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

Q: Who is the manufacturer of 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) filed the 510(k) submission for 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 (K232329).

Q: What is the FDA product code for 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?

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 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?

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

Q: What are the predicate devices for 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?

Defendo Disposable Air/Water Valve Model 100304 (K102409); Defendo Disposable Suction Valve Model 100305 (K102581); BioShield- Biopsy Valve (K210342); Endogator Endoscopy Irrigation Tubing (K220395); FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (K172916).

Q: Who can help prepare an FDA 510(k) submission like 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?

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.

K232329 · Medivators (A Subsidiary of Steris Corporation) · ODC · Dec 21, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K232329
Device Name	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
Applicant	Medivators (A Subsidiary of Steris Corporation)
Product Code	ODC · Gastroenterology, Urology
Decision Date	Dec 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

The 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, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The 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 Single Use Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure. The Single Use ENDOGATOR™ 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 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

Set of sterile, single-use accessories for Fujifilm 700 series GI endoscopes; includes biopsy, air/water, and suction valves, irrigation connector, and cleaning adapter. Valves manually actuate to control insufflation, suction, and instrument passage; connector facilitates irrigation via pump; cleaning adapter enables post-procedure channel flushing. Used in clinical settings by physicians/endoscopy staff. Single-use design eliminates reprocessing requirements for these components, reducing cross-contamination risk. Output is mechanical control of endoscope functions; assists clinicians in visualization, fluid removal, and therapeutic access during GI procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including gas/water flow rates, backflow prevention, mechanical depression/application/removal forces, instrument access, slit dimensional stability, and button cycling durability. Biocompatibility testing conducted per ISO 10993-1. Packaging integrity validated per ISO 11607/ASTM 4169.

Technological Characteristics

Sterile, single-use GI endoscope accessories. Materials: biocompatible polymers. Sterilization: EtO (SAL 10^-6). Manual actuation. Dimensions specific to Fujifilm 700 series ports. Packaging: PETG tray with Tyvek lid. No energy source or software.

Indications for Use

Indicated for patients undergoing GI endoscopic procedures requiring endoscope accessory valve functions (air/water control, suction control, biopsy port access, irrigation, or post-procedure channel cleaning).

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)
BioShield- Biopsy Valve (K210342)
Endogator Endoscopy Irrigation Tubing (K220395)
FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (K172916)

Related Devices

K232067 — 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) · Mar 22, 2024
K232244 — Disposable Endoscope Valves System · Changzhou Endoclean Medical Device Co., Ltd. · Nov 29, 2023
K210625 — JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve · Fujifilm Medwork GmbH · Sep 10, 2021
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

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 21, 2023 Medivators (A Subsidiary of STERIS Corporation) Nick Wang Senior Manager, Regulatory Affairs 3150 Pollok Drive Conroe, Texas 77303 ## Re: K232329 Trade/Device Name: 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 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC, FDF, OCX, FEQ Dated: November 21, 2023 Received: November 21, 2023 ## 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 Ouality System (OS) 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 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 (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) K232329 ## Device Name 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 ## Indications for Use (Describe) The 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, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The 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 Single Use Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure. The Single Use ENDOGATOR™ 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 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) | | |----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | \ 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}------------------------------------------------ K232329 Page 1 of 11 # 510(k) Summary ## Defendo Fujifilm 700 Single-Use Valves Set | Manufacturer: | Medivators 3150 Pollok Drive Conroe, TX 77303 | |---------------|-----------------------------------------------------------------------------------| | Submitter: | Nick Wang, Ph.D. RAC Senior Manager, Regulatory Affairs Phone: 440-392-7482 | 06 Dec 2023 Summary Date: {5}------------------------------------------------ ### 1. Device Name | Trade Name: | Defendo Fujifilm 700 Single-Use Valves Set | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Classification: | Class II | | Common/usual Name: | 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 | | Classification Name: | Endoscope and accessories | | Classification Number: | 21 CFR 876.1500 | | Product Code: | ODC, FDF, OCX, and FEQ | ### 2. Predicate Device(s) Primary predicate is listed first: K102409 - Defendo Disposable Air/Water Valve Model 100304 K102581 - Defendo Disposable Suction Valve Model 100305 K210342 - BioShield- Biopsy Valve K220395 - Endogator Endoscopy Irrigation Tubing K172916 - FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (Air/Water Cleaning Adapter) ### 3. Description of Device The Defendo Fujifilm 700 Single-Use Valves Set consists of a family of ready-to-use, sterile, single-use valves designed to be used on the Fujifilm 700 series GI endoscopes as accessories. The specific valves that are the subject of this 510(k) include the Defendo Fujifilm 700 Single-Use Air/Water Valve, the Defendo Fujifilm 700 Single-Use Suction Valve, the Defendo Fujifilm 700 Single Use Biopsy Valve, the Endogator Fujifilm 700 Connector, and the Defendo Fujifilm 700 Cleaning Adapter. - . The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's air/water feed channels 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 jet valve. - The Cleaning Adapter allows the user to pre-clean the air and water channels at the bedside prior to endoscope reprocessing. These valves are supplied in various sets. Each set may include combinations of two or more of the valves listed above. ### 4. Intended Use The 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, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The 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 Single Use Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure. The Single Use ENDOGATOR™ 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 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. {7}------------------------------------------------ ### 5. Technological Characteristic Comparison Table Table 1. Proposed/Predicate Device Technological Characteristics Comparison Table – Air / Water Valve | Feature | Defendo Fujifilm 700 Single-Use Air/Water Valve (Subject Device) | Defendo Disposable Air/Water Valve (Predicate K102409) | Comparison | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Intended use | The 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 Disposable Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI 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) | Air/Water Valve: Length: ~43.5 mm Diameter: ~19.2 mm | Air/Water Valve: Length: ~46 mm Diameter: ~17 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 700 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 | | Table 2. Proposed/Predicate Device Technological Characteristics | |------------------------------------------------------------------| | Comparison Table – Suction Valve | | Feature | Defendo Fujifilm 700 Single-Use Suction Valve (Subject Device) | Defendo Disposable Suction Valve (Predicate K102581) | Comparison | |--------------|-------------------------------------------------------------------------|------------------------------------------------------------|------------| | Intended Use | The Single Use Suction Valve is | The Defendo Disposable Suction | Same | {8}------------------------------------------------ | Feature | Defendo Fujifilm 700 Single-Use Suction Valve (Subject Device) | Defendo Disposable Suction Valve (Predicate K102581) | Comparison | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | | intended to be used to control the suction function on an endoscope during a GI endoscopic procedure. | Valve is intended to be used to control the suction function 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) | Suction Valve: Length: ~28.0 mm Diameter: ~17.2 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 700 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 | Table 5-3. Proposed/Predicate Device Technological Characteristics Comparison Table – Biopsy Valve | Feature | Defendo Single-Use Fujifilm 700 Biopsy Valves (Subject Device) | BioShield Biopsy Valve (for Fujifilm Endoscopes) (Predicate K210342) | Comparison | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The 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 | The single-use BioShield biopsy valve is used to cover the opening to the biopsy/suction channel of gastrointestinal endoscopes. It | Similar The intended use for the subject device biopsy valve is identical to that of other Defendo Biopsy Valves | | Feature | Defendo Single-Use Fujifilm 700 Biopsy Valves (Subject Device) | BioShield Biopsy Valve (for Fujifilm Endoscopes) (Predicate K210342) | Comparison | | | passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. | provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation. | currently marketed by Medivators. The minor differences in language between the BioShield and Defendo valves are mainly editorial in nature and do not represent a different intended use. | | Sterile/Non- sterile | Sterile | Sterile and Non- Sterile | See note below | | 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: ~16.8 mm Width (handle to tip): ~32.4 mm | Length: ~16.8 mm Width (handle to tip): ~32.4 mm | Same | | Target Population | Patients undergoing an endoscopic procedure | Patients undergoing an endoscopic procedure | Same | | Energy Used/ Delivered | None | None | Same | | Compatible Endoscopes | Fujifilm 700 series GI endoscope | Fuji Gen 5 or later 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 | {9}------------------------------------------------ Note: Defendo Fujifilm 700 Single Use Biopsy Valve, the subject valve, is identical to the black non-sterile BioShield Biopsy Valve from K210342, with the only difference is that the subject device is EO sterilized in the valves set. Device testing included in K210342 on both the sterile and non-sterile blue BioShield Biopsy Valves provides evidence that EO sterilization does not negatively affect device performance and both the sterile and non-sterile versions of the device met the performance requirements and performed as expected as the biopsy valve. In this submission, STERIS performed additional confirmatory testing to ensure the biopsy valve included in the subject device (black sterile) continued to perform as intended. {10}------------------------------------------------ | Feature | Endogator Fujifilm 700 Connector (Subject Device) | Endogator Connector (Predicate K220395) | Comparison | |-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Single Use ENDOGATOR™ Connector is intended to be used in conjunction with ENDOGATOR™ Irrigation Tubing to provide irrigation via sterile water during Gl 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 | | 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 700 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 | Table 5-4. Proposed/Predicate Device Technological Characteristics Comparison Table - Connector Note: Endogator Fujifilm 700 Connector (subject device) is the same as the Endogator Backflow Valve in the Endogator system (predicate device). The backflow valve is commonly used as the Auxiliary Water Jet Connector for the Fujifilm 700 Series endoscopes. Testing has been performed to provide evidence that the valve is compatible with and functions as intended when used with the Fujifilm 700 series GI endoscopes {11}------------------------------------------------ Table 5-5. Proposed/Predicate Device Technological Characteristics Comparison Table – Cleaning Adapter | Feature | Defendo Fujifilm 700 Single-Use Cleaning Adapter (Subject Device) | FUJIFILM Endoscope Models EG-760R, EG- 760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (Predicate K172916) | Comparison | |-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. | The predicate reusable air/water channel cleaning adapter is an accessory to Fujifilm 700 endoscopes. While no indications for use for the accessory is directly stated. The adapter's intended purpose is to pre-clean the endoscope's air/water channel post- procedure. The cleared indications for use statement provide in the predicate 510(k) is the indications for use statement of the entire endoscope, not just the cleaning adapter accessory.# | Same, the intended purposes of the predicate and subject cleaning adapters are the same. | | Sterility | Sterile | Non-Sterile | While sterility is not critical for the adapter application, the subject adapter is provided sterile as it is in the same packaging configuration as the other valves in the set. | | Usage | Single-Use | Reprocessed | Reason for this 510k, subject adapter is a single- use adapter, whereas the predicate is reusable and requires reprocessing. Single-use configuration mitigates the risk of | | Feature | Defendo Fujifilm 700 Single-Use Cleaning Adapter (Subject Device) | FUJIFILM Endoscope Models EG-760R, EG- 760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (Predicate K172916) | Comparison | | Main Device Dimensions (lengths/widths) | Length: ~45.7 mm Diameter: ~19.2 mm | Length: ~45.8 mm Diameter: ~18.7 mm | Similar, the minor difference do not affect device performance. | | Target Population | Patients undergoing an endoscopic procedure. The cleaning adapter does not have any patient contact as it is used post- procedure. | Patients undergoing an endoscopic procedure. The cleaning adapter does not have any patient contact as it is used post-procedure. | Same | | Energy Used/Delivered | None | None | Same | | Method of Application | Manual actuation | Manual actuation | Same | | Compatible Endoscopes | Fujifilm 700 Series GI endoscope | Fujifilm 700 Series Gl endoscope | Same | | Packaging | Supplied as a set in PETG Tray with Tyvek Lid | Supplied with endoscope or individually | Subject device package system maintains sterile barrier | {12}------------------------------------------------ # The indications for use listed in the predicate 510k summary is the following: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L, and EC-760ZP-V/L have following indications for use. FUJIFILM Endoscope Models EG-760R and EG-760Z are upper gastrointestinal endoscopes intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. FUJIFILM Endoscope Models EC-760R-V/L and EC-760ZP-V/L are lower gastrointestinal endoscopes intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. FUJIFILM Water Tank Model WT-603 has following indications for use. The Water Tank Model WT-603 is intended for use in combination with FUJIFILM 700 system scopes to deliver air and water through the endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose. ### 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 ● {13}------------------------------------------------ - Mechanical testing ● - Depression Force O - Valve Application Force O - o Valve Removal Force - o Force to Disassemble via Axial Pull - Valve Operation / Procedure Duration Test . Suction Valve - Suction Bypass ● - Suction Rate (water and soil) ● - Mechanical testing . - o Depression Force - o Valve Application Force - o Valve Removal Force - o Force to Disassemble via Axial Pull - . Valve Operation / Procedure Duration Test Biopsy Valve - Workability / Instrument Access Testing . - Slit Length / Dimensional Stability . Auxiliary Waterjet Valve (Connector) - Flow Rate / Durability Testing ● - Backflow Prevention Test ● Cleaning Adapter - . Gas Flow Rate - Water Flow Rate ● - Mechanical Testing ● - Depression Force o - Adapter Application Force o - Adapter Removal Force O - Button Cycling / Durability Testing ● 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. {14}------------------------------------------------ ### 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.