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
Electromechanical washer/high-level disinfector; processes up to two manually pre-cleaned, immersible, heat-sensitive endoscopes. Input: endoscopes, water, and Reliance DG Dry Germicide (single-use package). Operation: microprocessor-controlled cycles; automated dilution of dry germicide to generate peracetic acid in situ; circulation of solution through device lumens and exterior surfaces at 50-57°C; automated rinse with 0.2-micron filtered water; HEPA-filtered air purge. Used in clinical settings by healthcare personnel. Output: processed, high-level disinfected endoscopes; printed cycle summary. Benefits: automated, standardized reprocessing; reduced user exposure to chemicals; validated microbial efficacy; filter integrity monitoring ensures disinfection reliability.
Clinical Evidence
In-use study conducted in a US hospital. Three flexible endoscope types processed according to instructions. Triplicate evaluations showed no organisms recovered after processing. Bioburden levels on clinically used endoscopes prior to disinfection were as high as 10^8 CFU/device.
Technological Characteristics
Electromechanical washer-disinfector; microprocessor-controlled. Internal components: stainless steel and silicone. Energy source: electrical. Connectivity: printer output for cycle documentation; optional barcode reader. Filtration: 0.2-micron water filter; HEPA air filter. Sterilization/Disinfection: High-level disinfection via in situ generated peracetic acid. Cycle parameters: 50-57°C HLD phase.
Indications for Use
Indicated for washing and high-level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical medical devices, including GI flexible endoscopes and bronchoscopes. Not for use on non-immersible or non-heat-sensitive devices.
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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
Custom Ultrasonics System 83 Plus
STERIS 20 Sterilant Concentrate
Sterilox Liquid Chemical HLD System
Submission Summary (Full Text)
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#### Certification to electromagnetic standards, continued: Non-clinical Tests: Limits and Methods of Processor CISPR 22 (1997) Measurements of Radio Performance, (equivalent to EN 55022:1998) Disturbance Characteristics of continued Information Technology Equipment The Reliance Endoscope Processing System was evaluated in an inuse 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 Clinical Tests evaluations of each endoscope, no orqanisms 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 108 CFU/device. The above data document that the Reliance Endoscope Processing System meets the FDA requirements of the quidance 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 Conclusion Automated Endoscope Washers (1993). Conformity to the requirements of these quidances demonstrates the safety and effectiveness of the Reliance Endoscope Processing System. Based on the results of all testing conducted, this system is as safe and effective as the predicate devices.
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| Date | July 5, 2006 |
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| Submitter | STERIS Corporation<br>5960 Heisley Road<br>Mentor Ohio 44060 USA<br><br>Telephone: 440-354-2600 |
| Contact | Nancy A. Robinson<br>Director, Advanced Sterilization<br>STERIS Corporation<br>5960 Heisley Road<br>Mentor, OH 44060 USA<br><br>Tel.: 440-392-7742<br>Fax: 440-392-8955<br>E-mail: nancy_robinson@steris.com |
| | Trade name: The Reliance® Endoscope Processing System |
| | Common name: Automated endoscope reprocessing system |
| Device Name | The System includes the following<br>Classification names:<br>Processor: Medical Washer-Disinfector for High Level Disinfection of Medical Devices Germicide: Liquid Chemical Germicide Cleaners: Accessories to the Medical Washer-Disinfector |
| Legally Marketed<br>Devices to which<br>Substantial<br>Equivalence is<br>Claimed | The Reliance Endoscope Processing System is substantially<br>equivalent to the following legally marketed Class II medical devices:<br>Reliance Processor:<br>Custom Ultrasonic System 83 Plus, based on similar indications for use, designs, and features Reliance™ DG Dry germicide:<br>STERIS 20™ Sterilant Concentrate, with respect to device design, active ingredient, conditions of use, and chemical monitoring and<br>Sterilox Liquid Chemical HLD System, with respect to indications for use (high level disinfectant) and <i>in situ</i> generation of the active ingredient |
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| | Property ▼ | STERIS<br>Reliance Endoscope<br>Processor | | Custom Ultrasonics<br>System 83 Plus | |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| | Intended Use | Wash and high level<br>disinfect up to two<br>manually pre-cleaned,<br>immersible, reusable,<br>heat-sensitive, semi-<br>critical devices such as GI<br>flexible endoscopes,<br>bronchoscopes and their<br>accessories.<br>High level disinfection is<br>achieved within the<br>50 - 57°C HLD Phase of<br>the Endoscope<br>Processing Cycle<br>(4-minute generation<br>sequence followed by a<br>6-minute exposure<br>sequence). | | Clean and high level<br>disinfect one or two<br>submersible flexible<br>endoscopes intended<br>used to treat and<br>diagnose disorders of the<br>gastrointestinal and/or<br>pulmonary tracts.<br>High level disinfection<br>contact conditions vary<br>with the germicide used<br>in the processor. | |
| Summary of<br>technological<br>characteristics for<br>comparison to<br>predicate:<br>a) Processor | Operational<br>Principles | Pressure in control<br>handle boot drives<br>washing/disinfecting/rinse<br>solutions through lumens.<br>Circulation pump sprays<br>exterior surfaces. | | Fluid connectors/<br>attachments flow<br>cleaning/disinfecting/rinse<br>solution through lumens.<br>Immersion system with<br>ultrasonic cavitations<br>during all phases except<br>disinfection. | |
| | | Flow units are required<br>only for endoscope<br>channels that do not open<br>in the endoscope control<br>handle and when<br>mechanical action is<br>required for valve<br>operation | | Adaptors are required to<br>flow solutions through<br>lumens. | |
| | Cycle Description | Phase | Time | Phase | Time |
| | | | Optional:<br>Washing 1<br>(Wash with<br>rinse) | Wash time<br>can be<br>adjusted to<br>be between<br>5 and 10<br>minutes | Wash |
| | | Rinse | 40 seconds | Rinse | 1.5 minutes |
| | Property ▼ | STERIS<br>Reliance Endoscope<br>Processor | | Custom Ultrasonics<br>System 83 Plus | |
| | Cycle Description,<br>continued | Phase | Time | Phase | Time |
| | | Optional:<br>Washing 2<br>(Wash with<br>rinse) | Wash time<br>can be<br>adjusted to<br>be between<br>5 and 10<br>minutes | Not applicable | |
| | | Rinse | 40 seconds | | |
| | | Dry Germicide<br>Generation | 4 minutes | | |
| | | Dry Germicide<br>Exposure | 6 minutes | Chemical<br>Immersion | Varies with<br>germicide<br>used |
| | | Rinse 1 | 40 seconds | Rinse 1 | 1 minute |
| Summary of<br>technological<br>characteristics for<br>comparison to<br>predicate:<br>a) Processor,<br>continued | | Rinse 2 | 40 seconds | Rinse 2 | 1.5 minutes |
| | | Air purge | Air purge<br>time can be<br>adjusted to<br>be between<br>4 and 30<br>minutes | Air purge | 40 seconds |
| | | Alcohol Flush: Product<br>labeling instructs the user to<br>follow departmental<br>procedures regarding<br>flushing the endoscope<br>channels with alcohol and<br>storage of the endoscope<br>before use. | | Alcohol Flush: Product<br>labeling indicates that an<br>alcohol rinse can be<br>performed manually by the<br>user while the device is<br>attached to the processor. | |
| | Critical Design<br>Features | Intended for use with<br>Reliance DG Dry Germicide<br>only | | Intended for use with<br>different types of liquid<br>chemical germicides<br>(aldehydes and most<br>oxidizing germicides) | |
| | | Microprocessor controlled | | Microprocessor controlled | |
| | | Internal components<br>constructed of stainless steel<br>and silicone | | Internal components<br>constructed of stainless<br>steel | |
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## RELIANCE® ENDOSCOPE PROCESSING SYSTEM
| | Property ▼ | STERIS<br>Reliance Endoscope<br>Processor | Custom Ultrasonics<br>System 83 Plus |
|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Critical Design<br>Features,<br>continued | Processor provides<br>0.2 micron filtered water<br>for washing, disinfection<br>and rinsing | Water filtration system<br>external to device<br>(customer supplied) |
| | | Automated injection of<br>washing solution | Manual injection of<br>cleaning solution |
| | | Automated generation<br>and delivery of high level<br>disinfection solution | High level disinfectant<br>selected and added by<br>operator |
| | | Air intake for Air Purge is<br>HEPA filtered | No air cleaning option |
| Summary of<br>technological<br>characteristics for<br>comparison to<br>predicate:<br>a) Processor,<br>continued | Process<br>Parameters | Can select the following<br>endoscope processing<br>cycles:<br>• Disinfect only<br>• Wash and disinfect<br>Processor also provides<br>the following self-<br>decontamination cycles:<br>• D-SHORT (must be<br>run every 54 hours)<br>• D-LONG (must be<br>run when D-SHORT<br>has not been run in<br>the past 54 hours) | Can select the following<br>endoscope processing<br>cycles:<br>• Wash only<br>• Wash and disinfect<br>• Disinfect only |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | Disinfection time not<br>adjustable | Adjustable disinfection<br>time to accommodate<br>different HLD solutions. |
| | | Washing and air purge<br>times adjustable | Cleaning and air purge<br>times adjustable |
| | | Temperature not<br>adjustable | Temperature is<br>adjustable |
| | Property ▼ | STERIS<br>Reliance Endoscope<br>Processor | Custom Ultrasonics<br>System 83 Plus |
| Summary of<br>technological<br>characteristics for<br>comparison to<br>predicate:<br>a) Processor,<br>continued | Process<br>Parameters,<br>continued | Washing solution<br>concentration not adjustable<br>Reliance DG Dry Germicide<br>solution concentration not<br>adjustable | Cleaning solution is added by<br>operator (3 oz. Tergal 800)<br>Liquid chemical germicide<br>solution is adjustable |
| | | Water quality is not<br>adjustable; filtration systems<br>are provided with processor | Water quality external to<br>processor and provided by<br>customer |
| | Process Monitors | Control Handle Boot pressure<br>alarms if pressure too low to<br>process, or if too high and<br>could potentially damage<br>scopes | Pressure monitor cut off at<br>5 psi<br>Flow sensor for air/water<br>channel to detect<br>backpressure<br>Air restrictor allowing for<br>visual confirmation of flow (air<br>bubbles) through the air/water<br>channel. |
| | | Detection of a fresh Reliance<br>DG Dry Germicide container<br>in every processing cycle | No on-board monitoring for<br>presence of germicide or<br>germicide components |
| | | Washing solution level<br>monitored; alarm indicates<br>when container does not<br>have sufficient amount to<br>complete cycle | Cleaner solution level not<br>monitored |
| | | Temperature alarms if out of<br>range | No temperature monitoring<br>other than heater<br>thermocouple |
| | | Water filter integrity test | No water filter integrity test |
| | Maintenance<br>Requirements | D-SHORT decontamination<br>cycle required every 54 hours<br>D-LONG decontamination<br>cycle required if D-SHORT<br>not performed within past 54<br>hours. | Daily decontamination of<br>internal plumbing using<br>disinfectant solution |
| | | Periodic cleaning of debris<br>screen and spray arms | Daily cleaning with "Comet"<br>or "Ajax"<br>Cleaning when changing<br>disinfectant |
| | | Periodic replacement of<br>water and air filters | Filters provided by customer |
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| | Device▶ | Reliance DG Dry<br>Germicide | STERIS 20 | Sterilox Liquid<br>Chemical HLD<br>System |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| | General Features: The general features of Reliance DG Dry Germicide and the<br>predicate germicides are similar in that they are intended to process pre-<br>cleaned, immersible, reusable medical devices. The germicides are supplied in a<br>ready to use, single use dose. | | | |
| | Intended Use: | Dry germicide for<br>use only in the<br>Reliance<br>Endoscope<br>Processor. | Sterilant for use<br>only in the<br>SYSTEM 1<br>Processor. | High level<br>disinfectant for use<br>only with the<br>Sterilox Generator. |
| Summary of<br>technological<br>characteristics<br>for<br>comparison to<br>predicate:<br>b) Reliance<br>DG Dry<br>Germicide | | Provides high level<br>disinfection of up to<br>two manually pre-<br>cleaned,<br>immersible,<br>reusable, heat-<br>sensitive, semi-<br>critical medical<br>devices such as<br>endoscopes and<br>their accessories. | Provides sterile<br>processing of<br>manually pre-<br>cleaned<br>immersible,<br>reusable, semi-<br>critical and critical<br>devices. | Provides for high<br>level disinfection of<br>pre-cleaned,<br>immersible,<br>reusable, heat-<br>sensitive, semi-<br>critical medical<br>devices. |
| | Labeling: | Dry Germicide | Liquid Chemical<br>Sterilant | High Level<br>Disinfectant |
| | Germicide<br>Exposure Time<br>(min) for<br>intended use<br>(High Level<br>Disinfection or<br>Sterile<br>Processing) | 10<br>(4-minute<br>generation<br>sequence followed<br>by a 6-minute<br>exposure<br>sequence) | 12 | 10 |
| | Use<br>Temperature | 50 - 57°C | 50 - 56°C | 25°C |
| | Reuse | Single use | Single use | Single use |
| | Device▶ | Reliance DG Dry<br>Germicide | STERIS 20 | Sterilox Liquid<br>Chemical HLD<br>System |
| Human<br>Factors | | Dispensed ready to<br>use.<br>Container opened<br>automatically by<br>the processor,<br>limiting user<br>exposure to the<br>germicide. | Dispensed ready<br>to use.<br>Container opened<br>automatically by<br>the processor,<br>limiting user<br>exposure to the<br>germicide | Dispensed ready to<br>use. |
| Physical and Chemical Properties: The physical and chemical properties of<br>Reliance DG Dry Germicide and the predicate germicides are similar in that they<br>are supplied in a single use, ready to use dose in a form that is readily soluble in<br>water and results in a ~ pH neutral solution | | | | |
| Summary of<br>technological<br>characteristics<br>for<br>comparison to<br>predicate:<br>b) Reliance<br>DG Dry<br>Germicide,<br>continued | Container | Single-use,<br>2 Compartment<br>Container | Single-use,<br>2 Compartment<br>Container | Single use. |
| | Composition,<br>Packaged<br>Product | Dry/Dry | Dry/Liquid | Liquid |
| | Appearance | Translucent liquid | Lime green liquid | Colorless liquid |
| | Odor | Slightly acidic | Slightly acidic | odorless |
| | pH | 7.0 - 8.5 | 6 - 8 | 5 – 7 |
| | Solubility in<br>Water…
