(134 days)
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.
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 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 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.
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 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.
§ 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.