(108 days)
No
The summary describes an automated liquid chemical sterilization system with software modifications, but there is no mention of AI or ML technologies being used for control, analysis, or any other function. The software validation focuses on effective and designed operation, not learning or adaptive capabilities.
No.
The device is a sterilizing system for medical devices, not a device used for treating a patient's disease or condition directly.
No
The device is a chemical sterilant processing system designed for sterilizing medical devices. It does not perform any diagnostic functions.
No
The device is a liquid chemical sterilization system which includes a processor (hardware), sterilant concentrate (chemical), and processing trays/containers (hardware). While software modifications are mentioned, the core device is a physical system, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories." This describes a process for disinfecting medical equipment, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the mechanical and chemical process of sterilization using peracetic acid and filtered water. It doesn't mention any components or functions related to analyzing biological specimens.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes (proteins, DNA, chemicals, etc.)
- Providing diagnostic information about a patient's health status
The device is clearly designed for reprocessing medical instruments to make them safe for reuse, which falls under the category of sterilization equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
Product codes
MED
Device Description
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe certain software modifications made after the clearance of K182827.
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)
Nonclinical Testing
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is the same as the predicate device. New testing was performed to evaluate the modified device.
Tests:
- Software Validation: The software that controls the system was validated and determined to operate effectively and as designed.
- Result: Pass
Conclusion:
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K182827).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, K182827.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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September 5, 2019
STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K191343
Trade/Device Name: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: September 4, 2019 Received: September 4, 2019
Dear Jennifer Nalepka:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
Indications for Use (Describe)
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically diutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary For SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Jennifer Nalepka Contact: Senior Regulatory Affairs Specialist Tel: 440-392-7458 Fax: 440-357-9198
Submission Date: August 29, 2019
Premarket Notification Number: K191343
4
1. Device Name
| Trade Name: | SYSTEM 1 endo Liquid Chemical Sterilant
Processing System, Model P6900 |
|------------------------|---------------------------------------------------------------------------|
| Device Class: | Class 2 |
| Common/usual Name: | Liquid Chemical Sterilizer |
| Classification Name: | Sterilant, Medical devices, Liquid Chemical
Sterilants/Disinfectants |
| Classification Number: | 21 CFR 880.6885 |
| Product Code: | MED |
2. Predicate Device
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, K182827.
3. Description of Device
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe certain software modifications made after the clearance of K182827.
The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Ouick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Tables 1 and 2 compare the proposed and predicate devices.
5
Indications for Use 4.
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heatsensitive medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
5. Technological Characteristic Comparison Table
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System (LCSPS) is the same as the predicate device; the submission is for modifications to the SYSTEM 1 endo LCSPS software. A comparison between the proposed and predicate devices can be found in Table 1 and Table 2 below.
| Feature | Proposed Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System , Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K182827) | 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 mg/L peracetic | The SYSTEM 1 endo Processor
automatically dilutes the S40
Sterilant Concentrate to its use
dilution (> 1820 mg/L peracetic | |
| Feature | Proposed Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System , Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K182827) | Comparison |
| | 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. | acid), liquid chemically sterilizes
the load during a controlled 6-
minute exposure at 45.5 to 60°C,
and rinses the load with 0.2
micron filtered water. | |
| | The SYSTEM 1 endo Processor
uses only S40 Sterilant
Concentrate to liquid chemically
sterilize medical devices. | The SYSTEM 1 endo Processor
uses only S40 Sterilant
Concentrate to liquid chemically
sterilize medical devices. | |
| | 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 | 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 | |
| Operating
Principles
/
Technology | interfaced with the processor
using connectors, i.e. Quick
Connects. | interfaced with the processor
using connectors, i.e. Quick
Connects. | |
| | S40 Sterilant is placed in a
specialized compartment and
when the processor fills with
water, it creates the sterilant use
dilution from the single use
sterilant cup. | S40 Sterilant is placed in a
specialized compartment and
when the processor fills with
water, it creates the sterilant use
dilution from the single use
sterilant cup. | Identical |
| | The processor monitors and
controls the use dilution
temperature and contact time. The
processor automatically rinses the
load with 0.2 micron filtered
water to remove sterilant
residuals. | The processor monitors and
controls the use dilution
temperature and contact time. The
processor automatically rinses the
load with 0.2 micron filtered
water to remove sterilant
residuals. | |
| | Standardized cycle parameters
cannot be altered by operator. The
critical process parameters are: | Standardized cycle parameters
cannot be altered by operator. The
critical process parameters are: | |
| Process
Parameters | • Use dilution contact time | • Use dilution contact time | Identical |
| | • Use dilution temperature | • Use dilution temperature | |
| | • Peracetic acid concentration
• Integrity of the internal water | • Peracetic acid concentration
• Integrity of the internal water | |
| | filter (tested by the system) | filter (tested by the system) | |
| Feature | Proposed Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System , Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K182827) | Comparison |
| 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 |
| Design
Features | Microprocessor controlled unalterable and standardized liquid chemical sterilization and Diagnostic cycles Intended for use only with S40 Sterilant Concentrate Automated dilution and delivery of S40 Sterilant Processor provides 0.2 micron filtered water for liquid chemical sterilization and rinsing Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter Includes a barcode scanner; employs touchscreen display interface; has USB drive for electronic cycle download; facilitates use of a web-based data management system. Separate optional printer | Microprocessor controlled unalterable and standardized liquid chemical sterilization and Diagnostic cycles Intended for use only with S40 Sterilant Concentrate Automated dilution and delivery of S40 Sterilant Processor provides 0.2 micron filtered water for liquid chemical sterilization and rinsing Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter Includes a barcode scanner; employs touchscreen display interface; has USB drive for electronic cycle download; facilitates use of a web-based data management system. Separate optional printer | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System , Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K182827) | Comparison |
| | Cycle Parameters | | Comparison |
| Incoming
water temp. | ≥ 43°C | ≥ 43°C | Identical |
| Temperature
to start
sterilant
exposure | ≥ 46°C | ≥ 46°C | Identical |
| Temperature
alarm point
during LCS
exposure | 60°C | 60°C | Identical |
| Temperature
range of
typical LCS
cycle | 46 - 55°C | 46 - 55°C | Identical |
| Exposure
Time - S40
use dilution | 6 minutes | 6 minutes | Identical |
| Rinse water
preparation | Hot potable tap water
• is pre-filtered
• is filtered through 0.2 micron
bacterial retentive membrane
filter | Hot potable tap water
• is pre-filtered
• is filtered through 0.2 micron
bacterial retentive membrane
filter | Identical |
| Number of
rinses | 2 | 2 | Identical |
| Air Purge | Aids in removing excess water
from instrument lumens after
rinsing | Aids in removing excess water
from instrument lumens after
rinsing | Identical |
| Internal
Water Filter
Integrity Test | Conducted during the Diagnostic
cycle | Conducted during the Diagnostic
cycle | Identical |
| Approximate
Cycle Time | 18 - 20 minutes | 18 - 20 minutes | Identical |
| Diagnostic
Cycle | Performs 14 tests on processor's
systems confirming proper
function. Recommended to
perform each day of use. After a
failed Diagnostic cycle, a liquid
chemical sterilization cycle
cannot be performed until the
problem is rectified and a | 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 | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System , Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K182827) | Comparison |
| | successful Diagnostic cycle has
been completed. | successful Diagnostic cycle has
been completed. | |
| Accessories | | | Comparison |
| Sterilant | Uses S40 Sterilant Concentrate –
see Table 2 | Uses S40 Sterilant Concentrate –
see Table 2 | Identical |
| Processing
Trays and
Containers | Uses interchangeable processing
trays/containers
• 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
Tray/Container ports | Uses Quick Connects to attach
instrument lumens to the
Tray/Container ports | Identical |
| Chemical
Indicator | VERIFY Chemical Indicator for
S40 Sterilant is available for use
in SYSTEM 1 endo LCSPS | VERIFY Chemical Indicator for
S40 Sterilant is available for use
in SYSTEM 1 endo LCSPS | Identical |
| Spore Test
Strip | VERIFY Spore Test Strip for S40
Sterilant for use in SYSTEM 1
endo LCSPS | VERIFY Spore Test Strip for S40
Sterilant for use in SYSTEM 1
endo LCSPS | Identical |
| Operator
Maintenance | Periodic replacement of water
filters and air filter.
Periodic replacement of printer
tape, if using the external printer
option. | Periodic replacement of water
filters and air filter.
Periodic replacement of printer
tape, if using the external printer
option. | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System , Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K182827) | 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 | Identical |
| Feature | Proposed Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System , Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K182827) | 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 |
| Feature | Proposed Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System , Model P6900 | Predicate Device
SYSTEM 1 endo Liquid
Chemical Sterilant Processing
System, Model P6900
(K182827) | Comparison |
| 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 |
| 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 1. Processor Comparison Table
6
7
8
9
10
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
11
5 McDonnell et al., J. AOAC International (2000) 83:269-275
12
13
Description of Nonclinical Testing 6.
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is the same as the predicate device described in this submission and identified in Tables 1 and 2.
The proposed device and its predicate have identical intended use and technological characteristics. New testing was performed to evaluate the modified device and the results are summarized in Table 3.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Software Validation | The software that controls the system was | |
| validated and determined to operate | ||
| effectively and as designed. | Pass |
Table 3. Summary of verification activities
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K182827).