(245 days)
Not Found
No
The document describes a simple irrigation tubing system and does not mention any AI or ML components or functionalities.
No.
The device components are used to irrigate the gastrointestinal tract during an endoscopic procedure, which is a supportive function rather than a direct therapeutic action.
No
The device is an irrigation tubing used to provide sterile water during gastrointestinal endoscopic procedures. It does not perform any diagnostic function such as detecting, diagnosing, or identifying disease states.
No
The device description clearly indicates it is a physical tubing product intended for use with an irrigation pump and sterile water bottle, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Endoscopy Irrigation Tubing is a device used during a medical procedure (endoscopy) to deliver sterile water for irrigation. It is a tool used to facilitate the procedure itself, not to analyze a sample from the body to provide diagnostic information.
- Intended Use: The intended use clearly states it's for "providing irrigation via a sterile water bottle during gastrointestinal endoscopic procedures." This is a procedural function, not a diagnostic one.
The device is a medical device, but it falls under the category of devices used for surgical or procedural support, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
OCX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 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"
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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)
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
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.
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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 |
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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).