Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes an automated, computer-controlled sterilization system with specific physical and chemical processes. There is no mention of AI or ML in the intended use, device description, or performance studies. The modifications described are related to hardware obsolescence and chemical formulation, not software or algorithmic changes indicative of AI/ML.

Therapeutic

No
Explanation: This device is for liquid chemical sterilization of medical devices, not for treating patients or diagnosing diseases. Therefore, it is not a therapeutic device.

Diagnostic

No

The device is described as a "liquid chemical sterilization system" intended for sterilizing medical devices. Its function is to process and sterilize items, not to diagnose medical conditions or analyze patient data.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical system including a processor, sterilant concentrate, trays, containers, and quick connects. While it mentions the processor is "computer controlled and continually monitored," this indicates software is part of a larger hardware system, not a standalone software-only device.

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 in healthcare facilities. This is a process for preparing medical devices for use on or in a patient, not for performing tests on biological samples.
Device Description: The device description details a system that uses a chemical sterilant (peracetic acid) and filtered water to sterilize medical instruments. This process is focused on eliminating microorganisms from the surface and internal channels of medical devices.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (or animals) to provide information for diagnosis, monitoring, or treatment. The device does not analyze biological samples or produce diagnostic results.

The device is a medical device used for reprocessing other medical devices to ensure they are safe for patient use.

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.
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.
3.0.1 micron filtration:
- The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria. fungi and protozoa > 0.1 micron.

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

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

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

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

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

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

Product codes

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:

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

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

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

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

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

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

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

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

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

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

Obsolescence and replacement of silicone tubing
S40 Sterilant Concentrate design modification

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

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.

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)

Summary of Non-Clinical Testing:
Obsolescence and replacement of interface board and connector:
Test: Functional testing, Reliability testing, EMC/EMI and electrical safety.
Acceptance Criteria: The modification does not affect the operation of the device (Functional and Reliability). The device must meet UL 61010-1:2010 Third Edition and UL 61010-2-040:2015-7-07 (EMC/EMI and electrical safety).
Result: Pass for all tests.

Obsolescence and replacement of silicone tubing:
Test: Functional testing, Form and fit, Physical properties.
Acceptance Criteria: The modification does not affect the operation of the device (Functional). The replacement must fit within the device (Form and fit). The replacement must be equivalent to the current tubing (Physical properties).
Result: Pass for all tests.

S40 Sterilant Concentrate design modification:
Test: Stability of sterilant, Delivery of sterilant.
Acceptance Criteria: The design modification does not affect the stability of the sterilant (Stability). The design modification does not affect delivery of the sterilant (Delivery).
Result: Pass for both tests.

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

Not Found

Predicate Device(s)

K210737, K210737, K210737

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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.

September 7, 2021

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

Re: K211607

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

Dear Jennifer Nalepka:

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

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

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

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

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

Sincerely.

For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K211607

Device Name

SYSTEM 1E Liquid Chemical Sterilant Processing System

Indications for Use (Describe)

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

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

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

The extensive treatment of EPA potable water consists of:

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

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."

3

Indications for Use

510(k) Number (if known)

K211607

Device Name

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800

Indications for Use (Describe)

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

The SYSTEM 1 endo Processor 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)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

Indications for Use

510(k) Number (if known)

K211607

Device Name

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

Indications for Use (Describe)

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

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

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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 STERIS logo. The word "STERIS" is written in a serif font in all capital letters. Below the word is a graphic of several horizontal wavy lines in blue, resembling water waves. The registered trademark symbol is located to the right of the word STERIS.

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

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

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

Summary Date: September 1, 2021

Premarket Notification Number: K211607

6

1. Device Name

| 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 |

2. Predicate Device

SYSTEM 1E Liquid Chemical Sterilant Processing System, K210737

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:

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

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

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

7

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.

4. Indications for Use

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

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

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

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

ട. Technological Characteristic Comparison Table

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

8

Table 1. Processor Device Comparison Table
Feature	Proposed
SYSTEM 1E Processor	Predicate (K210737)
SYSTEM 1E Processor	Comparison
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 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.	Identical
	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. | * 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. | |
| Feature | Proposed
SYSTEM 1E Processor | Predicate (K210737)
SYSTEM 1E Processor | Comparison |
| | • 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 is filtered
through redundant, 0.1-
micron (absolute rated) | • 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
is filtered through
redundant, 0.1-micron
(absolute rated) membranes
to remove bacteria, fungi | |
| | membranes to remove
bacteria, fungi and
protozoa > 0.1 micron. | 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. | Identical |
| 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 | Identical |
| Process
Monitors | • Cycle Printout documents
successful cycle completion | • Cycle Printout documents
successful cycle completion | Identical |
| Feature | Proposed
SYSTEM 1E Processor | Predicate (K210737)
SYSTEM 1E Processor | Comparison |
| | or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates 0.1-micron water filter failed integrity test during liquid chemical sterilant processing and Diagnostic cycles. Alarms if UV monitor indicates UV intensity out of specification | or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates 0.1-micron water filter failed integrity test during liquid chemical sterilant processing and Diagnostic cycles. Alarms if UV monitor indicates UV intensity out of specification | |
| Design
Features | Microprocessor controlled unalterable and standardized liquid chemical sterilant processing and Diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron filtered, UV treated water for liquid chemical sterilant processing and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2-micron membrane air filter. | Microprocessor controlled unalterable and standardized liquid chemical sterilant processing and Diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron filtered, UV treated water for liquid chemical sterilant processing and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2-micron membrane air filter. | Identical |
| Processing Cycle | | | Comparison |
| Incoming water
temperature | ≥ 43°C | ≥ 43°C | Identical |
| Feature | Proposed
SYSTEM 1E Processor | Predicate (K210737)
SYSTEM 1E Processor | Comparison |
| Temperature to
start exposure
phase | $\geq$ 46°C | $\geq$ 46°C | Identical |
| Temperature
alarm point
during the
exposure phase | 60°C | 60°C | Identical |
| Temperature
range during a
typical Liquid
Chemical
Sterilant
Processing
Cycle | 46 - 55°C | 46 - 55°C | Identical |
| Exposure
Time | 6 minutes | 6 minutes | Identical |
| Rinse water
preparation | Hot potable tap water is:
• pre-filtered
• flowed through a UV Light
treatment chamber to
achieve $\geq$ a 6-log reduction
of virus
• Filtered through redundant
0.1-micron filter
membranes | Hot potable tap water is:
• pre-filtered
• flowed through a UV Light
treatment chamber to
achieve $\geq$ a 6-log reduction
of virus
• Filtered through redundant
0.1-micron filter
membranes | Identical |
| Number of
rinses | 2 | 2 | Identical |
| Air Purge | Aids in removing excess water
from instrument lumens after
rinsing | Aids in removing excess water
from instrument lumens after
rinsing | Identical |
| 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 | Identical |
| Approximate
Cycle time | 25 minutes | 25 minutes | Identical |
| 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. | Identical |
| Interchangeable Components | | | |
| Feature | Proposed
SYSTEM 1E Processor | Predicate (K210737)
SYSTEM 1E Processor | Comparison |
| 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) | Identical |
| | Accessories | | |
| Sterilant
Concentrate | Uses S40 Sterilant Concentrate | Uses S40 Sterilant Concentrate | Identical |
| 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 | Identical |
| Chemical
Indicator | VERIFY Chemical Indicator for
the S40 Sterilant Concentrate | VERIFY Chemical Indicator for
the S40 Sterilant Concentrate | Identical |
| Spore Test
Strip | VERIFY Spore Test Strip for
S40 Sterilant Concentrate | VERIFY Spore Test Strip for
S40 Sterilant Concentrate | Identical |
| Operator
Maintenance
Requirements | Periodic replacement of printer
tape, water filters and air filter | Periodic replacement of printer
tape, water filters and air filter | Identical |

Table 1. Processor Device Comparison Table

9

10

11

12

Table 2. S40 Sterilant Concentrate Device Comparison Table

| Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K210737) | Comparison |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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. | Identical |
| Germicidal
claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant | Identical |
| Germicide
Exposure
Time (min) for
intended use | 6 | 6 | Identical |
| Use
Temperature | 45.5-60°C – allowable
46-55°C - typical
Potency and simulated use
evaluations conducted at 1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.

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

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

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

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

14

15

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

Summary of Non-Clinical Testing 6.

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

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

Table 3. Summary of verification activities.

7. Conclusion

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

16

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

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

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

Contact:

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

Summary Date: September 1, 2021

Premarket Notification Number: K211607

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

17

1. Device Name

| Trade Name: | SYSTEM 1 endo Liquid Chemical 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, Model P6800, K210737

3. Description of Device

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

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

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

18

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

Intended Use 4.

The SYSTEM 1 endo 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 45.5 to 55°C, and rinses the load with 0.2 micron filtered potable water.

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

5. Description of Technological Similarities and Differences

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

| Feature | Proposed Device
SYSTEM 1 endo Processor,
Model P6800 | Predicate Device (K210737)
SYSTEM 1 endo Processor,
Model P6800 | Comparison |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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 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. | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Processor,
Model P6800 | Predicate Device (K210737)
SYSTEM 1 endo Processor,
Model P6800 | Comparison |
| | The SYSTEM 1 endo Processor
uses only S40 Sterilant
Concentrate to liquid chemically
sterilize medical devices. | The SYSTEM 1 endo Processor
uses only S40 Sterilant
Concentrate to liquid chemically
sterilize medical devices. | |
| 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
| Identical |
| 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 | Identical |
| 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 | • 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 | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Processor,
Model P6800 | Predicate Device (K210737)
SYSTEM 1 endo Processor,
Model P6800 | Comparison |
| | Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic cycle Alarms if pressure transducer indicates internal water filter failed integrity test | Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic cycle Alarms if pressure transducer indicates internal water filter failed integrity test | |
| 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 | Identical |
| Cycle Parameters | | | |
| Incoming
water temp. | ≥ 43°C | ≥ 43°C | Identical |
| Temperature
to start
sterilant
exposure | ≥ 46°C | ≥ 46°C | Identical |
| Temperature
alarm point
during LCS
exposure | 60°C | 60°C | Identical |
| Temperature
range of
typical LCS
cycle | 46-55°C | 46-55°C | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Processor,
Model P6800 | Predicate Device (K210737)
SYSTEM 1 endo Processor,
Model P6800 | Comparison |
| 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 | Identical |
| Number of
rinses | 2 | 2 | Identical |
| Air Purge | Aids in removing excess water
from instrument lumens after
rinsing | Aids in removing excess water
from instrument lumens after
rinsing | Identical |
| Internal water
filter integrity
test | Conducted during the Diagnostic
cycle | Conducted during the Diagnostic
cycle | Identical |
| Approximate
cycle time | 18 – 20 minutes | 18 – 20 minutes | Identical |
| 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. | Identical |
| Accessories | | | |
| Sterilant | Uses S40 Sterilant Concentrate –
See Table 2 | Uses S40 Sterilant Concentrate –
See Table 2 | Identical |
| 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 | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Processor,
Model P6800 | Predicate Device (K210737)
SYSTEM 1 endo Processor,
Model P6800 | Comparison |
| 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 | Identical |
| Chemical
Indicator | VERIFY Chemical Indicator for
S40 Sterilant is available for use
in SYSTEM 1 endo LCSPS | VERIFY Chemical Indicator for
S40 Sterilant is available for use
in SYSTEM 1 endo LCSPS | Identical |
| Spore Test
Strip | VERIFY Spore Test Strip for
S40 Sterilant for use in SYSTEM
1 endo LCSPS | VERIFY Spore Test Strip for S40
Sterilant for use in SYSTEM 1
endo LCSPS | Identical |
| Operator
Maintenance | Periodic replacement of printer
tape, water filters and air filter | Periodic replacement of printer
tape, water filters and air filter | Identical |

Table 1. Processor Comparison Table

19

20

21

22

Table 2. S40 Sterilant Concentrate Comparison Table

| Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K210737) | Comparison |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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. | Identical |
| Germicidal
claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant | Identical |
| Germicide
Exposure
Time (min) for
intended use | 6 | 6 | Identical |
| Use
Temperature | 45.5-60°C – allowable
46-55°C - typical
Potency and simulated use
evaluations conducted at Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Meets efficacy requirements5.
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Identical |
| Confirmatory
Sporicidal
Activity of
Disinfectants
AOAC
Official
Method 966.04 | Meets efficacy requirements6.
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Meets efficacy requirements 6.
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Identical |
| 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 | Identical |
| 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 | Identical |
| Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K210737) | Comparison |
| 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 | Identical |
| Tuberculocidal
Activity
Ascenzi
Quantitative
Suspension
Test | Solution is tuberculocidal
Mycobacterium terrae
Testing conducted in vitro | Solution is tuberculocidal
Mycobacterium terrae
Testing conducted in vitro | Identical |
| 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 | Identical |
| Clinical In-
Use | No surviving microorganisms
on representative medical
devices tested | No surviving microorganisms on
representative medical devices
tested | Identical |
| 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. | Identical |
| 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. | Identical |
| 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. | Identical |

23

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

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

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

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

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

24

6. Description of Safety and Substantial Equivalence

25

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

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

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

Table 3. Performance Testing

7. Conclusion

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

26

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

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

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

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

Summary Date: September 1, 2021

Premarket Notification Number: K211607

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

27

1. Device Name

| Trade Name: | SYSTEM 1 endo Liquid Chemical 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, K210737.

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 for:

Obsolescence and replacement of silicone tubing
S40 Sterilant Concentrate design modification

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

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

28

4. Indications for Use

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

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

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

5. Technological Characteristic Comparison Table

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

| 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
(K210737) | Comparison |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 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 heat-sensitive medical
devices and their accessories in
healthcare facilities.
The SYSTEM 1 endo Processor
automatically dilutes the S40
Sterilant Concentrate to its use
dilution (> 1820 mg/L peracetic
acid), liquid chemically sterilizes
the load during a controlled 6-
minute exposure at 45.5 to 60°C,
and rinses the load with 0.2
micron filtered water.
The SYSTEM 1 endo Processor
uses only S40 Sterilant | 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 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 | Identical |
| 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
(K210737) | Comparison |
| | Concentrate to liquid chemically
sterilize medical devices. | Concentrate to liquid chemically
sterilize medical devices. | |
| 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. | Identical |
| 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) | Identical |
| 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 | • 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 | Identical |
| 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
(K210737) | Comparison |
| Design
Features | • Alarms if conductivity probe
indicated conductivity
specification not met
• Alarms if pressure transducer
indicates circulation pressure
is out of specification in
Diagnostic cycle
• Alarms if pressure transducer
indicates internal water filter
failed integrity test
• Microprocessor controlled
unalterable and standardized
liquid chemical sterilization
and Diagnostic cycles
• Intended for use only with
S40 Sterilant Concentrate
• Automated dilution and
delivery of S40 Sterilant
• Processor provides 0.2 micron
filtered water for liquid
chemical 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 | • Alarms if conductivity probe
indicated conductivity
specification not met
• Alarms if pressure transducer
indicates circulation pressure
is out of specification in
Diagnostic cycle
• Alarms if pressure transducer
indicates internal water filter
failed integrity test
• Microprocessor controlled
unalterable and standardized
liquid chemical sterilization
and Diagnostic cycles
• Intended for use only with
S40 Sterilant Concentrate
• Automated dilution and
delivery of S40 Sterilant
• Processor provides 0.2 micron
filtered water for liquid
chemical 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 | Identical |
| Cycle Parameters | | | |
| Incoming
water temp. | ≥ 43°C | ≥ 43°C | Identical |
| Temperature
to start
sterilant
exposure | ≥ 46°C | ≥ 46°C | Identical |
| Temperature
alarm point
during LCS
exposure | 60°C | 60°C | Identical |
| Temperature | 46 - 55°C | 46 - 55°C | Identical |
| 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
(K210737) | Comparison |
| range of
typical LCS
cycle | | | |
| Exposure
Time - S40
use dilution | 6 minutes | 6 minutes | Identical |
| 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 | Identical |
| Number of
rinses | 2 | 2 | Identical |
| Air Purge | Aids in removing excess water
from instrument lumens after
rinsing | Aids in removing excess water
from instrument lumens after
rinsing | Identical |
| Internal
Water Filter
Integrity Test | Conducted during the Diagnostic
cycle | Conducted during the Diagnostic
cycle | Identical |
| Approximate
Cycle Time | 18 - 20 minutes | 18 - 20 minutes | Identical |
| 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. | Identical |
| Accessories | | | |
| Sterilant | Uses S40 Sterilant Concentrate | Uses S40 Sterilant Concentrate | Identical |
| Processing
Trays and
Containers | Uses interchangeable processing
trays/containers
• Universal Flex Processing Tray
• General Processing Container
& Tray
• Directed Flow Processing
Container & Tray
• Flexible Endoscope Processing
Container & Tray
• Ultrasound Processing Tray | Uses interchangeable processing
trays/containers
• Universal Flex Processing Tray
• General Processing Container
& Tray
• Directed Flow Processing
Container & Tray
• Flexible Endoscope Processing
Container & Tray
• Ultrasound Processing Tray | Identical |
| Quick | Uses Quick Connects to attach | Uses Quick Connects to attach | Identical |
| 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
(K210737) | Comparison |
| | Tray/Container ports | Tray/Container ports | |
| Chemical
Indicator | VERIFY Chemical Indicator for
S40 Sterilant is available for use
in SYSTEM 1 endo LCSPS | VERIFY Chemical Indicator for
S40 Sterilant is available for use
in SYSTEM 1 endo LCSPS | Identical |
| | Spore Test
Strip | VERIFY Spore Test Strip for S40
Sterilant for use in SYSTEM 1
endo LCSPS | VERIFY Spore Test Strip for S40
Sterilant for use in SYSTEM 1
endo LCSPS |
| Operator
Maintenance | | Periodic replacement of water
filters and air filter.
Periodic replacement of printer
tape, if using the external printer
option. | Periodic replacement of water
filters and air filter.
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
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K210737) | Comparison |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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. | Identical |
| Germicidal
claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant | Identical |
| Germicide
Exposure
Time (min) for
intended use | 6 | 6 | Identical |
| Use
Temperature | 45.5-60°C – allowable
46-55°C - typical
Potency and simulated use
evaluations conducted at 1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.

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

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

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

34

| Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K210737) | Comparison | | |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|--|
| Activity
Ascenzi
Quantitative
Suspension
Test | Mycobacterium terrae
Testing conducted in vitro | Mycobacterium terrae
Testing conducted in vitro | Identical | | |
| 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 | Identical | | |
| Clinical In-
Use | No surviving microorganisms
on representative medical
devices tested | No surviving microorganisms on
representative medical devices
tested | Identical | | |
| 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. | Identical | | |
| 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. | Identical | | |
| 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. | Identical | | |

6. Description of Safety and Substantial Equivalence

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

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.

35

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

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