Stone Retrieval Balloon
Device Facts
| Record ID | K200173 |
|---|---|
| Device Name | Stone Retrieval Balloon |
| Applicant | Hangzhou AGS MedTech Co., Ltd. |
| Product Code | GCA · Gastroenterology, Urology |
| Decision Date | May 1, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5010 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
Device Story
Stone Retrieval Balloon is a sterile, single-use endoscopic device for biliary stone removal. It consists of a latex balloon mounted on a 2000mm Pebax catheter with three internal lumens (balloon inflation, wire guide, injection). Radiopaque bands at the balloon ends allow fluoroscopic visualization. The device is operated by a physician during endoscopic procedures. The clinician inserts the catheter, inflates the balloon to a specific diameter (8.5mm to 18mm depending on model) via a proximal stopcock, and uses the inflated balloon to retrieve stones from the bile duct. Rapid exchange models feature a side hole for guide wire insertion. The device facilitates stone extraction, potentially reducing the need for more invasive surgical interventions.
Clinical Evidence
No clinical data included. Substantial equivalence is supported by bench performance testing, including balloon diameter, deflation, and strength testing, alongside biocompatibility (ISO 10993-5, ISO 10993-10) and sterility (ISO 11135) validation.
Technological Characteristics
Catheter: Pebax; Balloon: Natural latex; Radiopaque band: Tantalum; Bind wire: PET; Adhesive: UV-curing; Marker: Polyurethane ink. Dimensions: 2000mm length, 2.4mm OD. Balloon diameters: 8.5mm to 18mm. Three-lumen design (inflation, wire guide, injection). Sterilization: EO. Connectivity: None.
Indications for Use
Indicated for endoscopic removal of biliary stones in patients requiring biliary stone extraction.
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
- Tri-Ex Extraction Balloon With Multiple Sizing (K170292)
Reference Devices
- Single Use 3-Lumen Extraction Balloon V (K091495)
Submission Summary (Full Text)
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May 1, 2020
Hangzhou AGS MedTech Co., Ltd. Chunqi Han R&D Director Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, 311106 CHINA
K200173 Re: Trade/Device Name: Stone Retrieval Balloon Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: GCA Dated: January 21, 2020 Received: January 23, 2020
Dear Chunqi Han:
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
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(21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for 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 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,
Daniel G. Walter, Jr. 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
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# Indications for Use
510(k) Number (if known) K200173
Device Name Stone Retrieval Balloon
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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## 510(k) Summary
We submit this 510(k) Summary as per 21 CFR 807.92, it meets the content and format regulatory requirements.
## 5.1 Submitter
| Submitted by/Owner: | Hangzhou AGS MedTech Co., Ltd.<br>Building 5, Building 6, NO.597 Kangxin Road Yuhang<br>District, Hangzhou, Zhejiang 311106 China |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration Number: | 3010288205 |
| Registration Status: | Active |
| Contact Person: | Yanping Fu<br>Phone: 0086-15958493282<br>Fax: 0086-0571-87671225<br>Email: fuyp@bioags.com |
| Date Prepared: | July 18, 2019 |
## 5.2 Proposed Device
| Trade Name: | / |
|-------------------------|-------------------------------------------------------------------------------------------------|
| Device Name: | Stone Retrieval Balloon |
| Common Name: | Stone Retrieval Balloon |
| Regulation class: | Class II |
| Regulation Number: | 876.5010 |
| Regulation Description: | Biliary Catheter and Accessoriess |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | GCA |
| Product Code Name: | Biliary Catheter For Stone Removal That May Also<br>Allow For Irrigation And Contrast Injection |
# 5.3 Predicate Device
| Trade Name: | Tri-Ex Extraction Balloon With Multiple Sizing |
|-------------------------|-------------------------------------------------------------------------------------------------|
| Device Name: | Tri-Ex Extraction Balloon With Multiple Sizing |
| Common Name: | Extraction Balloon With Multiple Sizing |
| 510(k) Number: | K170292 |
| Regulation class: | Class II |
| Regulation Number: | 876.5010 |
| Regulation Description: | Biliary Catheter and Accessoriess |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | GCA |
| Product Code Name: | Biliary Catheter For Stone Removal That May Also Allow<br>For Irrigation And Contrast Injection |
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| Trade Name: | Single Use 3-Lumen Extraction Balloon V |
|-------------------------|---------------------------------------------------------------------------------|
| Device Name: | Single Use 3-Lumen Extraction Balloon V |
| Common Name: | 3-Lumen Extraction Balloon |
| 510(k) Number: | K091495 |
| Regulation class: | Class II |
| Regulation Number: | 876.5010 |
| Regulation Description: | Biliary Catheter and Accessoriess |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | FGE/LQR |
| Product Code Name: | Stents, Drains And Dilators For The Biliary Ducts/<br>Dislodger, Stone, Biliary |
### 5.4 Device Description
The subject Stone Retrieval Balloon is comprised of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens. For some models, the balloon can be inflated to 8.5mm, 12mm, 15mm and 18mm only. But for some models, the balloon can be inflated to three sizes, 8.5 mm, 12 mm and 15 mm diameters, or 13mm, 15mm and 18mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 2000mm with a outer diameter of 2.4mm. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly. EO Sterilization and use for single use only.
#### 5.5 Indication for use statement
The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
#### 5.6 Comparison of Technology Characteristics
Our proposed device Stone Retrieval Balloon is substantially equivalent to the predicate devices. The differences between the Stone Retrieval Balloon and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below
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| Difference Item | | Proposed device | Predicate device | Comparison |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name | | Stone Retrieval Balloon | Tri-Ex Extraction Balloon with<br>Multiple Sizing | / |
| Trade name | | / | Tri-Ex Extraction Balloon with<br>Multiple Sizing | / |
| Model number | | 5051 series, 5053 series, 5451series, 5453 series | TXR-8.5-12-15-A | / |
| 510(k) submitter | | Hangzhou AGS MedTech Co., Ltd. | Wilson-Cook Medical, Inc. | / |
| 510(k) number | | / | K170292 | / |
| Technical | Balloon<br>Max outer<br>diameter | 8.5/12/15/18/8.5-12-15/13-15-18mm | 8.5 mm, 12 mm and 15mm | Different.<br>Our balloon outer diameter includes a range from 8.5mm to<br>18mm, the predicate device includes a range from 8.5mm to<br>15mm. For the 18mm balloon, we provide the following<br>support evidence to demonstrate that it will not raise different<br>questions regarding its safety and effectiveness.<br>First, we searched in the FDA 510k Premarket Notification<br>database for other similar retrieval<br>balloon catheter, and we found Olympus's 3-Lumen<br>Extraction Balloon (K091495), maximum diameter of the<br>balloon(mm) is 20mm, it is shown in the 510(k) summary:<br>Second, there is a literature that retrieval balloon catheter is<br>used to remove stones in the bile duct which the mean<br>common bile duct (CBD) dilation was 19.2mm±3.9 and the<br>mean size of stones 15.8±2.9. |
| Difference Item | Proposed device | Predicate device | Comparison | |
| Recommended<br>Wire<br>Guide<br>Diameter<br>inch | 0.035 /0.025ich | 0.035ich | Different. Our proposed device has another option for wire<br>guide, the difference don't raise question about safety and<br>effectiveness. | |
| Performance | Balloon Diamater, Balloon Deflation, Balloon<br>Strength, etc. | Balloon Diameter, Balloon Deflation,<br>Balloon Strength, etc. | Different.<br>We conduct bench performance for our proposed device and<br>the predicate device, please refer to Section 18 of this<br>submission, the test results show that our proposed device is<br>substantial equivalence with the predicate device. | |
| Biological | Materials<br>or<br>substances<br>in contact<br>with the<br>same<br>human<br>tissue or<br>body<br>fluids | Sheath: Pebax;<br>Radiopaque band: Tal;<br>Bind wire: PET;<br>Latex balloon: Natural latex;<br>Binder: UV-curing adhesive;<br>Marker: Polyurethane ink. | Catheter: nylon;<br>Balloon: Latex. | Different.<br>Biocompatibility tests have been done for the difference.<br>Biological risks are acceptable. |
| | Biocompatibility | In Vitro Cytotoxicity Test : ISO 10993-5: 2009;<br>Skin sensitization Test : ISO 10993-10: 2010;<br>Intracutaneous Reactivity Test: ISO 10993-10: 2010; | Unknown | |
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5.7 Applicable Guidance Document NA
#### 5.8 Performance Data
The Stone Retrieval Balloon meets all design specifications and medical for biocompatibility (ISO 1099) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
### 5.9 Clinical Test
No Clinical test is included in this submission.
#### 5.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou AGS Medtech Co., Ltd has demonstrated that proposed device Electrosurgical System is substantially equivalent to the predicate devices.
