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510(k) Data Aggregation
(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 |
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(116 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 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.
Here's a breakdown of the acceptance criteria and study information for the Reliance® Endoscope Processing System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a formal table of "acceptance criteria," but rather describes various performance validations and their successful outcomes. I've synthesized this information into a table format based on the description of safety and substantial equivalence testing.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Microbiological Efficacy - Reliance DG Dry Germicide: | |
| Sporicidal activity | Proven sporicidal as defined by AOAC Sporicidal Activity Test with a 6-minute in situ exposure time, confirmed with supplemental testing in the processor and using aged germicide. |
| Tuberculocidal activity | Proven tuberculocidal as defined by AOAC Tuberculocidal Activity Test with a 6-minute exposure time, confirmed using aged germicide. |
| Virucidal activity | Reduced viable population of poliovirus Type 1, adenovirus Type 5, and herpes simplex virus Type 1 by > 4 log10. |
| Bactericidal activity | Proven bactericidal as defined by AOAC Bactericidal Activity Test with a 6-minute exposure time at worst-case conditions, both in situ and in vitro. |
| Fungicidal activity | Proven fungicidal as defined by AOAC Fungicidal Activity Test with a 6-minute exposure time, both in situ and in vitro. |
| Processor Performance - Endoscope Processing Cycle: | |
| Simulated-Use (Mycobacterium terrae reduction) | Reliably achieved > 6 log10 reduction of Mycobacterium terrae in triplicate trials using selected clinically relevant flexible endoscopes and accessories (representing challenging devices) within the processor, at minimum recommended germicide dose. |
| In-Use (no organism recovery) | No organisms recovered after processing of three flexible endoscopes in an in-use study in a US hospital. |
| Washing phase effectiveness (visual cleanliness & protein removal) | Devices pre-soiled with eggs, blood, mucin, and serum were visually clean and achieved greatly reduced extractable protein (173 µg/cm²). |
| Rinse phase effectiveness (residue removal, non-cytotoxicity) | Residuals remaining on devices were far below allowable limits and non-cytotoxic, even under worst-case exposure conditions. Processor final rinse water was found to be non-cytotoxic. |
| Air purge phase effectiveness | System's ability to remove rinse water from processed medical devices confirmed. |
| Filter integrity test system reliability | Documented to reliably detect filter failure. |
| Critical process parameters (e.g., temp, volume, boot pressure) | Each critical parameter was found to be within required specifications in replicate under worst-case conditions. |
| Processor Performance - Self-Decontamination Cycles: | |
| D-LONG cycle effectiveness | Can disinfect the processor after a high-level challenge with Pseudomonas aeruginosa followed by a 5-day inactive period. |
| D-SHORT cycle effectiveness | Can kill bacteria with the potential to form biofilm. |
| Biocompatibility: | |
| Safe handling and use of chemicals | Chemical formulations (as supplied and in-use dilutions) can be safely handled. Residues on medical endoscopes are below established limits and do not pose a risk. Safety statements are appropriate. |
| Residual toxicity on medical devices | Biocompatibility testing of extracts from processed medical devices demonstrated no toxic residuals remain under worst-case circumstances. Worst-case residue levels for high-risk components are far below allowable limits. Use dilution reaches non-cytotoxic levels with minimal dilution. |
| Material Compatibility: | |
| Effect on medical devices (e.g., endoscopes) | After 300 processing cycles, no deleterious effects were observed on intact medical devices, including flexible endoscopes and/or common materials of device construction, other than minor cosmetic changes. No functional changes were observed. |
| Germicide Stability: | |
| Shelf life | Found stable for 18 months in unopened moisture-resistant packaging at stated conditions. Once opened, containers must be used within 2 weeks or by expiration, whichever comes first. |
| Electrical Standards Compliance: | Certifield to ANSI/UL -61010-1, CAN/CSA C22.2 61010-1, IEC 61010-1:2001, IEC 61010-2-40, 1st Ed., and IEC 61326-1:2005, 1st Ed. |
2. Sample Sizes and Data Provenance
- Test Set (Simulated-Use): Triplicate trials for the Mycobacterium terrae reduction study, using "selected clinically relevant flexible endoscopes and their accessories." The document states these "represented the range of most challenging devices, accessories, and processing situations." No specific number of endoscopes or accessories is provided beyond "selected."
- Test Set (In-Use): Three flexible endoscopes were used, representing the range of types indicated in the product labeling. Triplicate evaluations were performed for each endoscope.
- Test Set (Material Compatibility): "300 processing cycles" were performed on medical devices, including flexible endoscopes and/or common materials of device construction.
- Data Provenance:
- The "In-Use" study was conducted in a "US hospital."
- Other studies (Sporicidal, Tuberculocidal, Virucidal, Bactericidal, Fungicidal, Simulated-Use, Biocompatibility, Material Compatibility, Stability) appear to be laboratory-based studies.
- All data are prospective as they are part of a premarket notification for a new device.
3. Number of Experts and Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for any of the described tests. The studies rely on established microbiological test methods (e.g., AOAC) and standard laboratory and in-use protocols rather than expert consensus on diagnostic imaging or similar subjective assessments.
4. Adjudication Method
Adjudication methods (like 2+1 or 3+1 for resolving discrepancies) are typically used in studies involving human interpretation or subjective assessment where a "ground truth" needs to be established from multiple readers. This document describes performance testing of a physical device and chemical efficacy, which relies on objective measurements (e.g., bacterial reduction, presence of residues, visual cleanliness, functional integrity) rather than subjective human interpretation. Therefore, no adjudication method as typically described in imaging studies was used or mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document is for an automated endoscope processing system, which does not involve human readers interpreting cases or images.
6. Standalone (Algorithm Only) Performance Study
The entire document describes the standalone performance of the "Reliance Endoscope Processing System," which is an automated device performing the washing and high-level disinfection process. All the performance figures reported (microbiological efficacy, cleaning efficacy, cycle performance, material compatibility) characterize the device's inherent capabilities without human intervention during the defined processing cycle (though human manual pre-cleaning and loading/unloading are explicit parts of the overall process).
7. Type of Ground Truth Used
The ground truth for the various tests was established using:
- Microbiological assays: For sporicidal, tuberculocidal, virucidal, bactericidal, fungicidal, and Mycobacterium terrae reduction (quantitative measures of organism reduction/kill).
- Visual inspection and quantitative protein assays: For cleaning efficacy (visual cleanliness and µg/cm² protein).
- Chemical analysis and cytotoxicity testing: For residue levels and biocompatibility.
- Functional and visual inspection after repeated cycles: For material compatibility.
- Analytical measurements: For critical process parameters (temperature, volume, pressure, etc.) and germicide stability.
- Clinical observation/microbiological cultures: For the in-use study (recovery of organisms).
- Standardized electrical tests: For electrical standards compliance.
8. Sample Size for the Training Set
The document focuses on validation studies, not on the development of a machine learning algorithm that would require a distinct "training set." Therefore, no training set sample size is applicable or mentioned. The device's operational parameters and design would have been developed iteratively, but not through a formal "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm involved, the question of how its ground truth was established is not applicable.
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