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 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.

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.

Summary

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K093106

Page 1 of 3

510(k) Premarket Notification ENDOSCOPE REPROCESSOR OER-Pro

510(k) Summary

FEB 1 2 2010

Date Prepared: February 3, 2010

o Applicant OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No: 8010047

o Official Correspondent Laura Storms-Tyler OLYMPUS AMERICA INC. 3500 Corporate Parkway, Center Valley, PA 18034-0610 Phone: (484) 896-5688 Fax: (484) 896-7128 Email: Laura.storms-tyler@olympus.com Establishment Registration No: 2429304

. Manufacturer AIZU OLYMPUS CO., LTD. 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No: 9610595

්‍යා Device Identification

Applicant Information

្ញ

•	Device Trade Name	ENDOSCOPE REPROCESSOR OER-Pro
•	Common Name	Endoscope washer/disinfector
•	Class	II
•	Regulation Number/Name	876.1500 Endoscope and accessories
•	Product Code	FEB - Accessories, Cleaning, For Endoscope
•	Classification Panel	Gastroenterology/Urology
•	Performance Standard	None established under Section 514 of FD&C Act

ប្រ Predicate Device (PD)

• Device Trade Name	Endoscope Disinfector DSD-91E
510(k) Number	K914145
• Manufacturer	MediVators, Inc.

OLYMPUS AMERICA INC.

3500 CORPORATE PARKWAY, P.O. BOX 610, CENTER VALLEY, PA 13034-0610 IELEBHONE (484) 800-2000

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RJSJC

Page 2 of 3

Device Description

The OER-Pro Endoscope Reprocessor is an automated endoscope reprocessor intended for highlevel disinfection of Olympus flexible cudoscopes 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 climinates 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.

D 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 endoscoves 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 cnables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Pro.

Comparison to Predicate Device បា

The OER-Pro is equivalent in indications and operational principles to the DSD-91E. Both devices are intended for high-level disinfection of flexible endoscopes, use an immersion system, flush water/disinfectant to endoscope channels via connectors, and utilize a detergent and FDAcleared liquid chemical germicide. Both devices can reprocess two endoscopes simultancously. The major difference is that the OER-Pro has one basin that can accommodate two endoscopes, whereas the DSD-91E has two basins that reprocess one endoscope in each basin,

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11 093106

Image /page/2/Picture/1 description: The image contains the word "OLYMPUS" in a bold, sans-serif font. The letters are black and have a slightly distressed or textured appearance, giving them a rugged or vintage feel. The word is presented in a straightforward, horizontal arrangement.

Page 3 of 3

ם Performance Data

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. The OER-Pro was validated with EndoQuick detergent and Aldahol III High-Level Disinfectant and Sterilant. 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 hisinfection 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. The test result showed that a greater than 6 log reduction in M. terrae was achieved for all sample locations affer completion of the water line disinfection procedure.

Toxicological Evaluation of Residues

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

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.

QLYMPUS AMERICA INC. 3500 CORPORATE PARKWAY. P.O. BOX 610, CENTER VALLEY, PA 18034-0610 TELEPHONE (484) 836-5000

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo, which features a stylized human figure embracing another. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

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. Laura Storms-Tyler Olympus America Incorporated 3500 Corporate Parkway Center Valley, Pennsylvania 18034-0610

Re: K093106

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 13, 2010 -Received: January 15, 2010

FEB 1 2 2010

Dear Ms. Storms-Tyler:

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. Storms-Tyler

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 (QS) 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/ResourcesforYou/Industry/default.htm.

Sincerelv vours.

Authen W.m

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 sonsitive of cleared high-level disinfectant/sterilant that Olympus has validated to be efficacions 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 endossope 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)

Elizabeth F. Clamin-Wells Page 1 of 1

(Division Sian-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K093106 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.