SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900

K191343 · STERIS Corporation · MED · Sep 5, 2019 · General Hospital

Device Facts

• Record ID: K191343
• Device Name: SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
• Applicant: STERIS Corporation
• Product Code: MED · General Hospital
• Decision Date: Sep 5, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6885
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

Automated liquid chemical sterilization system for semi-critical heat-sensitive medical devices; uses S40 Sterilant Concentrate (peracetic acid) to sterilize loads in 6-minute cycle at 45.5-60°C. System includes processor, interchangeable trays/containers, and Quick Connects for internal lumen access. Processor automatically dilutes sterilant, monitors cycle parameters (temperature, contact time, PAA concentration), and performs two rinses with 0.2-micron filtered water. Used in healthcare facilities; operated by staff. Provides cycle documentation via printout/electronic download. Ensures device sterility and removes sterilant residuals to non-cytotoxic levels; protects patient by preventing cross-contamination of reusable instruments.

Clinical Evidence

No clinical data. Bench testing only. Software validation confirmed system operates effectively and as designed.

Technological Characteristics

Microprocessor-controlled liquid chemical sterilizer. Uses S40 Sterilant Concentrate (peracetic acid). Features: touchscreen interface, barcode scanner, USB data export, web-based data management. Filtration: 0.2-micron bacterial retentive membrane filters for rinse water and make-up air. Cycle parameters: 6-minute exposure, 45.5-60°C. Automated diagnostic cycle performs 14 system tests.

Indications for Use

Indicated for liquid chemical sterilization of cleaned, immersible, reusable semi-critical heat-sensitive medical devices and 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 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K182827)

Submission Summary (Full Text)

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September 5, 2019

STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K191343

Trade/Device Name: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: September 4, 2019 Received: September 4, 2019

Dear Jennifer Nalepka:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### Device Name

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

#### Indications for Use (Describe)

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

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

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

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary For SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

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

Jennifer Nalepka Contact: Senior Regulatory Affairs Specialist Tel: [phone] Fax: [phone]

Submission Date: August 29, 2019

Premarket Notification Number: K191343

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#### 1. Device Name

| Trade Name: | SYSTEM 1 endo Liquid Chemical Sterilant<br>Processing System, Model P6900 |
|------------------------|---------------------------------------------------------------------------|
| 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

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, K182827.

#### 3. Description of Device

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe certain software modifications made after the clearance of K182827.

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Ouick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Tables 1 and 2 compare the proposed and predicate devices.

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#### Indications for Use 4.

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

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

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

#### 5. Technological Characteristic Comparison Table

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System (LCSPS) is the same as the predicate device; the submission is for modifications to the SYSTEM 1 endo LCSPS software. A comparison between the proposed and predicate devices can be found in Table 1 and Table 2 below.

| Feature | Proposed Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System , Model P6900 | Predicate Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System, Model P6900<br>(K182827) | Comparison |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended<br>Use<br>Indications<br>for 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 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. | Identical |
| | The SYSTEM 1 endo Processor<br>automatically dilutes the S40<br>Sterilant Concentrate to its use<br>dilution (> 1820 mg/L peracetic | The SYSTEM 1 endo Processor<br>automatically dilutes the S40<br>Sterilant Concentrate to its use<br>dilution (> 1820 mg/L peracetic | |
| Feature | Proposed Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System , Model P6900 | Predicate Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System, Model P6900<br>(K182827) | Comparison |
| | 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<br>micron filtered water. | 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<br>micron filtered water. | |
| | The SYSTEM 1 endo Processor<br>uses only S40 Sterilant<br>Concentrate to liquid chemically<br>sterilize medical devices. | The SYSTEM 1 endo Processor<br>uses only S40 Sterilant<br>Concentrate to liquid chemically<br>sterilize medical devices. | |
| | 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 | 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 | |
| Operating<br>Principles<br>/<br>Technology | interfaced with the processor<br>using connectors, i.e. Quick<br>Connects. | interfaced with the processor<br>using connectors, i.e. Quick<br>Connects. | |
| | 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. | 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 |
| | 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 0.2 micron filtered<br>water to remove sterilant<br>residuals. | |
| | Standardized cycle parameters<br>cannot be altered by operator. The<br>critical process parameters are: | Standardized cycle parameters<br>cannot be altered by operator. The<br>critical process parameters are: | |
| Process<br>Parameters | • Use dilution contact time | • Use dilution contact time | Identical |
| | • Use dilution temperature | • Use dilution temperature | |
| | • Peracetic acid concentration<br>• Integrity of the internal water | • Peracetic acid concentration<br>• Integrity of the internal water | |
| | filter (tested by the system) | filter (tested by the system) | |
| Feature | Proposed Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System , Model P6900 | Predicate Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System, Model P6900<br>(K182827) | Comparison |
| Process<br>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 in Diagnostic cycle Alarms if pressure transducer indicates internal water filter failed integrity test | Cycle Printout documents successful cycle completion or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification in Diagnostic cycle Alarms if pressure transducer indicates internal water filter failed integrity test | Identical |
| Design<br>Features | Microprocessor controlled unalterable and standardized liquid chemical sterilization and Diagnostic cycles Intended for use only with S40 Sterilant Concentrate Automated dilution and delivery of S40 Sterilant Processor provides 0.2 micron filtered water for liquid chemical sterilization and rinsing Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter Includes a barcode scanner; employs touchscreen display interface; has USB drive for electronic cycle download; facilitates use of a web-based data management system. Separate optional printer | Microprocessor controlled unalterable and standardized liquid chemical sterilization and Diagnostic cycles Intended for use only with S40 Sterilant Concentrate Automated dilution and delivery of S40 Sterilant Processor provides 0.2 micron filtered water for liquid chemical sterilization and rinsing Make-up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter Includes a barcode scanner; employs touchscreen display interface; has USB drive for electronic cycle download; facilitates use of a web-based data management system. Separate optional printer | Identical |
| Feature | Proposed Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System , Model P6900 | Predicate Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System, Model P6900<br>(K182827) | Comparison |
| | 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 |
| 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>• is filtered through 0.2 micron<br>bacterial retentive membrane<br>filter | Identical |
| 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 during the Diagnostic<br>cycle | Identical |
| Approximate<br>Cycle Time | 18 - 20 minutes | 18 - 20 minutes | Identical |
| 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 | 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 | Identical |
| Feature | Proposed Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System , Model P6900 | Predicate Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System, Model P6900<br>(K182827) | Comparison |
| | successful Diagnostic cycle has<br>been completed. | successful Diagnostic cycle has<br>been completed. | |
| 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<br>• Ultrasound Processing 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<br>• Ultrasound Processing Tray | Identical |
| 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 for<br>S40 Sterilant is available for use<br>in SYSTEM 1 endo LCSPS | VERIFY Chemical Indicator for<br>S40 Sterilant is available for use<br>in SYSTEM 1 endo LCSPS | Identical |
| Spore Test<br>Strip | VERIFY Spore Test Strip for S40<br>Sterilant for use in SYSTEM 1<br>endo LCSPS | VERIFY Spore Test Strip for S40<br>Sterilant for use in SYSTEM 1<br>endo LCSPS | Identical |
| Operator<br>Maintenance | Periodic replacement of water<br>filters and air filter.<br>Periodic replacement of printer<br>tape, if using the external printer<br>option. | Periodic replacement of water<br>filters and air filter.<br>Periodic replacement of printer<br>tape, if using the external printer<br>option. | Identical |
| Feature | Proposed Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System , Model P6900 | Predicate Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System, Model P6900<br>(K182827) | Comparison |
| Intended Use | For use in S1E or S1 endo<br>LCSPS | For use in S1E or S1 endo<br>LCSPS | Identical |
| Germicidal<br>claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant | Identical |
| Exposure<br>Time | 6 minutes | 6 minutes | Identical |
| Use<br>Temperature | 45.5 - 60°C - allowable range<br>Potency and simulated use<br>evaluations conducted at ≤ 43°C | 45.5 - 60°C - allowable range<br>Potency and simulated use<br>evaluations conducted at ≤ 43°C | Identical |
| Reuse | Single use | Single use | Identical |
| Human<br>Factors | Ready to use. Container is<br>opened and diluted by the<br>processor, limiting user exposure<br>to the sterilant concentrate | Ready to use. Container is<br>opened and diluted by the<br>processor, limiting user exposure<br>to the sterilant concentrate | Identical |
| Active<br>Ingredient | 35% peroxyacetic (peracetic)<br>acid automatically diluted for<br>use in the Processor | 35% peroxyacetic (peracetic)<br>acid automatically diluted for<br>use in the Processor | Identical |
| Mode of<br>Action | It is believed that peracetic acid<br>exerts its germicidal effect by<br>several mechanisms:<br>-oxidizing sulfhydral and sulfur<br>bonds in proteins and enzymes,<br>particularly in the cell walls 1<br>-hydroxyl radicals produced<br>from PAA are bactericidal 2<br>-PAA damages the viral capsid<br>and viral nucleic acid3,4 | It is believed that peracetic acid<br>exerts its germicidal effect by<br>several mechanisms:<br>-oxidizing sulfhydral and sulfur<br>bonds in proteins and enzymes,<br>particularly in the cell walls1<br>-hydroxyl radicals produced from<br>PAA are bactericidal2<br>-PAA damages the viral capsid<br>and viral nucleic acid3,4 | Identical |
| Rinses | 2 equivalent automated rinses<br>with pre-filtered, dual 0.2<br>micron membrane filtered,<br>potable hot water | 2 equivalent automated rinses<br>with pre-filtered, dual 0.2<br>micron membrane filtered,<br>potable hot water | Identical |
| Feature | Proposed Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System , Model P6900 | Predicate Device<br>SYSTEM 1 endo Liquid<br>Chemical Sterilant Processing<br>System, Model P6900<br>(K182827) | Comparison |
| Sporicidal<br>Activity of<br>Disinfectants<br>AOAC<br>Official<br>Method<br>966.04 | Meets efficacy requirements5<br>Bacillus subtilis<br>Clostridium sporogenes<br>Testing conducted in vitro…