enspire 3000 Cleaning and Liquid Chemical Sterile Processing System

K230930 · STERIS Corporation · FEB · Jun 30, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K230930
• Device Name: enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
• Applicant: STERIS Corporation
• Product Code: FEB · Gastroenterology, Urology
• Decision Date: Jun 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, semicritical, heat sensitive medical devices such as flexible endoscopes and their accessories. The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor. The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46.6 to 55°C and rinses the load with 0.2-micron filtered water.

Device Story

Automated, self-contained system for cleaning and liquid chemical sterilization of flexible endoscopes; uses Revital-Ox 2X Enzymatic Detergent and S40 Sterilant Concentrate (peracetic acid). Input: immersible, heat-sensitive endoscopes. Operation: automated pressure monitoring (start/end of cycle) to detect leaks; automated detergent delivery; automated dilution of S40 sterilant; 6-minute exposure at 46.6-55°C; rinse with 0.2-micron filtered water; HEPA-filtered air purge. Used in healthcare facilities; operated by trained staff. Output: processed, sterilized endoscopes; cycle documentation via computer control. Benefits: ensures effective sterilization, reduces manual cleaning requirements, and provides automated cycle verification to improve patient safety by minimizing infection risk.

Clinical Evidence

No clinical data. Bench testing only. Simulated-use and in-use testing performed on worst-case and clinically used devices. Cleaning efficacy validated via protein (< 6.4 µg/cm²) and TOC (< 12 µg/cm²) markers. Sterilization efficacy validated via > 6 log reduction of Geobacillus stearothermophilus spores. Biocompatibility, rinsing efficacy, and material compatibility confirmed per ISO 10993 standards.

Technological Characteristics

Microprocessor-controlled, single-basin system. Materials: compatible with flexible endoscopes (tested through 300 cycles). Energy: electrical (UL 61010-1, IEC 61010-2-040). Connectivity: USB for cycle download, web-based data management. Filtration: 0.2-micron water and air filters. Software: IEC 62304 compliant. Features: automated pressure monitoring, rotating spray arm, barcode scanner, touchscreen interface.

Indications for Use

Indicated for pressure monitoring, cleaning, liquid chemical sterilization, rinsing, and air purging of validated immersible, reusable, semi-critical, heat-sensitive medical devices, specifically flexible endoscopes and accessories. Requires manual pre-cleaning for duodenoscopes; otherwise, replaces manual cleaning.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• EVOTECH Endoscope Cleaner and Reprocessor (K152189)

Reference Devices

• SYSTEM 1 endo Liquid Chemical Sterilant Processing System (K210737)

Submission Summary (Full Text)

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June 30, 2023

STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K230930

Trade/Device Name: enspire 3000 Cleaning and Liquid Chemical Sterile Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: March 31, 2023 Received: April 3, 2023

Dear Anthony Piotrkowski:

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

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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,

# Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K230930

Device Name

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System

#### Indications for Use (Describe)

The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, semicritical, heat sensitive medical devices such as flexible endoscopes and their accessories.

The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor.

The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46.6 to 55°C and rinses the load with 0.2-micron filtered water.

| Type of Use (Select one or both, as applicable) |
|--------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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Image /page/3/Picture/1 description: The image shows the logo for STERIS. The word "STERIS" is written in a serif font at the top of the image. Below the word, there is a graphic of several horizontal wavy lines in blue.

# 510(k) Summary enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System K230930

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone]

Contact:

Tony Piotrkowski Director, Regulatory Affairs Tel: [phone] Email: tony [e-mail]

June 30, 2023 Summary Date:

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

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#### Device Name 1.

| Trade Name: | enspire 3000 Cleaning and Liquid Chemical<br>Sterilant Processing System |
|------------------------|--------------------------------------------------------------------------|
| Device Classification: | Class II |
| Common/usual Name: | Endoscope Cleaner and Reprocessor |
| Classification Name: | Accessories, Cleaning, for Endoscope |
| Classification Number: | 21 CFR 876.1500 |
| Product Code: | FEB |

#### 2. Predicate Device

EVOTECH Endoscope Cleaner and Reprocessor, K152189

Reference Device: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, K210737

#### 3. Description of Device

The enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS) is a medical device processing system used for cleaning and liquid chemically sterilizing immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 3000 Processor, Revital-Ox 2X Concentrate Enzymatic Detergent, S40 Sterilant Concentrate and Max Flow Connectors.

The enspire 3000 Cleaning and LCSPS is an automated, self-contained device for the effective cleaning and liquid chemical sterilization of semi-critical medical devices and their accessories. The devices will not require manual cleaning prior to processing in the enspire 3000 Processor with the exception of duodenoscopes which must be manually cleaned per the manufacturer's instructions for use. In addition, prior to placement in the enspire 3000 processor, the device will undergo a manual leak test and the user will ensure the lumens are not blocked. If the device has internal channels or lumens, Max Flow Connectors are used to facilitate the delivery of detergent, sterilant use-solution and rinse water to internal channels. Once the device is positioned in the enspire 3000 processor, the unit will create and maintain the conditions necessary for effective cleaning and liquid chemical sterilization of the load. At the beginning of the processing cycle, automated pressure monitoring is performed to assess the integrity of the flexible endoscope throughout the process. The enspire 3000 processor maintains inflation of the processed device to reduce the risk of ingress of fluid during processing and the pressure monitoring is repeated at the end of the processing cycle. At the end of the processing cycle, the cleaned and liquid chemically sterilized devices are rinsed with 0.2 micron filtered potable water followed by a HEPA-filtered air purge to aid

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in drying the endoscope. The processor, which is computer controlled and continually monitored, provides documentation of each cycle.

The enspire 3000 processor utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and S40 Sterilant Concentrate for liquid chemical sterilization. S40 Sterilant Concentrate is a single use chemical sterilant concentrate; its active ingredient, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

#### 4. Indications for Use

The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, reusable, semicritical, heat sensitive medical devices such as flexible endoscopes and their accessories.

The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor.

The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medical devices. It 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 46.6 to 55°C and rinses the load with 0.2micron filtered water.

#### ನ. Technological Characteristic Comparison Tables

| Feature | Proposed Device<br>enspire 3000 Cleaning and Liquid<br>Chemical Sterilant Processing System<br>(CLCSPS) | Predicate Device<br>EVOTECH Endoscope Cleaner and<br>Reprocessor<br>(K152189) | Comparison |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>Indications<br>for Use | The enspire™ 3000 Series Cleaning and<br>Liquid Chemical Sterilant Processing<br>System is intended to effectively provide a<br>pressure monitor, clean, provide liquid<br>chemical sterilization, rinse, and air purge<br>validated immersible, reusable, semi-<br>critical, heat sensitive medical devices such<br>as flexible endoscopes and their accessories. | The EVOTECH® ECR Endoscope<br>Cleaner and Reprocessor, a<br>washer/disinfector, is indicated for use<br>with high-level<br>disinfectant CIDEX® OPA Concentrate<br>Solution and an enzymatic detergent<br>(CIDEZYME XTRA) to achieve<br>cleaning<br>and high level disinfection of heat<br>sensitive $(>60°C)$ semi-critical | Similar. The<br>enspire 3000<br>Processor monitors<br>the pressure of the<br>devices and cleans<br>devices like the<br>EVOTECH ECR.<br>The enspire 3000<br>Processor provides<br>liquid chemical |
| Feature | Proposed Device<br>enspire 3000 Cleaning and Liquid<br>Chemical Sterilant Processing System<br>(CLCSPS) | Predicate Device<br>EVOTECH Endoscope Cleaner and<br>Reprocessor<br>(K152189) | Comparison |
| | The validated cleaning process replaces<br>cleaning for endoscopes other than<br>duodenoscopes. Manual cleaning of<br>duodenoscopes according to the<br>manufacturer's written instructions for use<br>is required prior to placement in the<br>enspire™ 3000 Series Processor.<br><br>The enspire™ 3000 Series Processor uses<br>only Revital-Ox 2X Concentrate Enzymatic<br>detergent to clean and S40 Sterilant<br>Concentrate to liquid chemically sterilize<br>medical devices. It automatically dilutes the<br>S40 Sterilant Concentrate<br>to its use dilution (> 1820 mg/L peracetic<br>acid), liquid chemically sterilizes the load<br>during a controlled 6-minute exposure at<br>46.6 to 55°C and rinses the load with 0.2-<br>micron filtered water. | endoscopes. Manual cleaning of<br>medical devices<br>(endoscopes) is not required prior to<br>placement in the EVOTECH® ECR<br>Endoscope Cleaner and Reprocessor<br>System<br>when selecting those cycles that contain<br>a wash stage. (Manual cleaning of<br>medical devices (endoscopes) is<br>required when<br>selecting the Disinfect only or<br>Disinfect/Alcohol Flush Cycle.) | sterilization while<br>the EVOTECH<br>ECR provides high<br>level disinfection. |
| Operating<br>Principles /<br>Technology | Microprocessor controlled unit with a fixed basin. The processor lid is opened with hands-free lid operation. Devices with internal lumens are<br>interfaced with the processor using<br>connectors, i.e. Max Flow Units Instrument pressure monitoring<br>performed at beginning and end of<br>cycle to monitor endoscope pressure Revital-Ox 2X Concentrate Enzymatic<br>Detergent is dispensed for the cleaning<br>phase of the processing cycle. Single-use cup of S40 Sterilant<br>Concentrate is placed in a specialized<br>compartment; when the processor fills<br>with water during the LCS phase of the<br>processing cycle, it creates the sterilant<br>use dilution The processor automatically rinses the<br>load with 0.2 micron filtered water after<br>cleaning and LCS phases HEPA-filtered air purge to aid in<br>drying | Microprocessor controlled unit with<br>two basins. The processor lid is opened with a<br>foot pedal. Devices with internal lumens are<br>interfaced with the processor using<br>connectors, i.e. EVOTECH<br>Connector Instrument leak test performed at<br>beginning and end of cycle to<br>monitor endoscope integrity Automatic blockage detection<br>system CIDEZYME XTRA Multi<br>Enzymatic Detergent dispensed<br>during wash phase of the<br>processing cycle. CIDEX OPA Concentrate High<br>Level Disinfectant dispensed during<br>HLD phase of the processing cycle. Processor provides rinsing with 0.2<br>micron filtered water after cleaning<br>and disinfection phases Optional alcohol rinse at end of<br>cycle to aid in drying. | Similar |
| Process<br>Parameters | Standardized cycle parameters cannot be<br>altered by the operator. The critical process<br>parameters monitored during processing: | Critical process parameters monitored<br>during processing:<br>Cleaning time | Similar |
| Feature | Proposed Device<br>enspire 3000 Cleaning and Liquid<br>Chemical Sterilant Processing System<br>(CLCSPS) | Predicate Device<br>EVOTECH Endoscope Cleaner and<br>Reprocessor<br>(K152189) | Comparison |
| | Detergent dilution and cleaning time Detergent dilution temperature Use dilution contact time Use dilution temperature | HLD contact time and temperature MEC Monitor of CIDEX OPA concentration | |
| Process<br>Monitors | The processor monitors and controls the detergent and LCS use dilution phase times. Cycle record documents successful cycle completion or identifies fault if cycle aborts Alarms if RTDs indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if pressure transducer indicates circulation pressure is out of specification Alarms if internal water filter failed Filter Pressure Monitor Test. Alarms if loss of pressure inside of endoscope indicates a leak | The processor monitors and controls the detergent and HLD contact times. Cycle record documents successful cycle completion or identifies fault if cycle aborts Alarms if loss of pressure inside of endoscope indicates a leak Monitors HLD contact time and temperature MEC Monitor will abort cycle if CIDEX OPA Concentrate solution does not meet preset limits | Similar |
| Design<br>Features | Unalterable and standardized Processing Cycle for cleaning and liquid chemical sterilization Filter Pressure Monitor Test for demonstrating 0.2 micron water filter maintains functionality after replacement or power outage Automated stand-alone system with one reprocessing basin Basin lid features a rotating spray arm. Intended for use with only Revital-Ox 2X Concentrate Enzymatic Detergent and S40 Sterilant Concentrate Automated delivery of Revital-Ox 2X Concentrate Enzymatic Detergent Automated dilution and delivery of S40 Sterilant Processor provides 0.2 micron filtered water for liquid chemical sterilization and rinsing after LCS phase of Processing Cycle Compressed air for processor during drain sequence is filtered through a 0.2 micron membrane air filter | Multiple processing cycles available by turning on or off the Wash and Alcohol Flush features: Wash, Disinfect, and Alcohol Flush Wash and Disinfect Cycle Disinfect and Alcohol Flush Disinfect Only Cycle Self-Disinfection Cycle Automated stand-alone system with two operating reprocessing basins comprising hardware, software and consumables. Basin lid features a rotating spray arm. Designed to perform process using only CIDEZYME XTRA Multi Enzymatic Detergent and high level disinfection using only CIDEX OPA. Processor provides rinsing with 0.2 micron filtered water after wash and disinfect phases Includes Bar code scanner, employs touchscreen display interface; has | Similar. enspire 3000 Processor has one unalterable processing cycle that always includes cleaning and liquid chemical sterilization. |
| Feature | Proposed Device<br>enspire 3000 Cleaning and Liquid<br>Chemical Sterilant Processing System<br>(CLCSPS) | Predicate Device<br>EVOTECH Endoscope Cleaner and<br>Reprocessor<br>(K152189) | Comparison |
| | Includes a bar code scanner; employs touchscreen display interface; has USB drive for electronic cycle download; facilitates use of a web-based data management system. Separate, optional printer | USB drive for electronic cycle download Printer integral to unit. | |
| | Cycle Parameters | | Comparison |
| Pressure<br>Monitor Test | Performed at beginning and end of cycle | Performed at beginning and end of cycle | Same |
| Pre-Rinse<br>Phase | Pre-filtered water at 40°C | 0.2 micron filtered water at 35°C | Similar |
| Incoming<br>Water Temp | 37 - 45°C | 37°C | Similar |
| Cleaning<br>Phase<br>Temperature | > 42.2°C | 37°C | Similar |
| Cleaning<br>Phase<br>Exposure<br>Time | 2 minutes | Not identified | No information<br>provided for the<br>predicate |
| Rinse Phase<br>after<br>Cleaning | Pre-filtered water below 55°C | 0.2 micron filtered water at 45°C | Similar |
| HLD or LCS<br>Phase<br>Temperature<br>Range | LCS: 46.6 - 50°C | HLD: Minimum of 50°C | Similar |
| HLD or LCS<br>Phase<br>Exposure<br>Time | 6 minutes | Minimum of 5 minutes | Similar |
| Rinse Phase<br>after HLD or<br>LCS | Hot potable tap water that is pre-filtered<br>then filtered through a 0.2 micron bacterial<br>retentive filter | 0.2 micron filtered water at 30°C for<br>first rinse, then at 25°C for second rinse | Similar |
| Number of<br>rinses | 2 after Cleaning Phase<br>2 after LCS Phase | 1 after Wash Phase<br>2 after Disinfection Phase | Similar |
| Alcohol<br>Rinse | No | Yes, if selected in cycle | enspire 3000<br>processor does not<br>offer alcohol flush |
| Air Purge | Yes | Yes | Same |
| Approximate<br>Cycle Time | 38 minutes | 33 minutes | Similar |
| | Accessories | | Comparison |
| Detergent | Revital-Ox 2X Concentrate Enzymatic<br>Detergent | CIDEZYME XTRA Multi Enzymatic<br>Detergent | Both are enzymatic<br>detergents |
| High Level<br>Disinfectant | N/A | CIDEX OPA | enspire does not<br>provide HLD. |
| Feature | Proposed Device<br>enspire 3000 Cleaning and Liquid<br>Chemical Sterilant Processing System<br>(CLCSPS) | Predicate Device<br>EVOTECH Endoscope Cleaner and<br>Reprocessor<br>(K152189) | Comparison |
| Liquid<br>Chemical<br>Sterilant | S40 Sterilant Concentrate | N/A | EVOTECH ECR<br>does not liquid<br>chemically sterilize<br>devices. |
| Connectors | Max Flow Connectors | EVOTECH Connectors | Similar, both<br>provide a means to<br>attach instruments<br>for flow of internal<br>lumens during<br>processing |
| Chemical<br>Indicator | Celerity Chemical Indicator for enspire<br>3000 Cleaning and Liquid Chemical Sterile<br>Processing System | Integrated automated Minimum<br>Effective Concentration (MEC) testing<br>during cycle | Both provide<br>means of<br>confirming<br>germicide reached<br>effective<br>concentration |
| Spore Test<br>Strip | VERIFY Spore Test Strip for S40 Sterilant | N/A | Spore Test Strip is<br>not recommended<br>or cleared for use<br>with the predicate<br>device. |
| Operator<br>Maintenance | Periodic replacement of detergent, water<br>filters and air filter. Periodic replacement<br>of printer tape if using the external printer<br>option. Cleaning outside of the unit and<br>basin drain screen as needed. | Cleaning seals, replacing solutions,<br>replacing 0.2 micron filters, cleaning<br>coarse screen, cleaning drip tray, printer<br>paper replacement, cleaning fan filter | Similar |

## Table 1. Predicate Device Comparison Table

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Table 2. Reference Device Comparison Table

| Feature | Proposed Device<br>enspire 3000 Cleaning and Liquid<br>Chemical Sterilant Processing System<br>(LCSPS) | Reference Device<br>SYSTEM 1 endo Liquid Chemical<br>Sterilant Processing System, Model<br>P6900<br>(K210737) | Comparison |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…