Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector

Q: Who is the manufacturer of Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector?

Medivators (A Subsidiary of Steris Corporation) filed the 510(k) submission for Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector (K232067).

Q: What is the FDA product code for Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector?

ODC. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector?

Defendo Disposable Air/Water Valve Model 100304 (K102409); Defendo Disposable Suction Valve Model 100305 (K102581); Defendo Biopsy Valves (K090851); Endogator Endoscopy Irrigation Tubing (K220395).

Q: Who can help prepare an FDA 510(k) submission like Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K232067 · Medivators (A Subsidiary of Steris Corporation) · ODC · Mar 22, 2024 · Gastroenterology, Urology

Device Facts

Record ID	K232067
Device Name	Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector
Applicant	Medivators (A Subsidiary of Steris Corporation)
Product Code	ODC · Gastroenterology, Urology
Decision Date	Mar 22, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

The DEFENDO™ FUJIFILM™ 500/600 Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure. The DEFENDO™ FUJIFILM™ 500/600 Single Use Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure. The DEFENDO™ FUJIFILM™ 500/600 Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The ENDOGATOR™ FUJIFILM™ 500/600 Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).

Device Story

Family of sterile, single-use accessories for Fujifilm 500/600 series GI endoscopes; includes air/water valve, suction valve, biopsy valve, and irrigation connector. Valves provide manual control of insufflation, lens washing, suction, and fluid removal. Biopsy valve allows instrument passage while maintaining insufflation and minimizing biomaterial leakage. Connector facilitates irrigation via sterile water when used with irrigation pump/cautery unit. Used in clinical GI endoscopy settings by physicians/clinicians. Devices are manually actuated; no energy delivery. Benefits include reduced risk of cross-contamination via single-use design compared to reusable alternatives.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including gas/water flow rates, backflow prevention, mechanical depression/application/removal forces, button cycling, suction bypass, leak testing, insufflation testing, flow durability, and torque testing. Biocompatibility confirmed per ISO 10993.

Technological Characteristics

Sterile, single-use, manually actuated endoscopic accessories. Materials evaluated for biocompatibility per ISO 10993. Sterilization via EtO (SAL 10^-6). Packaging validated per ISO 11607/ASTM 4169. No energy source or software components.

Indications for Use

Indicated for patients undergoing GI endoscopic procedures requiring air/water control, suction control, biopsy port access, or irrigation.

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 Disposable Air/Water Valve Model 100304 (K102409)
Defendo Disposable Suction Valve Model 100305 (K102581)
Defendo Biopsy Valves (K090851)
Endogator Endoscopy Irrigation Tubing (K220395)

Reference Devices

Endogator Connector (K092429)

Related Devices

K232329 — Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter · Medivators (A Subsidiary of Steris Corporation) · Dec 21, 2023
K232004 — Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector · Medivators (A Subsidiary of Steris Corporation) · Mar 6, 2024
K200769 — Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B · Wilson Instruments (Sha) Co., Ltd. · Jan 6, 2021
K192048 — Single Use Endoscope Valves Set · Anrei Medical (Hangzhou) Co., Ltd. · May 14, 2020
K221331 — Disposable Endoscope Valves System · Changzhou Endoclean Medical Device Co., Ltd. · Sep 8, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. March 22, 2024 Medivators (A Subsidiary of STERIS Corporation) Nick Wang Senior Manager, Regulatory Affairs 3150 Pollok Drive Conroe, Texas 77303 Re: K232067 Trade/Device Name: Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: February 22, 2024 Received: February 22, 2024 Dear Nick Wang: 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. {1}------------------------------------------------ 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). 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). {2}------------------------------------------------ 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K232067 ### Device Name Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector ### Indications for Use (Describe) The DEFENDO™ FUJIFILM™ 500/600 Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure. The DEFENDO™ FUJIFILM™ 500/600 Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure. The DEFENDO™ FUJIFILM™ 500/600 Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The ENDOGATOR™ FUJIFILM™ 500/600 Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit). | 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) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the STERIS logo. The text "K232067 Page 1 of 9" is at the top right of the image. The STERIS logo is in large, bold letters. Below the STERIS logo is a graphic of several horizontal wavy lines. # 510(k) Summary # Defendo Fujifilm 500/600 Single Use Valve Set | Manufacturer: | Medivators | |---------------|----------------------| | | 3150 Pollok Drive | | | Conroe, TX 77303 | | Submitter: | Nick Wang, Ph D., RA | - Nick Wang, Ph.D., RAC Submitter: Senior Manager, Regulatory Affairs Phone: 440-392-7482 - Summary Date: 14 March 2024 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "STERIS" in large, bold, sans-serif font. Above the word "STERIS" is the text "K232067 Page 2 of 9". Below the word "STERIS" is an image of several horizontal lines that are stacked on top of each other. The lines are blue and white. #### 1. Device Name | Trade Name: | Defendo Fujifilm 500/600 Single Use Valves Set | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Classification: | Class II | | Common/usual Name: | Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector | | Classification Name: | Endoscope and Accessories | | Classification Number: | 21 CFR 876.1500 | | Product Code: | ODC | #### 2. Predicate Device(s) Primary predicate is listed first: K102409 - Defendo Disposable Air/Water Valve Model 100304 K102581 - Defendo Disposable Suction Valve Model 100305 K090851 - Defendo Biopsy Valves K220395 - Endogator Endoscopy Irrigation Tubing #### 3. Description of Device The Defendo Fujifilm 500/600 Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single use valves designed to be used on the Fujifilm 500/600 series GI endoscopes as accessories. The specific valves include the Defendo Fujifilm 500/600 Single Use Air/Water Valve, the Defendo Fujifilm 500/600 Single Use Suction Valve, the Defendo Fujifilm 500/600 Single Use Biopsy Valve, and the Endoqator Fujifilm 500/600 Single Use Connector. - . The Air/Water valve allows the end-user to control and maintain air or CO> insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure. - . The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure. {6}------------------------------------------------ - . The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures. - The Connector allows attachment between the irrigation tube set via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water iet valve. These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above. #### 4. Intended Use The DEFENDO™ FUJIFILM™ 500/600 Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure. The DEFENDO™ FUJIFILM™ 500/600 Single Use Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure. The DEFENDO™ FUJIFILM™ 500/600 Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The ENDOGATOR™ FUJIFILM™ 500/600 Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit). #### 5. Technological Characteristic Comparison Table Table 1. Proposed/Predicate Device Technological Characteristics Comparison Table - Air / Water Valve | Feature | Defendo Fujifilm 500/600 Single Use Air/Water Valve (Subject Device) | Defendo Disposable Air/Water Valve (Predicate K102409) | Comparison | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------| | Intended use | The DEFENDO™ FUJIFILM™ 500/600 Single Use Air/Water Valve is intended to be used to control the | The Defendo Disposable Air/Water Valve is intended to be used to control the air/water function | Same | | Feature | Defendo Fujifilm 500/600 Single Use Air/Water Valve (Subject Device) | Defendo Disposable Air/Water Valve (Predicate K102409) | Comparison | | | air/water function on an endoscope during a GI endoscopic procedure. | on an endoscope during a GI endoscopic procedure. | | | Sterile/Non-sterile | Sterile | Sterile | Same | | Sterilization Method | EtO | EtO | Same | | Sterilization Assurance Level | 10-6 | 10-6 | Same | | Usage | Single-Use | Single-Use | Same | | Main Device Dimensions (lengths/widths) | Air/Water Valve: Length: ~32.0 mm Diameter: ~16.5 mm | Air/Water Valve: Length: ~46 mm Diameter: ~17 mm | Similar | | Target Population | Patients undergoing an endoscopic procedure | Patients undergoing an endoscopic procedure | Same | | Energy Used/Delivered | None | None | Same | | Method of Application | Manual actuation | Manual actuation | Same | | Compatible Endoscopes | Fujifilm 500/600 series GI endoscope | Olympus endoscope | Reason for this 510(k) | | Packaging | Supplied as a kit in PETG Tray with Tyvek Lid | Supplied individually in Tyvek Pouch | Package systems all maintain sterile barrier | {7}------------------------------------------------ Table 2. Proposed/Predicate Device Technological Characteristics Comparison Table – Suction Valve | Feature | Defendo Fujifilm 500/600 Single Use Suction Valve (Subject Device) | Defendo Disposable Suction Valve (Predicate K102581) | Comparison | |-----------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Intended Use | The DEFENDOTM FUJIFILMTM 500/600 Single Use Suction Valve is intended to be used to control | The Defendo Disposable Suction Valve is intended to be used to control the suction function on | Same | | Feature | Defendo Fujifilm 500/600 Single Use Suction Valve (Subject Device) | Defendo Disposable Suction Valve (Predicate K102581) | Comparison | | | the suction function on an endoscope during a Gl endoscopic procedure. | an endoscope during a GI endoscopic procedure. | | | Sterile/Non-sterile | Sterile | Sterile | Same | | Sterilization Method | EtO | EtO | Same | | Sterilization Assurance Level | 10-6 | 10-6 | Same | | Usage | Single Use | Single Use | Same | | Main Device Dimensions (lengths/widths) | Suction Valve: Length: ~29.1 mm Diameter: ~17.1 mm | Suction Valve: Length: ~27 mm Diameter: ~18 mm | Similar, the slight differences are due to the differences in the endoscope port. | | Target Population | Patients undergoing an endoscopic procedure | Patients undergoing an endoscopic procedure | Same | | Energy Used/Delivered | None | None | Same | | Method of Application | Manual actuation | Manual actuation | Same | | Compatible Endoscopes | Fujifilm 500/600 series GI endoscope | Olympus endoscope | Reason for this 510(k) | | Packaging | Supplied as a kit in PETG Tray with Tyvek Lid | Supplied individually in Tyvek Pouch | Package systems all maintain sterile barrier | {8}------------------------------------------------ {9}------------------------------------------------ Table 5-3. Proposed/Predicate Device Technological Characteristics Comparison Table – Biopsy Valve | Feature | Defendo Fujifilm 500/600 Single Use Biopsy Valve (Subject Device) | Defendo Biopsy Valve (for Olympus and Fujinon Endoscopes) (Predicate K090851) | Comparison | |-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | Intended Use | The DEFENDO™ FUJIFILM™ 500/600 Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure. | The Defendo Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure. | Same | | Sterile/Non- sterile | Sterile | Sterile | Same | | Sterilization Method | EtO | EtO | Same | | Sterilization Assurance Level | 10-6 | 10-6 | Same | | Usage | Single Use | Single Use | Same | | Main Device Dimensions (lengths/widths) | Length: ~17.8 mm Diameter: ~15.8 mm | Length: ~17 mm Diameter: ~17 mm | Similar, minor differences did not affect performance (confirmed through testing) | | Target Population | Patients undergoing an endoscopic procedure | Patients undergoing an endoscopic procedure | Same | | Energy Used/ Delivered | None | None | Same | | Feature | Defendo Fujifilm 500/600 Single Use Biopsy Valve (Subject Device) | Defendo Biopsy Valve (for Olympus and Fujinon Endoscopes) (Predicate K090851) | Comparison | | Compatible Endoscopes | Olympus and Fujifilm endoscope | Olympus and Fujinon endoscopes | Same | | Packaging | Continue to be supplied individually in Tyvek Pouch (predicate) and supplied as a set in PETG Tray with Tyvek Lid (new). | Supplied individually in Tyvek Pouch | Package systems all maintain sterile barrier | {10}------------------------------------------------ Table 5-4. Proposed/Predicate Device Technological Characteristics Comparison Table - Connector | Feature | Endogator Fujifilm 500/600 Single Use Connector (Subject Device) | Endogator Connector (K092429) | Comparison | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The ENDOGATOR™ FUJIFILM™ 500/600 Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit). | The Endogator system is intended to provide irrigation via sterile water supply during GI endoscopic procedure when sued in conjunction with an irrigation pump (or cautery unit). | Similar (Language modified for the subject device to reflect the connector provided does not include the Endogator tubing) | | Sterile/Non- sterile | Sterile | Sterile | Same | | Sterilization Method | EtO | EtO | Same | | Sterilization Assurance Level | 10⁻⁶ | 10⁻⁶ | Same | | Usage | Single Use | Single Use | Same | {11}------------------------------------------------ | Feature | Endogator Fujifilm 500/600 Single Use Connector (Subject Device) | Endogator Connector (K092429) | Comparison | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------| | Main Device Dimensions (lengths/widths) | Length: ~22 mm Diameter: ~12.7 mm | Length: ~22 mm Diameter: ~12.7 mm | Same | | Target Population | Patients undergoing an endoscopic procedure | Patients undergoing an endoscopic procedure | Same | | Energy Used/Delivered | None | None | Same | | Compatible Endoscopes | Fujifilm 500/600 series GI endoscope | None specified (commonly used with Fujifilm endoscopes) | Same | | Packaging | Continue to be supplied individually in Tyvek Pouch (predicate) and supplied as a set in PETG Tray with Tyvek Lid (new). | Supplied individually in Tyvek Pouch | Package systems all maintain sterile barrier | #### 4. Non-Clinical Performance Testing Non-clinical performance testing was performed on the subject device to support the substantial equivalence determination. The following tests were performed: Air / Water Valve - Gas (Air and CO2) flow rate testing ● - Water flow rate testing - Backflow prevention testing ● - Mechanical testing ● - o Depression Force - O Valve Application Force - o Valve Removal Force - o Force to Disassemble via Axial Pull - Button Cycling ● ## Suction Valve - Suction Bypass ● - Suction Rate (water and soil) . {12}------------------------------------------------ - Mechanical testing ● - Depression Force O - Valve Application Force O - Valve Removal Force O - Force to Disassemble via Axial Pull o - Valve Operation / Procedure Duration Test ● Biopsy Valve - Leak Testing - . Insufflation Testing Auxiliary Waterjet Valve (Connector) - Flow Durability Testing . - . Torque Test In addition to performance testing, ISO 11607/ASTM 4169 testing was completed to ensure the packaging of the subject device kit maintained sterile barrier after shipping/transit. #### 5. Biocompatibility The biocompatibility of the subject devices was assessed in accordance with the FDA guideline "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Biocompatibility testing conducted on the patient-contacting portions of the subject device in accordance with the ISO 10993 standard. The test result shows that the subject devices are biocompatible. #### 6. Conclusion Based on the intended use, technological characteristics, non-clinical performance testing, and biocompatibility assessment, the subject device has shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use.