enspire 300 Series Automated Endoscope Reprocessor System

K230560 · STERIS Corporation · NZA · Jul 21, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K230560
• Device Name: enspire 300 Series Automated Endoscope Reprocessor System
• Applicant: STERIS Corporation
• Product Code: NZA · Gastroenterology, Urology
• Decision Date: Jul 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The enspire™ 300 Series Automated Endoscope Reprocessor System is intended to effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle. The enspire 300 Series Automated Endoscope Reprocessor System uses Revital-Ox PAA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part A and Part B solutions, high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning. The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes, when used in the enspire 300 AER.

Device Story

Automated Endoscope Reprocessor (AER) for cleaning/high-level disinfection of flexible endoscopes/accessories. Input: endoscope device profile (created by user), operator/case/procedure/physician IDs. Operation: automated pressure monitoring (integrity check), channel flow coefficient evaluation (vs. stored reference), automated injection of Revital-Ox 2X Enzymatic Detergent and Revital-Ox PAA High Level Disinfectant. Output: cleaned/disinfected device, cycle documentation. Used in clinical settings by healthcare staff. Benefits: automated, validated cleaning/disinfection process; reduces manual labor; ensures standardized processing parameters; provides cycle documentation; maintains device inflation to prevent fluid ingress.

Clinical Evidence

No clinical data. Bench testing only. Simulated use testing demonstrated cleaning efficacy (protein < 6.4 µg/cm², TOC < 12 µg/cm²) and HLD efficacy (≥6 log10 reduction of M. terrae). In-use testing confirmed cleaning and HLD performance on clinically used devices. Biocompatibility, rinsing efficacy, and material compatibility testing passed.

Technological Characteristics

Materials: stainless steel, silicone, polypropylene, PVDF. Energy: electrical. Connectivity: barcode scanner, touchscreen, optional printer. Processing: microprocessor-controlled, automated injection, flow monitoring, pressure monitoring. Rinsing: 0.2-micron filtered water. Air purge: oil-free filtered compressed air. Software: IEC 62304 compliant.

Indications for Use

Indicated for cleaning and high-level disinfection of validated immersible, reusable, semi-critical, heat-sensitive medical devices, including flexible endoscopes and non-channeled naso-endoscopes. Validated cleaning replaces manual cleaning for all endoscopes except duodenoscopes.

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

• Reliance Advance Endoscope Processing System (K123768)

Submission Summary (Full Text)

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July 21, 2023

STERIS Corporation Gregory Land Lead Regulatory Affairs Specialist 5960 Heislev Road Mentor, Ohio 44060

Re: K230560

Trade/Device Name: enspire 300 Series Automated Endoscope Reprocessor System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NZA Dated: June 13, 2023 Received: June 13, 2023

Dear Gregory Land:

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

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

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

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

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

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

Sincerely,

# 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 Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K230560

#### Device Name

enspire 300 Series Automated Endoscope Reprocessor System

#### Indications for Use (Describe)

The enspire™ 300 Series Automated Endoscope Reprocessor System is intended to effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.

The enspire 300 Series Automated Endoscope Reprocessor System uses Revital-Ox PAA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part A and Part B solutions, high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.

The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes, when used in the enspire 300 AER.

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

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## 510(k) Summary enspire 300 Series Automated Endoscope Reprocessor System

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

Contact: Gregory Land Lead Regulatory Affairs Specialist Tel: [phone]

Summary Date: July 20, 2023

510(k) Number: K230560

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#### 1. Device Name

| Trade Name: | enspire 300 Series Automated Endoscope<br>Reprocessor System |
|------------------------|--------------------------------------------------------------|
| Device Classification: | Class II |
| Common/usual Name: | Endoscope Cleaner and Reprocessor |
| Classification Name: | Accessories, Germicide, Cleaning, For Endoscopes |
| Classification Number: | 21 CFR 876.1500 |
| Product Code: | NZA |

#### 2. Predicate Device

Reliance Advance Endoscope Processing System, K123768

#### 3. Description of Device

The enspire 300™ Series Automated Endoscope Reprocessor System (AER) is a medical device processing system used for cleaning and high level disinfection of immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 300 AER, Revital-Ox 2X Concentrate Enzymatic Detergent (R2X), and Revital-Ox Peracetic Acid High Level Disinfectant (HLD).

The enspire 300 series AER is an automated, self-contained device for the effective cleaning and high level disinfection of semi-critical medical devices and their accessories. Prior to placement in the processor, users will be instructed to perform bedside (point of use) cleaning and manual leak testing. The devices will not require manual cleaning prior to processing, with the exception of duodenoscopes which will still require manual cleaning per the manufacturer's written instructions. Channel Connectors, as identified in STERIS labeling, are used to facilitate the delivery of the R2X detergent, HLD solution and rinse water to internal channels of devices that have them.

On the first process of an endoscope, the user must create a scope profile for the endoscope in the AER. The creation of the scope profile saves key endoscope attributes to the AER which are used to monitor the cycle during processing of the device. Once the device is positioned in the enspire 300 AER and optional operator ID, case ID, procedure ID and physician information is inputted, the operator initiates the processing cycle during which the Processor will create and maintain the conditions necessary for effective cleaning and high level disinfection. At the beginning of the processing cycle, an automated pressure monitor is performed to assess the integrity of the flexible endoscope. In parallel with the pressure monitor and prior to initiation of the cleaning phase, the processing system will evaluate the flow coefficient of each individual channel and compare to their respective

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reference value stored in the device profile created prior to first processing. The enspire 300 AER maintains inflation of the processed device throughout the process to reduce the risk of ingress of fluid in the event of any loss of integrity. At the end of the processing cycle, the cleaned and high level disinfected devices are rinsed with 0.2 micron filtered potable water followed by a dried, oil free, filtered compressed air purge to evacuate rinse water from the endoscope channels. The AER, which is micro-processor controlled and continually monitored, provides documentation of each cycle.

The enspire 300 AER utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and Revital-Ox Peracetic Acid High Level Disinfectant for high level disinfection. Revital-Ox PAA HLD is a two part solution consisting of Part A, 15% PAA, and Part B. conditioner.

#### Indications for Use 4.

The enspire 300 Automated Endoscope Reprocessor System is intended to effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible. reusable, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled nasoendoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.

The enspire 300 Automated Endoscope Reprocessor System uses Revital-Ox PA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part A and Part B solutions; high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.

The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes, when used in the enspire 300 AER.

#### న. Technological Characteristic Comparison Tables

| Feature | Proposed enspire 300 Series<br>AER | Predicate K123768<br>Reliance Advanced EPS | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The enspire 300 Automated<br>Endoscope Reprocessor<br>System is intended to<br>effectively provide a pressure | Cleaning and high level<br>disinfection of up to two<br>immersible, reusable,<br>heat-sensitive, semi- | Similar – both<br>systems provide<br>cleaning and<br>high-level |
| Feature | Proposed enspire 300 Series AER | Predicate K123768 Reliance Advanced EPS | Comparison |
| | and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.. | critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.<br>During the system's standardized Endoscope Processing Cycle, cleaning is achieved within the Cleaning phase, and high level disinfection is achieved within the 50 – 57°C HLD phase (4 minute generation sequence followed by a 6-minute exposure sequence).<br>Manual cleaning is not required prior to processing in Reliance EPS version 2. | disinfection |
| | The enspire 300 Automated Endoscope Reprocessor System uses Revital-Ox PA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part A and Part B solutions; high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.<br>The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, reusable, semi critical heat sensitive | | |
| Feature | Proposed enspire 300 Series<br>AER | Predicate K123768<br>Reliance Advanced EPS | Comparison |
| | medical devices including, but<br>not limited to, flexible<br>endoscopes and non-channeled<br>naso-endoscopes, when used in<br>the enspire 300 AER. | | |
| Operating<br>Principles /<br>Technology | The enspire 300 AER provide<br>delivery of solutions and fluids<br>to endoscopes and their<br>accessories. Revital-Ox 2X<br>Concentrate Enzymatic<br>detergent and Revital-Ox PAA<br>HLD are introduced into the<br>enspire 300 AER to provide<br>cleaning and high level<br>disinfection. Decontamination<br>cycle is used to help with<br>routine maintenance and to<br>help prevent contamination of<br>the Reprocessor during period<br>of inactivity. Descaling Cycle<br>is used to help prevent and<br>remove scale build-up in the<br>Reprocessor. | The Reliance EPS and its<br>integrated endoscope<br>processing support<br>provide for delivery of<br>solutions and fluids to<br>endoscopes and their<br>accessories. Klenzyme<br>and Reliance DG are<br>introduced into the<br>Reliance EPS to provide<br>cleaning and high level<br>disinfection.<br>Decontamination cycles<br>(D-Long with CIP-200<br>and D-Short) are used to<br>prevent biofilm formation<br>in the Reliance EPS<br>Processor and ensure<br>effective processing<br>following periods of<br>processor inactivity | Similar - the<br>subject device<br>and the<br>predicate device<br>both use<br>enzymatic<br>cleaner and<br>peracetic acid<br>for cleaning and<br>high level<br>disinfection,<br>respectively.<br>The disinfection<br>differs between<br>the two, the<br>subject device<br>uses thermal<br>disinfection<br>while the<br>predicate uses<br>chemical. |
| Process<br>Parameters | The cycle parameters cannot<br>be altered by operator. The<br>critical process parameters are:<br>• Contact Time<br>• Use Dilution Temp<br>• Water Volume<br>• Chemical Volume<br>• Channel irrigation<br>flow/pressure | Standardized cycle<br>parameters cannot be<br>altered by operator. The<br>critical process<br>parameters are:<br>• Contact Time<br>• Use Dilution Temp<br>• Cleaning solution and<br>Reliance DG<br>concentration<br>• Water filter integrity | Similar- the<br>subject device<br>uses water and<br>chemical<br>volume rather<br>than solution<br>concentration.<br>The subject<br>device also<br>provides flow<br>monitoring |
| Process<br>Monitors | Channel irrigation flow alarms<br>when endoscope channel is<br>obstructed or disconnected, if<br>pressure too low or too high,<br>or if sensor defect is detected.<br>Chemical volume alarms if<br>chemical injected volume is | Control Handle Boot<br>pressure alarms if<br>pressure too low to<br>process, or if too high and<br>could potentially damage<br>scopes (specification 6.5<br>to 10.5 PSI) | Similar - the<br>proposed device<br>has additional<br>process<br>monitoring of<br>all endoscope<br>lumens |
| Feature | Proposed enspire 300 Series<br>AER | Predicate K123768<br>Reliance Advanced EPS | Comparison |
| | too high, too low, chemical<br>pump is defective or chemical<br>container has inadequate<br>volume to complete the cycle.<br>Water volume alarms when<br>water level is too high for<br>HLD.<br>Temperature alarm is triggered<br>when temperature is too high,<br>sump takes too long to heat,<br>RTD variance exceeded or a<br>sensor is defective. Alarm is<br>triggered if Real Time Clock<br>error is detected. | Detection of a fresh<br>Reliance DG container in<br>every processing cycle,<br>Cleaning Solution level<br>monitored; alarm<br>indicates when container<br>does not have sufficient<br>amount to complete cycle<br>Temperature alarms if<br>outside of range<br>Water filter integrity test<br>at end of each high level<br>disinfection cycle. | individually. |
| Design<br>Features | Intended for use with Revital-<br>Ox 2X Concentrate Enzymatic<br>Detergent and Revital-Ox<br>PAA HLD Microprocessor controlled Internal components<br>constructed of stainless steel,<br>silicone, polypropylene and<br>PVDF. Processor provides 0.2 micron<br>filtered water for rinsing Automated injection of<br>cleaning and HLD solutions,<br>with accuracy monitored by a<br>flow meter Uses dried, oil free and filtered<br>compressed air for Air Purge Automated endoscope pressure<br>monitor Monitors channel flow Includes a bar code scanner;<br>employs touchscreen display<br>interface Separate, optional printer | Intended for use with<br>Reliance DG only Microprocessor<br>controlled Internal components<br>constructed of stainless<br>steel, silicone,<br>polypropylene and<br>PVDF. Processor provides 0.2<br>micron filtered water for<br>washing, disinfection and<br>rinsing Automated injection of<br>solutions with accuracy<br>monitored by a flow<br>meter. Automated generation<br>and delivery of high level<br>disinfectant solution Air intake for Air Purge<br>is HEPA filtered Automated endoscope<br>leak test Barcode scanner Separate, optional printer | Similar – the<br>subject device<br>has additional<br>monitoring of<br>channel flow<br>and use of a<br>touch screen. |
| Cycle Parameters | | | |
| Pressure<br>Monitor | Performed at the beginning of<br>the cycle | Performed at the<br>beginning of the cycle | Same |
| Flow check | Performed at the beginning<br>and end of the cycle | Not present | Different – The<br>subject device<br>has a Flow |
| Feature | Proposed enspire 300 Series<br>AER | Predicate K123768<br>Reliance Advanced EPS | Comparison |
| Cleaning<br>Phase<br>Temperature | 50-55°C | 50-57°C | Check in the<br>cycle which<br>monitors the<br>flow to each<br>lumen of an<br>endoscope |
| Cleaning<br>Phase<br>Exposure time | 4.5 minutes wash | 5 minutes | Similar –<br>subject device is<br>quicker |
| Rinse phase<br>after cleaning | 30 seconds | 40 seconds | Similar –<br>subject device is<br>quicker |
| HLD phase<br>Temperature | 50-55°C | 50-57°C | Similar –<br>subject device<br>operates in a<br>narrower range<br>of the predicate<br>range |
| HLD phase<br>exposure time | 3 minutes | 6 minutes | Similar –<br>subject device is<br>quicker |
| Rinse Phase<br>after HLD<br>phase | 30 seconds | 40 seconds | Similar –<br>subject device is<br>quicker |
| Number of<br>rinses | 2 | 2 | Same |
| Air purge | Performed between each phase<br>and at the end of the cycle | Performed at the end of<br>the cycle | Same |
| Accessories | | | Comparison |
| Detergent | Revital-Ox 2X Concentrate<br>Enzymatic Detergent | Klenzyme | Similar – both<br>are enzymatic<br>cleaners |
| HLD | Revital-Ox PAA HLD | Reliance DG | Similar – both<br>are peracetic<br>acid based HLD |
| Chemical<br>Indicator | enspire 300 series AER<br>Process monitor. Peracetic<br>acid dose indicator for routine<br>monitoring of enspire 300<br>AER using Revital-Ox PAA | VERIFY Process<br>Indicator for Reliance<br>EPS. Peracetic acid dose<br>indicator for routine<br>monitoring of Reliance | Similar – both<br>use a chemical<br>indicator but the<br>indicator is<br>different |
| Feature | Proposed enspire 300 Series<br>AER | Predicate K123768<br>Reliance Advanced EPS | Comparison |
| | HLD. Chemical reaction on<br>indicator pad to produce color<br>change. | EPS using Reliance DG.<br>Chemical reaction on<br>indicator pad to produce<br>color change. | |
| Scope<br>Connectors /<br>Flow Units | Scope connectors are required<br>for all lumens of endoscopes. | Flow Units are required<br>only for scope channels<br>that do not open in the<br>endoscope control handle<br>or mechanical action is<br>required for valve<br>operation. | Similar – both<br>use connectors<br>to flush lumens<br>of endoscopes |
| Operator<br>Maintenance | Periodic replacement of water<br>filters. Periodic replacement<br>of printer tape if using the<br>external printer option.<br>Running the decontamination<br>cycle every 24 hours. | Periodic replacement of<br>water and air filters. D-<br>SHORT decontamination<br>cycle required every 54-<br>hours<br>D-LONG<br>decontamination cycle<br>required if D-SHORT not<br>performed within past 54<br>hours | Similar – both<br>require the<br>periodic<br>replacement of<br>filters and<br>running of<br>decontamination<br>cycles. |

#### Table 1. Predicate Device Comparison Table

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### Table 2. HLD Device Comparison Table

| Feature | Proposed Revital-Ox PAA<br>HLD | Predicate Reliance DG<br>Dry Germicide | Comparison |
|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Intended Use | The Revital-Ox PA High<br>Level Disinfectant (HLD) is a<br>two-part solution, which<br>when mixed, is intended to<br>provide high level<br>disinfection of validated<br>immersible, reusable, semi-<br>critical, heat sensitive<br>medical devices including,<br>but not limited to, flexible<br>endoscopes and non-<br>channeled naso-endoscopes,<br>when used in the enspire 300<br>AER. | The Reliance Endoscope<br>Processing System is<br>intended for washing and<br>high level disinfection of<br>up to two manually pre-<br>cleaned, immersible,<br>reusable, heat-sensitive,<br>semi-critical devices such<br>as GI flexible endoscopes,<br>bronchoscopes and their<br>accessories. High level<br>disinfection is achieved<br>within the 50-57°C HLD<br>phase of the endoscope<br>processing cycle (4-<br>minute generation<br>sequence followed by a 6-<br>minute exposure<br>sequence). | Same |
| Germicidal | High level disinfectant | High level disinfectant | Same |
| Feature | Proposed Revital-Ox PAA<br>HLD | Predicate Reliance DG<br>Dry Germicide | Comparison |
| claim<br>Germicide<br>Exposure time<br>for HLD (min) | 3 minutes | 10 minutes (4-minute<br>generation sequence<br>followed by a 6-minute<br>exposure sequence) | Similar – The<br>exposure time<br>for high level<br>disinfection is<br>quicker on the<br>subject device |
| Use<br>Temperature | 50-55°C | 50-57°C | Similar – the<br>operating range<br>is narrower and<br>included in the<br>predicate device |
| Reuse | Single Use dilution | Single Use dilution | Same |
| Active<br>Ingredient | Peracetic acid | Peracetic acid…