(108 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, 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.
The provided text describes a 510(k) premarket notification for a medical device (SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900) which has undergone "certain software modifications made after the clearance of K182827" (its predicate device). The document primarily focuses on demonstrating substantial equivalence to the predicate, K182827.
The "study" referenced in the text pertains to the Software Validation of the modified device.
Here's the breakdown of the acceptance criteria and study as requested, based on the provided document:
Acceptance Criteria and Device Performance for Software Validation
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The software that controls the system was validated and determined to operate effectively and as designed. | Pass |
Details of the Study (Software Validation)
-
Sample Size Used for the Test Set and Data Provenance:
- The document states "New testing was performed to evaluate the modified device," specifically for "Software Validation," and indicates that the software was "validated."
- However, no specific sample size (e.g., number of test cases, number of cycles) for this software validation test set is provided in the document.
- Data Provenance: Not explicitly stated, but it would logically be controlled testing data from the manufacturer (STERIS Corporation) rather than patient or clinical data. Given the regulatory submission context, it would be considered prospective testing for the purpose of validating the software modifications. Country of origin for the data is not specified, but the submission is to the US FDA.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. Software validation typically involves testing against pre-defined requirements and expected outcomes, which are established by software engineers and subject matter experts (SMEs). The document does not specify the number or qualifications of these individuals involved in establishing the testing parameters or reviewing the results.
-
Adjudication Method for the Test Set:
- The document states "The software that controls the system was validated and determined to operate effectively and as designed."
- The adjudication method is implicitly direct verification against established functional and design specifications. There is no mention of a human consensus-based adjudication method (e.g., 2+1, 3+1) as commonly seen in medical image analysis.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic aids or algorithms that directly impact human interpretation (e.g., radiologists reading images). This device is a sterilizing system with software controls, not a diagnostic tool requiring human reader performance evaluation.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- The software validation (implied as 'algorithm only' if considering the software as the 'algorithm') was indeed done. The device's operation is automated. The validation goal was to confirm the software performs as designed and controls the system effectively.
-
The Type of Ground Truth Used:
- The ground truth for the software validation is implicit in the design specifications and functional requirements of the software. It's based on engineering specifications and expected system behavior rather than expert consensus, pathology, or outcomes data. The "acceptance criteria" listed essentially serve as the definition of "ground truth" for the software's performance.
-
The Sample Size for the Training Set:
- This device is a hardware system with software controls, not an AI/ML algorithm that requires a "training set" in the conventional sense (e.g., for pattern recognition or predictive modeling). Therefore, the concept of a training set as used in machine learning is not applicable here, and no information about it is provided. The software was likely developed and then validated against its specifications.
-
How the Ground Truth for the Training Set Was Established:
- As explained above, the concept of a training set is not applicable to this device's software validation as described.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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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
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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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Image /page/3/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is in all capital letters and in a serif font. Below the word is a graphic of several horizontal wavy lines that are blue.
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
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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
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.
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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 DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem , Model P6900 | Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K182827) | 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 LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization of cleaned,immersible, and reusable semi-critical heat-sensitive medicaldevices and their accessories inhealthcare facilities. | Identical |
| The SYSTEM 1 endo Processorautomatically dilutes the S40Sterilant Concentrate to its usedilution (> 1820 mg/L peracetic | The SYSTEM 1 endo Processorautomatically dilutes the S40Sterilant Concentrate to its usedilution (> 1820 mg/L peracetic | ||
| Feature | Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem , Model P6900 | Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K182827) | Comparison |
| acid), 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. | acid), 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 Processoruses only S40 SterilantConcentrate to liquid chemicallysterilize medical devices. | ||
| A microprocessor controlled unitwith interchangeable processingtrays/containers. The processorlid opens to reveal the processingchamber in which the load isplaced.Devices with internal lumens are | A microprocessor controlled unitwith interchangeable processingtrays/containers. The processorlid opens to reveal the processingchamber in which the load isplaced.Devices with internal lumens are | ||
| OperatingPrinciples/Technology | interfaced with the processorusing connectors, i.e. QuickConnects. | interfaced 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. | S40 Sterilant is placed in aspecialized compartment andwhen the processor fills withwater, it creates the sterilant usedilution from the single usesterilant cup. | Identical | |
| 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 0.2 micron filteredwater to remove sterilantresiduals. | ||
| Standardized cycle parameterscannot be altered by operator. Thecritical process parameters are: | Standardized cycle parameterscannot be altered by operator. Thecritical process parameters are: | ||
| ProcessParameters | • 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 DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem , Model P6900 | Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K182827) | Comparison |
| ProcessMonitors: | 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 |
| DesignFeatures | 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 DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem , Model P6900 | Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K182827) | Comparison |
| 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 |
| Rinse waterpreparation | Hot potable tap water• is pre-filtered• is filtered through 0.2 micronbacterial retentive membranefilter | Hot potable tap water• is pre-filtered• is filtered through 0.2 micronbacterial retentive membranefilter | 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 |
| 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 a | 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 a | Identical |
| Feature | Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem , Model P6900 | Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K182827) | Comparison |
| successful Diagnostic cycle hasbeen completed. | successful Diagnostic cycle hasbeen completed. | ||
| 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• 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, if using the external printeroption. | Identical |
| Feature | Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem , Model P6900 | Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K182827) | 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, dual 0.2micron membrane filtered,potable hot water | Identical |
| Feature | Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem , Model P6900 | Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K182827) | 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 |
| Feature | Proposed DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem , Model P6900 | Predicate DeviceSYSTEM 1 endo LiquidChemical Sterilant ProcessingSystem, Model P6900(K182827) | Comparison |
| 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 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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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 wasvalidated and determined to operateeffectively 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).
§ 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.