(88 days)
Not Found
No
The summary describes an automated endoscope reprocessor with sensors and RFID functionality, but there is no mention of AI or ML being used for decision-making, data analysis, or process optimization. The focus is on automated physical processes and data logging.
No.
The device is an automated endoscope reprocessor used for cleaning and high-level disinfection of medical devices (endoscopes), not directly on a patient for therapeutic purposes.
No
The device is an automated endoscope reprocessor intended for cleaning and high-level disinfection of endoscopes and their accessories, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical automated endoscope reprocessor with hardware components such as a basin, sensors, pumps, filters, a printer, and an RFID function. While it includes software for control and data management, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
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 performed on medical devices (endoscopes) to prepare them for reuse, not a test performed on biological samples to diagnose a condition or provide information about a patient's health.
- Device Description: The device description details an automated reprocessor that performs physical processes like cleaning, disinfection, rinsing, and drying. It uses chemicals (detergent and disinfectant) and physical methods (ultrasonic cleaning, air/water filters) to achieve high-level disinfection. This is a device that acts on other medical devices, not on biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient. The performance studies focus on the effectiveness of the cleaning and disinfection process (reducing microbial load), not on the accuracy of a diagnostic test.
In summary, the OER-Elite is a medical device used for reprocessing other medical devices (endoscopes) to ensure they are safe for subsequent use. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor 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-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor 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-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of some endoscopes prior to automated cleaning and high-level disinfection in the OER-Elite.
Product codes
FEB
Device Description
The OER-Elite Endoscope Reprocessor is an automated endoscope reprocessor intended for high-level disinfection of Olympus flexible endoscopes, their accessories, and endoscope reprocessor 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, their accessories, and endoscope reprocessor accessories.
The OER-Elite is a one-basin automatic endoscope reprocessor that performs leak test, cleaning, disinfection, rinse, and alcohol flush to render a high-level disinfected endoscope, their accessories, and endoscope reprocessor accessories. The OER-Elite 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-Elite's cleaning cycle includes ultrasonic cleaning, which helps remove debris and dirt from endoscope surfaces.
The OER-Elite 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, fluid flow, and the operating states of the components within the OER-Elite.
The OER-Elite is also equipped with a RFID (Radio-Frequency Identification) function. With a built-in antenna, the OER-Elite 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, displayed on a touch screen, or exported to a portable memory.
The OER-Elite is capable of using a concentrated disinfectant (e.g., Acecide-C) sealed in dedicated cassette bottles. The concentrated disinfectant is automatically diluted by filtered water until it reaches a specified quantity in the device.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Process Parameter Test: The OER-Elite was tested to demonstrate that the device performs as intended. The test results showed that the OER-Elite 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-Elite was tested to evaluate its ability to clean endoscopes in both simulated and in-use conditions. The test results demonstrate that the OER-Elite effectively reduced protein and hemoglobin levels in all sample sites.
Validation Testing - High-Level Disinfection: The OER-Elite 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-Elite's disinfection cycle. In-use testing demonstrated no viable microorganisms were recovered from endoscopes and valves following reprocessing in the OER-Elite.
Validation Testing - Full Cycle: The OER-Elite 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 the OER-Elite 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-Elite. 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-Elite.
Simulated-Use Testing - Water Line Disinfection: The simulated-use testing was performed to validate disinfection of the OER-Elite 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-Elite was evaluated. The test results showed that the OER-Elite reprocessing cycle removes detergent and disinfectant residues to non-toxic levels. The testing was conducted in accordance with ISO 10993-5:2009.
Human Factors Testing: Human Factors studies were conducted with the OER-Elite. The study participants received training that was consistent with the commercial product. Usability evaluations were performed that included critical tasks and results of the study demonstrated that the potential benefits of the device outweighed the risks.
Risk analysis: Risk analysis for the OER-Elite was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Software verification and validation testing: Software verification and validation testing for the OER-Elite were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the OER-Elite. The system complies with the IEC 61010-1:2010 and IEC 61010-2-040:2015 standards for safety and the IEC 61326-1:2012 standards for EMC.
Federal Communication Commission (FCC) Rules and RFID function: The OER-Elite utilizes a radio frequency identification (RFID) system to identify both endoscope (model and serial number) and user identification for the development of printed reports following endoscope reprocessing in the OER-Elite. To perform these functions, the OER-Elite emits radio frequency (RF) output at the frequency of 13.56MHz. As the OER-Elite is considered to be an intentional radiator prescribed under Federal Communications Commission (FCC) 47 CFR Part 15 - Radio Frequency Devices, Subpart C - Intentional Radiators, it has also been evaluated to verify compliance with this regulation and FDA guidance "Radio-Frequency Wireless Technology in Medical Devices".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 9, 2019
Olympus Medical Systems Corp. % Daphney Germain-Kolawole Senior Project Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610
Re: K190969
Trade/Device Name: ENDOSCOPE REPROCESSOR OER-Elite Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: April 10, 2019 Received: April 12, 2019
Dear Daphney Germain-Kolawole:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190969
Device Name ENDOSCOPE REPROCESSOR OER-Elite
Indications for Use (Describe)
The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor 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-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor 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-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of some endoscopes prior to automated cleaning and high-level disinfection in the OER-Elite.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are slightly blurred, giving them a soft edge. The word is centered and takes up most of the frame, with a white background providing contrast.
510(k) Premarket Notification ENDOSCOPE REPROCESSOR OER-Elite
K190969 510(k) Summary
Applicant Information 0
Date Prepared: April 10, 2019
- . Applicant OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No: 8010047
- Official Correspondent Daphney Germain-Kolawole Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 Phone: 484-896-5691 Fax: 484-896-7128 Email: daphney.germain-kolawole@olympus.com
- AIZU OLYMPUS CO., LTD. ● Manufacturer 500 Aza-Muranishi, Ooaza-Iidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No: 9610595
Device Identification
-
Device Trade Name ENDOSCOPE REPROCESSOR OER-Elite ●
- Class
●
- Regulation Number/Name
- Product Code ●
- Classification Panel
Common Name
- Performance Standard
Predicate Device (PD) 0
- Device Trade Name
- 510(k) Number
- Manufacturer
Endoscope washer/disinfector
II
876.1500 Endoscope and accessories
FEB - Accessories, Cleaning, For Endoscope
- Gastroenterology/Urology
- None established under Section 514 of FD&C Act.
ENDOSCOPE REPROCESSOR OER-Pro K103264 AIZU OLYMPUS CO., LTD.
4
Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced together. The word is centered and takes up most of the image space.
Device Description
The OER-Elite Endoscope Reprocessor is an automated endoscope reprocessor intended for high-level disinfection of Olympus flexible endoscopes, their accessories, and endoscope reprocessor 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, their accessories, and endoscope reprocessor accessories.
The OER-Elite is a one-basin automatic endoscope reprocessor that performs leak test, cleaning, disinfection, rinse, and alcohol flush to render a high-level disinfected endoscope, their accessories, and endoscope reprocessor accessories. The OER-Elite 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-Elite's cleaning cycle includes ultrasonic cleaning, which helps remove debris and dirt from endoscope surfaces.
The OER-Elite 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, fluid flow, and the operating states of the components within the OER-Elite.
The OER-Elite is also equipped with a RFID (Radio-Frequency Identification) function. With a built-in antenna, the OER-Elite 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, displayed on a touch screen, or exported to a portable memory.
The OER-Elite is capable of using a concentrated disinfectant (e.g., Acecide-C) sealed in dedicated cassette bottles. The concentrated disinfectant is automatically diluted by filtered water until it reaches a specified quantity in the device.
Indications for Use
The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor 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-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor 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-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of some endoscopes prior to automated cleaning and highlevel disinfection in the OER-Elite.
5
Image /page/5/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. Below the word is a thin, horizontal, gold line. The word is the logo for the Olympus Corporation, a Japanese manufacturer of optics and reprography products.
ロ Technical Characteristics
| Features | Subject: K190969 OER-Elite | Predicate: K103264 OER-Pro | Comment on the Difference |
|---|---|---|---|
| Intended Use | The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor 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-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor 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-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of some endoscopes prior to automated cleaning and high-level disinfection in the OER-Elite. | The OER-Pro Endoscope Reprocessor is intended to clean and high-level disinfect heat sensitive Olympus flexible endoscopes and their accessories. Use of the OER-Pro requires both a 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 underlined expression is modified. However, the substantive content remains the same. |
| Disinfectant | Same as the predicate device except that the Aldahol is not compatible at this time. | Olympus validated , FDA cleared High-Level Disinfectant;
Ready-to-use-disinfectant(Aldahol)
Concentrated disinfectant (Acecide-C) | Currently, Aldahol is not compatible with the OER-Elite. |
| Detergent | Same as the predicate device | Olympus validated Detergent (EndoQuick) | None |
6
Page 4 of 8
Image /page/6/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly blurred, giving them a textured appearance. Below the word, there is a horizontal gold bar.
| Features | Subject: K190969 OER-Elite | Predicate: K103264 OER-Pro | Comment on the
Difference |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wash/HLD
Methods | Same as the predicate device | Cleaning method:
Exterior surfaces Ultrasonic cleaning,
turbulent bath
Channel interiors Fluid flushing
Valves Ultrasonic cleaning, fluid
flushing
Disinfection method:
Exterior surfaces Disinfectant solution
immersion
Channel interiors Disinfectant solution
flushing and filling
Valves Disinfectant solution immersion | None |
| Features | Subject: K190969 OER-Elite | Predicate: K103264 OER-Pro | Comment on the
Difference |
| Independent sub
functions | Functions:
- Heat LCG
- Mix LCG
- Rinse
- Air Purge
- Water Line Disinfection
- Self-Disinfection & Water Sampling
- Detergent Line Disinfection
- Alcohol Line Disinfection
- Manual Leak Test
- Auto Leak Test
- ALT Self-Check
- Alcohol Flush
- Leaking scope decontamination
- Heat LCG Timer
Replacement of Consumable Items: - Drain LCG
- Load LCG
- Replace Detergent
- Replace Water Filter
- Replace Air Filter
- Replace Gas Filter on the lid/tank | - Heat LCG
- Drain LCG
- Load LCG
- Water Line Disinfection
- Leak Test (Manual)
- Alcohol Flush
- Air Purge
- Rinse | The OER-Elite provides a
few new functions as
independent sub
functions. Process
parameter tests and risk
analysis were conducted
to validate the
modifications. As a result,
these modifications do not
affect the safety and
effectiveness of the
subject device. |
| Leak test method | Manual leak testing or Auto leak testing | Manual leak testing | Auto leak testing is
added. Process parameter
tests and risk analysis
were conducted to
validate the modification.
As a result, this
modification does not
affect the safety and
effectiveness of the
subject device. |
| Features | Subject: K190969 OER-Elite | Predicate: K103264 OER-Pro | Comment on the
Difference |
| Channel
monitoring
function | Available | Not available | Channel monitoring
function is added. Process
parameter tests and risk
management were
conducted to validate the
modification. As a result,
this modification does not
affect the safety and
effectiveness of the
subject device. |
| User Interface | Graphical User Interface (GUI) and manual
control buttons | Main and sub control panel | Graphical User Interface
(GUI) is added. Software
validation testing, Human
Factors testing, and risk
analysis were conducted
to validate the
modification. As a result,
this modification does not
affect the safety and
effectiveness of the
subject device. |
7
Page 5 of 8
Image /page/7/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly pixelated, suggesting the image may be a scan or a low-resolution copy. A thin, horizontal gold bar is located directly beneath the word, adding a subtle accent to the logo.
3500 CORPORATE PARKWAY, P.O. BOX 610, CENTER VALLEY, PA 18034-0610
8
Page 6 of 8
Image /page/8/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly blurred, giving them a soft appearance. A thick, horizontal, yellow line is located directly beneath the word.
9
Image /page/9/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The font is sans-serif and the letters are closely spaced together. The word appears to be a logo or brand name, and the overall impression is one of strength and stability due to the font and color choice.
0 Summary of Non-Clinical Testing
The OER-Elite has been tested following the requirements in the following FDA guidance documents.
- "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
- -"Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff", published on August 13, 2013
- -"Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005
- "Applying Human Factors and Usability Engineering to Medical Devices", issued on February 3, 2016
- -"Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", issued on March 17, 2015,
Test reports provided in this premarket notification include:
Process Parameter Test
The OER-Elite was tested to demonstrate that the device performs as intended. The test results showed that the OER-Elite 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-Elite was tested to evaluate its ability to clean endoscopes in both simulated and in-use conditions. The test results demonstrate that the OER-Elite effectively reduced protein and hemoglobin levels in all sample sites.
Validation Testing - High-Level Disinfection
The OER-Elite 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-Elite's disinfection cycle. In-use testing demonstrated no viable microorganisms were recovered from endoscopes and valves following reprocessing in the OER-Elite.
Validation Testing - Full Cycle
The OER-Elite was tested to evaluate its effectiveness for full-cycle reprocessing including both cleaning and disinfection under simulated-use conditions. The simulateduse testing demonstrated that the OER-Elite 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-Elite. 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-Elite.
10
Image /page/10/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced. The word appears to be a logo or brand name.
Simulated-Use Testing - Water Line Disinfection
The simulated-use testing was performed to validate disinfection of the OER-Elite 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-Elite was evaluated. The test results showed that the OER-Elite reprocessing cycle removes detergent and disinfectant residues to non-toxic levels. The testing was conducted in accordance with ISO 10993-5:2009.
Human Factors Testing
Human Factors studies were conducted with the OER-Elite. The study participants received training that was consistent with the commercial product. Usability evaluations were performed that included critical tasks and results of the study demonstrated that the potential benefits of the device outweighed the risks.
Risk analysis
Risk analysis for the OER-Elite was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Software verification and validation testing
Software verification and validation testing for the OER-Elite were conducted and documentation was provided as recommended by FDA' s Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the OER-Elite. The system complies with the IEC 61010-1:2010 and IEC 61010-2-040:2015 standards for safety and the IEC 61326-1:2012 standards for EMC.
Federal Communication Commission (FCC) Rules and RFID function
The OER-Elite utilizes a radio frequency identification (RFID) system to identify both endoscope (model and serial number) and user identification for the development of printed reports following endoscope reprocessing in the OER-Elite. To perform these functions, the OER-Elite emits radio frequency (RF) output at the frequency of 13.56MHz. As the OER-Elite is considered to be an intentional radiator prescribed under Federal Communications Commission (FCC) 47 CFR Part 15 - Radio Frequency Devices, Subpart C - Intentional Radiators, it has also been evaluated to verify compliance with this regulation and FDA guidance "Radio-Frequency Wireless Technology in Medical Devices".
Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K103264).