(28 days)
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℃ HLD Phase of the Endoscope Processing Cycle (4 minute generation sequence followed by a 6-minute exposure sequence).
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.
The provided text describes the STERIS® Reliance® Endoscope Processing System, an automated endoscope reprocessor. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to a predicate device and providing performance data.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the success of the tests conducted according to FDA guidance documents for germicidal efficacy, simulated-use, and in-use studies. The reported device performance indicates that these criteria were met.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Germicide Efficacy (Reliance DG Dry Germicide): | |
| Sporicidal activity (defined by AOAC Sporicidal Activity Test with 6 minutes exposure). | Proven sporicidal in situ. Confirmatory testing completed, supplemental confirmatory testing in the processor with aged germicide. |
| Tuberculocidal activity (defined by AOAC Tuberculocidal Activity Test with 6 minutes exposure). | Proven tuberculocidal. Potency confirmed with aged germicide. |
| Virucidal activity (reduction of poliovirus Type 1, adenovirus Type 5, and herpes simplex virus Type 1 by > 4 log₁₀). | Proven to reduce viable population by > 4 log₁₀. |
| Bactericidal activity (defined by AOAC Bactericidal Activity Test with 6 minutes exposure at worst case conditions). | Proven bactericidal in situ or in vitro. |
| Fungicidal activity (defined by AOAC Fungicidal Activity Test with 6 minutes exposure). | Proven fungicidal in situ or in vitro. |
| Simulated-Use Study (High-Level Disinfection performance within the processor): | |
| Greater than a 6 log₁₀ reduction of Mycobacterium terrae within the Reliance Endoscope Processor. | Reproducibly achieved greater than a 6 log₁₀ reduction of Mycobacterium terrae in triplicate trials using selected clinically relevant flexible endoscopes and accessories (representing most challenging devices). |
| In-Use Study (Clinical effectiveness after manual cleaning and high-level disinfection): | |
| No organisms recovered after processing clinically used endoscopes. | In triplicate evaluations of each of three flexible endoscopes (representing the product labeling range) used in clinical procedures, no organisms were recovered after processing. Bioburden levels prior to processing were as high as 10⁵ CFU/device. |
| Biocompatibility (Residues on medical devices): | |
| Residues remaining on medical endoscopes and accessories below established residue limits and non-cytotoxic. | Residues remaining on medical endoscopes and accessories are below established residue limits and do not pose a risk. Biocompatibility testing of extracts from processed devices demonstrated no toxic residuals. Processor final rinse water was found to be non-cytotoxic. |
| Material Compatibility: | |
| No deleterious effects or functional changes on medical devices (e.g., flexible endoscopes) after repeated processing cycles (e.g., 300 cycles). | After 300 processing cycles, no deleterious effects were observed other than minor cosmetic changes. No functional changes in flexible endoscopes were observed. |
| Processor Performance (Critical Process Parameters): | |
| 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 within required specifications under worst-case conditions. | Each critical parameter was evaluated in replicate under worst case conditions and found to be within required specifications. |
| Washing phase effectiveness: Devices pre-soiled with combination of eggs, blood, mucin, and serum in saline are visually clean and achieve greatly reduced yield of extractable protein per cm² device area (e.g., reduced from >173 to 173 to |
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.