(59 days)
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 in the intended use, device description, or performance studies.
No.
The device is a sterilizing system for medical devices, not a device used for therapy.
No
Explanation: The device is a sterilization system used to clean medical devices. It does not diagnose any conditions or diseases.
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.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for the liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices. This is a process for disinfecting and sterilizing medical instruments, not for performing diagnostic tests on biological samples.
- Device Description: The description details a system that uses a chemical sterilant (peracetic acid) and treated water to process medical devices. It describes the mechanics of the system and the chemical used, all related to sterilization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. There are no mentions of analyzing biological samples, detecting analytes, or providing diagnostic results.
The device is a medical device used for reprocessing other medical devices, specifically for sterilization. This falls under a different regulatory category than In Vitro Diagnostics.
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 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 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 device was originally cleared under K090036. Seven Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying the Indications for Use. The current submission is provided to describe the addition of a second supplier for a proprietary component of S40 Sterilant Concentrate.
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 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 the addition of a second supplier for of a proprietary component of S40 Sterilant Concentrate.
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)
The submission includes non-clinical performance data from biocompatibility and stability testing for the S40 Sterilant Concentrate with an alternate source of a proprietary component.
Biocompatibility of S40 Sterilant Concentrate with alternate source of a proprietary component: Medical devices shall be non-cytotoxic after exposure to S40 Sterilant Concentrate containing the alternate source of a proprietary component. Result: Pass.
Stability of S40 Sterilant Concentrate with alternate source of a proprietary component: S40 Sterilant Concentrate shall meet acceptance criteria after 6-months of storage. Result: Pass.
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.
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 contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
March 22, 2019
Steris Corporations Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K190104
Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: March 5, 2019 Received: March 6, 2019
Dear Jennifer Nalepka:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare 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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190104
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.
2. UV Irradiation:
- During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
-
- 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)
IX 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) K190104
Device Name
SYSTEM 1 endo Liquid Chemical Sterilant Processing System
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 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 Concentrate to liquid chemically sterilize medical devices.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is written in a serif font in black. Below the word is a graphic of several horizontal wavy lines in blue. The registered trademark symbol is in the upper right corner of the logo.
510(k) Summary For SYSTEM 1E Liquid Chemical Sterilant Processing System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
Contact: Jennifer Nalepka Senior Regulatory Affairs Specialist Tel: 440-392-7458 Fax: 440-357-9198
Summary Date: March 5, 2019
Premarket Notification Number: K190104
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
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 |
Predicate Device 2.
SYSTEM 1E Liquid Chemical Sterilant Processing System, K180342
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 device was originally cleared under K090036. Seven Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying the Indications for Use. The current submission is provided to describe the addition of a second supplier for a proprietary component of S40 Sterilant Concentrate.
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.
6
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.
Indications for Use 4.
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.
-
7
5. Technological Characteristic Comparison Table
The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device; the specific modification described in this submission is for an alternate supplier for a component of S40 Sterilant Concentrate. The differences between the proposed and predicate devices are limited to the addition of an alternate supplier for a proprietary component of S40 Sterilant Concentrate.
There were no changes to the SYSTEM 1E Processor.
| Feature | Proposed Device
SYSTEM 1E Processor | Predicate Device
SYSTEM 1E Processor
(K180432) | 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 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 | 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 | Identical | | | | | | | |
| | Concentrate to liquid
chemically sterilize medical | Concentrate to liquid
chemically sterilize medical | | | | | | | | |
| Feature | Proposed Device
SYSTEM 1E Processor | Predicate Device
SYSTEM 1E Processor
(K180432) | Comparison | | | | | | | |
| | devices. | devices. | | | | | | | | |
| | * The extensive treatment of
EPA potable water consists
of:
- Pre-filtration through
two pre-filters:
• Pre-filter A is a gross
depth filter that
removes
approximately 2.5
micron or larger
particles/contaminants.
• Pre-filter B is a surface
filter that removes
particles/contaminants
0.1 micron.
- UV Irradiation:
• During transit through
the UV water
treatment chamber, a
UV dose sufficient to
achieve a ≥ 6-log
reduction of MS2 virus | * 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 | is delivered to the | | | | | | | | |
| | water. | water. | | | | | | | | |
| | 3.
0.1-micron | 3.
0.1-micron | | | | | | | | |
| | filtration: | filtration: | | | | | | | | |
| | • The water prepared by | • The water prepared by | | | | | | | | |
| | pre-filtration and UV
irradiation is filtered | pre-filtration and UV
irradiation is filtered | | | | | | | | |
| | through redundant, | through redundant, | | | | | | | | |
| | 0.1-micron (absolute | 0.1-micron (absolute | | | | | | | | |
| | rated) membranes to | rated) membranes to | | | | | | | | |
| | remove bacteria, fungi | remove bacteria, fungi | | | | | | | | |
| | and protozoa > 0.1 | and protozoa > 0.1 | | | | | | | | |
| | micron. | micron. | | | | | | | | |
| Feature | Proposed Device
SYSTEM 1E Processor | Predicate Device
SYSTEM 1E Processor
(K180432) | 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.
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 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 1E Processor | Predicate Device
SYSTEM 1E Processor
(K180432) | Comparison | | | | | | | |
| | 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 | 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 | | | | | | | | | | |
| Incoming
water
temperature | $\geq 43°C$ | $\geq 43°C$ | Identical | | | | | | | |
| Temperature
to start
exposure | $\geq 46°C$ | $\geq 46°C$ | Identical | | | | | | | |
| Feature | Proposed Device
SYSTEM 1E Processor | Predicate Device
SYSTEM 1E Processor
(K180432) | Comparison | | | | | | | |
| phase | | | | | | | | | | |
| 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 ≥ a 6-log
reduction of virusFiltered 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 virusFiltered 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 | | | | | | | |
| Feature | Proposed Device
SYSTEM 1E Processor | Predicate Device
SYSTEM 1E Processor
(K180432) | Comparison | | | | | | | |
| 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 | | | | | | | | | | |
| 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 SYSTEM 1E
Processor (K102217) | VERIFY Chemical Indicator
for the SYSTEM 1E
Processor (K102217) | Identical | | | | | | | |
| Spore Test
Strip | VERIFY Spore Test Strip for
S40 Sterilant Concentrate
(K100049) | VERIFY Spore Test Strip for
S40 Sterilant Concentrate
(K100049) | 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 | | | | | | | |
| Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K180432) | Comparison | | | | | | | |
| Indications for
Use | S40 Sterilant Concentrate is
for use only with the
SYSTEM 1E Liquid
Chemical Sterilant
Processing System | S40 Sterilant Concentrate is
for use only with the
SYSTEM 1E Liquid
Chemical Sterilant
Processing System | 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
requirements6.
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
requirements6.
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 | | | | |
| | | | | 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 | |
| | | | | | | | Feature | Proposed Device
S40 Sterilant Concentrate | Predicate Device
S40 Sterilant Concentrate
(K180432) | Comparison |
| | | | | | | | 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 | | | | | | | |
| Chemical
Monitoring | VERIFY Chemical Indicator
for S40 Sterilant (K173428) | VERIFY Chemical Indicator
for the SYSTEM 1E
Processor (K102217) | K173428
included use
of the CI
(with name
change) in the
SYSTEM 1
endo
LCSPS.No
technological
characteristics
changed. | | | | | | | |
Table 1. Processor Device Comparison Table
8
9
10
11
12
13
Table 2. S40 Sterilant Concentrate Device Comparison Table
1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.
2 Clapp et al., Free Rad. Res., (1994) 21:147-167.
3 Maillard et. al., J. Med. Microbiol (1995) 42:415-420.
4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554.
14
5 McDonnell et al., J. AOAC International (2000) 83:269-276.
6 McDonnell et al., J. AOAC International (2000) 83:269-276.
15
16
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.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Biocompatibility of S40 | ||
| Sterilant Concentrate | ||
| with alternate source of a | ||
| proprietary component | Medical devices shall be non-cytotoxic | |
| after exposure to S40 Sterilant | ||
| Concentrate containing the alternate | ||
| source of a proprietary component | Pass | |
| Stability of S40 Sterilant | ||
| Concentrate with | ||
| alternate source of a | ||
| proprietary component | S40 Sterilant Concentrate shall meet | |
| acceptance criteria after 6-months of | ||
| storage. | Pass |
| Table 3. Summary of verification activities. | ||||
|---|---|---|---|---|
| -- | -- | -- | ---------------------------------------------- | -- |
6. 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 (K180342).
17
Image /page/17/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is written in a serif font in all caps. Below the word is an image of several horizontal wavy lines stacked on top of each other. The lines are blue.
510(k) Summary For SYSTEM 1 endo Liquid Chemical Sterilant Processing System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
Contact: Jennifer Nalepka Senior Regulatory Affairs Specialist Tel: 440-392-7458 Fax: 440-357-9198
March 5, 2019 Summary Date:
Premarket Notification Number: K190104
18
1. Device Name
| Trade Name: | SYSTEM 1 endo Liquid Chemical Sterilan
Processing System |
|------------------------|-------------------------------------------------------------------------|
| Device Class: | 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 1 endo Liquid Chemical Sterilant Processing System, K173256. Reference Device: SYSTEM 1 endo Liquid Chemical Sterilant Processing System (Model 6900), K182827
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 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 the addition of a second supplier for of a proprietary component of S40 Sterilant Concentrate.
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
19
required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Table 1 compares the proposed and predicate devices.
Indications for Use 4.
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heatsensitive medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
ട. Technological Characteristic Comparison Table
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is the same as the predicate device; the specific modification described in this submission is for an alternate supplier for a component of S40 Sterilant Concentrate. The differences between the proposed and predicate devices are limited to the addition of an alternate supplier for of a proprietary component of S40 Sterilant Concentrate.
The similarities and differences between the proposed and predicate devices are identified in Table 1 and Table 2 below.
| Feature | Proposed Device
SYSTEM 1 endo Processor | Predicate Device
SYSTEM 1 endo Processor
(K173256) | 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 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. | Identical |
| | The SYSTEM 1 endo
Processor automatically dilutes
the S40 Sterilant Concentrate
to its use dilution (> 1820 | The SYSTEM 1 endo
Processor automatically
dilutes the S40 Sterilant
Concentrate to its use dilution | |
| Feature | Proposed Device
SYSTEM 1 endo Processor | Predicate Device
SYSTEM 1 endo Processor
(K173256) | Comparison |
| | 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 | (> 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. | 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
extensively treated 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 | Standardized cycle
parameters cannot be altered
by operator. The critical
process parameters are:
• Use dilution contact time
• Use dilution temperature
• Peracetic acid
concentration | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Processor | Predicate Device
SYSTEM 1 endo Processor
(K173256) | Comparison |
| | • Integrity of the internal
water filter (tested by the
system) | • Integrity of the internal
water filter (tested by the
system) | |
| Process
Monitors: | • Cycle Printout documents
successful cycle
completion or identifies
fault if cycle aborts
• Alarms if thermocouples
indicate temperature out of
specification
• Alarms if pressure switch
indicates that high pressure
pump is not operating
• Alarms if conductivity
probe indicated
conductivity specification
not met
• Alarms if pressure
transducer indicates
circulation pressure is out
of specification in
Diagnostic cycle
• Alarms if pressure
transducer indicates
internal water filter failed
integrity test | • Cycle Printout documents
successful cycle
completion or identifies
fault if cycle aborts
• Alarms if thermocouples
indicate temperature out
of specification
• Alarms if pressure switch
indicates that high
pressure pump is not
operating
• Alarms if conductivity
probe indicated
conductivity specification
not met
• Alarms if pressure
transducer indicates
circulation pressure is out
of specification in
Diagnostic cycle
• Alarms if pressure
transducer indicates
internal water filter failed
integrity test | Identical
In the
Reference
Device,
K182827,
cycle records
are electronic |
| 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 | • 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 | Identical
Additional
design
features are
part of the
Reference
Device in
K182827:
The
reference
device uses
an updated
controller |
| Feature | Proposed Device
SYSTEM 1 endo Processor | Predicate Device
SYSTEM 1 endo Processor
(K173256) | Comparison |
| | Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter Has no barcode scanner, employs a membrane touch panel interface and small display, has no USB drive. Includes an onboard printer for cycle information | Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter Has no barcode scanner, employs a membrane touch panel interface and small display, has no USB drive. Includes an onboard printer for cycle information | and its respective software for identical processing parameters.
The proposed device uses an updated touchscreen display, has a barcode reader and USB drive for electronic cycle records, and facilitates use of a web-based data mgmt system.
Use of printer is optional. |
| 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 |
| 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 | Hot potable tap water | Hot potable tap water | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Processor | Predicate Device
SYSTEM 1 endo Processor
(K173256) | Comparison |
| preparation | is pre-filtered is filtered through 0.2 micron bacterial retentive membrane filter | is pre-filtered is filtered through 0.2 micron bacterial retentive membrane filter | |
| 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 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
Connects | Uses Quick Connects to attach
instrument lumens to the | Uses Quick Connects to
attach instrument lumens to | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Processor | Predicate Device
SYSTEM 1 endo Processor
(K173256) | Comparison |
| | Tray/Container ports | the 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 | Identical |
| Operator
Maintenance | Periodic replacement of water
filters and air filter.
Periodic replacement of
printer tape. | Periodic replacement of water
filters and air filter.
Periodic replacement of
printer tape. | Identical
In Reference
Device
K182827, the
printer is an
external
option. |
Table 1. Processor Comparison Table
20
21
22
23
24
25
| Feature | S40 Sterilant Concentrate
in S1 endo LCSPS | S40 Sterilant Concentrate
in S1 endo LCSPS
(K173256) | Comparison |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in S1E or S1 endo
LCSPS | For use in S1E or S1 endo
LCSPS | Identical |
| Germicidal
claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant | Identical |
| Exposure
Time | 6 minutes | 6 minutes | Identical |
| Use
Temperature | 45.5 - 60°C - allowable range
Potency and simulated use
evaluations conducted at ≤
43°C | 45.5 - 60°C - allowable range
Potency and simulated use
evaluations conducted at ≤
43°C | Identical |
| Reuse | Single use | Single use | Identical |
| Human
Factors | Ready to use. Container is
opened and diluted by the
processor, limiting user
exposure to the sterilant
concentrate | Ready to use. Container is
opened and diluted by the
processor, limiting user
exposure to the sterilant
concentrate | Identical |
| Active
Ingredient | 35% peroxyacetic (peracetic)
acid automatically diluted for
use in the Processor | 35% peroxyacetic (peracetic)
acid automatically diluted for
use in the Processor | Identical |
| Mode of
Action | It is believed that peracetic
acid exerts its germicidal
effect by several
mechanisms:
-oxidizing sulfhydral and
sulfur bonds in proteins and
enzymes, particularly in the
cell walls 1
-hydroxyl radicals produced
from PAA are bactericidal 2
-PAA damages the viral
capsid and viral nucleic
acid3,4 | It is believed that peracetic
acid exerts its germicidal
effect by several
mechanisms:
-oxidizing sulfhydral and
sulfur bonds in proteins and
enzymes, particularly in the
cell walls1
-hydroxyl radicals produced
from PAA are bactericidal2
-PAA damages the viral
capsid and viral nucleic
acid3.4 | Identical |
| | Rinses | 2 equivalent automated rinses
with pre-filtered, dual 0.2
micron membrane filtered,
potable hot water | 2 equivalent automated rinses
with pre-filtered, dual 0.2
micron membrane filtered,
potable hot water |
| Feature | S40 Sterilant Concentrate
in S1 endo LCSPS | S40 Sterilant Concentrate
in S1 endo LCSPS
(K173256) | Comparison |
| Sporicidal
Activity of
Disinfectants
AOAC
Official
Method
966.04 | Meets efficacy requirements5
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Meets efficacy requirements5
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Identical |
| Confirmatory
Sporicidal
Activity of
Disinfectants
AOAC
Official
Method
966.04 | Meets efficacy requirements5
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Meets efficacy requirements5
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | 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 |
| EPA Virucidal
Testing
(DIS/TSS-7,
Nov. 1981) | Solution is virucidal
Herpes simplex Type 1
Adenovirus Type 5
Poliovirus Type 1
Testing conducted in vitro | Solution is virucidal
Herpes simplex Type 1
Adenovirus Type 5
Poliovirus Type 1
Testing conducted in vitro | Identical |
| Tuberculocidal
Activity of
Disinfectants
AOAC
Official
Method
965.12 | Not performed; a quantitative
suspension Tuberculocidal
test was conducted | Not performed; a quantitative
suspension Tuberculocidal
test was conducted | Identical |
| Feature | S40 Sterilant Concentrate
in S1 endo LCSPS | S40 Sterilant Concentrate
in S1 endo LCSPS
(K173256) | Comparison |
| 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 | Meets efficacy requirement.
= 6 log10 reduction
Geobacillus
stearothermophilus spores in
a manual application. | Meets efficacy requirement.
6 log10 reduction
Geobacillus
stearothermophilus spores in
a manual application. | Identical |
| Clinical In Use | No surviving microorganisms
on representative medical
devices tested in S1 endo
LCSPS | No surviving microorganisms
on representative medical
devices tested in S1 endo
LCSPS | Identical |
| Cytotoxicity
Device
Extracts | Two Processor controlled
rinses with pre-filtered, dual
0.2 micron filtered potable
water effectively reduce
sterilant residues to non-
cytotoxic levels. | Two Processor controlled
rinses with pre-filtered, dual
0.2 micron filtered potable
water effectively reduce
sterilant residues to non-
cytotoxic levels. | Identical |
| Residue
Reduction | Two Processor controlled
rinses with pre-filtered, dual
0.2 micron filtered potable
water effectively reduce
sterilant residues to safe
levels. | Two Processor controlled
rinses with pre-filtered, dual
0.2 micron filtered potable
water effectively reduce
sterilant residues to safe
levels. | Identical |
| Material
Compatibility | Compatible with medical
devices as established by
testing finished medical
devices through 300 cycles.
No functional changes
occurred to devices. Some
materials show cosmetic
changes such as fading of
external markings (yet all
remained legible) and
bleaching of black anodized
aluminum without harm to
the base material. | Compatible with medical
devices as established by
testing finished medical
devices through 300 cycles.
No functional changes
occurred to devices. Some
materials show cosmetic
changes such as fading of
external markings (yet all
remained legible) and
bleaching of black anodized
aluminum without harm to
the base material. | Identical |
Table 2. S40 Sterilant Concentrate Comparison Table
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
26
5 McDonnell et al., J. AOAC International (2000) 83:269-275
27
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.
28
| Test | Acceptance Criteria | Result |
|---|---|---|
| Biocompatibility of S40 | ||
| Sterilant Concentrate with | ||
| alternate source of a | ||
| proprietary component | Medical devices shall be non-cytotoxic | |
| after exposure to S40 Sterilant | ||
| Concentrate containing the alternate | ||
| source of a proprietary component | Pass | |
| Stability of S40 Sterilant | ||
| Concentrate with | ||
| alternate source of a | ||
| proprietary component | S40 Sterilant Concentrate shall meet | |
| acceptance criteria after 6-months of | ||
| storage. | Pass |
Table 3. Summary of Verification Testing
6. 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 (K173256).