(171 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing.
Yes
The device is intended for the endoscopic removal of biliary stones, which directly treats a medical condition.
No
The device is intended for the endoscopic removal of biliary stones, which is a therapeutic intervention, not a diagnostic one. It functions by extracting already identified stones, rather than by identifying or characterizing their presence.
No
The device description clearly lists multiple physical components (balloon, catheter, handle, etc.) and describes physical operations (inflation/deflation, liquid injection) and performance testing related to physical properties (tensile strength, flexibility, burst pressure). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for endoscopic removal of biliary stones." This is a therapeutic procedure performed in vivo (within the body) to remove physical objects.
- Device Description: The description details a physical device (balloon, catheter, handle, etc.) designed for mechanical manipulation within the biliary tract.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample in vitro (outside the body), or provide information about a patient's health status based on the analysis of biological specimens.
- Anatomical Site: The device is used within the biliary system, which is an internal anatomical site. IVDs typically involve the analysis of samples taken from the body.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
GCA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary stones (bile duct)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device must be used by trained doctors or technicians.
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 Size, Appearance, Maneuverability, Strength, Airtightnes, Ruhr cone, Sterility and EO Residual amount. Non-clinical bench testing demonstrate that the Stone Extraction Balloon meets the performance criteria required to fulfill the intended use of the device. The following summarizes the Non-clinical bench testing conducted:
- Stone capture testing A
- A Tensile strength test
-
Operational performance test
- A Dimension Test
-
Luer Connector Test
-
Flexibility testing
-
X-Ray Development test
-
Rated Burst Pressure test
-
Flowrate test
The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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February 26, 2024
Jiangsu Vedkang Medical Science and Technology Co., Ltd. Zheng Xinxing RA No.52, Guoxiang Road, Wujin Economic Development Zone Changzhou, Jiangsu 213149 China
Re: K232752
Trade/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) Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter And Accessories Regulatory Class: Class II Product Code: GCA Dated: August 30, 2023 Received: September 8, 2023
Dear Zheng Xinxing:
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 (the 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 available 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
For comprehensive regulatory information about medical devices and radiation-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,
Anthony Lee -S
Anthony C. Lee, Ph.D. Assistant 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
3
Indications for Use
Submission Number (if known)
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-G,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
Indications for Use (Describe)
The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
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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4
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K232752
- Date of Preparation: 08/30/2023 1.
-
- Sponsor Identification
Jiangsu Vedkang Medical Science and Technology Co., Ltd. No.52, Guoxiang Road, Wujin Economic Development Zone, Changzhou, Jiangsu 213149 China
Establishment Registration Number: 3013526170
Contact Person: Zheng Xinxing Position: RA Tel: +86-519-69877791-8147 Email: zhengxinxing@yedkang.com
Ms. Xinxing Zheng Primary Contact Person) Ms.Lin Zhang(Alternative Contact Person)
5
3. Proposed Device
Trade Name: Stone Extraction Balloon (VDK-BAL-23-11/13/15-B, VDK-BAL-23-9/12/15-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,YDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-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)
Common Name: Stone Extraction Balloon
Regulatory Information Regulation Name: Biliary Catheter and Accessories Classification:Class II; Product Code: GCA Regulation Number: 21 CFR 876.5010 Review Panel: Gastroenterology/Urology
Indication for 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.
-
Predicate Device 4.
510(k) Number: K210660 Trade Name: Stone Retrieval Balloon Catheter Common Name: Stone Retrieval Balloon Catheter -
- Performance Data and Non-Clinical Test Conclusion
Performance testing consisting of Size, Appearance, Maneuverability, Strength, Airtightnes, Ruhr cone, Sterility and EO Residual amount. Non-clinical bench testing demonstrate that the Stone Extraction Balloon meets the performance criteria required to fulfill the intended use of the device. The following summarizes the Non-clinical bench testing conducted:
- Performance Data and Non-Clinical Test Conclusion
-
Stone capture testing A
-
A Tensile strength test
-
Operational performance test
-
A Dimension Test
-
Luer Connector Test
-
Flexibility testing
6
-
X-Ray Development test
-
Rated Burst Pressure test
-
Flowrate test
The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
- Clinical Test Conclusion 6.
No clinical study is included in this submission.
7
- Substantially Equivalent (SE) Comparison 7.
Our proposed device Stone Extraction Balloon is substantially equivalent to the predicate devices. The differences between the Stone Extraction Balloon and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below:
| Device
| Characteristic | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Product | Stone Extraction Balloon | Stone Retrieval Balloon | |
| Catheter | / | ||
| Product Code | GCA | GCA | / |
| Regulation | |||
| Number | 21 CFR §876.5010 | 21 CFR §876.5010 | / |
| Class | Class II | Class II | / |
| Indication for Use | The device is intended for | ||
| endoscopic removal of | |||
| biliary stones. The device is | |||
| supplied sterile and intended | |||
| for single use only | The device is intended for | ||
| endoscopic removal of | |||
| biliary stones. The device | |||
| is supplied sterile and | |||
| intended for single use only | Same | ||
| Environment of | |||
| use | Hospital | Hospital | Same |
| Intended users | The device must be used by | ||
| trained doctors or | |||
| technicians. | The device must be used | ||
| by trained doctors or | |||
| technicians. | Same | ||
| Single Use | Single Use | Single Use | Same |
| Label/Labeling | Complied with 21 CFR part | ||
| 801 | Complied with 21 CFR | ||
| part 801 | Same | ||
| Balloon Diameter | 8.5mm/11.5mm/15mm、 | ||
| 9mm/12mm/15mm、 | |||
| 10mm/13mm/16mm、 | |||
| 11mm/13mm/15mm、 | |||
| 12mm/15mm/18mm、 | |||
| 15mm/18mm/20mm | 8.5/12/15/18/8.5-12-15/12- | ||
| 15-18 | Different | ||
| Catheter Length | 2000mm | 2000mm | Same |
| Catheter diameter | 2.3mm | 2.3mm | Same |
| Lumens | |||
| corresponds | a balloon inflation port, a | ||
| wire guide port and an | |||
| injection port | a balloon inflation port, a | ||
| wire guide port and an | |||
| injection port | Same | ||
| Guidewire | |||
| Compatibility(in) | 0.035/0.025 | 0.035/0.025 | Same |
| Patient contact | |||
| material | Balloon:Natural latex | ||
| Radiopaque band:Ta | |||
| Three internal lumens: | |||
| Pebax; | |||
| Binder:UV-curing | |||
| adhensive; | Three internal lumens: | ||
| Pebax; | |||
| Radiopaque band: Ta; | |||
| Bind wire: PET; | |||
| Balloon: Natural latex; | |||
| Binder: UV-curing | |||
| adhensive; | |||
| Marker: TPU ink. | Different | ||
| Bocompatibility | In Vitro Cytotoxicity Test : | ||
| ISO 10993-5: 2009; | |||
| Skin sensitization Test :ISO | |||
| 10993-10: 2010; | |||
| Intracutaneous Reactivity | |||
| Test: ISO 10993-10: 2010. | In Vitro Cytotoxicity Test : | ||
| ISO 10993-5: 2009; | |||
| Skin sensitization Test :ISO | |||
| 10993-10: 2010; | |||
| Intracutaneous Reactivity | |||
| Test: ISO 10993-10: 2010. | Same | ||
| Sterilization | |||
| Method | EO Sterilized | EO Sterilized | Same |
8
Different - Balloon Diameter
The working length for proposed device is different from the predicate device K210660. The different length will be selected by physician per patient's condition and this difference does not affect intended use. For the 20mm balloon, we provide the following support evidence to demonstrate that it will not raise different questions regarding its safety and effectiveness. First, we searched in the FDA 510k Premarket Notification database for other similar retrieval balloon catheter, and we found Olympus's 3-Lumen Extraction Balloon (K091495), maximum diameter of the balloon(mm) is 20mm, it is shown in the 510(k) summary: Second, there is a literature that retrieval balloon catheter is used to remove stones in the bile duct which the mean common bile duct (CBD) dilation was 19.2mm=3.9 and the mean size of stones 15.8±2.9.At least, the performance tests were conducted on proposed device, and the test result does not show any significant difference. Therefore, this difference will not affectiveness of the proposed device.
Different-Material
The patient contact material for the proposed device is different from the predicate device. However, biocompatibility test has been conducted on the proposed device and the test result does not show any adverse effect. Therefore, this difference will not raise any safety issues.
9
510(k) Summary
Substantially Equivalent (SE) Conclusion 8.
Based on the comparison and analysis above, the proposed device, Stone Extraction Balloon, is determined to be Substantially Equivalent (SE) to the predicate device K210660.