(14 days)
Not Found
No
The description focuses on the chemical sterilization process, water filtration, and automated control of the system. There is no mention of AI or ML being used for decision-making, image analysis, or any other function. The "computer controlled and continually monitored" aspect refers to standard automation and process control, not AI/ML.
No
This device is a sterilizer for medical devices, not a device used for treating patients.
No
The device is a liquid chemical sterilant processing system, used for sterilizing medical devices. It does not perform any diagnostic functions.
No
The device description clearly outlines a physical system including a processor, sterilant concentrate, trays/containers, and quick connects, indicating it is a hardware device with integrated software control.
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, not for performing diagnostic tests on biological samples.
- Device Description: The device description details a system for sterilizing medical instruments using a chemical sterilant and filtered water. It does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
- 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 or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Reagents or kits for diagnostic testing
The device is a medical device used in a healthcare setting for the reprocessing of other medical devices.
N/A
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 SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution(> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable sensitive medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60% and rinses the load with 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
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 a modifications for the obsolescence of the support material in the pre-filters.
The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe a modifications for the obsolescence of the support material in the pre-filters.
The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Ouick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System. Model P6900 is a liguid chemical sterilization system, utilizing peracetic acid to process totally immersible semicritical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe a modifications for the obsolescence of the support material in the pre-filters.
The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.
The 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)
Performance testing with replacement pre-filters was conducted, and the result was 'Pass', indicating the modification does not affect the performance of the device.
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.
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 3, 2023
STERIS Corporation Jennifer Nalepka Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K232914
Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: September 19, 2023 Received: September 19, 2023
Dear Jennifer Nalepka:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
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:
-
- 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 > or equal to 6-log reduction of MS2 virus is delivered to the water.
- 3.0.1 micron filtration:
- · The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria. fungi and protozoa > 0.1 micron.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K232914
Device Name
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800
Indications for Use (Describe)
The SYSTEM 1 endo 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."
5
Indications for Use
510(k) Number (if known)
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% 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."
6
Image /page/6/Picture/1 description: The image shows the logo for STERIS. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue.
510(k) Summary For K232914 SYSTEM 1E Liquid Chemical Sterilant Processing System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600
Contact: Jennifer Nalepka Manager, Regulatory Affairs Tel: 440-392-7458
October 2, 2023 Summary Date:
Premarket Notification: K232914
7
Device Name 1.
| Trade Name: | SYSTEM 1E Liquid Chemical Sterilant 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, K222615
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 a modifications for the obsolescence of the support material in the pre-filters.
The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.
8
4. Indications for Use
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semicritical heat-sensitive medical devices in healthcare facilities.
The SYSTEM 1E Processor 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:
-
- 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 is filtered ● through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
-
5. Technological Characteristic Comparison Table
The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device with the exception of the proposed modification. A comparison between the proposed and predicate devices is included in Table 1 and Table 2.
| Feature | Proposed
SYSTEM 1E Processor | Predicate (K222615)
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 | 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 | Identical | | | | | | |
| Feature | Proposed | Predicate (K222615) | Comparison | | | | | | |
| | SYSTEM 1E Processor | SYSTEM 1E Processor | | | | | | | |
| | medical devices in healthcare
facilities. | medical devices in healthcare
facilities. | | | | | | | |
| | The SYSTEM 1E Processor | The SYSTEM 1E Processor | | | | | | | |
| | dilutes the S40 Sterilant | dilutes the S40 Sterilant | | | | | | | |
| | Concentrate to its use dilution | Concentrate to its use dilution | | | | | | | |
| | (>1820 mg/L peracetic acid), | (>1820 mg/L peracetic acid), | | | | | | | |
| | liquid chemically sterilizes the | liquid chemically sterilizes the | | | | | | | |
| | load during a controlled 6-minute | load during a controlled 6-minute | | | | | | | |
| | exposure at 45.5 to 60°C, and | exposure at 45.5 to 60°C, and | | | | | | | |
| | rinses the load with extensively | rinses the load with extensively | | | | | | | |
| | treated* potable water. After | treated* potable water. After | | | | | | | |
| | completion of a cycle, critical | completion of a cycle, critical | | | | | | | |
| | devices should be used | devices should be used | | | | | | | |
| | immediately; semi-critical | immediately; semi-critical | | | | | | | |
| | devices should be used | devices should be used | | | | | | | |
| | immediately or may be handled
and stored in a manner similar to | immediately or may be handled
and stored in a manner similar to | | | | | | | |
| | that of high level disinfected | that of high level disinfected | | | | | | | |
| | endoscopes. Critical devices not | endoscopes. Critical devices not | | | | | | | |
| | used immediately should be | used immediately should be | | | | | | | |
| | processed again before use. | processed again before use. | | | | | | | |
| | The SYSTEM 1E Processor uses | The SYSTEM 1E Processor uses | | | | | | | |
| | only S40 Sterilant Concentrate to | only S40 Sterilant Concentrate to | | | | | | | |
| | liquid chemically sterilize medical
devices. | liquid chemically sterilize medical
devices. | | | | | | | |
| | | | | | | | | | |
| | * The extensive treatment of EPA | * The extensive treatment of EPA | | | | | | | |
| | potable water consists of: | potable water consists of: | | | | | | | |
| | 1. Pre-filtration through two
pre-filters: | 1. Pre-filtration through two pre-
filters: | | | | | | | |
| | • Pre-filter A is a gross | • Pre-filter A is a gross depth | | | | | | | |
| | depth filter that removes | filter that removes | | | | | | | |
| | approximately 2.5 micron | approximately 2.5 micron or | | | | | | | |
| | or larger | larger | | | | | | | |
| | particles/contaminants. | particles/contaminants. | | | | | | | |
| | • Pre-filter B is a surface | • Pre-filter B is a surface filter | | | | | | | |
| | filter that removes
particles/contaminants > | filter that removes | | | | | | | |
| | 0.1 micron. | particles/contaminants >
0.1 micron.
2. UV Irradiation: | | | | | | | |
| | 2. UV Irradiation: | • During transit through the | | | | | | | |
| | • During transit through the | UV water treatment | | | | | | | |
| | UV water treatment | chamber, a UV dose | | | | | | | |
| | chamber, a UV dose | sufficient to achieve a > 6- | | | | | | | |
| | sufficient to achieve a > 6- | log reduction of MS2 virus is | | | | | | | |
| | log reduction of MS2 virus is | | | | | | | | |
| Feature | Proposed
SYSTEM 1E Processor | Predicate (K222615)
SYSTEM 1E Processor | Comparison | | | | | | |
| Operating
Principles/
Technology | delivered to the water.
3. 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. | delivered to the water.
3. 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. | Identical | | | | | | |
| | 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 | Identical | | | | |
| | | Process
Monitors | | • Cycle Printout documents
successful cycle completion
or identifies fault if cycle
aborts
• Alarms if thermocouples
indicate temperature out of
specification | | • Cycle Printout documents
successful cycle completion
or identifies fault if cycle
aborts
• Alarms if thermocouples
indicate temperature out of
specification | Identical | | |
| | | | | Feature | | Proposed | | Predicate (K222615) | Comparison |
| | | | | | | SYSTEM 1E Processor | | SYSTEM 1E Processor | |
| | | | | | | indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates 0.1-micron water filter failed integrity test during liquid chemical sterilant processing and Diagnostic cycles. Alarms if UV monitor indicates UV intensity out of specification | | indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates 0.1-micron water filter failed integrity test during liquid chemical sterilant processing and Diagnostic cycles. Alarms if UV monitor indicates UV intensity out of specification | |
| | 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 | $\geq 43°C$ | | $\geq 43°C$ | Identical | | | | |
| Temperature
to start
exposure | $\geq 46°C$ | $\geq 46°C$ | Identical | | | | | | |
| Feature | Proposed
SYSTEM 1E Processor | Predicate (K222615)
SYSTEM 1E Processor | Comparison | | | | | | |
| 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 and the
proposed filters have a
new support material.
• flowed through a UV Light
treatment chamber to
achieve ≥ 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 ≥ a 6-log reduction
of virus
• Filtered through redundant
0.1-micron filter membranes | Similar -
function and
biocompatibility
of pre-filter is
unchanged. | | | | | | |
| 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 | 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 | Identical | | | | | | |
| Feature | Proposed
SYSTEM 1E Processor | Predicate (K222615)
SYSTEM 1E Processor | Comparison | | | | | | |
| 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) | 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
13
Table 2. S40 Sterilant Concentrate Device Comparison Table
| Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K211607) | 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 = 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 | Compatible with medical
devices as established by testing
finished flexible endoscopes
through 300 cycles and rigid
devices through 150 cycles. | Identical |
| Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K211607) | Comparison |
| | 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. | 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. | |
14
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.
2 Clapp et al., Free Rad. Res., (1994) 21:147-167.
3 Maillard et. al., J. Med. Microbiol (1995) 42:415-420.
4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554.
5 McDonnell et al., J. AOAC International (2000) 83:269-276.
15
16
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
The proposed device and its predicate have identical intended use and technological characteristics. New testing was performed to evaluate the modified device and the results are summarized in Table 3.
Summary of Non-Clinical Testing 6.
Shown in Table 3 is the new testing that was performed to evaluate the modified device.
Table 3. Summary of verification activities.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Performance testing with | ||
| replacement pre-filters | The modification does not affect the | |
| performance of the device. | Pass |
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K222615), Class II (21 CFR 880.6885), product code MED.
17
Image /page/17/Picture/1 description: The image shows the STERIS logo. The word "STERIS" is written in a serif font in all caps. A registered trademark symbol is to the right of the word. Below the word is a graphic of several horizontal wavy lines in blue.
510(k) Summary For K232914 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600
Contact:
Jennifer Nalepka Manager, Regulatory Affairs Tel: 440-392-7458
Summary Date: October 2, 2023
Premarket Notification: K232914
18
Device Name 1.
| Trade Name: | SYSTEM 1 endo Liquid Chemical 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, K222615
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 a modifications for the obsolescence of the support material in the pre-filters.
The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Ouick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Table 1 compares the proposed and predicate devices.
19
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 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 60°C, and rinses the load with 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
ട്. Description of Technological Similarities and Differences
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is identical to the predicate device with the exception of the proposed modification. A comparison between the proposed and predicate devices is included in Table 1 and Table 2. Since there are no technological differences between the proposed and predicate devices, there are no new concerns of safety and effectiveness.
| Feature | Proposed Device
SYSTEM 1 endo Processor,
Model P6800 | Predicate Device
SYSTEM 1 endo Processor,
Model P6800
(K222615) | 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 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 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 Processor,
Model P6800 | Predicate Device
SYSTEM 1 endo Processor,
Model P6800
(K222615) | 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 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 | ● Cycle Printout documents
successful cycle completion
or identifies fault if cycle
aborts
● Alarms if thermocouples
indicate temperature out of
specification | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Processor,
Model P6800 | Predicate Device
SYSTEM 1 endo Processor,
Model P6800
(K222615) | Comparison |
| | Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic cycle Alarms if pressure transducer indicates internal water filter failed integrity test | Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic cycle Alarms if pressure transducer indicates internal water filter failed integrity test | |
| 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 | | | Comparison |
| Incoming
water temp. | $\geq$ 43°C | $\geq$ 43°C | Identical |
| Temperature
to start
sterilant
exposure | $\geq$ 46°C | $\geq$ 46°C | Identical |
| Temperature
alarm point | 60°C | 60°C | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Processor,
Model P6800 | Predicate Device
SYSTEM 1 endo Processor,
Model P6800
(K222615) | Comparison |
| during LCS
exposure | | | |
| Temperature
range of
typical LCS
cycle | 46-55°C | 46-55°C | Identical |
| Rinse water
preparation | Hot potable water
is pre-filtered and the proposed filters have a new support material.is filtered through 0.2 micron bacterial retentive filter | Hot potable water
is pre-filteredis filtered through 0.2 micron bacterial retentive filter | Similar -
function and
biocompatibility
of pre-filter is
unchanged. |
| 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 | | | Comparison |
| 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 | Uses interchangeable processing
trays/containers | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Processor,
Model P6800 | Predicate Device
SYSTEM 1 endo Processor,
Model P6800
(K222615) | Comparison |
| | Universal Flexible Processing Tray General Processing Container and Tray Directed Flow Processing Container and Tray Flexible Endoscope Processing Container and Tray Ultrasound Processing Tray | Universal Flexible Processing Tray General Processing Container and Tray Directed Flow Processing Container and Tray Flexible Endoscope Processing Container and Tray Ultrasound Processing Tray | |
| 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
20
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800,
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
21
SYSTEM 1E Liquid Chemical Sterilant Processing System,
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800,
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
22
SYSTEM 1E Liquid Chemical Sterilant Processing System,
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800,
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
23
SYSTEM 1E Liquid Chemical Sterilant Processing System,
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800,
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
Table 2. S40 Sterilant Concentrate Comparison Table
| Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K211607) | 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.
25
SYSTEM 1E Liquid Chemical Sterilant Processing System,
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800,
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 Predicate Device Proposed Device S40 Sterilant Concentrate Comparison Feature S40 Sterilant Concentrate (K211607) Official Method 955.17 Use Dilution Solution is bactericidal. Solution is bactericidal. Method AOAC. Salmonella choleraesuis Salmonella choleraesuis Official Staphylococcus aureus Staphylococcus aureus Identical Methods Pseudomonas aeruginosa Pseudomonas aeruginosa 955.14. 955.15. Testing conducted in vitro Testing conducted in vitro 964.02 Solution is viricidal. Solution is viricidal. EPA Viricidal Herpes simplex Type 1 Herpes simplex Type 1 Testing Adenovirus Type 5 Adenovirus Type 5 Identical (DIS/TSS-7, Poliovirus Type 1 Poliovirus Type 1 Nov. 1981) Testing conducted in vitro Testing conducted in vitro Tuberculocidal Solution is tuberculocidal Solution is tuberculocidal Activity Ascenzi Mycobacterium terrae Mycobacterium terrae Identical Ouantitative Testing conducted in vitro Testing conducted in vitro Suspension Test Meets efficacy requirement. Meets efficacy requirement. Simulated-Use > 6 log reduction Geobacillus > 6 log reduction Geobacillus Identical Test stearothermophilus spores in a stearothermophilus spores in a manual application manual application No surviving microorganisms No surviving microorganisms on Clinical Inon representative medical representative medical devices Identical Use devices tested tested Biocompatibility Two rinses with UV treated, Two rinses with UV treated, dual
26
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
| Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K211607) | Comparison |
|---------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------|
| | No functional changes have
occurred to flexible devices. | 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. | Some materials show cosmetic
changes such as fading of black
anodized aluminum without
harm to the base material. | |
6. Summary of Non-Clinical Testing
Shown in Table 3 is the new testing that was performed to evaluate the modified device.
Table 3. Summary of verification activities
| Test | Acceptance Criteria | Result |
|---|---|---|
| Performance testing with | ||
| replacement prefilters | The modification does not affect the | |
| performance of the device. | Pass |
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs at least as well as or better than the legally marketed predicate device (K222615), Class II (21 CFR 880.6885), product code MED.
27
Image /page/27/Picture/1 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a serif font, with the "R" having a registered trademark symbol next to it. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water or sound waves.
510(k) Summary For K232914 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600
Contact:
Jennifer Nalepka Manager, Regulatory Affairs Tel: 440-392-7458
October 2, 2023 Summary Date:
Premarket Notification: K232914
28
Device Name Trade Name: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 Class 2 Device Class: Common/usual Name: Liquid Chemical Sterilizer Classification Name: Sterilant, Medical devices, Liquid Chemical Sterilants/Disinfectants Classification Number: 21 CFR 880.6885 Product Code: MED
2. Predicate Device
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, K222615
3. Description of Device
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System. Model P6900 is a liguid chemical sterilization system, utilizing peracetic acid to process totally immersible semicritical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe a modifications for the obsolescence of the support material in the pre-filters.
The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.
The 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.
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4. Indications for Use
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heatsensitive medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
ನ. Technological Characteristic Comparison Table
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System (LCSPS) is the same as the predicate device with the exception of the proposed modification. A comparison between the proposed and predicate devices can be found in Table 1 and Table 2 below. Since there are no technological differences between the proposed and predicate devices, there are no new concerns of safety and effectiveness.
| 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
(K222615) | Comparison |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| | 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 | 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 | Identical |
| | uses only S40 Sterilant
Concentrate to liquid chemically
sterilize medical devices. | 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
(K222615) | Comparison |
| 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
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 Liquid
Chemical Sterilant Processing
System, Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K222615) | 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 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 | Identical |
| Cycle Parameters | | | Comparison |
| Incoming
water temp. | $\geq 43°C$ | $\geq 43°C$ | Identical |
| Temperature
to start
sterilant
exposure | $\geq 46°C$ | $\geq 46°C$ | Identical |
| Temperature
alarm point
during LCS
exposure | $ 60°C$ | $ 60°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
(K222615) | Comparison |
| Temperature
range of
typical LCS
cycle | 46 - 55°C | 46 - 55°C | Identical |
| Exposure
Time - S40
use dilution | 6 minutes | 6 minutes | Identical |
| Rinse water
preparation | Hot potable tap water
• is pre-filtered and the
proposed filters have a new
support material.
• 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 | Similar - function
and
biocompatibility
of pre-filter is
unchanged. |
| 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 | | Comparison |
| 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 | Uses interchangeable processing
trays/containers
• Universal Flex Processing Tray
• General Processing Container
& Tray
• Directed Flow Processing | 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
(K222615) | Comparison |
| | • Flexible Endoscope Processing
Container & Tray
• Ultrasound Processing Tray | • Flexible Endoscope Processing
Container & 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 | 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 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 | Identical |
Table 1. Processor Comparison Table
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STERIS SPECIAL 510(k) PREMARKET NOTIFICATION SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
Table 2. S40 Sterilant Concentrate Comparison Table
| Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K222615) | 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.
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STERIS SPECIAL 510(k) PREMARKET NOTIFICATION SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
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Summary of Non-Clinical testing 6.
Shown in Table 3 is the new testing that was performed to evaluate the modified device.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Performance testing with | ||
| replacement prefilters | The modification does not affect the | |
| performance of the device. | 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 as or better than the legally marketed predicate device (K222615), Class II (21 CFR 880.6885), product code MED.