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510(k) Data Aggregation
(318 days)
ENDOSCOPE REPROCESSOR OER-MINI
The OER-Mini is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, camera heads, light guide cables, miniature light sources and their accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Mini and Olympus flexible endoscopes, camera heads, light guide cables, miniature light sources and their accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and may damage the OER-Mini components and the endoscopes being reprocessed. Endoscopes must be subject to cleaning by the user prior to reprocessing; however, use of the OER-Mini enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Mini.
The OER-Mini Endoscope Reprocessor is an automated endoscope reprocessor intended for cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, camera heads, light guide cables, miniature light sources and their accessories. Use of the OER-Mini requires detergent and FDA cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Mini and its compatible endoscopes/devices.
Use of the OER-Mini enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Mini.
The OER-Mini has been developed to provide an AER that will suit reprocessing of endoscopes in the surgical field. The OER-Mini has a compact and smart-design for table-top use.
The OER-Mini is a one-basin table-top type automatic endoscope reprocessor that performs cleaning, disinfection, rinse to render a high-level disinfected endoscope, device and their accessories. The OER-Mini utilizes an immersion method for cleaning, disinfecting, and rinsing of endoscope/device and its accessory external surfaces, and connectors for endoscope channel cleaning, disinfecting, and rinsing.
The OER-Mini basically can reprocess one device at a time in one-basin, but the immersible certain combination of devices also can be reprocessed simultaneously at a time in a one-basin.
The OER-Mini is capable of automated disinfectant solution dispensing. The external 0.2-micron water filters are bacteria retentive and produce suitable rinse water for reprocessing. Built-in sensors detect fluid levels and temperatures in the reprocessing basin and disinfectant solution tank. If any abnormality/irregularity is detected, an error indicator lights up with an audible alarm and the reprocessing process is a stopped. The device utilizes a touch-panel user interface for program operation and settings. The disinfectant solution is automatically diluted by filtered water until specified quantity in the device. On the other hand, some functions are eliminated in order to realize compact table-top AER;
- . No detergent dispensing system. User should manually pour detergent into the device.
- No compressor for air purge.
- No alcohol dispensing system. User should manually pour alcohol into the device.
The OER-Mini does not have RFID (Radio-Frequency Identification) function. Instead of RFID function, OER-Mini can connect the external-printer (MAJ-1937), which enables to generate hard copy reprocessing record (i.e. operation record, error history etc.). On the reprocessing record, the entered section of user and scope data has been added.
Also, the OER-Mini has a built-in terminal for data communication, which enables the device to output specific information (i.e. operation record, error history, information for determining periodical maintenance timing etc.) to a computer with proprietary software installed for reprocessing record management. It is also possible to alter data and time settings of the OER-Mini from such a computer via this terminal.
This document describes the Olympus ENDOSCOPE REPROCESSOR OER-Mini, an automated endoscope reprocessor. The provided text, however, focuses on the device's design, indications for use, comparison to a predicate device, and the general types of performance data submitted to the FDA for 510(k) clearance. It does not contain specific acceptance criteria values or detailed study results (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance metrics, ground truth types for test/training sets, or training set sample size) that would allow for a comprehensive table of acceptance criteria and reported device performance as requested.
The document states that the device was tested to "Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities", issued in August 1993. This guidance document would contain the general principles for establishing acceptance criteria for such devices, but the specific values and detailed methods are not in the provided text.
Based on the information provided, here's what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Note: Specific quantitative acceptance criteria values (e.g., "Protein level reduction must be X%", "Carbohydrate level reduction must be Y%") and specific quantitative results are not provided in the document. The document only states that the device "achieves" and "effectively reduced" or "achieved" the required outcomes.
| Category | Acceptance Criteria (Implied by FDA Guidance/Study Goal) | Reported Device Performance |
|---|---|---|
| Process Parameter Test | Device performs as intended, maintains specified physical parameters, detects defined fault conditions, executes automatic response/processing following fault detection. | "The test results showed that the OER-Mini achieves and maintains the specified physical process parameters, including detection of the defined fault conditions and execution of automatic response/processing following fault detection." |
| Cleaning Validation | Effective reduction of protein and carbohydrate levels to safe limits on compatible devices in simulated and in-use conditions. | "The test results demonstrate that the OER-Mini effectively reduced protein and carbohydrate levels in all sample sites." |
| High-Level Disinfection (Simulated Use) | A 6 Log₁₀ reduction of M. terrae at all inoculated sites. | "The simulated use testing demonstrated a 6 Log₁₀ reduction of M. terrae at all inoculated sites was achieved after reprocessing in the OER-Mini's disinfection cycle." |
| High-Level Disinfection (In-Use) | No viable microorganisms recovered after reprocessing. | "In-use testing demonstrated no viable microorganisms were recovered from test samples following reprocessing in the OER-Mini." |
| Full Cycle (Cleaning & Disinfection) | Effective cleaning and high-level disinfection for compatible devices under simulated use conditions. | "The simulated use testing demonstrated that OER-Mini effectively cleaned and achieved high-level disinfection for its compatible devices." |
| Self-Disinfection (Simulated Use) | A greater than 6 log reduction in M. terrae for all sample locations after routine reprocessing. | "Testing demonstrated that a greater than 6 log reduction in M. terrae was achieved for all sample locations after completion of routine reprocessing of endoscopes/devices within the OER-Mini." |
| Water Line Disinfection (Simulated Use) | A greater than 6 log reduction in M. terrae for all sample locations after the water line disinfection procedure. | "The test result showed that a greater than 6 log reduction in M. terrae was achieved for all sample locations after completion of the water line disinfection procedure." |
| Toxicological Evaluation of Residues | Detergent and disinfectant residues removed to non-toxic levels. | "The test results showed that the OER-Mini reprocessing cycle removes detergent and disinfectant residues to non-toxic levels." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The studies mention "all sample sites" and "test samples" but do not quantify these.
- Data Provenance: Not specified, but given the manufacturer is based in Japan (OLYMPUS MEDICAL SYSTEMS CORP.) and the official correspondent is in the USA (OLYMPUS AMERICA INC.), the testing could have occurred in either region or globally. The document does not specify whether studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. The studies described are performance validation tests for a medical device (endoscope reprocessor), not studies involving human interpretation or image analysis where experts would typically establish ground truth. The "ground truth" here refers to objective microbiological and chemical standards (e.g., log reduction of bacteria, levels of residual protein/carbohydrate), rather than expert consensus on a diagnosis or interpretation.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers interpret data (e.g., medical images) and AI might assist them. The OER-Mini is an automated reprocessor, not an AI-powered diagnostic tool. The studies focus on the efficacy of the automated cleaning and disinfection process itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, the studies described are standalone performance evaluations of the device. The OER-Mini is an automated system designed to perform cleaning and high-level disinfection independently (after manual pre-cleaning and loading by a user). The tests evaluate the device's ability to achieve specific cleaning and disinfection outcomes without human intervention in the core reprocessing cycle.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on objective scientific standards and measurements:
- Microbiological assays: Specifically for high-level disinfection and self-disinfection, the "ground truth" is typically defined by a specified log reduction of a challenge microorganism (e.g., M. terrae) or the absence of viable microorganisms.
- Chemical analyses: For cleaning validation, the "ground truth" involves measuring the reduction of specific contaminants like protein and carbohydrates to predetermined safe or undetectable limits.
- Physical parameter monitoring: The device's ability to maintain specified temperatures, fluid levels, and execute responses to detected faults.
- Toxicological assessments: Measuring residual chemical levels to ensure they are below established toxic thresholds.
8. The Sample Size for the Training Set
- Not Applicable. The OER-Mini is an automated endoscope reprocessor that operates based on pre-programmed cycles and validated parameters, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its development would involve engineering, sterilization science, and material compatibility testing, but not a data-driven training phase like an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
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