SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate

K210737 · STERIS Corporation · MED · May 12, 2021 · General Hospital

Device Facts

• Record ID: K210737
• Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
• Applicant: STERIS Corporation
• Product Code: MED · General Hospital
• Decision Date: May 12, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6885
• Device Class: Class 2
• Attributes: Therapeutic

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 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: 1. 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 > or equal to 6-log reduction of MS2 virus is delivered to the water. 3.0.1 micron filtration: · The water prepared by pre-filtration 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; uses S40 Sterilant Concentrate (peracetic acid) to sterilize loads in 6 minutes at 45.5–60°C. System includes processor, interchangeable trays/containers, and Quick Connects for internal channel access. Processor dilutes sterilant, monitors temperature/contact time, and performs automated rinse with extensively treated water (pre-filtration, UV irradiation, 0.1-micron membrane filtration). Used in healthcare facilities by clinical staff. Provides printed cycle documentation. Modifications include firmware updates and varistor replacement. Benefits include effective sterilization of heat-sensitive instruments while maintaining material compatibility.

Clinical Evidence

No clinical data. Bench testing only. Software validation per IEC 62304 and functional testing of replacement components passed acceptance criteria.

Technological Characteristics

Microprocessor-controlled liquid chemical sterilizer. Uses S40 Sterilant Concentrate (35% peracetic acid). Features: interchangeable processing trays, Quick Connects, UV water treatment, 0.1-micron membrane filtration, barcode scanner, touchscreen interface, USB data download. Sterilization cycle: 6 minutes at 45.5–60°C. Firmware-controlled.

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

• SYSTEM 1E Liquid Chemical Sterilant Processing System (K192929)
• SYSTEM 1endo Liquid Chemical Sterilant Processing System, Model P6800 (K192929)
• SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K192929)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 12, 2021

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

Re: K210737

Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: April 9, 2021 Received: April 12, 2021

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.

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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) 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 (QS) 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 medical devices and radiation-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 Clarence W. Murray III, Ph.D. Acting Assistant Director 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)

### K210737

### 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 liquid chemically sterilize medical devices.

* The extensive treatment of EPA potable water consists of:

- 1. 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 > or equal to 6-log reduction of MS2 virus is delivered to the water.
- 3.0.1 micron filtration:
- · The water prepared by pre-filtration 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

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### Indications for Use

510(k) Number (if known)

K210737

Device Name

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800

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 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) | |
|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: sans-serif;"> <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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."

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# Indications for Use

510(k) Number (if known)

K210737

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 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)

### 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."

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Image /page/5/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is in a bold, serif font. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water.

# 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: Jennifer Nalepka Lead Regulatory Affairs Specialist Tel: [phone] Fax: [phone]

Summary Date: April 9, 2021

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 Processing<br>System |
|------------------------|-------------------------------------------------------------------------|
| Device Classification: | Class II |
| 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 1E Liquid Chemical Sterilant Processing System, K192929

#### 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 current submission is provided to describe modifications for:

- . Firmware update
- . Obsolescence and replacement of varistor

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 0.1micron 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 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

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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. Indications for 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:
- 1. 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.

#### ട. Technological Characteristic Comparison Table

The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device; the specific modifications described in this submission are for a firmware update and obsolescence to components.

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| Feature | Proposed<br>SYSTEM 1E Processor | Predicate (K192929)<br>SYSTEM 1E Processor | Comparison |
|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for<br>Use | The SYSTEM 1E Liquid<br>Chemical Sterilant Processing<br>System is intended for liquid<br>chemical sterilization of<br>cleaned, immersible, and<br>reusable critical and semi-<br>critical heat-sensitive medical<br>devices in healthcare facilities.<br>The SYSTEM 1E Processor<br>dilutes the S40 Sterilant | 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.<br>The SYSTEM 1E Processor<br>dilutes the S40 Sterilant | |
| | Concentrate to its use dilution<br>(>1820 mg/L peracetic acid),<br>liquid chemically sterilizes the<br>load during a controlled 6-<br>minute exposure at 45.5 to<br>60°C, and rinses the load with<br>extensively treated* potable<br>water. After completion of a<br>cycle, critical devices should be<br>used immediately; semi-critical<br>devices should be used<br>immediately or may be handled<br>and stored in a manner similar<br>to that of high level disinfected<br>endoscopes. Critical devices not<br>used immediately should be<br>processed again before use. | Concentrate to its use dilution<br>(>1820 mg/L peracetic acid),<br>liquid chemically sterilizes the<br>load during a controlled 6-<br>minute exposure at 45.5 to 60°C,<br>and rinses the load with<br>extensively treated* potable<br>water. After completion of a<br>cycle, critical devices should be<br>used 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. | Identical |
| | The SYSTEM 1E Processor<br>uses only S40 Sterilant<br>Concentrate to liquid<br>chemically sterilize medical<br>devices.<br>* The extensive treatment of<br>EPA potable water consists of:<br>1. Pre-filtration through two<br>pre-filters:<br>• Pre-filter A is a gross<br>depth filter that removes<br>approximately 2.5<br>micron or larger<br>particles/contaminants.<br>• Pre-filter B is a surface<br>filter that removes<br>particles/contaminants ><br>0.1 micron. | The SYSTEM 1E Processor uses<br>only S40 Sterilant Concentrate to<br>liquid chemically sterilize<br>medical devices.<br>* The extensive treatment of<br>EPA potable water consists of:<br>1. Pre-filtration through two pre-<br>filters:<br>• Pre-filter A is a gross depth<br>filter that removes<br>approximately 2.5 micron<br>or larger<br>particles/contaminants.<br>• Pre-filter B is a surface<br>filter that removes<br>particles/contaminants ><br>0.1 micron. | |
| Feature | Proposed<br>SYSTEM 1E Processor | Predicate (K192929)<br>SYSTEM 1E Processor | Comparison |
| | 2. UV Irradiation:<br>• During transit through<br>the UV water treatment<br>chamber, a UV dose<br>sufficient to achieve a ≥<br>6-log reduction of MS2<br>virus is delivered to the<br>water.<br>3. 0.1 micron filtration:<br>• The water prepared by<br>pre-filtration and UV<br>irradiation is filtered<br>through redundant, 0.1-<br>micron (absolute rated)<br>membranes to remove<br>bacteria, fungi and<br>protozoa > 0.1 micron. | 2. UV Irradiation:<br>• During transit through the<br>UV water treatment<br>chamber, a UV dose<br>sufficient to achieve a ≥ 6-<br>log reduction of MS2 virus<br>is 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<br>redundant, 0.1-micron<br>(absolute rated) membranes<br>to remove bacteria, fungi<br>and protozoa > 0.1 micron. | |
| Operating<br>Principles/<br>Technology | A microprocessor controlled<br>unit with interchangeable<br>processing trays/containers.<br>The processor lid opens to<br>reveal the processing chamber<br>in which the load is placed.<br>Devices with internal lumens<br>are interfaced with the<br>processor using connectors.<br>Sterilant Concentrate is placed<br>in a specialized compartment<br>and when the processor fills<br>with water, it creates the<br>sterilant use dilution from the<br>single use sterilant cup. The<br>processor monitors and controls<br>the use dilution temperature and<br>contact time. The processor<br>automatically rinses the load<br>with extensively treated water<br>to remove sterilant residuals. | A microprocessor controlled unit<br>with interchangeable processing<br>trays/containers. The processor<br>lid opens to reveal the<br>processing chamber in which the<br>load is placed. Devices with<br>internal lumens are interfaced<br>with the processor using<br>connectors. Sterilant<br>Concentrate 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. The processor<br>monitors and controls the use<br>dilution temperature and contact<br>time. The processor<br>automatically rinses the load<br>with extensively treated water to<br>remove sterilant residuals. | Identical |
| Process<br>Parameters | Standardized cycle parameters<br>cannot be altered by operator.<br>The critical process parameters<br>are:<br>• Contact Time<br>• Use Dilution Temperature<br>• Peracetic acid<br>concentration<br>• Bacterial retentive water<br>filter integrity | Standardized cycle parameters<br>cannot be altered by operator.<br>The critical process parameters<br>are:<br>• Contact Time<br>• Use Dilution Temperature<br>• Peracetic acid concentration<br>• Bacterial retentive water<br>• filter integrity<br>• UV irradiation | Identical |
| Feature | Proposed<br>SYSTEM 1E Processor | Predicate (K192929)<br>SYSTEM 1E Processor | Comparison |
| | UV irradiation | | |
| 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 during Diagnostic cycle Alarms if pressure transducer indicates 0.1-micron water filter failed integrity test during liquid chemical sterilant 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 0.1-micron water filter failed integrity test during liquid chemical sterilant processing and Diagnostic cycles. Alarms if UV monitor indicates UV intensity out of specification | Identical |
| Feature | Proposed<br>SYSTEM 1E Processor | Predicate (K192929)<br>SYSTEM 1E Processor | Comparison |
| Design<br>Features | Microprocessor controlled<br>unalterable and<br>standardized liquid<br>chemical sterilant<br>processing and Diagnostic<br>cycles Intended for use with S40<br>Sterilant Concentrate Processor provides dual<br>0.1 micron filtered, UV<br>treated water for liquid<br>chemical sterilant<br>processing and rinsing Automated dilution and<br>delivery of sterilant Make up air for processor<br>during drain sequences is<br>filtered through a 0.2-<br>micron membrane air<br>filter. | Microprocessor controlled<br>unalterable and<br>standardized liquid<br>chemical sterilant<br>processing and Diagnostic<br>cycles Intended for use with S40<br>Sterilant Concentrate Processor provides dual 0.1<br>micron filtered, UV treated<br>water for liquid chemical<br>sterilant processing and<br>rinsing Automated dilution and<br>delivery of sterilant Make up air for processor<br>during drain sequences is<br>filtered through a 0.2-<br>micron membrane air filter. | Identical |
| Processing Cycle | | | |
| Incoming water<br>temperature | $\geq$ 43°C | $\geq$ 43°C | Identical |
| Temperature to<br>start exposure<br>phase | $\geq$ 46°C | $\geq$ 46°C | Identical |
| Temperature<br>alarm point<br>during the<br>exposure phase | <45.5 or >60°C | <45.5 or >60°C | Identical |
| Temperature<br>range during a<br>typical Liquid<br>Chemical<br>Sterilant<br>Processing<br>Cycle | 46 - 55°C | 46 - 55°C | Identical |
| Exposure<br>Time | 6 minutes | 6 minutes | Identical |
| Rinse water<br>preparation | Hot potable tap water is:<br>pre-filtered flowed through a UV Light<br>treatment chamber to<br>achieve $\geq$ a 6-log reduction<br>of virus Filtered through redundant<br>0.1-micron filter<br>membranes | Hot potable tap water is:<br>pre-filtered flowed through a UV Light<br>treatment chamber to<br>achieve $\geq$ a 6-log reduction<br>of virus Filtered through redundant<br>0.1-micron filter<br>membranes | Identical |
| Number of | 2 | 2 | Identical |
| Feature | Proposed<br>SYSTEM 1E Processor | Predicate (K192929)<br>SYSTEM 1E Processor | Comparison |
| rinses | | | |
| 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 |
| Water Filter<br>Integrity Test | Conducted at the end of every<br>liquid chemical sterilant<br>processing cycle and during the<br>Diagnostic cycle | Conducted at the end of every<br>liquid chemical sterilant<br>processing cycle and during the<br>Diagnostic cycle | Identical |
| Approximate<br>Cycle time | 25 minutes | 25 minutes | Identical |
| Diagnostic<br>Cycle | Performs 15 tests on<br>processor's systems confirming<br>proper function (same tests as<br>predicate device except for an<br>added UV monitor test).<br>Recommended to perform<br>every 24 hours. After a failed<br>Diagnostic cycle, a liquid<br>chemical sterilant processing<br>cycle cannot be performed until<br>the 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 (same tests as predicate<br>device except for an added UV<br>monitor test). Recommended to<br>perform every 24 hours. After a<br>failed Diagnostic cycle, a liquid<br>chemical sterilant processing<br>cycle cannot be performed until<br>the problem is rectified and a<br>successful Diagnostic cycle has<br>been completed. | Identical |
| | | Interchangeable Components | |
| Processing<br>Tray /<br>Containers | Uses interchangeable<br>processing trays/containers<br>• Universal Flexible Processing<br>Tray (C1160E)<br>• General Processing<br>Container/Tray (C1200)<br>• Directed Flow Processing<br>Container/Tray (C1220)<br>• Flexible Endoscope<br>Processing Container / Tray<br>(C1140)<br>• Ultrasound Processing Tray<br>(C3000XL) | Uses interchangeable processing<br>trays/containers<br>• Universal Flexible Processing<br>Tray (C1160E)<br>• General Processing<br>Container/Tray (C1200)<br>• Directed Flow Processing<br>Container/Tray (C1220)<br>• Flexible Endoscope<br>Processing Container / Tray<br>(C1140)<br>• Ultrasound Processing Tray<br>(C3000XL) | Identical |
| Accessories | | | |
| Sterilant<br>Concentrate | Uses S40 Sterilant Concentrate | Uses S40 Sterilant Concentrate | Identical |
| Quick<br>Connects | Uses Quick Connects to adapt<br>instrument lumens to the<br>Tray/Container ports | Uses Quick Connects to adapt<br>instrument lumens to the<br>Tray/Container ports | Identical |
| Chemical<br>Indicator | VERIFY Chemical Indicator<br>for the S40 Sterilant<br>Concentrate | VERIFY Chemical Indicator for<br>the S40 Sterilant Concentrate | Identical |
| Spore Test<br>Strip | VERIFY Spore Test Strip for<br>S40 Sterilant Concentrate | VERIFY Spore Test Strip for<br>S40 Sterilant Concentrate | Identical |
| Feature | Proposed<br>SYSTEM 1E Processor | Predicate (K192929)<br>SYSTEM 1E Processor | Comparison |
| Operator<br>Maintenance<br>Requirements | 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 Device Comparison Table

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Table 2. S40 Sterilant Concentrate Device Comparison Table

| Feature | Proposed Device<br>S40 Sterilant Concentrate | Predicate Device<br>S40 Sterilant Concentrate<br>(K192929) | Comparison |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for<br>Use | The SYSTEM 1E Processor<br>uses only S40 Sterilant<br>Concentrate to liquid chemically<br>sterilize medical devices. | The SYSTEM 1E Processor<br>uses only S40 Sterilant<br>Concentrate to liquid chemically<br>sterilize medical devices. | Identical |
| Germicidal<br>claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant | Identical |
| Germicide<br>Exposure<br>Time (min) for<br>intended use | 6 | 6 | Identical |
| Use<br>Temperature | 45.5-60°C – allowable<br>46-55°C - typical<br>Potency and simulated use<br>evaluations conducted at <43°C | 45.5-60°C – allowable<br>46-55°C - typical<br>Potency and simulated use<br>evaluations conducted at <43°C | Identical |
| Reuse | Single use | Single use | Identical |
| Human<br>Factors | Dispensed ready to use.<br>Container is opened and diluted<br>by the processor, thus limiting<br>user exposure to the active<br>ingredient | Dispensed ready to use<br>Container is opened and diluted<br>by the processor, thus limiting<br>user exposure to the active<br>ingredient | Identical |
| Active<br>Ingredient | 35% peroxyacetic (peracetic)<br>acid automatically diluted for<br>use in the SYSTEM 1E<br>Processor. | 35% peroxyacetic (peracetic)<br>acid automatically diluted for<br>use in the SYSTEM 1E<br>Processor. | Identical |
| Mode of<br>Action | It…