Who is the manufacturer of Disposable Endoscope Valves Kit?

Shanghai SeeGen Photoelectric Technology Co., Ltd. filed the 510(k) submission for Disposable Endoscope Valves Kit (K222499).

What is the FDA product code for Disposable Endoscope Valves Kit?

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 Kit?

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

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

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 Kit

Q: What are the predicate devices for Disposable Endoscope Valves Kit?

Disposable Endoscopy Adapter Set (K220210).

K222499 · Shanghai SeeGen Photoelectric Technology Co., Ltd. · ODC · Nov 22, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K222499
Device Name	Disposable Endoscope Valves Kit
Applicant	Shanghai SeeGen Photoelectric Technology Co., Ltd.
Product Code	ODC · Gastroenterology, Urology
Decision Date	Nov 22, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

The values are used in conventional gastrointestinal endoscope to control the functions of water/gas injection and suction during the endoscopic operation.

Device Story

Disposable Endoscope Valves Kit comprises water/gas button, suction button, biopsy cap, and water injection adapter. Used in hospital/clinic settings by clinicians during gastrointestinal endoscopy. Components install onto endoscope operating handle ports to manage fluid/gas flow and suction. Device facilitates endoscopic operation by providing necessary control interfaces for the endoscope. Benefits include maintaining sterile, single-use functionality to prevent cross-contamination between procedures.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing (appearance, physical properties) and adherence to ISO 10993 (biocompatibility) and ISO 11135/10993-7 (sterilization).

Technological Characteristics

Materials: Polycarbonate, silicone rubber, stainless steel. Components: Water/gas button, suction button, biopsy cap, water injection adapter. Sterilization: Ethylene Oxide (EO). Connectivity: None (mechanical accessory).

Indications for Use

Indicated for use in conjunction with conventional gastrointestinal endoscopes to control water/gas injection and suction functions during endoscopic procedures.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

Disposable Endoscopy Adapter Set (K220210)

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
K221331 — Disposable Endoscope Valves System · Changzhou Endoclean Medical Device Co., Ltd. · Sep 8, 2022
K232118 — ANDORATE® Valve Kit · Ga Health Company Limited · Oct 16, 2023
K222980 — Pentax Medical Valve Set · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Nov 21, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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. November 22, 2023 Shanghai SeeGen Photoelectric Technology Co., Ltd. Yihua Ma RA Supervisor 3 Floor, Building No.1, 4299 JinDu Road, Minhang District Shanghai, Shanghai 201108 China Re: K222499 Trade/Device Name: Disposable Endoscope Valves Kit Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: November 3, 2023 Received: November 3, 2023 Dear Yihua Ma: 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ Sincerely, # Shanil P. Haugen -S Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222499 Device Name Disposable Endoscope Valves Kit Indications for Use (Describe) The values are used in conventional gastrointestinal endoscope to control the functions of water/gas injection and suction during the endoscopic operation. 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}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for SEEGEN, a company specializing in vision technology. The logo features the company name in a stylized font, with the tagline "vision borderless" underneath. The text "机分光电" is also present, possibly indicating the company's focus on optical or photoelectric technology. The overall design suggests a modern and innovative approach to vision-related solutions. Section 5 510(k) Summary {5}------------------------------------------------ ## 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. ## 5.1 Submitter | Submitted by: | Shanghai SeeGen Photoelectric Technology Co., Ltd. | |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Address: 3 Floor, Building No.1, 4299 JinDu Road, Minhang District, Shanghai, China | | Contact Person: | Yihua Ma RA Supervisor | | | Shanghai SeeGen Photoelectric Technology Co., Ltd Address: 3 Floor, Building No.1, 4299 JinDu Road, Minhang District, Shanghai, China Phone: 0086-18616909737 Email: mayihua@seegen.com.cn | | Date Prepared: | July 15, 2022 | #### 5.2 Device | Device Name: | Disposable Endoscope Valves Kit | |--------------------|---------------------------------| | Common Name: | Endoscope Channel Accessory | | Regulatory Class: | Class II | | Regulation Number: | 21 CFR 876.1500 | | Regulation Name: | Endoscope and Accessories | | Product Code: | ODC | # 5.3 Predicate Device | Device Name: | Disposable Endoscopy Adapter Set, K220210 | |--------------------|-------------------------------------------| | Common Name: | Endoscope Channel Accessory | | Regulatory Class: | Class II | | Regulation Number: | 21 CFR 876.1500 | | Regulation Name: | Endoscope and Accessories | | Product Code: | ODC | {6}------------------------------------------------ ## 5.4 Device Description Disposable Endoscope Valves Kit consists of Water/gas button, Attraction button, Biopsy cap and Water injection adapter. Disposable Endoscope Valves Kit connect the endoscope operating handle matched with the model, and install the water gas button into the water gas port of the operating handle; Align the positioning boss of the suction button with the card slot of the operating handle and install it into the suction port; Install the biopsy cap into the clamp opening of the operating handle. ## 5.5 Indication for Use: The values are used in conjunction with conventional gastrointestinal endoscope to control the functions of water/gas injection and suction during the endoscopic operation. | Item | Disposable Endoscope Valves Kit (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion | | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------| | Indication for Use | The values are used in conjunction with conventional gastrointestinal endoscope to control the functions of water/gas injection and suction during the endoscopic operation. | The Disposable Endoscopy Adapter 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. - Disposable 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. - Disposable 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. - Disposable 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. - Disposable Water Jet Adapter: This unit is intended | Substantially equivalent | | | SEEEGEN 视介光电 vision borderless | | | | Section 5 510(k) | | Item | Disposable Endoscope Valves Kit (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion | | | | | to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump. | | | | Product Code | ODC | ODC | Same | | | Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same | | | Classificatio n | II | II | Same | | | Water/gas button | | Air/Water Valve | | | | Compatible Endoscopes | OLYMPUS 100/200 series upper and lower gastrointestinal electronic endoscopes FUJIFILM 600/700 series upper and lower gastrointestinal electronic endoscopes PENTAX i10/90K series upper and lower gastrointestinal electronic endoscopes PENTAX NP1 series upper and lower gastrointestinal electronic endoscopes PENTAX NP2 series upper and lower gastrointestinal electronic endoscopes | Olympus 140/160/180/190/240/260/2 90 series endoscopes; PENTAX GI Video Endoscope 90K/90i Series, K10/i10 Series; Fujifilm® 500/600/ 700 series endoscopes | Substantially equivalent supported by bench testing. | | | Sterile | EO Sterilization | EO Sterilization | Same | | | Material | Polycarbonate, Silicone rubber, Stainless Steel | Silicone Rubber, ABS, SUS304 | Substantially equivalent supported by biocompatibility testing. | | | Environment Use | Hospital/clinics | Hospital/clinics | Same | | | Suction button | | Suction Valve | | | | Compatible Endoscopes | OLYMPUS 100/200 series upper and lower gastrointestinal electronic endoscopes FUJIFILM 600/700 series upper and lower | Olympus 140/160/180/190/240/260/2 90 series endoscopes; PENTAX GI Video Endoscope 90K/90i Series, K10/i10 Series; | Substantially equivalent supported by bench testing. | | | Item | Disposable Endoscope Valves Kit (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion | | | | gastrointestinal electronic endoscopes PENTAX i10/90K series upper and lower gastrointestinal electronic endoscopes PENTAX NP1 series upper and lower gastrointestinal electronic endoscopes PENTAX NP2 series upper and lower gastrointestinal electronic endoscopes | Fujifilm® 500/600/ 700 series endoscopes | | | | Sterile | EO Sterilization | EO Sterilization | Same | | | Material | Polycarbonate, Silicone rubber, Stainless Steel | ABS, Silicone, Rubber, SUS304 | Substantially equivalent supported by biocompatibility testing. | | | Environment Use | Hospital/clinics | Hospital/clinics | Same | | | Biopsy cap | | Biopsy Valve | | | | Compatible Endoscopes | OLYMPUS 100/200 series upper and lower gastrointestinal electronic endoscopes FUJIFILM 600/700 series upper and lower gastrointestinal electronic endoscopes PENTAX i10/90K series upper and lower gastrointestinal electronic endoscopes PENTAX NP1 series upper and lower gastrointestinal electronic endoscopes PENTAX NP2 series upper and lower gastrointestinal electronic endoscopes | Olympus 140/160/180/190/240/260/2 90 series endoscopes; PENTAX GI Video Endoscope 90K/90i Series, K10/i10 Series; Fujifilm® 500/600/ 700 series endoscopes | Substantially equivalent supported by bench testing. | | | Item | Disposable Endoscope Valves Kit (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion | | | Environment Use | Hospital/clinics | Hospital/clinics | Same | | | Water injection adapter | | Water Jet Adapter | | | | Compatible Endoscopes | OLYMPUS 100/200 series upper and lower gastrointestinal electronic endoscopes FUJIFILM 600/700 series upper and lower gastrointestinal electronic endoscopes PENTAX i10/90K series upper and lower gastrointestinal electronic endoscopes PENTAX NP1 series upper and lower gastrointestinal electronic endoscopes PENTAX NP2 series upper and lower gastrointestinal electronic endoscopes | Olympus 140/160/180/190/240/260/2 90 series endoscopes; PENTAX GI Video Endoscope 90K/90i Series, K10/i10 Series; Fujifilm® 500/600/ 700 series endoscopes | Substantially equivalent supported by bench testing. | | | Sterile | EO Sterilization | EO Sterilization | Same | | | Material | Polycarbonate, Silicone rubber | Metal Type: PC, SUS303, Silicone Rubber, Plastic Type: PC, Silicone Rubber | Same as Plastic Type | | | Environment Use | Hospital/clinics | Hospital/clinics | Same | | ## 5.6 Substantial Equivalence and Technological Characteristics {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for SEEGEN, which is written in red, along with the Chinese characters "顺介光电". Below the Chinese characters, the words "vision borderless" are written in a smaller font. The logo is simple and modern, and the colors are eye-catching. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for SEEGEN, with the number 7 stylized to look like a lightning bolt. To the right of the logo are Chinese characters, and below the logo is the text "vision borderless". The logo is in red, while the Chinese characters and the text "vision borderless" are in gray. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for SEEGEN, a vision borderless company. The logo is in red and white. The text "SEEGEN" is in red, and the text "vision borderless" is in white. #### 5.7 Substantial Equivalence Disposable Endoscopy Adapter Set, K220210 are used as predicate device compared to proposed device Disposable Endoscope Valves Kit manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd. ## 5.8 Non-clinical Performance Data The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals". The following bench tests were performed on Disposable Endoscopy Adapter Set: Appearance, Physical properties. The results of all testing were passing. {10}------------------------------------------------ #### 5.9 Clinical Test Data No Clinical Study is included in this submission. ## 5.10 Conclusion In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Shanghai SeeGen Photoelectric Technology Co., Ltd. has demonstrated that proposed device Disposable Endoscope Valves Kit is substantially equivalent to Yangzhou Fartley Medical Instrument Technology Co., Ltd.'s currently marketed Disposable Endoscopy Adapter Set, K220210.