Who is the manufacturer of Endoscopy Irrigation Tubing?

Zhejiang Chuangxiang Medical Technology Co., Ltd. filed the 510(k) submission for Endoscopy Irrigation Tubing (K230773).

What is the FDA product code for Endoscopy Irrigation Tubing?

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

What is the regulatory pathway for Endoscopy Irrigation Tubing?

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

Who can help prepare an FDA 510(k) submission like Endoscopy Irrigation Tubing?

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.

Endoscopy Irrigation Tubing

K230773 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · OCX · Nov 21, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K230773
Device Name	Endoscopy Irrigation Tubing
Applicant	Zhejiang Chuangxiang Medical Technology Co., Ltd.
Product Code	OCX · Gastroenterology, Urology
Decision Date	Nov 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

The 24 hour use Endoscopy Irrigation Tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrontestinal endoscopic procedures when used in conjunction with an irrigation pump.

Device Story

Endoscopy Irrigation Tubing facilitates delivery of sterile water to GI endoscopes during endoscopic procedures. Device consists of tubing and accessories designed to connect a sterile water bottle to an irrigation pump; pump drives water through auxiliary water channel to distal end of endoscope. Used in hospitals or clinics by medical professionals. Features a diaphragm in the connector for one-way flow to prevent backflow. Device is single-use, disposable, and intended for 24-hour use. Benefits include maintaining clear visualization during procedures by providing irrigation. Supplied sterile via EO gas.

Clinical Evidence

Bench testing only. Performance verification tests confirmed flow rates met established specifications. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity) performed per ISO 10993-1. Shelf life validated via accelerated aging per ASTM F1980-21. Sterilization validated per ISO 11135 and EO residuals confirmed per ISO 10993-7.

Technological Characteristics

Materials: PC, PVC, PP, PTFE, MABS, Silicone, POM. Principle: Mechanical fluid transfer via irrigation pump. Form factor: Tubing set with connectors. Connectivity: Compatible with various GI endoscopes and pumps (e.g., ENDOGATOR, OLYMPUS, ERBE). Sterilization: EO gas per ISO 11135. Shelf life: 3 years (ASTM F1980-21). Packaging: Sealed pouch per ISO 11607-1/2.

Indications for Use

Indicated for patients undergoing gastrointestinal endoscopic procedures requiring irrigation via a sterile water bottle and an irrigation pump.

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

AquaPulse® Irrigation Tubing (K202560)

Related Devices

K223171 — AquaPulse® Irrigation Tubing · Ga Health Company Limited · Nov 10, 2022
K220395 — EndoGator Endoscopy Irrigation Tubing · STERIS Corporation · Mar 11, 2022
K202560 — AquaPulse Irrigation Tubing · Ga Health Company Limited · Dec 10, 2020
K133747 — ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM · Endochoice, Inc. · Jan 8, 2014
K181457 — EndoStream(TM) · Partnership Medical Limited · Jul 11, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. November 21, 2023 Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long RA manager Room 101,201,301,401,501, Building 50, No.650 Hongfeng Road Donghu Street, Yuhang District Hangzhou, Zhejiang Province 311100 China Re: K230773 Trade/Device Name: Endoscopy Irrigation Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCX Dated: October 25, 2023 Received: October 26, 2023 Dear Lucius Long: 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) K230773 Device Name Endoscopy Irrigation Tubing Indications for Use (Describe) The 24 hour use Endoscopy Irrigation Tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrontestinal endoscopic procedures when used in conjunction with an irrigation pump. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <div> ☒ </div> | |----------------------------------------------|----------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> ☐ </div> | #### 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}------------------------------------------------ # 1. Submitter's information Name: Zhejiang Chuangxiang Medical Technology Co., LTD. Address: Room 101, 201, 301, 401, 501, Building 50, No.650 Hongfeng Road Donghu Street, Yuhang District, Hangzhou City, Zhejiang Province, 311100, P.R. China Contact person: Lucius Long, RA manager Email: lucius.long@med-nova.com Telephone: 86-571-89167088 Fax: 86-571-89167086 #### 2. Date of Submission 9-March- 2023 ## 3. Device Trade/Device Name: Endoscopy Irrigation Tubing Regulation name: Endoscope and accessories. Regulation class: II Regulation number: 876.1500 Panel: Gastroenterology/Urology Product code: OCX Product Code Name: Endoscopic Irrigation/Suction System # 4. Predicative device 510(k) Number: K202560 Device Name: AquaPulse® Irrigation Tubing Product Code: OCX #### 5. Device description The Endoscopy Irrigation Tubing is intended for 24-hour use and then discarded. The endoscopy irrigation tubing is manufactured for use in conjunction with sterile water bottle, and together with irrigation pumps. The endoscopy irrigation tubing is individually packed in sealed package, sold as a sterile device. The endoscopy irrigation tubing is designed to be attached to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope. {5}------------------------------------------------ # 6. Indications for use The 24 hour use Endoscopy Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. ### 7. Comparison of Technological Characteristics: | Item | Proposed device | Predicate device | Comparison to Predicate Devices | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Device name | Endoscopy Irrigation Tubing | AquaPulse® Irrigation Tubing | / | | Product code | OCX | OCX | Same | | Regulation No. | 876.1500 | 876.1500 | Same | | Regulatory Classification | II | II | Same | | Regulation Description | Endoscope and accessories | Endoscope and accessories | Same | | Indications for Use | The 24 hour use Endoscopy Irrigation Tubing(tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. | The 24 hour use AquaPulse® Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. | Same | | Compatibility | Model A is suitable for ENDOGATOR™ EGP-100 Irrigation Pump, OLYMPUS® OFP Pump, OLYMPUS® AFU-100 Pump and ERBE EIP2® Pump Model B is suitable for Olympus® OFP, OFP-2, OFP-3 and OPF-3 Plus Irrigation Pump | Olympus® OFP, Endo Status™ EGA-500 and Endogator® EGP- 100 Irrigation Pump | Substantial Equivalent | | Materials | Polycarbonate (PC),Polyvinyl Chloride (PVC), Polypropylene (PP), Polytetrafluoroethylene(PTFE), Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS) and Silicone, Polyformaldehyde Resin(POM) | Polycarbonate and Polyvinyl Chloride | Similar, we have conducted the biocompatibility test and all tests have passed with acceptable results. | | Environment of Use | Hospital and or clinics | Hospital and or clinics | Same | | Single Use, Disposable | 24-hour use then discard | 24-hour use then discard | Same | | Backflow Prevention Design | Diaphragm in the connector allow pressurized water passing through in one-way but not the other way | Diaphragm in the connector allow pressurized water passing through in one-way but not the other way | Substantial Equivalent | | Supplied Sterile | Yes | Yes | Same | | Packaging | Irrigation tubing is packaged in a sealed pouch | Irrigation tubing is packaged in a sealed pouch | Same | | Manufacturing method | Injection molding and extrusion | Injection molding and extrusion | Same | | Sterilization | EO gas | EO gas | Same | | Shelf Life | Three years | One year | Substantial Equivalent | {6}------------------------------------------------ {7}------------------------------------------------ ## 8. Performance Test The bench testing was performed on Endoscopy Irrigation Tubing to support substantial equivalence such as verification tests on flow performances of proposed devices and predicate devices. The performance data demonstrated that the proposed device met established specifications. # 9. Sterilization The proposed device are sold in a sterile package. The proposed device have been sterilized in a validated EO sterilization cycle. The EO residual was measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014-07-15"Sterilization of Health Care products Ethylene Oxide - Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices [Including: Amendment 1 (2018)]", and ISO 10993-7 Second Edition 2008-10-15 "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]". # 10. Shelf Life The shelf-life of 3 years has been validated through accelerated aging testing according to ASTM F1980-21 and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 Second Edition 2019-02 and ISO 11607-2 Second Edition 2019-02 are also met. The test result can imply that the subject devices can provide and maintain a sterile barrier and its intended performance for at least the claimed shelf life. # 11. Biocompatibility The Biocompatibility testing was performed to show that all patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2018 and the FDA guidance: Use of International Standard ISO 10993-1 "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process". The cytotoxicity, sensitization and intracutaneous reactivity were performed to show that the proposed devices are biocompatible. # 12. Conclusions There are no significant differences between the proposed device and the predicate device, the proposed device doesn't raise any new issues of safety and effectiveness. From a clinical perspective and comparing design specifications, the proposed device Endoscopy Irrigation Tubing is substantially equivalent to GA Health Company Limited currently marketed AquaPulse® Irrigation Tubing (K202560).