System 1 endo Liquid Chemical Sterilant Processing System

K173256 · STERIS Corporation · MED · Mar 2, 2018 · General Hospital

Device Facts

• Record ID: K173256
• Device Name: System 1 endo Liquid Chemical Sterilant Processing System
• Applicant: STERIS Corporation
• Product Code: MED · General Hospital
• Decision Date: Mar 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6885
• Device Class: Class 2

Intended Use

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.

Device Story

Automated liquid chemical sterilization system for semi-critical heat-sensitive medical devices; uses S40 Sterilant Concentrate (peracetic acid). Processor dilutes concentrate, maintains 45.5-60°C for 6-minute exposure, and rinses with 0.2 micron filtered water. Operated in healthcare facilities; uses interchangeable trays/containers and Quick Connects for internal lumens. Microprocessor-controlled; provides printed cycle documentation. Monitors temperature, pressure, and conductivity; includes diagnostic cycles to verify system function and water filter integrity. Replaces extensive water treatment (UV/0.1 micron) of predicate with 0.2 micron filtration. Benefits include rapid sterilization of heat-sensitive instruments, automated residue removal, and standardized, unalterable cycle parameters ensuring consistent sterilization.

Clinical Evidence

Bench testing only. Includes in-use testing on clinically soiled semi-critical devices, water filter performance/integrity testing, electrical safety (UL 61010-1/2-040), and software validation. No clinical trials performed.

Technological Characteristics

Microprocessor-controlled liquid chemical sterilizer. Uses S40 Sterilant Concentrate (35% peracetic acid). Features interchangeable processing trays/containers and Quick Connects. Water filtration: 0.2 micron bacterial retentive membrane. Electrical safety: UL 61010-1, UL 61010-2-040. Connectivity: Printed documentation. Sterilization principle: Chemical oxidation via peracetic acid.

Indications for Use

Indicated for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories 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

• SYSTEM 1E Liquid Chemical Sterilant Processing System (K170956)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

March 2, 2018

Steris Corporation Marcia Benedict Senior Director, Regulatory Affairs 5976 Heisley Rd Mentor, Ohio 44060

Re: K173256

Trade/Device Name: System 1 endo Liquid Chemical Sterilant Processing System Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: January 31, 2018 Received: February 1, 2018

Dear Marcia Benedict:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

K173256

Device Name

SYSTEM 1 endo Liquid Chemical Sterilant Processing System

Indications for Use (Describe)

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.

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

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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

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

Contact:

Marcia Benedict Senior Director, Regulatory Affairs Tel: [phone] Fax: [phone]

Submission Date: February 26, 2018

Premarket Notification Number: K173256

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

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#### 1. Device Name

| Trade Name: | SYSTEM 1 endo Liquid Chemical Sterilant<br>Processing System |
|------------------------|-------------------------------------------------------------------------|
| Device Class: | Class 2 |
| 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

The claimed primary predicate device is the SYSTEM 1E Liquid Chemical Sterilant Processing System, cleared most recently under K170956.

The S1E prior clearances include Premarket submissions K090036, K101409. K102462, K110352, K131078, K161683.

#### 3. Description of Device

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects.

This new liquid chemical sterilant processing system is based substantially on the predicate device, which was most recently cleared via K170956.

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Ouick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Table 1 compares the proposed and predicate devices.

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#### 4. Intended Use

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heatsensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.

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

#### 5. Description of Technological Similarities and Differences

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific differences described in this submission. The differences between the proposed and predicate devices, identified in Table 1 and 2 below, include use of a 0.2 micron bacterial retentive water filter in place of the predicate's extensive water treatment process. Appropriate changes are made to software and labeling as a result. These differences raise no new concerns of safety and effectiveness when compared to the predicate device.

| Feature | Proposed Device<br>SYSTEM 1 endo Processor<br>(K173256) | Predicate Device<br>SYSTEM 1E Processor<br>(K170956) | Comparison |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System is intended for liquid<br>chemical sterilization of cleaned,<br>immersible, and reusable semi-<br>critical heat-sensitive medical<br>devices and their accessories in<br>healthcare facilities. | The SYSTEM 1E Liquid<br>Chemical Sterilant Processing<br>System is intended for liquid<br>chemical sterilization of cleaned,<br>immersible, and reusable critical<br>and semi-critical heat-sensitive<br>medical devices in healthcare<br>facilities. | The S1 endo<br>LCSPS's<br>intended use is<br>limited to<br>semi-critical<br>medical<br>devices and<br>their<br>accessories. |
| Indications<br>for Use | The SYSTEM 1 endo Processor<br>automatically dilutes the S40<br>Sterilant Concentrate to its use<br>dilution (> 1820 mg/L peracetic<br>acid), liquid chemically sterilizes<br>the load during a controlled 6-<br>minute exposure at 45.5 to 60°C,<br>and rinses the load with 0.2 | The SYSTEM 1E Processor<br>dilutes the S40 Sterilant<br>Concentrate to its use dilution<br>(> 1820 mg/L peracetic acid),<br>liquid chemically sterilizes the<br>load during a controlled 6-minute<br>exposure at 45.5 to 60°C, and<br>rinses the load with extensively | |
| Feature | Proposed Device<br>SYSTEM 1 endo Processor<br>(K173256) | Predicate Device<br>SYSTEM 1E Processor<br>(K170956) | Comparison |
| | micron filtered water.<br>The SYSTEM 1 endo Processor<br>uses only S40 Sterilant<br>Concentrate to liquid chemically<br>sterilize medical devices. | treated* potable water. After<br>completion of a cycle, critical<br>devices should be used<br>immediately; semi-critical<br>devices should be used<br>immediately or may be handled<br>and stored in a manner similar to<br>that of high level disinfected<br>endoscopes. Critical devices not<br>used immediately should be<br>processed again before use.<br>The SYSTEM 1E Processor uses<br>only S40 Sterilant Concentrate to<br>liquid chemically sterilize<br>medical devices.<br>* The extensive treatment of EPA<br>potable water consists of:<br>1. Pre-filtration through two pre-<br>filters:<br>• Pre-filter 1 is a gross depth<br>filter that removes<br>approximately 5 micron or<br>larger<br>particles/contaminants.<br>• Pre-filter 2 is a surface filter<br>that removes<br>particles/contaminants<br>$ > $ 0.1 micron.<br>2. UV Irradiation:<br>• During transit through the<br>UV water treatment<br>chamber, a UV dose<br>sufficient to achieve a $ \ge $ 6-<br>log reduction of MS2 virus is<br>delivered to the water.<br>3. 0.1 micron filtration:<br>• The water prepared by pre-<br>filtration and UV irradiation<br>is filtered through redundant,<br>0.1-micron (absolute rated)<br>membranes to remove<br>bacteria, fungi and protozoa<br>$ > $ 0.1 micron. | |
| Feature | Proposed Device<br>SYSTEM 1 endo Processor<br>(K173256) | Predicate Device<br>SYSTEM 1E Processor<br>(K170956) | Comparison |
| Operating<br>Principles<br>/ Technology | A microprocessor controlled unit<br>with interchangeable processing<br>trays/containers. The processor<br>lid opens to reveal the processing<br>chamber in which the load is<br>placed.<br>Devices with internal lumens are<br>interfaced with the processor<br>using connectors, i.e. Quick<br>Connects.<br>S40 Sterilant is placed in a<br>specialized compartment and<br>when the processor fills with<br>water, it creates the sterilant use<br>dilution from the single use<br>sterilant cup. | A microprocessor controlled unit<br>with interchangeable processing<br>trays/containers. The processor<br>lid opens to reveal the processing<br>chamber in which the load is<br>placed.<br>Devices with internal lumens are<br>interfaced with the processor<br>using connectors, i.e. Quick<br>Connects.<br>S40 Sterilant is placed in a<br>specialized compartment and<br>when the processor fills with<br>water, it creates the sterilant use<br>dilution from the single use<br>sterilant cup. | Identical,<br>except that the<br>proposed<br>device uses<br>0.2 micron<br>filtered water<br>in place of<br>extensively<br>treated water. |
| | The processor monitors and<br>controls the use dilution<br>temperature and contact time. The<br>processor automatically rinses the<br>load with 0.2 micron filtered<br>water to remove sterilant<br>residuals. | The processor monitors and<br>controls the use dilution<br>temperature and contact time. The<br>processor automatically rinses the<br>load with extensively treated<br>filtered water to remove sterilant<br>residuals. | |
| Process<br>Parameters | Standardized cycle parameters<br>cannot be altered by operator. The<br>critical process parameters are:<br>• Use dilution contact time<br>• Use dilution temperature<br>• Peracetic acid concentration<br>• Integrity of the internal water<br>filter (tested by the system) | Standardized cycle parameters<br>cannot be altered by operator. The<br>critical process parameters are:<br>• Use dilution contact time<br>• Use dilution temperature<br>• Peracetic acid concentration<br>• Integrity of the internal water<br>filter (tested by the system) | Identical |
| Process<br>Monitors: | • Cycle Printout documents<br>successful cycle completion<br>or identifies fault if cycle<br>aborts<br>• Alarms if thermocouples<br>indicate temperature out of<br>specification<br>• Alarms if pressure switch<br>indicates that high pressure<br>pump is not operating<br>• Alarms if conductivity probe<br>indicated conductivity<br>specification not met | • Cycle Printout documents<br>successful cycle completion<br>or identifies fault if cycle<br>aborts<br>• Alarms if thermocouples<br>indicate temperature out of<br>specification<br>• Alarms if pressure switch<br>indicates that high pressure<br>pump is not operating<br>• Alarms if conductivity probe<br>indicated conductivity<br>specification not met | Identical,<br>except there is<br>no UV system<br>intensity to be<br>monitored in<br>the proposed<br>device. |
| Feature | Proposed Device<br>SYSTEM 1 endo Processor<br>(K173256) | Predicate Device<br>SYSTEM 1E Processor<br>(K170956) | Comparison |
| | Alarms if pressure transducer<br>indicates circulation pressure<br>is out of specification in<br>Diagnostic cycle<br>Alarms if pressure transducer<br>●<br>indicates internal water filter<br>failed integrity test | Alarms if pressure transducer<br>indicates circulation pressure<br>is out of specification in<br>Diagnostic cycle<br>Alarms if pressure transducer<br>indicates internal water filter<br>failed integrity test<br>Alarms if UV monitor<br>indicates UV intensity out of<br>specification | |
| Design<br>Features | Microprocessor controlled<br>●<br>unalterable and standardized<br>liquid chemical sterilization<br>and Diagnostic cycles<br>Intended for use only with<br>●<br>S40 Sterilant Concentrate<br>Automated dilution and<br>●<br>delivery of S40 Sterilant<br>Processor provides 0.2 micron<br>●<br>filtered water for liquid<br>chemical sterilization and<br>rinsing<br>Make-up air for processor<br>●<br>during drain sequences is<br>filtered through a 0.2 micron<br>membrane air filter | Microprocessor controlled<br>unalterable and standardized<br>liquid chemical sterilization<br>and Diagnostic cycles<br>Intended for use only with<br>S40 Sterilant Concentrate<br>Automated dilution and<br>delivery of S40 Sterilant<br>· Processor provides<br>extensively treated (UV<br>irradiated, 0.1 micron filtered)<br>water for liquid chemical<br>sterilization and rinsing<br>Make-up air for processor<br>during drain sequences is<br>filtered through a 0.2 micron<br>membrane air filter | Identical,<br>except that<br>the proposed<br>device uses<br>0.2 micron<br>filtered water<br>in place of<br>extensively<br>treated water. |
| Cycle Parameters | | | Comparison |
| Incoming<br>water temp. | > 43°C | > 43°C | Identical |
| Temperature<br>to start<br>sterilant<br>exposure | > 46°C | > 46°C | Identical |
| Temperature<br>alarm point<br>during LCS<br>exposure | < 45.5 or > 60°C | < 45.5 or > 60°C | Identical |
| Temperature<br>range of<br>typical LCS<br>cycle | 46 - 55°C | 46 - 55°C | Identical |
| Exposure<br>Time - S40<br>use dilution | 6 minutes | 6 minutes | Identical |
| Feature | Proposed Device<br>SYSTEM 1 endo Processor<br>(K173256) | Predicate Device<br>SYSTEM 1E Processor<br>(K170956) | Comparison |
| Rinse water<br>preparation | Hot potable tap water<br>• is pre-filtered<br>• is filtered through 0.2 micron<br>bacterial retentive membrane<br>filter | Hot potable tap water<br>• is pre-filtered<br>• flows through a UV light<br>water treatment chamber to<br>achieve > a 6-log reduction<br>of virus<br>• is filtered through redundant<br>0.1 micron membranes | The proposed<br>device uses<br>0.2 micron<br>filtered water<br>in place of<br>extensively<br>treated water. |
| Number of<br>rinses | 2 | 2 | Identical |
| Air Purge | Aids in removing excess water<br>from instrument lumens after<br>rinsing | Aids in removing excess water<br>from instrument lumens after<br>rinsing | Identical |
| Internal<br>Water Filter<br>Integrity Test | Conducted during the Diagnostic<br>cycle | Conducted at the end of every<br>Liquid Chemical Sterilization<br>cycle and during the Diagnostic<br>cycle | Only in<br>Diagnostic<br>Cycle of S1<br>endo LCSPS |
| Approximate<br>Cycle Time | 18 - 20 minutes | 23 - 25 minutes | S1 endo has<br>shorter total<br>cycle time |
| Diagnostic<br>Cycle | Performs 14 tests on processor's<br>systems confirming proper<br>function. Recommended to<br>perform each day of use. After a<br>failed Diagnostic cycle, a liquid<br>chemical sterilization cycle<br>cannot be performed until the<br>problem is rectified and a<br>successful Diagnostic cycle has<br>been completed. | Performs 15 tests on processor's<br>systems confirming proper<br>function. Recommended to<br>perform each day of use. After a<br>failed Diagnostic cycle, a liquid<br>chemical sterilization cycle<br>cannot be performed until the<br>problem is rectified and a<br>successful Diagnostic cycle has<br>been completed. | Identical<br>except that<br>proposed S1<br>endo LCSPS<br>has no UV<br>unit test |
| Accessories | | | Comparison |
| Sterilant | Uses S40 Sterilant Concentrate -<br>see Table 2 | Uses S40 Sterilant Concentrate -<br>see Table 2 | Identical |
| Processing<br>Trays and<br>Containers | Uses interchangeable processing<br>trays/containers<br>• Universal Flex Processing Tray<br>• General Processing Container<br>& Tray<br>• Directed Flow Processing<br>Container & Tray<br>• Flexible Endoscope Processing<br>Container & Tray | Uses interchangeable processing<br>trays/containers<br>• Universal Flex Processing Tray<br>• General Processing Container<br>& Tray<br>• Directed Flow Processing<br>Container & Tray<br>• Flexible Endoscope Processing<br>Container & Tray | Identical |
| Feature | Proposed Device<br>SYSTEM 1 endo Processor<br>(K173256) | Predicate Device<br>SYSTEM 1E Processor<br>(K170956) | Comparison |
| | • Ultrasound Processing Tray | • Ultrasound Processing Tray | |
| Quick<br>Connects | Uses Quick Connects to attach<br>instrument lumens to the<br>Tray/Container ports | Uses Quick Connects to attach<br>instrument lumens to the<br>Tray/Container ports | Identical |
| Chemical<br>Indicator | VERIFY Chemical Indicator is<br>available for use in SYSTEM 1<br>endo LCSPS (separate clearance) | VERIFY Chemical Indicator is<br>available for SYSTEM 1E<br>(K102217) | Identical<br>design |
| Spore Test<br>Strip | VERIFY Spore Test Strip for S40<br>Sterilant for use in SYSTEM 1<br>endo LCSPS (separate clearance) | VERIFY Spore Test Strip for S40<br>Sterilant (DEN110002) | Identical<br>design |
| Operator<br>Maintenance | Periodic replacement of printer<br>tape, water filters and air filter | Periodic replacement of printer<br>tape, water filters and air filter | Identical |

Table 1. Processor Comparison Table

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