Reliance Endoscope Processing System

K200989 · STERIS Corporation · NZA · May 14, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K200989
• Device Name: Reliance Endoscope Processing System
• Applicant: STERIS Corporation
• Product Code: NZA · Gastroenterology, Urology
• Decision Date: May 14, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories. High level disinfection is achieved within the 50-57°C HLD phase of the endoscope processing cycle (4-minute generation sequence followed by a 6-minute exposure sequence).

Device Story

Automated endoscope reprocessor (AER) for washing and high-level disinfection (HLD) of flexible endoscopes; utilizes proprietary Reliance DG Dry Germicide (peracetic acid-generating oxidative chemistry). System processes up to two devices simultaneously; includes optional enzymatic wash phase (Klenzyme) and mandatory HLD phase (50-57°C). Features include microprocessor-controlled cycles, 0.2-micron bacterial-retentive water filtration with automated integrity testing, and HEPA-filtered air purge. Operator loads pre-cleaned scopes; system automates chemical delivery, circulation, and rinsing. Provides printed cycle summaries for documentation. Includes self-decontamination cycles (D-SHORT/D-LONG) to prevent biofilm. Used in clinical settings to ensure device safety for reuse; protects staff by automating germicide handling.

Clinical Evidence

Bench testing only. Biocompatibility testing (ISO 10993-5:2009 Neutral Red Assay) was performed to verify that the alternate label ink on the Reliance DG Dry Germicide does not cause a cytotoxic response. Results passed.

Technological Characteristics

Electromechanical washer/disinfector; microprocessor-controlled. Internal components: stainless steel, silicone, polypropylene, PVDF. Energy: electrical. Connectivity: optional barcode reader for data logging. Filtration: 0.2-micron bacterial-retentive water filter; HEPA air filter. Chemistry: Reliance DG (peracetic acid generated in situ). Sterilization/Disinfection: HLD via peracetic acid at 50-57°C. Cycle parameters are fixed and non-adjustable by the operator.

Indications for Use

Indicated for washing and high-level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices, including GI flexible endoscopes and bronchoscopes, and their accessories.

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 Endoscope Processing System (K102244)

Reference Devices

• Reliance CI Process Indicator (K063285)

Submission Summary (Full Text)

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May 14, 2020

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

Re: K200989

Trade/Device Name: Reliance Endoscope Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NZA Dated: April 14, 2020 Received: April 15, 2020

Dear Jennifer Nalepka:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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,

CAPT Elizabeth Claverie, M.S. 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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K200989

### Device Name

Reliance Endoscope Processing System

### Indications for Use (Describe)

The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes and their accessories. High level disinfection is achieved within the 50 - 57°C HLD Phase of the endoscope processing cycle (4 minute generation sequence followed by a 6-minute exposure sequence).

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)

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# 510(k) Summary For Reliance Endoscope Processing System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Telephone: [phone] Fax No: 440-357-9198

Contact: Jennifer Nalepka Lead Regulatory Affairs Specialist Telephone: [phone] Fax No: 440-357-9198

Summary Date: May 7, 2020

Premarket Notification Number: K200989

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

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#### 1. Device Name

Trade Name: Reliance Endoscope Processing System Device Classification: Class II Common/usual Name: Automated Endoscope Reprocessor Classification Name: Accessories, Germicide, Cleaning, For Endoscopes Classification Number: 21 CFR 876.1500 Product Code: NZA

#### 2. Predicate Device

Reliance Endoscope Processing System, K102244

#### 3. Description of Device

The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfect up to two manually precleaned, immersible, reusable, heatsensitive, semi-critical devices such as GI flexible endoscopes and related accessories.

The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering the highest level of patient and staff safety. The Reliance Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.

- The Reliance Endoscope Processor is an electromechanical washer/high level . disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor self-decontamination cycles.
- Reliance DG Dry Germicide is a proprietary, two-part, dry, single-use oxidative . chemistry, designed to generate the high level disinfection solution upon automatic dilution in water within the Reliance Endoscope Processor.
- Optional washing is provided through the automated delivery of Klenzyme Enzymatic Presoak and Cleaner during the wash phase of the cycle.
- CIP 200 Acid-Based Process and Research Cleaner, a general cleaning agent, is used ● in one of the two self-decontamination cycles provided by the processor.
- . Various accessories are available to accommodate the processing needs of specific endoscopes and endoscopic accessories.
- Verify Reliance CI Process Indicator is available to monitor for the presence of the ● Reliance DG active ingredient, peracetic acid.

The Reliance Endoscope Processing Cycle has the following features:

- The first part of this cycle is an optional programmable washing phase. This phase ● consists of a wash that uses Klenzyme, followed by a rinse. The washing phase can

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be programmed on or off. In the "on" mode, the user can choose either one or two washing phases per processing cycle, and the wash time can be adjusted to be between 5 and 10 minutes. The Reliance cleaning phase does not replace manual cleaning by the user.

- . The second part is a high level disinfection phase that is non-optional and the parameters cannot be changed by the user. In this phase, the proprietary Reliance DG components, provided in a single use container, are dissolved with water at ~50°C for four minutes of generation time and circulated throughout the processor and through device lumens for a 6 minutes of high level disinfecting solution exposure time.
- Following the high level disinfection phase, the Reliance Endoscope Processor removes the high level disinfecting solution through a rinse phase which is nonoptional and the parameters cannot be changed by the user. The processor filters the rinse water (as well as all of the water used throughout the cycle) through a 0.2 micron bacterial-retentive filter. It also incorporates an automatic internal integrity check of this filter at the end of each processing cycle. If the integrity check fails, an alarm alerts the user, and the processor does not complete the cycle.
- . The last step in the processing cycle is an air purge phase using HEPA-filtered air. The air purge helps to remove excess rinse water from the processed devices. The final air purge is preset to run for 4 minutes; additional air purge time may be selected by the operator.
- . The processor will print a detailed cycle summary at the end of each cycle that includes information such as processor number, cycle date, start and stop times, as well as phase parameters. With an optional bar code reader, the printouts can also include identification numbers for the operator, patient, device, doctor and procedure.

The processor features two decontamination cycles that are to be used without endoscopes in the processor:

- The first, called D-SHORT, consists of hot water circulating through the processor for . 10 minutes, followed by a 10-minute hot air purge. This cycle is to be run every 54 hours. D-SHORT is intended to prevent biofilm from forming.
- . The second, called D-LONG, consists of a cycle in which CIP 200 Acid-Based Process and Research Cleaner is added to hot water. The cleaning solution is then circulated through the processor for 20 minutes; this is followed by three rinses to remove the solution from the processor and a 10-minute hot air purge. D-LONG is to be used on those occasions when the D-SHORT cycle has not been run within the past 54 hours.

#### 4. Intended Use

The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semicritical devices such as GI flexible endoscopes, bronchoscopes and their accessories. High level disinfection is achieved within the 50-57°C HLD phase of the endoscope processing cycle (4-minute generation sequence followed by a 6-minute exposure sequence).

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#### 5. Technological Characteristic Comparison Tables

The Reliance Endoscope Processing System (EPS) is the same as the predicate device; the specific modification described in this submission is for a change to the ink on the label of the Reliance DG Dry Germicide. A comparison between the predicate and proposed devices can be found in Tables 1 and 2.

| Table 1: Technological comparison for Reliance EPS | | | |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Feature | Proposed Device<br>Reliance EPS | Predicate Device<br>Reliance EPS<br>K102244 | Comparison |
| Intended Use | The Reliance Endoscope<br>Processing System is intended<br>for washing and high level<br>disinfection of up to two<br>manually pre-cleaned,<br>immersible, reusable, heat-<br>sensitive, semi-critical devices<br>such as GI flexible endoscopes,<br>bronchoscopes and their<br>accessories. High level<br>disinfection is achieved within<br>the 50-57°C HLD phase of the<br>endoscope processing cycle (4-<br>minute generation sequence<br>followed by a 6-minute exposure<br>sequence). | The Reliance Endoscope<br>Processing System is intended<br>for washing and high level<br>disinfection of up to two<br>manually pre-cleaned,<br>immersible, reusable, heat-<br>sensitive, semi-critical devices<br>such as GI flexible endoscopes,<br>bronchoscopes and their<br>accessories. High level<br>disinfection is achieved within<br>the 50-57°C HLD phase of the<br>endoscope processing cycle (4-<br>minute generation sequence<br>followed by a 6-minute exposure<br>sequence). | Identical |
| Operating<br>Principles/<br>Technology | The Reliance EPS and its<br>integrated endoscope processing<br>support provide for delivery of<br>solutions and fluids to<br>endoscopes and their accessories.<br>Klenzyme and Reliance DG are<br>introduced into the Reliance EPS<br>to provide washing and high<br>level disinfection.<br>Decontamination cycles (D-Long<br>with CIP-200 and D-Short) are<br>used to prevent biofilm<br>formation in the Reliance EPS<br>Processor and ensure effective<br>processing following periods of<br>processor inactivity. | The Reliance EPS and its<br>integrated endoscope processing<br>support provide for delivery of<br>solutions and fluids to<br>endoscopes and their accessories.<br>Klenzyme and Reliance DG are<br>introduced into the Reliance EPS<br>to provide washing and high<br>level disinfection.<br>Decontamination cycles (D-Long<br>with CIP-200 and D-Short) are<br>used to prevent biofilm<br>formation in the Reliance EPS<br>Processor and ensure effective<br>processing following periods of<br>processor inactivity. | Identical |
| Process<br>Parameters | Standardized cycle parameters<br>cannot be altered by operator.<br>The critical process parameters<br>are:<br>● Contact Time<br>● Use Dilution Temperature | Standardized cycle parameters<br>cannot be altered by operator.<br>The critical process parameters<br>are:<br>● Contact Time<br>● Use Dilution Temperature | Identical |

| | Table 1. Technological comparison for Reliance EPS | |
|--|----------------------------------------------------|--|
| | | |

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| Feature | Proposed Device<br>Reliance EPS | Predicate Device<br>Reliance EPS<br>K102244 | Comparison |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Cleaning solution and Reliance DG concentration Water filter integrity | Cleaning solution and Reliance DG concentration Water filter integrity | |
| | Control Handle Boot pressure alarms if pressure too low to process, or if too high and could potentially damage scopes (specification 6.5 to 10.5 PSI). Detection of a fresh Reliance DG container in every processing cycle Cleaning Solution level monitored; alarm indicates when container does not have sufficient amount to complete cycle Temperature alarms if outside of range Water filter integrity test at end of each high level disinfection cycle. | Control Handle Boot pressure alarms if pressure too low to process, or if too high and could potentially damage scopes (specification 6.5 to 10.5 PSI). Detection of a fresh Reliance DG container in every processing cycle Cleaning Solution level monitored; alarm indicates when container does not have sufficient amount to complete cycle Temperature alarms if outside of range Water filter integrity test at end of each high level disinfection cycle. | |
| Process<br>Monitors | | | Identical |
| Design<br>Features | Intended for use with Reliance DG only Microprocessor controlled Internal components constructed of stainless steel, silicone, polypropylene and PVDF. Processor provides 0.2 micron filtered water for washing, disinfection and rinsing Automated injection of cleaning solutions Automated generation and delivery of high level disinfecting solution Air intake for Air Purge is | Intended for use with Reliance DG only Microprocessor controlled Internal components constructed of stainless steel, silicone, polypropylene and PVDF. Processor provides 0.2 micron filtered water for washing, disinfection and rinsing Automated injection of cleaning solutions Automated generation and delivery of high level disinfecting solution Air intake for Air Purge is | Identical |
| Feature | Proposed Device<br>Reliance EPS | Predicate Device<br>Reliance EPS<br>K102244 | Comparison |
| Cycle<br>Description | Optional: Wash 1 with 1<br>• rinse or Wash 2 with 1 rinse<br>o Wash time can be<br>adjusted to be between 5<br>and 10 minutes, 40<br>second rinse<br>Additional "smart rinse"<br>• occurs after optional wash if<br>boot pressure < 7.0 psi is<br>detected during the heating<br>phase prior to generation<br>phase: 40 second rinse<br>• HLD Generation: 4 minutes<br>• HLD Exposure: 6 minutes<br>• Rinse 1: 40 seconds<br>• Rinse 2: 40 seconds<br>• Air purge<br>o Can be adjusted to be<br>between 4 and 30<br>minutes | Optional: Wash 1 with 1<br>• rinse or Wash 2 with 1 rinse<br>o Wash time can be<br>adjusted to be between 5<br>and 10 minutes, 40<br>second rinse<br>Additional "smart rinse"<br>• occurs after optional wash if<br>boot pressure < 7.0 psi is<br>detected during the heating<br>phase prior to generation<br>phase: 40 second rinse<br>• HLD Generation: 4 minutes<br>• HLD Exposure: 6 minutes<br>• Rinse 1: 40 seconds<br>• Rinse 2: 40 seconds<br>• Air purge<br>o Can be adjusted to be<br>between 4 and 30<br>minutes | Identical |
| Maintenance<br>Requirements | • D-SHORT decontamination<br>cycle required every 54-<br>hours<br>• D-LONG decontamination<br>cycle required if D-SHORT<br>not performed within past 54<br>hours.<br>• Periodic cleaning of debris<br>screen and spray arms<br>• Periodic replacement of<br>water and air filters | • D-SHORT decontamination<br>cycle required every 54-<br>hours<br>• D-LONG decontamination<br>cycle required if D-SHORT<br>not performed within past 54<br>hours.<br>• Periodic cleaning of debris<br>screen and spray arms<br>• Periodic replacement of<br>water and air filters | Identical |
| Accessories | | | |
| Chemical<br>Indicator | Reliance CI Process Indicator,<br>K063285. Peracetic acid dose<br>indicator for routine monitoring<br>of Reliance EPS using Reliance<br>DG. Chemical reaction on<br>indicator pad to produce color<br>change. | Reliance CI Process Indicator,<br>K063285. Peracetic acid dose<br>indicator for routine monitoring<br>of Reliance EPS using Reliance<br>DG. Chemical reaction on<br>indicator pad to produce color<br>change. | Identical |
| Flow Units | Flow units are required only for<br>scope channels that do not open<br>in the endoscope control handle<br>or mechanical action is required<br>for valve operation. 11 Flow<br>Units are available. | Flow units are required only for<br>scope channels that do not open<br>in the endoscope control handle<br>or mechanical action is required<br>for valve operation. 11 Flow<br>Units are available. | Identical |
| | Proposed Device | Predicate Device | Comparison |
| Feature | Reliance DG Dry Germicide | Reliance DG Dry Germicide | |
| Indications<br>for Use | High level disinfectant for use<br>only in the Reliance Endoscope<br>Processor. The REPS is intended<br>for washing and high level<br>disinfection of up to two<br>manually pre-cleaned,<br>immersible, reusable, heat-<br>sensitive, semi-critical devices<br>such as GI flexible endoscopes,<br>bronchoscopes and their<br>accessories. High level<br>disinfection is achieved within<br>the 50 - 57°C HLD Phase of the<br>Endoscope Processing Cycle (4-<br>minute generation sequence<br>followed by a 6-minute exposure<br>sequence). | High level disinfectant for use<br>only in the Reliance Endoscope<br>Processor. The REPS is intended<br>for washing and high level<br>disinfection of up to two<br>manually pre-cleaned,<br>immersible, reusable, heat-<br>sensitive, semi-critical devices<br>such as GI flexible endoscopes,<br>bronchoscopes and their<br>accessories. High level<br>disinfection is achieved within<br>the 50 - 57°C HLD Phase of the<br>Endoscope Processing Cycle (4-<br>minute generation sequence<br>followed by a 6-minute exposure<br>sequence). | Identical |
| Germicide<br>Exposure<br>Time (min)<br>for HLD | 10 minutes<br>(4-minute generation sequence<br>followed by a 6-minute exposure<br>sequence) | 10 minutes<br>(4-minute generation sequence<br>followed by a 6-minute exposure<br>sequence) | Identical |
| Use<br>Temperature | 50 - 57°C | 50 - 57°C | Identical |
| Reuse | Single use | Single use | Identical |
| Human<br>Factors | Dispensed ready to use.<br>Container opened automatically<br>by the processor, limiting user<br>exposure to the germicide. | Dispensed ready to use.<br>Container opened automatically<br>by the processor, limiting user<br>exposure to the germicide. | Identical |
| Physical and Chemical Properties | | | |
| Container | Single-use,<br>2 Compartment Container | Single-use,<br>2 Compartment Container | Identical |
| Composition,<br>Packaged<br>product | Dry/Dry | Dry/Dry | Identical |
| Active<br>Ingredient | Peracetic acid, generated in situ | Peracetic acid, generated in situ | Identical |
| Feature | Proposed Device<br>Reliance DG Dry Germicide | Predicate Device<br>Reliance DG Dry Germicide | Comparison |
| Mode of<br>Action | It is believed that peracetic acid<br>exerts its germicidal effect by<br>several mechanisms:<br>-oxidizing sulfhydral and sulfur<br>bonds in proteins and enzymes,<br>particularly in the cell walls1 -<br>hydroxyl radicals produced from<br>PAA are bactericidal2<br>-PAA damages the viral capsid<br>and viral nucleic acid3,4 | It is believed that peracetic acid<br>exerts its germicidal effect by<br>several mechanisms:<br>-oxidizing sulfhydral and sulfur<br>bonds in proteins and enzymes,<br>particularly in the cell walls1<br>-hydroxyl radicals produced from<br>PAA are bactericidal2<br>-PAA damages the viral capsid<br>and viral nucleic acid3,4 | Identical |
| Rinses | 2 rinses, 40 seconds each, with<br>0.2µ filtered water. | 2 rinses, 40 seconds each, with<br>0.2µ filtered water. | Identical |
| | Microbial Efficacy | | |
| Sporicidal<br>Activity of<br>Disinfectants<br>AOAC<br>Official<br>Method<br>966.04 | Meets efficacy requirements.5<br><i>Bacillus subtilis</i><br><i>Clostridium sporogenes</i> | Meets efficacy requirements.5<br><i>Bacillus subtilis</i><br><i>Clostridium sporogenes</i> | Identical |
| Confirmatory<br>Sporicidal<br>Activity of<br>Disinfectants<br>AOAC<br>Official<br>Method<br>966.04 | Meets efficacy requirements.5<br><i>Bacillus subtilis</i><br><i>Clostridium sporogenes</i> | Meets efficacy requirements.5<br><i>Bacillus subtilis</i><br><i>Clostridium sporogenes</i> | Identical |
| Fungicidal<br>Activity of<br>Disinfectants<br>AOAC<br>Official<br>Method<br>955.17 | Solution is fungicidal.<br><i>Trichophyton mentagrophytes</i> | Solution is fungicidal.<br><i>Trichophyton mentagrophytes</i> | Identical |
| Use-Dilution<br>Method<br>AOAC,<br>Official<br>Methods<br>955.14,<br>955.15, 964.02 | Solution is bactericidal.<br><i>Salmonella choleraesuis</i><br><i>Staphylococcus aureus</i><br><i>Pseudomonas aeruginosa</i> | Solution is bactericidal.<br><i>Salmonella choleraesuis</i><br><i>Staphylococcus aureus</i><br><i>Pseudomonas aeruginosa</i> | Identical |

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Table 2. Technological comparison of Reliance DG Dry Germicide

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^&#x27; Block, S. ed., Disinfection, Sterilization, and Preservation. 5ª edition, 2001
² Clapp et al., Free Rad. Res., (1994) 21:147-167
³ Maillard et al., J. Med Microbiol. (1996)

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| Feature | Proposed Device<br>Reliance DG Dry Germicide | Predicate Device<br>Reliance DG Dry Germicide | Comparison | | |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|--|
| EPA Virucidal<br>Testing<br>(DIS/TSS-7,<br>Nov. 1981) | Process conditions are virucidal.<br>Herpes simplex Type 1<br>Adenovirus Type 5<br>Poliovirus Type 1 | Process conditions are virucidal.<br>Herpes simplex Type 1<br>Adenovirus Type 5<br>Poliovirus Type 1 | Identical | | |
| Tuberculocidal<br>Activity of<br>Disinfectants<br>AOAC<br>Official<br>Method<br>965.12 | Solution is tuberculocidal.<br>Mycobacterium bovis | Solution is tuberculocidal.<br>Mycobacterium bovis | Identical | | |
| Tuberculocidal<br>Activity<br>Ascenzi<br>Quantitative<br>Suspension<br>Test | Solution is tuberculocidal<br>Mycobacterium terrae | Solution is tuberculocidal<br>Mycobacterium terrae | Identical | | |
| Simulated-Use<br>Test | Meets efficacy requirement<br>Mycobacterium terrae | Meets efficacy requirement<br>Mycobacterium terrae | Identical | | |
| Biocompatibility | | | | | |
| Cytotoxicity<br>Device<br>Extracts | Non-cytotoxic per ISO 10993-5 | Non-cytotoxic per ISO 10993-5 | Identical | | |
| Residue<br>Reduction | Automatic within the Reliance<br>Endoscope Processor, 2 x 15 L -<br>0.2 µ filtered water rinses after<br>HLD cycle effectively reduces<br>germicide residues to safe levels. | Automatic within the Reliance<br>Endoscope Processor, 2 x 15 L -<br>0.2 µ filtered water rinses after<br>HLD cycle effectively reduces<br>germicide residues to safe levels. | Identical | | |
| Device<br>Material<br>Compatibility | Compatible with intended flexible<br>endoscopes and accessories<br>established through testing<br>finished medical devices. No<br>device functional changes.<br>Some materials show cosmetic<br>changes such as fading of<br>external markings but all<br>remained legible, and bleaching<br>of black anodized aluminum<br>without harm to the base<br>material. | Compatible with intended flexible<br>endoscopes and accessories<br>established through testing<br>finished medical devices. No<br>device functional changes.<br>Some materials show cosmetic<br>changes such as fading of<br>external markings but all<br>remained legible, and bleaching<br>of black anodized aluminum<br>without harm to the base<br>material. | Identical | | |

{12}------------------------------------------------

#### 6. Summary of Non-Clinical Testing

Shown in Table 3 is the new testing that was performed to evaluate the modified device.

| Test | Purpose | Acceptance Criteria | Result |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Biocompatibility<br>with alternate ink<br>used on the label<br>of Reliance DG<br>Dry Germicide | To ensure the alternate new<br>ink used on the label of the<br>Reliance DG Dry<br>Germicide does not cause a<br>cytotoxic response. | Extracts from devices<br>processed in the Reliance EPS<br>with Reliance DG with the<br>alternate ink on the label shall<br>meet the acceptance criteria for<br>cytotoxicity in ISO 10993-<br>5:2009, Annex A Neutral Red<br>Assay | PASS |

Table 3. Summary of verification activities

#### 7. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well or better than the legally marketed predicate device (K102244), Class II (21 CFR 876.1500), product code NZA.