Defendo Single Use Cleaning Adapter for Olympus Endoscopes

K240352 · STERIS Corporation · ODC · Mar 6, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K240352
• Device Name: Defendo Single Use Cleaning Adapter for Olympus Endoscopes
• Applicant: STERIS Corporation
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Mar 6, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

Device Story

Single-use, non-sterile disposable valve; attaches to air/water cylinder of Olympus GI endoscopes (excluding those with balloon channels). Used post-procedure by clinical staff to facilitate cleaning of endoscope air/water channels. Device assembly includes cap, spring, spring cup, overmolded boot, valve stem, backflow umbrella valve, and sealing gaskets. Operation: attached to endoscope air/water channel; allows air flow; depressing device enables water flow; release returns to air flow. Facilitates removal of debris from channels prior to high-level disinfection or sterilization. Non-patient contacting; includes warning tag against patient use.

Clinical Evidence

No clinical data. Bench testing only, including button cycling, external leak, water/air flow rates, cap breakage strength, force to depress, backpressure hold, and force to attach.

Technological Characteristics

Single-use, non-sterile mechanical valve. Components: cap, spring, spring cup, overmolded boot, valve stem, backflow umbrella valve, sealing gaskets. Manual actuation via depression. Dimensions/form factor designed for Olympus endoscope air/water cylinder interface. No software or electronic components.

Indications for Use

Indicated for pre-cleaning the air/water channel of Olympus GI endoscopes post-procedure. Not for use during patient procedures.

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.

Predicate Devices

• Defendo Fujifilm 700 Single Use Cleaning Adapter (K232329)

Reference Devices

• ProArmor Endoscope Tip Protector (K191715)
• Roth Net (K182909)

Submission Summary (Full Text)

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March 6. 2024

STERIS Corporation Carroll Martin Director, Regulatory Affairs 5976 Heisley Road Mentor, Ohio 44060

Re: K240352

Trade/Device Name: Defendo Single Use Cleaning Adapter for Olympus Endoscopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: February 5, 2024 Received: February 5, 2024

Dear Carroll Martin:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a

change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,

# Sivakami Venkatachalam -S

for

Shanil P. Haugen. Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital, and Urology 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) K240352

Device Name

Defendo Single Use Cleaning Adapter for Olympus Endoscopes

Indications for Use (Describe)

The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel postprocedure, and not to be used during a patient procedure.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in large, bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word is an image of several horizontal wavy lines stacked on top of each other. At the top right of the image is the text "K240352 Page 1 of 4".

# 510(k) Summary For Defendo Single Use Cleaning Adapter for Olympus Endoscopes

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

Contact:

Carroll Martin Regulatory Affairs Director Tel: [phone] Email: [e-mail]

Submission Date: February 5, 2024

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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#### 1. Device Name

| Trade Name: | Defendo Single Use Cleaning Adapter for Olympus<br>Endoscopes |
|--------------------|---------------------------------------------------------------|
| Device Class: | Class II |
| Regulation Name: | Endoscope and Accessories |
| Common/usual Name: | Cleaning Adapter |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | ODC |

#### 2. Predicate Device

Defendo Fujifilm 700 Single Use Cleaning Adapter, K232329

#### 3. Device Description

This device is intended as part of the pre-cleaning process, to help clear the air/water channel of Olympus GI endoscopes post procedure.

The Defendo Single Use Cleaning Adapter for Olympus Endoscopes is a single use, non-sterile disposable valve that fits onto the air/water cylinder of Olympus endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are non-patient contacting. The adapter is used post-procedure to pre-clean the endoscope before it goes thru high-level disinfection and/or sterilization. The adapter is attached to the air/water channel of an endoscope. When the adapter is attached to the endoscope, air can flow down the channel of the endoscope. If water is desired to flow down the channel, the device is depressed. When released, air will once again flow down the endoscope channel. The Defendo Olympus Single-Use Cleaning Adapter for Olympus Endoscopes assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.

#### 4. Indications for Use

The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

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#### 5. Technological Characteristics Comparison Table

A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.

| Features | Defendo Fujifilm 700 Single<br>Use Cleaning Adapter,<br>K232329 – Predicate Device | Defendo Cleaning<br>Adapter for Olympus<br>Endoscopes- Modified<br>Device | Comparison |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The Single Use Cleaning<br>Adapter is intended to be used<br>only to pre-clean the<br>endoscope's air/water channel<br>post-procedure, and not to be<br>used during a patient<br>procedure. | The Single Use Cleaning<br>Adapter is intended to be<br>used only to pre-clean the<br>endoscope's air/water<br>channel post-procedure,<br>and not to be used during<br>a patient procedure. | Identical |
| Construction | Cap<br>Cap Colorant - Yellow<br>Spring<br>Spring cup (substrate)<br>Boot (overmold)<br>Cleaning Valve stem<br>Valve stem sealing gaskets (5)<br>Gaskets Colorant - Black | Cap<br>Cap Colorant - Orange<br>Spring<br>Spring cup (substrate)<br>Boot (overmold)<br>Cleaning Valve Stem<br>Valve stem backflow<br>umbrella valve<br>Valve stem sealing gaskets<br>(4)<br>Gaskets Colorant - Black | Similar<br>The only difference is the<br>proposed device has a valve<br>stem backflow umbrella<br>valve. This component is<br>not utilized in the function<br>of the proposed device as<br>there are no concerns for<br>preventing backflow. It is<br>generated from the current<br>mold used in manufacturing. |
| Sterile/Non-<br>sterile | Sterile | Non-Sterile | Different<br>Although the predicate<br>device is sterile and the<br>proposed is non-sterile, this<br>does not impact safety,<br>effectiveness or how the<br>device is used. Sterility is<br>not critical for the device<br>because it is not used in<br>patient procedures and the<br>endoscopes on which it is<br>used go on for further<br>processing. 1 |

## Table 1. Technological Characteristics Comparison Table

1 Please note that there have been other devices cleared by FDA that are used in a non-sterile condition that either have direct contact with an endoscope after processing that will be used in a patient (ProArmor Endoscope Tip Protector, K191715) or contact a patient directly (Roth Net, K182909). Whereas these do not have the same intended use as the Olympus Cleaning Adapter, they are non-sterile devices that will come in contact with a patient.

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#### 6. Summary of Non-Clinical Performance Testing

The purpose of this Special 510(k) is to obtain clearance for a non-sterile version of the Defendo Fujifilm 700 Single Use Cleaning Adapter that is used on Olympus endoscopes. The non-clinical testing involved the following:

| Testing Conducted | Acceptance Criteria | Results |
|------------------------------|--------------------------|---------|
| Button cycling/external leak | Meet acceptance criteria | Pass |
| Water Flow Rate | Meet acceptance criteria | Pass |
| Air Flow Rate | Meet acceptance criteria | Pass |
| Cap breakage strength | Meet acceptance criteria | Pass |
| Force to depress | Meet acceptance criteria | Pass |
| Backpressure Hold Test | Meet acceptance criteria | Pass |
| Force to Attach | Meet acceptance criteria | Pass |

The above testing is similar to testing conducted for the predicate device under 510(k), K232329.

## Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is substantially equivalent to the legally marketed predicate device, Defendo Fujifilm 700 Single Use Cleaning Adapter, K232329, Class II (21 CFR 876.1500), product code ODC.