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

K192929 · STERIS Corporation · MED · Dec 10, 2019 · General Hospital

Device Facts

• Record ID: K192929
• 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
• Applicant: STERIS Corporation
• Product Code: MED · General Hospital
• Decision Date: Dec 10, 2019
• 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 > 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 process loads in 6 minutes at 45.5–60°C. System comprises processor, interchangeable trays/containers, and Quick Connects for internal channel irrigation. Processor is computer-controlled; monitors cycle parameters (temperature, contact time, sterilant concentration, filter integrity). Post-sterilization, devices are rinsed with extensively treated (pre-filtered, UV-irradiated, 0.1/0.2 micron filtered) water. Used in healthcare facilities; operated by staff. Provides printed cycle documentation. Modifications in this submission address upper lid seal glue obsolescence and firmware updates. Benefits include effective sterilization of heat-sensitive instruments without damage.

Clinical Evidence

Bench testing only. No clinical data presented. Verification activities included biocompatibility (ISO 10993-5:2009 Neutral Red Assay), material compatibility (seal integrity after multiple cycles), and processor performance (leak testing during sterilization/diagnostic cycles).

Technological Characteristics

Microprocessor-controlled liquid chemical sterilizer. Uses peracetic acid (S40 Sterilant). Features: interchangeable trays/containers, Quick Connects, UV water treatment, 0.1/0.2 micron membrane filtration. Connectivity: barcode scanner, touchscreen, USB for data download, web-based data management. Sterilization cycle: 6-minute exposure at 45.5–60°C. Firmware-controlled, unalterable cycle parameters.

Indications for Use

Indicated for liquid chemical sterilization of cleaned, immersible, and reusable critical and 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 (K190104)
• SYSTEM 1endo Liquid Chemical Sterilant Processing System (K173256)
• SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K191343)

Reference Devices

• VERIFY Chemical Indicator for S40 Sterilant (K173428)
• VERIFY Spore Test Strip for S40 Sterilant (K180553)

Submission Summary (Full Text)

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December 10, 2019

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

Re: K192929

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 Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: November 18, 2019 Received: November 19, 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.

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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 (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 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 Elizabeth Claverie, M.S. Assistant Director for THT4B2 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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

## K192929

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 \$40 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 > 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)

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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K192929

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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

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."

{4}------------------------------------------------

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

## K192929

## 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 cleand, 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)

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

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

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

December 2, 2019 Summary Date:

Premarket Notification: K192929

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### Device Name 1.

| 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 |

### Predicate Device 2.

SYSTEM 1E Liquid Chemical Sterilant Processing System, K190104

### 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 a obsolescence of the glue for creating the upper lid seal.

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 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.

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### 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.

### ട്. 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.

| Feature | Proposed Device | Predicate Device |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SYSTEM 1E Processor | SYSTEM 1E Processor (K190104) |
| Indications<br>for Use | The SYSTEM 1E Liquid Chemical<br>Sterilant Processing System is<br>intended for liquid chemical<br>sterilization of cleaned, immersible,<br>and reusable critical and semi- | The SYSTEM 1E Liquid Chemical<br>Sterilant Processing System is<br>intended for liquid chemical<br>sterilization of cleaned, immersible,<br>and reusable critical and semi- |
| Feature | Proposed Device<br>SYSTEM 1E Processor | Predicate Device<br>SYSTEM 1E Processor (K190104) |
| | critical heat-sensitive medical<br>devices in healthcare facilities. | critical heat-sensitive medical<br>devices in healthcare facilities. |
| | The SYSTEM 1E Processor dilutes<br>the S40 Sterilant Concentrate to its<br>use dilution (>1820 mg/L peracetic<br>acid), liquid chemically sterilizes the<br>load during a controlled 6-minute<br>exposure at 45.5 to 60°C, and rinses<br>the load with extensively treated*<br>potable water. After completion of a<br>cycle, critical devices should be used<br>immediately; semi-critical devices<br>should be used immediately or may<br>be handled and stored in a manner<br>similar to that of high level<br>disinfected endoscopes. Critical<br>devices not used immediately should<br>be processed again before use. | The SYSTEM 1E Processor dilutes<br>the S40 Sterilant Concentrate to its<br>use dilution (>1820 mg/L peracetic<br>acid), liquid chemically sterilizes the<br>load during a controlled 6-minute<br>exposure at 45.5 to 60°C, and rinses<br>the load with extensively treated*<br>potable water. After completion of a<br>cycle, critical devices should be used<br>immediately; semi-critical devices<br>should be used immediately or may<br>be handled and stored in a manner<br>similar to that of high level<br>disinfected endoscopes. Critical<br>devices not used immediately should<br>be processed again before use. |
| | The SYSTEM 1E Processor uses<br>only S40 Sterilant Concentrate to<br>liquid chemically sterilize medical<br>devices. | The SYSTEM 1E Processor uses<br>only S40 Sterilant Concentrate to<br>liquid chemically sterilize medical<br>devices. |
| | * The extensive treatment of EPA<br>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 or<br>larger particles/contaminants.<br>• Pre-filter B is a surface filter<br>that removes<br>particles/contaminants ><br>0.1 micron.<br>2. UV Irradiation:<br>• During transit through the UV<br>water treatment chamber, a<br>UV dose sufficient to achieve<br>a ≥ 6-log reduction of MS2<br>virus is delivered to the water.<br>3. 0.1-micron filtration:<br>• The water prepared by pre-<br>filtration and UV irradiation | * The extensive treatment of EPA<br>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 or<br>larger particles/contaminants.<br>• Pre-filter B is a surface filter<br>that removes<br>particles/contaminants ><br>0.1 micron.<br>2. UV Irradiation:<br>• During transit through the UV<br>water treatment chamber, a<br>UV dose sufficient to achieve<br>a ≥ 6-log reduction of MS2<br>virus is delivered to the water.<br>3. 0.1-micron filtration:<br>• The water prepared by pre-<br>filtration and UV irradiation |
| Feature | Proposed Device<br>SYSTEM 1E Processor | Predicate Device<br>SYSTEM 1E Processor (K190104) |
| | membranes to remove<br>bacteria, fungi and protozoa ><br>0.1 micron. | membranes to remove<br>bacteria, fungi and protozoa<br>> 0.1 micron. |
| Operating<br>Principles/<br>Technology | A microprocessor controlled unit<br>with interchangeable processing<br>trays/containers. The processor lid<br>opens to reveal the processing<br>chamber in which the load is placed.<br>Devices with internal lumens are<br>interfaced with the processor using<br>connectors. Sterilant Concentrate is<br>placed in a specialized compartment<br>and when the processor fills with<br>water, it creates the sterilant use<br>dilution from the single use sterilant<br>cup. The processor monitors and<br>controls the use dilution temperature<br>and contact time. The processor<br>automatically rinses the load with<br>extensively treated water to remove<br>sterilant residuals. | A microprocessor controlled unit<br>with interchangeable processing<br>trays/containers. The processor lid<br>opens to reveal the processing<br>chamber in which the load is placed.<br>Devices with internal lumens are<br>interfaced with the processor using<br>connectors. Sterilant Concentrate is<br>placed in a specialized compartment<br>and when the processor fills with<br>water, it creates the sterilant use<br>dilution from the single use sterilant<br>cup. The processor monitors and<br>controls the use dilution temperature<br>and contact time. The processor<br>automatically rinses the load with<br>extensively treated water to remove<br>sterilant residuals. |
| Process<br>Parameters | Standardized cycle parameters<br>cannot be altered by operator. The<br>critical process parameters are:<br>● Contact Time<br>● Use Dilution Temperature<br>● Peracetic acid concentration<br>● Bacterial retentive water filter<br>integrity<br>● UV irradiation | Standardized cycle parameters<br>cannot be altered by operator. The<br>critical process parameters are:<br>● Contact Time<br>● Use Dilution Temperature<br>● Peracetic acid concentration<br>● Bacterial retentive water filter<br>integrity<br>● UV irradiation |
| Process<br>Monitors | ● Cycle Printout documents<br>successful cycle completion or<br>identifies fault if cycle 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<br>● Alarms if pressure transducer<br>indicates circulation pressure is<br>out of specification during<br>Diagnostic cycle | ● Cycle Printout documents<br>successful cycle completion or<br>identifies fault if cycle 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<br>● Alarms if pressure transducer<br>indicates circulation pressure is<br>out of specification during<br>Diagnostic cycle |
| Feature | Proposed Device<br>SYSTEM 1E Processor | Predicate Device<br>SYSTEM 1E Processor (K190104) |
| Design<br>Features | 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 | 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 |
| | Microprocessor controlled unalterable and standardized liquid chemical sterilant processing and Diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron filtered, UV treated water for liquid chemical sterilant processing and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2-micron membrane air filter. | Microprocessor controlled unalterable and standardized liquid chemical sterilant processing and Diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron filtered, UV treated water for liquid chemical sterilant processing and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2-micron membrane air filter. |
| Processing Cycle | | |
| Incoming<br>water<br>temperature | ≥ 43°C | ≥ 43°C |
| Temperature<br>to start<br>exposure<br>phase | ≥ 46°C | ≥ 46°C |
| Temperature<br>alarm point<br>during the<br>exposure<br>phase | <45.5 or >60°C | <45.5 or >60°C |
| Temperature<br>range during a<br>typical Liquid<br>Chemical<br>Sterilant<br>Processing<br>Cycle | 46 - 55°C | 46 - 55°C |
| Exposure<br>Time | 6 minutes | 6 minutes |
| Rinse water<br>preparation | Hot potable tap water is:<br>pre-filtered | Hot potable tap water is:<br>pre-filtered |
| Feature | Proposed Device<br>SYSTEM 1E Processor | Predicate Device<br>SYSTEM 1E Processor (K190104) |
| | flowed through a UV Light treatment chamber to achieve ≥ a 6-log reduction of virus Filtered through redundant 0.1-micron filter membranes | flowed through a UV Light treatment chamber to achieve ≥ a 6-log reduction of virus Filtered through redundant 0.1-micron filter membranes |
| Number of rinses | 2 | 2 |
| Air Purge | Aids in removing excess water from instrument lumens after rinsing | Aids in removing excess water from instrument lumens after rinsing |
| Water Filter Integrity Test | Conducted at the end of every liquid chemical sterilant processing cycle and during the Diagnostic cycle | Conducted at the end of every liquid chemical sterilant processing cycle and during the Diagnostic cycle |
| Approximate Cycle time | 25 minutes | 25 minutes |
| Diagnostic Cycle | Performs 15 tests on processor's systems confirming proper function (same tests as predicate device except for an added UV monitor test). Recommended to perform every 24 hours. After a failed Diagnostic cycle, a liquid chemical sterilant processing cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed. | Performs 15 tests on processor's systems confirming proper function (same tests as predicate device except for an added UV monitor test). Recommended to perform every 24 hours. After a failed Diagnostic cycle, a liquid chemical sterilant processing cycle cannot be performed until the problem is rectified and a successful Diagnostic cycle has been completed. |
| Interchangeable Components | | |
| Processing Tray / Containers | Uses interchangeable processing trays/containers Universal Flexible Processing Tray (C1160E) General Processing Container/Tray (C1200) Directed Flow Processing Container/Tray (C1220) Flexible Endoscope Processing Container / Tray (C1140) Ultrasound Processing Tray (C3000XL) | Uses interchangeable processing trays/containers Universal Flexible Processing Tray (C1160E) General Processing Container/Tray (C1200) Directed Flow Processing Container/Tray (C1220) Flexible Endoscope Processing Container / Tray (C1140) Ultrasound Processing Tray (C3000XL) |
| Accessories | | |
| Sterilant Concentrate | Uses S40 Sterilant Concentrate | Uses S40 Sterilant Concentrate |
| Quick Connects | Uses Quick Connects to adapt instrument lumens to the Tray/Container ports | Uses Quick Connects to adapt instrument lumens to the Tray/Container ports |
| Chemical Indicator | VERIFY Chemical Indicator for S40 Sterilant (K173428) | VERIFY Chemical Indicator for S40 Sterilant (K173428) |
| Feature | Proposed Device<br>SYSTEM 1E Processor | Predicate Device<br>SYSTEM 1E Processor (K190104) |
| Spore Test<br>Strip | VERIFY Spore Test Strip for S40<br>Sterilant (K180553) | VERIFY Spore Test Strip for S40<br>Sterilant (K180553) |
| Operator<br>Maintenance<br>Requirements | Periodic replacement of printer tape,<br>water filters and air filter | Periodic replacement of printer tape,<br>water filters and air filter |

Table 1. Processor Device Comparison Table

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| Feature | Proposed Device<br>S40 Sterilant Concentrate | Predicate Device<br>S40 Sterilant Concentrate<br>(K180432) | |
|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The SYSTEM 1E Processor uses<br>only S40 Sterilant Concentrate to<br>liquid chemically sterilize medical<br>devices. | The SYSTEM 1E Processor uses<br>only S40 Sterilant Concentrate to<br>liquid chemically sterilize medical<br>devices. | |
| | Germicidal<br>claim | Liquid Chemical Sterilant | Liquid Chemical Sterilant |
| Germicide<br>Exposure<br>Time (min) for<br>intended use | 6 | 6…