Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)

• K Number: K232752
• Device Name: Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
• Manufacturer: Jiangsu Vedkang Medical Science and Technology Co., Ltd.
• Date Cleared: 2024-02-26 ( 171 days)
• Product Code: GCA
• Regulation Number: 876.5010
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: K091495 , K210660

Intended Use

The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.

Device Description

Stone Extraction Balloon is composed of balloon, radiopaque marker, catheter, handle, standard connector, two-way valve, support wire and inflators. Stone Extraction Balloon is operated by the inflation and deflation of balloon, as well as liquid is injection port to assist in imaging or flushing, and complete the removal of biliary calculus the endoscopic channel. The Stone Extraction Balloon is classified to different specifications according to the diameter of balloon and the liquid outlet. There are a total of 12 models, the largest balloon diameter is 20mm, the smallest balloon diameter is only 8.5mm, the operator can choose according to different clinical needs. EO sterilization and use for single use only.

AI/ML Overview

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device meets the criteria. The provided document is a 510(k) summary for a medical device (Stone Extraction Balloon) and does not contain any information about acceptance criteria or a study that uses AI or involves human readers.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It clearly states:

• "No clinical study is included in this submission." on page 6.
• The performance data section lists various non-clinical bench tests (e.g., stone capture, tensile strength, dimension test, Luer connector test, X-ray development test, rated burst pressure test, flowrate test) and concludes that the device meets "performance criteria required to fulfill the intended use" and "design specification". However, it does not specify the quantitative acceptance criteria for these tests or provide details of a study with human readers or AI.

Therefore, I cannot extract the requested information from the provided text.

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.