RELIANCE ENDOSCOPE PROCESSING SYSTEM

K102244 · STERIS Corporation · NZA · Dec 3, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K102244
• Device Name: RELIANCE ENDOSCOPE PROCESSING SYSTEM
• Applicant: STERIS Corporation
• Product Code: NZA · Gastroenterology, Urology
• Decision Date: Dec 3, 2010
• Decision: SESE
• Submission Type: Traditional
• 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

The Reliance Endoscope Processing System is an electromechanical washer/disinfector for reprocessing flexible endoscopes. It processes up to two devices simultaneously. The system uses Reliance DG Dry Germicide, a two-part dry chemistry that generates peracetic acid when mixed with water. The processing cycle includes an optional enzymatic wash phase, a high-level disinfection phase (50-57°C), a rinse phase using 0.2-micron filtered water, and a HEPA-filtered air purge. A microprocessor-based controller manages cycles and performs self-decontamination (D-SHORT and D-LONG cycles). The device is operated by clinical staff in a healthcare setting. It provides a printed cycle summary for documentation, which can include operator, patient, and device identifiers via an optional barcode reader. The system ensures patient safety by automating disinfection parameters, monitoring chemical presence via process indicators, and verifying filter integrity. It benefits patients by providing standardized, validated high-level disinfection of heat-sensitive endoscopes, reducing the risk of cross-contamination.

Clinical Evidence

Bench testing included microbiological efficacy studies (AOAC sporicidal, tuberculocidal, bactericidal, fungicidal tests) and simulated-use studies demonstrating >6 log10 reduction of Mycobacterium terrae. In-use clinical evaluation in a US hospital processed three types of flexible endoscopes; no organisms were recovered after processing. Bioburden levels prior to HLD were up to 10^5 CFU/device. Material compatibility was validated over 300 cycles with no functional degradation.

Technological Characteristics

Electromechanical washer/disinfector; microprocessor-controlled. Uses Reliance DG Dry Germicide (peracetic acid-generating oxidative chemistry). Features 0.2-micron bacterial-retentive water filtration with automated integrity check and HEPA-filtered air purge. Certified to ANSI/UL 61010-1, CAN/CSA C22.2 61010-1, IEC 61010-1, IEC 61010-2-40, and IEC 61326-1. Materials evaluated for biocompatibility and device compatibility. Standalone system.

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, 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 (K040049)

Submission Summary (Full Text)

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DEC 3 2010

# 510(k) Summary For Reliance® Endoscope Processing System

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

Contact:

Robert F. Sullivan Senior Director, Regulatory Affairs Telephone: [phone] [phone] Fax No:

October 14, 2010 Summary Date:

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

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#### Device Name 1.

| Trade Name: | Reliance Endoscope Processing System |
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| Common/usual Name: | Automated Endoscope Reprocessor |
| Classification Name: | 21 CFR 876.1500<br>Endoscope Cleaning Germicide Accessories |

#### 2. Predicate Device

Reliance Endoscope Processing System K040049

### 3. Description of Device

The Reliance Endoscope Processing System is an economical, easy-to-use high level disinfection system intended to wash and high level disinfect up to two manually cleaned, immersible, reusable, heat-sensitive, 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.

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## 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 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.
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- => 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 6 minutes of high level disinfection solution exposure time.
- > Following the high level disinfection phase, the Reliance Endoscope Processor removes the high level disinfection solution through a rinse phase which is non-optional 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 HEPAfiltered 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 10minute 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.

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#### 4. Intended Use

The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually 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 6minute exposure sequence).

#### 5. Description of Safety and Substantial Equivalence

The Reliance Endoscope Processing System has the same technological characteristics as the predicate device.

A summary of performance testing applicable to both the proposed Reliance Endoscope Processing System and its predicate Reliance Endoscope Processing System is provided in the Table attached.

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The Reliance Endoscope Processing System was developed and validated in accord with two primary FDA Guidance documents: Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants (2000), and · Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers (1993). A summary of this testing follows: · Reliance DG Dry Germicide Efficacy: Reliance DG Dry Germicide was tested and shown to generate an effective high level disinfection solution using the standard array of microbiological tests for germicidal efficacy. The following testing was performed at conditions of use that were worst case with respect to contact time, circulation, water hardness, temperature, artificial soiling, and germicide concentration (at or below the minimum effective dose of 9000 mg/L PAA minutes): Sporicidal: Reliance DG Dry Germicide was proven to be sporicidal as defined by AOAC Sporicidal Activity Test with an in situ exposure time of 6 minutes. Confirmatory testing was completed successfully and supplemental confirmatory testing was completed in the Reliance Endoscope Processor. Potency was subsequently confirmed in the processor using Reliance DG Dry Germicide containers that were aged beyond the end of its shelf life. > Tuberculocidal: Reliance DG Dry Germicide was proven to be tuberculocidal as defined by the AOAC Tuberculocidal Activity Test on-clir with an exposure time of 6 minutes. Potency was subsequently confirmed using Reliance DG Dry Germicide aged beyond the end of its shelf life. > Virucidal: The Reliance Process was proven to reduce the viable population of poliovirus Type 1, adenovirus Type 5, and herpes simplex virus Type 1 by > 4 log10-> Bactericidal: Reliance DG Dry Germicide was proven to be bactericidal as defined by the AOAC Bactericidal Activity Test with an exposure time of 6 minutes at worst case conditions, whether performed in situ or in vitro. > Fungicidal: Reliance DG Dry Germicide was proven to be fungicidal as defined by the AQAC Fungicidal Activity Test with an exposure time of 6 minutes, whether performed in situ or in vitro. Simulated-Use: Reliance DG Dry Germicide, at the minimum recommended dose, reproducibly achieved greater than a 6 log10 reduction of Mycobacterium terrae in triplicate trials within the Reliance Endoscope Processor for selected clinically relevant flexible endoscopes and their accessories. The test articles represented the range of most challenging devices, accessories, and processing situations. In-Use: Reliance Endoscope Processing System was evaluated in an in use study in a US hospital. Three flexible endoscopes representing the range of types indicated in the product labeling were used in clinical procedures and processed according to instructions for use. In triplicate evaluations of each endoscope, no organisms were recovered after processing. Bioburden levels on the clinically used endoscopes after manual cleaning and before high level disinfection were determined to be as high as 105 CFU/device.

Appendix A: Page 6 of 8

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Non-clinica Germicide Biocompatibili Material Compatibility

### Biocompatibility:

The Reliance chemical formulations, as supplied in packaging as well as in use dilutions, can be safely handled and used by customers. Residues that may remain on medical endoscopes and accessories are below established residue limits and do not pose a risk to patients. Safety statements in product labeling are appropriate to the potential risk.

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- Reliance DG Dry Germicide, its components, reaction products, and residuals remaining on medical devices were evaluated for biocompatibility and possible risks to users. Testing included acute oral and ocular toxicity tests, dermal irritation studies, in vitro bacterial mutation genotoxicity studies, sensitization tests, and in vitro cytotoxicity evaluations; literature reviews of raw material toxicity data were also performed. Certain components in the single-use container, which under normal use conditions never contact the user, have the potential for irritation or skin sensitization; therefore appropriate warnings and instructions are displayed on labeling for the unusual event of a spill or container breakage.
- Use dilution reaches non-cytotoxic levels with minimal dilution. îî
- > Biocompatibility testing of extracts from processed medical devices demonstrated that no toxic residuals remain on devices under worst case circumstances. The test data indicate that the worst case residue levels for the components of maximum potential risk are far below the allowable limits. Furthermore, the processor final rinse water was found to be non-cytotoxic.

### · Reliance Endoscope Processing System Material Compatibility:

The Reliance System was evaluated for its effect on intact medical devices. including flexible endoscopes and/or common materials of device construction. After 300 processing cycles, no deleterious effects were observed other than minor cosmetic changes. No functional changes in flexible endoscopes were observed.

### · Reliance DG Dry Germicide Stability:

Reliance DG was tested and found stable for 18 months in the unopened moisture-resistant packaging at the stated conditions for storage. Once opened, the containers within each pouch are to be used within 2 weeks, or by the expiration date on the container, whichever comes first.

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| | <b>Reliance Endoscope Processor Performance</b> | |
|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The critical process parameters for the processor (water temperature and volume, fresh Reliance DG Dry Germicide container detection, boot pressure, delivery of washing solutions and high level disinfection solution and water filter integrity testing) were each evaluated in replicate under worst case conditions and found to be within required specifications. | |
| | Each processor phase or cycle was separately evaluated and documented to be effective under worst case conditions: | |
| | ⇒ Validation of the <b>washing phase</b> of the Endoscope Processing Cycle documented that after the shortest possible washing phase, devices pre-soiled with a combination of eggs, blood, mucin and serum in saline: 1) were visually clean, and 2) achieved greatly reduced yield of extractable protein per cm2 device area (assayed to be reduced from >173 to < 5 µg/cm2). | |
| Non-clinical Tests:<br>Processor Performance | ⇒ Validation of the <b>high level disinfection phase</b> of the Endoscope Processing Cycle was performed through a simulated-use study in challenging clinically relevant endoscopes, as well as in an in-use study. | |
| | ⇒ The <b>rinse phase</b> of the endoscope processing cycle was shown to be effective. Evaluations of extracts of devices exposed to worst case conditions in the Endoscope Processing Cycle documented that levels of residuals remaining on devices were far below allowable limits and were not cytotoxic. | |
| | ⇒ The <b>air purge phase</b> was validated to confirm the ability to remove rinse water from processed medical devices. | |
| | ⇒ The <b>filter integrity test</b> system of the processor was documented to reliably detect filter failure. | |
| | ⇒ The <b>two self-decontamination cycles</b> were shown to be effective as follows: | |
| | D-LONG cycle - can disinfect the Reliance Endoscope Processor after a high level challenge with <i>Pseudomonas aeruginosa</i> followed by a 5 day inactive period; D-SHORT cycle - can kill bacteria that have potential to form biofilm. | |
| Reliance Endoscope Processor is certified to the following electrical standards | ANSI/UL -61010-1, 2nd Ed., | Electrical equipment for measurement, control and laboratory use Part 1, 2nd Edition |
| | CAN/CSA C22.2 61010-1, 2nd Ed. | Electrical equipment for measurement, control and laboratory use Part 1, 2nd Edition |
| | IEC 61010-1:2001 | Safety requirements for electrical equipment for measurement, control and laboratory use, Part 1: General requirements, |
| | IEC 61010-2-40, 1st Ed. | Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| | IEC 61326-1:2005, 1st Ed. | Electrical equipment for measurement, control and laboratory use, EMC requirements Part 1: General requirements |

K102244

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Robert F. Sullivan Senior Director, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

Re: K102244

Trade/Device Name: Reliance® Endoscope Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II DEC - 3 2010 Product Code: NZA Dated: October 26, 2010 Received: October 27, 2010

Dear Mr. Sullivan:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your secures of the device is substantially equivalent (for the relerched doove and have a trennilosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmisered prof to may 20, 10, 10, 10, 10, 10, 20, 20, 2011, 10, 2019, 10, 2019, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 Amendinents, or to de riocs that navis Act (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosment . At (Prec) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . approval uppireation (1 Milly). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, requirencens for annual rogistration, including 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 (FINA), It may be subject to ademicined Regulations, Title 21, Parts 800 to 898. In device can be found in the Code of Pourial Regarmers, concerning your device in the Federal Register.

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### Page 2- Mr. Sullivan

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 incall that it DAT has made a determand regulations administered by other Federal agencies. Of the Act of ally I ederal banks in requirements, including, but not limited to: registration 1 ou must comps) with 807); labeling (21 CFR Part 801); medical device reporting allu listing (21 OF R F ar vor ); lated adverse events) (21 CFR 803); good manufacturing (reporting of modical device to the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerery yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Reliance® Endoscope Processing System

Indications for 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).

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elzath & Clamine-Wels

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ivision of Anesthesiology, General Hospital
Anesthes
fection Control, Dental Devices

510(k) Number: K102244
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