(118 days)
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, cleaned semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo LCS Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects.
This submission describes modifications to the processor's user interface and controller, to be introduced in Model P6900. The modifications will provide several user convenience features as compared to the originally cleared processor. Model P6800. The advantages for users include an intuitive touchscreen display, a barcode scanner, and the ability to electronically save and download cycle data for facility records. The P6900 model utilizes an updated electronic controller and suitable software, while providing cycles for liquid chemical sterilization (LCS) and system diagnostics identical to those of the original device. The modified SYSTEM 1 endo Processor, which is computer controlled and continually monitored, provides electronic documentation of each cycle. An external printer is available for printed records, if preferred.
The SYSTEM 1 endo Processor (whether Model P6800 or P6900) is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in six (6) minutes. After liquid chemical sterilant 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.
The STERIS SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical medical devices and their accessories in healthcare facilities. The device 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 P6900 model introduces modifications to the user interface and controller compared to its predicate device, Model P6800, including an intuitive touchscreen display, a barcode scanner, and the ability to electronically save and download cycle data for facility records, while maintaining identical processing parameters.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety Conformance and EMC | Conformance to: - UL 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use – Part 1: General Requirements, 3rd Edition - UL 61010-2-040 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use – Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials, 2nd Edition - IEC 61326-1:2012 Electrical equipment for measurement, control and laboratory use – EMC Requirements – Part 1: General Requirements | PASS |
| Cycle Performance Qualification | All cycle specifications were met for three (3) Liquid Chemical Sterilization and three (3) Diagnostic Cycles. | PASS |
| Software Validation | The software that controls the system was validated and determined to operate effectively and as designed. | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify a separate "test set" in the context of typical validation studies with human readers or clinical data. Instead, for Cycle Performance Qualification, the testing involved running three (3) Liquid Chemical Sterilization cycles and three (3) Diagnostic Cycles. The provenance of this data is not explicitly stated but is presumed to be from laboratory testing conducted by the manufacturer (STERIS Corporation). The data is retrospective in the sense that it's reported after the tests were conducted for regulatory submission. Its country of origin is not specified, but the manufacturer is based in Mentor, Ohio, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the device is a chemical sterilant processing system, and its performance is evaluated against engineering and microbiological specifications, not based on expert interpretation of images or other subjective data. No human experts were explicitly mentioned for establishing ground truth related to the device's operational performance in the provided summary.
4. Adjudication Method for the Test Set:
Not applicable. The qualification tests rely on objective measurements and predefined pass/fail criteria for electrical safety, cycle parameters, and software functionality, not on human adjudication of subjective data.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The STERIS SYSTEM 1 endo is a medical device sterilization system, and its effectiveness is determined by its ability to sterilize, not by human interpretation or diagnosis.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The "Cycle Performance Qualification" and "Software Validation" tests, along with the Electrical Safety and EMC conformance, demonstrate the standalone performance of the algorithm (software) and the overall device. The device was tested to ensure it operates effectively and as designed (software validation) and that all cycle specifications (e.g., temperature, contact time, peracetic acid concentration) are met during the sterilization and diagnostic cycles.
7. Type of Ground Truth Used:
The ground truth used for the performance evaluation includes:
- Engineering and Safety Standards: For electrical safety and EMC (UL 61010-1, UL 61010-2-040, IEC 61326-1).
- Predefined Cycle Specifications: For cycle performance qualification (e.g., specific temperatures, contact times, chemical concentrations).
- Software Design Requirements: For software validation, ensuring the software operates as designed and effectively controls the system.
- Microbial Efficacy Data (from predicate device's S40 Sterilant Concentrate tables): Although not specifically re-tested for the P6900 device as the sterilant concentrate is unchanged, the efficacy of the sterilant (S40) itself is based on numerous in vitro and simulated use tests demonstrating sporocidal, fungicidal, bactericidal, and virucidal activity, as well as tuberculocidal activity (e.g., > 6 log10 reduction of Geobacillus stearothermophilus spores, absence of surviving microorganisms in clinical in-use tests).
8. Sample Size for the Training Set:
Training set information is not applicable to this device submission. This is a 510(k) submission for a physical medical device (sterilizer) with software modifications, not a machine learning or artificial intelligence-driven diagnostic tool that requires training data in the typical sense. The software validation ensures that the software correctly implements the predefined control logic and algorithms for the sterilization process, rather than "learning" from a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the context of machine learning for this device. The software functionality is based on deterministic control logic and pre-established sterilization parameters derived from extensive microbiological and engineering studies (as indicated by the numerous efficacy tests referenced in the S40 Sterilant Concentrate Comparison Table in the original submission for the predicate device, which are identical for this device).
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January 31, 2019
STERIS Corporation Marcia Benedict Senior Director, Regulatory Affairs 5976 Heisley Rd Mentor, Ohio 44060
Re: K182827
Trade/Device Name: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: January 7, 2019 Received: January 8, 2019
Dear Marcia Benedict:
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/cfpmr/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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 Iii 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
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Indications for Use
510(k) Number (if known) K182827
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-critive 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 Part D or SEP 331 Subsidy Payment | |
|---|---|
| Care Transition or SEP 331 Subsidy Start |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the STERIS logo. The word STERIS is in large, bold, sans-serif font. Below the word STERIS is an image of several horizontal wavy lines in blue. The lines are stacked on top of each other, creating a visual representation of water or waves.
510(k) Summary For SYSTEM 1 endo Liquid Chemical Sterilant Processing System Model P6900
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Marcia Benedict Senior Director, Regulatory Affairs Tel: 440-392-7063 Fax: 440-357-9198
Submission Date: January 31, 2019
Premarket Notification Number: K182827
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | SYSTEM 1 endo Liquid Chemical SterilantProcessing System, Model P6900 |
|---|---|
| Device Class: | Class 2 |
| Common/usual Name: | Liquid Chemical Sterilizer |
| Classification Name: | Sterilant, Medical devices, Liquid ChemicalSterilants/Disinfectants |
| Classification Number: | 21 CFR 880.6885 |
| Product Code: | MED |
2. Predicate Device
The predicate device is the SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800 cleared under K173256.
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, cleaned semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo LCS Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects.
This submission describes modifications to the processor's user interface and controller, to be introduced in Model P6900. The modifications will provide several user convenience features as compared to the originally cleared processor. Model P6800. The advantages for users include an intuitive touchscreen display, a barcode scanner, and the ability to electronically save and download cycle data for facility records. The P6900 model utilizes an updated electronic controller and suitable software, while providing cycles for liquid chemical sterilization (LCS) and system diagnostics identical to those of the original device. The modified SYSTEM 1 endo Processor, which is computer controlled and continually monitored, provides electronic documentation of each cycle. An external printer is available for printed records, if preferred.
The SYSTEM 1 endo Processor (whether Model P6800 or P6900) is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in six (6) minutes. After liquid chemical sterilant processing, the liquid chemically sterilized articles are rinsed
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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. 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.
5. Technological Characteristics Comparison Table
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific differences described in this submission, identified in Table 1 below.
Table 2 is provided to demonstrate that the S40 Sterilant Concentrate in the modified processor is unchanged.
Appropriate changes are made to the processor's software and labeling as a result of the different design features identified.
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| Feature | Proposed DeviceSYSTEM 1 endo ProcessorModel P6900 – K182827 | Predicate DeviceSYSTEM 1 endo ProcessorModel P6800 – K173256 | Comparison |
|---|---|---|---|
| IntendedUseIndicationsfor Use | The SYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable semi-critical heat-sensitive medicaldevices and their accessories inhealthcare facilities.The SYSTEM 1 endo Processorautomatically dilutes the S40Sterilant Concentrate to its usedilution (> 1820 mg/L peraceticacid), liquid chemically sterilizesthe load during a controlled 6-minute exposure at 45.5 to 60°C,and rinses the load with 0.2micron filtered water.The SYSTEM 1 endo Processoruses only S40 SterilantConcentrate to liquid chemicallysterilize medical devices. | The SYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable semi-critical heat-sensitive medicaldevices and their accessories inhealthcare facilities.The SYSTEM 1 endo Processorautomatically dilutes the S40Sterilant Concentrate to its usedilution (> 1820 mg/L peraceticacid), liquid chemically sterilizesthe load during a controlled 6-minute exposure at 45.5 to 60°C,and rinses the load with 0.2micron filtered water.The SYSTEM 1 endo Processoruses only S40 SterilantConcentrate to liquid chemicallysterilize medical devices. | Identical |
| OperatingPrinciples/Technology | A microprocessor controlled unitwith interchangeable processingtrays/containers. The processorlid opens to reveal the processingchamber in which the load isplaced.Devices with internal lumens areinterfaced with the processorusing connectors, i.e. QuickConnects.S40 Sterilant is placed in aspecialized compartment andwhen the processor fills withwater, it creates the sterilant usedilution from the single usesterilant cup.The processor monitors andcontrols the use dilutiontemperature and contact time. Theprocessor automatically rinses theload with 0.2 micron filteredwater to remove sterilantresiduals | A microprocessor controlled unitwith interchangeable processingtrays/containers. The processorlid opens to reveal the processingchamber in which the load isplaced.Devices with internal lumens areinterfaced with the processorusing connectors, i.e. QuickConnects.S40 Sterilant is placed in aspecialized compartment andwhen the processor fills withwater, it creates the sterilant usedilution from the single usesterilant cup.The processor monitors andcontrols the use dilutiontemperature and contact time. Theprocessor automatically rinses theload with extensively treatedfiltered water to remove sterilantresiduals. | |
| Feature | Proposed DeviceSYSTEM 1 endo ProcessorModel P6900 – K182827 | Predicate DeviceSYSTEM 1 endo ProcessorModel P6800 – K173256 | Comparison |
| ProcessParameters | Standardized cycle parameterscannot be altered by operator. Thecritical process parameters are:• Use dilution contact time• Use dilution temperature• Peracetic acid concentration• Integrity of the internal waterfilter (tested by the system) | Standardized cycle parameterscannot be altered by operator. Thecritical process parameters are:• Use dilution contact time• Use dilution temperature• Peracetic acid concentration• Integrity of the internal waterfilter (tested by the system) | Identical |
| ProcessMonitors: | • Electronic and/or printedcycle records documentsuccessful cycle completionor identify fault if cycle aborts• Alarms if thermocouplesindicate temperature out ofspecification• Alarms if pressure switchindicates that high pressurepump is not operating• Alarms if conductivity probeindicated conductivityspecification not met• Alarms if pressure transducerindicates circulation pressureis out of specification inDiagnostic Cycle• Alarms if pressure transducerindicates internal water filterfailed integrity test inDiagnostic Cycle | • Cycle printout documentssuccessful cycle completionor identifies fault if cycleaborts• Alarms if thermocouplesindicate temperature out ofspecification• Alarms if pressure switchindicates that high pressurepump is not operating• Alarms if conductivity probeindicated conductivityspecification not met• Alarms if pressure transducerindicates circulation pressureis out of specification inDiagnostic Cycle• Alarms if pressure transducerindicates internal water filterfailed integrity test inDiagnostic Cycle | Identical,except cyclerecords areelectronic |
| DesignFeatures | • Microprocessor controlledunalterable and standardizedliquid chemical sterilizationand Diagnostic cycles• Intended for use only withS40 Sterilant Concentrate• Automated dilution anddelivery of S40 Sterilant• Processor provides 0.2 micronfiltered water for liquidchemical sterilization andrinsing• Make-up air for processorduring drain sequences is | • Microprocessor controlledunalterable and standardizedliquid chemical sterilizationand Diagnostic cycles• Intended for use only withS40 Sterilant Concentrate• Automated dilution anddelivery of S40 Sterilant• Processor provides 0.2 micronfiltered water for liquidchemical sterilization andrinsing• Make-up air for processorduring drain sequences is | The proposeddevice usesan updatedcontroller andits respectivesoftware toprovideidenticalprocessingparameters.The proposeddevice usesan updatedtouchscreen |
| Feature | Proposed DeviceSYSTEM 1 endo ProcessorModel P6900 – K182827 | Predicate DeviceSYSTEM 1 endo ProcessorModel P6800 – K173256 | Comparison |
| filtered through a 0.2 micronmembrane 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 | filtered through a 0.2 micronmembrane 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 | 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 | ||
| Incomingwater temp. | $\geq$ 43°C | $\geq$ 43°C | Identical |
| Temperatureto startsterilantexposure | $\geq$ 46°C | $\geq$ 46°C | Identical |
| Temperaturealarm pointduring LCSexposure | $<$ 45.5 or $>$ 60°C | $<$ 45.5 or $>$ 60°C | Identical |
| Temperaturerange oftypical LCScycle | 46 - 55°C | 46 - 55°C | Identical |
| ExposureTime - S40use dilution | 6 minutes | 6 minutes | Identical |
| Rinse waterpreparation | 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 ofrinses | 2 | 2 | Identical |
| Air Purge | Aids in removing excess waterfrom instrument lumens afterrinsing | Aids in removing excess waterfrom instrument lumens afterrinsing | Identical |
| InternalWater FilterIntegrity Test | Conducted during the Diagnosticcycle | Conducted during the Diagnosticcycle | Identical |
| ApproximateCycle Time | 18 - 20 minutes | 18 - 20 minutes | Identical |
| Feature | Proposed DeviceSYSTEM 1 endo ProcessorModel P6900 – K182827 | Predicate DeviceSYSTEM 1 endo ProcessorModel P6800 – K173256 | Comparison |
| DiagnosticCycle | Performs 14 tests on processor'ssystems confirming properfunction. Recommended toperform each day of use. After afailed Diagnostic cycle, a liquidchemical sterilization cyclecannot be performed until theproblem is rectified and asuccessful Diagnostic cycle hasbeen completed. | Performs 14 tests on processor'ssystems confirming properfunction. Recommended toperform each day of use. After afailed Diagnostic cycle, a liquidchemical sterilization cyclecannot be performed until theproblem is rectified and asuccessful Diagnostic cycle hasbeen completed. | Identical |
| Accessories | |||
| Sterilant | Uses S40 Sterilant Concentrate –see Table 2 | Uses S40 Sterilant Concentrate –see Table 2 | Identical |
| ProcessingTrays andContainers | Uses interchangeable processingtrays/containers• Universal Flex Processing Tray• General Processing Container& Tray• Directed Flow ProcessingContainer & Tray• Flexible Endoscope ProcessingContainer & Tray• Ultrasound Processing Tray | Uses interchangeable processingtrays/containers• Universal Flex Processing Tray• General Processing Container& Tray• Directed Flow ProcessingContainer & Tray• Flexible Endoscope ProcessingContainer & Tray• Ultrasound Processing Tray | Identical |
| QuickConnects | Uses Quick Connects to attachinstrument lumens to theTray/Container ports | Uses Quick Connects to attachinstrument lumens to theTray/Container ports | Identical |
| ChemicalIndicator | VERIFY Chemical Indicator forS40 Sterilant is available for usein SYSTEM 1 endo LCSPS | VERIFY Chemical Indicator forS40 Sterilant is available for usein SYSTEM 1 endo LCSPS | Identical |
| Spore TestStrip | VERIFY Spore Test Strip for S40Sterilant for use in SYSTEM 1endo LCSPS | VERIFY Spore Test Strip for S40Sterilant for use in SYSTEM 1endo LCSPS | Identical |
| OperatorMaintenance | Periodic replacement of waterfilters and air filter.Periodic replacement of printertape, if using the external printeroption. | Periodic replacement of waterfilters and air filter.Periodic replacement of printertape. | Identical,excepting thatthe printer isan externaloption |
| Feature | S40 Sterilant Concentratein S1 endo LCSPSModel P6900 – K182827 | S40 Sterilant Concentratein S1 endo LCSPSModel P6800 - K173256 | Comparison |
| Intended Use | For use in S1E or S1 endoLCSPS | For use in S1E or S1 endoLCSPS | Identical |
| Germicidalclaim | Liquid Chemical Sterilant | Liquid Chemical Sterilant | Identical |
| ExposureTime | 6 minutes | 6 minutes | Identical |
| UseTemperature | 45.5 - 60°C - allowable rangePotency and simulated useevaluations conducted at $<$ 43°C | 45.5 - 60°C - allowable rangePotency and simulated useevaluations conducted at $<$ 43°C | Identical |
| Reuse | Single use | Single use | Identical |
| HumanFactors | Ready to use. Container isopened and diluted by theprocessor, limiting user exposureto the sterilant concentrate | Ready to use. Container isopened and diluted by theprocessor, limiting user exposureto the sterilant concentrate | Identical |
| ActiveIngredient | 35% peroxyacetic (peracetic)acid automatically diluted foruse in the Processor | 35% peroxyacetic (peracetic)acid automatically diluted foruse in the Processor | Identical |
| Mode ofAction | It is believed that peracetic acidexerts its germicidal effect byseveral mechanisms:-oxidizing sulfhydral and sulfurbonds in proteins and enzymes,particularly in the cell walls 1-hydroxyl radicals producedfrom PAA are bactericidal 2-PAA damages the viral capsidand viral nucleic acid3,4 | It is believed that peracetic acidexerts its germicidal effect byseveral mechanisms:-oxidizing sulfhydral and sulfurbonds in proteins and enzymes,particularly in the cell walls1-hydroxyl radicals produced fromPAA are bactericidal2-PAA damages the viral capsidand viral nucleic acid3.4 | Identical |
| Rinses | 2 equivalent automated rinseswith pre-filtered, dual 0.2micron membrane filtered,potable hot water | 2 equivalent automated rinseswith pre-filtered, UV irradiated,dual 0.1 micron membranefiltered, potable hot water | Identical |
| Feature | S40 Sterilant Concentratein S1 endo LCSPSModel P6900 - K182827 | S40 Sterilant Concentratein S1 endo LCSPSModel P6800 - K173256 | Comparison |
| SporicidalActivity ofDisinfectantsAOACOfficialMethod966.04 | Meets efficacy requirements5Bacillus subtilisClostridium sporogenesTesting conducted in vitro | Meets efficacy requirements5Bacillus subtilisClostridium sporogenesTesting conducted in vitro | Identical |
| ConfirmatorySporicidalActivity ofDisinfectantsAOACOfficialMethod966.04 | Meets efficacy requirements5Bacillus subtilisClostridium sporogenesTesting conducted in vitro | Meets efficacy requirements5Bacillus subtilisClostridium sporogenesTesting conducted in vitro | Identical |
| FungicidalActivity ofDisinfectantsAOACOfficialMethod955.17 | Solution is fungicidalTrichophyton mentagrophytesTesting conducted in vitro | Solution is fungicidalTrichophyton mentagrophytesTesting conducted in vitro | Identical |
| Use DilutionMethodAOAC,OfficialMethods955.14,955.15, 964.02 | Solution is bactericidalSalmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosaTesting conducted in vitro | Solution is bactericidalSalmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosaTesting conducted in vitro | Identical |
| EPA VirucidalTesting(DIS/TSS-7,Nov. 1981) | Solution is virucidalHerpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro | Solution is virucidalHerpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro | Identical |
| TuberculocidalActivity ofDisinfectantsAOACOfficialMethod965.12 | Not performed; a quantitativesuspension Tuberculocidal testwas conducted | Not performed; a quantitativesuspension Tuberculocidal testwas conducted | Identical |
| Feature | S40 Sterilant Concentratein S1 endo LCSPSModel P6900 – K182827 | S40 Sterilant Concentratein S1 endo LCSPSModel P6800 - K173256 | Comparison |
| TuberculocidalActivityAscenziQuantitativeSuspensionTest | Solution is tuberculocidalMycobacterium terraetesting conducted in vitro | Solution is tuberculocidalMycobacterium terraetesting conducted in vitro | Identical |
| Simulated Use | Meets efficacy requirement.> 6 log10 reduction Geobacillusstearothermophilus spores in amanual application. | Meets efficacy requirement.> 6 log10 reduction Geobacillusstearothermophilus spores in amanual application. | Identical |
| Clinical In Use | No surviving microorganisms onrepresentative medical devicestested in S1 endo LCSPS | No surviving microorganisms onrepresentative medical devicestested in S1 endo LCSPS | Identical |
| CytotoxicityDeviceExtracts | Two Processor controlled rinseswith pre-filtered, dual 0.2micron filtered potable watereffectively reduce sterilantresidues to non-cytotoxic levels. | Two Processor controlled rinseswith pre-filtered, dual 0.2 micronfiltered potable water effectivelyreduce sterilant residues to non-cytotoxic levels. | Identical |
| ResidueReduction | Two Processor controlled rinseswith pre-filtered, dual 0.2micron filtered potable watereffectively reduce sterilantresidues to safe levels. | Two Processor controlled rinseswith pre-filtered, dual 0.2 micronfiltered potable water effectivelyreduce sterilant residues to safelevels. | Identical |
| MaterialCompatibility | Compatible with medicaldevices as established by testingfinished medical devices through300 cycles. No functionalchanges occurred to devices.Some materials show cosmeticchanges such as fading ofexternal markings (yet allremained legible) and bleachingof black anodized aluminumwithout harm to the basematerial. | Compatible with medicaldevices as established by testingfinished medical devices through300 cycles. No functionalchanges occurred to devices.Some materials show cosmeticchanges such as fading ofexternal markings (yet allremained legible) and bleachingof black anodized aluminumwithout harm to the basematerial. | Identical |
Table 1. Processor Comparison Table
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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
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5 McDonnell et al., J. AOAC International (2000) 83:269-275
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Summary of Non-Clinical Performance Testing 6.
Performance testing was conducted to evaluate the modified device and the results are summarized in Table 3.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Electrical SafetyConformanceand EMC | UL 61010-1 Safety Requirements for ElectricalEquipment for Measurement, Control, and LaboratoryUse – Part 1: General Requirements, 3rd EditionUL 61010-2-040 Safety Requirements for ElectricalEquipment for Measurement, Control, and LaboratoryUse – Part 2-040: Particular Requirements forSterilizers and Washer-Disinfectors Used to TreatMedical Materials, 2nd EditionIEC 61326-1:2012 Electrical equipment formeasurement, control and laboratory use – EMCRequirements – Part 1: General Requirements | PASS |
| CyclePerformanceQualification | All cycle specifications were met for three (3) LiquidChemical Sterilization and three (3) DiagnosticCycles. | PASS |
| SoftwareValidation | The software that controls the system was validatedand determined to operate effectively and as designed. | PASS |
Table 3. Performance Testing Summary Table
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 (K173256).
§ 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.