(340 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°C HLD Phase of the Endoscope Processing Cycle (4 minute generation sequence followed by a 6 minute exposure sequence).
The Reliance Endoscope Processing System includes the Reliance Endoscope Processor, Reliance DG Dry Germicide, Klenzyme Enzymatic Presoak and Cleaner, and CIP 200 Acid-Based Process and Research Cleaner. 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. The processor utilizes a proprietary, single use, dry, germicide package (Reliance DG Dry Germicide) that generates the active ingredient, peracetic acid, upon automatic dilution in water by the processor. In the optional washing phase, washing is provided through the automated delivery of Klenzyme Enzymatic Presoak and Cleaner. CIP 200 Acid-Based Process and Research Cleaner is used in one of the two self-decontamination cycles. The system provides endoscope processing cycles with optional programmable washing phases and a non-optional high level disinfection phase, followed by a rinse phase and an air purge phase. The processor prints a detailed cycle summary. The processor also features two decontamination cycles, D-SHORT and D-LONG, to be used without endoscopes in the processor.
Acceptance Criteria and Device Performance for Reliance® Endoscope Processing System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the Reliance® Endoscope Processing System, which is designed for washing and high-level disinfection of semi-critical medical devices. The acceptance criteria and device performance are primarily focused on germicidal efficacy, biocompatibility, material compatibility, and processor performance, adhering to FDA guidance documents.
Here's a summary:
| Acceptance Criteria Category | Specific Criteria/Test | Acceptance Criteria (from FDA Guidence Documents) | Reported Device Performance (Reliance® Endoscope Processing System) |
|---|---|---|---|
| Germicidal Efficacy (High-Level Disinfection) | Sporicidal Activity (AOAC Sporicidal Activity Test) | Must demonstrate sporicidal activity against relevant spores. | Proven to be sporicidal within 6 minutes of in situ exposure (Bacillus subtilis, Clostridium sporogenes). Confirmatory and supplemental testing successful, including with aged germicide. |
| Tuberculocidal Activity (AOAC Tuberculocidal Activity Test) | Must demonstrate tuberculocidal activity against relevant mycobacteria. | Proven to be tuberculocidal within 6 minutes of exposure (Mycobacterium bovis). Potency confirmed with aged germicide. (Additionally, tuberculocidal against Mycobacterium terrae via Ascenzi Quantitative Suspension Test). | |
| Virucidal Activity (EPA Virucidal Testing DIS/TSS-7) | Must demonstrate virucidal activity against representative viruses. | Proven to reduce viable population of Poliovirus Type 1, Adenovirus Type 5, and Herpes Simplex Virus Type 1 by > 4 log10. | |
| Bactericidal Activity (AOAC Bactericidal Activity Test) | Must demonstrate bactericidal activity against relevant bacteria. | Proven to be bactericidal within 6 minutes of exposure at worst-case conditions (Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa). | |
| Fungicidal Activity (AOAC Fungicidal Activity Test) | Must demonstrate fungicidal activity against relevant fungi. | Proven to be fungicidal within 6 minutes of exposure (Trichophyton mentagrophytes). | |
| Simulated-Use Test (High-Level Disinfection) | Must achieve a significant log reduction of challenge organisms on clinically relevant devices under worst-case conditions. | Reproducibly achieved > 6 log10 reduction of Mycobacterium terrae in triplicate trials within the processor for challenging flexible endoscopes and accessories at minimum recommended dose. | |
| Cleaning Performance | Washing Phase Efficacy | Devices should be visually clean and show significant reduction in extractable protein. | Devices were visually clean and achieved greatly reduced yield of extractable protein (reduced from ≥173 to ≤5 µg/cm2) after shortest possible washing phase, using a combination of eggs, blood, mucin, and serum as soiling agents. |
| Biocompatibility/Safety | Acute Oral Toxicity (Use Dilution) | Safe handling and minimal toxicity from use dilution. | LD50 = >5000 mg/kg (meaning very low acute oral toxicity). |
| Rabbit Eye Irritation | Minimal to non-irritating to eyes. | Minimally irritating. | |
| Rabbit Skin Irritation | Non-irritating to skin. | Non-irritating. | |
| Cytotoxicity (of Use Dilution) | Should reach non-cytotoxic levels with minimal dilution. | Dilution Cytotoxicity Score: 1:1 to 1:2 (3 - moderate), 1:4 to 1:16 (2 - mild), 1:20-1:40 (1 - slight), 0 - nontoxic. Use dilution reaches non-cytotoxic levels with minimal dilution. | |
| Residuals (on Medical Devices) | Residues remaining on devices must be below established limits and non-toxic. | Extracts from processed medical devices demonstrated no toxic residuals remain on devices under worst-case circumstances; worst-case residue levels were far below allowable limits and final rinse water was non-cytotoxic. | |
| Material Compatibility | Effect on Medical Devices/Materials | No deleterious functional effects on medical devices; cosmetic changes should be acceptable and comparable to predicate devices. | No deleterious effects observed on flexible endoscopes and common materials of device construction after 300 processing cycles, other than minor cosmetic changes (e.g., fading markings, bleaching of black anodized aluminum) similar to predicate. No functional changes. |
| System Performance | Critical Process Parameters (e.g., temperature, germicide detection, boot pressure, water filter integrity) | Parameters must be within required specifications under worst-case conditions. | Each critical parameter was found to be within required specifications under worst-case conditions. |
| Rinse Phase Efficacy | Effective removal of high-level disinfection solution. | Effective; evaluations of extracts showed residual levels far below allowable limits and non-cytotoxic. | |
| Air Purge Phase Efficacy | Ability to remove rinse water from processed devices. | Validated to confirm ability to remove rinse water. | |
| Filter Integrity Test System Reliability | Reliable detection of filter failure. | Documented to reliably detect filter failure. | |
| D-LONG Decontamination Cycle Efficacy | Processor can be disinfected after high-level challenge. | Can disinfect the processor after a high-level challenge with P. aeruginosa followed by a 5-day inactive period. | |
| D-SHORT Decontamination Cycle Efficacy | Can kill bacteria to prevent biofilm formation. | Can kill bacteria that have potential to form biofilm. | |
| Clinical Performance (In-Use Study) | No Organisms Recovered | No organisms should be recovered after processing clinically used devices. | No organisms were recovered after processing in triplicate evaluations. Bioburden before disinfection was as high as 10^8 CFU/device. |
2. Sample Size Used for the Test Set and the Data Provenance
- Clinical In-Use Study: Three flexible endoscopes representing the range of types indicated in the product labeling were used in clinical procedures. Data provenance is a US hospital (retrospective or prospective is not explicitly stated, but "in-use study" strongly implies prospective).
- Simulated-Use Test: Performed in "triplicate trials" on "selected clinically relevant flexible endoscopes and their accessories." The exact number of endoscopes or accessories is not specified beyond "selected," but implies at least the number required for triplicate testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth for the test sets. The studies referenced are based on recognized microbiological and toxicology standards (AOAC, EPA) and FDA guidance documents.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method. For the in-use studies and simulated-use studies, the reported results are quantitative microbial reductions or absence of organisms. For material compatibility, it refers to "no deleterious effects" and "minor cosmetic changes."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the device's ability to disinfect rather than human interpretation aided by AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies are standalone performance evaluations of the automated reprocessing system (processor and germicide) without direct human intervention impacting the disinfection efficacy once the cycle is initiated. Human actions primarily involve manual pre-cleaning and loading the device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is primarily microbiological viability (log reduction of specific microorganisms, absence of microorganisms) and chemical/physical property measurements (protein levels, toxicity, material changes, electrical standards conformity).
8. The Sample Size for the Training Set
The document does not refer to a training set in the context of an AI/ML algorithm. This is a medical device (endoscope reprocessing system), not an AI/ML product. Therefore, the concept of a training set as typically understood for machine learning is not applicable here. The development and validation of the system involved extensive laboratory testing (e.g., germicidal efficacy, material compatibility, functional performance) and a clinical in-use study.
9. How the Ground Truth for the Training Set Was Established
As stated above, the concept of a training set for an AI/ML algorithm is not applicable to this device. The "ground truth" for the device's performance was established through standardized testing methodologies (e.g., AOAC, EPA methods) and adherence to FDA guidance, which define the expected outcomes for high-level disinfection and safety. For instance, sporicidal activity is proven by demonstrating a reduction in specified spores to required levels, and biocompatibility by demonstrating toxicity profiles below established thresholds.
§ 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.