SYSTEM 1.5 STERILE PROCESSING SYSTEM

K090036 · STERIS Corporation · MED · Apr 5, 2010 · General Hospital

Device Facts

• Record ID: K090036
• Device Name: SYSTEM 1.5 STERILE PROCESSING SYSTEM
• Applicant: STERIS Corporation
• Product Code: MED · General Hospital
• Decision Date: Apr 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6885
• Device Class: Class 2

Intended Use

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 46 to 55°C, and rinses the load with extensively treated* potable water. The processed load should be used immediately. The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. - The extensive treatment of EPA potable water consists of: * - 1. Pre-filtration through two pre-filters: - Pre-filter 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants. - Pre-filter 2 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.

Device Story

Automated liquid chemical sterilization system for heat-sensitive medical devices (e.g., endoscopes, microsurgical instruments). Input: S40 Sterilant Concentrate (peracetic acid) and EPA potable water. Operation: Processor automatically dilutes sterilant, maintains 46-55°C for 6-minute exposure, and performs automated rinse using UV-treated, 0.1-micron filtered water. Output: Sterilized instruments ready for immediate use. Used in healthcare facilities by clinical staff. Processor provides printed cycle documentation and continuous monitoring of parameters (temperature, pressure, conductivity, UV intensity, filter integrity). Benefits: Rapid sterilization of heat-sensitive devices without damage; automated process reduces user exposure to chemicals.

Clinical Evidence

Bench testing only. Efficacy validated via AOAC Official Methods (966.04, 955.17, 955.14, 955.15, 964.02) and EPA virucidal testing. Demonstrated >6-log10 reduction of Geobacillus stearothermophilus spores in simulated-use testing. Biocompatibility confirmed via cytotoxicity testing of device extracts. No clinical data required.

Technological Characteristics

Microprocessor-controlled liquid chemical sterilizer. Uses peracetic acid (S40 Concentrate). Features: interchangeable processing trays, Quick Connects, UV water treatment chamber, redundant 0.1-micron absolute-rated membrane filters, and 0.2-micron air filters. Connectivity: printed cycle documentation. Sterilization: liquid chemical, 6-minute cycle at 46-55°C. Automated diagnostic cycles perform 15 system checks.

Indications for Use

Indicated for liquid chemical sterilization of cleaned, immersible, reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• STERIS SYSTEM 1 PROCESSOR and STERIS 20 STERILANT (K875280)
• Sterilox Liquid Chemical High Level Disinfection System (K013280)

Submission Summary (Full Text)

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## Appendix 2

APR - 5 2010

## Revised 510(k) Summary

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## 510(k) Summary For SYSTEM 1E Liquid Chemical Sterilant Processing System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact:

Peter A. Burke, Ph. D. Senior Vice President and Chief Technology Officer Tel: [phone] Fax: [phone]

Summary Date: April 1, 2010

·

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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#### 1. Device Name

| Trade Name: | SYSTEM 1E Liquid Chemical Sterilant<br>Processing System |
|------------------------|-------------------------------------------------------------------------|
| Common/usual Name: | Liquid Chemical Sterilizer |
| Classification Name: | Sterilant, Medical devices, Liquid Chemical<br>Sterilants/Disinfectants |
| Classification Number: | 21 CFR 880.6885 |
| Product Code: | MED |

#### 2. Predicate Device

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STERIS SYSTEM 1 PROCESSOR and STERIS 20 STERILANT, K875280, cleared September 13, 1988.

Sterilox Liquid Chemical High Level Disinfection System, K013280, cleared September 18, 2002

### Description of Device 3.

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 SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following the 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 system, 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 IE Processor. The active ingredient in S40, peracetic acid, is combined with inert ingredients to form a use dilution which inhibits corrosion of metals, polymers and other materials.

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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 ensure thorough circulation of the sterilant solution and rinses.

#### 4. Intended Use

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 46 to 55°C, and rinses the load with extensively treated* potable water. The processed load should be used immediately.

The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

- The extensive treatment of EPA potable water consists of: *
- 1. Pre-filtration through two pre-filters:
- Pre-filter 1 is a gross depth filter that removes approximately 5 micron . or larger particles/contaminants.
- Pre-filter 2 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.

### Description of Safety and Substantial Equivalence ડ.

The SYSTEM 1E Processor and S40 Sterilant Concentrate are substantially equivalent in function and intended use to the STERIS SYSTEM 1 and STERIS 20 Sterilant and Sterilox Liquid Chemical High Level Disinfection System.

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### Device Comparison Table

| Feature | SYSTEM 1E Processor | SYSTEM 1 Processor(K875280) |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The SYSTEM 1E Liquid Chemical<br>Sterilant Processing System is intended<br>for liquid chemical sterilization of<br>cleaned, immersible, and reusable<br>critical and semi-critical heat-sensitive<br>medical devices in healthcare facilities.<br><br>The SYSTEM 1E Processor<br>automatically dilutes the S40 Sterilant<br>Concentration to its use dilution (≥1820<br>mg/L peracetic acid) and liquid<br>chemically sterilizes the load during a<br>controlled 6-minute exposure at 46 to<br>55°C and rinses the load with<br>extensively treated potable water. The<br>processed load should be used<br>immediately.<br><br>The SYSTEM 1E Processor uses only<br>S40 Sterilant Concentrate to liquid<br>chemically sterilize medical devices. | The SYSTEM 1 is a liquid chemical<br>sterilization system used for the rapid<br>liquid chemical sterilization of clean<br>reusable immersible medical devices<br>such as flexible and rigid endoscopes,<br>and other medical and dental devices<br>in hospitals, medical, surgical and<br>dental clinics/offices. |
| Operating<br>Principles/<br>Technology | A microprocessor controlled unit with interchangeable processing<br>trays/containers. The processor lid opens to reveal the processing chamber in<br>which the load is placed. Devices with internal lumens are interfaced with the<br>processor using connectors. Sterilant is placed in a specialized compartment and<br>when the processor fills with water, it creates the sterilant use dilution from the<br>single use sterilant cup. The processor monitors and controls the use dilution<br>temperature and contact time. The processor automatically rinses the load with<br>extensively treated potable water to remove sterilant residuals. | |
| Process Parameters | Standardized cycle parameters cannot<br>be altered by operator. The critical<br>process parameters are:<br>● Contact Time<br>● Use Dilution Temperature<br>● Peracetic acid concentration<br>● Dual membrane, 0.1 micron water<br>filter integrity<br>● UV irradiation | Standardized cycle parameters cannot<br>be altered by operator. The critical<br>process parameters are:<br>● Contact Time<br>● Use Dilution Temperature<br>● Peracetic acid concentration<br>● 0.2 micron water filter integrity |
| Feature | SYSTEM 1E Processor | SYSTEM 1 Processor(K875280) |
| Process Monitors: | Cycle Printout documents successful cycle completion or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates dual membrane 0.1 micron water filter failed integrity test during liquid chemical sterilization processing and Diagnostic cycles Alarms if UV monitor indicates UV intensity out of specification | 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 during Diagnostic cycle Alarms if pressure transducer indicates sterile water filter failed integrity test during Diagnostic cycle |
| Design Features | Microprocessor controlled unalterable and standardized liquid chemical sterilization and diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron membrane filtered, UV treated water for liquid chemical sterilization and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter. | Microprocessor controlled unalterable and standardized liquid chemical sterilization and diagnostic cycles Intended for use with STERIS 20 Sterilant Concentrate only. Processor provides 0.2 micron filtered water for liquid chemical sterilization and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter. |
| Liquid Chemical Sterilization Cycle | | |
| Incoming water<br>temperature | $\geq 43°C$ | $\geq 42°C$ |
| Temperature to<br>start sterilant<br>exposure | $\geq 46°C$ | $\geq 50°C$ |
| Temperature alarm<br>point during the<br>sterilant exposure | <45.5 or >60°C | <50 or >60°C |
| Feature | SYSTEM 1E Processor | SYSTEM 1 Processor(K875280) |
| Temperature range during a typical<br>Liquid Chemical Sterilization Cycle | 46 - 55°C | 50 - 55°C |
| Sterilant Exposure Time | 6 minutes | 12 minutes |
| Rinse water preparation | Hot potable tap water is:<br>• pre-filtered<br>• flown through a UV Light treatment chamber to achieve ≥ a 6-log reduction of MS2 virus<br>• Filtered through redundant 0.1 micron filter membranes | Hot potable tap water is:<br>• pre-filtered<br>• Filtered through 0.2 micron filter membrane |
| Number of rinses | 2 | 4 |
| Air Purge | Aids in removing excess water from instrument lumens after rinsing | |
| Water Filter Integrity Test | Conducted at the end of every liquid chemical sterilization s cycle and during the Diagnostic cycle | Conducted during the Diagnostic cycle only |
| Approximate Cycle time | 25 minutes | 30 minutes |
| Diagnostic Cycle | 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 sterilization processing cycle can not be performed until the problem is rectified and a successful Diagnostic cycle has been completed. | Performs 14 tests on processor's systems confirming proper function. Recommended to perform every 24 hours. After a failed Diagnostic cycle a liquid chemical sterilization processing cycle can not be performed until the problem is rectified and a successful Diagnostic cycle has been completed. |
| Accessories | | |
| Sterilant | Uses S40 Sterilant Concentrate (see Table 5-2 for predicate comparison) | Uses STERIS 20 Sterilant |
| Processing Tray/Containers | Uses interchangeable processing trays/containers | |
| Quick Connects | Uses Quick Connects to adapt instrument lumens to the Tray/Container ports | |
| Operator Maintenance Requirements | Periodic replacement of printer tape, water filters and air filter | |

## Table 5-1. Processor Device Comparison Table

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| Feature | S40 Sterilant<br>Concentrate | STERIS 20<br>STERILANT<br>(K875280) | Sterilox Liquid<br>Chemical HLD System<br>(013280) |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | S40 Sterilant<br>Concentrate is for use<br>only with the SYSTEM<br>IE Liquid Chemical<br>Sterilant Processing<br>System | STERIS 20 Sterilant<br>Concentrate is for use<br>only in the SYSTEM 1<br>Sterile Processing<br>System | Sterilox is for use<br>with manual or<br>automated endoscope<br>reprocessing<br>protocols |
| Germicidal claim | Liquid Chemical<br>Sterilant | Liquid Chemical<br>Sterilant | High Level Disinfectant |
| Germicide<br>Exposure Time<br>(min) for intended<br>use | 6 | 12 | 10 |
| Use Temperature | 45.5-60°C - allowable<br>46-55°C - typical<br>Potency and simulated<br>use evaluations<br>conducted at <43°C | 50 - 60°C - allowable<br>50 - 55°C - typical | 25°C |
| Reuse | Single use | Single use | Single use |
| Human Factors | Dispensed ready to use.<br>Container is opened and<br>diluted by the<br>processor, thus limiting<br>user exposure to the<br>active ingredient | Dispensed ready to use<br>Container is opened and<br>diluted by the<br>processor, thus limiting<br>user exposure to the<br>active ingredient | Dispensed ready to use. |
| Active Ingredient | 35% peroxyacetic<br>(peracetic) acid<br>automatically diluted<br>for use in the SYSTEM<br>1E Processor. | 35% peroxyacetic<br>(peracetic) acid<br>automatically diluted<br>for use in the SYSTEM<br>1 Processor. | Electrolytic generation<br>of the active (mainly<br>hypochlorous acid)<br>from saline solution in<br>the Sterilox Generator<br>(in situ). |

| Table 5-2. Sterilant Device Comparison Table | | | | |
|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Feature | S40 Sterilant<br>Concentrate | STERIS 20<br>STERILANT<br>(K875280) | Sterilox Liquid<br>Chemical HLD System<br>(013280) | |
| Mode of Action | It is believed that<br>peracetic acid exerts its<br>germicidal effect by<br>several mechanisms:<br>-oxidizing sulfhydral<br>and sulfur bonds in<br>proteins and enzymes,<br>particularly in the cell<br>walls1<br>-hydroxyl radicals<br>produced from PAA are<br>bactericidal2<br>-PAA damages the viral<br>capsid and viral nucleic<br>acid3,4. | It is believed that<br>peracetic acid exerts its<br>germicidal effect by<br>several mechanisms:<br>-oxidizing sulfhydral<br>and sulfur bonds in<br>proteins and enzymes,<br>particularly in the cell<br>walls1<br>-hydroxyl radicals<br>produced from PAA are<br>bactericidal2<br>-PAA damages the viral<br>capsid and viral nucleic<br>acid3,4 | Attacks surface and<br>plasma membrane<br>proteins impairing<br>transport of solutes and<br>the salt balance of<br>bacterial cells5. | |
| Rinses | Automatic, UV-<br>irradiated, dual 0.1<br>micron filtered, potable<br>hot water. | Automatic, 0.2 micron<br>filtered potable hot<br>water. | Dependent upon use. | |
| Sporicidal Activity<br>of Disinfectants<br>AOAC Official<br>Method 966.04 | Meets efficacy<br>requirements6.<br>Bacillus subtilis<br>Clostridium sporogenes<br>Testing conducted in<br>vitro | Meets efficacy<br>requirements6.<br>Bacillus subtilis<br>Clostridium sporogenes<br>Testing conducted in<br>situ | Meets efficacy<br>requirements6.<br>Bacillus subtilis<br>Clostridium sporogenes<br>Testing conducted in<br>vitro | |
| Confirmatory<br>Sporicidal Activity<br>of Disinfectants<br>AOAC Official<br>Method 966.04 | Meets efficacy<br>requirements6.<br>Bacillus subtilis<br>Clostridium sporogenes<br>Testing conducted in<br>vitro | Meets efficacy<br>requirements6.<br>Bacillus subtilis<br>Clostridium sporogenes<br>Testing conducted in<br>situ | Meets efficacy<br>requirements6.<br>Bacillus subtilis<br>Clostridium sporogenes<br>Testing conducted in<br>vitro | |
| Fungicidal Activity<br>of Disinfectants<br>AOAC Official<br>Method 955.17 | Solution is fungicidal.<br>Trichophyton<br>mentagrophytes<br>Testing conducted in<br>vitro | Solution is fungicidal.<br>Trichophyton<br>mentagrophytes<br>Testing conducted in<br>situ | Solution is fungicidal.<br>Trichophyton<br>mentagrophytes<br>Testing conducted in<br>vitro | |
| Feature | S40 Sterilant<br>Concentrate | STERIS 20<br>STERILANT<br>(K875280) | Sterilox Liquid<br>Chemical HLD System<br>(013280) | |
| Use Dilution<br>Method AOAC,<br>Official Methods<br>955.14, 955.15,<br>964.02 | Solution is bactericidal.<br>Salmonella<br>choleraesuis<br>Staphylococcus aureus<br>Pseudomonas<br>aeruginosa<br>Testing conducted in<br>vitro | Solution is bactericidal.<br>Salmonella<br>choleraesuis<br>Staphylococcus aureus<br>Pseudomonas<br>aeruginosa<br>Testing conducted in<br>situ | Solution is bactericidal.<br>Salmonella<br>choleraesuis<br>Staphylococcus aureus<br>Pseudomonas<br>aeruginosa<br>Testing conducted in<br>vitro | |
| EPA Virucidal<br>Testing (DIS/TSS-<br>7, Nov. 1981) | Solution is virucidal.<br>Herpes simplex Type 1<br>Adenovirus Type 5<br>Poliovirus Type 1<br>Testing conducted in<br>vitro | Solution is virucidal.<br>Herpes simplex Type 2<br>Poliovirus Type 1<br>Influenza A<br>Testing conducted in<br>situ | Solution is virucidal.<br>Herpes simplex Type 1<br>Poliovirus Type 2<br>Human<br>immunodeficiciency<br>virus Type I<br>Testing conducted in<br>vitro | |
| Tuberculocidal<br>Activity of<br>Disinfectants<br>AOAC Official<br>Method 965.12 | Not performed. A<br>quantitative suspension<br>Tuberculocidal test was<br>conducted. | Solution is<br>tuberculocidal.<br>Mycobacterium bovis<br>Testing conducted in<br>situ | Solution is<br>tuberculocidal.<br>Mycobacterium bovis<br>Testing conducted in<br>vitro | |
| Tuberculocidal<br>Activity Ascenzi<br>Quantitative<br>Suspension Test | Solution is<br>tuberculocidal<br>Mycobacterium terrae<br>Testing conducted in<br>vitro | Not performed. The<br>AOAC Tuberculocidal<br>Activity of<br>Disinfectants was<br>conducted. | Not performed. The<br>AOAC Tuberculocidal<br>Activity of<br>Disinfectants was<br>conducted. | |
| Simulated-Use Test | Meets efficacy<br>requirement.<br>$≥ 6 log10$ reduction<br>Geobacillus<br>stearothermophilus<br>spores | Meets efficacy<br>requirement.<br>$≥ 6 log10$ reduction<br>Bacillus subtilus spores | Meets efficacy<br>requirement<br>$≥ 6 log10$ reduction of<br>Mycobacterium terrae | |
| Clinical In-Use | No surviving<br>microorganisms on<br>representative medical<br>devices tested | Not required at time of<br>submission. | No surviving<br>microorganisms on the<br>endoscopes tested. | |
| Biocompatibility | | | | |
| Cytotoxicity Device<br>Extracts | Two rinses with UV<br>treated, dual 0.1 micron<br>membrane filtered<br>water effectively<br>reduces sterilant<br>residues to safe levels. | Not performed | Not performed | |
| Residue Reduction | Automatic within the | Automatic within | Effectively removed | |
| Feature | S40 Sterilant<br>Concentrate | STERIS 20<br>STERILANT<br>(K875280) | Sterilox Liquid<br>Chemical HLD System<br>(013280) | |
| Device Material<br>Compatibility | SYSTEM 1E Processor:<br>Two rinses with UV<br>treated, dual 0.1 micron<br>membrane filtered<br>water effectively<br>reduces sterilant<br>residues to safe levels. | SYSTEM 1 Processor:<br>Four 0.2 micron filtered<br>water rinses effectively<br>reduce sterilant residues<br>to safe levels. | from devices by the<br>rinses following<br>disinfection. | |
| | Compatible with<br>medical devices as<br>established by testing<br>finished flexible<br>endoscopes through 300<br>cycles and rigid devices<br>through 150 cycles.<br>No functional changes<br>have occurred to<br>flexible devices.<br>Some materials show<br>cosmetic changes such<br>as fading of black<br>anodized aluminum<br>without harm to the<br>base material. | Compatible with<br>medical devices and<br>their materials of<br>construction, as<br>established by testing<br>materials and finished<br>medical devices through<br>100 - 300 cycles.<br>No device functional<br>changes.<br>Some materials show<br>cosmetic changes such<br>as fading of external<br>markings but all<br>remained legible, and<br>bleaching of black<br>anodized aluminum<br>without harm to the<br>base material. | Device components and<br>materials were<br>subjected to continuous<br>immersion for unstated<br>time periods.<br>Does not produce any<br>corrosion or other<br>visible damage in the<br>majority of endoscope<br>components.<br>Color changes and the<br>"tack" of the coating of<br>the outer endoscope<br>sheaths were noted on<br>some endoscopes.<br>Corrosion was noted on<br>anodized aluminum. | |

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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.

S Pieterson et al., Water SA (1996) 22(1); 43-48.

⁶ McDonnell et al., J. AOAC International (2000) 83:269-276.

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### Conclusion -

Based on the non-clinical and clinical tests described above, the SYSTEM 1E Dased on the non ontenteate demonstrate demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.

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Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

## APR - 5 2010

Dr. Peter A. Burke Senior Vice President STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

Re: K090036

> Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System Regulation Number: 21CFR 880.6885 Regulation Name: Liquid Chemical Sterilants / High Level Disinfectants Regulatory Class: II Product Code: MED Dated: March 16, 2010 Received: March 17, 2010

Dear Dr. Burke:

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.

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Page 2- Dr. Burke

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Cintron D. Ruiz

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. 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): K090036

SYSTEM 1E Liquid Chemical Sterilant Processing System Device Name:

Indications for Use:

The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heatsensitive 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 6minute exposure at 46 to 55℃, and rinses the load with extensively treated* potable water. The processed load should be used immediately.

The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

- The extensive treatment of EPA potable water consists of: *
- 1. Pre-filtration through two pre-filters:
- · Pre-filter 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants.
- · Pre-filter 2 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:

{{ D In

- .

- 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. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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|----------------|--------------------------------------------|
| | Jfi) |
| | on of Anesthesiology, General Hospital |
| | Infection Control, Dental Devices |
| 510(k) Number: | K090036 |

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