ENDOSCOPE REPROCESSOR OER-Elite

K190969 · Olympus Medical Systems Corp. · FEB · Jul 9, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K190969
• Device Name: ENDOSCOPE REPROCESSOR OER-Elite
• Applicant: Olympus Medical Systems Corp.
• Product Code: FEB · Gastroenterology, Urology
• Decision Date: Jul 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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.

Device Story

Automated endoscope reprocessor (AER) for high-level disinfection of Olympus flexible endoscopes; utilizes immersion method for exterior surfaces and channel connectors for internal cleaning/disinfection. Performs leak testing (manual/auto), ultrasonic cleaning, disinfection, rinsing, and alcohol/air drying. Features RFID for user/scope identification; built-in printer, touch screen, and portable memory export for reprocessing results. Uses concentrated disinfectant (e.g., Acecide-C) in cassettes, automatically diluted. 0.2-micron filters provide bacteria-retentive air/water. Used in clinical settings by trained personnel. Sensors monitor fluid levels, temperature, pressure, and flow. Output includes reprocessed endoscopes and printed/digital reports. Benefits include standardized, validated cleaning/disinfection process reducing manual error and ensuring patient safety.

Clinical Evidence

No clinical data. Bench testing only. Validation included cleaning efficacy (protein/hemoglobin reduction), high-level disinfection (6-log10 reduction of M. terrae), and self-disinfection/water line disinfection (6-log reduction). Toxicological evaluation confirmed residues are non-toxic per ISO 10993-5:2009. Electrical safety and EMC compliance per IEC 61010-1, IEC 61010-2-040, and IEC 61326-1.

Technological Characteristics

Automated one-basin reprocessor. Features: ultrasonic cleaning, RFID (13.56MHz), 0.2-micron air/water filters, touch screen GUI. Connectivity: printer, portable memory export. Standards: ISO 10993-5 (toxicology), ISO 14971 (risk), IEC 61010-1/2-040 (safety), IEC 61326-1 (EMC), FCC 47 CFR Part 15 (RFID).

Indications for Use

Indicated for cleaning and high-level disinfection of heat-sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories in healthcare settings.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• ENDOSCOPE REPROCESSOR OER-Pro (K103264)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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)

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### 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: [phone] Fax: [phone] Email: [e-mail]
- 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.

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#### 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.

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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.<br><br>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.<br><br>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;<br>Ready-to-use-disinfectant(Aldahol)<br>Concentrated disinfectant (Acecide-C) | Currently, Aldahol is not compatible with the OER-Elite. |
| Detergent | Same as the predicate device | Olympus validated Detergent (EndoQuick) | None |

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| Features | Subject: K190969 OER-Elite | Predicate: K103264 OER-Pro | Comment on the<br>Difference |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wash/HLD<br>Methods | Same as the predicate device | Cleaning method:<br>Exterior surfaces Ultrasonic cleaning,<br>turbulent bath<br>Channel interiors Fluid flushing<br>Valves Ultrasonic cleaning, fluid<br>flushing<br><br>Disinfection method:<br>Exterior surfaces Disinfectant solution<br>immersion<br>Channel interiors Disinfectant solution<br>flushing and filling<br>Valves Disinfectant solution immersion | None |
| Features | Subject: K190969 OER-Elite | Predicate: K103264 OER-Pro | Comment on the<br>Difference |
| Independent sub<br>functions | Functions:<br>- Heat LCG<br>- Mix LCG<br>- Rinse<br>- Air Purge<br>- Water Line Disinfection<br>- Self-Disinfection & Water Sampling<br>- Detergent Line Disinfection<br>- Alcohol Line Disinfection<br>- Manual Leak Test<br>- Auto Leak Test<br>- ALT Self-Check<br>- Alcohol Flush<br>- Leaking scope decontamination<br>- Heat LCG Timer<br>Replacement of Consumable Items:<br>- Drain LCG<br>- Load LCG<br>- Replace Detergent<br>- Replace Water Filter<br>- Replace Air Filter<br>- Replace Gas Filter on the lid/tank | - Heat LCG<br>- Drain LCG<br>- Load LCG<br>- Water Line Disinfection<br>- Leak Test (Manual)<br>- Alcohol Flush<br>- Air Purge<br>- Rinse | The OER-Elite provides a<br>few new functions as<br>independent sub<br>functions. Process<br>parameter tests and risk<br>analysis were conducted<br>to validate the<br>modifications. As a result,<br>these modifications do not<br>affect the safety and<br>effectiveness of the<br>subject device. |
| Leak test method | Manual leak testing or Auto leak testing | Manual leak testing | Auto leak testing is<br>added. Process parameter<br>tests and risk analysis<br>were conducted to<br>validate the modification.<br>As a result, this<br>modification does not<br>affect the safety and<br>effectiveness of the<br>subject device. |
| Features | Subject: K190969 OER-Elite | Predicate: K103264 OER-Pro | Comment on the<br>Difference |
| Channel<br>monitoring<br>function | Available | Not available | Channel monitoring<br>function is added. Process<br>parameter tests and risk<br>management were<br>conducted to validate the<br>modification. As a result,<br>this modification does not<br>affect the safety and<br>effectiveness of the<br>subject device. |
| User Interface | Graphical User Interface (GUI) and manual<br>control buttons | Main and sub control panel | Graphical User Interface<br>(GUI) is added. Software<br>validation testing, Human<br>Factors testing, and risk<br>analysis were conducted<br>to validate the<br>modification. As a result,<br>this modification does not<br>affect the safety and<br>effectiveness of the<br>subject device. |

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3500 CORPORATE PARKWAY, P.O. BOX 610, CENTER VALLEY, PA 18034-0610

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#### 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.

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#### 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).