(56 days)
Not Found
No
The description focuses on the chemical sterilization process, water filtration, and hardware/software modifications, with no mention of AI or ML.
No
This device is a sterilizing system for medical equipment, not a device used for therapeutic purposes on patients.
No
The device is a liquid chemical sterilant processing system, which sterilizes medical devices. While it performs "diagnostic cycles" for self-evaluation, its primary intended use is sterilization, not diagnosing medical conditions or diseases.
No
The device description clearly outlines hardware components such as the "SYSTEM 1E Processor," "S40 Sterilant Concentrate," "interchangeable processing trays/containers," "Quick Connects," "pre-filters," "ultraviolet light treatment subsystem," and "0.1micron filter membranes." While the processor is "computer controlled," the system is fundamentally a hardware-based sterilization system with integrated software for control and monitoring.
Based on the provided information, the SYSTEM 1E Liquid Chemical Sterilant Processing System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities." This describes a process for disinfecting or sterilizing medical instruments, not for performing tests on biological samples to diagnose or monitor a patient's condition.
- Device Description: The description details a system for processing medical devices using a chemical sterilant and treated water. It does not mention any components or functions related to analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or treatment decisions based on biological sample analysis.
The SYSTEM 1E is a medical device used for reprocessing other medical devices to ensure they are safe for use on patients. It falls under the category of sterilization or disinfection equipment, not IVD.
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 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 is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
-
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. Six 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 bacterial retentive water filter, referred to in labeling as the MaxPure filter and A and B Pre-filters and to add an alternate resin for the construction of the sterilant capsule.
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 exclusively 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.
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 provided document details verification activities to ensure the safety and effectiveness of the device after modifications.
Test: MaxPure Filter alternate supplier
Verification/Validation Activity: Accumulation of successful liquid chemical sterilization cycles and diagnostic cycles to represent the filter's 3-months use life.
Acceptance Criteria: The modification does not change the final product release specifications
Result: Pass
Test: MaxPure Filter alternate supplier
Verification/Validation Activity: Evaluation of filter integrity by microbial retention challenge based on ASTM F838-15 following the accumulation of liquid chemical sterilization cycles and diagnostic cycles representing 3 months use.
Acceptance Criteria: The modification does not change the final product release specifications
Result: Pass
Test: Pre-filter A and B alternate supplier
Verification/Validation Activity: Accumulation of successful liquid chemical sterilization cycles and diagnostic cycles to represent the filter's 3-month use life.
Acceptance Criteria: The modification does not change the final product release specifications
Result: Pass
Test: S40 Sterilant Concentrate Acid
Verification/Validation Activity: Evaluation of the concentration of peracetic acid over the shelf life.
Acceptance Criteria: The modification does not change the final product release specifications
Result: Pass
Test: Capsule Alternate Resin and Supplier
Verification/Validation Activity: Physical evaluation of compatibility of the alternate resin with container contents.
Acceptance Criteria: The container contents are compatible with the container package and labeling
Result: Pass
The document also refers to previous efficacy testing for the predicate device, which is stated to be identical for the proposed device:
- Sporicidal Activity of Disinfectants AOAC Official Method 966.04: Meets efficacy requirements. Bacillus subtilis, Clostridium sporogenes. Testing conducted in vitro.
- Confirmatory Sporicidal Activity of Disinfectants AOAC Official Method 966.04: Meets efficacy requirements. Bacillus subtilis, Clostridium sporogenes. Testing conducted in vitro.
- Fungicidal Activity of Disinfectants AOAC Official Method 955.17: Solution is fungicidal. Trichophyton mentagrophytes. Testing conducted in vitro.
- 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.
- 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.
- Tuberculocidal Activity Ascenzi Quantitative Suspension Test: Solution is tuberculocidal. Mycobacterium terrae. Testing conducted in vitro.
- Simulated-Use Test: Meets efficacy requirement. > 6 log reduction Geobacillus stearothermophilus spores in a manual application.
- Clinical In-Use: No surviving microorganisms on representative medical devices tested.
- Cytotoxicity Device Extracts: Two rinses with UV treated, dual 0.1-micron membrane filtered water effectively reduce sterilant residues to safe levels.
- Residue Reduction: Automatic within the SYSTEM 1E Processor: Two rinses with UV treated, dual 0.1-micron membrane filtered water effectively reduce sterilant residues to safe levels.
- 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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
April 4, 2018
Steris Corporations Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K180342
Trade/Device Name: SYSTEM 1E 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 12, 2018 Received: March 13, 2018
Dear Jennifer Nalepka:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Michael J. Ryan -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) K180342
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 > 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)
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3
Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word "STERIS" is written in a serif font in all capital letters. Below the word is an image of several horizontal wavy lines in blue.
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
March 27, 2018 Summary Date:
Premarket Notification Number: K180342
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
1. Device Name
| Trade Name: | SYSTEM 1E Liquid Chemical Sterilant
Processing System |
|------------------------|-------------------------------------------------------------------------|
| Device Classification: | Class II |
| Common/usual Name: | Liquid Chemical Sterilizer |
| Classification Name: | Sterilant, Medical devices, Liquid Chemical
Sterilants/Disinfectants |
| Classification Number: | 21 CFR 880.6885 |
| Product Code: | MED |
2. Predicate Device
SYSTEM 1E Liquid Chemical Sterilant Processing System cleared under K170956
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. Six 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 bacterial retentive water filter, referred to in labeling as the MaxPure filter and A and B Pre-filters and to add an alternate resin for the construction of the sterilant capsule.
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.
5
S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively 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.
4. Intended 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.
-
6
5. Description of Technological Similarities and Differences
The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific modification described in this submission. The differences between the proposed and predicate devices are limited to the addition of an alternate supplier for the MaxPure Filter and A and B Pre-filters and to add an alternate resin for the construction of the sterilant capsule. These proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.
Device Comparison Table
| Feature | Proposed
SYSTEM 1E Processor | K170956
SYSTEM 1E Processor | Comparison |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications
for Use | The SYSTEM 1E Liquid
Chemical Sterilant Processing
System is intended for liquid
chemical sterilization of
cleaned, immersible, and
reusable critical and semi-
critical heat-sensitive medical
devices in healthcare
facilities.
The SYSTEM 1E 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℃, 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 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℃, 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. | Identical |
| Table 6-1. Processor Device Comparison Table | |||||
|---|---|---|---|---|---|
| ----------------------------------------------- | -- | -- | -- | -- | -- |
7
| Feature | Proposed
SYSTEM 1E Processor | K170956
SYSTEM 1E Processor | Comparison | | | |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | The SYSTEM 1E Processor
uses only S40 Sterilant
Concentrate to liquid
chemically sterilize medical
devices. | The SYSTEM 1E Processor
uses only S40 Sterilant
Concentrate to liquid
chemically sterilize medical
devices. | | | | |
| | * The extensive treatment of
EPA potable water consists
of:
- Pre-filtration through
two pre-filters:
• Pre-filter A is a gross
depth filter that
removes
approximately 2.5
micron or larger
particles/contaminants.
• Pre-filter B is a surface
filter that removes
particles/contaminants
0.1 micron. | * The extensive treatment of
EPA potable water consists
of:
- Pre-filtration through
two pre-filters:
• Pre-filter A is a gross
depth filter that
removes
approximately 2.5
micron or larger
particles/contaminants.
• Pre-filter B is a surface
filter that removes
particles/contaminants
0.1 micron. | | | | |
| | 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. | 2. UV Irradiation:
• During transit through
the UV water
treatment chamber, a
UV dose sufficient to
achieve a ≥ 6-log
reduction of MS2 virus
is delivered to the
water. | | | | |
| | 3. 0.1-micron filtration:
• The water prepared by
pre-filtration and UV
irradiation is filtered
through redundant,
0.1-micron (absolute
rated) membranes to
remove bacteria, fungi
and protozoa > 0.1
micron | 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 | | | | |
| Feature | Proposed
SYSTEM 1E Processor | K170956
SYSTEM 1E Processor | 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
SYSTEM 1E Processor | K170956
SYSTEM 1E Processor | Comparison |
| | | | Design
Features | 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 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. | 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 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
phase | $\geq 46°C$ | $\geq 46°C$ | Identical | |
| | Feature | Proposed
SYSTEM 1E Processor | K170956
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
• 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 | 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
SYSTEM 1E Processor | K170956
SYSTEM 1E Processor | 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 | | | |
| | 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
S40 Sterilant Concentrate | K170956
S40 Sterilant Concentrate | 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 $\le$ 43°C | 45.5-60°C – allowable
46-55°C - typical
Potency and simulated use evaluations conducted at $\le$ 43°C | Identical | | | |
| Reuse | Single use | Single use | Identical | | | |
| Human Factors | Dispensed ready to use.
Container is opened and diluted by the processor, thus limiting user exposure to the active ingredient | Dispensed ready to use
Container is opened and diluted by the processor, thus limiting user exposure to the active ingredient | Identical | | | |
| Active Ingredient | 35% peroxyacetic (peracetic) acid automatically diluted for use in the SYSTEM 1E Processor. | 35% peroxyacetic (peracetic) acid automatically diluted for use in the SYSTEM 1E Processor. | Identical | | | |
| Mode of Action | It is believed that peracetic acid exerts its germicidal effect by several mechanisms:
-oxidizing sulfhydryl and sulfur bonds in proteins and enzymes, particularly in the cell walls 1
-hydroxyl radicals produced from PAA are bactericidal 2
-PAA damages the viral capsid and viral nucleic acid3,4 | It is believed that peracetic acid exerts its germicidal effect by several mechanisms:
-oxidizing sulfhydryl and sulfur bonds in proteins and enzymes, particularly in the cell walls1
-hydroxyl radicals produced from PAA are bactericidal2
-PAA damages the viral capsid and viral nucleic acid3,4 | Identical | | | |
| Feature | Proposed | K170956 | Comparison | | | |
| | S40 Sterilant Concentrate | S40 Sterilant Concentrate | | | | |
| Rinses | Automatic, UV-irradiated,
dual 0.1 micron filtered,
potable hot water. | Automatic, UV-irradiated,
dual 0.1 micron filtered,
potable hot water. | Identical | | | |
| Microbial Efficacy | | | | | | |
| Sporicidal
Activity of
Disinfectants
AOAC
Official
Method 966.04 | Meets efficacy
requirements5.
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | Meets efficacy
requirements6.
Bacillus subtilis
Clostridium sporogenes
Testing conducted in vitro | 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 | Meets efficacy requirement.
6 log reduction
Geobacillus | Identical | | | |
| Feature | Proposed | K170956 | Comparison | | | |
| | S40 Sterilant Concentrate
stearothermophilus spores in | S40 Sterilant Concentrate
stearothermophilus spores in | | | | |
| | a manual application | a manual application | | | | |
| 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 the SYSTEM 1E
Processor(K102217) | VERIFY Chemical Indicator
for the SYSTEM 1E
Processor(K102217) | Identical | | | |
8
9
10
11
12
Table 6-2. S40 Sterilant Concentrate Device Comparison Table
No changes have been made to the S40 Sterilant Concentrate
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.
13
4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554.
5 McDonnell et al., J. AOAC International (2000) 83:269-276.
14
Table 6-3 summarizes the verification activity that was performed with its respective acceptance criteria to ensure that this modification does not affect the safety or effectiveness of the SYSTEM 1E Liquid Chemical Sterilant Processing System.
15
| Test | Verification/Validation
Activity | Acceptance Criteria | Result |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------|
| MaxPure
Filter
alternate
supplier | Accumulation of successful
liquid chemical sterilization
cycles and diagnostic cycles to
represent the filter's 3-months
use life. | The modification does
not change the final
product release
specifications | Pass |
| MaxPure
Filter
alternate
supplier | Evaluation of filter integrity
by microbial retention challenge
based on ASTM F838-15
following the accumulation of
liquid chemical sterilization
cycles and diagnostic cycles
representing 3 months use. | The modification does
not change the final
product release
specifications | Pass |
| Pre-filter A
and B
alternate
supplier | Accumulation of successful
liquid chemical sterilization
cycles and diagnostic cycles to
represent the filter's 3-month
use life. | The modification does
not change the final
product release
specifications | Pass |
| S40
Sterilant
Concentrate
Acid | Evaluation of the concentration
of peracetic acid over the shelf
life. | The modification does
not change the final
product release
specifications | Pass |
| Capsule
Alternate
Resin and
Supplier | Physical evaluation of
compatibility of the alternate
resin with container contents. | The container contents
are compatible with
the container package
and labeling | Pass |
| Table 6-3. 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 as the legally marketed predicate device (K170956), Class II (21 CFR 880.6885), product code MED.