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.

Summary

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113264 age 1 of 4

FEB 2 3 2011

510(k) Premarket Notification ENDOSCOPE REPROCESSOR OER-Pro

510(k) Summary

Date Prepared: October 28, 2010

Applicant Information ロ

Applicant OLYMPUS MEDICAL SYSTEMS CORP. ● 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No: 8010047
Stacy Abbatiello Kluesner, M.S., RAC Official Correspondent . Regulatory Affairs & Quality Assurance OLYMPUS AMERICA INC. 3500 Corporate Parkway, Center Valley, PA 18034-0610 Phone: (484) 896-5405 Fax: (484) 896-7128 Email: stacy.kluesner@olympus.com Establishment Registration No: 2429304
AIZU OLYMPUS CO., LTD. Manufacturer . 500 Aza-Muranishi, Ooaza-Iidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No: 9610595

Device Identification 0

ENDOSCOPE REPROCESSOR OER-Pro Device Trade Name .
II
Endoscope washer/disinfector
Gastroenterology/Urology

876.1500 Endoscope and accessories

FEB - Accessories, Cleaning, For Endoscope

None established under Section 514 of FD&C Act.

Common Name Class
. Regulation Number/Name
Product Code .

� .

Classification Panel .
Performance Standard .

Predicate Device (PD) 0

Device Trade Name .
. 510(k) Number
Manufacturer .

ENDOSCOPE REPROCESSOR OER-Pro K093106 AIZU OLYMPUS CO., LTD.

OLYMPUS AMERICA INC.

3500 CORPORATE PARKWAY, P.O. BOX 610, CENTER VALLEY, PA 18034-0610 TELEPHONE (484) 896-5000

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Device Description

ロ Indications for Use

The OER-Pro is intended for use in cleaning and high-level disinfection of heat sensitive Olymous 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.

Image /page/1/Picture/11 description: The image contains a series of numbers, specifically '23323'. The numbers are presented in a clear, legible font, making them easily readable. The arrangement of the numbers suggests they might be part of a code, sequence, or numerical identifier.

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Comparison to Predicate Device o

The OER-Pro is equivalent in indications and operational principles to the predicate device. Subject device is same as the predicate device except using an FDA cleared concentrated disinfectant. In the predicate device, the user pours the FDA cleared readyto-use disinfectant into the basin without dilution. Compare to the predicate device, the subject device is compatible with the newly validated FDA-cleared concentrated disinfectant solution (Acecide-C), and the software of the subject device can automatically dilute the concentrated disinfectant solution in the tank. In addition, the concentrated disinfectant solution is loaded in a different way from the predicate device.

Performance Data o

The OER-Pro has been tested following the requirements in the FDA guidance document titled "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. Test reports provided in this premarket notification include:

Process Parameter Test

The OER-Pro was tested to demonstrate that the device performs as intended. 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

The OER-Pro was tested to evaluate its ability to clean endoscopes in both simulated and in-use conditions. The test results demonstrate that the OER-Pro effectively reduced protein and hemoglobin levels in all sample sites.

Validation Testing - High-Level Disinfection

The OER-Pro was tested to evaluate its ability to high-level disinfect endoscopes and valves in both simulated and in-use conditions. The simulated use testing demonstrated a 6 Logio reduction of M.terrae at all inoculated sites was achieved after reprocessing in the OER-Pro's disinfection cycle. In-use testing demonstrated no viable microorganisms were recovered from endoscopes and valves following reprocessing in the OER-Pro.

Validation Testing - Full Cycle

The OER-Pro was tested to evaluate its effectiveness for full cycle reprocessing including both cleaning and disinfection under simulated use conditions. 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

Simulated-use testing was performed to validate self-disinfection of the OER-Pro. 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

The simulated-use testing was performed to validate disinfection of the OER-Pro water line piping which does not contact high-level disinfectant during routine reprocessing.

OLYMPUS AMERICA INC.

3500 CORPORATE PARKWAY, P.O. BOX 610, CENTER VALLEY, PA 18034-0610 TELEPHONE (484) 896-5000

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K103264
Page 4 of 4

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

The safety of residual chemicals remaining on endoscopes after reprocessing in the OER-Pro was evaluated. The test results showed that the OER-Pro reprocessing cycle removes detergent and disinfectant residues to non-toxic levels.

ם Conclusion

The information and performance data presented in this premarket notification support the claim that the OER-Pro is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Olympus Medical Systems Corporation C/O Ms. Stacy Abbatiell Kluesner Olympus America Incorporated 3500 Corporate Parkway Center Valley, Philadelphia 18034-0610

FEB 2 3 2011

Re: K103264

Trade/Device Name: ENDOSCOPE REPROCESSOR OER-Pro Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB Dated: January 28, 2011 Received: January 31, 2011

Dear Ms. Kluesner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Ms. Kluesner

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson. B.S.. M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: ENDOSCOPE REPROCESSOR OER-Pro

Indications For Use:

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 FDAcleared 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.

Prescription Use_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

Page 1 of 1
Elijah A. F. Clamin-Well

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Regulation Number and Section

§ 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.