(175 days)
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.
The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
- The extensive treatment of EPA potable water consists of:
- Pre-filtration through two pre-filters:
- · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
- · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron.
- UV Irradiation:
- During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
- 0.1 micron filtration:
· The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Five Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, and labeling. This premarket notification introduces a new processing tray that will accommodate ultrasound endoscopes and other large flexible devices and their associated Quick Connects. Additionally, minor inconsistent statements in the cleared Indications for Use are corrected, and clarification is provided on post-processing handling and storage of critical and semi-critical medical devices.
The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1 micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.
This document is a 510(k) summary for the SYSTEM 1E Liquid Chemical Sterilant Processing System, seeking substantial equivalence to a previously cleared device (K161683). The primary changes are the addition of a new Ultrasound Processing Tray and related Quick Connects, and minor labeling updates. The document relies heavily on the predicate device's performance data, as the technological principles are largely identical.
Here's an attempt to extract the requested information based on the provided text, acknowledging that much of the "study" detail refers to previously established performance for the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in a typical quantitative clinical trial format. Instead, it describes performance characteristics and equivalency to the predicate device. The primary performance criterion is achieving sterilization.
| Feature / Criterion (as implied) | Reported Device Performance (Proposed SYSTEM 1E Processor) | Comment (Comparison to predicate K161683) |
|---|---|---|
| Sterilization Efficacy | ||
| Sporicidal Activity (B. subtilis, C. sporogenes) | Meets efficacy requirements (in vitro) | Identical to predicate |
| Confirmatory Sporicidal Activity (B. subtilis, C. sporogenes) | Meets efficacy requirements (in vitro) | Identical to predicate |
| Fungicidal Activity (Trichophyton mentagrophytes) | Solution is fungicidal (in vitro) | Identical to predicate |
| Bactericidal Activity (Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa) | Solution is bactericidal (in vitro) | Identical to predicate |
| Virucidal Activity (Herpes simplex Type 1, Adenovirus Type 5, Poliovirus Type 1) | Solution is virucidal (in vitro) | Identical to predicate |
| Tuberculocidal Activity (Mycobacterium terrae) | Solution is tuberculocidal (in vitro) | Identical to predicate |
| Simulated-Use Test (Geobacillus stearothermophilus spores) | Meets efficacy requirement: > 6 log10 reduction (manual application) | Identical to predicate |
| Clinical In-Use | No surviving microorganisms on representative medical devices tested | Identical to predicate |
| Processing Cycle Parameters | ||
| Contact Time | 6 minutes | Identical to predicate |
| Use Dilution Temperature | 45.5-60°C (allowable), 46-55°C (typical) | Identical to predicate |
| Peracetic acid concentration | >1820 mg/L | Identical to predicate |
| Incoming water temperature | $\ge 43^\circ C$ | Identical to predicate |
| Temperature to start exposure phase | $\ge 46^\circ C$ | Identical to predicate |
| Temperature alarm point during exposure phase | <45.5 or >60°C | Identical to predicate |
| Rinse water preparation | Pre-filtered, UV treated ($\ge$ 6-log reduction of virus), redundant 0.1 micron filtered | Identical to predicate |
| Number of rinses | 2 | Identical to predicate |
| Water Filter Integrity Test | Conducted at end of every liquid chemical sterilant processing cycle and during Diagnostic cycle | Identical to predicate |
| Approximate Cycle Time | 25 minutes | Identical to predicate |
| Biocompatibility | ||
| Cytotoxicity / Residue Reduction | Two rinses effectively reduce sterilant residues to safe levels (with UV treated, dual 0.1 micron membrane filtered water) | Identical to predicate |
| Device Material Compatibility | Compatible with medical devices (tested flexible endoscopes through 300 cycles and rigid devices through 150 cycles). No functional changes to flexible devices. Some cosmetic changes (fading) on specific materials without harm to base material. | Identical to predicate |
Study Proving Device Meets Acceptance Criteria
The document states, "Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as the legally marketed predicate device (K161683)..." This indicates that the primary "study" is a demonstration of substantial equivalence to a previously cleared device. For the specific modifications introduced in this submission (new Ultrasound Processing Tray and Quick Connects), the document states: "Any new safety and efficacy concerns were addressed through verification testing."
Since this is a 510(k) submission primarily demonstrating substantial equivalence, direct clinical efficacy studies for the new model in comparison to the predicate are not detailed. Instead, the focus is on showing that the minor changes do not introduce new questions of safety or effectiveness and that the established sterilization efficacy of the previous model (K161683) still applies.
Specific Study Types Mentioned/Implied:
- Microbial Efficacy Testing: This refers to in vitro and simulated-use tests proving the sporicidal, fungicidal, bactericidal, virucidal, and tuberculocidal claims. These are likely standardized tests (e.g., AOAC Official Methods, EPA Virucidal Testing, Ascenzi Quantitative Suspension Test).
- Biocompatibility Testing: Focusing on cytotoxicity, residue reduction, and device material compatibility after repeated processing cycles.
- Verification Testing: Specifically for the new Ultrasound Processing Tray and Quick Connects, to address any new safety and efficacy concerns. This would typically involve validating fluid flow, sterilant contact, rinse effectiveness, and material compatibility for the new components and devices intended to be processed in them.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a dataset for an AI model. This is a medical device sterilization system, not an AI/Software as a Medical Device.
- Microbial Efficacy (In vitro/Simulated-Use): The exact sample sizes for these tests are not provided in the summary, but they would typically involve established protocols for sterility testing.
- Device Material Compatibility: "testing finished flexible endoscopes through 300 cycles and rigid devices through 150 cycles."
- Data Provenance: Not explicitly stated as "country of origin" for data, but the tests cited (AOAC, EPA, Ascenzi) are standard scientific and regulatory compliance tests. The company STERIS Corporation is based in Ohio, USA. The testing context is for regulatory approval within the USA (FDA). The nature of these tests is generally prospective in a lab setting, following predefined validated protocols.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a sterilizing system, not an AI diagnostic tool that requires human experts for ground truth establishment on a test set of data. The "ground truth" for sterilization is the absence of viable microorganisms, determined through microbiological testing.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
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
This information is not applicable. This is not an AI/Software as a Medical Device, and no human reader interpretation is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical sterilizing system and does not involve AI algorithms in the sense of image interpretation or diagnostic performance. Its performance is evaluated through its ability to mechanically and chemically sterilize devices autonomously.
7. The type of ground truth used
The "ground truth" for this device is sterility, meaning the complete absence of viable microorganisms. This is established through various microbiological tests:
- Spore-kill validation: Using highly resistant bacterial spores (e.g., Bacillus subtilis, Clostridium sporogenes, Geobacillus stearothermophilus) that are considered the gold standard for sterilization efficacy.
- Absence of other microorganisms: Fungi, bacteria, viruses, and mycobacteria are also tested, demonstrating broader microbicidal activity.
- Clinical In-Use data: Demonstrating no surviving microorganisms on representative medical devices after processing.
8. The sample size for the training set
This information is not applicable. This is not an AI/Machine Learning device that requires a "training set" of data.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as #8.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are arranged in a way that suggests movement or flow. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2017
Steris Corporation Tricia Cregger Senior Manager, Regulatory Affairs 5960 Heisley Rd Mentor. Ohio 44060
Re: K170956
Trade/Device Name: System 1E Liquid Chemical Sterilant Processing System Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: August 25, 2017 Received: August 28, 2017
Dear Tricia Cregger:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Tara A. Ryan -S 2017.09.22 19:20:55 -04'00'
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K170956
Device Name
SYSTEM 1E Liquid Chemical Sterilant Processing System
Indications for Use (Describe)
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.
The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liguid chemically sterilize medical devices.
- The extensive treatment of EPA potable water consists of:
- Pre-filtration through two pre-filters:
- · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
- · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron.
2. UV Irradiation:
- During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
3.0.1 micron filtration:
· The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word "STERIS" is written in a serif font in all capital letters. Below the word is a graphic of several horizontal wavy lines in blue. The registered trademark symbol is to the right of the word STERIS.
510(k) Summary For SYSTEM 1E Liquid Chemical Sterilant Processing System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
Tricia Cregger, Ph. D. Contact: Senior Manager, Regulatory Affairs Tel: 440-392-7189 Fax: 440-357-9198
September 22, 2017 Summary Date:
Premarket Notification Number: K170956
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
{4}------------------------------------------------
1. Device Name
| Trade Name: | SYSTEM 1E Liquid Chemical SterilantProcessing System |
|---|---|
| Device Classification: | Class II |
| 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 1E Liquid Chemical Sterilant Processing System cleared under K161683
3. Description of Device
The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Five Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, and labeling. This premarket notification introduces a new processing tray that will accommodate ultrasound endoscopes and other large flexible devices and their associated Quick Connects. Additionally, minor inconsistent statements in the cleared Indications for Use are corrected, and clarification is provided on post-processing handling and storage of critical and semi-critical medical devices.
The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1 micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
{5}------------------------------------------------
S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.
4. Intended Use
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semicritical heat-sensitive medical devices in healthcare facilities.
The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.
The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
- 米 The extensive treatment of EPA potable water consists of:
-
- Pre-filtration through two pre-filters:
- Pre-filter A is a gross depth filter that removes approximately 2.5 . micron or larger particles/contaminants.
- Pre-filter B is a surface filter that removes particles/contaminants > . 0.1 micron.
-
- UV Irradiation:
- During transit through the UV water treatment chamber, a UV dose . sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
-
- 0.1 micron filtration:
- The water prepared by pre-filtration and UV irradiation is filtered ● through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
-
{6}------------------------------------------------
ડ. Description of Technological Similarities and Differences
The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific modification described in this submission. The differences between the proposed and predicate devices are limited to the addition of a new Ultrasound Processing Tray and the Quick Connects that enable the processing of large flexible ultrasound devices and labeling updates to correct errors and provide clarity to users and these proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.
| Feature | ProposedSYSTEM 1E Processor | K161683SYSTEM 1E Processor | Comparison |
|---|---|---|---|
| Indicationsfor Use | The SYSTEM 1E LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization ofcleaned, immersible, andreusable critical and semi-critical heat-sensitive medicaldevices in healthcare facilities. | The SYSTEM 1E LiquidChemical Sterilant ProcessingSystem is intended for liquidchemical sterilization ofcleaned, immersible, andreusable critical and semi-critical heat-sensitive medicaldevices in healthcare facilities. | The minordifferencesbetween theIndications forUse for theproposed andpredicate devicesare for thecorrection oferrors in theIndications forUse, for changesin designation ofthe pre-filtersfrom 1 and 2 to Aand B forconsistency withall other labelingand to provideclarity for usageand storage ofprocesseddevices. Therewere no changesin performance. |
| The SYSTEM 1E Processordilutes the S40 SterilantConcentrate to its use dilution(>1820 mg/L peracetic acid),liquid chemically sterilizes theload during a controlled 6-minute exposure at 45.5 to60℃, and rinses the load withextensively treated* potablewater. After completion of acycle, critical devices shouldbe used immediately; semi-critical devices should be usedimmediately or may behandled and stored in amanner similar to that of highlevel disinfected endoscopes.Critical devices not usedimmediately should beprocessed again before use. | The SYSTEM 1E Processordilutes the S40 SterilantConcentrate to its use dilution(>1820 mg/L peracetic acid),liquid chemically sterilizes theload during a controlled 6-minute exposure at 46 to55℃, and rinses the load withextensively treated* potablewater. The processed loadshould be used immediately.The SYSTEM 1E Processoruses only S40 SterilantConcentrate to liquidchemically sterilize medicaldevices.* The extensive treatment ofEPA potable water consists of:1. Pre-filtration through two | ||
| Proposed | K161683 | ||
| Feature | SYSTEM 1E Processor | SYSTEM 1E Processor | Comparison |
| The SYSTEM 1E Processoruses only S40 SterilantConcentrate to liquidchemically sterilize medicaldevices.* The extensive treatment ofEPA potable water consists of:1. Pre-filtration through twopre-filters:• Pre-filter A is a grossdepth filter thatremoves approximately2.5 micron or largerparticles/contaminants.• Pre-filter B is a surfacefilter that removesparticles/contaminants> 0.1 micron.2. UV Irradiation:• During transit throughthe UV water treatmentchamber, a UV dosesufficient to achieve a$\ge$ 6-log reduction ofMS2 virus is deliveredto the water.3. 0.1 micron filtration:• The water prepared bypre-filtration and UVirradiation is filteredthrough redundant, 0.1-micron (absolute rated)membranes to removebacteria, fungi andprotozoa > 0.1 micron. | pre-filters:• Pre-filter 1 is a grossdepth filter thatremoves approximately5 micron or largerparticles/contaminants.• Pre-filter 2 is a surfacefilter that removesparticles/contaminants> 0.1 micron.2. UV Irradiation:• During transit throughthe UV water treatmentchamber, a UV dosesufficient to achieve a$\ge$ 6-log reduction ofMS2 virus is deliveredto the water.3. 0.1 micron filtration:• The water prepared bypre-filtration and UVirradiation is filteredthrough redundant, 0.1-micron (absolute rated)membranes to removebacteria, fungi andprotozoa > 0.1 micron. | ||
| Feature | ProposedSYSTEM 1E Processor | K161683SYSTEM 1E Processor | Comparison |
| OperatingPrinciples/Technology | A microprocessor controlledunit with interchangeableprocessing trays/containers.The processor lid opens toreveal the processing chamberin which the load is placed.Devices with internal lumensare interfaced with theprocessor using connectors.Sterilant Concentrate is placedin a specialized compartmentand when the processor fillswith water, it creates thesterilant use dilution from thesingle use sterilant cup. Theprocessor monitors andcontrols the use dilutiontemperature and contact time.The processor automaticallyrinses the load withextensively treated water toremove sterilant residuals. | A microprocessor controlledunit with interchangeableprocessing trays/containers.The processor lid opens toreveal the processing chamberin which the load is placed.Devices with internal lumensare interfaced with theprocessor using connectors.Sterilant Concentrate is placedin a specialized compartmentand when the processor fillswith water, it creates thesterilant use dilution from thesingle use sterilant cup. Theprocessor monitors andcontrols the use dilutiontemperature and contact time.The processor automaticallyrinses the load withextensively treated water toremove sterilant residuals. | Identical |
| ProcessParameters | Standardized cycle parameterscannot be altered by operator.The critical processparameters are:Contact Time Use Dilution Temperature Peracetic acidconcentration Bacterial retentive waterfilter integrity UV irradiation | Standardized cycle parameterscannot be altered by operator.The critical processparameters are:Contact Time Use Dilution Temperature Peracetic acidconcentration Bacterial retentive waterfilter integrity UV irradiation | Identical |
| ProcessMonitors | Cycle Printout documentssuccessful cyclecompletion or identifiesfault if cycle aborts Alarms if thermocouplesindicate temperature outof specification Alarms if pressure switchindicates that highpressure pump is notoperating | Cycle Printout documentssuccessful cyclecompletion or identifiesfault if cycle aborts Alarms if thermocouplesindicate temperature outof specification Alarms if pressure switchindicates that highpressure pump is notoperating | Identical |
| Proposed | K161683 | ||
| Feature | SYSTEM 1E Processor | SYSTEM 1E Processor | Comparison |
| DesignFeatures | probe indicatedconductivity specificationnot met Alarms if pressuretransducer indicatescirculation pressure is outof specification duringDiagnostic cycle Alarms if pressuretransducer indicates 0.1micron water filter failedintegrity test duringliquid chemical sterilantprocessing andDiagnostic cycles. Alarms if UV monitorindicates UV intensityout of specification Microprocessorcontrolled unalterableand standardized liquidchemical sterilantprocessing andDiagnostic cycles Intended for use with S40Sterilant Concentrate Processor provides dual0.1 micron filtered, UVtreated water for liquidchemical sterilantprocessing and rinsing Automated dilution anddelivery of sterilant Make up air for processorduring drain sequences isfiltered through a 0.2micron membrane airfilter. | probe indicatedconductivity specificationnot met Alarms if pressuretransducer indicatescirculation pressure is outof specification duringDiagnostic cycle Alarms if pressuretransducer indicates 0.1micron water filter failedintegrity test duringliquid chemical sterilantprocessing andDiagnostic cycles. Alarms if UV monitorindicates UV intensityout of specification Microprocessorcontrolled unalterableand standardized liquidchemical sterilantprocessing andDiagnostic cycles Intended for use with S40Sterilant Concentrate Processor provides dual0.1 micron filtered, UVtreated water for liquidchemical sterilantprocessing and rinsing Automated dilution anddelivery of sterilant Make up air for processorduring drain sequences isfiltered through a 0.2micron membrane airfilter. | Identical |
| Processing Cycle | |||
| Incomingwatertemperature | $ \u2265 43°C $ | $ \u2265 43°C $ | Identical |
| Temperatureto startexposurephase | $ \u2265 46°C $ | $ \u2265 46°C $ | Identical |
| Feature | ProposedSYSTEM 1E Processor | K161683SYSTEM 1E Processor | Comparison |
| Temperaturealarm pointduring theexposurephase | <45.5 or >60°C | <45.5 or >60°C | Identical |
| Temperaturerange duringa typicalLiquidChemicalSterilantProcessingCycle | 46 - 55°C | 46 - 55°C | Identical |
| ExposureTime | 6 minutes | 6 minutes | Identical |
| Rinse waterpreparation | Hot potable tap water is:• pre-filtered• flowed through a UVLight treatment chamberto achieve ≥ a 6-logreduction of virus• Filtered throughredundant 0.1 micronfilter membranes | Hot potable tap water is:• pre-filtered• flowed through a UVLight treatment chamberto achieve ≥ a 6-logreduction of virus• Filtered throughredundant 0.1 micronfilter membranes | 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 |
| Water FilterIntegrityTest | Conducted at the end of everyliquid chemical sterilantprocessing cycle and duringthe Diagnostic cycle | Conducted at the end of everyliquid chemical sterilantprocessing cycle and duringthe Diagnostic cycle | Identical |
| ApproximateCycle time | 25 minutes | 25 minutes | Identical |
| Feature | ProposedSYSTEM 1E Processor | K161683SYSTEM 1E Processor | Comparison |
| DiagnosticCycle | Performs 15 tests on processor's systems confirming proper function (same tests as predicate device except for an added UV monitor test). Recommended to perform every 24 hours. After a failed Diagnostic cycle, a liquid chemical sterilant processing cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed. | Performs 15 tests on processor's systems confirming proper function (same tests as predicate device except for an added UV monitor test). Recommended to perform every 24 hours. After a failed Diagnostic cycle, a liquid chemical sterilant processing cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed. | Identical |
| Interchangeable Components | |||
| Processing Tray / Containers | Uses interchangeable processing trays/containers Universal Flexible Processing Tray (C1160E) General Processing Container/Tray (C1200) Directed Flow Processing Container/Tray (C1220) Flexible Endoscope Processing Container / Tray (C1140) Ultrasound Processing Tray (C3000XL) | Uses interchangeable processing trays/containers Universal Flexible Processing Tray (C1160E) General Processing Container/Tray (C1200) Directed Flow Processing Container/Tray (C1220) Flexible Endoscope Processing Container / Tray (C1140) | The proposed device has available one more interchangeable tray than does the predicate device. This additional tray is designed for processing large ultrasound devices that do not fit into the other trays. Any new safety and efficacy concerns were addressed through verification testing. |
| Accessories | |||
| Sterilant Concentrate | Uses S40 Sterilant Concentrate | Uses S40 Sterilant Concentrate | Identical |
| Quick Connects | Uses Quick Connects to adapt instrument lumens to the Tray/Container ports | Uses Quick Connects to adapt instrument lumens to the Tray/Container ports | The proposed device has additional Quick Connects to enable the processing of the larger ultrasound devices in the Ultrasound |
| Feature | ProposedSYSTEM 1E Processor | K161683SYSTEM 1E Processor | Comparison |
| Processing Tray.These QuickConnectsfunction in asimilar manner tocurrentlymarketed QuickConnects. Anynew safety andefficacy concernswere addressedthroughverificationtesting. | |||
| ChemicalIndicator | VERIFY Chemical Indicatorfor the SYSTEM 1E Processor(K102217) | VERIFY Chemical Indicatorfor the SYSTEM 1EProcessor (K102217) | Identical |
| Spore TestStrip | VERIFY Spore Test Strip forS40 Sterilant Concentrate(K100049) | VERIFY Spore Test Strip forS40 Sterilant Concentrate(K100049) | Identical |
| OperatorMaintenanceRequirements | Periodic replacement ofprinter tape, water filters andair filter | Periodic replacement ofprinter tape, water filters andair filter | Identical |
Device Comparison Table
Table 5-1. Processor Device Comparison Table
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
Table 5-2. Sterilant Concentrate Device Comparison Table
| Feature | ProposedS40 Sterilant Concentrate | K161683S40 Sterilant Concentrate | Comparison |
|---|---|---|---|
| Indications forUse | S40 Sterilant Concentrate isfor use only with theSYSTEM 1E LiquidChemical SterilantProcessing System | S40 Sterilant Concentrate isfor use only with theSYSTEM 1E LiquidChemical SterilantProcessing System | Identical |
| Germicidalclaim | Liquid Chemical Sterilant | Liquid Chemical Sterilant | Identical |
| GermicideExposure Time(min) forintended use | 6 | 6 | Identical |
| UseTemperature | 45.5-60°C -- allowable46-55°C - typicalPotency and simulated useevaluations conducted at<43°C | 45.5-60°C -- allowable46-55°C - typicalPotency and simulated useevaluations conducted at<43°C | Identical |
| Feature | ProposedS40 Sterilant Concentrate | K161683S40 Sterilant Concentrate | Comparison |
| Reuse | Single use | Single use | Identical |
| Human Factors | Dispensed ready to use.Container is opened anddiluted by the processor,thus limiting user exposureto the active ingredient | Dispensed ready to useContainer is opened anddiluted by the processor,thus limiting user exposureto the active ingredient | Identical |
| ActiveIngredient | 35% peroxyacetic(peracetic) acidautomatically diluted for usein the SYSTEM 1EProcessor. | 35% peroxyacetic(peracetic) acidautomatically diluted for usein the SYSTEM 1EProcessor. | Identical |
| Mode of Action | It is believed that peraceticacid exerts its germicidaleffect by severalmechanisms:-oxidizing sulfhydryl andsulfur bonds in proteins andenzymes, particularly in thecell walls 1-hydroxyl radicals producedfrom PAA are bactericidal 2-PAA damages the viralcapsid and viral nucleicacid3,4. | It is believed that peraceticacid exerts its germicidaleffect by severalmechanisms:-oxidizing sulfhydryl andsulfur bonds in proteins andenzymes, particularly in thecell walls1-hydroxyl radicals producedfrom PAA are bactericidal2-PAA damages the viralcapsid and viral nucleicacid3,4 | Identical |
| Rinses | Automatic, UV-irradiated,dual 0.1 micron filtered,potable hot water. | Automatic, UV-irradiated,dual 0.1 micron filtered,potable hot water. | Identical |
| Microbial Efficacy | |||
| SporicidalActivity ofDisinfectantsAOAC OfficialMethod 966.04 | Meets efficacyrequirements5.Bacillus subtilisClostridium sporogenesTesting conducted in vitro | Meets efficacyrequirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro | Identical |
| ConfirmatorySporicidalActivity ofDisinfectantsAOAC OfficialMethod 966.04 | Meets efficacyrequirements 6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro | Meets efficacyrequirements6.Bacillus subtilisClostridium sporogenesTesting conducted in vitro | Identical |
| FungicidalActivity of | Solution is fungicidal.Trichophyton | Solution is fungicidal.Trichophyton | Identical |
| Feature | ProposedS40 Sterilant Concentrate | K161683S40 Sterilant Concentrate | Comparison |
| DisinfectantsAOAC OfficialMethod 955.17 | mentagrophytesTesting conducted in vitro | mentagrophytesTesting conducted in vitro | |
| Use DilutionMethod AOAC,OfficialMethods 955.14,955.15, 964.02 | Solution is bactericidal.Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosaTesting conducted in vitro | Solution is bactericidal.Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosaTesting conducted in vitro | Identical |
| EPA VirucidalTesting(DIS/TSS-7,Nov. 1981) | Solution is virucidal.Herpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro | Solution is virucidal.Herpes simplex Type 1Adenovirus Type 5Poliovirus Type 1Testing conducted in vitro | Identical |
| TuberculocidalActivity AscenziQuantitativeSuspension Test | Solution is tuberculocidalMycobacterium terraeTesting conducted in vitro | Solution is tuberculocidalMycobacterium terraeTesting conducted in vitro | Identical |
| Simulated-UseTest | Meets efficacy requirement.> 6 log10 reductionGeobacillusstearothermophilus sporesin a manual application | Meets efficacy requirement.> 6 log10 reductionGeobacillusstearothermophilus sporesin a manual application | Identical |
| Clinical In-Use | No survivingmicroorganisms onrepresentative medicaldevices tested | No survivingmicroorganisms onrepresentative medicaldevices tested | Identical |
| Biocompatibility | |||
| CytotoxicityDevice Extracts | Two rinses with UV treated,dual 0.1 micron membranefiltered water effectivelyreduce sterilant residues tosafe levels. | Two rinses with UV treated,dual 0.1 micron membranefiltered water effectivelyreduce sterilant residues tosafe levels. | Identical |
| ResidueReduction | Automatic within theSYSTEM 1E Processor:Two rinses with UV treated,dual 0.1 micron membranefiltered water effectivelyreduce sterilant residues tosafe levels. | Automatic within theSYSTEM 1E Processor:Two rinses with UV treated,dual 0.1 micron membranefiltered water effectivelyreduce sterilant residues tosafe levels. | Identical |
| Device MaterialCompatibility | Compatible with medicaldevices as established bytesting finished flexibleendoscopes through 300 | Compatible with medicaldevices as established bytesting finished flexibleendoscopes through 300 | Identical |
| Feature | ProposedS40 Sterilant Concentrate | K161683S40 Sterilant Concentrate | Comparison |
| cycles and rigid devicesthrough 150 cycles. | cycles and rigid devicesthrough 150 cycles. | ||
| No functional changes haveoccurred to flexible devices. | No functional changes haveoccurred to flexible devices. | ||
| Some materials showcosmetic changes such asfading of black anodizedaluminum without harm tothe base material. | Some materials showcosmetic changes such asfading of black anodizedaluminum without harm tothe base material. | ||
| ChemicalMonitoring | VERIFY ChemicalIndicator for the SYSTEM1E Processor(K102217) | VERIFY ChemicalIndicator for the SYSTEM1E Processor(K102217) | Identical |
| Chemical reaction onindicator pad to producecolor change. | Chemical reaction onindicator pad to producecolor change. | Identical |
{13}------------------------------------------------
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) 83:269-276.
6 McDonnell et al., J. AOAC International (2000) 83:269-276.
{14}------------------------------------------------
{15}------------------------------------------------
Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as the legally marketed predicate device (K161683), 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.