Who is the manufacturer of Disposable Endoscope Valves Set (AF series)?

Alton (Shanghai) Medical Instruments Co., Ltd. filed the 510(k) submission for Disposable Endoscope Valves Set (AF series) (K241285).

What is the FDA product code for Disposable Endoscope Valves Set (AF series)?

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 Disposable Endoscope Valves Set (AF series)?

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

What are the predicate devices for Disposable Endoscope Valves Set (AF series)?

Disposable Endoscope Valve Sets (K220884).

Who can help prepare an FDA 510(k) submission like Disposable Endoscope Valves Set (AF series)?

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.

Disposable Endoscope Valves Set (AF series)

K241285 · Alton (Shanghai) Medical Instruments Co., Ltd. · ODC · Oct 1, 2024 · Gastroenterology, Urology

Device Facts

Record ID	K241285
Device Name	Disposable Endoscope Valves Set (AF series)
Applicant	Alton (Shanghai) Medical Instruments Co., Ltd.
Product Code	ODC · Gastroenterology, Urology
Decision Date	Oct 1, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

The Disposable Endoscope Valve Sets is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector. - Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow. - Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction. whilst preventing inflow of air. - Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure. - Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

Device Story

Disposable Endoscope Valves Set (AF series) comprises sterile, single-use components: Air/Water Valve, Suction Valve, Biopsy Valve, and Auxiliary Water Connector. Used in clinical settings by medical professionals during GI endoscopy. Air/Water and Suction valves attach to respective endoscope ports to manage gas/fluid flow and suction via spring-loaded sealing mechanisms. Biopsy valve covers the biopsy port to allow instrument passage while maintaining insufflation and preventing biomaterial leakage. Auxiliary Water Connector links to an irrigation pump to facilitate sterile water supply. Device ensures proper endoscope function, lens cleansing, and debris aspiration, enhancing procedural visibility and patient safety by preventing backflow and leakage.

Clinical Evidence

No clinical data provided. Substantial equivalence demonstrated through non-clinical bench testing, including biocompatibility (ISO 10993), sterilization validation (ISO 11135), shelf-life/packaging validation (ASTM F1980, ISO 11607), and performance testing (endoscope compatibility, flow rates, leakage, and backflow performance).

Technological Characteristics

Materials: ABS, Silicone Rubber, TPE, PC, Stainless steel 304. Components: Air/Water Valve, Suction Valve, Biopsy Valve, Auxiliary Water Connector. Principle: Mechanical sealing rings and spring-loaded control. Sterilization: Ethylene Oxide. Single-use. Compatible with specific Olympus, Pentax, and Fujifilm GI endoscopes.

Indications for Use

Indicated for use in GI endoscopic procedures to control fluid/gas flow and prevent leakage/backflow via endoscope channels. Compatible with Olympus 140/160/180/190/240/260/290, Pentax 90/i10, and Fujifilm 700 series endoscopes.

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

Disposable Endoscope Valve Sets (K220884)

Related Devices

K220884 — Disposable Endoscope Valve Sets · Sml Med-Tech Solutions Limited · Jan 17, 2023
K200769 — Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B · Wilson Instruments (Sha) Co., Ltd. · Jan 6, 2021
K250732 — Disposable Endoscopy Valve Set · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Jun 20, 2025
K151714 — Disposable Endoscope Valves Set A · Wilson Instruments (Shanghai) Company Limited · Dec 3, 2015
K191231 — Andorate Auxiliary Water Connector, Andorate Valves Set · Smartdata Suzhou Co., Ltd. · Jun 7, 2019

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. October 1, 2024 Alton (Shanghai) Medical Instruments Co. Ltd Johnny Song R&D Engineer No.24 Building Jinshao Rd.1688, Baoshan District Shanghai, Shanghai 200949 China Re: K241285 Trade/Device Name: Disposable Endoscope Valves Set (AF series) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: May 7, 2024 Received: August 29, 2024 Dear Johnny Song: 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" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K241285 Device Name Disposable Endoscope Valves Set (AF series) #### Indications for Use (Describe) The Disposable Endoscope Valve Sets is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector. - Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow. - Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction. whilst preventing inflow of air. - Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure. - Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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}------------------------------------------------ # 510(k) Summary #### I. SUBMITTER Name: Alton (Shanghai) Medical Instruments Co. Ltd. Address: No.24 Building, JinShao Rd. 1688, Baoshan District, 200949 Shanghai, P. R. China Name of contact person: Vivian Li Position: Director of Quality Department Tel: +86 21 56771811 Fax: +86 21 66307823 Mail: vivian@alton.com.cn Date prepared: 2024-09-27 # II. Identification of Subjective Device Device trade name: Disposable Endoscope Valves Set (AF series) Regulation Name: Endoscope and accessories Regulation number: 21CFR 876.1500 Regulation class: 2 Review Panel: Gastroenterology/Urology Product Code Description: Endoscope Channel Accessory Product code: ODC # III. Identification of Predicate device Predicate Submission Number: K220884 Trade/Device Name: Disposable Endoscope Valve Sets Regulation Name: Endoscope and accessories Regulation Number: 21 CFR 876.1500 Regulatory Class: 2 Review Panel: Gastroenterology/Urology Product Code Description: Endoscope Channel Accessory Product Code: ODC {5}------------------------------------------------ ### IV. Device description The Disposable Endoscope Valves Set is a collection of several sterile units, it is intended for single-use and supplied sterile. The subject device is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector. - The Suction Valve component of the Disposable Endoscope Valves Set is designed to be attached to the suction port of the endoscope, allowing the user to aspirate excess fluids or other debris obscuring the endoscopic image. - The Air/Water Valve component of the Disposable Endoscope Valves Set is designed to be attached to the air/ water port of the endoscope, the activation of the air/ water valve allows the user to control air and water flow to assist in cleansing the lens during procedures. - The Biopsy Valve component of the Disposable Endoscope Valves Set is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. - The Auxiliary Water Connector component of the Disposable Endoscope Valves Set is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve that prevents the backflow of water or biomaterials from the endoscope to the sterile water bottle. And there were no prior submissions for the subject devices. ### V. Indication for use The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector. - Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow. {6}------------------------------------------------ - Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air. - Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure. - Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump. | Attribute | Subject device | Predicative device (K220884) | Discussion/ Conclusion | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | Manufacturer | Alton (Shanghai) Medical Instruments Co. Ltd | SML Med-Tech Solutions Limited | / | | Trade name | Disposable Endoscope Valves Set (AF series) | Disposable Endoscope Valve Sets | / | | Regulation name | Endoscope and accessories | Endoscope and accessories | Same | | Regulatory Class | II | II | Same | | Product code | ODC | ODC | Same | | Clinical characteristics | | | | | Indications for use | The Disposable Endoscope Valve Sets is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector. | The Disposable Endoscope Valve Same Sets is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector. - Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow. - Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air. - Biopsy Valve: This unit is intended to be fitted to an | Same | | Attribute | Subject device | Predicative device (K220884) | Discussion/ Conclusion | | | intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure. - Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump. | endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure. - Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump. | | | Compatible endoscopes | AF-DVS3-O, AF-DVS4-O, AF-BVC-O: Olympus® 140/ 160/ 180/ 190/ 240/ 260/ 290 Series GI Endoscope AF-DVS3-P, AF-DVS4-P, AF-BVC-P: Pentax® 90/ i10 GI Endoscope AF-DVS3-F, AF-DVS4-F, AF-BVC-F: Fujifilm® 700 Series GI Endoscope | SML002_LP01_AW: Olympus® 140/160/ 180/ 190/ 240/ 260/ 290 Series GI Endoscope SML001_PT01_AW: Pentax® 90/i10 GI Endoscope SML003_FJ01_AW: Fujifilm® 700 Series GI Endoscope | Same | | General technological characteristics | | | | | Device composition and specifications | AF-DVS3-O: Air/Water Valve+ Suction Valve+ Biopsy Valve AF-DVS4-O: Air/Water Valve+ Suction Valve+ Biopsy Valve+ Auxiliary Water Connector AF-BVC-O: Biopsy Valve AF-DVS3-P: Air/Water Valve+ Suction Valve+ Biopsy Valve AF-DVS4-P: Air/Water Valve+ Suction Valve+ Biopsy Valve+ Auxiliary Water Connector AF-BVC-P: Biopsy Valve AF-DVS3-F: Air/Water Valve+ Suction Valve+ Biopsy Valve AF-DVS4-F: Air/Water Valve+ Suction Valve+ Biopsy Valve+ Auxiliary Water Connector AF-BVC-F: Biopsy Valve | SML002: Air/Water Valve+ Suction Valve+ Biopsy Valve+ Auxiliary Water Connector SML001: Air/Water Valve+ Suction Valve+ Biopsy Valve SML003: Air/Water Valve+ Suction Valve+ Biopsy Valve | Same | | Principle of | Biopsy Valve: The Biopsy valve | Biopsy Valve: The Biopsy valve | Same | | Attribute | Subject device | Predicative device (K220884) | Discussion/ Conclusion | | | port to prevents gas and liquid | port to prevents gas and liquid from | | | | from overflowing from the forceps port, the cross cutting on the | overflowing from the forceps port, the cross cutting on the surface can | | | | surface can reduce friction between the instrument and the | reduce friction between the instrument and the forceps port. | | | | forceps port. Air/Water Valve: The principal | Air/Water Valve: The principal axis of Air/Water valve is equipped with | | | | axis of Air/Water valve is equipped with different sizes of | different sizes of sealing rings, which use spring to control advance | | | | sealing rings, which use spring to control advance and retreat, and | and retreat, and control the water supply and air supply function of | | | | control the water supply and air supply function of endoscope in | endoscope in endoscopic surgery. Suction Valve: The principal axis of | | | | endoscopic surgery. Suction Valve: The principal axis | Suction valve is equipped with different sizes of sealing rings, | | | | of Suction valve is equipped with different sizes of sealing rings, | which use spring to control advance and retreat, and endoscope suction | | | | which use spring to control advance and retreat, and | function in endoscopic surgery. Auxiliary Water Connector: The | | | | endoscope suction function in endoscopic surgery. | principal axis of Auxiliary Water Connector is equipped with sealing | | | | Auxiliary Water Connector: The principal axis of Auxiliary Water | rings, which used to prevent leakage. One end is connected to an | | | | Connector is equipped with sealing rings, which used to | irrigation pump and the other to a pipe. It acts as a connector through | | | | prevent leakage. One end is connected to an irrigation pump | which water passes. | | | | and the other to a pipe. It acts as a connector through which water | | | | | passes. | | | | Material | Air/Water Valve: ABS, Silicone Rubber, TPE, Stainless steel 304 | Air/Water Valve: ABS, Silicone Rubber, TPE, Stainless steel 304 | Same | | | Suction Valve: ABS, PC, Silicone Rubber, Stainless steel 304 | Suction Valve: ABS, PC, Silicone Rubber, Stainless steel 304 | | | | Biopsy Valve: Silicone Rubber | Biopsy Valve: Silicone Rubber | | | | Water Connector: PC, Silicone Rubber | Water Connector: PC, Silicone Rubber | | | Sterilization | Ethylene Oxide sterilization | Ethylene Oxide sterilization | Same | | Attribute | Subject device | Predicative device (K220884) | Discussion/ Conclusion | | Single use/reuse | For single use | For single use | Same | | Shelf life | 3 years | Not known | Different, see discussion 1 | VI. Comparison of technological characteristics with the predicate device {7}------------------------------------------------ # K241285 {8}------------------------------------------------ # K241285 {9}------------------------------------------------ ### Discussion on differences between the subject device and the predicate device Discussion 1: Although shelf life between the subject device and the predicate device is different, sterile process validation and shelf-life validation including performance test are performed on the subject device according to relevant standards, such differences will not affect the safety and effectiveness of the subject device. #### VII. Summary of substantial equivalence discussion Based on the above comparison table, the subject device and the predicate device are totally same on design features and performance specifications. There are no differences on device composition, specification and component material used as well on both devices. the only differences between the subject device and the predicate device are the sterile barrier system and other packages used for both devices. As all sterile process validation and shelf-life validation including performance test, transportation simulated test and biocompatibility tests are performed on the subject device according to relevant standards, such differences between the subject device and the predicate device do not affect the safety and effectiveness of the subject device when used as labeled. ### VIII. Summary of Non-clinical Data Non-clinical testing for Disposable Endoscope Valves Set was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance based on current applicable standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed. #### A Biocompatibility The biocompatibility evaluation for the Disposable Endoscope Valves Set was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing {10}------------------------------------------------ within a risk management process"" September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. - MTT Cytotoxicity Test: ISO 10993-5:2009, Biological evaluation of medical . devices -- Part 5: Tests for In Vitro cytotoxicity - Skin Sensitization Test, Skin Irritation Test: ISO 10993-10:2010, Biological . evaluation of medical devices -- Part 10: Tests for irritation and sensitization - . Acute Systemic Toxicity Test and Pyrogen Test: ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity A Sterilization Validation > The EO sterilization of the Disposable Endoscope Valves Set has been validated according to the following applicable standards: - ISO11135:2014+A1:2018 Sterilization of medical device- validation and . routine control of ethylene oxide sterilization - ISO 11737-2:2019 Sterilization of Medical Device-Microbiological . methods-part 2: Tests of sterility performed in the validation of a sterilization process - ISO 10993-7:2008 Biological evaluation of medical devices Part 7: ● Ethylene oxide sterilization residuals - USP <85> Bacterial endotoxins test . - A Shelf Life and Sterile Barrier System Shelf Life and Sterile Barrier System of the Disposable Endoscope Valves Set has been validated according to the following applicable standards: - ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier . Systems for Medical Devices - . ISO11607-1:2019 Packaging for terminally sterilized Medical Device Part 1: Requirement for materials, sterile barrier systems and packaging systems - . ISO11607-2:2019 Packaging for terminally sterilized Medical Device Part 2: Validation Requirement for forming, sealing and assembly process - ASTM F 1929-15: Standard Test Method for Detecting Seal Leaks in Porous . page 7 of 9 {11}------------------------------------------------ Medical Packaging by Dye Penetration - ASTM D 3078-02(2013): Standard Test Method for Determination of Leaks . in Flexible Packaging by Bubble Emission - DIN 58593-6: 2016 Sterilization - Sterile Supply - Part 6: Microbial Barrier Testing of Packaging Materials for Medical Devices Which Are to Be Sterilized - . ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials - ASTM D4169-16 Standard practice for performance testing of shipping ● containers and systems (DC-13, Level II) - Performance Data Bench A The performance tests were implemented on both the subject device and the predicate device to demonstrate substantial equivalence according to the specific product specification as below listed: # Suction Valve: - Endoscope Compatibility - Depression Force - Leakage Test - Suction Flow # Air/Water Valve: - Endoscope Compatibility - Air flow rate - Water flow rate - Leakage Test - Depression Force - Backflow Performance Test # Biopsy Valve: - Endoscope Compatibility - Leakage Test # Auxiliary Water Connector: {12}------------------------------------------------ - Endoscope Compatibility - Leakage Test - Water Flow Rate - Backflow Performance Test - A Performance Data – Animal N/A, no animal studies are available for the subject device. # IX. Summary of Clinical Data N/A, no clinical studies are available for the subject device. #### X. Conclusions In conclusion, the technological characteristics, features, specifications, materials, principle of operation, and intended use of the subject device substantially equivalent to the predicate devices quoted above. The differences between the subjective device and its predicate devices do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device is substantially equivalent to the legally marketed predicate device.