(202 days)
Not Found
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 indicated for endoscopically dilating strictures of the alimentary tract, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is a treatment device, specifically a balloon dilation catheter used to dilate strictures. It does not perform any diagnostic function like detecting, analyzing, or identifying a medical condition.
No
The device description clearly details a physical medical device (a balloon dilation catheter) with mechanical components and features, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "endoscopically dilate strictures of the alimentary tract." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical device (a balloon catheter) used for mechanical dilation. It does not describe any components or processes for analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples in vitro (outside the body).
- Providing diagnostic information about a patient's health status.
- Reagents, calibrators, or controls typically associated with IVD tests.
In summary, this device is a therapeutic medical device used for a physical intervention, not a diagnostic device used for analyzing samples to provide information about a patient's condition.
N/A
Intended Use / Indications for Use
It is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract.
Product codes (comma separated list FDA assigned to the subject device)
FGE, KNQ
Device Description
The 3-Stage Balloon Dilation Catheter can provide 3 different sizes and gradually increasing diameters through controlled radial expansion. The specific balloon size is printed on the label of each package and catheter. The 3-Stage Balloon Dilation Catheter is designed to pass through the working channel of the endoscope, and its guidewire cavity can accommodate a 0.035inches (0.89mm diameter) guidewire. In the package, a 0.035inches (0.89mm diameter) guidewire is pre-installed in the guidewire cavity. There is a guidewire locking device connected to the guide wire hole of the catheter. The locking device will be in the "OFF" (closed) position when it leaves the factory. Only when the switch of the locking device is in the "ON" position can it be pushed or moved forward. The guide wire is removed from the catheter. After turning the switch to the "OFF" position, the guide wire will be fixed in the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract
Indicated Patient Age Range
adult and adolescent populations
Intended User / Care Setting
Intended users: The device must be used by trained doctors or technicians.
Environment of use: 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 Non-clinical bench testing demonstrate that the 3-Stage Balloon Dilation Catheter meets the performance criteria required to fulfill the intended use of the device. The following summarizes the Non-clinical bench testing conducted:
- Rated burst pressure test
- Balloon tightness test
- Connection firmness test
- Maneuverability test
- X-ray development performance test
- Sterility test
- Residual amount of ethylene oxide Test
- Balloon fatigue Test
- Burst Test of Guidewire
- Bend Test of Guidewire
- Connection Strength Test of Guidewire
- Corrosion resistance Test of Guidewire
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
February 15, 2024
Jiangsu Vedkang Medical Science and Technology Co., Ltd. Zhang Lin Regulatory Affairs No.52, Guoxiang Road, Wujin Economic Development Zone Changzhou, Jiangsu 213149 China
Re: K232245
Trade/Device Name: VedDilator™ Common Name: 3-Stage Balloon Dilation Catheter Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter And Accessories Regulatory Class: Class II Product Code: FGE, KNO Dated: January 15, 2024 Received: January 16, 2024
Dear Zhang Lin:
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 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"
1
(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 OS 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.
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,
Anthony Lee -S
Anthony Lee, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices
2
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
510(k) Number (if known) K232245
Device Name VedDilator
Indications for Use (Describe)
It is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract.
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: K232245
- Date of Preparation: 01/15/2024 1.
-
- Sponsor Identification
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: Zhang Lin
Position: RA
Tel: +86-519-69877791-8147
Email:lin.zhang@yedkang.com
Ms. Zhang Lin (Primary Contact Person)
Ms. Chen Jie(Alternative Contact Person)
-
- Proposed Device
Trade Name: VedDilator TM Common Name: 3-Stage Balloon Dilation Catheter Regulatory Information Regulation Name: Biliary Catheter and Accessories Classification:Class II; Product Code: FGE, KNQ Regulation Number: 21 CFR 876.5010 Review Panel: Gastroenterology/Urology
- Proposed Device
Predicate Device 4.
510(k) Number: K112994 Trade Name: CRE Dilatation Balloon Common Name: CRE Wireguided Dilatation Balloon
5
న. Indication for use:
It is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract.
Device Description
The 3-Stage Balloon Dilation Catheter can provide 3 different sizes and gradually increasing diameters through controlled radial expansion. The specific balloon size is printed on the label of each package and catheter. The 3-Stage Balloon Dilation Catheter is designed to pass through the working channel of the endoscope, and its guidewire cavity can accommodate a 0.035inches (0.89mm diameter) guidewire. In the package, a 0.035inches (0.89mm diameter) guidewire is pre-installed in the guidewire cavity. There is a guidewire locking device connected to the guide wire hole of the catheter. The locking device will be in the "OFF" (closed) position when it leaves the factory. Only when the switch of the locking device is in the "ON" position can it be pushed or moved forward. The guide wire is removed from the catheter. After turning the switch to the "OFF" position, the guide wire will be fixed in the catheter.
6. Performance Data and Non-Clinical Test Conclusion
Performance testing consisting of sterilization, shelf life, biocompatibility, and Non-clinical bench testing demonstrate that the 3-Stage Balloon Dilation Catheter meets the performance criteria required to fulfill the intended use of the device. The following summarizes the Non-clinical bench testing conducted:
-
Rated burst pressure test
-
Balloon tightness test
- A Connection firmness test
-
Maneuverability test
-
X-ray development performance test
-
Sterility test
-
Residual amount of ethylene oxide Test
-
Balloon fatigue Test
-
Burst Test of Guidewire
-
Bend Test of Guidewire
-
Connection Strength Test of Guidewire
- A Corrosion resistance Test of Guidewire
The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
7. Clinical Test Conclusion
No clinical study is included in this submission.
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8. Substantially Equivalent (SE) Comparison
Our proposed device 3-Stage Balloon Dilation Catheter is substantially equivalent to the predicate devices. The differences between the 3-Stage Balloon Dilation Catheter 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 | Remark |
|---|---|---|---|
| K112994 | |||
| Common name | 3-Stage Balloon Dilation Catheter | CRE Wireguided Dilatation Balloon | / |
| Trade Name | VedDilator ™ | CRE Dilatation Balloon | / |
| Product Code | FGE,KNQ | 1) KOG, 2) KNQ, 3) FGE | Same |
| Regulation | |||
| Number | 21 CFR 876.5010,21 CFR | ||
| 876.5365 | 1) 876.5010, 2) 876.5365, 3) 876.5010 | Same | |
| Class | Class II | Class II | Same |
| Indication for | |||
| Use | It is indicated for use in adult and | ||
| adolescent populations to | |||
| endoscopically dilate or auxiliary | |||
| dilate strictures of the alimentary | |||
| tract. | The CRE™ Wireguided Balloon | ||
| Dilatation Catheter is indicated for use | |||
| in adult and adolescent populations to | |||
| endoscopically dilate strictures of the | |||
| alimentary tract. It is also indicated in | |||
| adults for endoscopic dilatation of the | |||
| Sphincter of Oddi with or without prior | |||
| sphincterotomy. | Same | ||
| Configuration | balloon, radiopaque bands, | ||
| catheter and three-way handle | balloon, radiopaque bands, catheter | ||
| and three-way handle | 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 |
| Specifications | |||
| guidewire | |||
| lumen | 0.035 in (0.89 mm) | 0.035 in (0.89 mm) | Same |
| Minimum | |||
| working | |||
| channel | Endoscope:some models is 2.0 | ||
| mm, some are 2.8 mm, and some | |||
| are 3.2 mm | Endoscope:2.8mm | ||
| Duodenoscope and Endoscope:3.2 or | |||
| 4.2 mm | Different | ||
| Diameter of | |||
| balloon (mm) | 4/5/6、6/7/8、8/9/10、10/11/12、 | ||
| 12/13.5/15、15/16.5/18、18/19/20 | 6/7/8、8/9/10、10/11/12、12/13.5/15、 | ||
| 15/16.5/18、18/19/20 | Different | ||
| Working | |||
| Length (mm) | 900、1200、1800、2000、2300 | 1800、2400 | Different |
| Performance | Rated burst pressure test, Balloon | Unknown | Different |
| test,Maneuverability | |||
| test,X-ray | |||
| development performance | |||
| test,Sterility test,Residual amount | |||
| of ethylene oxide Test,Balloon | |||
| fatigue Test,Burst Test of | |||
| Guidewire,Bend Test of | |||
| Guidewire, Connection Strength | |||
| Test of Guidewire and Corrosion | |||
| resistance Test of Guidewire;etc | |||
| Biocompatibility | |||
| Patient contact | |||
| material | Guide head (PA) | ||
| Balloon (Pebax) | |||
| Catheter (PA) | |||
| Guidewire (SUS304,PTFE) | Guide head (Pebax) | ||
| Balloon (Pebax) | |||
| Catheter (Pebax) | |||
| Guidewire (stainless steel) | Different | ||
| Cytotoxicity | No cytotoxicity | Unknown | |
| Irritation | No intracutaneous reactivity | ||
| Sensitization | No skin sensitization | ||
| Acute Systemic | |||
| Toxicity | No acute toxicity | Different | |
| Material | |||
| mediated | |||
| pyrogenicity | No pyrogens | ||
| Sterilization | |||
| Method | EO Sterilized | EO Sterilized | Same |
7
Different - Minimum working channel
The minimum working channel for proposed device is different from the predicate device K112994. The proposed 2.8mm working channel is same as the prodicate device, while the proposed 2.0mm working channel is not overed by the predicate device. The reason for this difference is that the device balloon diameter for the proposed device and predicate device are not same. The different size will be selected by physician per patient's condition and this difference does not affect intended use. Therefore, this difference will not affectiveness of the proposed device.
Different – Diameter of balloon
Compared with predicate devices, the balloon diameter of proposed device has a 45/6 specification, which is suitable for some very narrow parts and is more suitable for clinical needs. The difference does not raise different questions regarding its safety and effectiveness.
Different - Working Length
The working length for proposed device is different from the predicate device K112994. The proposed 1800mm specification is also included by the predicate device. While the proposed 900mm and 1200mm specifications are
8
shorter than the predicate device 1800 specifications,2000mm specification are shorter than the predicate device 2400 specifications. The different length will be selected by physician per patient's condition and this difference does not affect intended use. In addition, the performance tests were conducted on proposed device and predicate device, and the test result does not significant difference. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different - Performance
We conduct bench performance for our proposed device and the predicate device, please refer to Section 24 of this submission, the test results show that our proposed device is substantial equivalence with the predicate device.
Different-Biocompatibility
The patient contact material for the proposed device is different from the predicate device.The material of the Guide head and catheter that is proposed device to contact the human body is PA, and the material of the Guide head and catheter that is predicate device to contact the human body is - Pebax, Actually PA and Pebax are both nylon. 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. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device, 3-Stage Balloon Dilation Catheter, is determined to be Substantially Equivalent (SE) to the predicate device K112994.