Defendo Fujifilm 700 Single Use Cleaning Adapter

K250140 · Steris Corparation · ODC · Feb 20, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K250140
• Device Name: Defendo Fujifilm 700 Single Use Cleaning Adapter
• Applicant: Steris Corparation
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Feb 20, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Defendo Fujifilm 700 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 Fujifilm endoscopes. Manual operation; allows flushing of air/water channels post-procedure to remove debris. Components include polycarbonate cap, stainless steel spring, spring cup, overmolded thermoplastic elastomer boot, valve stem, and sealing gaskets. Non-patient contacting. Used by clinical staff in reprocessing areas. Output is physical channel clearance; facilitates endoscope cleaning/maintenance. Benefits include standardized, single-use cleaning interface to reduce cross-contamination risks associated with reusable adapters.

Clinical Evidence

No clinical data. Bench testing only. Testing included button cycling, leak testing, water/air flow rates, cap breakage strength, force to depress/attach, backpressure hold, and ASTM D4169 ship testing. All tests met acceptance criteria.

Technological Characteristics

Materials: Polycarbonate (cap, spring cup, valve stem), stainless steel (spring), thermoplastic elastomer (boot, gaskets). Manual actuation; no energy source. Dimensions: 1.800" L x 0.748" W. Non-sterile. Connectivity: None. Software: None.

Indications for Use

Indicated for use as a single-use accessory to pre-clean the air/water channel of Fujifilm endoscopes (excluding those with a balloon channel) 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 Adaptor (K232329)

Submission Summary (Full Text)

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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 20, 2025

STERIS Corparation Gregory Land Lead Regulatory Affairs Specialist 5960 Heislev Road Mentor, Ohio 44060

Re: K250140

Trade/Device Name: Defendo Fujifilm 700 Single Use Cleaning Adapter Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: January 16, 2025 Received: January 17, 2025

Dear Gregory Land:

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"

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(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).

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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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).

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Sincerely,

# Shanil P. Haugen -S

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

Submission Number (if known)

K250140

Device Name

Defendo Fujifilm 700 Single Use Cleaning Adapter

Indications for Use (Describe)

The Defendo Fujifilm 700 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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### 1. Device Name

| Trade Name: | Defendo Fujifilm 700 Single Use Cleaning Adaptor<br>for Olympus Endoscopes |
|--------------------|----------------------------------------------------------------------------|
| Device Class: | Class II |
| Regulation Name: | Endoscope And Accessories |
| Common/usual Name: | Cleaning Adaptor |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | ODC |

#### 2. Predicate Device

Defendo Fujifilm 700 Single Use Cleaning Adaptor, K232329

#### 3. Device Description

This device 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.

The Defendo Fujifilm 700 Single Use Cleaning Adapter is a single use, non-sterile disposable valve that fits onto the air/water cylinder of Fujifilm 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 nonpatient contacting. The Defendo Fujifilm 700 Single Use Cleaning Adapter 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.

#### Indications for Use 4.

The Defendo Fujifilm 700 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.

#### 5. Technological Characteristics Comparison Table

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

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| Features | Defendo Fujifilm 700<br>Single Use Cleaning<br>Adaptor, K232329 –<br>Predicate Device | Defendo Fujifilm 700<br>Single Use Cleaning<br>Adaptor - Modified<br>Device | Comparison |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | The Defendo Fujifilm 700 Single Use<br>Cleaning Adapter is intended to be used only<br>to pre-clean the endoscope's air/water<br>channel post-procedure, and not to be used<br>during a patient procedure. | The Defendo Fujifilm 700 Single Use<br>Cleaning Adapter is intended to be used<br>only to pre-clean the endoscope's air/water<br>channel post-procedure, and not to be used during a<br>patient procedure. | Same |
| Construction | Cap | Cap | Same |
| | Cap Colorant - Yellow | Cap Colorant - Yellow | |
| | Spring | Spring | |
| | Spring cup (substrate) | Spring cup (substrate) | |
| | Boot (overmold) | Boot (overmold) | |
| | Cleaning Valve stem | Cleaning Valve stem | |
| | Valve stem sealing<br>gaskets (5) | Valve stem sealing<br>gaskets (5) | |
| | Gaskets Colorant –<br>Black | Gaskets Colorant –<br>Black | |
| Sterile/Non-sterile | Sterile | Non-Sterile | Different |
| Sterilization<br>Method | EtO | None | Different |
| Sterilization<br>Assurance Level | 10⁻⁶ | None | Different. |
| Usage | Single use | Single use | Same |
| Materials (by<br>component) | Cap - Polycarbonate | Cap - Polycarbonate | Same |
| | Cap Colorant - Avient<br>PC Yellow #3 HC<br>CC10312800WE | Cap Colorant - Avient<br>PC Yellow #3 HC<br>CC10312800WE | |
| | Spring – Stainless steel | Spring – Stainless steel | |
| | Spring cup (substrate) -<br>Polycarbonate | Spring cup (substrate) -<br>Polycarbonate | |
| | Boot (overmold) -<br>Thermoplastic elastomer | Boot (overmold) -<br>Thermoplastic elastomer | |
| | Valve stem –<br>Polycarbonate | Valve stem –<br>Polycarbonate | |
| | Valve Stem Colorant -<br>Avient PC Yellow #3 | Valve Stem Colorant -<br>Avient PC Yellow #3 | |
| Features | Defendo Fujifilm 700<br>Single Use Cleaning<br>Adaptor, K232329 –<br>Predicate Device | Defendo Fujifilm 700<br>Single Use Cleaning<br>Adaptor - Modified<br>Device | Comparison |
| | HC CC10312800WE | HC CC10312800WE | |
| | Valve stem sealing<br>gaskets – Thermoplastic<br>elastomer | Valve stem sealing<br>gaskets – Thermoplastic<br>elastomer | |
| | Gasket colorant -<br>Clariant Mevopur<br>PE9SAA17700 PE 2%<br>Black | Gasket colorant -<br>Clariant Mevopur<br>PE9SAA17700 PE 2%<br>Black | |
| Device<br>Dimensions<br>(lengths/widths) | Length: 1.800 inches<br>Width: 0.748 inches | Length: 1.800 inches<br>Width: 0.748 inches | Same |
| Operating<br>Principle | Manual actuation | Manual actuation | Same |
| Energy<br>Used/Delivered | None | None | Same |
| Applicable<br>Endoscopes | Fuji | Fuji | Same |
| Packaging | PETG Tray with Tyvek<br>Lid | Poly bag | Different |

## Table 1. Technological Characteristics Comparison Table

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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 Adaptor. 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 |
| ASTM D4169 Ship Test | Meet acceptance criteria | Pass |

### 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 or better than the legally marketed predicate device, Defendo Fujifilm 700 Single Use Cleaning Adaptor, K232329, Class II (21 CFR 876.1500), product code ODC.