Clean Connecting Tube

K220785 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · OCX · Sep 27, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K220785
• Device Name: Clean Connecting Tube
• Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
• Product Code: OCX · Gastroenterology, Urology
• Decision Date: Sep 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Clean Connecting Tube (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air(via an air pump) or CO2(Via a CO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction pump or electrosurgical unit.

Device Story

Clean Connecting Tube is a disposable tubing set for GI endoscopic procedures; connects sterile water bottles and air/CO2 pumps to endoscope auxiliary water channels or biopsy irrigation accessories. Device facilitates irrigation and gas insufflation during procedures. Designed for 24-hour multi-patient use (up to 15 patients/15 hours max); check valve requires replacement after every patient. Used in clinical settings by medical staff. Benefits include reduced infection risk compared to manual cleaning/sterilization of reusable components.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing, including appearance and physical property verification, and compliance with ISO 10993 (biocompatibility) and ISO 11135 (EO sterilization) standards.

Technological Characteristics

Disposable tubing set; EO sterilized (SAL 10^-6); biocompatible per ISO 10993-1. Connects to external irrigation/CO2 pumps and sterile water sources. No electronic components or software; purely mechanical fluid/gas delivery system.

Indications for Use

Indicated for male and female patients, pediatric to adult, undergoing GI endoscopic procedures requiring irrigation with sterile water and air/CO2 supply via irrigation pump or electrosurgical unit.

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

• Universal Irrigation Solution HybirdTM (K102855)

Submission Summary (Full Text)

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September 27, 2022

Yangzhou Fartley Medical Instrument Technology Co., Ltd. % Ethan Liu RA Specialist Shanghai Thinkwell Consulting Co., Ltd Room 211/6F, Xinling Road, Minhang District Shanghai, Shanghai 201100 China

Re: K220785

> Trade/Device Name: Clean Connecting Tube Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCX Dated: August 23, 2022 Received: August 24, 2022

Dear Ethan Liu:

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 (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 located 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.

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K220785

Device Name Clean Connecting Tube

#### Indications for Use (Describe)

The Clean Connecting Tube (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air(via an air pump) or CO2(Via a CO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction pump or electrosurgical unit.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|-----------------------------------------|
| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 20px;">☑</span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 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: | Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
|---------------|------------------------------------------------------------------------------------------|
| | Address:Beizhou Road, Lidian Town, Guangling District,<br>Yangzhou 225106 Jiangsu, China |
| | |
| Contact | Ethan Liu |
| Person: | RA Specialist |
| | Shanghai Thinkwell Consulting Co., Ltd |
| | Address: Room 211/6F, Xinling Road, Minhang Districtt, |
| | Shanghai, China. |
| | Phone: [phone] |
| | Email: [e-mail] |
| Date | August 22, 2022 |
| Prepared: | August 22, 2022 |

#### 5.2 Device

| Device Name: | Clean Connecting Tube |
|----------------------|--------------------------------------|
| Classification Name: | Endoscopic Irrigation/Suction System |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Product Code: | OCX |

#### 5.3 Predicate Device

| Device Name: | Universal Irrigation Solution HybirdTM |
|----------------------|----------------------------------------|
| | K102855 |
| Manufacturer: | BYRNE MEDICAL, INC. |
| Classification Name: | Endoscopic Irrigation/Suction System |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Product Code: | OCX |

# 5.4 Device Description

The Clean Connecting Tube is intended for 24 hour multiple-patient use and then discarded. The Clean Connecting Tube design minimizes infection control risks that are associated with manual cleaning and sterilization.The maximum number of patient

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is up to 15 in 24 hours , and maximum duration of us shall not exceed 15h. The check valve attached to the irrigation tubing shall be replaced after every patient use.

The Clean Connecting Tube is manufactured for use in conjunction with sterile water bottle, and together with irrigation pump. The Clean Connecting Tube 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 pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.

### 5.5 Indication for Use:

The Clean Connecting Tube (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air(via an air pump) or CO2(Via a CO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.

### 5.6 Comparison of Technological Characteristics

The Clean Connecting Tube has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device BYRNE MEDICAL, INC's Universal Irrigation Solution Hybird™, K102855. The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.

| Item | Clean Connecting<br>Tube(Proposed Device) | Universal Irrigation<br>Solution Hybird™,<br>K102855 | Discussion |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Indication for Use | The Clean Connecting<br>Tube (tubing and<br>accessories to<br>accommodate various<br>GI endoscopes and<br>irrigation pumps) is<br>intended to provide<br>irrigation via sterile<br>water and to supply<br>air(via an air pump) or<br>CO2(Via a CO2 pump)<br>along with sterile water<br>during GI endoscopic<br>procedures when used<br>in conjunction with an<br>irrigation pump or<br>electrosurgical unit. | The Universal<br>Irrigation<br>Solution<br>Hybrid™ (tubing and<br>accessories to<br>accommodate various<br>GI endoscopes and<br>irrigation pumps) is<br>intended to provide<br>irrigation via sterile<br>water and to supply<br>air(via an air pump) or<br>CO2(Via a CO2 pump)<br>along with sterile<br>water during GI<br>endoscopic procedures<br>when used in<br>conjunction with an | Substantiall<br>y<br>equivalent |

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Image /page/5/Picture/1 description: The image shows the brand logo for "ARTLEY UNIQUE ENDOSCOPY". The logo is in blue, with the word "ARTLEY" in a stylized font. Below the brand name is the phrase "UNIQUE ENDOSCOPY", with the word "UNIQUE" stacked on top of the word "ENDOSCOPY". There is a yellow line that extends from the top right of the "Y" in "ARTLEY".

| K220/85 | |
|---------|--------|
| Page | 3 of 3 |

| Item | Clean Connecting<br>Tube(Proposed Device) | Universal Irrigation<br>Solution Hybird™,<br>K102855<br>irrigation pump or<br>Cautery unit. | Discussion |
|------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------|------------|
| Product Code | OCX | OCX | Same |
| Classification | 2 | 2 | Same |
| Regulation Number | 876.1500 | 876.1500 | Same |
| Single Use | Yes(24 hr.) | Yes(24 hr.) | Same |
| Patient Population | Male/Female, Pediatric<br>to Adult | Male/Female, Pediatric<br>to Adult | Same |
| Reusable or Disposable | Disposable | Disposable | Same |
| SAL | 10-6 | 10-6 | Same |
| Biocompatibility | Comply with ISO<br>10993-1 | Comply with ISO<br>10993-1 | Same |
| Sterilization Method | EO Sterilization | EO Sterilization | Same |

#### 5.7 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 Clean Connecting Tube: Appearance, Physical properties. The results of all testing were passing.

#### 5.8 Clinical Test Data

No Clinical Study is included in this submission.

#### 5.9 Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Yangzhou Fartley Medical Instrument Technology Co., Ltd. has demonstrated that proposed device Clean Connecting Tube is substantially equivalent to BYRNE MEDICAL, INC's currently marketed Universal Irrigation Solution HybirdTM, K102855.