(193 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The device is used for the endoscopic removal of stones in the biliary system and foreign bodies, which is a therapeutic intervention.
No
The device description indicates its purpose is for "Endoscopic removal of stones in the biliary system and foreign bodies," which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components such as guiding head, pulling wire, outer tube, handle components, and a basket, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device is used for the "Endoscopic removal of stones in the biliary system and foreign bodies." This is a surgical or interventional procedure performed inside the body (in vivo) to remove physical objects.
- No Specimen Analysis: The device description does not mention any analysis of biological specimens. Its purpose is mechanical removal, not diagnostic testing of samples.
Therefore, based on the intended use and device description, this Stone Extraction Basket is a surgical or interventional device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Endoscopic removal of stones in the biliary system and foreign bodies.
Product codes
LQR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
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)
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
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
§ 876.5010 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.
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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
1
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
2
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
-
- Designated Submission Correspondent
Ms. Qian Wen (Primary Contact Person) Ms. Zhang Lin (Alternative Contact Person)
- Designated Submission Correspondent
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
-
- Device
Trade Name: VedBasket, Stone Extraction Baskets Common Name: Stone Extraction Baskets
- Device
Regulatory Information Classification Name: Biliary Catheter and Accessories Classification: II; Product Code: LOR Regulation Number: 21 CFR 876.5010 Review Panel: Gastroenterology/Urology
4
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
5
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
K171969 | Remark |
|---------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Common name | Stone Extraction Baskets | Dislodger, Stone, Biliary | / |
| Trade Name | VedBasket,
Stone Extraction Baskets | 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 | / |
| Indication for Use | Endoscopic removal of stones in the
biliary system and foreign bodies. | Endoscopic removal of stones in the
biliary system and foreign bodies. | Same |
| Environment of
use | Hospital | Hospital | Same |
| Single Use | Single Use | Single Use | Same |
| Outer tube
diameter | 1.8mm,2.3mm | 5.5Fr (≈1.83mm)
7.0 Fr (~2.33mm) | Different |
| Minimum
Accessory
Channel | 2.0mm, 2.8mm | 2mm | Different |
| Open width | 10mm,15mm,20mm,25mm,30mm,3
5mm,40mm | 20mm, 30mm | Different |
| Handle type | Two handle type, Single handle type | Rotatable pin vise, two handle type. | Different |
| Sterilization
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.