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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Endoscopy Irrigation Tubing" device. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance criteria through a rigorous clinical trial or AI model validation.

Therefore, many of the requested sections related to AI model validation, ground truth establishment, expert consensus, MRMC studies, and effect sizes cannot be directly extracted from this document, as the device is not an AI/ML-driven diagnostic tool. The document describes a medical device (tubing) and its physical and chemical properties and basic performance.

However, I can extract information related to the acceptance criteria and the type of study done to prove the device meets these criteria as described for this specific type of medical device submission.

Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not applicable due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (Endoscopy Irrigation Tubing), the "acceptance criteria" are related to its physical and functional equivalence to the predicate device and its compliance with relevant standards. The "performance" is demonstrated through bench testing and compliance with various material and sterilization standards.

Acceptance Criteria (Related to Substantial Equivalence and Safety/Performance)	Reported Device Performance (as per submission)
Functional/Technical Equivalence
Product Code: OCX	Same as predicate device (OCX)
Regulation No.: 876.1500	Same as predicate device (876.1500)
Regulatory Classification: Class II	Same as predicate device (Class II)
Regulation Description: Endoscope and accessories	Same as predicate device
Indications for Use (24-hour use, irrigation via sterile water bottle, GI endo procedures, with irrigation pump)	Same as predicate device.
Compatibility with GI endoscopes and irrigation pumps	Model A: ENDOGATOR™ EGP-100 Irrigation Pump, OLYMPUS® OFP Pump, OLYMPUS® AFU-100 Pump and ERBE EIP2® Pump. Model B: Olympus® OFP, OFP-2, OFP-3 and OPF-3 Plus Irrigation Pump. (Note: Predicate lists Olympus® OFP, Endo Status™ EGA-500 and Endogator® EGP-100. Manufacturer states "Substantial Equivalent" for compatibility.)
Single Use, Disposable (24-hour use)	Same as predicate device (24-hour use then discard).
Backflow Prevention Design	Diaphragm in the connector allowing one-way pressurized water flow. Similar to predicate.
Supplied Sterile	Yes, individually packed in sealed package.
Packaging	Irrigation tubing packaged in a sealed pouch.
Manufacturing Method: Injection molding and Extrusion	Same as predicate.
Biocompatibility/Material Safety
Materials: Polycarbonate (PC), Polyvinyl Chloride (PVC), Polypropylene (PP), Polytetrafluoroethylene(PTFE), Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS), Silicone, Polyformaldehyde Resin(POM)	Wider range than predicate (Polycarbonate and Polyvinyl Chloride). Biocompatibility tests conducted and all passed with acceptable results per ISO 10993-1:2018. Cytotoxicity, sensitization and intracutaneous reactivity tests performed.
Sterilization & Shelf-Life
Sterilization Method: EO gas	Validated EO sterilization cycle per ISO 11135 and ISO 10993-7 (EO residual).
Shelf Life: Minimum 1 year (predicate)	Claimed 3 years. Validated through accelerated aging testing (ASTM F1980-21) and packaging requirements met (ISO 11607-1, ISO 11607-2).
Performance (Functional)
Flow Performance	Bench testing performed on Endoscopy Irrigation Tubing to support substantial equivalence. Performance data demonstrated the proposed device met established specifications (details of specific flow rates/pressures not provided in this summary but implied as equivalent or meeting internal specs).

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified in the provided text. The "Performance Test" states "bench testing was performed" but does not give sample sizes for devices tested.
Data Provenance: The tests are analytical bench tests, not clinical data from patients. The manufacturer is Zhejiang Chuangxiang Medical Technology Co., LTD., located in Hangzhou, Zhejiang Province, P.R. China. The data would originate from their internal testing or contracted labs. It is not retrospective or prospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a medical device (tubing), not a diagnostic or AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device's performance is established by compliance with engineering standards, material properties, and functional specifications defined by recognized standards (e.g., ISO, ASTM) and internal quality control.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. This is a medical device, not an AI/ML algorithm or clinical study requiring adjudication of interpretations. The "test set" involves laboratory measurements and comparisons to predicate device specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This device is a passive medical tube. There is no AI component, and no human reader interpretation is involved or enhanced.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Engineering Specifications and Standard Compliance: The "ground truth" for this device's acceptance is based on meeting pre-defined physical, chemical, and functional specifications derived from engineering standards (e.g., flow rate requirements, material biocompatibility limits, sterilization efficacy) and demonstrating substantial equivalence to a legally marketed predicate device. This is primarily a bench testing and material characterization ground truth.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

Summary

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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"

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(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).

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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

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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)	☒
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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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

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6. Indications for use

7. Comparison of Technological Characteristics:

Item	Proposed device	Predicate device	Comparison toPredicate Devices
Device name	Endoscopy Irrigation Tubing	AquaPulse® Irrigation Tubing	/
Product code	OCX	OCX	Same
RegulationNo.	876.1500	876.1500	Same
RegulatoryClassification	II	II	Same
RegulationDescription	Endoscope and accessories	Endoscope and accessories	Same
Indications forUse	The 24 hour use EndoscopyIrrigation Tubing(tubing andaccessories to accommodatevarious GI endoscopes andirrigation pumps) is intended toprovide irrigation via a sterilewater bottle duringgastrointestinal endoscopicprocedures when used inconjunction with an irrigationpump.	The 24 hour use AquaPulse®Irrigation Tubing (tubing andaccessories to accommodatevarious GI endoscopes andirrigation pumps) is intended toprovide irrigation via a sterilewater bottle duringgastrointestinal endoscopicprocedures when used inconjunction with an irrigationpump.	Same
Compatibility	Model A is suitable forENDOGATOR™ EGP-100Irrigation Pump, OLYMPUS®OFP Pump, OLYMPUS® AFU-100Pump and ERBE EIP2® PumpModel B is suitable forOlympus® OFP, OFP-2, OFP-3and OPF-3 Plus Irrigation Pump	Olympus® OFP, Endo Status™EGA-500 and Endogator® EGP-100 Irrigation Pump	SubstantialEquivalent
Materials	Polycarbonate (PC),PolyvinylChloride (PVC), Polypropylene (PP),Polytetrafluoroethylene(PTFE),Methyl Methacrylate AcrylonitrileButadiene Styrene (MABS) andSilicone,Polyformaldehyde Resin(POM)	Polycarbonate and PolyvinylChloride	Similar, we haveconducted thebiocompatibility testand all tests havepassed withacceptable results.
Environmentof Use	Hospital and or clinics	Hospital and or clinics	Same
Single Use,Disposable	24-hour use then discard	24-hour use then discard	Same
BackflowPreventionDesign	Diaphragm in the connectorallow pressurized water passingthrough in one-way but not theother way	Diaphragm in the connectorallow pressurized water passingthrough in one-way but not theother way	SubstantialEquivalent
SuppliedSterile	Yes	Yes	Same
Packaging	Irrigation tubing is packaged in asealed pouch	Irrigation tubing is packaged in asealed pouch	Same
Manufacturingmethod	Injection molding and extrusion	Injection molding and extrusion	Same
Sterilization	EO gas	EO gas	Same
Shelf Life	Three years	One year	SubstantialEquivalent

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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).

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.