Who is the manufacturer of DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)?

STERIS Corporation filed the 510(k) submission for DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (K240098).

What is the FDA product code for DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)?

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

What is the regulatory pathway for DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)?

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

Who can help prepare an FDA 510(k) submission like DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)?

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.

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)

Q: What are the predicate devices for DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)?

BioGuard EUS Air/Water and Suction Valves (K202104).

K240098 · STERIS Corporation · ODC · Feb 9, 2024 · Gastroenterology, Urology

Device Facts

Record ID	K240098
Device Name	DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
Applicant	STERIS Corporation
Product Code	ODC · Gastroenterology, Urology
Decision Date	Feb 9, 2024
Decision	SESE
Submission Type	Special
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

The DEFENDO EUS Air/Water Valve is intended to be used to control the air/water function of an endoscope during a GI endoscopic procedure. The DEFENDO EUS Suction Valve is intended to be used to control the suction function of an endoscope during a GI endoscopic procedure.

Device Story

DEFENDO Single Use Valve Kit consists of an Air/Water Valve and a Suction Valve designed as accessories for Olympus echoendoscopes. The Air/Water valve controls air/CO2 insufflation, lens washing, and distal balloon inflation. The Suction valve controls suction through the accessory channel and distal balloon. Both are single-use, sterile, mechanical devices operated by clinicians during GI endoscopic procedures. They function by manual actuation to regulate fluid/gas flow. The device provides physical control of endoscope functions, enabling visualization and therapeutic access. No software or electronic components are involved.

Clinical Evidence

Bench testing only. Performance testing included leakage testing, valve insertion/seating, suction strength, repeated actuation, and anti-sticking functionality. All tests passed against established acceptance criteria.

Technological Characteristics

Mechanical valves; materials include PC-ABS, stainless-steel, TPE, Ultem plastic, and brass. Dimensions: Air/Water valve (46mm length, 11.25mm diameter); Suction valve (33mm length, 3.8mm stem diameter). Sterile, single-use, EtO sterilized (SAL 10^-6). No energy source or software.

Indications for Use

Indicated for patients undergoing GI endoscopic procedures requiring air/water or suction control via an echoendoscope.

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

BioGuard EUS Air/Water and Suction Valves (K202104)

Related Devices

K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) · STERIS Corporation · Oct 11, 2024
K230932 — ANDORATE® Valve Kit · Ga Health Company Limited · Jul 7, 2023
K222980 — Pentax Medical Valve Set · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Nov 21, 2022
K192048 — Single Use Endoscope Valves Set · Anrei Medical (Hangzhou) Co., Ltd. · May 14, 2020
K202104 — BioGuard EUS Air/Water and Suction Valves · STERIS Corporation · Jan 14, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 9, 2024 Steris Corporation Jackie Oliver Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060 ### Re: K240098 Trade/Device Name: DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: January 12, 2024 Received: January 12, 2024 ### Dear Jackie Oliver: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ 2 Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ## Sivakami Venkatachalam -S for Shanil P. Haugen. Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K240098 Device Name DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) Indications for Use (Describe) The DEFENDO EUS Air/Water Valve is intended to control the air/water function of an endoscope during an GI Endoscopic procedure. The DEFENDO EUS Suction Valve is intended to be used to control the suction function of an endosocpe during a GI Endoscopic 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." {3}------------------------------------------------ ## 510(k) Summary for the # DEFENDO Single Use Valve Kit AW/S Valves -2pc for OLYMPUS EUS #### Company Name and Address 1. ## 1.1 Sponsor STERIS Corporation 5960 Heisley Rd. Mentor, Ohio 44060 Contact: Jackie Oliver Senior Regulatory Affairs Specialist Telephone: (440) 358-6289 Jackie Oliver@steris.com Email: ## 1.2 Manufacturing Facility US Endoscopy 5976 Heisley Road Mentor, Ohio 44060 #### 2. Device Name | Proprietary Name: | DEFENDO Single Use Valve Kit AW/S Valves – 2pc for OLYMPUS EUS (00711900) | |----------------------|------------------------------------------------------------------------------| | Common Usual Name: | Endoscope channel accessory | | Classification Name: | Endoscopic and accessories | #### 3. Establishment Registration Number STERIS Corporation 5960 Heisley Rd. Mentor, Ohio 44060 Registration number: 1527821 {4}------------------------------------------------ US Endoscopy 5976 Heisley Road Mentor, Ohio 44060 Registration number: 1528319 #### Device Classification 4. Class: II Classification Number: Classification Panel: FDA Review Product Code: ODC 21 CFR 876.1500 Gastroenterology/Urology #### 5. Predicate Devices BioGuard EUS Air/Water and Suction Valves K202104 #### 6. Device Description The DEFENDO EUS Air/Water Valve and the DEFENDO EUS Suction Valve are accessories to an echoendoscope. The EUS Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel, control water used to wash the lens of the endoscope and insufflate a balloon at the distal end of the echoendoscope The DEFENDO EUS Suction valve allows the user to control suction through the echoendoscope's accessory channel and suction to the balloon at the distal end of the echoendoscope. Both devices are single-use devices, supplied sterile. #### 7. Intended Use/Indications for Use The DEFENDO EUS Air/Water Valve is intended to be used to control the air/water function of an endoscope during a GI endoscopic procedure. The DEFENDO EUS Suction Valve is intended to be used to control the suction function of an endoscope during a GI endoscopic procedure. #### 8. Device Comparison Table The DEFENDO Single Use Valve Kit AW/S Valves – 2pc for OLYMPUS EUS are similar in design to the predicate and have the same intended use. The differences between the proposed and predicate devices are summarized in the table below. {5}------------------------------------------------ ## Table 1. Device Comparison Table for the DEFENDO Single Use Valve Kit AW/S Valves – 2pc for OLYMPUS EUS and predicate device. | Features | BioShield Air/Water Suction Valves EUS K202104 (Predicate Device) | DEFENDO Single Use Valve Kit AW/S Valves – 2-pc for OLYMPUS EUS (Proposed Device) | Comparison | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | Intended Use | The BioGuard EUS Air/Water Valve is intended to be used to control the air/water function of an endoscope during a GI endoscopic procedure. The BioGuard EUS Suction Valve is intended to be used to control the suction function of an endoscope during a GI endoscopic procedure. | The DEFENDO EUS Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure. The DEFENDO EUS Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure. | Identical (Only a name change) | | Construction: | Air/Water Valve Stem, Gaskets, Spring Guide, Spring(s), and Endcap with Skirt # of Gaskets: 9 # of Springs: 2 | Stem, Gaskets, Spring Guide, Spring(s), and Endcap with Skirt # of Gaskets: 9 # of Springs: 2 | Identical | | | Suction Valve Stem, Spring Guide, Spring(s), and Endcap with Skirt # of gaskets: 4 # of springs: 2 | Stem, Spring Guide, Spring(s), Endcap with Skirt, and Stainless-Steel Collar # of gaskets: 4 # of springs: 2 | Similar | | Sterile/ Non-sterile | Sterile | Sterile | Identical | | Sterilization Method | EtO | EtO | Identical | | Sterilization Assurance Level | 10-6 | 10-6 | Identical | | Usage | Single-Use | Single-Use | Identical | | Materials: | Air/Water Valve | | | | | Cap: PC-ABS Spring(s): Stainless-Steel Valve Stem: Top Half - Stainless-Steel / Bottom Half - PC-ABS Spring Guide: PC-ABS Gaskets: TPE Skirt: TPE Endcap: PC-ABS | Cap: PC-ABS Spring(s): Stainless-Steel Valve Stem: Top Half - Stainless-Steel / Bottom Half - PC-ABS Spring Guide: PC-ABS Gaskets: TPE Skirt: TPE Endcap: PC-ABS | Identical | | | Suction Valve | | | | | Cap: PC-ABS Spring(s): Stainless-Steel Center Valve Stem: Stainless-Steel Offset Valve Stem: Ultem Plastic Spring Guide: PC-ABS Gaskets: TPE Skirt: TPE Endcap: PC-ABS Cap Insert: Brass | Cap: PC-ABS Spring(s): Stainless - Steel Center Valve stem: Stainless-Steel Offset Valve Stem: Ultem Plastic Spring Guide: PC-ABS Gaskets: TPE Skirt: TPE Endcap: Ultem Cap Insert: Brass Metal collar: Stainless-Steel | Similar | | Device Dimensions (lengths/widths) | Air/Water Valve: | Air/Water Valve: | Similar | | | Overall Length: 46 mm Endcap Overmold Diameter: 11 mm | Overall Length: 46 mm Endcap Overmold Diameter: 11.25 mm | | | | Suction Valve: | Suction Valve: | Identical | | | Overall Length: 33 mm Stem Diameter: 3.8 mm | Overall Length: 33 mm Stem Diameter: 3.8 | | | Target Population | Patients undergoing an endoscopic procedure | Patients undergoing an endoscopic procedure | Identical | | Energy Used/Delivered | None | None | Identical | | Compatible Endoscopes | Olympus endoscope with a balloon channel | Olympus endoscope with a balloon channel | Identical | | Packaging | Sealed thermoform tray | Sealed thermoform tray | Identical | | Testing | Acceptance Criteria | Results | | | Air/Water Valve | | | | | Leakage Testing | The EUS Air/Water Valve shall not leak. | Pass | | | Insertion | The valves shall stay seated on the air/water port once placed. | Pass | | | Suction Valve | | | | | Strength of Suction Valve | The valve shall maintain suction capability and strength. | Pass | | | Insertion | The valve must not be able to be inserted incorrectly into EUS scope's suction port. | Pass | | | Valve actuation | The Suction Valve shall withstand repeated actuation. | Pass | | | Valve usage without sticking | The Suction Valve shall be used without any sticking. | Pass | | {6}------------------------------------------------ {7}------------------------------------------------ #### 9. Summary of Non-Clinical Performance Testing Non-clinical testing consisted of the following: #### 10. Conclusion Based on the Construction and materials and non-clinical performance data, the subject device is shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use.