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 Description

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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device (Defendo Single Use Cleaning Adapter for Olympus Endoscopes) and uses the term "acceptance criteria" in the context of non-clinical performance testing. However, the document does not detail a study proving that the device meets acceptance criteria related to an AI/ML component or algorithmic performance, as would be expected for a product with an AI/ML component.

Instead, the "acceptance criteria" mentioned refer to engineering and performance specifications for a mechanical device. The information provided is about a physical cleaning adapter, not a software or AI/ML algorithm.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size and ground truth establishment) are not applicable to the device described in this 510(k) submission, as it is a physical, non-AI medical device.

I will populate the table and answer the questions based on the information available in the document, while explicitly stating when information is not present or not applicable due to the nature of the device.

Acceptance Criteria and Device Performance for Defendo Single Use Cleaning Adapter for Olympus Endoscopes

1. Table of Acceptance Criteria and Reported Device Performance

Testing Conducted	Acceptance Criteria	Reported Device Performance (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

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the document. The testing described is for a physical device, and the "sample size" would refer to the number of physical units tested, which is not detailed.
Data Provenance: Not applicable in the context of clinical AI/ML data. The "data" are results from mechanical and functional tests of the device. The testing was non-clinical, likely conducted in a lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This device is a physical cleaning adapter, not an AI/ML system requiring expert-adjudicated ground truth labels for a test set. The "ground truth" for its performance is determined by engineering specifications and direct physical measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No human adjudication method (like those used for clinical image labeling) is relevant for the non-clinical performance tests of this mechanical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. No MRMC study was conducted as this is a mechanical medical device, not an AI/ML system designed to assist human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This device is not an algorithm. Its performance is evaluated through direct physical and functional tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. The "ground truth" for this device's performance is objective engineering and functional specifications (e.g., specific flow rates, force measurements, presence/absence of leaks, breakage strength). It does not involve clinical "ground truth" like pathology or outcomes data.

8. The sample size for the training set:

Not Applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

Not Applicable. As there is no AI/ML model or training set, the concept of establishing ground truth for training is irrelevant.

Summary

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Image /page/0/Picture/0 description: The image shows 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 440-358-6259 Email: Carroll_Martin@steris.com

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 OlympusEndoscopes
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.

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 SingleUse Cleaning Adapter,K232329 – Predicate Device	Defendo CleaningAdapter for OlympusEndoscopes- ModifiedDevice	Comparison
IntendedUse	The Single Use CleaningAdapter is intended to be usedonly to pre-clean theendoscope's air/water channelpost-procedure, and not to beused during a patientprocedure.	The Single Use CleaningAdapter is intended to beused only to pre-clean theendoscope's air/waterchannel post-procedure,and not to be used duringa patient procedure.	Identical
Construction	CapCap Colorant - YellowSpringSpring cup (substrate)Boot (overmold)Cleaning Valve stemValve stem sealing gaskets (5)Gaskets Colorant - Black	CapCap Colorant - OrangeSpringSpring cup (substrate)Boot (overmold)Cleaning Valve StemValve stem backflowumbrella valveValve stem sealing gaskets(4)Gaskets Colorant - Black	SimilarThe only difference is theproposed device has a valvestem backflow umbrellavalve. This component isnot utilized in the functionof the proposed device asthere are no concerns forpreventing backflow. It isgenerated from the currentmold used in manufacturing.
Sterile/Non-sterile	Sterile	Non-Sterile	DifferentAlthough the predicatedevice is sterile and theproposed is non-sterile, thisdoes not impact safety,effectiveness or how thedevice is used. Sterility isnot critical for the devicebecause it is not used inpatient procedures and theendoscopes on which it isused go on for furtherprocessing. 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.

Regulation Number and Section

§ 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.