(194 days)
Not Found
No
The document describes a simple tubing and accessory system for irrigation during GI endoscopic procedures and makes no mention of AI or ML.
No
The device is an accessory that provides irrigation and air/CO2 during GI endoscopic procedures. It does not exert any direct therapeutic effect on the patient.
No
The device is described as providing irrigation and air/CO2 during GI endoscopic procedures. Its purpose is to facilitate the procedure itself, not to diagnose a condition.
No
The device description clearly describes physical components (tubing, accessories, check valve) and their intended use in conjunction with hardware (GI endoscopes, irrigation pumps, air/CO2 pumps, sterile water bottle). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to provide irrigation and supply air/CO2 during GI endoscopic procedures. This is a therapeutic or procedural support function, not a diagnostic one.
- Device Description: The description focuses on the physical components and how they facilitate irrigation and air/CO2 delivery during the procedure. It does not mention any analysis of biological samples or diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on facilitating the endoscopic procedure itself.
N/A
Intended Use / Indications 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 pump or electrosurgical unit.
Product codes
OCX
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI
Indicated Patient Age Range
Pediatric to Adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following bench tests were performed on Clean Connecting Tube: Appearance, Physical properties. The results of all testing were passing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| 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)
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3
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, | |
| 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: 0086-15216699240 | |
| Email: xtdeepwater@126.com | |
| 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
4
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
Tube(Proposed Device) | Universal Irrigation
Solution Hybird™,
K102855 | Discussion |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| 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. | The Universal
Irrigation
Solution
Hybrid™ (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 | Substantiall
y
equivalent |
5
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
Tube(Proposed Device) | Universal Irrigation
Solution Hybird™,
K102855
irrigation pump or
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
to Adult | Male/Female, Pediatric
to Adult | Same |
| Reusable or Disposable | Disposable | Disposable | Same |
| SAL | 10-6 | 10-6 | Same |
| Biocompatibility | Comply with ISO
10993-1 | Comply with ISO
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.