The Stone Extraction Baskets is a sterile, single use device compatible with the accessory channel of endoscopes (Minimum Endoscope Channel Inner Diameter: 2mm and 2.8mm).

Diameters of Outer Tube of the device are 1.8mm and 2.3mm, working lengths are 700mm,200mm and 2300mm, and open widths are 10mm, 15mm, 20mm,35mm,40mm, and the devices have eight types of baskets and two kinds of handles (single hand type and two hands type).

It is comprised of guiding head (stainless steel/nitinol), pulling wire (stainless steel), outer tube(PTFE) and handle components (ABS, stainless steel and etc.). Basket is advanced out of and retracted into the polytetrafluoroethylene outer tube using the handle. The device is not compatible with any mechanical lithotripter.

AI/ML Overview

This document is a 510(k) summary for a medical device called "Stone Extraction Baskets." It details the device's characteristics and compares it to a predicate device to establish substantial equivalence for FDA clearance.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it lists the types of non-clinical bench tests performed and concludes that the device "meets the performance criteria required to fulfill the intended use of the device."

Test Category	Acceptance Criteria (Not explicitly stated as quantitative values)	Reported Device Performance (Implied as "passed")
Sterilization	Must ensure sterility (implied)	Meets performance criteria required for intended use (implied, as sterilization is a prerequisite for a sterile device)
Shelf Life	Must maintain integrity and functionality over its shelf life	Meets performance criteria required for intended use (implied)
Biocompatibility	Must be biocompatible with the human body (implied)	Meets performance criteria required for intended use (implied)
Endoscope insertion removal	Device must withstand repeated insertion/removal from endoscope	Passed durability test
Durability test
Dimension test	Dimensions must conform to specifications	Passed dimension test
Tensile strength test	Components must withstand specified tensile forces	Passed tensile strength test
Operational performance test	Device must function as intended (e.g., basket deployment)	Passed operational performance test (including flexibility)
(Flexibility Testing included)
Stone and Foreign Body Capture	Device must effectively capture stones and foreign bodies	Passed stone and foreign body capture test
Test

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on sample sizes used for the non-clinical bench tests. It only lists the types of tests performed. There is no information about data provenance (country of origin, retrospective/prospective) because this document describes a pre-market submission, not a clinical study involving patient data. The tests are bench tests performed on the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the provided document. The tests described are non-clinical bench tests and do not involve human expert interpretation of data or images to establish a "ground truth" in the same way a clinical diagnostic study would. The performance is assessed against engineering specifications and functional requirements.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving multiple expert readers to resolve discrepancies in diagnoses or assessments. The tests described here are physical and functional assessments of the device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on establishing substantial equivalence through bench testing, not on comparing human reader performance with and without AI assistance. This device is a manual tool (stone extraction basket), not an AI-powered diagnostic or assistive technology.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm or software. Its operation inherently involves a human operator (a clinician).

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology, outcomes data, or expert consensus is not directly applicable to the bench tests described. For these engineering and functional tests, the "ground truth" is typically defined by:

Engineering specifications: (e.g., dimensions, tensile strength).
Functional requirements: (e.g., successful capture of a simulated stone, ability to pass through an endoscope).
Regulatory standards: (e.g., biocompatibility testing according to ISO standards, sterility assurance level).

8. The Sample Size for the Training Set

There is no mention of a training set sample size because this device is not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is not an AI/ML algorithm requiring a training set with established ground truth.

Summary

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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.

September 12, 2023

Jiangsu Vedkang Medical Science and TechnologyCo., Ltd. Oian Wen, RA No.52, Guoxiang Road, Wujin Economic Development Zone Changzhou, Jiangsu 213149 China

Re: K230598

Trade/Device Name: Stone Extraction Baskets Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter And Accessories Regulatory Class: Class II Product Code: LQR Dated: August 14, 2023 Received: August 15, 2023

Dear Qian Wen:

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 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

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devices or postmarketing safety reporting (21 CFR 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 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.

Glenn B. Bell -S

Glenn B. Bell, PhD Division 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) K230598

Device Name Stone Extraction Baskets

Indications for Use (Describe)
Endoscopic removal of stones in the biliary system and foreign bodies.

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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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

Date of Preparation: 08/31/2023 1.
Sponsor Identification 2.

Jiangsu Vedkang Medical Science and Technology Co., Ltd.

No.52, Guoxiang Road, Wujin Economic Development Zone, Changzhou 213149, Jiangsu, P.R. China

Establishment Registration Number: 3013526170

Contact Person: Qian Wen Position: RA Tel: +86-519-69877791-8147 Email: info@vedkang.com

1. Designated Submission Correspondent
  Ms. Qian Wen (Primary Contact Person) Ms. Zhang Lin (Alternative Contact Person)

Jiangsu Vedkang Medical Science and Technology Co., Ltd.

No.52, Guoxiang Road, Wujin Economic Development Zone, Changzhou 213149, Jiangsu, P.R. China

Tel: +86-519-69877757 Email: info@vedkang.com

1. Device
  Trade Name: VedBasket, Stone Extraction Baskets Common Name: Stone Extraction Baskets

Regulatory Information Classification Name: Biliary Catheter and Accessories Classification: II; Product Code: LOR Regulation Number: 21 CFR 876.5010 Review Panel: Gastroenterology/Urology

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Indication for use:

Endoscopic removal of stones in the biliary system and foreign bodies.

Device Description

The Stone Extraction Baskets is a sterile, single use device compatible with the accessory channel of endoscopes (Minimum Endoscope Channel Inner Diameter: 2mm and 2.8mm).

న్. Predicate Device
510(k) Number: K171969

Trade Name: Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket

Common Name: Dislodger, Stone, Biliary

Performance Data and Non-Clinical Test Conclusion 6.
Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrate that the Stone Extraction Basket meets the performance criteria required to fulfill the intended use of the device. The following summarizes the non-clinical bench testing conducted:
Endoscope insertion removal durability test
A Dimension test
A Tensile strength test
Operational performance test (Flexibility Testing included)
Stone and Foreign Body Capture Test

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Substantially Equivalent (SE) Comparison 7.

Our proposed device Stone Extraction Basket is substantially equivalent to the predicate devices. The differences between the Stone Extraction Basket and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below:

ITEM	Proposed Device	Predicate DeviceK171969	Remark
Common name	Stone Extraction Baskets	Dislodger, Stone, Biliary	/
Trade Name	VedBasket,Stone Extraction Baskets	Web II Memory Extraction Basketor Memory II Double LumenExtraction Basket, Memory 5 Fr.Soft Wire Baskets or MemoryHelical Stone Extractor, MemoryEight Wire Baskets or MemoryHard Wire Baskets, Fusion WireGuided Extraction Basket, Non-Lithotripsy Extraction Basket	/
Indication for Use	Endoscopic removal of stones in thebiliary system and foreign bodies.	Endoscopic removal of stones in thebiliary system and foreign bodies.	Same
Environment ofuse	Hospital	Hospital	Same
Single Use	Single Use	Single Use	Same
Outer tubediameter	1.8mm,2.3mm	5.5Fr (≈1.83mm)7.0 Fr (~2.33mm)	Different
MinimumAccessoryChannel	2.0mm, 2.8mm	2mm	Different
Open width	10mm,15mm,20mm,25mm,30mm,35mm,40mm	20mm, 30mm	Different
Handle type	Two handle type, Single handle type	Rotatable pin vise, two handle type.	Different
SterilizationMethod	EO Sterilized	EO Sterilized	Same

Conclusion: The fundamental principle of operation for both the subject and predicate devices are the same. There are differences in the subject and predicate device technology - outer tube diameter, open widths, working lengths and handle types. These differences between the Stone Extraction Basket and the predicated utilizing performance testing and do not raise any questions regarding its safety and effectiveness.

8. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device, Stone Extraction Baskets, is determined to be Substantially Equivalent (SE) to the predicate device K171969.

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.