(143 days)
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.
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects.
The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| In-Use Testing | Clinically used, cleaned semi-critical heat-sensitive medical devices exposed to varied clinical soils were effectively liquid chemically sterilized. | PASS |
| Electrical Safety Conformance | UL 61010-1:2012 Ed.3+R:29 Apr2016 Electrical Equipment for Measurement, Control, and Laboratory Use Part 1: General RequirementsUL 61010-2-040:2016 Ed.2 Electrical Equipment For Measurement, Control, And Laboratory Use Part 2-040: Particular Requirements For Sterilizers And Washer-Disinfectors Used To Treat Medical Materials | PASS |
| Water Filter Performance through Use Life | The 0.2 micron MaxLife filter maintained its integrity and achieved effective bacterial retention performance after numerous Liquid Chemical Sterilization Cycles and Diagnostic Cycles representing 6 months of active use. | PASS |
| Water Filter Integrity Test | The Diagnostic Cycle correctly detects loss of filter integrity or absence of a filter. | PASS |
| Cycle Qualification | All cycle specifications were met for three (3) cycles each, Liquid Chemical Sterilization and Diagnostic. | PASS |
| Software Validation | The software that controls the system was validated and determined to operate effectively and as designed. | PASS |
Points not explicitly addressed in the provided text:
The provided text (a 510(k) Summary for a medical device) focuses on demonstrating substantial equivalence to a predicate device, rather than a typical clinical study report for AI/machine learning devices. Therefore, several points in your requested information are not applicable or explicitly mentioned in this type of document.
Here's how the remaining points relate to the provided text:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated for each test. For "In-Use Testing," it mentions "Clinically used, cleaned semi-critical heat-sensitive medical devices," implying a sample was used but the size isn't quantified. For Water Filter Performance, refers to "numerous Liquid Chemical Sterilization Cycles and Diagnostic Cycles." For Cycle Qualification, it states "three (3) cycles each, Liquid Chemical Sterilization and Diagnostic."
- Data Provenance: Not explicitly stated. The document is submitted to the FDA in the USA, suggesting the testing was likely conducted in accordance with US regulatory standards, but the physical location or origin of the samples/data is not mentioned.
- Retrospective or Prospective: Not explicitly stated, though "In-Use Testing" implies real-world usage, which could be prospective if the testing was specifically set up for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable for this type of device. The device is a liquid chemical sterilant processing system. Ground truth is established through microbiological testing (e.g., absence of viable microorganisms) and engineering verification, not human expert interpretation of images or other subjective data. No experts (like radiologists) are involved in establishing ground truth for this device's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device. Adjudication methods are typically used in studies where human interpretation or classification is compared, often with disagreements needing resolution. For a sterilization system, the performance is measured objectively against predefined microbial reduction targets or engineering specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Partially applicable, but not in the AI sense. The "device performance" in this context (sterilization efficacy, electrical safety, filter performance, software operation) is inherently "standalone" in that it's the system itself performing its intended function. There isn't an "algorithm-only" performance study distinct from the device's operational performance, as the device is the sterilizing algorithm/process. The tests described (e.g., In-Use Testing, Water Filter Performance) evaluate the device's standalone capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Microbiological Negativity / Sterility: For the "In-Use Testing," the ground truth of "effectively liquid chemically sterilized" implies the absence of viable microorganisms (i.e., sterility) after processing. This would typically be verified through standard microbiological culture methods.
- Engineering Specifications: For Electrical Safety, Water Filter Performance, Water Filter Integrity Test, Cycle Qualification, and Software Validation, the ground truth is adherence to predefined engineering specifications, industry standards (e.g., UL standards), or functional requirements.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set. The device operates based on fixed chemical and physical parameters, not learned data.
9. How the ground truth for the training set was established
- Not applicable. No training set is used for this device.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
March 2, 2018
Steris Corporation Marcia Benedict Senior Director, Regulatory Affairs 5976 Heisley Rd Mentor, Ohio 44060
Re: K173256
Trade/Device Name: System 1 endo Liquid Chemical Sterilant Processing System Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: January 31, 2018 Received: February 1, 2018
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. 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);
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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
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Indications for Use
510(k) Number (if known)
Device Name
SYSTEM 1 endo Liquid Chemical Sterilant Processing System
Indications for Use (Describe)
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary For SYSTEM 1 endo Liquid Chemical Sterilant Processing System
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: February 26, 2018
Premarket Notification Number: K173256
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 |
|---|---|
| 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 claimed primary predicate device is the SYSTEM 1E Liquid Chemical Sterilant Processing System, cleared most recently under K170956.
The S1E prior clearances include Premarket submissions K090036, K101409. K102462, K110352, K131078, K161683.
3. Description of Device
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects.
This new liquid chemical sterilant processing system is based substantially on the predicate device, which was most recently cleared via K170956.
The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Ouick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Table 1 compares the proposed and predicate devices.
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4. Intended Use
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heatsensitive medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
5. Description of Technological Similarities and Differences
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. The differences between the proposed and predicate devices, identified in Table 1 and 2 below, include use of a 0.2 micron bacterial retentive water filter in place of the predicate's extensive water treatment process. Appropriate changes are made to software and labeling as a result. These differences raise no new concerns of safety and effectiveness when compared to the predicate device.
| Feature | Proposed DeviceSYSTEM 1 endo Processor(K173256) | Predicate DeviceSYSTEM 1E Processor(K170956) | Comparison |
|---|---|---|---|
| Intended 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 1E LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable criticaland semi-critical heat-sensitivemedical devices in healthcarefacilities. | The S1 endoLCSPS'sintended use islimited tosemi-criticalmedicaldevices andtheiraccessories. |
| Indicationsfor Use | 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 0.2 | The SYSTEM 1E Processordilutes the S40 SterilantConcentrate to its use dilution(> 1820 mg/L peracetic acid),liquid chemically sterilizes theload during a controlled 6-minuteexposure at 45.5 to 60°C, andrinses the load with extensively | |
| Feature | Proposed DeviceSYSTEM 1 endo Processor(K173256) | Predicate DeviceSYSTEM 1E Processor(K170956) | Comparison |
| micron filtered water.The SYSTEM 1 endo Processoruses only S40 SterilantConcentrate to liquid chemicallysterilize medical devices. | treated* potable water. Aftercompletion of a cycle, criticaldevices should be usedimmediately; semi-criticaldevices should be usedimmediately or may be handledand stored in a manner similar tothat of high level disinfectedendoscopes. Critical devices notused immediately should beprocessed again before use.The SYSTEM 1E Processor usesonly S40 Sterilant Concentrate toliquid chemically sterilizemedical devices.* The extensive treatment of EPApotable water consists of:1. Pre-filtration through two pre-filters:• Pre-filter 1 is a gross depthfilter that removesapproximately 5 micron orlargerparticles/contaminants.• Pre-filter 2 is a surface filterthat removesparticles/contaminants$ > $ 0.1 micron.2. UV Irradiation:• During transit through theUV water treatmentchamber, a UV dosesufficient to achieve a $ \ge $ 6-log reduction of MS2 virus isdelivered to the water.3. 0.1 micron filtration:• The water prepared by pre-filtration and UV irradiationis filtered through redundant,0.1-micron (absolute rated)membranes to removebacteria, fungi and protozoa$ > $ 0.1 micron. | ||
| Feature | Proposed DeviceSYSTEM 1 endo Processor(K173256) | Predicate DeviceSYSTEM 1E Processor(K170956) | Comparison |
| 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. | 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. | Identical,except that theproposeddevice uses0.2 micronfiltered waterin place ofextensivelytreated water. |
| The processor monitors andcontrols the use dilutiontemperature and contact time. Theprocessor automatically rinses theload with 0.2 micron filteredwater to remove sterilantresiduals. | The processor monitors andcontrols the use dilutiontemperature and contact time. Theprocessor automatically rinses theload with extensively treatedfiltered water to remove sterilantresiduals. | ||
| 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: | • 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 | • 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 | Identical,except there isno UV systemintensity to bemonitored inthe proposeddevice. |
| Feature | Proposed DeviceSYSTEM 1 endo Processor(K173256) | Predicate DeviceSYSTEM 1E Processor(K170956) | Comparison |
| Alarms if pressure transducerindicates circulation pressureis out of specification inDiagnostic cycleAlarms if pressure transducer●indicates internal water filterfailed integrity test | Alarms if pressure transducerindicates circulation pressureis out of specification inDiagnostic cycleAlarms if pressure transducerindicates internal water filterfailed integrity testAlarms if UV monitorindicates UV intensity out ofspecification | ||
| DesignFeatures | Microprocessor controlled●unalterable and standardizedliquid chemical sterilizationand Diagnostic cyclesIntended for use only with●S40 Sterilant ConcentrateAutomated dilution and●delivery of S40 SterilantProcessor provides 0.2 micron●filtered water for liquidchemical sterilization andrinsingMake-up air for processor●during drain sequences isfiltered through a 0.2 micronmembrane air filter | Microprocessor controlledunalterable and standardizedliquid chemical sterilizationand Diagnostic cyclesIntended for use only withS40 Sterilant ConcentrateAutomated dilution anddelivery of S40 Sterilant· Processor providesextensively treated (UVirradiated, 0.1 micron filtered)water for liquid chemicalsterilization and rinsingMake-up air for processorduring drain sequences isfiltered through a 0.2 micronmembrane air filter | Identical,except thatthe proposeddevice uses0.2 micronfiltered waterin place ofextensivelytreated water. |
| Cycle Parameters | Comparison | ||
| Incomingwater temp. | > 43°C | > 43°C | Identical |
| Temperatureto startsterilantexposure | > 46°C | > 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 |
| Feature | Proposed DeviceSYSTEM 1 endo Processor(K173256) | Predicate DeviceSYSTEM 1E Processor(K170956) | Comparison |
| Rinse waterpreparation | Hot potable tap water• is pre-filtered• is filtered through 0.2 micronbacterial retentive membranefilter | Hot potable tap water• is pre-filtered• flows through a UV lightwater treatment chamber toachieve > a 6-log reductionof virus• is filtered through redundant0.1 micron membranes | The proposeddevice uses0.2 micronfiltered waterin place ofextensivelytreated water. |
| 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 at the end of everyLiquid Chemical Sterilizationcycle and during the Diagnosticcycle | Only inDiagnosticCycle of S1endo LCSPS |
| ApproximateCycle Time | 18 - 20 minutes | 23 - 25 minutes | S1 endo hasshorter totalcycle time |
| 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 15 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. | Identicalexcept thatproposed S1endo LCSPShas no UVunit test |
| Accessories | Comparison | ||
| 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 | Uses interchangeable processingtrays/containers• Universal Flex Processing Tray• General Processing Container& Tray• Directed Flow ProcessingContainer & Tray• Flexible Endoscope ProcessingContainer & Tray | Identical |
| Feature | Proposed DeviceSYSTEM 1 endo Processor(K173256) | Predicate DeviceSYSTEM 1E Processor(K170956) | Comparison |
| • Ultrasound Processing Tray | • Ultrasound Processing Tray | ||
| 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 isavailable for use in SYSTEM 1endo LCSPS (separate clearance) | VERIFY Chemical Indicator isavailable for SYSTEM 1E(K102217) | Identicaldesign |
| Spore TestStrip | VERIFY Spore Test Strip for S40Sterilant for use in SYSTEM 1endo LCSPS (separate clearance) | VERIFY Spore Test Strip for S40Sterilant (DEN110002) | Identicaldesign |
| OperatorMaintenance | Periodic replacement of printertape, water filters and air filter | Periodic replacement of printertape, water filters and air filter | Identical |
Table 1. Processor Comparison Table
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Table 2. S40 Sterilant Concentrate Comparison Table
| Feature | S40 Sterilant Concentratein S1 endo LCSPS (K173256) | S40 Sterilant Concentratein S1E LCSPS (K170956) | Comparison |
|---|---|---|---|
| Intended Use | For use in S1E and S1 endo | For use in S1E only | Adds a newintended use |
| 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 is openedand diluted by the processor,limiting user exposure to thesterilant concentrate | Identical |
| ActiveIngredient | 35% peroxyacetic (peracetic)acid automatically diluted foruse in the Processor | 35% peroxyacetic (peracetic) acidautomatically diluted for use inthe Processor | Identical |
| Feature | S40 Sterilant Concentratein S1 endo LCSPS (K173256) | S40 Sterilant Concentratein S1E LCSPS (K170956) | Comparison |
| 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 walls1-hydroxyl radicals producedfrom PAA are bactericidal2-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 rinses withpre-filtered, UV irradiated, dual0.1 micron membrane filtered.potable hot water | Identical |
| 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,OfficialMethods | Solution is bactericidalSalmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosa | Solution is bactericidalSalmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosa | Identical |
| Feature | S40 Sterilant Concentratein S1 endo LCSPS (K173256) | S40 Sterilant Concentratein S1E LCSPS (K170956) | Comparison |
| 955.14,955.15, 964.02 | Testing conducted in vitro | Testing 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 |
| 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 S1E LCSPS | Identical |
| CytotoxicityDeviceExtracts | Two Processor controlled rinses(time, temperature, and volumeequivalent to predicate) withpre-filtered, dual 0.2 micronfiltered potable water effectivelyreduce sterilant residues to non-cytotoxic levels. | Two Processor controlled rinseswith pre-filtered, UV treated, dual0.1 micron membrane filteredpotable water effectively reducesterilant residues to non-cytotoxiclevels. | Identical |
| ResidueReduction | Two Processor controlled rinses(time, temperature, and volumeequivalent to predicate) withpre-filtered, dual 0.2 micronfiltered potable water effectivelyreduce sterilant residues to safelevels. | Two Processor controlled rinseswith pre-filtered, UV irradiated,dual 0.1 micron membrane filteredpotable water effectively reducesterilant residues to safe levels. | Identical |
| Feature | S40 Sterilant Concentratein S1 endo LCSPS (K173256) | S40 Sterilant Concentratein S1E LCSPS (K170956) | Comparison |
| 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 medical devicesas established by testing finishedmedical devices through 300cycles. No functional changesoccurred to devices. Somematerials show cosmetic changessuch as fading of externalmarkings (yet all remainedlegible) and bleaching of blackanodized aluminum without harmto the base material. | Identical |
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1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001
2 Clapp et al., Free Rad. Res., (1994) 21:147-167
3 Maillard et. al., J. Med. Microbiol (1995) 42:415-420
4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554
5 McDonnell et al., J. AOAC International (2000) 83:269-275
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6. Description of Safety and Substantial Equivalence
The SYSTEM endo Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific differences described in this submission and identified in Tables 1 and 2.
The proposed device and its predicate have similar intended use and technological characteristics. The differences raise no new concerns of safety and effectiveness when compared to the predicate device. New testing was performed to evaluate and demonstrate substantial equivalence to the predicate as summarized in Table 3.
| Test | Acceptance Criteria | Result |
|---|---|---|
| In-Use Testing | Clinically used, cleaned semi-critical heat-sensitivemedical devices exposed to varied clinical soils wereeffectively liquid chemically sterilized. | PASS |
| Electrical SafetyConformance | UL 61010-1:2012 Ed.3+R:29 Apr2016 ElectricalEquipment for Measurement, Control, and LaboratoryUse Part 1: General RequirementsUL 61010-2-040:2016 Ed.2 Electrical Equipment ForMeasurement, Control, And Laboratory Use Part 2-040:Particular Requirements For Sterilizers And Washer-Disinfectors Used To Treat Medical Materials | PASS |
| Water FilterPerformancethrough Use Life | The 0.2 micron MaxLife filter maintained its integrityand achieved effective bacterial retention performanceafter numerous Liquid Chemical Sterilization Cycles andDiagnostic Cycles representing 6 months of active use. | PASS |
| Water FilterIntegrity Test | The Diagnostic Cycle correctly detects loss of filterintegrity or absence of a filter. | PASS |
Table 3. Performance Testing
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| CycleQualification | All cycle specifications were met for three (3) cycleseach, Liquid Chemical Sterilization and Diagnostic. | PASS |
|---|---|---|
| SoftwareValidation | The software that controls the system was validated anddetermined to operate effectively and as designed. | PASS |
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs at least as well as the legally marketed predicate device (K170956), Class II (21 CFR 880.6885), product code MED.
§ 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.