(109 days)
The Air/Water Bottle Tubing 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.
The 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 than 24 hours. It is a 24-hour multi-patient use device.
The proposed device includes two (2) categories:
- Air/Water Bottle Tubing
- CO2 Source Tubing
The Air/Water Bottle Tubing and CO2 Source Tubing are intended for 24-hour multi-patient use. Air/water bottle tubing is supplied in sterile and CO₂ Source Tubing is supplied in non-sterile.
6.1 The Air/Water Bottle Tubing
The Air/Water Bottle Tubing is manufactured for use in conjunction with a sterile water bottle, and together with OLYMPUS®140/240, 160/260, 180/280, 190/290 series endoscopes. The Air/Water Bottle Tubing is individually packed in sealed package, sold as a sterile device. The Air/Water Bottle Tubing is designed to be attached to the air/water port of the endoscopes to provide irrigation through the air/water channel to the distal end of endoscope.
There are two types of the device Air/Water Bottle Tubing provided by the manufacturer, such as type A and type B. Type B has an additional air extended tubing but type A does not. The clinician selects the appropriate model according to the actual clinical needs.
6.2 The CO2 Source Tubing
The CO2 Source Tubing is manufactured for use in conjunction with air/water bottle tubing and CO2 insufflator. The CO2 Source tubing is individually packed in a sealed package, and sold as a non-sterile device. The 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.
The provided FDA 510(k) summary (K231471) describes the Chuangxiang Medical Technology Co., LTD.'s Air/Water Bottle Tubing and CO2 Source Tubing. This submission focuses on non-clinical performance data to demonstrate substantial equivalence to predicate devices, rather than a clinical study involving human subjects or complex AI algorithms. Therefore, many of the requested categories related to clinical studies, AI performance metrics, and expert adjudication are not applicable to this document.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document details various performance tests conducted on the devices. It claims these tests successfully demonstrated essential performance and substantial equivalence to predicate devices, implying that the devices met pre-defined acceptance criteria for these tests. However, the specific quantitative acceptance criteria or detailed numerical results for each test are not provided in this summary. Instead, the summary states that the testing "successfully demonstrated essential performance" and that the manufacturer "believes that no significant differences exist."
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Air/Water Bottle Tubing | |
| Assembling Integrity | Successfully demonstrated essential performance |
| Two-Way Valve Integrity | Successfully demonstrated essential performance |
| Air Flow Test | Successfully demonstrated essential performance |
| Water Flow Test | Successfully demonstrated essential performance |
| Air Leak Test | Successfully demonstrated essential performance |
| Flow Clamp Test | Successfully demonstrated essential performance |
| Water Backflow Test | Successfully demonstrated essential performance |
| 24-Hour Use Test | Successfully demonstrated essential performance |
| Endoscope Compatibility | Successfully demonstrated essential performance |
| Compatibility With Bottle | Successfully demonstrated essential performance |
| CO2 Source Tubing | |
| Assembling Integrity | Successfully demonstrated essential performance |
| CO2 Delivery Test | Successfully demonstrated essential performance |
| Water Delivery Test | Successfully demonstrated essential performance |
| Air Leak Test | Successfully demonstrated essential performance |
| Compatibility With Air/Water Bottle Tubing | Successfully demonstrated essential performance |
| Sterilization | EO sterilization cycle achieved SAL of 10^-6; EO residuals below ISO 10993-7:2008 limits. |
| Shelf Life | Three (3) years shelf life validated per ASTM F1980-21 and ISO 11607-1/2:2019 standards; essential performance achieved before and after. |
| Biocompatibility | All patient contacting materials meet ISO 10993-1:2009 and FDA guidance, including Acute Systemic Toxicity, In Vitro Cytotoxicity, Skin Sensitization, and Intracutaneous Reactivity. Devices classified as surface device with mucosal membrane contact for limited duration. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document states that performance tests were performed on "samples from initial lots." However, the specific sample size for each test or for the overall test set is not quantified.
The data provenance is retrospective, as the testing was conducted by the manufacturer (Zhejiang Chuangxiang Medical Technology Co., LTD. in China) on their newly manufactured devices to support the 510(k) submission. The country of origin of the data is China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable. This submission relies on non-clinical, bench testing, not expert interpretation of medical images or patient data to establish ground truth. The "ground truth" for these tests would be the measurement against established engineering or performance specifications.
4. Adjudication Method for the Test Set
Not Applicable. As this is non-clinical bench testing, there is no need for expert adjudication of results in the way it would be applied to a clinical study involving human interpretation. The results are based on objective measurements and predefined performance parameters.
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 submission is for medical device accessories (tubing) and does not involve an AI algorithm or human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This submission does not involve an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on engineering specifications, industry standards (e.g., ISO, ASTM), and predefined performance parameters for air/water flow, leak integrity, compatibility, sterilization, shelf life, and biocompatibility.
8. The Sample Size for the Training Set
Not Applicable. There is no AI algorithm involved, so no "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. There is no AI algorithm involved, so no need to establish ground truth for a training set.
§ 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.