutes |
| Diagnostic
Cycle | Performs 14 tests on processor's
systems confirming proper function.
Recommended to perform each day of
use. After a failed Diagnostic cycle, a
liquid chemical sterilization cycle
cannot be performed until the
problem is rectified and a successful
Diagnostic cycle has been completed. | Performs 14 tests on processor's
systems confirming proper function.
Recommended to perform each day of
use. After a failed Diagnostic cycle, a
liquid chemical sterilization cycle
cannot be performed until the
problem is rectified and a successful
Diagnostic cycle has been completed. |
| Accessories | | |
| Sterilant | Uses S40 Sterilant Concentrate - see
Table 2 | Uses S40 Sterilant Concentrate - see
Table 2 |
| Feature | Proposed Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System , Model
P6900 | Predicate Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System, Model
P6900 (K191343) |
| Processing
Trays and
Containers | Uses interchangeable processing
trays/containers | Uses interchangeable processing
trays/containers |
| | • Universal Flex Processing Tray | • Universal Flex Processing Tray |
| | • General Processing Container &
Tray | • General Processing Container &
Tray |
| | • Directed Flow Processing
Container & Tray | • Directed Flow Processing
Container & Tray |
| | • Flexible Endoscope Processing
Container & Tray | • Flexible Endoscope Processing
Container & Tray |
| | • Ultrasound Processing Tray | • Ultrasound Processing Tray |
| Quick
Connects | Uses Quick Connects to attach
instrument lumens to the
Tray/Container ports | Uses Quick Connects to attach
instrument lumens to the
Tray/Container ports |
| Chemical
Indicator | VERIFY Chemical Indicator for S40
Sterilant (K173428) | VERIFY Chemical Indicator for S40
Sterilant (K173428) |
| Spore Test
Strip | VERIFY Spore Test Strip for S40
Sterilant (K180553) | VERIFY Spore Test Strip for S40
Sterilant (K180553) |
| Operator | Periodic replacement of water filters
and air filter. | Periodic replacement of water filters
and 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. |

Table 1. Processor Comparison Table

29

30

31

32

Table 2. S40 Sterilant Concentrate Comparison Table

| Feature | Proposed Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System ,
Model P6900 | Predicate Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System,
Model P6900 (K191343) |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The SYSTEM 1E Processor uses
only S40 Sterilant Concentrate to
liquid chemically sterilize medical
devices | The SYSTEM 1E Processor uses
only S40 Sterilant Concentrate to
liquid chemically sterilize medical
devices |
| Germicidal
claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant |
| Exposure
Time | 6 minutes | 6 minutes |
| Use
Temperature | 45.5 - 60°C - allowable range
Potency and simulated use
evaluations conducted at ≤ 43°C | 45.5 - 60°C - allowable range
Potency and simulated use
evaluations conducted at ≤ 43°C |
| Reuse | Single use | Single use |
| Human
Factors | Ready to use. Container is opened
and diluted by the processor, limiting
user exposure to the sterilant | Ready to use. Container is opened
and diluted by the processor, limiting
user exposure to the sterilant |
| Feature | Proposed Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System ,
Model P6900 | Predicate Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System,
Model P6900 (K191343) |
| | concentrate | concentrate |
| Active
Ingredient | 35% peroxyacetic (peracetic) acid
automatically diluted for use in the
Processor | 35% peroxyacetic (peracetic) acid
automatically diluted for use in the
Processor |
| | It is believed that peracetic acid
exerts its germicidal effect by
several mechanisms: | It is believed that peracetic acid
exerts its germicidal effect by
several mechanisms: |
| Mode of
Action | -oxidizing sulfhydral and sulfur
bonds in proteins and enzymes,
particularly in the cell walls 1
-hydroxyl radicals produced from
PAA are bactericidal 2
-PAA damages the viral capsid and
viral nucleic acid3,4 | -oxidizing sulfhydral and sulfur
bonds in proteins and enzymes,
particularly in the cell walls1
-hydroxyl radicals produced from
PAA are bactericidal2
-PAA damages the viral capsid and
viral nucleic acid3.4 |
| Rinses | 2 equivalent automated rinses with
pre-filtered, dual 0.2 micron
membrane filtered, potable hot water | 2 equivalent automated rinses with
pre-filtered, UV irradiated, dual 0.1
micron membrane filtered, potable
hot water |
| Sporicidal
Activity of
Disinfectants
AOAC
Official
Method
966.04 | Meets efficacy requirements5
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Meets efficacy requirements5
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro |
| Confirmatory
Sporicidal
Activity of
Disinfectants
AOAC
Official
Method
966.04 | Meets efficacy requirements5
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Meets efficacy requirements5
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro |
| Fungicidal
Activity of
Disinfectants
AOAC
Official
Method
955.17 | Solution is fungicidal
Trichophyton mentagrophytes
Testing conducted in vitro | Solution is fungicidal
Trichophyton mentagrophytes
Testing conducted in vitro |
| | Proposed Device | Predicate Device |
| Feature | SYSTEM 1 endo Liquid Chemical
Sterilant Processing System ,
Model P6900 | SYSTEM 1 endo Liquid Chemical
Sterilant Processing System,
Model P6900 (K191343) |
| Use Dilution
Method
AOAC,
Official
Methods
955.14,
955.15, 964.02 | Solution is bactericidal
Salmonella choleraesuis
Staphylococcus aureus
Pseudomonas aeruginosa
Testing conducted in vitro | Solution is bactericidal
Salmonella choleraesuis
Staphylococcus aureus
Pseudomonas aeruginosa
Testing conducted in vitro |
| EPA Virucidal
Testing
(DIS/TSS-7,
Nov. 1981) | Solution is virucidal
Herpes simplex Type 1
Adenovirus Type 5
Poliovirus Type 1
Testing conducted in vitro | Solution is virucidal
Herpes simplex Type 1
Adenovirus Type 5
Poliovirus Type 1
Testing conducted in vitro |
| Tuberculocidal
Activity of
Disinfectants
AOAC
Official
Method
965.12 | Not performed; a quantitative
suspension Tuberculocidal test was
conducted | Not performed; a quantitative
suspension Tuberculocidal test was
conducted |
| Tuberculocidal
Activity
Ascenzi
Quantitative
Suspension
Test | Solution is tuberculocidal
Mycobacterium terrae
testing conducted in vitro | Solution is tuberculocidal
Mycobacterium terrae
testing conducted in vitro |
| Simulated Use | Meets efficacy requirement.

6 log10 reduction Geobacillus
stearothermophilus spores in a
manual application. | Meets efficacy requirement.
6 log10 reduction Geobacillus
stearothermophilus spores in a
manual application. |
| Clinical In Use | No surviving microorganisms on
representative medical devices tested
in S1 endo LCSPS | No surviving microorganisms on
representative medical devices tested
in S1 endo LCSPS |
| Cytotoxicity
Device
Extracts | Two Processor controlled rinses with
pre-filtered, dual 0.2 micron filtered
potable water effectively reduce
sterilant residues to non-cytotoxic
levels. | Two Processor controlled rinses with
pre-filtered, dual 0.2 micron filtered
potable water effectively reduce
sterilant residues to non-cytotoxic
levels. |
| Residue
Reduction | Two Processor controlled rinses with
pre-filtered, dual 0.2 micron filtered
potable water effectively reduce
sterilant residues to safe levels. | Two Processor controlled rinses with
pre-filtered, dual 0.2 micron filtered
potable water effectively reduce
sterilant residues to safe levels. |
| Feature | Proposed Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System ,
Model P6900 | Predicate Device
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System,
Model P6900 (K191343) |
| Material
Compatibility | Compatible with medical devices as
established by testing finished
medical devices through 300 cycles.
No functional changes occurred to
devices. Some materials show
cosmetic changes such as fading of
external markings (yet all remained
legible) and bleaching of black
anodized aluminum without harm to
the base material. | Compatible with medical devices as
established by testing finished
medical devices through 300 cycles.
No functional changes occurred to
devices. Some materials show
cosmetic changes such as fading of
external markings (yet all remained
legible) and bleaching of black
anodized aluminum without harm to
the base material. |

33

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

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

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

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

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

34

35

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 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
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
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	PASS

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

36

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.