(111 days)
Not Found
No
The summary describes an automated endoscope reprocessor with sensors and RFID for tracking, but there is no mention of AI or ML for decision-making, image analysis, or other functions. The performance studies focus on the effectiveness of the cleaning and disinfection process parameters.
No
The device is an automated endoscope reprocessor, intended for cleaning and high-level disinfection of medical devices (flexible endoscopes), not for treating a disease or condition in a patient.
No
The OER-Pro is an automated endoscope reprocessor designed for cleaning and high-level disinfection of flexible endoscopes; it does not diagnose medical conditions.
No
The device description clearly outlines a physical automated endoscope reprocessor with hardware components such as a basin, connectors, ultrasonic cleaning, sensors, RFID function, and a built-in printer. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cleaning and high-level disinfection of flexible endoscopes and their accessories. This is a process for preparing medical devices for reuse, not for performing diagnostic tests on biological samples.
- Device Description: The description details an automated endoscope reprocessor that performs cleaning, disinfection, rinsing, and drying. It focuses on the physical and chemical processes involved in reprocessing medical devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the effectiveness of the cleaning and disinfection process (reduction of microorganisms, removal of residues), not on the accuracy or reliability of a diagnostic test.
In summary, the OER-Pro is a medical device used for reprocessing other medical devices (endoscopes), not for performing in vitro diagnostic tests.
N/A
Intended Use / 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.
Product codes
FEB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 Log10 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. 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.
Key Metrics
High-Level Disinfection: 6 Log10 reduction of M.terrae
Self-Disinfection: greater than 6 log reduction in M. terrae
Water Line Disinfection: greater than 6 log reduction in M. terrae
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the word "OLYMPUS" in a bold, sans-serif font. The letters are large and black, creating a strong visual impact. A horizontal line is located underneath the word.
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
1
Image /page/1/Picture/0 description: The image shows the word "OLYMPUS" in bold, black letters. The font is sans-serif and the letters are tightly spaced. The word appears to be a logo or brand name.
Image /page/1/Picture/1 description: The image shows the text "K103264 Page 2 of 4". The text appears to be handwritten in a dark ink. The words "Page 2 of 4" are smaller than the other text and are located below the other text.
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.
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.
2
Image /page/2/Picture/0 description: The image shows the word "OLYMPUS" in bold, black letters. The font is sans-serif and the letters are tightly spaced. There is a horizontal line underneath the word, which is slightly thinner than the letters.
Image /page/2/Picture/1 description: The image shows the text "K103264" in a handwritten style. Below this, the text "Page 3 of 4" is printed in a smaller font size. This indicates that the image is likely a page number from a document.
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
3
Image /page/3/Picture/0 description: The image displays the word "OLYMPUS" in bold, black capital letters. A thick, black line runs horizontally beneath the word, emphasizing the brand name. The font is sans-serif, giving the logo a clean and modern appearance.
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.
4
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.
5
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
6
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: