(53 days)
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-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 originally featured an "extra disinfection process" which can provide an extra three-minute process for delivering fluid to both the forceps elevator area and elevator wire channel when reprocessing endoscopes with a forceps elevator.
The software of the OER-Elite was changed to apply the "extra disinfection process" to the ultrasound endoscope with balloon channel in addition to the endoscopes with a forceps elevator.
The proposed OER-Elite differs from the predicate OER-Elite in the following minor modifications:
Add "Extra disinfection process" to ultrasound endoscope with balloon channel.
Optimize the threshold values of existing error codes.
Replace the electronic cooling fan due to discontinuing of the product.
Change the material used for fluid pathways.
The OER-Elite is a one-basin automatic endoscope reprocessor that performs leak testing, cleaning, disinfection, rinsing, and an 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.
The provided text describes the 510(k) premarket notification for the Olympus OER-Elite Endoscope Reprocessor. This document focuses on demonstrating substantial equivalence to a predicate device for a medical device (endoscope reprocessor), not an AI / Machine Learning (ML) enabled medical device. Therefore, the information requested in points 1-9 (acceptance criteria, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this document, as these are typically requirements for AI/ML device submissions, particularly for those involving image analysis or diagnostic support.
The OER-Elite is a physical device that cleans and disinfects endoscopes. The changes in this submission are minor modifications to its software (applying an "extra disinfection process" to an ultrasound endoscope with a balloon channel and optimizing error code thresholds), a hardware component change (cooling fan), and a material change for fluid pathways. The "performance testing" described is for the device's physical and operational parameters, not for an AI's analytical performance on data.
Therefore, since this document is not about an AI/ML device, I cannot extract the information requested in questions 1-9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 1, 2020
Olympus Medical Systems Corp. % Lisa Boyle Regulatory Affairs Specialist II Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610
Re: K201920
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: July 6, 2020 Received: July 10, 2020
Dear Lisa Boyle:
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.
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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 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 (OS) 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.
CAPT Elizabeth Claverie, M.S. Assistant Director 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K201920
Device Name ENDOSCOPE REPROCESSOR OER-Elite
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)
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Date Prepared: September 1, 2020
K201920 510(k) Summary
1. GENERAL INFORMATION
| ■ 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP. | ||
|---|---|---|---|
| 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 |
- Contact Person: Lisa Boyle Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 Fax: 484-896-7128 Email: lisa.boyle@olympus.com
- Manufacturing site: Aizu Olympus Co., Ltd., 500 Muranishi, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima 965-8520, Japan
2. DEVICE IDENTIFICATION
- ENDOSCOPE REPROCESSOR OER-Elite ■ Device Name:
- Model Name: OER-Elite
- Common Name: Endoscope washer/disinfector
- Regulation Number: 876.1500
- Regulation Name: Endoscope and accessories
- Regulatory Class: II
- Product Code: FEB - Accessories, Cleaning, For Endoscope
- Gastroenterology/Urology ■ Classification Panel:
Olympus Corporation of the Americ 3500 CORPORATE PARKWAY, P.O. BOX 610, CENTER VALLEY, PA 18034-0610 TELEPHONE (484) 896-5000
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3. PREDICATE DEVICE
■ Predicate device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| ENDOSCOPE REPROCESSOROER-Elite | OLYMPUS MEDICALSYSTEMS CORP. | K190969 |
4. DEVICE DESCRIPTION
■ General Description of the subject device
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 originally featured an "extra disinfection process" which can provide an extra three-minute process for delivering fluid to both the forceps elevator area and elevator wire channel when reprocessing endoscopes with a forceps elevator.
The software of the OER-Elite was changed to apply the "extra disinfection process" to the ultrasound endoscope with balloon channel in addition to the endoscopes with a forceps elevator.
The proposed OER-Elite differs from the predicate OER-Elite in the following minor modifications:
Add "Extra disinfection process" to ultrasound endoscope with balloon a) channel.
- Optimize the threshold values of existing error codes. b)
- Replace the electronic cooling fan due to discontinuing of the product. c)
- Change the material used for fluid pathways. d)
■ Principle of Operation
The principle of operation has not been changed from that of the predicate OER-Elite.
The OER-Elite is a one-basin automatic endoscope reprocessor that performs leak testing, cleaning, disinfection, rinsing, and an alcohol flush to render a high-level disinfected endoscope, their accessories, and endoscope reprocessor accessories.
Olympus Corporation of the Americas
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OLYMPUS
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.
5. 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.
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6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The OER-Elite has the same technological characteristics and design as the predicate device except for the subject of the "extra disinfection process" to the ultrasound endoscope with balloon channel. All other technological characteristics of both the subject and predicate device are identical.
| Features | Subject Device: OER-Elite | Predicate Device: OER-Elite(K190969) | Comment ondifference |
|---|---|---|---|
| Intended Use | The OER-Elite is intended for use incleaning and high-level disinfection ofheat sensitive Olympus flexibleendoscopes, their accessories, andendoscope reprocessor accessories.Safe use requires detergent and anFDA-cleared high-leveldisinfectant/sterilant that Olympus hasvalidated to be efficacious andcompatible with the materials of theOER-Elite and Olympus flexibleendoscopes, their accessories, andendoscope reprocessor accessories. | The OER-Elite is intended for use incleaning and high-level disinfection ofheat sensitive Olympus flexibleendoscopes, their accessories, andendoscope reprocessor accessories.Safe use requires detergent and anFDA-cleared high-leveldisinfectant/sterilant that Olympus hasvalidated to be efficacious andcompatible with the materials of theOER-Elite and Olympus flexibleendoscopes, their accessories, andendoscope reprocessor accessories. | Same |
| Use of a detergent or high-leveldisinfectant/sterilant that has not beenvalidated by Olympus may beineffective and can damage the OER-Elite components and the endoscopesbeing reprocessed. Endoscopes mustbe cleaned by the user prior toreprocessing; however, use of theOER-Elite enables the user to performmodified manual cleaning of someendoscopes prior to automatedcleaning and high-level disinfection inthe OER-Elite. | Use of a detergent or high-leveldisinfectant/sterilant that has not beenvalidated by Olympus may beineffective and can damage the OER-Elite components and the endoscopesbeing reprocessed. Endoscopes mustbe cleaned by the user prior toreprocessing; however, use of theOER-Elite enables the user to performmodified manual cleaning of someendoscopes prior to automatedcleaning and high-level disinfection inthe OER-Elite. | ||
| Disinfectant | Olympus validated, FDA clearedHigh-Level Disinfectant (Acecide-C); | Olympus validated, FDA clearedHigh-Level Disinfectant (Acecide-C); | Same |
| Detergent | Olympus validated Detergent(EndoQuick) | Olympus validated Detergent(EndoQuick) | Same |
| Features | Subject Device: OER-Elite | Predicate Device: OER-Elite(K190969) | Comment ondifference |
| Wash/HLDMethods | Cleaning method:- Exterior surfaces Ultrasoniccleaning, turbulent bath Channelinteriors Fluid flushing- Valves Ultrasonic cleaning, fluid flushingDisinfection method:- Exterior surfaces Disinfectantsolution immersion Channelinteriors Disinfectant solutionflushing and filling- Valves Disinfectant solutionimmersion | Cleaning method:- Exterior surfaces Ultrasoniccleaning, turbulent bath Channelinteriors Fluid flushing- Valves Ultrasonic cleaning, fluid flushingDisinfection method:- Exterior surfaces Disinfectantsolution immersion Channelinteriors Disinfectant solutionflushing and filling- Valves Disinfectant solutionimmersion | Same |
| Independentsub functions | Functions:- Heat LCG- Mix LCG- Rinse- Air Purge- Water Line Disinfection- Self-Disinfection & WaterSampling- Detergent Line Disinfection- Alcohol Line Disinfection- Manual Leak Test- Auto Leak Test- ALT Self-Check- Alcohol Flush- Leaking scopedecontamination- Heat LCG TimerReplacement of Consumable Items:- Drain LCG- Load LCG- Replace Detergent- Replace Water Filter- Replace Air Filter- Replace Gas Filter on thelid/tank | Functions:- Heat LCG- Mix LCG- Rinse- Air Purge- Water Line Disinfection- Self-Disinfection & WaterSampling- Detergent Line Disinfection- Alcohol Line Disinfection- Manual Leak Test- Auto Leak Test- ALT Self-Check- Alcohol Flush- Leaking scopedecontamination- Heat LCG TimerReplacement of Consumable Items:- Drain LCG- Load LCG- Replace Detergent- Replace Water Filter- Replace Air Filter- Replace Gas Filter on thelid/tank | Same |
| Leak testmethod | Manual leak testing or Auto leaktesting | Manual leak testing or Auto leaktesting | Same |
| Channelmonitoringfunction | Available | Available | Same |
| User Interface | Graphical User Interface (GUI)and manual control buttons | Graphical User Interface (GUI)and manual control buttons | Same |
| Features | Subject Device: OER-Elite | Predicate Device: OER-Elite(K190969) | Comment ondifference |
| ExtraDisinfectionProcess | Applied to endoscope models withforcepselevator and/or balloon channel | Applied to endoscope modelswith forceps elevator only. | Endoscopemodels withballoon channelwas added tothe subject ofthe extradisinfectionprocess |
The comparison to the Predicate Device was summarized in the Table shown below.
Page 6 of 6
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OLY MPUS
3500 CORPORATE PARKWAY, P.O. BOX 610, CENTER VALLEY, PA 18034-0610
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7. NON-CLINICAL PERFORMANCE TESTING
Performance testing of the OER-Elite was performed to evaluate the modified device and the results are summarized as follows.
1) Process Parameter Test
Process parameter testing was conducted on the OER-Elite in accordance with recommendations in the FDA Guidance: "FDA guidance "Guidance on Premarket [510(k)] Submissions for Notification Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities" to demonstrate that the machine achieves and maintains the specified physical process parameters, including detection of the defined fault conditions and execution of automatic response/processing following fault detection.
2) Software verification and validation testing
Software verification and validation testing for the OER-Elite was conducted and documentations were 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".
3) Electrical Safety
A Design/Specification review of the OER-Elite cooling fan was conducted to demonstrate the new cooling fan does not deviate from the technical specifications of the previous cooling fan which was previously evaluated in the electrical safety testing in accordance with IEC 61010-1:2010 and IEC 61010-2-040:2015.
4) Durability
The components with new fluid pathway materials of the OER-Elite were exposed to the reprocessing chemicals. No functional degradation was observed.
8. CONCLUSIONS
Based on the indications for use, technological characteristics, non-clinical performance testing and technological comparison to the predicate device, the OER-Elite is as safe, as effective, and performs as well or better than the legally marketed predicate device (K190969).
§ 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.