Stone Extraction Baskets

K230598 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · LQR · Sep 12, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K230598
• Device Name: Stone Extraction Baskets
• Applicant: Jiangsu Vedkang Medical Science and Technology Co., Ltd.
• Product Code: LQR · Gastroenterology, Urology
• Decision Date: Sep 12, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Stone Extraction Baskets are sterile, single-use endoscopic accessories used for the removal of biliary stones and foreign bodies. The device consists of a guiding head (stainless steel/nitinol), a pulling wire (stainless steel), a PTFE outer tube, and a handle (ABS/stainless steel). It is inserted through the accessory channel of an endoscope (2.0mm or 2.8mm minimum diameter). The operator, typically a physician, uses the handle to advance the basket out of the outer tube to capture the stone or foreign body, then retracts the basket into the tube for removal. The device is used in a hospital setting. It is not compatible with mechanical lithotripters. By facilitating the retrieval of biliary obstructions, the device assists in clearing the biliary system, potentially relieving symptoms and complications associated with biliary stones.

Clinical Evidence

Bench testing only. Testing included endoscope insertion/removal durability, dimensional verification, tensile strength, operational performance (including flexibility), and stone/foreign body capture testing. Biocompatibility, sterilization, and shelf-life validation were also performed.

Technological Characteristics

Materials: stainless steel, nitinol, PTFE, ABS. Dimensions: Outer tube 1.8mm/2.3mm; working lengths 700mm-2300mm; open widths 10mm-40mm. Energy source: None (manual). Connectivity: None. Sterilization: Ethylene Oxide (EO). Operation: Manual mechanical actuation via handle to extend/retract basket.

Indications for Use

Indicated for endoscopic removal of stones in the biliary system and foreign bodies in patients requiring such procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• 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 (K171969)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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

| <b>Indications for Use (Describe)</b> |
|------------------------------------------------------------------------|
| Endoscopic removal of stones in the biliary system and foreign bodies. |

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone]-8147 Email: [e-mail]

- 3. 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: [phone] Email: [e-mail]

- 4. 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).

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.

- 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 Device<br>K171969 | Remark |
|---------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Common name | Stone Extraction Baskets | Dislodger, Stone, Biliary | / |
| Trade Name | VedBasket,<br>Stone Extraction Baskets | Web II Memory Extraction Basket<br>or Memory II Double Lumen<br>Extraction Basket, Memory 5 Fr.<br>Soft Wire Baskets or Memory<br>Helical Stone Extractor, Memory<br>Eight Wire Baskets or Memory<br>Hard Wire Baskets, Fusion Wire<br>Guided Extraction Basket, Non-<br>Lithotripsy Extraction Basket | / |
| Indication for Use | Endoscopic removal of stones in the<br>biliary system and foreign bodies. | Endoscopic removal of stones in the<br>biliary system and foreign bodies. | Same |
| Environment of<br>use | Hospital | Hospital | Same |
| Single Use | Single Use | Single Use | Same |
| Outer tube<br>diameter | 1.8mm,2.3mm | 5.5Fr (≈1.83mm)<br>7.0 Fr (~2.33mm) | Different |
| Minimum<br>Accessory<br>Channel | 2.0mm, 2.8mm | 2mm | Different |
| Open width | 10mm,15mm,20mm,25mm,30mm,3<br>5mm,40mm | 20mm, 30mm | Different |
| Handle type | Two handle type, Single handle type | Rotatable pin vise, two handle type. | Different |
| Sterilization<br>Method | 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.