(155 days)
Not Found
No
The device description and performance studies focus on the physical components and functional performance of tubing and connectors for delivering fluids and gases during endoscopic procedures. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device specifically provides sterile water, CO2, and/or air to an endoscope to assist in gastrointestinal endoscopic procedures, rather than directly treating a condition or disease.
No
The device is described as tubes and connectors intended to supply sterile water, CO2, and/or air to an endoscope during gastrointestinal endoscopic procedures. Its function is to facilitate the procedure by providing necessary substances, not to diagnose a condition.
No
The device description clearly outlines physical components like tubes, connectors, and filters, and mentions sterilization and shelf life, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide sterile water and/ or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure." This is a functional purpose related to the operation of an endoscope during a medical procedure.
- Device Description: The description details tubing and connectors for delivering fluids and gases to an endoscope.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. IVDs are typically used to analyze blood, urine, tissue, or other bodily fluids.
- Performance Studies: The performance studies focus on functional aspects like flow rate, leakage, and compatibility, not on diagnostic accuracy or analytical performance related to biological samples.
The device is a medical device used during a medical procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Endoscopic Clean Connecting Tubes includes five subsets as below, they are intended to o provide sterile water and/or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healthcare professional only. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile.
Irrigation Tube
The Irrigation Tube (tube and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
Clean Cap
Clean cap is intended to be used with an air or CO2 source and / or pump along with a sterile water source to supply air or CO2 and sterile water to gastrointestinal endoscope during endoscopic procedures.
Clean Cap with CO2 Source Tube
Clean cap with CO2 source tube is intended to be used with CO2 source along with a sterile water source to supply CO2 and sterile water to gastrointestinal endoscope during endoscopic procedures.
Hybrid Irrigation Tubing
The Hybrid irrigation tubing (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 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump.
Hybrid Irrigation Tubing With CO2 source tube
The Hybrid Irrigation Tubing with CO2 Source Tube (tubing and accessories to accommodate various GI endoscopes, irrigation pumps and CO2 source) is intended to provide irrigation via sterile water when used in conjunction with an irrigation pump, and to supply CO2 along with sterile water during GI endoscopic procedures.
Endoscopic CO2 Source Tubing is intended to be used with a CO2 insufflator along with Clean Cap or Hybrid Irrigation Tubing to supply CO2 to a GI endoscope during GI endoscopic procedures.
Product codes
OCX, FCX
Device Description
The proposed device includes two (2) categories:
- Endoscopic Clean Connecting Tubes -
- -Endoscopic CO2 Source Tubing
The proposed device, Endoscopic Clean Connecting Tubes, is to connect an air/ CO2 source, a sterile water source (water bottle), and an endoscope to supply air/ CO2 and water during gastrointestinal endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile.
The Endoscopic Clean Connecting Tubes includes five (5) subsets:
- Irrigation Tube; ●
- Clean Cap ●
- Clean Cap with CO2 Source Tube ●
- Hybrid Irrigation Tubing ●
- Hybrid Irrigation Tubing With CO2 source tube ●
The Endoscopic CO2 Source Tubing is designed to be attached to the air/water bottle tubing and the outlet of the CO2 insufflator to provide irrigation and CO2 insufflation through the air/water channel to the distal end of endoscope. It is composed of one female luer connector, one male luer connector, one rigid tube and air/gas filter. The air/gas filter can filter particulates from the CO2 source and keeps fluid from flowing into the CO2 Source.
The Endoscopic Clean Connecting Tubes and CO2 Source Tubing are provided sterile. The both device is sterilized by EO and the shelf life is three (3) years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI (gastrointestinal)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional only. Hospital and/or clinics
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing
The non-clinical tests were conducted to verify that the proposed device met all design specifications as was substantial equivalence to the predicate device.
Biocompatibility testing
Biocompatibility of the Endoscope Valves System were evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface - Mucosal Membrane" with a contact duration of "Limited (
§ 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.
0
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October 7, 2022
Changzhou Endoclean Medical Device Co., Ltd. Wang Qi, QA Manager West Side of 4th Floor, Building E2, No.9 Changyang Road Changzhou. Jiangsu 213149 CHINA
Re: K221310
Trade/Device Name: Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCX, FCX Dated: September 1, 2022 Received: September 6, 2022
Dear Wang Qi:
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. You must comply with all the
1
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-regulatory-information/postmarketing-safetyreporting-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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,
for
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
2
Indications for Use
510(k) Number (if known) K221310
Device Name
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
Indications for Use (Describe)
The Endoscopic Clean Connecting Tubes includes five subsets as below, they are intended to o provide sterile water and/ or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healthcare professional only. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile.
Irrigation Tube
The Irrigation Tube (tube and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
Clean Cap
Clean cap is intended to be used with an air or CO2 source and / or pump along with a sterile water source to supply air or CO2 and sterile water to gastrointestinal endoscope during endoscopic procedures.
Clean Cap with CO2 Source Tube
Clean cap with CO2 source tube is intended to be used with CO2 source along with a sterile water source to supply CO2 and sterile water to gastrointestinal endoscope during endoscopic procedures.
Hybrid Irrigation Tubing
The Hybrid irrigation tubing (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 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump.
Hybrid Irrigation Tubing With CO2 source tube
The Hybrid Irrigation Tubing with CO2 Source Tube (tubing and accessories to accommodate various GI endoscopes, irrigation pumps and CO2 source) is intended to provide irrigation via sterile water when used in conjunction with an irrigation pump, and to supply CO2 along with sterile water during GI endoscopic procedures.
Endoscopic CO2 Source Tubing is intended to be used with a CO2 insufflator along with Clean Cap or Hybrid Irrigation Tubing to supply CO2 to a GI endoscope during GI endoscopic procedures.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) summary
l. Submitter
Changzhou Endoclean Medical Device Co., Ltd.
West Side of 4th Floor, Building E2, No.9 Changyang Road, West Taihu Science and Technology Industrial Park, Wujin District, 213149 Changzhou City, Jiangsu Province, China
Establishment Registration Number: 3021349683
Contact person: Ms Wang Qi
Position: QA Manager Tel.: +86-0519-68213060 E-mail: lena@endocleanmedical.com
Preparation date: Sep 21, 2022
II. Proposed Device
| Device Trade Name: | Endoscopic Clean Connecting Tubes
Endoscopic CO2 Source Tubing |
|-------------------------|---------------------------------------------------------------------------------------------|
| Common name: | Endoscopic irrigation/suction system
Insufflator, automatic carbon-dioxide for endoscope |
| Regulation Number: | 21 CFR 876.1500 |
| Regulatory Class: | Class II |
| Product code: | OCX |
| Subsequent Product Code | FCX |
| Review Panel: | Gastroenterology/Urology |
The Gastroenterology/Urology devices panel has classified Endoscopic Irrigation/Suction System as Class II under 21 CFR §876.1500. OCX is the product code that has been assigned for Endoscopic Clean Connecting Tubes. FCX is the product code that has been assigned for Endoscopic CO2 Source Tubing.
III. Predicate Devices
510(k) Number: K203350
5
| Trade name: | Endoscopic tubing kit |
|---|---|
| Property Name: | ENDOtube |
| Classification: | Class II |
| Product Code: | OCX |
| Manufacturer | NISSHA MEDICAL TECHNOLOGIES SAS |
IV. Device description
The proposed device includes two (2) categories:
- Endoscopic Clean Connecting Tubes -
- -Endoscopic CO2 Source Tubing
The proposed device, Endoscopic Clean Connecting Tubes, is to connect an air/ CO2 source, a sterile water source (water bottle), and an endoscope to supply air/ CO2 and water during gastrointestinal endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile.
The Endoscopic Clean Connecting Tubes includes five (5) subsets:
- Irrigation Tube; ●
- Clean Cap ●
- Clean Cap with CO2 Source Tube ●
- Hybrid Irrigation Tubing ●
- Hybrid Irrigation Tubing With CO2 source tube ●
The Endoscopic CO2 Source Tubing is designed to be attached to the air/water bottle tubing and the outlet of the CO2 insufflator to provide irrigation and CO2 insufflation through the air/water channel to the distal end of endoscope. It is composed of one female luer connector, one male luer connector, one rigid tube and air/gas filter. The air/gas filter can filter particulates from the CO2 source and keeps fluid from flowing into the CO2 Source.
The Endoscopic Clean Connecting Tubes and CO2 Source Tubing are provided sterile. The both device is sterilized by EO and the shelf life is three (3) years.
V. Indication for use
The Endoscopic Clean Connecting Tubes includes five subsets as below, they are intended to o provide sterile water and/or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by
6
healthcare professional only. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile.
Irrigation Tube
The Irrigation Tube (tube and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
Clean Cap
Clean cap is intended to be used with an air or CO2 source and / or pump along with a sterile water source to supply air or CO2 and sterile water to gastrointestinal endoscope during endoscopic procedures.
Clean Cap with CO2 Source Tube
Clean cap with CO2 source tube is intended to be used with CO2 source along with a sterile water source to supply CO2 and sterile water to gastrointestinal endoscope during endoscopic procedures.
Hybrid Irrigation Tubing
The Hybrid irrigation tubing (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 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump.
Hybrid Irrigation Tubing With CO2 source tube
The Hybrid Irrigation Tubing with CO2 Source Tube (tubing and accessories to accommodate various GI endoscopes, irrigation pumps and CO2 source) is intended to provide irrigation via sterile water when used in conjunction with an irrigation pump, and to supply CO2 along with sterile water during GI endoscopic procedures.
Endoscopic CO2 Source Tubing is intended to be used with a CO2 insufflator along with Clean Cap or Hybrid Irrigation Tubing to supply CO2 to a GI endoscope during GI endoscopic procedures.
VI. Comparison of technological characteristics with the predicate devices
Table 1 summaries the proposed device technological characteristics with compared to the predicate device from ENDOtube under K203350.
3
7
| Item | Proposed device | Predicate device
(K203350) | Discussion |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Endoscopic Clean
Connecting Tubes
Endoscopic CO2
Source Tubing | ENDOtube | same |
| Product Code | OCX, FCX | OCX | same |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | same |
| Class | Class II | Class II | same |
| Indications* | The Endoscopic Clean Connecting Tubes are intended to o provide sterile water and/or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healthcare professional only. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile. The Endoscopic CO2 Source Tubing is intended to be used with a carbon dioxide (CO2) source with the purpose of supplying CO2 to the endoscope during endoscopic procedures. This device is intended to be used for not more | The ENDOtube devices are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healthcare professional only. In procedure room, all ENDOtube devices are 24 hours use disposable products except the one-way valves which are single use products and the insufflation connectors which are multiple patient use. | similar |
| Environment
of use | Hospital and/or clinics | Hospital and/or clinics | same |
| Materials | PC,
PVC,
POM,
SUS303, TPE,
NBR,
Silicone, PE | PVC, Silicone, SAN/ABS,
TPU | similar¹ |
| Duration of
Use | Less than 24 hours | Less than 24 hours | same |
| Endoscope
column
compatibility | Olympus Endoscopes
140/160/180/190/240/260
/290;
PENTAX 90 series
endoscopes;
FUJIFILM 500/600/700
endoscopes; | OLYMPUS® GI
endoscopes 140, 160, 180
and 190;
PENTAX® GI
endoscopes;
FUJIFILM® GI 500/600
series and 700 series
endoscopes | similar² |
| Irrigation
peristatic
pump
compatibility | Olympus AFU-100,
Olympus OFP,
Olympus OFP-2
Medivators EGP-100,
ERBE EIP2 or
Endotechnik Irrigation
Units | OLYMPUS®,
Erbe®,
EMED® | |
| Sterile water
bottle
compatibility | B.Braun,
Fresenius,
Asia-Pacific Baxter | Not provided in 510(k)
Summary | |
| Sterilization | EO | EO | same |
| Shelf life | 3 years | 2 years | similar³ |
| Biocompatibilit
y | Confirm to the
requirements of ISO
10993 series standards | Confirm to the
requirements of ISO 10993
series standards | same |
Table 1 Technological Characteristics Comparison
24-hour multi-patient use device.
8
1 The difference in the materials does not raise additional questions for safety and effectiveness of the device. The biocompatibility evaluation test of the subject devices have been performed on the final finished device which includes all construction materials. The test results show pass the requirements.
2 The compatibility testing was conducted to support that proposed device can able to compatible with claimed various endoscopes, irrigation pumps and sterile water bottle.
9
3 The shelf life of the proposed device is 3 years, which is longer than the predicated device. The determined based on accelerated aging study. The result of demonstrated that the packaging was able to maintains sterility of the sterilized finished device during its shelf life of 3 years.
VII. Non-Clinical Testing
The non-clinical tests were conducted to verify that the proposed device met all design specifications as was substantial equivalence to the predicate device.
Biocompatibility testing
Biocompatibility of the Endoscope Valves System were evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface - Mucosal Membrane" with a contact duration of "Limited (