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The OER-Pro is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes 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-Pro and Olympus flexible endoscopes and their accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and can damage the OER-Pro components and the endoscopes being reprocessed. Endoscopes must be subject to cleaning by the user prior to reprocessing; however, use of the OER-Pro enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Pro.

Device Description

The OER-Pro Endoscope Reprocessor is an automated endoscope reprocessor intended for high-level disinfection of Olympus flexible endoscopes and its accessories, utilizing both a detergent and FDA cleared high-level disinfectant validated by Olympus to be efficacious and compatible with the materials of the OER-Pro and Olympus flexible endoscopes and accessories.

The OER-Pro is a one-basin automatic endoscope reprocessor that performs leak test, cleaning, disinfection, rinse, and alcohol flush to render a high-level disinfected endoscope and accessories. The OER-Pro utilizes an immersion method for cleaning, disinfecting, and rinsing of endoscope and accessory external surfaces, and connectors for endoscope channel cleaning, disinfecting, and rinsing. Two endoscopes, with several exceptions, can be reprocessed simultaneously in the basin during one reprocessing cycle. The OER-Pro's cleaning cycle includes ultrasonic cleaning, which helps remove debris and dirt from endoscope surfaces.

The OER-Pro is capable of fully automated detergent/disinfectant solution dispensing and alcohol/air drying of endoscope channels. The 0.2-micron air/water filters are bacteria retentive and produce suitable rinse water and air for reprocessing. Built-in sensors detect fluid levels, fluid temperature, air/fluid pressure, and the operating states of the components within the OER-Pro.

The OER-Pro is also equipped with a RFID (Radio-Frequency Identification) function. With a built-in antenna, the OER-Pro is capable of reading user and scope ID data from the proprietary ID tag/chip. The scope/user ID information and each reprocessing result can be printed out with a built-in printer.

The OER-Pro is capable of either using a ready-to-use disinfectant (e.g., Aldahol) or a concentrated disinfectant (e.g., Acecide-C) sealed in dedicated cassette bottles. The concentrated disinfectant is automatically diluted by filtered water until specified quantity in the device. Only Olympus service engineers can switch the disinfection mode.

AI/ML Overview

The document describes the OER-Pro Endoscope Reprocessor, an automated device for the cleaning and high-level disinfection of Olympus flexible endoscopes. It outlines various performance tests conducted to demonstrate the device's efficacy and safety.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Process Parameter Test	Device performs as intended, achieving and maintaining specified physical process parameters, detecting fault conditions, and executing automatic responses.	The test results showed that the OER-Pro achieves and maintains the specified physical process parameters, including detection of the defined fault conditions and execution of automatic response/processing following fault detection.
Validation Testing - Cleaning	Effectively reduce protein and hemoglobin levels.	The test results demonstrate that the OER-Pro effectively reduced protein and hemoglobin levels in all sample sites.
Validation Testing - High-Level Disinfection (Simulated Use)	Achieve a 6 Log$_{10}$ reduction of M. terrae.	Simulated use testing demonstrated a 6 Log$_{10}$ reduction of M. terrae at all inoculated sites was achieved after reprocessing in the OER-Pro's disinfection cycle.
Validation Testing - High-Level Disinfection (In-Use)	No viable microorganisms recovered.	In-use testing demonstrated no viable microorganisms were recovered from endoscopes and valves following reprocessing in the OER-Pro.
Validation Testing - Full Cycle (Simulated Use)	Effectively clean and achieve high-level disinfection.	The simulated use testing demonstrated that OER-Pro effectively cleaned and achieved high-level disinfection for Olympus endoscopes and valves.
Simulated-Use Testing - Self-Disinfection	Greater than 6 log reduction in M. terrae.	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 within the OER-Pro.
Simulated-Use Testing - Water Line Disinfection	Greater than 6 log reduction in M. terrae.	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	Residues removed to non-toxic levels.	The test results showed that the OER-Pro reprocessing cycle removes detergent and disinfectant residues to non-toxic levels.

2. Sample size used for the test set and the data provenance:

The document mentions "tests" and "testing" but does not explicitly state the specific sample sizes (number of endoscopes, cycles, or sites tested) for each validation study.

Data Provenance: The studies are described as "simulated use" and "in-use" conditions. This implies prospective studies carried out to evaluate the device under controlled laboratory settings and, in the case of "in-use" testing, potentially in real-world clinical environments, though specific locations are not provided. The manufacturer is AIZU OLYMPUS CO., LTD., Japan, with the applicant/correspondent in the US (Olympus America Inc.). The testing was conducted to meet FDA guidance, so it's likely the tests were performed in a manner acceptable to the FDA, possibly at qualified facilities in the US or Japan.

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 involved in establishing ground truth for the test set. For cleaning and disinfection studies, ground truth typically involves microbiological cultures and chemical assays performed by trained laboratory personnel, rather than subjective expert opinion.

4. Adjudication method for the test set:

Not applicable. The tests described are objective performance evaluations (e.g., measuring microbial reduction, protein/hemoglobin levels, chemical residues) rather than assessments requiring human interpretation and adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an automated endoscope reprocessor, not an AI-assisted diagnostic or imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The studies described are standalone device performance studies, meaning they evaluate the OER-Pro's ability to clean and disinfect endoscopes autonomously, without human intervention as part of the primary reprocessing function. The cleaning and disinfection cycles are fully automated. However, it's important to note that the device's instructions for use state, "Endoscopes must be subject to cleaning by the user prior to reprocessing; however, use of the OER-Pro enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Pro." This highlights that manual pre-cleaning is a critical human-in-the-loop step before the automated reprocessing by the device. The studies evaluate the device's performance given appropriate pre-cleaning.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance evaluations primarily relies on:

Microbiological assays: For high-level disinfection and self-disinfection, a specific challenge organism (M. terrae) was used, and the ground truth was established by quantifying microbial reduction (e.g., 6 Log$_{10}$ reduction). "No viable microorganisms were recovered" also indicates microbiological cultural methods.
Chemical assays: For cleaning validation, ground truth was based on measurements of protein and hemoglobin levels. For toxicological evaluation, ground truth was based on measurements of residual detergent and disinfectant to ensure they were below toxic levels.
Physical parameter monitoring: For process parameter tests, ground truth was the observation and verification that the device maintained specified physical parameters (e.g., temperature, pressure, fluid levels).

8. The sample size for the training set:

Not applicable. This is a medical device for disinfection, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a device involves engineering design, manufacturing, and calibration based on established scientific principles and prior knowledge of materials and processes.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set in the context of AI/ML. The device's performance parameters are established through rigorous engineering design, material compatibility testing, and process validation, often based on industry standards and regulatory guidance for medical device reprocessing.

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K Number

K093106

Device Name

ENDOSCOPE REPROCESSOR OER-PRO

Manufacturer

OLYMPUS MEDICAL SYSTEMS CORPORATION

Date Cleared

2010-02-12

(134 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K914145

Intended Use

Device Description

The OER-Pro Endoscope Reprocessor is an automated endoscope reprocessor intended for highlevel disinfection of Olympus flexible endoscopes and its accessories, utilizing both a detergent and FDA cleared high-level disinfectant validated by Olympus to be efficacious and compatible with the materials of the OER-Pro and Olympus flexible endoscopes and accessories.

The OER-Pro enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Pro. The modified manual cleaning process eliminates several steps including the syringe flushing into the endoscope channels. The OER-Pro is capable of fully automated detergent/disinfectant solution dispensing and alcohol/air drying of endoscope channels. The 0.2-micron air/water filters are bacteria retentive and produce suitable rinse water and air for reprocessing. Built-in sensors detect fluid levels, fluid temperature, air/fluid pressure, and the operating states of the components within the OER-Pro.

AI/ML Overview

The provided submission document K093106 describes the OER-Pro Endoscope Reprocessor, an automated device for high-level disinfection of flexible endoscopes.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., "X% reduction in protein levels," or "disinfection efficacy must be greater than Y log reduction"). Instead, it reports on the demonstration that the device achieved its intended functions. The performance is summarized qualitatively.

Acceptance Criteria (Inferred from descriptions)	Reported Device Performance
Process Parameter Test:
Device performs as intended, maintains specified physical process parameters, detects fault conditions, and executes automatic response/processing following fault detection.	Device 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 hemoglobin levels in all sample sites in both simulated and in-use conditions.	OER-Pro effectively reduced protein and hemoglobin levels in all sample sites in both simulated and in-use conditions.
High-Level Disinfection Validation:
Achieve high-level disinfection of endoscopes and valves in both simulated and in-use conditions.	Simulated Use: Demonstrated a 6 Log₁₀ reduction of M. terrae at all inoculated sites after reprocessing.
In-use Testing: No viable microorganisms were recovered from endoscopes and valves following reprocessing.
Full Cycle Validation (Cleaning & Disinfection):
Effective cleaning and disinfection under simulated use conditions.	OER-Pro effectively cleaned and achieved disinfection for Olympus endoscopes and valves under simulated use conditions.
Self-Disinfection Validation:
Achieve self-disinfection of the OER-Pro.	Greater than 6 log reduction in M. terrae was achieved for all sample locations after completion of routine reprocessing of endoscopes within the OER-Pro.
Water Line Disinfection Validation:
Achieve disinfection of the OER-Pro water line piping.	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:
Removal of detergent and disinfectant residues to non-toxic levels.	OER-Pro reprocessing cycle removes detergent and disinfectant residues to non-toxic levels.

2. Sample Size and Data Provenance

The document does not provide specific numerical sample sizes for the test sets (e.g., number of endoscopes, number of cycles, number of test locations). It refers to "all sample sites" or "all sample locations" in the context of cleaning and disinfection tests.

Test Set Sample Size: Not explicitly stated (e.g., number of endoscopes, cycles, or specific test points).
Data Provenance: The studies were conducted by Olympus, presumably in a controlled laboratory setting (simulated use) and potentially in real-world clinical environments ("in-use conditions"). The country of origin for the studies is not specified, but the manufacturer is based in Japan and USA. The data would be considered prospective as it's generated specifically for the submission.

3. Number of Experts and Qualifications for Ground Truth

This device is an automated reprocessor, and its performance is evaluated based on objective, measurable parameters (e.g., microbial reduction, chemical residue levels). Therefore, the concept of "experts" establishing ground truth in the sense of medical image interpretation or clinical diagnosis is not applicable here.

The "ground truth" is established through standardized microbiological and chemical testing methods. The "experts" in this context would be laboratory personnel with expertise in microbiology and analytical chemistry, responsible for performing and interpreting these tests according to established protocols and guidance documents (e.g., FDA guidance). Their specific number and qualifications are not mentioned in this summary but are implicit in the execution of such validation studies.

4. Adjudication Method

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers independently assess data and discrepancies are resolved by a third expert. This submission concerns device performance measured by objective laboratory tests, not human interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a diagnostic AI device requiring human reader interaction or comparison. It is an automated reprocessing device.

6. Standalone (Algorithm Only) Performance

Yes, the studies conducted are standalone performance evaluations of the OER-Pro device. They assess the device's ability to perform its intended functions (cleaning, disinfection, residue removal) without human intervention after the initial setup and loading of endoscopes. The results directly reflect the "algorithm only" or "device only" performance in performing the reprocessing cycles.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

Microbiological assays: Quantifying the reduction of specific microorganisms (e.g., M. terrae) to determine disinfection efficacy.
Chemical analysis: Measuring protein and hemoglobin levels for cleaning efficacy, and residual detergent/disinfectant levels for toxicological evaluation.
Physical parameter monitoring: Sensors and data logging within the device to confirm temperature, fluid levels, pressure, etc., are within specifications.

This can be categorized as laboratory-based objective measurements and performance-based outcomes (i.e., whether the device successfully cleaned and disinfected according to established standards).

8. Sample Size for the Training Set

Not applicable. This is a physical device submission demonstrating the performance of a medical reprocessor, not an AI/ML algorithm that requires a training set of data. The device's operation is based on its engineering design, not learned from a dataset.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this device and its validation.

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